Text · Amendment list
On the proposal for a regulation of the European Parliament and of the Council Amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements
Full title
On the proposal for a regulation of the European Parliament and of the Council Amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements
Document CJ14-AM-790946 · COM(2025)1030 – C100359/2025 – 2025/0410(COD)
- Kind
- Amendment list CJ14-AM-790946
- Date
- 28 July 2026
- Committee
- Committee on the Environment, Climate and Food Safety Committee on Agriculture and Rural Development
- Dossier
- 2025-0410
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- COM(2025)1030 – C100359/2025 – 2025/0410(COD)
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| Proposal for a rejection | |
| – The European Parliament rejects the Commission proposal. |
The proposal introduces substantial amendments to Union food and feed legislation without being accompanied by a comprehensive impact assessment, despite the far-reaching nature of the proposed changes. It was presented without meaningful public consultation and without sufficient evidence demonstrating that the proposed measures would achieve their stated objective of simplifying procedures or reducing administrative burdens. The Commission has also failed to adequately assess alternative measures that could address regulatory delays, including targeted improvements to existing procedures, additional resources for the European Food Safety Authority, and other administrative reforms that would preserve the current level of protection. The proposal has been subject to extensive criticism from the scientific community, with numerous scientific publications, open letters and expert analyses questioning both its evidence base and its likely effectiveness. In light of these significant procedural shortcomings, the colegislators are unable to properly assess the likely consequences of the proposal or whether it complies with the principles of better law-making and the precautionary principle.
| Draft legislative resolution | Amendment |
| – The European Parliament rejects the Commission's proposal. |
| Text proposed by the Commission | Amendment |
|---|---|
| Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2), Article 114, Article 168(4)(b) and Article 192(1) thereof, | Having regard to the Treaty on the Functioning of the European Union, and in particular Article 43(2), Article 114, Article 168(4)(b), 191 and Article 192(1) thereof, |
| Text proposed by the Commission | Amendment |
|---|---|
| (-1) The European Commission set out in its European Green Deal how to make Europe the first climate-neutral continent by 2050. The Farm to Fork Strategy is at the heart of the Green Deal. It addresses comprehensively the challenges of sustainable food systems and recognises the inextricable links between healthy people, healthy societies and a healthy planet. The strategy is also central to the Commission’s agenda to achieve the United Nations’ Sustainable Development Goals (SDGs). All citizens and operators across value chains, in the EU and elsewhere, should benefit from a just transition. A shift to a sustainable food system can bring environmental, health and social benefits, offer economic gains and ensure that the recovery from the crisis puts us onto a sustainable path. |
| Text proposed by the Commission | Amendment |
|---|---|
| (-1a) The European Parliament, in its resolution on the Farm to Fork Strategy, emphasised that Europe’s food system should deliver high quality food and nutrition security in a way that contributes to social well-being and public health, maintains and restores ecosystem health, respects the planetary boundaries and ensures animal health and welfare, and pointed out that currently, the whole food system is responsible for a range of impacts on human and animal health and welfare and on the environment, the climate and biodiversity, including deforestation and ecosystem degradation outside the EU; |
| Text proposed by the Commission | Amendment |
|---|---|
| (-1b) Impact assessments are an integral part of the EU rulemaking process. The Commission has announced that it intends to perform detailed impact assessments, including public consultations, in line with the Better Regulation guidelines for any legislative initiative under the farm to fork strategy, including those regarding effective quantitative targets 1a. Ex-ante scientific impact assessments should include robust environmental assessments, should cover the three dimensions of sustainability (environmental, economic and social, including health) in a holistic and systemic approach and consider cumulative effects, and should include the cost of non-action in terms of immediate and long-term impact on human health, environment, biodiversity, and general sustainability, as well as taking into account generational renewal, possible trade-offs between policy goals, the availability of means to achieve the targets and the different farming models across the EU Member States. It is important to describe the methods of calculation, baselines and reference periods of each individual target and to consult and collaborate with Member States. | |
| 1a Answers by Ms Kyriakides to written question E-000689/2021 |
| Text proposed by the Commission | Amendment |
|---|---|
| (-1c) Imprudent use of pesticides is a significant source of soil, water and air pollution and negatively affects human, animal and plant health. It is therefore necessary to intensify efforts to significantly reduce the dependence on, risk from and use of harmful pesticides, and the use of fertilisers and antibiotics. Sustainable farming practices, such as the sound implementation of IPM, agroforestry, agroecology and organic farming and precision farming techniques, can help to provide solutions to reduce pesticide use at EU level and globally, and should be encouraged. Scientific research indicates that pesticide use can be reduced substantially without affecting profitability and productivity negatively, especially when accompanied by increased availability of sustainable alternatives; |
| Text proposed by the Commission | Amendment |
|---|---|
| (1) In its Communication A Vision for Agriculture and Food1 , the European Commission announced a cross-cutting simplification package aimed at reducing unnecessary regulatory burdens while maintaining high standards for food and feed safety, human and animal health, and environmental protection. | (1) In its Communication A Vision for Agriculture and Food1 , the European Commission announced a cross-cutting simplification package aimed at reducing unnecessary regulatory burdens while maintaining high standards for food and feed safety, human and animal health, and environmental protection as well as carefully considering any further ban of plant protection products if alternatives are not yet available and that agriculture relies upon for its viability. |
| 1 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Vision for Agriculture and Food Shaping together an attractive farming and agri-food sector for future generations, COM/2025/75, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC0075 | 1 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Vision for Agriculture and Food Shaping together an attractive farming and agri-food sector for future generations, COM/2025/75, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC0075 |
This extension of the reference to the Communication underlines the link between the availability of plant protection products and the viability of agriculture.
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Viktória Ferenc, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (1) In its Communication A Vision for Agriculture and Food1, the European Commission announced a cross-cutting simplification package aimed at reducing unnecessary regulatory burdens while maintaining high standards for food and feed safety, human and animal health, and environmental protection. | (1) In its Communication A Vision for Agriculture and Food1, the European Commission announced a cross-cutting simplification package aimed at reducing unnecessary regulatory burdens to strengthen the Union’s food production and food sovereignty while maintaining high standards for food and feed safety, human and animal health, and environmental protection. |
| 1 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Vision for Agriculture and Food Shaping together an attractive farming and agri-food sector for future generations, COM/2025/75, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC0075 | 1 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Vision for Agriculture and Food Shaping together an attractive farming and agri-food sector for future generations, COM/2025/75, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC0075 |
| Text proposed by the Commission | Amendment |
|---|---|
| (1) In its Communication A Vision for Agriculture and Food1 , the European Commission announced a cross-cutting simplification package aimed at reducing unnecessary regulatory burdens while maintaining high standards for food and feed safety, human and animal health, and environmental protection. | (1) In its Communication A Vision for Agriculture and Food1 , the European Commission announced a cross-cutting simplification package aimed at reducing unnecessary regulatory burdens while maintaining, and where necessary strengthening, high standards for food and feed safety, human and animal health, animal welfare, biodiversity, climate action and environmental protection. |
| 1 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Vision for Agriculture and Food Shaping together an attractive farming and agri-food sector for future generations, COM/2025/75, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC0075 | 1 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Vision for Agriculture and Food Shaping together an attractive farming and agri-food sector for future generations, COM/2025/75, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC0075 |
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Pascal Canfin, Olivier Chastel, Andreas Glück, Charles Goerens, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (1) In its Communication A Vision for Agriculture and Food1 , the European Commission announced a cross-cutting simplification package aimed at reducing unnecessary regulatory burdens while maintaining high standards for food and feed safety, human and animal health, and environmental protection. | (1) In its Communication A Vision for Agriculture and Food1 , the European Commission announced a cross-cutting simplification package aimed at reducing unnecessary regulatory burdens while maintaining high standards for food and feed safety, food security, human and animal health, and environmental protection. |
| 1 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Vision for Agriculture and Food Shaping together an attractive farming and agri-food sector for future generations, COM/2025/75, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC0075 | 1 Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, A Vision for Agriculture and Food Shaping together an attractive farming and agri-food sector for future generations, COM/2025/75, https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52025DC0075 |
Gerben-Jan Gerbrandy, Martin Hojsík, Pascal Canfin, Sigrid Friis, Stine Bosse, Michal Wiezik, Yvan Verougstraete
| Text proposed by the Commission | Amendment |
|---|---|
| (1a) Under the Farm to Fork Strategy, the Union set out two non-legally binding targets for the reduction of pesticide use and risk by 2030, namely a 50% reduction in the overall use and risk of chemical pesticides and a 50% reduction in the use of more hazardous pesticides, in pursuit of the objectives set out in the European Green Deal. The workload of the European Food Safety Authority has, however, become a significant bottleneck in the approval of plant protection products containing biocontrol active substances, thereby delaying the market uptake of such products. It is therefore necessary to provide the Authority with increased resources and to improve the efficiency of its procedures, in order to accelerate the assessment and approval of biocontrol active substances, contribute to the achievement of the Farm to Fork targets and the objectives of the Green Deal, and ensure that farmers have access to a broad and diverse toolbox of plant protection solutions, while maintaining the highest level of protection of human health and the environment. |
Anja Hazekamp, Per Clausen, Valentina Palmisano, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
| Text proposed by the Commission | Amendment |
|---|---|
| (2) Ten legal acts in the area of food and feed safety are amended by this Food and Feed Simplification Regulation in order to address certain requirements and procedures which are particularly burdensome for the industry and the competent authorities of the Member States. The targeted amendments aim at rendering the food and feed legislation more efficient and cost-effective for the industry, reduce burdens on the industry and authorities, while at the same time ensuring a high level of protection of human and animal health and of the environment. | deleted |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Viktória Ferenc, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (2) Ten legal acts in the area of food and feed safety are amended by this Food and Feed Simplification Regulation in order to address certain requirements and procedures which are particularly burdensome for the industry and the competent authorities of the Member States. The targeted amendments aim at rendering the food and feed legislation more efficient and cost-effective for the industry, reduce burdens on the industry and authorities, while at the same time ensuring a high level of protection of human and animal health and of the environment. | (2) Ten legal acts in the area of food and feed safety are amended by this Food and Feed Simplification Regulation in order to address certain requirements and procedures which are particularly burdensome for the industry and the competent authorities of the Member States, which have resulted in greater food dependence and a loss of productivity and income for farmers, within the broader context of strong international competition caused by extensive liberalisation of the markets. The targeted amendments aim at rendering the food and feed legislation more efficient and cost-effective for the industry, reduce burdens on the industry and authorities, with the ultimate aim of reviving food production, while at the same time ensuring a high level of protection of human and animal health and of the environment. |
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Pascal Canfin, Olivier Chastel, Andreas Glück, Charles Goerens, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (2) Ten legal acts in the area of food and feed safety are amended by this Food and Feed Simplification Regulation in order to address certain requirements and procedures which are particularly burdensome for the industry and the competent authorities of the Member States. The targeted amendments aim at rendering the food and feed legislation more efficient and cost-effective for the industry, reduce burdens on the industry and authorities, while at the same time ensuring a high level of protection of human and animal health and of the environment. | (2) Ten legal acts in the area of food and feed safety are amended by this Food and Feed Simplification Regulation in order to address certain requirements and procedures which are particularly burdensome for the industry and the competent authorities of the Member States. The targeted amendments aim at rendering the food and feed legislation more efficient and cost-effective for the industry, reduce burdens on the industry and authorities, while at the same time ensuring food security, a high level of protection of human and animal health and of the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| (2) Ten legal acts in the area of food and feed safety are amended by this Food and Feed Simplification Regulation in order to address certain requirements and procedures which are particularly burdensome for the industry and the competent authorities of the Member States. The targeted amendments aim at rendering the food and feed legislation more efficient and cost-effective for the industry, reduce burdens on the industry and authorities, while at the same time ensuring a high level of protection of human and animal health and of the environment. | (2) Ten legal acts in the area of food and feed safety are amended by this Food and Feed Simplification Regulation in order to address certain requirements and procedures that have led to delays in regulatory assessments, creating unnecessary administrative burden for competent authorities and applicants. The targeted amendments aim to improve the efficiency, coherence and implementation of Union legislation, while maintaining a high level of protection of human and animal health, animal welfare, biodiversity and of the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) Consumer protection is both a primary objective of Union food law, as established by Regulation (EC) No 178/2002, and a Treaty objective and fundamental rights commitment of the Union under Article 169 of the Treaty on the Functioning of the European Union and Article 38 of the Charter of Fundamental Rights. Union environmental policy, as established under Article 191 of the Treaty on the Functioning of the European Union, shall pursue a high level of protection and be based, inter alia, on the precautionary principle. In accordance with Article 7 of Regulation (EC) No 178/2002, where the possibility of harmful effects on human health has been identified but scientific uncertainty persists, provisional risk management measures may be adopted to ensure a high level of health protection. This simplification package shall not be interpreted or applied in a manner that lowers the level of consumer, human health or environmental protection law. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Viktória Ferenc, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (2a) whereas the uncontrolled liberalisation of trade has encouraged the introduction and spread of pests, diseases and invasive alien species, resulting in the need for stronger crop protection, while the resources allocated to phytosanitary surveillance, controls on imported products and early-detection mechanisms are still inadequate for choosing a preventative approach rather than a remedial one; accordingly calls for a re-opening of Regulation (EU) 1143/2014 in order to reinforce the prevention and management of the introduction and spread of invasive alien species. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Viktória Ferenc, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (2b) whereas the continuous reduction in the number of phytosanitary solutions deprives farmers of a varied toolkit, which is essential for protecting crops in a targeted way, and this makes them resort to the same substances more frequently, resulting in a greater risk of resistance, an increase in costs, and less efficient use of plant protection products. A diversified toolkit of both conventional and biocontrol products promotes integrated crop protection by allowing the most appropriate solution to be chosen for each agronomical situation, thus limiting the use of unhelpful treatments, the number of doses applied and the development of resistance. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Viktória Ferenc, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (2c) whereas the systematic renewal of approval for active substances, the profiles of which have already been documented widely, uses considerable administrative and scientific resources, at the expense of assessing new conventional and biocontrol substances, thus slowing down farmers’ access to more modern solutions that perform better and are better adapted to current environmental challenges; |
| Text proposed by the Commission | Amendment |
|---|---|
| (3a) The simplification measures introduced by this Regulation concerning Regulation (EC) No 1107/2009 should not lower the level of protection of human health, animal health or the environment. They should be implemented in accordance with the precautionary principle. |
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Pascal Canfin, Olivier Chastel, Andreas Glück, Charles Goerens, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (4) In order to decrease farmers’ dependency on plant protection products containing chemical active substances and in line with the announcements in the Communication A Vision for Agriculture and Food, the accessibility and availability of sustainable plant protection products, including plant protection products containing biocontrol substances, needs to increase. | (4) In order to decrease farmers’ dependency on plant protection products containing chemical active substances and in line with the announcements in the Communication A Vision for Agriculture and Food, the accessibility and availability of sustainable plant protection products, including plant protection products containing biocontrol substances, needs to increase. Biocontrol active substances should be recognised as one of the components of a broad and balanced toolbox available to farmers alongside other plant protection products; |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Viktória Ferenc, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (4) In order to decrease farmers’ dependency on plant protection products containing chemical active substances and in line with the announcements in the Communication A Vision for Agriculture and Food, the accessibility and availability of sustainable plant protection products, including plant protection products containing biocontrol substances, needs to increase. | (4) With the aim of diversifying the farmers’ toolkit in line with the announcements in the Communication A Vision for Agriculture and Food, the accessibility and availability of sustainable, effective and economically viable plant protection products, including plant protection products containing biocontrol substances, needs to increase. |
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) whereas the outermost regions of the European Union referred to in Article 349 of the Treaty on the Functioning of the European Union face specific structural, climate-related, agri-ecological and phytosanitary constraints, particularly tropical or sub-tropical climates, immense and unrelenting pressure from harmful organisms, particular crop cycles, constraints relating to the gradient, humidity and precipitation, and geographical remoteness that creates particular logistical and economic constraints; whereas these specific features may mean that the ordinary procedures for the approval, authorisation, renewal, extension of use, mutual recognition and grace-period management of plant protection products are not adequately adapted to the realities of production in these regions; whereas, therefore, it is worth ensuring that the application of Regulation (EC) No 1107/2009 takes proper account of these constraints in order to prevent dead ends for plant health, guarantee genuine access to reliable, effective and adapted solutions, and ensure the continuity of sustainable and competitive agricultural production in these regions, without prejudice to a high level of protection for human health, animal health and the environment; |
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) whereas the outermost regions of the European Union referred to in Article 349 of the Treaty on the Functioning of the European Union face specific structural, climate-related, agri-ecological and phytosanitary constraints, particularly tropical or sub-tropical climates, immense and unrelenting pressure from harmful organisms, particular crop cycles, constraints relating to the gradient, humidity and precipitation, and geographical remoteness that creates particular logistical and economic constraints; whereas these specific features may mean that the ordinary procedures for the approval, authorisation, renewal, extension of use, mutual recognition and grace-period management of plant protection products are not adequately adapted to the realities of production in these regions; whereas, therefore, it is worth ensuring that the application of Regulation (EC) No 1107/2009 takes proper account of these constraints in order to prevent dead ends for plant health, guarantee genuine access to reliable, effective and adapted solutions, and ensure the continuity of sustainable and competitive agricultural production in these regions, without prejudice to a high level of protection for human health, animal health and the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) Considering that the Outermost Regions referred to in Article 349 of the Treaty on the Functioning of the European Union face specific structural, climatic, agroecological and phytosanitary constraints, including tropical or subtropical climates, continuous pest pressure, specific crop cycles, constraints relating to slope, humidity and rainfall, and geographical remoteness giving rise to particular logistical and economic constraints; considering that those specific characteristics may render the ordinary procedures for the approval, authorisation, renewal, extension of use, mutual recognition and management of grace periods for plant protection products insufficiently adapted to the production conditions prevailing in those regions; considering that it is therefore necessary to ensure that Regulation (EC) No 1107/2009 is applied in a manner that takes due account of those constraints, with a view to preventing situations in which no effective plant protection solution is available, ensuring effective access to safe, effective and appropriate solutions, and safeguarding the continuity of sustainable and competitive agricultural production in those regions, without prejudice to a high level of protection of human and animal health and the environment; |
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) The European Food Safety Authority (EFSA) is central to the Union’s risk assessment system for active substances used in plant protection products. EFSA has indicated that an additional allocation of approximately 50 staff members and EUR 15 million per year would enable it to address the current backlog within an estimated period of three years. Strengthening EFSA’s staffing and financial resources accordingly is therefore essential to ensure timely delivery of scientific conclusions, maintain the quality and independence of risk assessments, as required under this Regulation. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Viktória Ferenc, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) whereas, in order to maintain a balance between environmental concerns, productivity and farmers’ incomes, no single approach should be followed exclusively but rather a combination of several levers is required, including biocontrol, alongside agronomic practices, genetic improvement of plants, agricultural equipment, digital technology and plant protection products where there are no viable alternatives in agronomic and economic terms; |
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Pascal Canfin, Olivier Chastel, Andreas Glück, Charles Goerens, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (4a) The broader uptake of biocontrol substances can contribute to achieving EU environmental, food security and health objectives while offering solutions to farmers who are facing a reduction in the number of approved active substances which can lead to a shortage of viable protection alternatives and undermine the productivity and competitiveness of the European agricultural sector. |
Benoit Cassart, Gerben-Jan Gerbrandy, Martin Hojsík, Christine Singer, Olivier Chastel, Michal Wiezik, Charles Goerens, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (5) In order to facilitate faster market access for biocontrol substances and products containing them, biocontrol substances need to be more clearly defined and identified under Regulation (EC) No 1107/2009. A definition for biocontrol substances should include micro-organisms, inorganic substances as occurring in nature, with the exception of heavy metals and their salts, or substances of biological origin or produced synthetically that are functionally identical and structurally similar to them such as semiochemicals, biological macromolecules or molecules comprised of components thereof, as well as substances, including of unknown and variable composition, originating from living organisms or derived by biological processes (e.g. extracts from plant products, metabolites produced by micro-organisms). | (5) In order to facilitate faster market access for biocontrol substances and products containing them, biocontrol substances need to be more clearly defined and identified under Regulation (EC) No 1107/2009. A definition for biocontrol substances should include micro-organisms, inorganic substances as occurring in nature, with the exception of heavy metals and their salts, or substances of biological origin or produced synthetically that are functionally identical and structurally similar to them such as semiochemicals, biological macromolecules or molecules comprised of components thereof, as well as substances, including of unknown and variable composition, originating from living organisms or derived by biological processes (e.g. extracts from plant products, metabolites produced by micro-organisms). The Commission should develop guidance to clarify “functionnally identical and structurally similiar” based on recommandations from the Authority. |
| Text proposed by the Commission | Amendment |
|---|---|
| (5) In order to facilitate faster market access for biocontrol substances and products containing them, biocontrol substances need to be more clearly defined and identified under Regulation (EC) No 1107/2009. A definition for biocontrol substances should include micro-organisms, inorganic substances as occurring in nature, with the exception of heavy metals and their salts, or substances of biological origin or produced synthetically that are functionally identical and structurally similar to them such as semiochemicals, biological macromolecules or molecules comprised of components thereof, as well as substances, including of unknown and variable composition, originating from living organisms or derived by biological processes (e.g. extracts from plant products, metabolites produced by micro-organisms). | (5) In order to facilitate faster market access for low-risk biocontrol substances and products containing them, biocontrol substances need to be more clearly defined and identified under Regulation (EC) No 1107/2009. A definition for biocontrol substances should include micro-organisms, provided that they are not genetically modified organisms within the meaning of Directive 2001/18/EC, inorganic substances as occurring in nature, with the exception of heavy metals and their salts, or substances of biological origin or produced synthetically that are functionally identical and structurally identical to them such as semiochemicals, biological macromolecules or molecules comprised of components thereof, as well as substances, including of unknown and variable composition, originating from living organisms or derived by biological processes (e.g. extracts from plant products, metabolites produced by micro-organisms). |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Viktória Ferenc, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (5) In order to facilitate faster market access for biocontrol substances and products containing them, biocontrol substances need to be more clearly defined and identified under Regulation (EC) No 1107/2009. A definition for biocontrol substances should include micro-organisms, inorganic substances as occurring in nature, with the exception of heavy metals and their salts, or substances of biological origin or produced synthetically that are functionally identical and structurally similar to them such as semiochemicals, biological macromolecules or molecules comprised of components thereof, as well as substances, including of unknown and variable composition, originating from living organisms or derived by biological processes (e.g. extracts from plant products, metabolites produced by micro-organisms). | (5) In order to facilitate faster market access for effective, economically viable biocontrol substances and products containing them, biocontrol substances need to be more clearly defined and identified under Regulation (EC) No 1107/2009. A definition for biocontrol substances should include micro-organisms, inorganic substances as occurring in nature, with the exception of heavy metals and their salts, or substances of biological origin or produced synthetically that are functionally identical and structurally similar to them such as semiochemicals, biological macromolecules or molecules comprised of components thereof, as well as substances, including of unknown and variable composition, originating from living organisms or derived by biological processes (e.g. extracts from plant products, metabolites produced by micro-organisms). |
| Text proposed by the Commission | Amendment |
|---|---|
| (5) In order to facilitate faster market access for biocontrol substances and products containing them, biocontrol substances need to be more clearly defined and identified under Regulation (EC) No 1107/2009. A definition for biocontrol substances should include micro-organisms, inorganic substances as occurring in nature, with the exception of heavy metals and their salts, or substances of biological origin or produced synthetically that are functionally identical and structurally similar to them such as semiochemicals, biological macromolecules or molecules comprised of components thereof, as well as substances, including of unknown and variable composition, originating from living organisms or derived by biological processes (e.g. extracts from plant products, metabolites produced by micro-organisms). | (5) In order to facilitate faster market access for low-risk biocontrol substances and products containing them, biocontrol substances need to be more clearly defined and identified under Regulation (EC) No 1107/2009. A definition for biocontrol substances should include micro-organisms, inorganic substances as occurring in nature, with the exception of heavy metals and their salts, or substances of biological origin or produced synthetically that are functionally identical and structurally identical to them such as semiochemicals, biological macromolecules or molecules comprised of components thereof, as well as substances, including of unknown and variable composition, originating from living organisms or derived by biological processes (e.g. extracts from plant products, metabolites produced by micro-organisms). |
Biljana Borzan, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim
| Text proposed by the Commission | Amendment |
|---|---|
| (5) In order to facilitate faster market access for biocontrol substances and products containing them, biocontrol substances need to be more clearly defined and identified under Regulation (EC) No 1107/2009. A definition for biocontrol substances should include micro-organisms, inorganic substances as occurring in nature, with the exception of heavy metals and their salts, or substances of biological origin or produced synthetically that are functionally identical and structurally similar to them such as semiochemicals, biological macromolecules or molecules comprised of components thereof, as well as substances, including of unknown and variable composition, originating from living organisms or derived by biological processes (e.g. extracts from plant products, metabolites produced by micro-organisms). | (5) In order to facilitate faster market access for biocontrol substances and products containing them, biocontrol substances need to be more clearly defined and identified under Regulation (EC) No 1107/2009. A definition for biocontrol substances should include micro-organisms, semiochemicals, inorganic substances as occurring in nature, or substances that are structurally similar and functionally identical to natural substances of biological origin or produced synthetically such as biological macromolecules or molecules comprised of components thereof, as well as substances, including of unknown and variable composition, originating from living organisms or derived by biological processes (e.g. extracts from plant products, metabolites produced by micro-organisms). |
| Text proposed by the Commission | Amendment |
|---|---|
| (5a) To further clarify the scope of this Regulation, the Commission shall, no later than three months prior to the date of application of this Regulation, publish a guidance document identifying the scope of the definition of biocontrols as set out herein. |
| Text proposed by the Commission | Amendment |
|---|---|
| (6) As many biocontrol substances may also have plant growth stimulation functions, a clearer borderline should be set with regard to fertilising products, in particular plant biostiumlants as referred to in Regulation (EU) No 2019/1009 on the making available on the market of EU fertilising products3 . Thus, the scope of Regulation (EC) No 1107/2009 should be clarified to exclude substances which influence positively the life processes of crops, as those substances qualify as plant biostimulants from a plant physiological perspective. Substances interfering with life processes of plants and controlling the growth of the plants or parts of them, should remain in the scope of Regulation (EC) No 1107/2009. | (6) As many biocontrol substances may also have plant growth stimulation functions, a clearer borderline should be set with regard to fertilising products, in particular plant biostiumlants as referred to in Regulation (EU) No 2019/1009 on the making available on the market of EU fertilising products3 . Thus, the scope of Regulation (EC) No 1107/2009 should be clarified to exclude substances which influence positively the life processes of crops, as those substances qualify as plant biostimulants from a plant physiological perspective. Such clarification should not create regulatory gaps nor should it affect the application of Union legislation governing genetically modified organisms. Substances interfering with life processes of plants and controlling the growth of the plants or parts of them, should remain in the scope of Regulation (EC) No 1107/2009. |
| 3 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003, PE/76/2018/REV/1, OJ L 170, 25.6.2019, pp. 1–114, ELI: http://data.europa.eu/eli/reg/2019/1009/oj. | 3 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003, PE/76/2018/REV/1, OJ L 170, 25.6.2019, pp. 1–114, ELI: http://data.europa.eu/eli/reg/2019/1009/oj. |
| Text proposed by the Commission | Amendment |
|---|---|
| (6) As many biocontrol substances may also have plant growth stimulation functions, a clearer borderline should be set with regard to fertilising products, in particular plant biostiumlants as referred to in Regulation (EU) No 2019/1009 on the making available on the market of EU fertilising products3 . Thus, the scope of Regulation (EC) No 1107/2009 should be clarified to exclude substances which influence positively the life processes of crops, as those substances qualify as plant biostimulants from a plant physiological perspective. Substances interfering with life processes of plants and controlling the growth of the plants or parts of them, should remain in the scope of Regulation (EC) No 1107/2009. | (6) As many biocontrol substances may also have plant growth stimulation effects, a clearer borderline should be set with regard to fertilising products, in particular plant biostiumlants as referred to in Regulation (EU) No 2019/1009 on the making available on the market of EU fertilising products3 . Thus, the scope of Regulation (EC) No 1107/2009 should be clarified to exclude products which influence positively the life processes of plants, as those products qualify as plant biostimulants from a plant physiological perspective. Products interfering with life processes of plants and controlling the growth of the plants or parts of them, should remain in the scope of Regulation (EC) No 1107/2009. |
| 3 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003, PE/76/2018/REV/1, OJ L 170, 25.6.2019, pp. 1–114, ELI: http://data.europa.eu/eli/reg/2019/1009/oj. | 3 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003, PE/76/2018/REV/1, OJ L 170, 25.6.2019, pp. 1–114, ELI: http://data.europa.eu/eli/reg/2019/1009/oj. |
The borderline between a plant protection product and a biostimulant is drawn at product level, according to the wording used in the Fertilising Products Regulation ((EU) 2019/1009). This avoids two conflicting definitions for the same product and ensures that the regime under which the manufacturer falls is known in advance.
| Text proposed by the Commission | Amendment |
|---|---|
| (6) As many biocontrol substances may also have plant growth stimulation functions, a clearer borderline should be set with regard to fertilising products, in particular plant biostiumlants as referred to in Regulation (EU) No 2019/1009 on the making available on the market of EU fertilising products3 . Thus, the scope of Regulation (EC) No 1107/2009 should be clarified to exclude substances which influence positively the life processes of crops, as those substances qualify as plant biostimulants from a plant physiological perspective. Substances interfering with life processes of plants and controlling the growth of the plants or parts of them, should remain in the scope of Regulation (EC) No 1107/2009. | (6) As many biocontrol substances may also have plant growth stimulation effects, a clearer borderline should be set with regard to fertilising products, in particular plant biostiumlants as referred to in Regulation (EU) No 2019/1009 on the making available on the market of EU fertilising products3 . Thus, the scope of Regulation (EC) No 1107/2009 should be clarified to exclude products which influence positively the life processes of plants, as those products qualify as plant biostimulants from a plant physiological perspective. Products interfering with life processes of plants and controlling the growth of the plants or parts of them, should remain in the scope of Regulation (EC) No 1107/2009. |
| 3 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003, PE/76/2018/REV/1, OJ L 170, 25.6.2019, pp. 1–114, ELI: http://data.europa.eu/eli/reg/2019/1009/oj. | 3 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003, PE/76/2018/REV/1, OJ L 170, 25.6.2019, pp. 1–114, ELI: http://data.europa.eu/eli/reg/2019/1009/oj. |
| (Directive (EC) nº 1107/2009) |
| Text proposed by the Commission | Amendment |
|---|---|
| (6) As many biocontrol substances may also have plant growth stimulation functions, a clearer borderline should be set with regard to fertilising products, in particular plant biostiumlants as referred to in Regulation (EU) No 2019/1009 on the making available on the market of EU fertilising products3 . Thus, the scope of Regulation (EC) No 1107/2009 should be clarified to exclude substances which influence positively the life processes of crops, as those substances qualify as plant biostimulants from a plant physiological perspective. Substances interfering with life processes of plants and controlling the growth of the plants or parts of them, should remain in the scope of Regulation (EC) No 1107/2009. | (6) As many biocontrol substances may also have plant growth stimulation effects, a clearer borderline should be set with regard to fertilising products, in particular plant biostiumlants as referred to in Regulation (EU) No 2019/1009 on the making available on the market of EU fertilising products3 . Thus, the scope of Regulation (EC) No 1107/2009 should be clarified to exclude products which influence positively the life processes of plants, as those products qualify as plant biostimulants from a plant physiological perspective. Products interfering with life processes of plants and controlling the growth of the plants or parts of them, should remain in the scope of Regulation (EC) No 1107/2009. |
| 3 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003, PE/76/2018/REV/1, OJ L 170, 25.6.2019, pp. 1–114, ELI: http://data.europa.eu/eli/reg/2019/1009/oj. | 3 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003, PE/76/2018/REV/1, OJ L 170, 25.6.2019, pp. 1–114, ELI: http://data.europa.eu/eli/reg/2019/1009/oj. |
Improves legal clarity by ensuring that the distinction between plant biostimulants and plant protection products is made at product level, consistent with the existing EU regulatory framework.It preserves the European Commission's objective of providing a clearer boundary between the two regulatory frameworks, while avoiding unintended legal uncertainty created by the current wording in the Council compromise.It provides greater certainty for competent authorities, manufacturers and farmers, helping to ensure consistent implementation across Member States.
| Text proposed by the Commission | Amendment |
|---|---|
| (6) As many biocontrol substances may also have plant growth stimulation functions, a clearer borderline should be set with regard to fertilising products, in particular plant biostiumlants as referred to in Regulation (EU) No 2019/1009 on the making available on the market of EU fertilising products3 . Thus, the scope of Regulation (EC) No 1107/2009 should be clarified to exclude substances which influence positively the life processes of crops, as those substances qualify as plant biostimulants from a plant physiological perspective. Substances interfering with life processes of plants and controlling the growth of the plants or parts of them, should remain in the scope of Regulation (EC) No 1107/2009. | (6) As many biocontrol substances may also have plant growth stimulation effects, a clearer borderline should be set with regard to fertilising products, in particular plant biostiumlants as referred to in Regulation (EU) No 2019/1009 on the making available on the market of EU fertilising products3 . Thus, the scope of Regulation (EC) No 1107/2009 should be clarified to exclude products which influence positively the life processes of plants, as those products qualify as plant biostimulants from a plant physiological perspective. Products interfering with life processes of plants and controlling the growth of the plants or parts of them, should remain in the scope of Regulation (EC) No 1107/2009. |
| 3 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003, PE/76/2018/REV/1, OJ L 170, 25.6.2019, pp. 1–114, ELI: http://data.europa.eu/eli/reg/2019/1009/oj. | 3 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003, PE/76/2018/REV/1, OJ L 170, 25.6.2019, pp. 1–114, ELI: http://data.europa.eu/eli/reg/2019/1009/oj. |
| Text proposed by the Commission | Amendment |
|---|---|
| (6) As many biocontrol substances may also have plant growth stimulation functions, a clearer borderline should be set with regard to fertilising products, in particular plant biostiumlants as referred to in Regulation (EU) No 2019/1009 on the making available on the market of EU fertilising products3. Thus, the scope of Regulation (EC) No 1107/2009 should be clarified to exclude substances which influence positively the life processes of crops, as those substances qualify as plant biostimulants from a plant physiological perspective. Substances interfering with life processes of plants and controlling the growth of the plants or parts of them, should remain in the scope of Regulation (EC) No 1107/2009. | (6) As many biocontrol substances may also have plant growth stimulation effects, a clearer borderline should be set with regard to fertilising products, in particular plant biostiumlants as referred to in Regulation (EU) No 2019/1009 on the making available on the market of EU fertilising products3. Thus, the scope of Regulation (EC) No 1107/2009 should be clarified to exclude products which influence positively the life processes of plants, as those substances qualify as plant biostimulants from a plant physiological perspective. Products interfering with life processes of plants and controlling the growth of the plants or parts of them, should remain in the scope of Regulation (EC) No 1107/2009. |
| 3 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003, PE/76/2018/REV/1, OJ L 170, 25.6.2019, pp. 1–114, ELI: http://data.europa.eu/eli/reg/2019/1009/oj. | 3 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003, PE/76/2018/REV/1, OJ L 170, 25.6.2019, pp. 1–114, ELI: http://data.europa.eu/eli/reg/2019/1009/oj. |
| Text proposed by the Commission | Amendment |
|---|---|
| (6) As many biocontrol substances may also have plant growth stimulation functions, a clearer borderline should be set with regard to fertilising products, in particular plant biostiumlants as referred to in Regulation (EU) No 2019/1009 on the making available on the market of EU fertilising products3 . Thus, the scope of Regulation (EC) No 1107/2009 should be clarified to exclude substances which influence positively the life processes of crops, as those substances qualify as plant biostimulants from a plant physiological perspective. Substances interfering with life processes of plants and controlling the growth of the plants or parts of them, should remain in the scope of Regulation (EC) No 1107/2009. | (6) As many biocontrol substances may also have plant growth stimulation effects, a clearer borderline should be set with regard to fertilising products, in particular plant biostimulants as referred to in Regulation (EU) No 2019/1009 on the making available on the market of EU fertilising products. Thus, the scope of Regulation(EC) No 1107/2009 should be clarified to exclude products which influence positively the life processes of plants, as those products qualify as plant biostimulants from a plant physiological perspective. Products interfering with life processes of plants and controlling the growth of the plants or partsof them, should remain in the scope of Regulation (EC) No 1107/2009. |
| 3 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003, PE/76/2018/REV/1, OJ L 170, 25.6.2019, pp. 1–114, ELI: http://data.europa.eu/eli/reg/2019/1009/oj. | 3 Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003, PE/76/2018/REV/1, OJ L 170, 25.6.2019, pp. 1–114, ELI: http://data.europa.eu/eli/reg/2019/1009/oj. |
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Pascal Canfin, Olivier Chastel, Charles Goerens, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (7) For the same purpose, the evaluation of applications for approval of such active substances and for the authorisation of plant protection products containing them should be given priority to ensure timely crop protection from existing pests and diseases. | (7) For the same purpose, the evaluation of applications for approval of such active substances and for the authorisation of plant protection products containing biocontrol active substances and low-risk active substances should be given priority to ensure timely crop protection from existing pests and diseases. While accelerating the assessment and authorisation of biocontrol solutions is essential for the realisation of EU environmental, food security and health objectives, such measures should not lead to any further delay in the risk assessment and authorisation of conventional active substances and plant protection products. Furthermore, this prioritisation should not result in excessive delayed reviews of substances and products that have been on the market for more than 10 years, thereby ensuring that a high level of protection for human health, animal health, and the environment is consistently maintained. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Viktória Ferenc, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (7) For the same purpose, the evaluation of applications for approval of such active substances and for the authorisation of plant protection products containing them should be given priority to ensure timely crop protection from existing pests and diseases. | (7) For the same purpose, the evaluation of applications for approval of such effective, economically viable active substances and for the authorisation of plant protection products containing them should be faster to ensure timely crop protection from existing pests and diseases. In order for such approvals to be more frequent, particularly for small and medium-sized enterprises, it is essential that the authorisation and renewal procedures be streamlined, particularly by not systematically applying the authorisation expiry dates other than for the substances that require it. |
| Text proposed by the Commission | Amendment |
|---|---|
| (7) For the same purpose, the evaluation of applications for approval of such active substances and for the authorisation of plant protection products containing them should be given priority to ensure timely crop protection from existing pests and diseases. | (7) For the same purpose, the evaluation of applications for approval of such low-risk active substances and for the authorisation of plant protection products containing them should be given priority, provided that the available scientific evidence demonstrates that they meet the applicable criteria for low-risk substances and that such prioritisation does not compromise the quality or thoroughness of the scientific assessment to ensure timely crop protection from existing pests and diseases. |
| Text proposed by the Commission | Amendment |
|---|---|
| (7a) To foster innovation in low-risk and biological crop protection solutions, the regulatory burden and processing timeframes must be optimized without compromising safety standards. A predictable regulatory pathway not exceeding three years is essential to encourage investment in the biocontrol sector and to provide farmers with the necessary tools for integrated pest management. To enforce this target, the Commission should track authorization durations annually. Any failure to meet the three-year average target must trigger a mandatory transparency and remedy mechanism, compelling the Commission to diagnose the underlying procedural bottlenecks and outline concrete legislative or administrative actions in its upcoming work programmes to rectify the delays. |
| Text proposed by the Commission | Amendment |
|---|---|
| (8) The risk assessment of biocontrol substances requires specific technical knowledge, and some Member States do not have enough experts specialised in this type of assessment. As a result, some applicants for approval of biocontrol substances face difficulties in finding a rapporteur Member State. In order to increase capacity for the assessment of new biocontrol substances, it should be possible for the European Food Safety Authority (“the Authority”) to assume the role of the rapporteur Member State for the assessment of applications for approval and the Authority’s resources should be increased accordingly. The Authority should put in place appropriate safeguards to ensure independence of the subsequent peer review and to avoid any possible conflict of interests for the experts involved at the different stages of the assessment. | (8) The risk assessment of biocontrol substances requires specific technical knowledge, and some Member States do not have enough experts specialised in this type of assessment. A dedicated assessment pathway should therefore be established for biocontrol substances in order to ensure that they are assessed using methodologies appropriate to their specific characteristics, while maintaining a high level of protection of human and animal health, biodiversity and the environment. Hazard- and risk-based assessment methodologies based on conventional pesticides can result in unnecessary data requirements or disproportionate regulatory barriers that are not scientifically justified. It is therefore necessary to establish a dedicated risk assessment framework where data requirements, technical guidelines, and evaluation principles are fully adapted and proportionate to the biological nature and expected exposure of these substances. Furthermore, a specific sub-category of low-risk biocontrol substances should be established for substances that fulfil the applicable low-risk criteria on the basis of a scientific assessment, allowing for simplified procedures commensurate with their risk profile. Where Member States are unable to assume the role of rapporteur Member State, it should be possible for the European Food Safety Authority (“the Authority”) to act as rapporteur for the assessment of applications for approval and the Authority’s resources should be increased accordingly. The Authority should put in place appropriate safeguards to ensure independence of the subsequent peer review and to avoid any possible conflict of interests for the experts involved at the different stages of the assessment. |
Benoit Cassart, Gerben-Jan Gerbrandy, Martin Hojsík, Christine Singer, Pascal Canfin, Olivier Chastel, Michal Wiezik, Charles Goerens, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (8) The risk assessment of biocontrol substances requires specific technical knowledge, and some Member States do not have enough experts specialised in this type of assessment. As a result, some applicants for approval of biocontrol substances face difficulties in finding a rapporteur Member State. In order to increase capacity for the assessment of new biocontrol substances, it should be possible for the European Food Safety Authority (“the Authority”) to assume the role of the rapporteur Member State for the assessment of applications for approval and the Authority’s resources should be increased accordingly. The Authority should put in place appropriate safeguards to ensure independence of the subsequent peer review and to avoid any possible conflict of interests for the experts involved at the different stages of the assessment. | (8) The risk assessment of biocontrol substances requires specific technical knowledge, and some Member States do not have enough experts specialised in this type of assessment. As a result, some applicants for approval of biocontrol substances face difficulties in finding a rapporteur Member State. In order to increase capacity for the assessment of new biocontrol substances, Member States should ensure that their national competent authorities have sufficient budget, staff and expertise to deal with the application for approval of biocontrol substances to carry out assessments within the expected deadlines and avoid undue delays. In addition, it should be possible for the European Food Safety Authority (“the Authority”) to assume the role of the rapporteur Member State for the assessment of applications for approval and the Authority’s resources should be increased accordingly. The Authority should put in place appropriate safeguards to ensure independence of the subsequent peer review and to avoid any possible conflict of interests for the experts involved at the different stages of the assessment. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (8) The risk assessment of biocontrol substances requires specific technical knowledge, and some Member States do not have enough experts specialised in this type of assessment. As a result, some applicants for approval of biocontrol substances face difficulties in finding a rapporteur Member State. In order to increase capacity for the assessment of new biocontrol substances, it should be possible for the European Food Safety Authority (“the Authority”) to assume the role of the rapporteur Member State for the assessment of applications for approval and the Authority’s resources should be increased accordingly. The Authority should put in place appropriate safeguards to ensure independence of the subsequent peer review and to avoid any possible conflict of interests for the experts involved at the different stages of the assessment. | (8) The risk assessment of biocontrol substances requires specific technical knowledge, and some Member States do not have enough experts specialised in this type of assessment. As a result, some applicants for approval of biocontrol substances face difficulties in finding a rapporteur Member State, leading to procedural delays and constraints in the assessment process. In order to increase capacity for the assessment of new biocontrol substances, it should be possible for the European Food Safety Authority (“the Authority”) to assume the role of the rapporteur Member State for the assessment of applications for approval and the Authority’s resources should be increased accordingly. The Authority should put in place appropriate safeguards to ensure independence of the subsequent peer review and to avoid any possible conflict of interests for the experts involved at the different stages of the assessment. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (8) The risk assessment of biocontrol substances requires specific technical knowledge, and some Member States do not have enough experts specialised in this type of assessment. As a result, some applicants for approval of biocontrol substances face difficulties in finding a rapporteur Member State. In order to increase capacity for the assessment of new biocontrol substances, it should be possible for the European Food Safety Authority (“the Authority”) to assume the role of the rapporteur Member State for the assessment of applications for approval and the Authority’s resources should be increased accordingly. The Authority should put in place appropriate safeguards to ensure independence of the subsequent peer review and to avoid any possible conflict of interests for the experts involved at the different stages of the assessment. | (8) The risk assessment of biocontrol substances in particular, requires technical knowledge, and some Member States do not have enough experts. As a result, some applicants for approval of biocontrol substances in particular, face difficulties in finding a rapporteur Member State. In order to increase capacity for the assessment of new biocontrol substances in particular, it should be possible for the European Food Safety Authority (“the Authority”) to assume the role of the rapporteur Member State for the assessment of applications for approval and the Authority’s resources should be increased accordingly for all substance authorisations and renewals. The Authority should put in place appropriate safeguards to ensure independence of the subsequent peer review and to avoid any possible conflict of interests for the experts involved at the different stages of the assessment. |
Anja Hazekamp, Per Clausen, Valentina Palmisano, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
| Text proposed by the Commission | Amendment |
|---|---|
| (9) To accelerate the accessibility and availability to farmers of plant protection products containing new biocontrol substances, Member States should have the possibility to grant provisional authorisations for such products as soon as the draft assessment report for an application for approval has been delivered concluding that the substance can be approved. When the new biocontrol substance is approved, and in order to avoid unnecessary administrative procedures, it should be possible to transform such provisional authorisations into regular authorisations without the need of reassessment unless the conditions set out in the approval require an amendment of the conditions set out in the provisional authorisations. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (9) To accelerate the accessibility and availability to farmers of plant protection products containing new biocontrol substances, Member States should have the possibility to grant provisional authorisations for such products as soon as the draft assessment report for an application for approval has been delivered concluding that the substance can be approved. When the new biocontrol substance is approved, and in order to avoid unnecessary administrative procedures, it should be possible to transform such provisional authorisations into regular authorisations without the need of reassessment unless the conditions set out in the approval require an amendment of the conditions set out in the provisional authorisations. | (9) To accelerate the accessibility and availability to farmers of plant protection products containing new low-risk biocontrol substances, Member States should have the possibility to grant provisional authorisations for such products as soon as the draft assessment report for an application for approval has been delivered concluding that the substance can be approved. When the new low-risk biocontrol substance is approved, and in order to avoid unnecessary administrative procedures, it should be possible to transform such provisional authorisations into regular authorisations without the need of reassessment unless the conditions set out in the approval require an amendment of the conditions set out in the provisional authorisations. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (9) To accelerate the accessibility and availability to farmers of plant protection products containing new biocontrol substances, Member States should have the possibility to grant provisional authorisations for such products as soon as the draft assessment report for an application for approval has been delivered concluding that the substance can be approved. When the new biocontrol substance is approved, and in order to avoid unnecessary administrative procedures, it should be possible to transform such provisional authorisations into regular authorisations without the need of reassessment unless the conditions set out in the approval require an amendment of the conditions set out in the provisional authorisations. | (9) To accelerate the accessibility and availability to farmers of plant protection products containing new substances, Member States should have the possibility to grant provisional authorisations for such products as soon as the draft assessment report for an application for approval has been delivered concluding that the substance can be approved. When the new substance is approved, and in order to avoid unnecessary administrative procedures, it should be possible to transform such provisional authorisations into regular authorisations without the need of reassessment unless the conditions set out in the approval require an amendment of the conditions set out in the provisional authorisations. |
Anja Hazekamp, Per Clausen, Valentina Palmisano, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
| Text proposed by the Commission | Amendment |
|---|---|
| (10) To reduce burdens on applicants and Member States and to facilitate the availability of plant protection products containing only biocontrol substances or low-risk active substances, the Union should be considered as one zone for applications for the authorisation of such products. Considering also that plant protection products containing only biocontrol substances are not expected to pose different levels of risk in different Member States, mutual recognition of authorisations for such products granted by one Member States should be considered as granted by tacit agreement if decisions on applications for mutual recognition are not adopted within the prescribed deadline. | deleted |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (10) To reduce burdens on applicants and Member States and to facilitate the availability of plant protection products containing only biocontrol substances or low-risk active substances, the Union should be considered as one zone for applications for the authorisation of such products. Considering also that plant protection products containing only biocontrol substances are not expected to pose different levels of risk in different Member States, mutual recognition of authorisations for such products granted by one Member States should be considered as granted by tacit agreement if decisions on applications for mutual recognition are not adopted within the prescribed deadline. | (10) To reduce burdens on applicants and Member States and to facilitate the availability of plant protection products containing only biocontrol substances or low-risk active substances, the Union should be considered as one zone for applications for the authorisation of such products. Given the fragmented access to plant health products between different Member States, which results in serious distortions of competition, mutual recognition of authorisations for such products granted by one Member States should be considered as granted by tacit agreement if decisions on applications for mutual recognition are not adopted within the prescribed deadline. Before the Member State refuses mutual recognition to the applicant, or as part of a zone-specific authorisation, it should first have ensured that the applicant has had a genuine opportunity to provide the necessary information or data while preparing the file, but also that a rejection based on specific national conditions, such as the absence of risk-prevention measures or the presence of special agronomic, phytosanitary or environmental circumstances that might not have been taken into account, is always reasoned and justified. |
| Text proposed by the Commission | Amendment |
|---|---|
| (10) To reduce burdens on applicants and Member States and to facilitate the availability of plant protection products containing only biocontrol substances or low-risk active substances, the Union should be considered as one zone for applications for the authorisation of such products. Considering also that plant protection products containing only biocontrol substances are not expected to pose different levels of risk in different Member States, mutual recognition of authorisations for such products granted by one Member States should be considered as granted by tacit agreement if decisions on applications for mutual recognition are not adopted within the prescribed deadline. | (10) To reduce burdens on applicants and Member States and to facilitate the availability of plant protection products containing only low-risk biocontrol substances or low-risk active substances, the Union should be considered as one zone for applications for the authorisation of such products. Such simplification should be based on a prior scientific assessment demonstrating that the applicable low-risk criteria are fulfilled and should not affect the assessment of risks that may arise from specific environmental, agronomic or climatic conditions in individual Member States. Mutual recognition of authorisations for such products should therefore be facilitated, while allowing Member States to object where duly justified on the basis of specific local or environmental circumstances. |
| Text proposed by the Commission | Amendment |
|---|---|
| (10) To reduce burdens on applicants and Member States and to facilitate the availability of plant protection products containing only biocontrol substances or low-risk active substances, the Union should be considered as one zone for applications for the authorisation of such products. Considering also that plant protection products containing only biocontrol substances are not expected to pose different levels of risk in different Member States, mutual recognition of authorisations for such products granted by one Member States should be considered as granted by tacit agreement if decisions on applications for mutual recognition are not adopted within the prescribed deadline. | (10) To reduce burdens on applicants and Member States and to facilitate the availability of plant protection products containing only biocontrol substances , the Union should be considered as one zone for applications for the authorisation of such products. Considering also that plant protection products containing only biocontrol substances are not expected to pose different levels of risk in different Member States, mutual recognition of authorisations for such products granted by one Member States should be considered as granted by tacit agreement if decisions on applications for mutual recognition are not adopted within the prescribed deadline. |
Benoit Cassart, Gerben-Jan Gerbrandy, Martin Hojsík, Christine Singer, Pascal Canfin, Olivier Chastel, Michal Wiezik, Charles Goerens, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (10a) It has been observed that a significant number of application for approval of active substances submitted to the European Food Safety Authority are either incomplete or do not meet applicable regulatory and scientific specifications requirements to enable the best quality scientific assessment by the Authority, resulting in the need for requests for additional information during the risk assessment process and, consequently, leading sometimes to significant delays in the assessment and placing on the markets of approved of plant protection products. Applicants, in particular small and medium-sized entreprises do not always have a clear understanding of the applicable regulatory and scientific requirements when preparing application dossiers, in particular as regards the types and details of studies to be conducted. Pre-submission advice provided by the Authority should be allowed at the request of a potential applicant to receive information on applicable rules, guidance documents and data requirements including on study design and testing strategies. This advice should be provided by the staff and exprts of the Authority to ensure the most updated scientific advice. |
| Text proposed by the Commission | Amendment |
|---|---|
| (10a) To ensure that the zonal authorisation and mutual recognition system operates effectively, the demarcation of zones specified in Annex I must reflect existing agronomic, climatic and environmental conditions at all times. Given the effects of climate change on agricultural practices, on trends in the distribution of pests and on the conditions of use of plant protection products, as well as the significant differences between regions of the same Member State, the Commission should regularly reassess the delimitation of these zones and be empowered to adjust it by way of delegated acts, including by establishing subzones or allocating certain regions to different zones, where this is justified on the basis of scientific and technical criteria. |
| Text proposed by the Commission | Amendment |
|---|---|
| (10a) The effective deployment of plant protection products containing biocontrol active substances often depends on adapted application techniques, which highlights the need for continued and increased investment in training, infrastructure, technical and advisory support to farmers, in order to accelerate the transition towards more sustainable plant protection practices, reduce dependency on chemical active substances, and support the objectives of integrated pest management, thereby contributing to the protection of biodiversity, pollinators, soil health and water quality, and to the achievement of the Union's environmental and Green Deal objectives. |
Benoit Cassart, Gerben-Jan Gerbrandy, Martin Hojsík, Christine Singer, Pascal Canfin, Olivier Chastel, Michal Wiezik, Charles Goerens, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (10b) Over the past years, application for approval of active substances and authorisation of plant protection product have faced significant delayed partly due to a lack of resources within the Authority and national competent authorities. It is therefore of utermost importance to allocate additional resources, funding and staff within the Authority and national competent authorities in order to carry out their respective tasks within the applicable deadlines and to accelerate the placing on the market of plant protection product containing biocontrol and low-risk active substances. |
Benoit Cassart, Gerben-Jan Gerbrandy, Martin Hojsík, Christine Singer, Pascal Canfin, Olivier Chastel, Andreas Glück, Michal Wiezik, Charles Goerens, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (10c) The effective deployment of plant protection product containing biocontrol active substances often depends on adapted application techniques, which highlight the need for continued investment in training, infrastructure, technical and advisory support to farmers to ensure the successful uptake of plant protection products containing biocontrol active substances. |
Anja Hazekamp, Per Clausen, Valentina Palmisano, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
| Text proposed by the Commission | Amendment |
|---|---|
| (11) Article 67(1) of Regulation (EC) No 1107/2009 requires that professional users of plant protection products shall, for at least three years, keep records of the plant protection products they use, containing the name of the product, the time and the dose of application, the area and the crop where the plant protection product was used in order to raise the protection of human and animal health and the environment by ensuring the traceability and potential exposure, to increase the efficiency of monitoring and control and to reduce the costs of monitoring water quality. Considering that such information is less relevant for plant protection products containing biocontrol substances, and to reduce the administrative burden for farmers, the obligation to keep records should not apply to plant protection products containing only biocontrol substances. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (11) Article 67(1) of Regulation (EC) No 1107/2009 requires that professional users of plant protection products shall, for at least three years, keep records of the plant protection products they use, containing the name of the product, the time and the dose of application, the area and the crop where the plant protection product was used in order to raise the protection of human and animal health and the environment by ensuring the traceability and potential exposure, to increase the efficiency of monitoring and control and to reduce the costs of monitoring water quality. Considering that such information is less relevant for plant protection products containing biocontrol substances, and to reduce the administrative burden for farmers, the obligation to keep records should not apply to plant protection products containing only biocontrol substances. | (11) Article 67(1) of Regulation (EC) No 1107/2009 requires that professional users of plant protection products shall, for at least three years, keep records of the plant protection products they use, containing the name of the product, the time and the dose of application, the area and the crop where the plant protection product was used in order to raise the protection of human and animal health and the environment by ensuring the traceability and potential exposure, to increase the efficiency of monitoring and control and to reduce the costs of monitoring water quality. Considering that such information is less relevant for plant protection products containing biocontrol substances, and to reduce the administrative burden for farmers, the obligation to keep records should not apply to plant protection products containing only biocontrol substances. Moreover, in order to reduce the administrative burden on farmers, the Commission shall, by no later than 18 months following the adoption of this Regulation, amend Commission Implementing Regulation (EU) 564/2023 so as to simplify the content and delete information with no added value, particularly the EPPO codes and the growth stages of crops according to the BBCH reference work. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (11) Article 67(1) of Regulation (EC) No 1107/2009 requires that professional users of plant protection products shall, for at least three years, keep records of the plant protection products they use, containing the name of the product, the time and the dose of application, the area and the crop where the plant protection product was used in order to raise the protection of human and animal health and the environment by ensuring the traceability and potential exposure, to increase the efficiency of monitoring and control and to reduce the costs of monitoring water quality. Considering that such information is less relevant for plant protection products containing biocontrol substances, and to reduce the administrative burden for farmers, the obligation to keep records should not apply to plant protection products containing only biocontrol substances. | (11) Article 67(1) of Regulation (EC) No 1107/2009 requires that professional users of plant protection products shall, for at least three years, keep records of the plant protection products they use, containing the name of the product, the time and the dose of application, the area and the crop where the plant protection product was used in order to assess in the best possible way the effectiveness of the plant health product in protecting crops, to raise the protection of human and animal health and the environment by ensuring the traceability and potential exposure, to increase the efficiency of monitoring and control and to reduce the costs of monitoring water quality. |
| Text proposed by the Commission | Amendment |
|---|---|
| (11) Article 67(1) of Regulation (EC) No 1107/2009 requires that professional users of plant protection products shall, for at least three years, keep records of the plant protection products they use, containing the name of the product, the time and the dose of application, the area and the crop where the plant protection product was used in order to raise the protection of human and animal health and the environment by ensuring the traceability and potential exposure, to increase the efficiency of monitoring and control and to reduce the costs of monitoring water quality. Considering that such information is less relevant for plant protection products containing biocontrol substances, and to reduce the administrative burden for farmers, the obligation to keep records should not apply to plant protection products containing only biocontrol substances. | (11) Article 67(1) of Regulation (EC) No 1107/2009 requires that professional users of plant protection products shall, for at least three years, keep records of the plant protection products they use, containing the name of the product, the time and the dose of application, the area and the crop where the plant protection product was used in order to raise the protection of human and animal health and the environment by ensuring the traceability and potential exposure, to increase the efficiency of monitoring and control and to reduce the costs of monitoring water quality. Given the importance of reliable data for monitoring, enforcement and the assessment of potential risks, this obligation should continue to apply to plant protection products containing biocontrol substances. The administrative burden linked to record-keeping should be addressed through proportionate and efficient implementation, without compromising traceability and the protection of human and animal health and the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| (11a) In order to ensure long-term regulatory fitness, enable agricultural innovation, and guarantee that European farmers have access to sustainable crop protection tools at a speed competitive with other major global agricultural regions, it is essential to evaluate the long-term appropriateness of the current framework. The Commission should therefore conduct a comprehensive evaluation of procedures for biocontrol authorisation and approval by 31 December 2028. This evaluation should assess whether a standalone legislative framework for biocontrol products with potentially more centralised approach is necessary to establish dedicated, proportionate, and scientifically sound assessment and authorisation and approval procedures. |
| Text proposed by the Commission | Amendment |
|---|---|
| (12) Article 22 of Regulation (EC) No 1107/2009 sets out criteria to identify low-risk active substances, referring to hazard-based criteria for the substance set out in point 5 of Annex II to that Regulation and risk-based criteria for the plant protection products containing them set out in its Article 47. Implementation of these provisions has proven difficult in practice as, at the time of the approval or renewal of approval of active substances, it is generally not known whether the criteria related to products in Article 47 can be fulfilled or not. The criteria should therefore be simplified to only refer to intrinsic properties of the active substance. Furthermore, there have been cases where an active substance could not be approved as low-risk because certain elements related to the criteria could not be fully clarified during the approval or renewal of approval procedure, while further information generated later showed that these are fulfilled. To address such situation, he possibility to apply for a change of the status of an approved active substance to low-risk should be introduced. | (12) Article 22 of Regulation (EC) No 1107/2009 sets out criteria to identify low-risk active substances, referring to hazard-based criteria for the substance set out in point 5 of Annex II to that Regulation and risk-based criteria for the plant protection products containing them set out in its Article 47. Implementation of these provisions has proven difficult in practice as, at the time of the approval or renewal of approval of active substances, it is generally not known whether the criteria related to products in Article 47 can be fulfilled or not. The criteria should therefore be simplified to only refer to intrinsic properties of the active substance, provided that such simplification does not lower the overall level of protection of human health, animal health and the environment, and that the intrinsic hazard-based criteria applied are at least as stringent as those previously required under the combined reading of point 5 of Annex II and Article 47. Furthermore, there have been cases where an active substance could not be approved as low-risk because certain elements related to the criteria could not be fully clarified during the approval or renewal of approval procedure, while further information generated later showed that these are fulfilled. To address such situation, the possibility to apply for a change of the status of an approved active substance to low-risk should be introduced, subject to the same rigorous assessment, evidentiary standards and full re-verification of all criteria in point 5 of Annex II as apply to an initial low-risk approval, and only where that reassessment is based on complete and reliable data leaving no unresolved scientific uncertainty, in order to ensure that low-risk status is granted only where it is clearly and conclusively warranted. |
| Text proposed by the Commission | Amendment |
|---|---|
| (12) Article 22 of Regulation (EC) No 1107/2009 sets out criteria to identify low-risk active substances, referring to hazard-based criteria for the substance set out in point 5 of Annex II to that Regulation and risk-based criteria for the plant protection products containing them set out in its Article 47. Implementation of these provisions has proven difficult in practice as, at the time of the approval or renewal of approval of active substances, it is generally not known whether the criteria related to products in Article 47 can be fulfilled or not. The criteria should therefore be simplified to only refer to intrinsic properties of the active substance. Furthermore, there have been cases where an active substance could not be approved as low-risk because certain elements related to the criteria could not be fully clarified during the approval or renewal of approval procedure, while further information generated later showed that these are fulfilled. To address such situation, he possibility to apply for a change of the status of an approved active substance to low-risk should be introduced. | (12) Article 22 of Regulation (EC) No 1107/2009 sets out criteria to identify low-risk active substances, referring to hazard-based criteria for the substance set out in point 5 of Annex II to that Regulation and risk-based criteria for the plant protection products containing them set out in its Article 47. Implementation of these provisions has proven difficult in practice as, at the time of the approval or renewal of approval of active substances, it is generally not known whether the criteria related to products in Article 47 can be fulfilled or not. The criteria should therefore be clarified and simplified where appropriate, while ensuring that the low-risk status is based on a robust scientific assessment and that a high level of protection of human and animal health and the environment is maintained. Furthermore, there have been cases where an active substance could not be approved as low-risk because certain elements related to the criteria could not be fully clarified during the approval or renewal of approval procedure, while further information generated later showed that these are fulfilled. To address such situation, he possibility to apply for a change of the status of an approved active substance to low-risk should be introduced. Where new scientific evidence demonstrates that an active substance no longer fulfils the applicable criteria for low-risk status, that status should be reassessed and, where appropriate, withdrawn. |
| Text proposed by the Commission | Amendment |
|---|---|
| (12) Article 22 of Regulation (EC) No 1107/2009 sets out criteria to identify low-risk active substances, referring to hazard-based criteria for the substance set out in point 5 of Annex II to that Regulation and risk-based criteria for the plant protection products containing them set out in its Article 47. Implementation of these provisions has proven difficult in practice as, at the time of the approval or renewal of approval of active substances, it is generally not known whether the criteria related to products in Article 47 can be fulfilled or not. The criteria should therefore be simplified to only refer to intrinsic properties of the active substance. Furthermore, there have been cases where an active substance could not be approved as low-risk because certain elements related to the criteria could not be fully clarified during the approval or renewal of approval procedure, while further information generated later showed that these are fulfilled. To address such situation, he possibility to apply for a change of the status of an approved active substance to low-risk should be introduced. | (12) Article 22 of Regulation (EC) No 1107/2009 sets out criteria to identify low-risk active substances, referring to hazard-based criteria for the substance set out in point 5 of Annex II to that Regulation and risk-based criteria for the plant protection products containing them set out in its Article 47. Implementation of these provisions has proven difficult in practice as, at the time of the approval or renewal of approval of active substances, it is generally not known whether the criteria related to products in Article 47 can be fulfilled or not. The criteria should therefore be simplified to only refer to intrinsic properties of the active substance. Furthermore, there have been cases where an active substance could not be approved as low-risk because certain elements related to the criteria could not be fully clarified during the approval or renewal of approval procedure, while further information generated later showed that these are fulfilled. To address such situation, he possibility to apply for a change of the status of an approved active substance to low-risk should be introduced. |
| Text proposed by the Commission | Amendment |
|---|---|
| (13) The provisions related to basic substances in Regulation (EC) No 1107/2009 have proven to be unclear, which has led to disharmonised implementation across Member States and hinders the availability of those substances to farmers. Therefore, a clear definition of basic substance should be included in Article 3. specifying that basic substances include foodstuff as defined under Article 2 of Regulation (EC) No 178/2002 as well as substances for which any relevant evaluations, carried out in accordance with other Union legislation regulating the use of that substance for purposes other than for a plant protection product, show that the substance has neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment. | (13) The provisions related to basic substances in Regulation (EC) No 1107/2009 have proven to be unclear, which has led to disharmonised implementation across Member States and hinders the availability of those substances to farmers. Therefore, a clear definition of basic substance should be included in Article 3. specifying that basic substances include foodstuff as defined under Article 2 of Regulation (EC) No 178/2002 as well as substances for which any relevant evaluations, carried out in accordance with other Union legislation regulating the use of that substance for purposes other than for a plant protection product, show that the substance has neither an immediate or delayed harmful effect on human or animal health nor an unacceptable effect on the environment, provided that such evaluations are sufficiently comprehensive to assess the relevant risks arising from the use of the substance as a basic substance under Regulation (EC) No 1107/2009.. |
| Text proposed by the Commission | Amendment |
|---|---|
| (13a) Certain active substances approved under Regulation (EC) No 1107/2009 are identified as candidates for substitution due to their higher intrinsic hazard profiles or persistent properties. While these substances may still be authorised under strict agricultural conditions where no viable alternatives exist, their use in non-agricultural settings poses a disproportionate and unnecessary exposure risk to the public, and in particular to vulnerable groups. Vulnerable populations, including children, the elderly, pregnant women, and persons undergoing medical treatment, are highly sensitive to chemical exposure and often frequent specific public or semi-public spaces. In order to guarantee a high level of health protection, plant protection products containing candidates for substitution should be strictly excluded from non-agricultural uses, particularly in areas where these populations are present or care is provided, such as nurseries, kindergartens, schools, playgrounds, hospitals, healthcare facilities, care homes and other public spaces. Minimizing chemical exposure at source in these sensitive environments is a necessary precautionary measure to safeguard public health. |
| Text proposed by the Commission | Amendment |
|---|---|
| (13a) Aligning unlimited low-risk and biocontrol approvals with unlimited product authorisations would enhance commercial predictability and encourage investment in product authorisations and the expansion of authorised uses. | |
| Safety safeguards would be maintained through ad hoc reviews under Article 21 of Regulation (EC) No 1107/2009, based on new scientific evidence, and through the emergency measures provided for in Article 69 of Regulation (EC) No 1107/2009. In addition, selective periodic reviews triggered by objective criteria would enable more efficient use of resources and enhance competitiveness, considering that several major jurisdictions do not require mandatory periodic renewals of active substance approvals. |
| Text proposed by the Commission | Amendment |
|---|---|
| Separate provisions for the approval criteria for basic substances and the application procedure should be set out, as well as more specific labelling requirements to better inform users about the conditions of use. It should also be clarified that in addition to use, the placing on the market of approved basic substances for plant protection purposes does not require an authorisation by Member States to allow for easier access to basic substances by farmers in a suitable form. Transitional provisions should be added so that all basic substances that are approved at the moment of the entry into force of this Regulation could be placed on the market in the Union, without any restrictions stemming from the superseded rules, ensuring level-playing field for all users in all Member States. | Separate provisions for the approval criteria for basic substances and the application procedure should be set out, as well as more specific labelling requirements to better inform users about the conditions of use. It should also be clarified that in addition to use, the placing on the market of approved basic substances for plant protection purposes does not require an authorisation by Member States to allow for easier access to basic substances by farmers in a suitable form. Transitional provisions should be added so that all basic substances that are approved at the moment of the entry into force of this Regulation could be placed on the market in the Union, without any restrictions stemming from the superseded rules, ensuring level-playing field for all users in all Member States. In order to support the transition towards greater simplification and harmonisation of the internal market, the European Commission should propose a single authorisation for placing plant protection products on the market at Union level, rather than a system based on a European approval for active substances followed by national authorisations for products. |
Biljana Borzan, Gheorghe Cârciu, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| Separate provisions for the approval criteria for basic substances and the application procedure should be set out, as well as more specific labelling requirements to better inform users about the conditions of use. It should also be clarified that in addition to use, the placing on the market of approved basic substances for plant protection purposes does not require an authorisation by Member States to allow for easier access to basic substances by farmers in a suitable form. Transitional provisions should be added so that all basic substances that are approved at the moment of the entry into force of this Regulation could be placed on the market in the Union, without any restrictions stemming from the superseded rules, ensuring level-playing field for all users in all Member States. | Separate provisions for the approval criteria for basic substances and the application procedure should be set out, as well as more specific labelling requirements to better inform users about the conditions of use. It should also be clarified that in addition to their use, the placing on the market of approved basic substances for plant protection purposes does not require an authorisation by Member States, to allow for easier access on the market of approved basic substances for plant protection purposes does not require an authorisation by Member States to allow for easier access to basic substances by farmers in a suitable form. Transitional provisions should be added so that all basic substances that are approved at the moment of the entry into force of this Regulation could be placed on the market in the Union, without any restrictions stemming from the superseded rules, ensuring level-playing field for all users in all Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| The European Food Safety Authority (EFSA) is central to the Union’s risk assessment system for active substances used in plant protection products. EFSA has indicated that an additional allocation of approximately 50 staff members and EUR 15 million per year would enable it to address the current backlog within an estimated period of three years. Strengthening EFSA’s staffing and financial resources accordingly is therefore essential to ensure timely delivery of scientific conclusions, maintain the quality and independence of risk assessments, as required under this Regulation. |
| Text proposed by the Commission | Amendment |
|---|---|
| In order to support a transition towards more sustainable active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Therefore, approvals for active substances should become unlimited in time, except for active substances that are candidates for substitution, those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these have properties that are of concern to human or animal health or the environment and those approved for a limited period for reasons linked to the results of the risk assessment. It should still be possible to set time limits for approvals if found appropriate in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The Commission should also be able to identify active substances with unlimited approval for which a full renewal procedure should be carried out or identify active substances with unlimited or limited approval periods for targeted reassessment. Identification of active substances should be based on multiple criteria and requests from Member States. In addition, the possibility for ad-hoc reviews of active substances at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| In order to support a transition towards more sustainable active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Therefore, approvals for active substances should become unlimited in time, except for active substances that are candidates for substitution, those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these have properties that are of concern to human or animal health or the environment and those approved for a limited period for reasons linked to the results of the risk assessment. It should still be possible to set time limits for approvals if found appropriate in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The Commission should also be able to identify active substances with unlimited approval for which a full renewal procedure should be carried out or identify active substances with unlimited or limited approval periods for targeted reassessment. Identification of active substances should be based on multiple criteria and requests from Member States. In addition, the possibility for ad-hoc reviews of active substances at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained. | deleted |
A periodic review of active substances is essential. Since 2011, the renewal process has led to the non-approval or withdrawal of 54 active substances due to identified risks to human health or the environment. Without periodical review, harmful substances might have remained on the market. Also, the introduction of unlimited approvals shifts the burden of identifying harmful properties to public authorities and publicly funded researches, thereby shifting costs from industry to taxpayers.
| Text proposed by the Commission | Amendment |
|---|---|
| In order to support a transition towards more sustainable active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Therefore, approvals for active substances should become unlimited in time, except for active substances that are candidates for substitution, those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these have properties that are of concern to human or animal health or the environment and those approved for a limited period for reasons linked to the results of the risk assessment. It should still be possible to set time limits for approvals if found appropriate in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The Commission should also be able to identify active substances with unlimited approval for which a full renewal procedure should be carried out or identify active substances with unlimited or limited approval periods for targeted reassessment. Identification of active substances should be based on multiple criteria and requests from Member States. In addition, the possibility for ad-hoc reviews of active substances at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained. | deleted |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| In order to support a transition towards more sustainable active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Therefore, approvals for active substances should become unlimited in time, except for active substances that are candidates for substitution, those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these have properties that are of concern to human or animal health or the environment and those approved for a limited period for reasons linked to the results of the risk assessment. It should still be possible to set time limits for approvals if found appropriate in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The Commission should also be able to identify active substances with unlimited approval for which a full renewal procedure should be carried out or identify active substances with unlimited or limited approval periods for targeted reassessment. Identification of active substances should be based on multiple criteria and requests from Member States. In addition, the possibility for ad-hoc reviews of active substances at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained. | In order to support a transition towards more sustainable active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Administrative simplification should not weaken the preventive, science-based system of periodic review of active substances. Approvals should therefore remain time-limited and subject to periodic renewal in accordance with this Regulation. Where appropriate, longer approval periods may be provided for low-risk active substances, provided that the applicable approval criteria continue to be fulfilled. Periodic renewal remains the appropriate mechanism to ensure that approvals continue to reflect the latest scientific and technical knowledge while allowing competent authorities to prioritise the assessment of innovative and lower-risk active substances. |
Simplification should reduce administrative burden without weakening the preventive, science-based system for assessing active substances. Periodic renewal remains an essential safeguard to ensure that approvals reflect the latest scientific evidence while supporting faster access to innovative, low-risk and biocontrol solutions.
| Text proposed by the Commission | Amendment |
|---|---|
| In order to support a transition towards more sustainable active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Therefore, approvals for active substances should become unlimited in time, except for active substances that are candidates for substitution, those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these have properties that are of concern to human or animal health or the environment and those approved for a limited period for reasons linked to the results of the risk assessment. It should still be possible to set time limits for approvals if found appropriate in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The Commission should also be able to identify active substances with unlimited approval for which a full renewal procedure should be carried out or identify active substances with unlimited or limited approval periods for targeted reassessment. Identification of active substances should be based on multiple criteria and requests from Member States. In addition, the possibility for ad-hoc reviews of active substances at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained. | In order to support a transition towards more sustainable active substances and plant protection products, resources should be made available for the assessment of applications for new active substances and products. Therefore, approvals for low-risk active substances and low risk biocontrol should become unlimited in time as these have properties that are of low concern to human or animal health or the environment. The Commission should also be able to identify active substances with unlimited approval for which a full renewal procedure should be carried out or identify active substances and low risk biocontrol with unlimited or limited approval periods for targeted reassessment. Identification of active substances and low risk biocontrol should be based on multiple criteria and requests from Member States. In addition, the possibility for ad-hoc reviews of active substances and low risk biocontrol at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained. |
| Text proposed by the Commission | Amendment |
|---|---|
| In order to support a transition towards more sustainable active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Therefore, approvals for active substances should become unlimited in time, except for active substances that are candidates for substitution, those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these have properties that are of concern to human or animal health or the environment and those approved for a limited period for reasons linked to the results of the risk assessment. It should still be possible to set time limits for approvals if found appropriate in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The Commission should also be able to identify active substances with unlimited approval for which a full renewal procedure should be carried out or identify active substances with unlimited or limited approval periods for targeted reassessment. Identification of active substances should be based on multiple criteria and requests from Member States. In addition, the possibility for ad-hoc reviews of active substances at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained. | In order to support a transition towards more sustainable, modern and effective active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Therefore, approvals for active substances should not follow any calendar-based logic in being defined by an expiry date, except for active substances that are candidates for substitution, those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these have properties that are of concern to human or animal health or the environment and those approved for a limited period for reasons linked to the results of the risk assessment. It should still be possible to set time limits for approvals if found appropriate in the light of the outcome of the risk assessment conducted prior to a decision on an approval. It is therefore not a matter of having no unlimited period, but rather the absence of a predetermined expiry date. The Commission should also be able to identify active substances with approval without a defined expiry date for which a full renewal procedure should be carried out or identify active substances with approval periods with or without a defined expiry date for targeted reassessment. Identification of active substances should be based on multiple criteria and requests from Member States, without any influence from stakeholders. In addition, the possibility for ad-hoc reviews of active substances at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained. |
Benoit Cassart, Gerben-Jan Gerbrandy, Pascal Canfin, Olivier Chastel, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen
| Text proposed by the Commission | Amendment |
|---|---|
| In order to support a transition towards more sustainable active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Therefore, approvals for active substances should become unlimited in time, except for active substances that are candidates for substitution, those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these have properties that are of concern to human or animal health or the environment and those approved for a limited period for reasons linked to the results of the risk assessment. It should still be possible to set time limits for approvals if found appropriate in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The Commission should also be able to identify active substances with unlimited approval for which a full renewal procedure should be carried out or identify active substances with unlimited or limited approval periods for targeted reassessment. Identification of active substances should be based on multiple criteria and requests from Member States. In addition, the possibility for ad-hoc reviews of active substances at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained. | In order to support a transition towards more sustainable active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Therefore, approvals for active substances should become unlimited in time only for biocontrol active substances and low-risk active substances as well as plant protection products containing them. It should still be possible to set time limits for approvals if found appropriate in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The Commission should also be able to identify active substances with unlimited approval for which a full renewal procedure should be carried out or identify active substances with unlimited or limited approval periods for targeted reassessment. Identification of active substances should be based on multiple criteria and requests from Member States. In addition, the possibility for ad-hoc reviews of active substances at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained. |
| Text proposed by the Commission | Amendment |
|---|---|
| In order to support a transition towards more sustainable active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Therefore, approvals for active substances should become unlimited in time, except for active substances that are candidates for substitution, those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these have properties that are of concern to human or animal health or the environment and those approved for a limited period for reasons linked to the results of the risk assessment. It should still be possible to set time limits for approvals if found appropriate in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The Commission should also be able to identify active substances with unlimited approval for which a full renewal procedure should be carried out or identify active substances with unlimited or limited approval periods for targeted reassessment. Identification of active substances should be based on multiple criteria and requests from Member States. In addition, the possibility for ad-hoc reviews of active substances at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained. | In order to support a transition towards more sustainable active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Therefore, approvals for active substances should become unlimited in time, except for active substances that are candidates for substitution, those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these have properties that are of concern to human or animal health or the environment and those approved for a limited period for reasons linked to the results of the risk assessment. It should still be possible to set reasonable time limits for approvals if found appropriate in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The Commission should also be able to identify active substances with unlimited approval for which a full renewal procedure should be carried out or identify active substances with unlimited or limited approval periods for targeted reassessment. Identification of active substances should be based on multiple criteria and requests from Member States. In addition, the possibility for ad-hoc reviews of active substances at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained, the identification of active substances carried out at the request of a Member State should be applied in all Member States. |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| In order to support a transition towards more sustainable active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Therefore, approvals for active substances should become unlimited in time, except for active substances that are candidates for substitution, those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these have properties that are of concern to human or animal health or the environment and those approved for a limited period for reasons linked to the results of the risk assessment. It should still be possible to set time limits for approvals if found appropriate in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The Commission should also be able to identify active substances with unlimited approval for which a full renewal procedure should be carried out or identify active substances with unlimited or limited approval periods for targeted reassessment. Identification of active substances should be based on multiple criteria and requests from Member States. In addition, the possibility for ad-hoc reviews of active substances at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained. | In order to support a transition towards more sustainable active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Therefore, approvals for active substances should be granted for a period not exceeding 15 years, with shorter approval periods maintained for active substances that are candidates for substitution, those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these have properties that are of concern to human or animal health or the environment, and those approved for a limited period for reasons linked to the results of the risk assessment. It should still be possible to set shorter time limits, within this maximum period, for approvals if found appropriate in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The Commission should also be able to identify active substances approaching the end of their approval period for which a full renewal procedure should be carried out or identify active substances with limited approval periods for targeted reassessment. Identification of active substances should be based on multiple criteria and requests from Member States. In addition, the possibility for ad-hoc reviews of active substances at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained. |
| Text proposed by the Commission | Amendment |
|---|---|
| In order to support a transition towards more sustainable active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Therefore, approvals for active substances should become unlimited in time, except for active substances that are candidates for substitution, those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these have properties that are of concern to human or animal health or the environment and those approved for a limited period for reasons linked to the results of the risk assessment. It should still be possible to set time limits for approvals if found appropriate in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The Commission should also be able to identify active substances with unlimited approval for which a full renewal procedure should be carried out or identify active substances with unlimited or limited approval periods for targeted reassessment. Identification of active substances should be based on multiple criteria and requests from Member States. In addition, the possibility for ad-hoc reviews of active substances at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained. | In order to support a transition towards more sustainable active substances and plant protection products, resources in the Member States currently dedicated to renewal procedures should be made available for the assessment of applications for new active substances and products. Therefore, approvals for active substances should become unlimited in time, except for active substances that are candidates for substitution, those approved under Article 4(7) of Regulation (EC) No 1107/2009 as these have properties that are of concern to human or animal health or the environment and those approved for a limited period for reasons linked to the results of the risk assessment. It should still be possible to set time limits for approvals if found appropriate in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The Commission should also be able to identify low-risk active substances with unlimited approval for which a full renewal procedure should be carried out or identify active substances with unlimited or limited approval periods for targeted reassessment. Identification of active substances should be based on multiple criteria and requests from Member States. In addition, the possibility for ad-hoc reviews of active substances at any time as already foreseen in Article 21 of Regulation (EC) No 1107/2009 should be maintained. |
| Text proposed by the Commission | Amendment |
|---|---|
| For each low-risk plant protection product and biocontrol approved for an unlimited duration, the European Food Safety Authority should, in cooperation with the Commission and the Member States, develop a product-specific detection protocol, drawing on the example of risk-based monitoring systems established for medicinal products. That protocol should be accompanied by monitoring parameters, including relevant indicators, trigger values and follow-up criteria, in order to ensure that risk-based follow-up measures are triggered on the basis of post-registration data and safety signals, in a manner analogous to pharmacovigilance systems used for the continuous monitoring of the safety of medicinal products after their placing on the market. |
Benoit Cassart, Christine Singer, Pascal Canfin, Olivier Chastel, Ciaran Mullooly, Asger Christensen
| Text proposed by the Commission | Amendment |
|---|---|
| Furthermore, to reduce the administrative burden for the Authority, the national competent authorities and the economic operators while ensuring a stable and predictable framework for the farmers, active substances which are neither biocontrol nor low-risk active substance should benefit from longer period for the first approval and subsequent renewals of approval except for active substances that are candidates for subsitution, those approved under Article 4(7) of Regulation (EC) No 1107/2009 and those approved for a limited period for reasons linked to the results of the risk assessment which remain unchanged. |
| Text proposed by the Commission | Amendment |
|---|---|
| (15) In the interest of predictability, efficiency, consistency and transparency, rules setting out the provisions necessary for the implementation of targeted reassessments should also be created. | (15) In the interest of predictability, efficiency, consistency and transparency, rules setting out the provisions necessary for the implementation of targeted reassessments should also be created. |
| To maintain a high level of human health and the environment, the Commission should have the possibility to ask the Authority to review relevant scientific literature and monitoring data, when available, on approved active substances. Targeted reassessments should be conducted through a dedicated work programme. This work programme should be communicated transparently with clear planning and timelines, so that competent authorities of Member States and economic actors can plan accordingly. |
| Text proposed by the Commission | Amendment |
|---|---|
| (15a) Following the targeted reassessment of an active substance, safener or synergist, existing plant protection products containing those substances should also be reassessed to check whether they comply with the conditions of approval for the active substance, safener or synergist contained therein, and with the requirements for authorisation of plant protection products set out in Article 29 of Regulation (EC) No 1107/2009. Applicants should provide the necessary information to demonstrate such compliance and Member States should assess it. |
| Text proposed by the Commission | Amendment |
|---|---|
| (16) Article 4(7) of Regulation (EC) No 1107/2009 provides for a derogation to allow for the approval of active substances not meeting the approval criteria laid down in Article 4 and Annex II where it is necessary to do so because of a serious danger to plant health which cannot be contained by other reasonable means including chemical and non-chemical methods with comparable costs, availability and efficacy, except for active substances having particularly hazardous properties. Experience has shown that it is necessary to clarify the scope of the criteria for which such derogation is possible. A harmonised derogation in certain cases where a serious danger to plant health which cannot be contained by other reasonable means would reduce the administrative burden for Member States authorising plant protection products containing such active substances under Article 53 and will contribute to reducing disparity for access to plant protection products containing the substances concerned between the farmers located in different Member States. It should also be possible that in addition to the information included in an application for approval or renewal of approval of an active substance any other information provided in the course of the approval procedure may also be taken into account when considering the possibility to grant the derogation. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (16) Article 4(7) of Regulation (EC) No 1107/2009 provides for a derogation to allow for the approval of active substances not meeting the approval criteria laid down in Article 4 and Annex II where it is necessary to do so because of a serious danger to plant health which cannot be contained by other reasonable means including chemical and non-chemical methods with comparable costs, availability and efficacy, except for active substances having particularly hazardous properties. Experience has shown that it is necessary to clarify the scope of the criteria for which such derogation is possible. A harmonised derogation in certain cases where a serious danger to plant health which cannot be contained by other reasonable means would reduce the administrative burden for Member States authorising plant protection products containing such active substances under Article 53 and will contribute to reducing disparity for access to plant protection products containing the substances concerned between the farmers located in different Member States. It should also be possible that in addition to the information included in an application for approval or renewal of approval of an active substance any other information provided in the course of the approval procedure may also be taken into account when considering the possibility to grant the derogation. | (16) Article 4(7) of Regulation (EC) No 1107/2009 provides for a derogation to allow for the approval of active substances not meeting the approval criteria laid down in Article 4 and Annex II only in strictly exceptional and time-limited circumstances where it has been independently demonstrated, on the basis of documented evidence included in the application or provided in the course of the approval procedure and verified by the European Food Safety Authority, that such approval is necessary because of a serious danger to plant health which cannot be contained by other reasonable means including integrated pest management, resistant crop varieties, agronomic practices, biological control and other non-chemical or lower-risk methods. Such derogation should not undermine the approval criteria laid down in Article 4 and Annex II and should not apply to active substances meeting the hazard-based exclusion criteria established by this Regulation. Experience has shown that it is necessary to clarify the scope of the criteria for which such derogation is possible and the conditions under which it may be applied, ensuring that the derogation remains exceptional and does not lower the level of protection of human and animal health and the environment. A harmonised derogation in certain cases where a serious danger to plant health which cannot be contained by other reasonable means would reduce the administrative burden for Member States authorising plant protection products containing such active substances under Article 53 and will contribute to reducing disparity for access to plant protection products containing the substances concerned between the farmers located in different Member States. Such approvals should be restricted to the crops, target organisms, geographical areas and duration strictly necessary to address the identified danger and should be subject to appropriate risk mitigation measures and regular review. It should also be possible that in addition to the information included in an application for approval or renewal of approval of an active substance any other information provided in the course of the approval procedure may also be taken into account when considering the possibility to grant the derogation. Approvals granted pursuant to this derogation should be accompanied by measures to promote the development, assessment and deployment of sustainable alternatives, with a view to phasing out the use of such active substances. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (16) Article 4(7) of Regulation (EC) No 1107/2009 provides for a derogation to allow for the approval of active substances not meeting the approval criteria laid down in Article 4 and Annex II where it is necessary to do so because of a serious danger to plant health which cannot be contained by other reasonable means including chemical and non-chemical methods with comparable costs, availability and efficacy, except for active substances having particularly hazardous properties. Experience has shown that it is necessary to clarify the scope of the criteria for which such derogation is possible. A harmonised derogation in certain cases where a serious danger to plant health which cannot be contained by other reasonable means would reduce the administrative burden for Member States authorising plant protection products containing such active substances under Article 53 and will contribute to reducing disparity for access to plant protection products containing the substances concerned between the farmers located in different Member States. It should also be possible that in addition to the information included in an application for approval or renewal of approval of an active substance any other information provided in the course of the approval procedure may also be taken into account when considering the possibility to grant the derogation. | (16) Article 4(7) of Regulation (EC) No 1107/2009 provides for a derogation to allow for the approval of active substances not meeting the approval criteria laid down in Article 4 and Annex II where it is necessary to do so because of a serious danger to plant health which cannot be contained by other reasonable means including chemical and non-chemical methods with comparable costs, availability and efficacy, except for active substances having particularly hazardous properties. Experience has shown that it is necessary to clarify the scope of the criteria for which such derogation is possible, because as things stand, no derogations have been granted. As things stand, such a derogation may only be applied for during the procedure to approve or renew the active substance, in other words, even though developments in scientific knowledge, resistance or the availability of alternatives may occur at any point during the period in respect of which the approval is granted. It is therefore worth allowing the owner to be able to apply for such a derogation at any time during that period. A harmonised derogation in certain cases where a serious danger to plant health which cannot be contained by other reasonable means would reduce the administrative burden for Member States authorising plant protection products containing such active substances under Article 53 and will contribute to reducing disparity for access to plant protection products containing the substances concerned between the farmers located in different Member States. It should also be possible that in addition to the information included in an application for approval or renewal of approval of an active substance any other information provided in the course of the approval procedure may also be taken into account when considering the possibility to grant the derogation. |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| (16) Article 4(7) of Regulation (EC) No 1107/2009 provides for a derogation to allow for the approval of active substances not meeting the approval criteria laid down in Article 4 and Annex II where it is necessary to do so because of a serious danger to plant health which cannot be contained by other reasonable means including chemical and non-chemical methods with comparable costs, availability and efficacy, except for active substances having particularly hazardous properties. Experience has shown that it is necessary to clarify the scope of the criteria for which such derogation is possible. A harmonised derogation in certain cases where a serious danger to plant health which cannot be contained by other reasonable means would reduce the administrative burden for Member States authorising plant protection products containing such active substances under Article 53 and will contribute to reducing disparity for access to plant protection products containing the substances concerned between the farmers located in different Member States. It should also be possible that in addition to the information included in an application for approval or renewal of approval of an active substance any other information provided in the course of the approval procedure may also be taken into account when considering the possibility to grant the derogation. | (16) Article 4(7) of Regulation (EC) No 1107/2009 provides for a derogation to allow for the approval of active substances not meeting the approval criteria laid down in Article 4 and Annex II where it is necessary to do so because of a serious danger to plant health which cannot be contained by other reasonable means including chemical and non-chemical methods with comparable costs, availability and efficacy, except for active substances having particularly hazardous properties. Experience has shown that the scope of this derogation should be clarified while preserving its exceptional nature. The derogation should remain limited to cases where no other reasonable means of control are available and should not be extended to active substances with the most hazardous properties. The obligation for Member States to draw up a phasing-out plan should be maintained in order to support the progressive replacement of such substances with safer alternatives. However, without an obligation on companies to submit updated toxicity data at regular intervals, significantly fewer new scientific data would be generated.The state of knowledge could then evolve only through independent scientific literature, without industry being obliged to contribute to it. The exceptions provided for candidates for substitution or for active substances falling under the Article 4(7) derogation are insufficient, on their own, to ensure an acceptable level of protection, as they would concern only a small proportion of active substances. |
Article 4(7) is an exceptional derogation and should remain narrowly defined. Clarifying its scope should not result in broader access to derogations or the removal of safeguards designed to promote the substitution of the most hazardous active substances.
| Text proposed by the Commission | Amendment |
|---|---|
| (16) Article 4(7) of Regulation (EC) No 1107/2009 provides for a derogation to allow for the approval of active substances not meeting the approval criteria laid down in Article 4 and Annex II where it is necessary to do so because of a serious danger to plant health which cannot be contained by other reasonable means including chemical and non-chemical methods with comparable costs, availability and efficacy, except for active substances having particularly hazardous properties. Experience has shown that it is necessary to clarify the scope of the criteria for which such derogation is possible. A harmonised derogation in certain cases where a serious danger to plant health which cannot be contained by other reasonable means would reduce the administrative burden for Member States authorising plant protection products containing such active substances under Article 53 and will contribute to reducing disparity for access to plant protection products containing the substances concerned between the farmers located in different Member States. It should also be possible that in addition to the information included in an application for approval or renewal of approval of an active substance any other information provided in the course of the approval procedure may also be taken into account when considering the possibility to grant the derogation. | (16) Article 4(7) of Regulation (EC) No 1107/2009 provides for a derogation to allow for the approval of active substances not meeting the approval criteria laid down in Article 4 and Annex II where it is necessary to do so because of a serious danger to plant health which cannot be contained by other reasonable means with comparable costs and efficiency including chemical and non-chemical methods with comparable costs, availability and efficacy, except for active substances having particularly hazardous properties. Experience has shown that it is necessary to clarify the scope of the criteria for which such derogation is possible. A harmonised derogation in certain cases where a serious danger to plant health which cannot be contained by other reasonable means would reduce the administrative burden for Member States authorising plant protection products containing such active substances under Article 53 and will contribute to reducing disparity for access to plant protection products containing the substances concerned between the farmers located in different Member States. It should also be possible that in addition to the information included in an application for approval or renewal of approval of an active substance any other information provided in the course of the approval procedure may also be taken into account when considering the possibility to grant the derogation. |
| Text proposed by the Commission | Amendment |
|---|---|
| (16a) In the interest of predictability, efficiency, consistency and transparency, binding rules setting out the provisions necessary for the implementation of targeted reassessments should also be established without delay to verify, on the basis of complete and reliable data leaving no unresolved scientific uncertainty, whether existing criteria continue to be met or whether new criteria are fulfilled. Such reassessments should be conducted systematically and on a mandatory basis, whenever new scientific or technical knowledge, including post-registration monitoring data or safety signals, indicates that this may not be the case. Targeted reassessments should be conducted through a dedicated work programme that is legally binding on the Authority and the Commission. This work programme should be published and communicated transparently, with clear planning and timelines, including binding deadlines for completion of each reassessment, so that competent authorities of Member States can plan accordingly and so that low-risk or other status is not maintained beyond the point at which it is scientifically justified. |
| Text proposed by the Commission | Amendment |
|---|---|
| (16a) Minor crops and minor uses often face limited availability of authorised plant protection products due to the high costs and administrative burden associated with generating the data required for authorisation. To improve the availability of plant protection solutions for those crops and uses, those costs and administrative requirements should be minimised. Furthermore, Member States should establish minimal fees for the assessment of the submitted data. Where necessary, Member States may make use test and studies in their possession required for the authorisation of a plant protection product for minor uses, provided that the applicants are scientific bodies, agricultural research institutions, or professional agricultural organisations. |
The European Commission and Member States should not use public funds to generate data for registering plant protection products that primarily benefit commercial companies. However, Member States may reduce assessment costs and data requirements for minor uses, provided safety is maintained. Allowing public bodies, research institutions, and farmers’ organisations to use existing industry-owned data would facilitate registrations, as new studies are often unnecessary. For example, residue data for carrots can often be extrapolated to parsnips.
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (16a) Agricultural land plays a fundamental role in ensuring the production of food, feed and raw materials and is essential for the Union’s food security, competitiveness and strategic autonomy. Plant protection products contribute to safeguarding agricultural production and should support the sustainable use of agricultural land for these purposes. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (16b) In exceptional circumstances, the non-approval or non-renewal of an active substance may have disproportionate consequences for agricultural viability, food production or food security compared to the risks arising from its use. This may occur where endemic soil pests cause recurrent crop losses, effective alternatives are unavailable and seed treatment remains the only technically viable preventive measure. In such cases, approval or renewal should be possible, provided that appropriate risk mitigation measures are applied. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (16c) The efficacy and risk assessment of active substances should adequately reflect the diversity of agronomic, climatic and environmental conditions across the Union. Where an intended use concerns biogeographical regions with specific pedoclimatic conditions not covered by the rapporteur Member State, relevant Member States, competent authorities and research institutes should be consulted to ensure that regional specificities, scientific expertise and available monitoring data are duly taken into account and that any data gaps are identified before the completion of the peer review. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (16d) Minor crops and minor uses often face limited availability of authorised plant protection products due to the high costs and administrative burden associated with generating the data required for authorisation. To improve the availability of plant protection solutions for those crops and uses, those costs and administrative requirements should be minimised, and the Commission should support the generation of the necessary data and authorisations of the such plant protection products for minor uses. |
| Text proposed by the Commission | Amendment |
|---|---|
| (17a) In order to reduce administrative burdens and significantly shorten waiting times for market access, it is essential to ensure that applications for the approval or modification of active substances are fully complete and of high quality upon initial submission. Incomplete or substandard dossiers clog the regulatory system and create systemic delays that exhaust public resources and stall innovative market entrants. Member States should therefore verify admissibility stringently and reject applications that fail to meet required quality standards. To ensure consistency and transparency across the Union, the Commission should establish detailed criteria for dossier completeness and quality. To facilitate this process, applicants should have access to pre-submission advice. This advisory mechanism should leverage artificial intelligence (AI) and advanced digital tools to optimize dossier preparation, predict data gaps, and automate compliance checks. Furthermore, special focus and tailored administrative support under this pre-submission advice should be directed toward small and medium-sized enterprises (SMEs) and start-ups, which often face resource constraints, thereby safeguarding competitiveness and fostering technological innovation in the agri-food sector. |
Biljana Borzan, Christophe Clergeau, Gheorghe Cârciu, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| (17a) Timely, high-quality scientific assessments depend on the availability of sufficient independent scientific expertise and resources within the European Food Safety Authority. Administrative simplification should therefore be accompanied by adequate funding and staffing for the Authority. Incomplete dossiers submitted by applicants should not delay the regulatory process or compromise the protection of human health or the environment. |
Instead of relying primarily on procedural simplification, the Union should ensure that EFSA has sufficient resources to carry out timely and high-quality scientific assessments. Delays resulting from incomplete dossiers should remain the responsibility of applicants and should not compromise the precautionary approach.
| Text proposed by the Commission | Amendment |
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| (18) Following the non-renewal of approval of an active substance, Member States are to withdraw all authorisations of plant protection products containing that active substance and farmers are to stop using those products. In such situations, Member States need time to enact withdrawals of product authorisations and existing stocks of products become waste unless grace periods are foreseen to allow for placing on the market and use of such stocks. In addition, farmers need time to find alternatives for the no-longer authorised products. Article 20 of Regulation (EC) No 1107/2009 provides the possibility in certain cases the Commission to set maximum grace periods for placing on the market and use of existing stocks of plant protection products for which authorisations are to be withdrawn. However, the conditions set in Article 20 for when such maximum grace periods can be granted should be amended to clarify that the setting of a maximum grace period for distribution and use of existing stocks of plant protection products for which authorisations have to be withdrawn is possible in general, except for cases where there are immediate and serious concerns for human or animal health or the environment and to clarify the link with Article 46. Additionally, the time limit for grace periods of 18 months is insufficient in cases where there are no alternative plant protection products available on the market in particular Member State at the time of withdrawal of the authorisations. Therefore, the maximum duration of grace periods that Member States may set should be increased to a total period of 3 years in such cases so that it allows the Member States enough time to have alternative plant protection products authorised and to allow the farmers to adapt their crop protection solutions. For the same reasons, the grace periods in which the Member States may grant under Article 46 following withdrawals or amendments of authorisations should be aligned with the maximum possible under Article 20. | deleted |
Anja Hazekamp, Per Clausen, Valentina Palmisano, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
| Text proposed by the Commission | Amendment |
|---|---|
| (18) Following the non-renewal of approval of an active substance, Member States are to withdraw all authorisations of plant protection products containing that active substance and farmers are to stop using those products. In such situations, Member States need time to enact withdrawals of product authorisations and existing stocks of products become waste unless grace periods are foreseen to allow for placing on the market and use of such stocks. In addition, farmers need time to find alternatives for the no-longer authorised products. Article 20 of Regulation (EC) No 1107/2009 provides the possibility in certain cases the Commission to set maximum grace periods for placing on the market and use of existing stocks of plant protection products for which authorisations are to be withdrawn. However, the conditions set in Article 20 for when such maximum grace periods can be granted should be amended to clarify that the setting of a maximum grace period for distribution and use of existing stocks of plant protection products for which authorisations have to be withdrawn is possible in general, except for cases where there are immediate and serious concerns for human or animal health or the environment and to clarify the link with Article 46. Additionally, the time limit for grace periods of 18 months is insufficient in cases where there are no alternative plant protection products available on the market in particular Member State at the time of withdrawal of the authorisations. Therefore, the maximum duration of grace periods that Member States may set should be increased to a total period of 3 years in such cases so that it allows the Member States enough time to have alternative plant protection products authorised and to allow the farmers to adapt their crop protection solutions. For the same reasons, the grace periods in which the Member States may grant under Article 46 following withdrawals or amendments of authorisations should be aligned with the maximum possible under Article 20. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (18) Following the non-renewal of approval of an active substance, Member States are to withdraw all authorisations of plant protection products containing that active substance and farmers are to stop using those products. In such situations, Member States need time to enact withdrawals of product authorisations and existing stocks of products become waste unless grace periods are foreseen to allow for placing on the market and use of such stocks. In addition, farmers need time to find alternatives for the no-longer authorised products. Article 20 of Regulation (EC) No 1107/2009 provides the possibility in certain cases the Commission to set maximum grace periods for placing on the market and use of existing stocks of plant protection products for which authorisations are to be withdrawn. However, the conditions set in Article 20 for when such maximum grace periods can be granted should be amended to clarify that the setting of a maximum grace period for distribution and use of existing stocks of plant protection products for which authorisations have to be withdrawn is possible in general, except for cases where there are immediate and serious concerns for human or animal health or the environment and to clarify the link with Article 46. Additionally, the time limit for grace periods of 18 months is insufficient in cases where there are no alternative plant protection products available on the market in particular Member State at the time of withdrawal of the authorisations. Therefore, the maximum duration of grace periods that Member States may set should be increased to a total period of 3 years in such cases so that it allows the Member States enough time to have alternative plant protection products authorised and to allow the farmers to adapt their crop protection solutions. For the same reasons, the grace periods in which the Member States may grant under Article 46 following withdrawals or amendments of authorisations should be aligned with the maximum possible under Article 20. | (18) Following the non-renewal of approval of an active substance, Member States are to withdraw all authorisations of plant protection products containing that active substance and farmers are to stop using those products. In such situations, Member States need time to enact withdrawals of product authorisations and existing stocks of products become waste unless grace periods are foreseen to allow for placing on the market and use of such stocks. In addition, farmers need time to find alternatives for the no-longer authorised products. Article 20 of Regulation (EC) No 1107/2009 provides the possibility in certain cases for the Commission to set maximum grace periods that Member States may apply when withdrawing or amending authorisations of plant protection products following non-renewal of approval of an active substance. Such grace periods should be limited in time and should ensure that the risks to human and animal health and the environment are not prolonged. However, the conditions set in Article 20 for when such maximum grace periods can be granted should be amended to establish clear limits and to ensure that no grace period may be set where the non-renewal of approval is based on the exclusion criteria laid down in Annex II, including criteria relating to carcinogenicity, mutagenicity, reproductive toxicity, endocrine disruption, persistence, bioaccumulation, mobility or other properties of particular concern. For the same reasons, the grace periods provided for under Article 46 following withdrawals, amendments or non-renewals of authorisations should be aligned with the maximum grace periods established under Article 20 and should respect the same limitations. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (18) Following the non-renewal of approval of an active substance, Member States are to withdraw all authorisations of plant protection products containing that active substance and farmers are to stop using those products. In such situations, Member States need time to enact withdrawals of product authorisations and existing stocks of products become waste unless grace periods are foreseen to allow for placing on the market and use of such stocks. In addition, farmers need time to find alternatives for the no-longer authorised products. Article 20 of Regulation (EC) No 1107/2009 provides the possibility in certain cases the Commission to set maximum grace periods for placing on the market and use of existing stocks of plant protection products for which authorisations are to be withdrawn. However, the conditions set in Article 20 for when such maximum grace periods can be granted should be amended to clarify that the setting of a maximum grace period for distribution and use of existing stocks of plant protection products for which authorisations have to be withdrawn is possible in general, except for cases where there are immediate and serious concerns for human or animal health or the environment and to clarify the link with Article 46. Additionally, the time limit for grace periods of 18 months is insufficient in cases where there are no alternative plant protection products available on the market in particular Member State at the time of withdrawal of the authorisations. Therefore, the maximum duration of grace periods that Member States may set should be increased to a total period of 3 years in such cases so that it allows the Member States enough time to have alternative plant protection products authorised and to allow the farmers to adapt their crop protection solutions. For the same reasons, the grace periods in which the Member States may grant under Article 46 following withdrawals or amendments of authorisations should be aligned with the maximum possible under Article 20. | (18) Following the non-renewal of approval of an active substance, Member States are to withdraw all authorisations of plant protection products containing that active substance and farmers are to stop using those products. In such situations, Member States need time to enact withdrawals of product authorisations and existing stocks of products become waste unless grace periods are foreseen to allow for placing on the market and use of such stocks. In addition, farmers need the necessary time to find effective and affordable alternatives for the no-longer authorised products and, in the best-case scenarios, well before the end of the derogation to use those products. Article 20 of Regulation (EC) No 1107/2009 provides the possibility in certain cases the Commission to set maximum grace periods for placing on the market and use of existing stocks of plant protection products for which authorisations are to be withdrawn. However, the conditions set in Article 20 for when such maximum grace periods can be granted should be amended to clarify that the setting of a maximum grace period for distribution and use of existing stocks of plant protection products for which authorisations have to be withdrawn is possible in general, except for cases where there are immediate and serious concerns for human or animal health or the environment and to clarify the link with Article 46. Additionally, the time limit for grace periods of 18 months is insufficient in cases where there are no alternative plant protection products available on the market in particular Member State at the time of withdrawal of the authorisations. Therefore, the maximum duration of grace periods that Member States may set should be increased to a total period of 3 years, with the opportunity to renew it once, in such cases, unless there are immediate and serious concerns for human or animal health or for the environment, so that it allows the Member States enough time to have alternative plant protection products authorised and to allow the farmers to adapt their crop protection solutions. |
| Text proposed by the Commission | Amendment |
|---|---|
| (18) Following the non-renewal of approval of an active substance, Member States are to withdraw all authorisations of plant protection products containing that active substance and farmers are to stop using those products. In such situations, Member States need time to enact withdrawals of product authorisations and existing stocks of products become waste unless grace periods are foreseen to allow for placing on the market and use of such stocks. In addition, farmers need time to find alternatives for the no-longer authorised products. Article 20 of Regulation (EC) No 1107/2009 provides the possibility in certain cases the Commission to set maximum grace periods for placing on the market and use of existing stocks of plant protection products for which authorisations are to be withdrawn. However, the conditions set in Article 20 for when such maximum grace periods can be granted should be amended to clarify that the setting of a maximum grace period for distribution and use of existing stocks of plant protection products for which authorisations have to be withdrawn is possible in general, except for cases where there are immediate and serious concerns for human or animal health or the environment and to clarify the link with Article 46. Additionally, the time limit for grace periods of 18 months is insufficient in cases where there are no alternative plant protection products available on the market in particular Member State at the time of withdrawal of the authorisations. Therefore, the maximum duration of grace periods that Member States may set should be increased to a total period of 3 years in such cases so that it allows the Member States enough time to have alternative plant protection products authorised and to allow the farmers to adapt their crop protection solutions. For the same reasons, the grace periods in which the Member States may grant under Article 46 following withdrawals or amendments of authorisations should be aligned with the maximum possible under Article 20. | (18) Following the non-renewal of approval of an active substance, Member States are to withdraw all authorisations of plant protection products containing that active substance and farmers are to stop using those products after a 30-day notice period. In such situations, Member States need time to enact withdrawals of product authorisations and existing stocks of products become waste unless grace periods are foreseen to allow for placing on the market and use of such stocks. In addition, farmers need time to find alternatives for the no-longer authorised products. Article 20 of Regulation (EC) No 1107/2009 provides the possibility in certain cases the Commission to set maximum grace periods for placing on the market and use of existing stocks of plant protection products for which authorisations are to be withdrawn. However, the conditions set in Article 20 for when such maximum grace periods can be granted should be amended to clarify that the setting of a maximum grace period for distribution and use of existing stocks of plant protection products for which authorisations have to be withdrawn is possible in general, except for cases where there are immediate and serious concerns for human or animal health or the environment and to clarify the link with Article 46. Additionally, the time limit for grace periods of 18 months is insufficient in cases where there are no alternative plant protection products available on the market in particular Member State at the time of withdrawal of the authorisations. Therefore, the maximum duration of grace periods that Member States may set should be increased to a total period of 3 years in such cases so that it allows the Member States enough time to have alternative plant protection products authorised and to allow the farmers to adapt their crop protection solutions. For the same reasons, the grace periods in which the Member States may grant under Article 46 following withdrawals or amendments of authorisations should be aligned with the maximum possible under Article 20. |
| Text proposed by the Commission | Amendment |
|---|---|
| (19) The requirement for Member States to consider current scientific and technical knowledge relevant for the active substance in the context of product authorisations has led to some confusion and divergent interpretation among Member State, diverging outcomes of risk assessments, and, as a consequence, unequal access to plant protection products for farmers depending on the Member State of their establishment. It is therefore necessary to clarify that the Member States should normally rely on in the latest active substance assessments at Union level, while also acknowledging that updates may be needed and in such cases the Member States should notify the Commission so that the scientific and technical knowledge is assessed in a harmonised way. | deleted |
This proposal contradicts EU case law and a national ruling (Paris court of appeal) which established that Member States are obliged to consider the most up-to-date scientific evidence. Furthermore, the proposal possibly contradicts subsidiarity as it could unduly undermine national authorities' power to fully assess product toxicity.https://curia.europa.eu/juris/document/document.jsf%3Bjsessionid%3DEE470B7CF12503FB294CCF661F3BE6AB?cid=1198324&dir=&docid=285185&doclang=EN&mode=lst&occ=first&pageIndex=0&part=1&text=&utm
Anja Hazekamp, Per Clausen, Valentina Palmisano, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
| Text proposed by the Commission | Amendment |
|---|---|
| (19) The requirement for Member States to consider current scientific and technical knowledge relevant for the active substance in the context of product authorisations has led to some confusion and divergent interpretation among Member State, diverging outcomes of risk assessments, and, as a consequence, unequal access to plant protection products for farmers depending on the Member State of their establishment. It is therefore necessary to clarify that the Member States should normally rely on in the latest active substance assessments at Union level, while also acknowledging that updates may be needed and in such cases the Member States should notify the Commission so that the scientific and technical knowledge is assessed in a harmonised way. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (19a) Regulation (EC) No 1107/2009 establishes a system for the approval of active substances and the authorisation of plant protection products based on scientific risk assessment. However, pre-market assessments may not fully capture real-world exposure patterns, in particular for residents, bystanders and vulnerable groups. Vulnerable groups, including children, pregnant persons and persons with increased sensitivity to certain substances, may require particular consideration in accordance with the precautionary principle. Coordinated post-market monitoring should therefore complement existing Union monitoring systems by assessing exposure of humans and the environment, including cumulative and combined exposure, including in areas where residents and vulnerable groups may be exposed, such as residential areas adjacent to treated fields, schools, childcare facilities, healthcare establishments and public spaces. and provide relevant information for the review of approvals and authorisations where the criteria established under this Regulation may no longer be fulfilled. |
| Text proposed by the Commission | Amendment |
|---|---|
| (19a) Following the judgment of the Court of Justice of the European Union in Case C-162/21, which restricted the use of emergency authorizations under Article 53 for Union-restricted substances, an operational and legal impasse has emerged regarding seed treatments in regions facing chronic and documented pest pressures. In accordance with the principle of effectiveness (effet utile), it is imperative to establish a structural, alternative legal framework allowing for the safe, strictly controlled use of treated seeds in specific biogeographical regions, such as the Steppe region, whose distinct pedoclimatic conditions are not adequately represented by standard testing parameters. To prevent systemic disruptions while this long-term framework is being implemented, a complementary, time-limited emergency mechanism under Article 53 should remain accessible to Member States to address acute plant health threats. |
| Text proposed by the Commission | Amendment |
|---|---|
| (19b) Member States whose external borders coincide with the outer boundaries of the Union face exceptional and asymmetric phytosanitary challenges. These border regions are directly exposed to transboundary biological risks from neighboring third countries, where significantly higher predator and pest densities per square meter are tolerated, and where active substances banned within the Union continue to be heavily deployed. Due to this regulatory asymmetry, highly resistant and invasive agricultural pests systematically cross these external borders, causing rapid and widespread infestations in adjacent Member State territories. To safeguard Union food security and the economic viability of border agricultural sectors, it is necessary to establish tailored regulatory mechanisms and derogations that allow these frontline Member States to effectively contain transboundary pest migrations under strict, controlled conditions. |
| Text proposed by the Commission | Amendment |
|---|---|
| (20) Regulation (EU) 2016/20314 aims at preventing the establishment or spreading of pests that would have unacceptable economic, environmental or social impacts on the Union territory including impacts on agricultural production. The timely availability of authorised plant protection product uses is essential to apply the provisions of this Regulation. Member States have repeatedly mentioned difficulties in this regard and, therefore, the timely availability of authorised plant protection product uses across all Member States to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3), 37(2) of Regulation (EU) 2016/2031 should be facilitated. | deleted |
| 4 Regulation (EU) 2016/2031 of the European Parliament of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (OJ L 317, 23.11.2016, pp. 4–104, ELI: http://data.europa.eu/eli/reg/2016/2031/oj). |
| Text proposed by the Commission | Amendment |
|---|---|
| (21) In order to prevent abuse of the mutual recognition system in the light of divergent fees set by the Member States for obtaining authorisations for plant protection products, applications for mutual recognition of a product authorisation should only be possible if the product for which authorisation by mutual recognition is sought is actually placed on the market in the reference Member State. Furthermore, in cases where companies decide to only apply for authorisation of a plant protection product in certain Member States but not in others, it should be made easier for official or scientific bodies involved in agricultural activities or professional agricultural organisations to apply for mutual recognition of product authorisations in these other Member States by lifting the obligation to obtain the consent of the authorisation holder. Moreover, the administrative burden for such applicants, as well as for applicants for the extension of authorisations of products for minor uses, should be reduced by removing the obligation to provide, as part of the applications, certain documents which can be obtained directly from the reference Member State having granted the authorisation for which mutual recognition or extension is sought. | (21) In order to prevent abuse of the mutual recognition system in the light of divergent fees set by the Member States for obtaining authorisations for plant protection products, applications for mutual recognition of a product authorisation should only be possible if the product for which authorisation by mutual recognition is sought is actually placed on the market in the reference Member State. |
Anne-Sophie Frigout, Mireia Borrás Pabón, Gilles Pennelle, Marie-Luce Brasier-Clain, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (22) Divergent views among Member States on whether the sowing of treated seeds constitutes a use of plant protection products has created confusion amongst producers of treated seeds, farmers and competent authorities. Additionally, there are different interpretations as to whether the provision on treated seeds cover also other types of plant reproductive materials such as tubers, bulbs, or seed potatoes. The lack of clarity creates barriers for the free circulation of treated seeds and plant reproductive materials and at the same time has created disparity between the Member States as regards imports of seeds treated with active substances not approved for use in the Union and their sowing. Therefore, the relevant provisions should be clarified, in order to increase harmonisation among Member States. The measures would not create additional burden for the seed treatment industry as treated seeds themselves are still not to be considered a plant protection product. The administrative burden for the farmers should be limited thus specific derogation for the machinery used for the sowing of treated seeds should be provided so that it is not to be regarded as pesticides application equipment within the meaning of Directive 2009/128/EC5 on the sustainable use of pesticides. | deleted |
| 5 Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides, (OJ L 309, 24.11.2009, pp. 71–86, ELI: http://data.europa.eu/eli/dir/2009/128/oj) |
| Text proposed by the Commission | Amendment |
|---|---|
| (22) Divergent views among Member States on whether the sowing of treated seeds constitutes a use of plant protection products has created confusion amongst producers of treated seeds, farmers and competent authorities. Additionally, there are different interpretations as to whether the provision on treated seeds cover also other types of plant reproductive materials such as tubers, bulbs, or seed potatoes. The lack of clarity creates barriers for the free circulation of treated seeds and plant reproductive materials and at the same time has created disparity between the Member States as regards imports of seeds treated with active substances not approved for use in the Union and their sowing. Therefore, the relevant provisions should be clarified, in order to increase harmonisation among Member States. The measures would not create additional burden for the seed treatment industry as treated seeds themselves are still not to be considered a plant protection product. The administrative burden for the farmers should be limited thus specific derogation for the machinery used for the sowing of treated seeds should be provided so that it is not to be regarded as pesticides application equipment within the meaning of Directive 2009/128/EC5 on the sustainable use of pesticides. | (22) Divergent views among Member States on whether the sowing of treated seeds constitutes a use of plant protection products has created confusion amongst producers of treated seeds, farmers and competent authorities. Additionally, there are different interpretations as to whether the provision on treated seeds cover also other types of plant reproductive materials such as tubers, bulbs, or seed potatoes. The lack of clarity creates barriers for the free circulation of treated seeds and plant reproductive materials and at the same time has created disparity between the Member States as regards imports of seeds treated with active substances not approved for use in the Union and their sowing. Therefore, the relevant provisions should be clarified, in order to increase harmonisation among Member States. The measures would not create additional burden for the seed treatment industry as treated seeds themselves are still not to be considered a plant protection product. |
| 5 Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides, (OJ L 309, 24.11.2009, pp. 71–86, ELI: http://data.europa.eu/eli/dir/2009/128/oj) | 5 Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides, (OJ L 309, 24.11.2009, pp. 71–86, ELI: http://data.europa.eu/eli/dir/2009/128/oj) |
| Text proposed by the Commission | Amendment |
|---|---|
| (22) Divergent views among Member States on whether the sowing of treated seeds constitutes a use of plant protection products has created confusion amongst producers of treated seeds, farmers and competent authorities. Additionally, there are different interpretations as to whether the provision on treated seeds cover also other types of plant reproductive materials such as tubers, bulbs, or seed potatoes. The lack of clarity creates barriers for the free circulation of treated seeds and plant reproductive materials and at the same time has created disparity between the Member States as regards imports of seeds treated with active substances not approved for use in the Union and their sowing. Therefore, the relevant provisions should be clarified, in order to increase harmonisation among Member States. The measures would not create additional burden for the seed treatment industry as treated seeds themselves are still not to be considered a plant protection product. The administrative burden for the farmers should be limited thus specific derogation for the machinery used for the sowing of treated seeds should be provided so that it is not to be regarded as pesticides application equipment within the meaning of Directive 2009/128/EC49 on the sustainable use of pesticides. | (22) Divergent views among Member States on whether the sowing of treated seeds constitutes a use of plant protection products has created confusion amongst producers of treated seeds, farmers and competent authorities. Additionally, there are different interpretations as to whether the provision on treated seeds cover also other types of plant reproductive materials such as tubers, bulbs, or seed potatoes. The lack of clarity creates barriers for the free circulation of treated seeds and plant reproductive materials and at the same time has created disparity between the Member States as regards imports of seeds treated with active substances not approved for use in the Union and their sowing and has fragmented the internal market. Therefore, the relevant provisions should be clarified, in order to increase harmonisation among Member States. The measures would not create additional burden for the seed treatment industry as treated seeds themselves are still not to be considered a plant protection product. The administrative burden for the farmers should be limited thus specific derogation for the machinery used for the sowing of treated seeds should be provided so that it is not to be regarded as pesticides application equipment within the meaning of Directive 2009/128/EC49 on the sustainable use of pesticides. |
| 49 Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides, (OJ L 309, 24.11.2009, pp. 71–86, ELI: http://data.europa.eu/eli/dir/2009/128/oj) | 49 Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides, (OJ L 309, 24.11.2009, pp. 71–86, ELI: http://data.europa.eu/eli/dir/2009/128/oj) |
| Text proposed by the Commission | Amendment |
|---|---|
| (22) Divergent views among Member States on whether the sowing of treated seeds constitutes a use of plant protection products has created confusion amongst producers of treated seeds, farmers and competent authorities. Additionally, there are different interpretations as to whether the provision on treated seeds cover also other types of plant reproductive materials such as tubers, bulbs, or seed potatoes. The lack of clarity creates barriers for the free circulation of treated seeds and plant reproductive materials and at the same time has created disparity between the Member States as regards imports of seeds treated with active substances not approved for use in the Union and their sowing. Therefore, the relevant provisions should be clarified, in order to increase harmonisation among Member States. The measures would not create additional burden for the seed treatment industry as treated seeds themselves are still not to be considered a plant protection product. The administrative burden for the farmers should be limited thus specific derogation for the machinery used for the sowing of treated seeds should be provided so that it is not to be regarded as pesticides application equipment within the meaning of Directive 2009/128/EC5 on the sustainable use of pesticides. | (22) Divergent views among Member States on whether the sowing of treated seeds constitutes a use of plant protection products has created confusion amongst producers of treated seeds, farmers and competent authorities. Additionally, there are different interpretations as to whether the provision on treated seeds cover also other types of plant reproductive materials such as tubers, bulbs, or seed potatoes. The lack of clarity creates barriers for the free circulation of treated seeds and plant reproductive materials and at the same time has created disparity between the Member States as regards imports of seeds treated with active substances not approved for use in the Union and their sowing. Therefore, the relevant provisions should be clarified, in order to increase harmonisation among Member States. The measures would not create additional burden for the seed treatment industry as treated seeds themselves are still not to be considered a plant protection product. The administrative burden for the farmers should be limited thus specific derogation for open spaces, for the machinery used for the sowing of treated seeds should be provided so that it is not to be regarded as pesticides application equipment within the meaning of Directive 2009/128/EC5 on the sustainable use of pesticides. |
| 5 Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides, (OJ L 309, 24.11.2009, pp. 71–86, ELI: http://data.europa.eu/eli/dir/2009/128/oj) | 5 Directive 2009/128/EC of the European Parliament and of the Council of 21 October 2009 establishing a framework for Community action to achieve the sustainable use of pesticides, (OJ L 309, 24.11.2009, pp. 71–86, ELI: http://data.europa.eu/eli/dir/2009/128/oj) |
| Text proposed by the Commission | Amendment |
|---|---|
| (22a) In order to ensure the predictable and proportionate application of Regulation 1107/2009, consideration must be given to the situation of products whose regulatory classification does not follow clearly from the wording of this Regulation and may depend on the interpretive practice of the competent authorities. In particular, this concerns foreign products which have been placed on the market or used in one or more Member States for a significant period of time within a defined regulatory context, including on the basis of existing guidelines, Commission working documents, the practices of domestic authorities or other positions aimed at harmonising the approach followed by the Member States. It has been reasonable for operators and users to assume that the regulatory status of such products does not require them to be brought within the scope of Regulation 1107/2009, in particular if the competent authorities have not previously questioned their presence on the market. If, as a result of a change in interpretive approach or amendments to the working documents, guidelines or positions of the competent authorities, these products are then deemed to be covered by the scope of Regulation 1107/2009, the consequences of such a change or such amendments should be implemented in an orderly and proportionate manner. This requires consideration to be given not only to the protection of human and animal health and the environment, but also to the legitimate interests of users and the need to avoid sudden and excessive disturbances in economic activity. |
Anja Hazekamp, Per Clausen, Valentina Palmisano, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
| Text proposed by the Commission | Amendment |
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| (23) Some of the conditions for obtaining authorisations for plant protection products for minor uses set out in Article 51 of Regulation (EC) No 1107/2009 haven proven to be too restrictive and should be removed in order to make more products available to farmers. Furthermore, the implementation of that Article varies significantly across Member States. Therefore, the transparency should be improved, and the Commission should be empowered to adopt implementing acts harmonising the procedures for granting extensions of authorisations for minor uses and for authorisations by mutual recognition in order to achieve more harmonised availability of plant protection products for minor uses. | deleted |
Biljana Borzan, Gheorghe Cârciu, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
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| (23a) A priority evaluation procedure shall be established for biological control products presenting a favourable risk profile, in order to accelerate their availability to farmers as substitutes for higher-risk synthetic substances, without prejudice to the full scientific assessment required under this Regulation. Existing maximum residue levels shall continue to be subject to periodic review in accordance with Article 12, considering the latest scientific and technical knowledge, monitoring data, biomonitoring evidence and new toxicological information. The Commission shall publish a publicly accessible overview of all ongoing reviews of maximum residue levels, indicating the scientific basis for the review and the expected timetable for completion. |
The retained periodic review of maximum residue levels under Article 12, anchored explicitly to monitoring data, biomonitoring evidence and new toxicological information, is the safeguard that must not be traded away elsewhere in the package. Where the Article 4(7) derogation and the removal of periodic toxicity resubmission for approved substances weaken the evidence base upstream, an MRL review mechanism that stays responsive to new data downstream becomes even more important as a residual check.
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
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| (23b) Periodic review should be maintained for all active substances, irrespective of their risk profile, since the availability of smarter and more targeted testing methods reduces the administrative and technical burden of such review without requiring its removal. The precautionary principle underpinning the current legislative framework should continue to guide the approval and renewal of active substances, and the burden of proof should remain with producers to demonstrate that a substance meets the applicable safety criteria. At the same time, simplification should be pursued through differentiation rather than through a reduction of safeguards: dedicated 'green lanes' should be established for biocontrol products, allowing risk assessments to be conducted in a manner adapted to the specific characteristics of this class of substances, so as to accelerate their availability to farmers as lower-risk alternatives to synthetic substances. |
The precautionary principle, and the placement of the burden of proof on producers, is the structural foundation of the current system and must remain untouched by this package. Shifting that burden, even indirectly through weakened data obligations or extended unlimited-approval categories, would mark a change in the underlying philosophy of EU food and plant protection law, not merely a procedural adjustment, and goes beyond the simplification mandate the Commission has invoked.
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Text proposed by the Commission | Amendment |
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| (24) Experience has shown that the provisions in Regulation (EC) No 1107/2009 related to the protection of data in test and study reports submitted for the authorisation of plant protection products are complex and create barriers to market entry for new suppliers of plant protection products and unequal distribution and different costs of plant protection products depending on the size of the Member States, thus creating unfair competition between plant protection product manufacturers and farmers. Furthermore, the data protection regime lacks transparency in terms of when data protection for a given test or study report expires in the different Member States, in particular for studies or tests used for renewals of approvals or extensions of authorisations for minor uses. The relevant provisions should therefore be amended to set the same data protection period for a given study or test across the Union to increase transparency and facilitate market access for alternative suppliers to increase the availability of plant protection products at comparable costs to farmers independent from the Member States where they are established. | (24) Experience has shown that the provisions in Regulation (EC) No 1107/2009 related to the protection of data in test and study reports submitted for the authorisation of plant protection products are complex and create barriers to market entry for new suppliers of plant protection products and unequal distribution and different costs of plant protection products depending on the size of the Member States, thus creating unfair competition between plant protection product manufacturers and farmers. Furthermore, the data protection regime lacks transparency in terms of when data protection for a given test or study report expires in the different Member States, in particular for studies or tests used for renewals of approvals or extensions of authorisations for minor uses. The relevant provisions should therefore be amended to facilitate market access for alternative suppliers to increase the availability of plant protection products at comparable costs to farmers independent from the Member States where they are established, but without harming the competitiveness of undertakings for which the cost of producing data is very high and requires adequate protection. |
Anja Hazekamp, Per Clausen, Valentina Palmisano, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
| Text proposed by the Commission | Amendment |
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| (25) The obligation of the Member States under Article 68 to transmit to the Commission reports on the official controls on the enforcement of Regulation (EC) No 1107/2009 has already been superseded by the obligation to transmit annual reports under Article 113(1) of Regulation (EU) 2017/625. Thus Article 68 should be deleted in order to avoid confusion and unnecessary administrative burden for the Member States. | deleted |
| Text proposed by the Commission | Amendment |
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| (25) The obligation of the Member States under Article 68 to transmit to the Commission reports on the official controls on the enforcement of Regulation (EC) No 1107/2009 has already been superseded by the obligation to transmit annual reports under Article 113(1) of Regulation (EU) 2017/625. Thus Article 68 should be deleted in order to avoid confusion and unnecessary administrative burden for the Member States. | deleted |
| Text proposed by the Commission | Amendment |
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| (26) Transitional provisions are necessary in order to ensure a smooth transition for the pending approval and renewal procedures for active substances used in plant protection products, so that they are completed under the current rules but the approval period is granted under the new rules. A transitional provision is also necessary in order to ensure that a test or study report whose data protection started under the old rules does not get double protection in the same Member State under the new EU wide rules. It is further clarified that all basic substances approved at the entry into force of this Regulation could be placed on the market independent of their approval as regular active substances in order to ensure equal treatment and fair competition for all basic substances and for all farmers independent from the Member State they are based. | (26) Transitional provisions are necessary in order to ensure legal certainty for procedures that are already ongoing at the time of entry into force of this Regulation. Time-limited approvals serve a protective function, as they ensure that active substances are reassessed before their authorisation continues, considering evolving scientific knowledge and new evidence. Any transitional arrangement must preserve continuity of safety scrutiny and shall not be used to convert existing time-limited approvals to unlimited duration.. |
| Text proposed by the Commission | Amendment |
|---|---|
| (26) Transitional provisions are necessary in order to ensure a smooth transition for the pending approval and renewal procedures for active substances used in plant protection products, so that they are completed under the current rules but the approval period is granted under the new rules. A transitional provision is also necessary in order to ensure that a test or study report whose data protection started under the old rules does not get double protection in the same Member State under the new EU wide rules. It is further clarified that all basic substances approved at the entry into force of this Regulation could be placed on the market independent of their approval as regular active substances in order to ensure equal treatment and fair competition for all basic substances and for all farmers independent from the Member State they are based. | (26) A transitional provision is necessary in order to ensure that a test or study report whose data protection started under the old rules does not get double protection in the same Member State under the new EU wide rules. It is further clarified that all basic substances approved at the entry into force of this Regulation could be placed on the market independent of their approval as regular active substances in order to ensure equal treatment and fair competition for all basic substances and for all farmers independent from the Member State they are based. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Viktória Ferenc, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (26a) In light of the urgent need to revive food production by streamlining the authorisation procedures for plant health substances and products, and in order to have a clear view of the impact of these new provisions, the Commission should produce an impact assessment on the effects of this Regulation, and particularly on the availability of plant health substances and products, at least two years after its date of entry into force and every two years thereafter. If this assessment reveals that the objectives pursued by this Regulation have not been achieved, the Commission should, within a period of six months, submit draft legislation with a view to reviewing Regulation (EC) No 1107/2009 and to adopting additional simplification measures. |
Benoit Cassart, Gerben-Jan Gerbrandy, Martin Hojsík, Christine Singer, Olivier Chastel, Michal Wiezik, Charles Goerens, Billy Kelleher, Barry Cowen, Elsi Katainen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
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| (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries or Codex maximum limits may be set at the limit of quantification (technical zero). | (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To ensure a level playing field for European farmers and to address their call to have greater coherence between European trade, environmental and agricultural policies, it is necessary to adopt measures to implement the principle of reciprocity to ensure that imported products that do not meet European standards are not placed on European market. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position, its food security and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005, following an impact assessment to evaluate the impact on farmers and their competitiveness, the food and feed chain, the environment and human health, should already be amended provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, have negative effects on bees or accumulate in the groundwater, MRLs that have been set based on good agricultural practices in third countries or Codex maximum limits should be set at the limit of quantification (technical zero) for food intended for human consumption. For feed, MRLs that have been set based on good agricultural practices in third countries or Codex maximum limit may be established if the impact assessment demonstrates that such measure will not create disproprotionate disruptions in the feed supply chain provided that residues in feed will not result in residues for food intended for human consumption taking into account scientific knowledge. |
| 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) | 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Viktória Ferenc, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries nor Codex maximum limits may be set at the limit of quantification (technical zero). | (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission committed itself to a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle that hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. The risk-based approach set out in Regulation (EC) No 396/2005 was not actually consistent with the hazard-based approach retained by Regulation (EC) No 1107/2009. This inconsistency resulted in the maximum residue limits and import tolerances being retained for some substances, even though their use is prohibited in the Union, in contravention of the EU’s health and environmental standards, while applying very strict rules with regard to the authorisation of active substances, which reinforced unfair competition. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications before quickly proposing amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 will already be amended to provide that the reduction in MRLs and import tolerances at the limit of detection, where an active substance is no longer authorised in the EU, will be the general principle, with the exception of a category for substances intended for alien crops, the production of which cannot be guaranteed by the EU; the possibility is also envisaged of exceptional measures for certain substances for which there is a dependency on imports in certain sectors, subject to the implementation of plans to revive European production with a view to re-establishing our economic growth and our agricultural and food independence as a matter of urgency. |
| 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) | 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) |
| Text proposed by the Commission | Amendment |
|---|---|
| (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries nor Codex maximum limits may be set at the limit of quantification (technical zero). | (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries nor Codex maximum limits may be set at the limit of quantification (technical zero) if considered appropriate in the light of the outcome of an impact assessment. Such an impact assessment for each substance must take into account, in particular, the Union’s dependency on imports of the agricultural raw materials concerned, the specific characteristics and needs of the EU’s food and feed chain, including its vulnerability in crisis situations such as geopolitical disruptions, the effects that reducing MRLs to the limit of quantification would have on all actors in the food and feed chain, such as arable and livestock farmers, traders, processors, retailers, service providers and consumers, as well as the compatibility of such measures with WTO rules. |
| 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) | 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) |
Before the import tolerance (MRL) of a particularly hazardous substance that has not been approved in the EU is reduced to the limit of quantification, an impact assessment must be performed for each substance. This assessment will take into account the EU’s import dependency, the impact on the entire food and feed chain (including sensitivity to crises), the competitive position and WTO rules, to ensure that setting the level at zero does not inadvertently harm trade and supplies.
| Text proposed by the Commission | Amendment |
|---|---|
| (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries or Codex maximum limits may be set at the limit of quantification (technical zero). | (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries or Codex maximum limits may be set at the limit of quantification (technical zero), if considered appropriate in the light of the outcome of a substance-specific impact assessment. Such an assessment shall, in particular, take into account the EU's import dependency on the agricultural commodities concerned; the specificities and resilience needs of the EU food and feed supply chain, including its vulnerability in crisis situations such as geopolitical disruptions; the effects of lowering MRLs to the LOQ on all actors in the food and feed supply chain, including crop and livestock farmers, traders, processors, retailers, service providers and consumers; as well as the compatibility of such measures with WTO rules. |
| 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) | 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) |
An impact assessment should be carried out before lowering MRLs to the limit of quantification, taking into account the effects on all actors of the EU food and feed supply chain and other relevant economic and trade considerations.
| Text proposed by the Commission | Amendment |
|---|---|
| (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries or Codex maximum limits may be set at the limit of quantification (technical zero). | (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries or Codex maximum limits may be set at the limit of quantification (technical zero) if considered appropriate in the light of the outcome of an impact assessment. Such a substance-by substance impact assessment should consider, in particular, the EU import dependency on the targeted agricultural commodities, the specificities and needs of the EU food and feed supply chain, including its vulnerability in crisis situations such as geopolitical disorders, the respective effects of lowering MRLs to LOQ on all actors of the food and feed supply chain, such as crop and livestock farmers, traders, processors, retailers, services providers, and consumers, as well as the compatibility of such measures with the WTO rules. |
| 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) | 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) |
Article 3(4) of the FFS Omnibus, amending article 14(2) of Regulation (EC) No 396/2005, conditions the lowering to technical zero of MRLS for hazardous substances not authorized in the EU to an impact assessment that may conclude to the appropriateness of such a lowering. This condition is an essential element of the proposal and should therefore be reflected in Recital 27
| Text proposed by the Commission | Amendment |
|---|---|
| (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries or Codex maximum limits may be set at the limit of quantification (technical zero). | (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries or Codex maximum limits may be set at the limit of quantification (technical zero) if considered appropriate in the light of the outcome of an impact assessment. Such a substance-by-substance impact assessment should consider, in particular, the EU immprt dependency on the targeted agricultural commodities, the specifities and needs of the EU food and feed supply chain, including its vulnerability in crisis situations such as geopolitical disorders, the respective effects of lowering MRLs to LOQ on all actors of the food and feed supply chain, such as crop and livestock farmers, traders, processors, retailers, services providers, and consumers, as well as the compatibility of such measures with the WTO rules. |
| 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) | 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) |
| Text proposed by the Commission | Amendment |
|---|---|
| (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries or Codex maximum limits may be set at the limit of quantification (technical zero). | (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries or Codex maximum limits may be set at the limit of quantification (technical zero). The system for applying the limit of quantification set out in this Regulation should not apply to feed materials placed on the market solely for the purpose of animal feed, in order to prevent disproportionate burdens and avoidable barriers to trade. The monitoring and risk management of those feed materials are already ensured by specific requirements and by the downstream assessment of residue transfer into products of animal origin. |
| 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) | 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) |
| Text proposed by the Commission | Amendment |
|---|---|
| (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries or Codex maximum limits may be set at the limit of quantification (technical zero). | (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries or Codex maximum limits may be set at the limit of quantification (technical zero) or at a higher limit, based on a prior impact assessment. The impact assessment should follow specific criteria taking into account especially a risk assessment carried out by the Authority whether safe MRLs (CXL or GAP) could be derived, compatibility with WTO and SPS requirements, the impact on EU Member States as well as on third countries, and the needs of the entire food and feed chain. |
| 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) | 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) |
| Text proposed by the Commission | Amendment |
|---|---|
| (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries or Codex maximum limits may be set at the limit of quantification (technical zero). | (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union, MRLs that have been set based on good agricultural practices in third countries or Codex maximum limits should be set at the limit of quantification (technical zero). |
| 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) | 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) |
| Text proposed by the Commission | Amendment |
|---|---|
| (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that, for substances that are not approved in the Union and that have certain particularly hazardous properties, MRLs that have been set based on good agricultural practices in third countries nor Codex maximum limits may be set at the limit of quantification (technical zero). | (27) Regulation (EC) No 396/20056 sets the procedure for defining maximum residue levels (“MRLs”) of pesticides in or on food and feed of plant and animal origin. In the Vision for Agriculture and Food, the Commission announced it would pursue a stronger alignment of production standards applied to imported products, notably on pesticides and establish the principle, in compliance with the EU‘s international obligations, that the most hazardous pesticides banned in the EU for health and environmental reasons should not be allowed back to the EU through imported products. To advance on this, the Commission has launched in November 2025 a study to prepare an impact assessment that will consider the impacts on the EU’s competitive position and the international implications and, if appropriate, propose amendments to the legal framework. In the meantime Regulation (EC) No 396/2005 should already be amended to provide that the reduction in MRLs and import tolerances (ITs) up to the limit of detection, where an active substance is no longer authorised in the European Union, will be the general principle. A safety margin may be planned to take account of residues present in the environment in Europe. |
| 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) | 6 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, pp. 1–16, ELI: http://data.europa.eu/eli/reg/2005/396/oj ) |
| Text proposed by the Commission | Amendment |
|---|---|
| (27a) In its Vision for Agriculture and Food the Commission announced that it will enshrine the principle that the most hazardous plant protection products banned in the Union for health and environmental reasons should not be allowed back into the Union through imported products. This principle is intended not only to protect consumers, but also to ensure equivalence of production standards and consequently fairness for Union producers, who meet the highest standards anywhere in the world. It is not acceptable for farms based in the Union to have to forgo the use of an active substance, while third-country products produced using the same active substance may be placed freely on the market. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (27a) To ensure a level playing field between Union producers and those in third countries, and to uphold the Union’s high environmental and health objectives, it is necessary to further develop the principle of reciprocity in production standards. The Commission shall, following the completion of the ongoing impact assessment launched in November 2025, evaluate the necessity of establishing a formal definition and framework for reciprocity. This framework should ensure that imported products are subject to requirements equivalent to those applicable in the Union, particularly regarding the use of pesticides with global environmental impacts, such as those affecting biodiversity and the climate, in accordance with the Union's international obligations. |
| Text proposed by the Commission | Amendment |
|---|---|
| (27a) Regulation (EC) No 396/2005 and Regulation (EC) No 1107/2009 constitute complementary elements of the Union framework governing plant protection products and pesticide residues. Decisions adopted pursuant to Regulation (EC) No 1107/2009 concerning the approval, non-renewal or withdrawal of approval of active substances should therefore be duly reflected in the review of corresponding maximum residue levels established under this Regulation while preserving the scientific basis of residue assessments. |
Biljana Borzan, Christophe Clergeau, Gheorghe Cârciu, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| (27a) The establishment and review of maximum residue levels should ensure that consumer protection keeps pace with scientific developments. Regulatory simplification should not reduce the frequency or quality of scientific review. The implementation of this Regulation shall ensure a high level of protection of human health, in accordance with Articles 114(3), 168 and 191 of the Treaty on the Functioning of the European Union. |
| Text proposed by the Commission | Amendment |
|---|---|
| (27b) The gradual reduction in the active substances available in the Union has already placed a substantial burden on farmers and has led to shortfalls in the supply of plant protection products for specific crops. Aligning the requirements applicable to imported products with those that apply in the Union therefore does not place an additional burden on the Union’s agricultural sector, but actually eliminates an existing distortion of competition that is detrimental to it. Such a step will contribute significantly to the competitiveness and income security of farms within the Union and to the safeguarding of the Union’s food sovereignty. |
| Text proposed by the Commission | Amendment |
|---|---|
| (27b) Where an active substance is no longer approved pursuant to Regulation (EC) No 1107/2009, the corresponding maximum residue levels should be reviewed without undue delay, taking due account of the scientific findings and regulatory considerations underlying that decision while ensuring a high level of consumer protection. |
| Text proposed by the Commission | Amendment |
|---|---|
| (27c) If, for a period of three consecutive years, no Member State grants an emergency authorisation under Article 53 of Regulation (EC) No 1107/2009 for an active substance that is not approved in the Union, this shall constitute objective, verifiable evidence, collected uniformly across the Union, that the Union no longer has any agricultural need for this active substance and that there are alternatives available in the Union. Maintaining maximum levels for imported products based on Codex maximum limits or good agricultural practices in third countries is no longer justified in this case. The maximum levels should therefore be reduced automatically to the limit of quantification without the need for a separate decision in each individual case. |
| Text proposed by the Commission | Amendment |
|---|---|
| (27d) Union agriculture must be capable of responding to new harmful organisms, resistances and climate-induced diseases. If, following a reduction, a Member State once again grants an emergency authorisation under Article 53 of Regulation (EC) No 1107/2009, this shall constitute evidence of a renewed agricultural need. In such a case, the maximum level that previously applied, based on a risk assessment by the Authority, should automatically become effective again. Otherwise, an illogical situation would arise in which producers in the Union can lawfully use an active substance, but are unable to market their harvest due to the maximum level having been reduced to zero. The mechanism is therefore effective in both directions and ensures the equal treatment of domestic production and imports. |
| Text proposed by the Commission | Amendment |
|---|---|
| (27e) For active substances that have one or more of the properties set out in points 3.6.2 to 3.6.5, 3.7.1 to 3.7.3, and 3.8.2 of Annex II to Regulation (EC) No 1107/2009 – in particular, mutagenic, carcinogenic, reprotoxic and endocrine-disrupting properties, as well as persistence, bioaccumulation and toxicity – no safe exposure level can be justified. In the case of these active substances, the reduction to the limit of quantification should be a mandatory and permanent measure; the possibility of increasing the level again following a new emergency authorisation must be excluded. The possibility proposed by the Commission of making decisions in individual cases in the light of an impact assessment does not do justice to the Union’s self-imposed level of protection. |
| Text proposed by the Commission | Amendment |
|---|---|
| (27f) A maximum level that has been reduced to the limit of quantification only has an effect if the compliance of imported products with this limit is effectively controlled. The current sampling rates for imports are insufficient for this purpose. Member States should therefore be required to include in their national control programmes a minimum number of samples to be taken from imports, which should at least correspond to the share of imports in the consumption of the products concerned, and to publish the results annually. |
| Text proposed by the Commission | Amendment |
|---|---|
| (27g) The measures provided for in this Regulation shall be based on the scientific hazard criteria set out in Regulation (EC) No 1107/2009 and on objectively verifiable assessments establishing that there is no agricultural need within the Union. They shall apply equally to Union products and to imported products and therefore shall not constitute arbitrary or unjustified discrimination or a disguised restriction on international trade. To allow the Union’s trading partners to adapt in an orderly manner, the reductions should be implemented with appropriate transition periods and the World Trade Organization should be notified in good time. |
| Text proposed by the Commission | Amendment |
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| (28) This concerns substances with mutagenic, carcinogenic, or reprotoxic properties as well as endocrine disruptors that may cause adverse effects in humans. Therefore, no level of residues leading to exposure of consumers should be allowed in order to ensure a high level of protection for consumers in the Union. | (28) This concerns substances with mutagenic, carcinogenic, or reprotoxic properties as well as endocrine disruptors that cause adverse effects in humans. Therefore, no level of residues leading to exposure of consumers should be allowed in order to ensure a high level of protection for consumers in the Union. |
| Text proposed by the Commission | Amendment |
|---|---|
| (29) In addition, this concerns substances that are persistent organic pollutants (POP), persistent, bioaccumulative and toxic (PBT) substances, and very persistent and very bioaccumulative (vPvB) substances, as well as substances with endocrine disrupting properties that may cause adverse effect in non-target organisms. Persistent substances, by their very nature, resist degradation, resulting in prolonged presence in the environment. Their accumulation poses a significant threat to ecosystems, endangering biodiversity, agricultural production and food security. Endocrine disruptors, similarly, interfere with the hormonal systems of living organisms, causing detrimental effects not only to individual species, including migratory species, but also to entire ecosystems across national boundaries. Therefore, these substances create environmental concerns of a global nature that have a connection with the territory of the Union. Not allowing residues of these substances in food in the Union aligns with international efforts to combat pollution and supports global initiatives aimed at sustainable development and biodiversity conservation7 . | deleted |
| 7 Stockholm Convention on Persistent Organic Pollutants (POPs), https://www.pops.int/; Convention on Biological Diversity, https://www.cbd.int/ |
Recital 29 should be deleted because it introduces a “no exposure” hazard-based principle which is incompatible with the risk- and exposure-based approach that underpins Regulation (EC) No 396/2005. This approach is also incompatible with Article 5 of the WTO’s SPS Agreement.
Gerben-Jan Gerbrandy, Martin Hojsík, Pascal Canfin, Karin Karlsbro, Michal Wiezik, Yvan Verougstraete
| Text proposed by the Commission | Amendment |
|---|---|
| (29) In addition, this concerns substances that are persistent organic pollutants (POP), persistent, bioaccumulative and toxic (PBT) substances, and very persistent and very bioaccumulative (vPvB) substances, as well as substances with endocrine disrupting properties that may cause adverse effect in non-target organisms. Persistent substances, by their very nature, resist degradation, resulting in prolonged presence in the environment. Their accumulation poses a significant threat to ecosystems, endangering biodiversity, agricultural production and food security. Endocrine disruptors, similarly, interfere with the hormonal systems of living organisms, causing detrimental effects not only to individual species, including migratory species, but also to entire ecosystems across national boundaries. Therefore, these substances create environmental concerns of a global nature that have a connection with the territory of the Union. Not allowing residues of these substances in food in the Union aligns with international efforts to combat pollution and supports global initiatives aimed at sustainable development and biodiversity conservation7 . | (29) In addition, this concerns substances that are persistent organic pollutants (POP), persistent, concernss toxic (PBT) substances, and very persistent and very bioaccumulative (vPvB) substances, as well as substances with endocrine disrupting properties that may cause adverse effects in non-target organisms. Persistent substances, by their very nature, resist degradation, resulting in prolonged presence in the environment. Their accumulation poses a significant threat to ecosystems, endangering biodiversity, pollinator populations, agricultural production and food security. In particular, active substances which have unacceptable effects on bees or on the survival or development of their colonies give rise to serious concern, given the growing worldwide recognition that the decline of pollinators constitutes a critical threat to biodiversity, ecosystem resilience and global food security, and given the essential role pollinators play in maintaining agricultural productivity. Endocrine disruptors, similarly, interfere with the hormonal systems of living organisms, causing detrimental effects not only to individual species, including migratory species, but also to entire ecosystems across national boundaries. Furthermore, this concerns active substances for which normal conditions of use would lead to a concentration of the active substance, or of its metabolites, degradation or reaction products, in groundwater or surface water at a level not complying with the approval criteria for active substances. Water contamination by such substances is frequently difficult, and in some cases impossible, to reverse. Where contamination does occur, the resulting costs of water treatment and purification, necessary to restore water intended for human consumption or environmental use to a safe standard, are typically borne by public authorities, water utilities and, ultimately, consumers and taxpayers, rather than by the operators placing the substances on the market. It is therefore necessary to prevent such contamination at source.. Therefore, these substances create environmental concerns of a global nature that have a connection with the territory of the Union. Not allowing residues of these substances in food in the Union aligns with international efforts to combat pollution and supports global initiatives aimed at sustainable development and biodiversity conservation. |
| 7 Stockholm Convention on Persistent Organic Pollutants (POPs), https://www.pops.int/; Convention on Biological Diversity, https://www.cbd.int/ | 7 Stockholm Convention on Persistent Organic Pollutants (POPs), https://www.pops.int/; Convention on Biological Diversity, https://www.cbd.int/ |
| Text proposed by the Commission | Amendment |
|---|---|
| (29a) For coherence puposes, and in order not to undermine the efforts already undertaken within the Union to ensure a high level of protection of human health and the environment, it is important to apply a stringent approach to residues in imported products, in compliance with international obligations. The aim is enhanced consumer health protection and fair competition for farmers. Therefore, a case-by-case impact assessment should be required to justify the maintenance or establishment of an import MRL that should under no circumstances significantly contribute to consumer exposure. Such measure would not apply to substances that remain approved at the European level, including those approved on a derogatory basis. The decision on setting or lowering MRLs should take into account, in addition to the risk assessment of the Authority, an assessment of the impact on the food and feed chain in the Member States, in compliance with international obligations, in particular the General Agreement on Tariffs and Trade (GATT) 1994 and the Sanitary and Phytosanitary Measures Agreement. |
| Text proposed by the Commission | Amendment |
|---|---|
| (29a) Where an active substance is not approved, or where its approval is withdrawn or not renewed pursuant to Regulation (EC) No 1107/2009, the corresponding maximum residue levels should be aligned with the regulatory status of that active substance. Therefore, the corresponding maximum residue levels should be amended to the value referred to in Article 18(1)(b), unless specific circumstances under Regulation (EC) No 396/2005 justify maintaining another value. As such amendments result from a regulatory decision already adopted under Regulation (EC) No 1107/2009 and do not constitute a new scientific assessment of the risks arising from residues, no separate opinion of the European Food Safety Authority should be required for that purpose. |
| Text proposed by the Commission | Amendment |
|---|---|
| (30a) According to the World Trade Organisation Agreement on the Application of Sanitary and Phytosanitary Measures, measures that affect maximum residue limits should be based on scientific principles and a risk assessment, should take account of relevant international standards, including the Codex maximum residue limits, and should not restrict trade more than necessary to achieve the appropriate Union level of protection. Where the Union deems it necessary to depart from a Codex maximum residue limit or from a maximum residue level based on good agricultural practices implemented in a third country, the decision should be transparent, based on a risk assessment, and proportionate to the level of risk. |
Raffaele Stancanelli, Silvia Sardone, Isabella Tovaglieri, Mireia Borrás Pabón, Anne-Sophie Frigout, Marie-Luce Brasier-Clain, Roman Haider, Gilles Pennelle, Ton Diepeveen
| Text proposed by the Commission | Amendment |
|---|---|
| (30a) While Union farmers are required to comply with stringent production standards, agricultural products imported from third countries into the Union may contain residues of substances prohibited in the Union, pursuant to import tolerances establishing maximum residue levels (MRLs). This situation places Union producers at a competitive disadvantage, undermines fair competition and the objective of reciprocity. Import tolerances establishing MRLs for active substances that are no longer approved in the Union should therefore no longer be granted. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (31) When lowering MRLs under Regulation (EC) No 396/2005, a reasonable period should be allowed to elapse before the new MRLs become applicable, in order to permit Member States, third countries and food business operators to adapt themselves to the new requirements. It is recognised that fresh products, being perishable, are typically sold and consumed prior to the date of applicability of new MRLs. However, products with extended shelf lives, often processed, may still be on the market when the new lower MRLs become effective. To ensure legal certainty and to prevent unnecessary economic losses for farmers and food business operators, as well as to prevent food waste, it is deemed proportionate that products lawfully placed on the market in the Union before the applicable date of the new measure, and compliant with the MRLs valid at the time of their placing on the market in the Union, should be permitted to remain on the market unless food safety is compromised. | (31) When lowering MRLs under Regulation (EC) No 396/2005, a period should be allowed to elapse before the new MRLs become applicable, in order to permit Member States, third countries and food business operators to adapt themselves to the new requirements. It is recognised that fresh products, being perishable, are typically sold and consumed prior to the date of applicability of new MRLs. However, products with extended shelf lives, often processed, may still be on the market when the new lower MRLs become effective. To ensure legal certainty and to prevent unnecessary economic losses for farmers and food business operators, as well as to prevent food waste, it is deemed proportionate that products lawfully placed on the market in the Union before the applicable date of the new measure, and compliant with the MRLs valid at the time of their placing on the market in the Union, should be permitted to remain on the market unless food safety is compromised. Following the principle of reducing to the quantification threshold level (technical zero) any imported products containing residues of active substances that are prohibited in the EU, it is worth providing the opportunity of reasonable periods during which products that were already imported before the reduction may still be marketed for a given amount of time, thus avoiding any excessive destabilisation in the food chain and any excessive food waste. |
| Text proposed by the Commission | Amendment |
|---|---|
| (31) When lowering MRLs under Regulation (EC) No 396/2005, a reasonable period should be allowed to elapse before the new MRLs become applicable, in order to permit Member States, third countries and food business operators to adapt themselves to the new requirements. It is recognised that fresh products, being perishable, are typically sold and consumed prior to the date of applicability of new MRLs. However, products with extended shelf lives, often processed, may still be on the market when the new lower MRLs become effective. To ensure legal certainty and to prevent unnecessary economic losses for farmers and food business operators, as well as to prevent food waste, it is deemed proportionate that products lawfully placed on the market in the Union before the applicable date of the new measure, and compliant with the MRLs valid at the time of their placing on the market in the Union, should be permitted to remain on the market unless food safety is compromised. | (31) Maximum residue levels are established to protect consumers from exposure to pesticide residues in food. Where maximum residue levels are lowered on grounds of safety concern, including newly identified toxicological data or revised exposure assessments, consumer protection constitutes the primary consideration and takes precedence over economic interests. Products that no longer comply with current maximum residue levels established for safety reasons must not remain on the market beyond the minimum period strictly necessary for their withdrawal. |
| Text proposed by the Commission | Amendment |
|---|---|
| (31) When lowering MRLs under Regulation (EC) No 396/2005, a reasonable period should be allowed to elapse before the new MRLs become applicable, in order to permit Member States, third countries and food business operators to adapt themselves to the new requirements. It is recognised that fresh products, being perishable, are typically sold and consumed prior to the date of applicability of new MRLs. However, products with extended shelf lives, often processed, may still be on the market when the new lower MRLs become effective. To ensure legal certainty and to prevent unnecessary economic losses for farmers and food business operators, as well as to prevent food waste, it is deemed proportionate that products lawfully placed on the market in the Union before the applicable date of the new measure, and compliant with the MRLs valid at the time of their placing on the market in the Union, should be permitted to remain on the market unless food safety is compromised. | (31) When lowering MRLs under Regulation (EC) No 396/2005, a reasonable period should be allowed to elapse before the new MRLs become applicable, in order to permit Member States, third countries and food business operators to adapt themselves to the new requirements. It is recognised that fresh products, being perishable, are typically sold and consumed prior to the date of applicability of new MRLs. However, products with extended shelf lives, often processed, may still be on the market when the new lower MRLs become effective. To ensure legal certainty and to prevent unnecessary economic losses for farmers and food business operators, as well as to prevent food waste, it is deemed proportionate that products lawfully placed on the market in the Union before the applicable date of the new measure, and compliant with the MRLs valid at the time of their placing on the market in the Union, should be permitted to remain on the market unless food safety is compromised, for a period not exceeding 6 months. |
| Text proposed by the Commission | Amendment |
|---|---|
| (32) Article 16 to Regulation (EC) No 396/2005 sets out the procedure for establishing temporary MRLs based on monitoring data, with a mandatory review scheduled within a specified time frame, not exceeding ten years. However, certain MRLs based on monitoring data pertain to active substances that have not been approved in the Union for several decades, and for which residue levels have remained stable over time. Reviewing such temporary MRLs every ten years imposes an unnecessary burden on Member States, food business operators, and the Authority the Authority in terms of data generation and analysis. Given that MRLs can be reviewed at any time under Article 43 of Regulation (EC) No 396/2005, it is appropriate to foresee the establishment of MRLs based on monitoring data on a permanent basis. | (32) Maximum residue levels based on monitoring data serve to limit consumer exposure to residues of substances that are no longer approved for use in the Union. The scientific basis for such limits must reflect the best available evidence on exposure levels and long-term health effects. Any review of the procedural framework governing these limits must preserve the obligation to update them considering new toxicological knowledge and must not reduce the incentive to minimise residue levels over time. |
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Olivier Chastel, Andreas Glück, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (32) Article 16 to Regulation (EC) No 396/2005 sets out the procedure for establishing temporary MRLs based on monitoring data, with a mandatory review scheduled within a specified time frame, not exceeding ten years. However, certain MRLs based on monitoring data pertain to active substances that have not been approved in the Union for several decades, and for which residue levels have remained stable over time. Reviewing such temporary MRLs every ten years imposes an unnecessary burden on Member States, food business operators, and the Authority the Authority in terms of data generation and analysis. Given that MRLs can be reviewed at any time under Article 43 of Regulation (EC) No 396/2005, it is appropriate to foresee the establishment of MRLs based on monitoring data on a permanent basis. | (32) Article 16 to Regulation (EC) No 396/2005 sets out the procedure for establishing temporary MRLs based on monitoring data, with a mandatory review scheduled within a specified time frame, not exceeding ten years. However, certain MRLs based on monitoring data pertain to active substances that have not been approved in the Union for several decades, and for which residue levels have remained stable over time. Reviewing such temporary MRLs every ten years imposes an unnecessary burden on Member States, food business operators, and the Authority in terms of data generation and analysis. Given that MRLs can be reviewed at any time under Article 43 of Regulation (EC) No 396/2005, it is appropriate to foresee the establishment of MRLs based on monitoring data on a permanent basis. |
| Text proposed by the Commission | Amendment |
|---|---|
| (34) Regulation (EU) No 528/20128 sets out the procedures for approval of biocidal active substances and authorisation and making available on the market and use of biocidal products. The completion of the review programme of existing biocidal active substances set out in Article 89 of that Regulation is significantly delayed. In order to ensure that Member States can dedicate their resources to the completion of the review programme, it is appropriate to set an unlimited duration for the approval of active substances, except for active substances meeting exclusion or substitution criteria under Articles 5(1) or 10 of that Regulation as those have properties that are of concern to human or animal health or the environment, and except for active substances for which time limits of approvals are considered necessary in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The approval of active substances already approved should be converted into unlimited approvals following these new rules, except for active substances identified as meeting exclusion or substitution criteria under Articles 5(1) or 10 of that Regulation, active substances for which the renewal examination already started for which the renewal evaluation should continue or for which the approval should expire when no application for renewal was submitted by the deadline. A possibility should be foreseen that the Commission periodically selects a number of active substances based on specific criteria for which a renewal procedure should be triggered, while also maintaining the possibility to initiate early reviews pursuant to Article 15 of Regulation (EU) No 528/2012. Criteria for the selection of active substances subject to the renewal procedure should include, among others, relevant new or updated data requirements or guidance documents, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, and might take into account requests from Member States. | deleted |
| 8 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( OJ L 167, 27.6.2012, pp. 1–123, ELI: http://data.europa.eu/eli/reg/2012/528/oj) |
Anja Hazekamp, Per Clausen, Valentina Palmisano, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
| Text proposed by the Commission | Amendment |
|---|---|
| (34) Regulation (EU) No 528/20128 sets out the procedures for approval of biocidal active substances and authorisation and making available on the market and use of biocidal products. The completion of the review programme of existing biocidal active substances set out in Article 89 of that Regulation is significantly delayed. In order to ensure that Member States can dedicate their resources to the completion of the review programme, it is appropriate to set an unlimited duration for the approval of active substances, except for active substances meeting exclusion or substitution criteria under Articles 5(1) or 10 of that Regulation as those have properties that are of concern to human or animal health or the environment, and except for active substances for which time limits of approvals are considered necessary in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The approval of active substances already approved should be converted into unlimited approvals following these new rules, except for active substances identified as meeting exclusion or substitution criteria under Articles 5(1) or 10 of that Regulation, active substances for which the renewal examination already started for which the renewal evaluation should continue or for which the approval should expire when no application for renewal was submitted by the deadline. A possibility should be foreseen that the Commission periodically selects a number of active substances based on specific criteria for which a renewal procedure should be triggered, while also maintaining the possibility to initiate early reviews pursuant to Article 15 of Regulation (EU) No 528/2012. Criteria for the selection of active substances subject to the renewal procedure should include, among others, relevant new or updated data requirements or guidance documents, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, and might take into account requests from Member States. | (34) Regulation (EU) No 528/20128 sets out the procedures for approval of biocidal active substances and authorisation and making available on the market and use of biocidal products. The completion of the review programme of existing biocidal active substances set out in Article 89 of that Regulation is significantly delayed. In order to ensure that Member States dedicate their resources to the completion of the review programme, it is appropriate to revoke the possibility to extend approvals and authorisations. |
| 8 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( OJ L 167, 27.6.2012, pp. 1–123, ELI: http://data.europa.eu/eli/reg/2012/528/oj) | 8 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( OJ L 167, 27.6.2012, pp. 1–123, ELI: http://data.europa.eu/eli/reg/2012/528/oj) |
| Text proposed by the Commission | Amendment |
|---|---|
| (34) Regulation (EU) No 528/20128 sets out the procedures for approval of biocidal active substances and authorisation and making available on the market and use of biocidal products. The completion of the review programme of existing biocidal active substances set out in Article 89 of that Regulation is significantly delayed. In order to ensure that Member States can dedicate their resources to the completion of the review programme, it is appropriate to set an unlimited duration for the approval of active substances, except for active substances meeting exclusion or substitution criteria under Articles 5(1) or 10 of that Regulation as those have properties that are of concern to human or animal health or the environment, and except for active substances for which time limits of approvals are considered necessary in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The approval of active substances already approved should be converted into unlimited approvals following these new rules, except for active substances identified as meeting exclusion or substitution criteria under Articles 5(1) or 10 of that Regulation, active substances for which the renewal examination already started for which the renewal evaluation should continue or for which the approval should expire when no application for renewal was submitted by the deadline. A possibility should be foreseen that the Commission periodically selects a number of active substances based on specific criteria for which a renewal procedure should be triggered, while also maintaining the possibility to initiate early reviews pursuant to Article 15 of Regulation (EU) No 528/2012. Criteria for the selection of active substances subject to the renewal procedure should include, among others, relevant new or updated data requirements or guidance documents, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, and might take into account requests from Member States. | (34) Regulation (EU) No 528/20128 sets out the procedures for approval of biocidal active substances and authorisation and making available on the market and use of biocidal products. The completion of the review programme of existing biocidal active substances set out in Article 89 of that Regulation is significantly delayed. In order to ensure that Member States can dedicate their resources to the completion of the review programme, it is appropriate to set an unlimited approval for substances in Annex I. This should never apply for active substances meeting exclusion or substitution criteria under Articles 5(1) or 10 of that Regulation as those have properties that are of concern to human or animal health or the environment, and except for active substances for which shorter time limits of approvals are considered necessary in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The approval of active substances already approved that are not taken up in Annex one should follow the existing re-approval procedure.The Commission maintains the possibility to initiate early reviews pursuant to Article 15 of Regulation (EU) No 528/2012 and the Commission shall take into account requests from Member States. |
| 8 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( OJ L 167, 27.6.2012, pp. 1–123, ELI: http://data.europa.eu/eli/reg/2012/528/oj) | 8 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( OJ L 167, 27.6.2012, pp. 1–123, ELI: http://data.europa.eu/eli/reg/2012/528/oj) |
| Text proposed by the Commission | Amendment |
|---|---|
| (34) Regulation (EU) No 528/20128 sets out the procedures for approval of biocidal active substances and authorisation and making available on the market and use of biocidal products. The completion of the review programme of existing biocidal active substances set out in Article 89 of that Regulation is significantly delayed. In order to ensure that Member States can dedicate their resources to the completion of the review programme, it is appropriate to set an unlimited duration for the approval of active substances, except for active substances meeting exclusion or substitution criteria under Articles 5(1) or 10 of that Regulation as those have properties that are of concern to human or animal health or the environment, and except for active substances for which time limits of approvals are considered necessary in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The approval of active substances already approved should be converted into unlimited approvals following these new rules, except for active substances identified as meeting exclusion or substitution criteria under Articles 5(1) or 10 of that Regulation, active substances for which the renewal examination already started for which the renewal evaluation should continue or for which the approval should expire when no application for renewal was submitted by the deadline. A possibility should be foreseen that the Commission periodically selects a number of active substances based on specific criteria for which a renewal procedure should be triggered, while also maintaining the possibility to initiate early reviews pursuant to Article 15 of Regulation (EU) No 528/2012. Criteria for the selection of active substances subject to the renewal procedure should include, among others, relevant new or updated data requirements or guidance documents, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, and might take into account requests from Member States. | (34) Regulation (EU) No 528/20128 sets out the procedures for approval of biocidal active substances and authorisation and making available on the market and use of biocidal products. The completion of the review programme of existing biocidal active substances set out in Article 89 of that Regulation is significantly delayed. In order to ensure that Member States can dedicate their resources to the completion of the review programme, it is appropriate to set an unlimited duration for the approval of active substances, except for active substances meeting exclusion or substitution criteria under Articles 5(1) or 10 of that Regulation as those have properties that are of concern to human or animal health or the environment, and except for active substances for which time limits of approvals are considered necessary in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The approval of active substances already approved should be converted into unlimited approvals following these new rules, except for active substances identified as meeting exclusion or substitution criteria under Articles 5(1) or 10 of that Regulation, active substances for which the renewal examination already started for which the renewal evaluation should continue or for which the approval should expire when no application for renewal was submitted by the deadline. A possibility should be foreseen that the Commission periodically selects a number of active substances based on specific criteria for which a renewal procedure should be triggered, while also maintaining the possibility to initiate early reviews pursuant to Article 15 of Regulation (EU) No 528/2012. Criteria for the selection of active substances subject to the renewal procedure should include, among others, relevant new or updated data requirements or guidance documents, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, and might take into account requests from Member States. Otherwise, as part of the assessment for the authorisation of biocidal products, it is essential that the Commission take full account of the health hazards that rodents pose, particularly to the sites, food and operators that are exposed to them. It is therefore essential that the Commission has a framework for maintaining permanent baiting with anti-vitamin K rodenticides, under the conditions currently defined by European regulations, in other words for trained professionals and on sites that pose a high risk of re-infestation. |
| 8 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( OJ L 167, 27.6.2012, pp. 1–123, ELI: http://data.europa.eu/eli/reg/2012/528/oj) | 8 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( OJ L 167, 27.6.2012, pp. 1–123, ELI: http://data.europa.eu/eli/reg/2012/528/oj) |
| Text proposed by the Commission | Amendment |
|---|---|
| (34) Regulation (EU) No 528/20128 sets out the procedures for approval of biocidal active substances and authorisation and making available on the market and use of biocidal products. The completion of the review programme of existing biocidal active substances set out in Article 89 of that Regulation is significantly delayed. In order to ensure that Member States can dedicate their resources to the completion of the review programme, it is appropriate to set an unlimited duration for the approval of active substances, except for active substances meeting exclusion or substitution criteria under Articles 5(1) or 10 of that Regulation as those have properties that are of concern to human or animal health or the environment, and except for active substances for which time limits of approvals are considered necessary in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The approval of active substances already approved should be converted into unlimited approvals following these new rules, except for active substances identified as meeting exclusion or substitution criteria under Articles 5(1) or 10 of that Regulation, active substances for which the renewal examination already started for which the renewal evaluation should continue or for which the approval should expire when no application for renewal was submitted by the deadline. A possibility should be foreseen that the Commission periodically selects a number of active substances based on specific criteria for which a renewal procedure should be triggered, while also maintaining the possibility to initiate early reviews pursuant to Article 15 of Regulation (EU) No 528/2012. Criteria for the selection of active substances subject to the renewal procedure should include, among others, relevant new or updated data requirements or guidance documents, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, and might take into account requests from Member States. | (34) Regulation (EU) No 528/20128 sets out the procedures for approval of biocidal active substances and authorisation and making available on the market and use of biocidal products. The completion of the review programme of existing biocidal active substances set out in Article 89 of that Regulation is significantly delayed. In order to ensure that Member States can dedicate their resources to the completion of the review programme, it is appropriate to set an unlimited duration for the approval of active substances, except for active substances meeting exclusion or substitution criteria under Articles 5(1) or 10 of that Regulation as those have properties that are of concern to human or animal health or the environment, and except for active substances for which time limits of approvals are considered necessary in the light of the outcome of the risk assessment conducted prior to a decision on an approval. The approval of low-risk active substances already approved should be converted into unlimited approvals following these new rules, except for active substances identified as meeting exclusion or substitution criteria under Articles 5(1) or 10 of that Regulation, active substances for which the renewal examination already started for which the renewal evaluation should continue or for which the approval should expire when no application for renewal was submitted by the deadline. A possibility should be foreseen that the Commission periodically selects a number of active substances based on specific criteria for which a renewal procedure should be triggered, while also maintaining the possibility to initiate early reviews pursuant to Article 15 of Regulation (EU) No 528/2012. Criteria for the selection of active substances subject to the renewal procedure should include, among others, relevant new or updated data requirements or guidance documents, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, and might take into account requests from Member States. |
| 8 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( OJ L 167, 27.6.2012, pp. 1–123, ELI: http://data.europa.eu/eli/reg/2012/528/oj) | 8 Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products ( OJ L 167, 27.6.2012, pp. 1–123, ELI: http://data.europa.eu/eli/reg/2012/528/oj) |
| Text proposed by the Commission | Amendment |
|---|---|
| (34a) The approval period for biocidal active substances meeting the exclusion or substitution criteria under Articles 5(1) or 10 of Regulation (EU) No 528/2012 shall be extended to 10 years, in order to reduce the administrative burden associated with frequent renewal cycles and further accelerate the completion of the review programme. |
A 10-year approval period for substances meeting the exclusion or substitution criteria would reduce the administrative burden of frequent renewals, improve predictability and support a more efficient implementation of the Biocidal Products Regulation while maintaining an appropriate level of protection.
| Text proposed by the Commission | Amendment |
|---|---|
| (34b) Authorisations of biocidal products under Regulation (EU) No 528/2012 are likewise affected by significant delays. To enable Member States to focus their resources on completing the review programme, it is appropriate to provide for authorisations of unlimited duration, except for biocidal products containing active substances meeting the substitution criteria. |
Aligning the duration of biocidal product authorisations with the approval status of active substances would improve regulatory coherence, reduce unnecessary administrative burden and allow resources to be redirected towards innovation and more sustainable solutions.
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| (35a) The approval of biocidal active substances meeting exclusion or substitution criteria under Articles 5(1) or 10 of Regulation (EU) No 528/2012 shall be extended to 10 years, to lighten the burden linked to their frequently recurring renewal cycles, and therefore accelerate further the completion of the review programme. |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| (35b) Authorisations of biocidal products under Regulation (EU) No 528/2012 are similarly affected by significant delays. In order to redirect Members States resources towards the completion of the review programme, it is appropriate to set an unlimited duration for the authorisation of biocidal products, except for biocidal products that contain an active substance meeting the substitution criteria. |
| Text proposed by the Commission | Amendment |
|---|---|
| (36) Regulation (EC) No 1829/2003 covers food and feed produced ‘from’ a GMO but not food and feed produced ‘with’ a GMO. In this regard, Recital 16 of that Regulation recalls that the Regulation does not apply to processing aids, or to food and feed which are manufactured with the help of a genetically modified processing aid. However, the scope of Regulation (EC) No 1829/2003 as regards food and feed products obtained using genetically modified micro-organisms (GMMs) as production strains is unclear given that, on the one hand, Recital 16 of that Regulation also states that the determining criterion between food and feed produced ‘from’ or ‘with’ a GMO is whether material derived from the genetically modified source material is present in the food or in the feed and, on the other hand, the definition of ‘processing aid’ in EU food and feed law allows, under certain conditions, for the presence in the final product of residues of the substance or its derivatives. Furthermore, the increasing sensitivity of detection methods has the consequence that food and feed that have been considered free from residues of GMMs and have been placed on the market as conventional products for many years may at some point be considered as containing such residues. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (36) Regulation (EC) No 1829/2003 covers food and feed produced ‘from’ a GMO but not food and feed produced ‘with’ a GMO. In this regard, Recital 16 of that Regulation recalls that the Regulation does not apply to processing aids, or to food and feed which are manufactured with the help of a genetically modified processing aid. However, the scope of Regulation (EC) No 1829/2003 as regards food and feed products obtained using genetically modified micro-organisms (GMMs) as production strains is unclear given that, on the one hand, Recital 16 of that Regulation also states that the determining criterion between food and feed produced ‘from’ or ‘with’ a GMO is whether material derived from the genetically modified source material is present in the food or in the feed and, on the other hand, the definition of ‘processing aid’ in EU food and feed law allows, under certain conditions, for the presence in the final product of residues of the substance or its derivatives. Furthermore, the increasing sensitivity of detection methods has the consequence that food and feed that have been considered free from residues of GMMs and have been placed on the market as conventional products for many years may at some point be considered as containing such residues. | (36) Regulation (EC) No 1829/2003 covers food and feed produced ‘from’ a GMO but not food and feed produced ‘with’ a GMO. In this regard, Recital 16 of that Regulation recalls that the Regulation does not apply to processing aids, or to food and feed which are manufactured with the help of a genetically modified processing aid. However, the scope of Regulation (EC) No 1829/2003 as regards food and feed products obtained using genetically modified micro-organisms (GMMs) as production strains is unclear given that, on the one hand, Recital 16 of that Regulation also states that the determining criterion between food and feed produced ‘from’ or ‘with’ a GMO is whether material derived from the genetically modified source material is present in the food or in the feed and, on the other hand, the definition of ‘processing aid’ in EU food and feed law allows, under certain conditions, for the presence in the final product of residues of the substance or its derivatives. Furthermore, the increasing sensitivity of detection methods has the consequence that food and feed that have been considered free from residues of GMMs and have been placed on the market as conventional products for many years may at some point be considered as containing such residues. Where their production involves the use of genetically modified microorganisms, it is essential that the end product may never contain viable cells. The use of GMMs as production strains requires a consistent and precautionary approach, taking into account potential risks associated with genetic modification, including persistence and spread of genetic traits, gene transfer and effects on human health, animal health and the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| (37) Therefore, to ensure the good functioning of the internal market and provide legal certainty to food and feed business operators, food and feed products obtained using a GMM as production strain and from which the GMM has been removed should not fall within the scope of Regulation (EC) No 1829/2003 even if residues of the GMM are present in the food or feed, provided that they are limited to non-viable cells, that the presence thereof is minimized through reasonable attempts to remove them and have no technological effect on the final food or feed. In particular, in order to ensure that reasonable attempts to remove residues have been made, it should be required that they have been carried out in accordance with good manufacturing practices as those used in similar food and feed products to minimize the presence of residues. | deleted |
Benoit Cassart, Gerben-Jan Gerbrandy, Martin Hojsík, Christine Singer, Pascal Canfin, Olivier Chastel, Michal Wiezik, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (37) Therefore, to ensure the good functioning of the internal market and provide legal certainty to food and feed business operators, food and feed products obtained using a GMM as production strain and from which the GMM has been removed should not fall within the scope of Regulation (EC) No 1829/2003 even if residues of the GMM are present in the food or feed, provided that they are limited to non-viable cells, that the presence thereof is minimized through reasonable attempts to remove them and have no technological effect on the final food or feed. In particular, in order to ensure that reasonable attempts to remove residues have been made, it should be required that they have been carried out in accordance with good manufacturing practices as those used in similar food and feed products to minimize the presence of residues. | (37) Therefore, to ensure the good functioning of the internal market and provide legal certainty to food and feed business operators, while fostering innovation in agricultural sector, food and feed products obtained using a GMM as production strain and from which the GMM has been removed should not fall within the scope of Regulation (EC) No 1829/2003 even if residues of the GMM are present in the food or feed, provided that they are limited to non-viable cells, that the presence thereof is minimized through as low as reasonably achievable attempts to remove them and have no technological effect on the final food or feed. In particular, in order to ensure that reasonable attempts to remove residues have been made, it should be required that they have been carried out in accordance with good manufacturing practices as those used in similar food and feed products to minimize the presence of residues. |
| Text proposed by the Commission | Amendment |
|---|---|
| (38) The reference to GMMs in the definition of ‘produced from GMOs’ should refer to GMMs as defined in Directive 2009/41/EC of the European Parliament and the Council of 6 May 2009,9 with the exclusion of animal and plant cells in culture. In order to be consistent with the overall applicable framework on GMOs, it should be ensured that the same rules apply to animal and plant cells, regardless of whether they are in culture, not in culture or embedded in the complete organisms. The specific provisions should therefore cover only micro-organisms in the biological sense, including the taxonomic groups Archaea and Bacteria, the unicellular species and life stages of Protozoa, Chromista and Fungi, as well as filamentous fungi and viruses, while excluding animal and plant cells in culture. | (38) The reference to GMMs in the definition of ‘produced from GMOs’ should refer to GMMs as defined in Directive 2009/41/EC of the European Parliament and the Council of 6 May 2009,9 with the exclusion of animal and plant cells in culture. In order to be consistent with the overall applicable framework on GMOs, it should be ensured that the same rules apply to animal and plant cells, regardless of whether they are in culture, not in culture or embedded in the complete organisms. The specific provisions should therefore cover only micro-organisms in the biological sense, including the taxonomic groups Archaea and Bacteria, the unicellular species and life stages of Protozoa, Chromista and Fungi, as well as filamentous fungi and viruses, while excluding animal and plant cells in culture. Such clarification should not result in the exclusion of genetically modified microorganisms or genetically modified cells from GMO risk assessment requirements where their use and particularly release into the environment may give rise to risks related to persistence and spread of genetic traits, gene transfer, effects on non-target organisms, ecosystem-level effects or reversibility following release. |
| 9 Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance); OJ L 125, 21.5.2009, pp. 75–97 | 9 Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (Text with EEA relevance); OJ L 125, 21.5.2009, pp. 75–97 |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| (38a) In order to improve predictability in the supply chain for economic operators placing on the market biocidal products via the Union authorisation route, it is appropriate to define a timeline for the adoption of the decisions on applications for Union authorisation. |
| Text proposed by the Commission | Amendment |
|---|---|
| (38a) In order to improve predictability for economic operators placing biocidal products on the market through the Union authorisation route, it is appropriate to establish a clear timeline for the adoption of decisions on Union authorisation applications. |
The absence of clear timelines for the adoption and publication of Union authorisation decisions creates significant uncertainty for companies, affecting their ability to plan label updates, production and supply chain management effectively. Establishing a predictable timeframe would improve regulatory certainty and facilitate business planning.
| Text proposed by the Commission | Amendment |
|---|---|
| (39) Regulation (EC) No 1831/200310 sets out the grounds and procedures for authorisation of feed additives in the Union. It provides that authorisations of feed additives are valid for ten years and are renewable for ten-year periods upon submission of an application in due time. This renewal requirement has proved to generate high administrative and regulatory burden and financial costs for businesses, in particular SMEs, but also for the Authority, the Member States and the Commission involved in the renewal procedure. In addition, the implementation of Regulation (EC) No 1831/2003 has so far led to only very few withdrawals or denials of authorisation for safety reasons, in particular on the occasion of the renewal of authorisations. In order to avoid unnecessary administrative and financial burdens, and thereby making available resources to research, product development and market expansion, the authorisation of feed additives should be granted for an unlimited period of time, except for additives belonging to the category of coccidiostats and histomonostats which should remain under the ten-year authorisation regime due to their antimicrobial nature and their derived higher risk profile. | deleted |
| 10 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj). |
| Text proposed by the Commission | Amendment |
|---|---|
| (39) Regulation (EC) No 1831/200310 sets out the grounds and procedures for authorisation of feed additives in the Union. It provides that authorisations of feed additives are valid for ten years and are renewable for ten-year periods upon submission of an application in due time. This renewal requirement has proved to generate high administrative and regulatory burden and financial costs for businesses, in particular SMEs, but also for the Authority, the Member States and the Commission involved in the renewal procedure. In addition, the implementation of Regulation (EC) No 1831/2003 has so far led to only very few withdrawals or denials of authorisation for safety reasons, in particular on the occasion of the renewal of authorisations. In order to avoid unnecessary administrative and financial burdens, and thereby making available resources to research, product development and market expansion, the authorisation of feed additives should be granted for an unlimited period of time, except for additives belonging to the category of coccidiostats and histomonostats which should remain under the ten-year authorisation regime due to their antimicrobial nature and their derived higher risk profile. | (39) Regulation (EC) No 1831/200310 sets out the grounds and procedures for authorisation of feed additives in the Union. It provides that authorisations of feed additives are valid for ten years and are renewable for ten-year periods upon submission of an application in due time. This renewal requirement has proved to generate high administrative and regulatory burden and financial costs for businesses, in particular SMEs, but also for the Authority, the Member States and the Commission involved in the renewal procedure. In addition, the implementation of Regulation (EC) No 1831/2003 has so far led to only very few withdrawals or denials of authorisation for safety reasons, in particular on the occasion of the renewal of authorisations. In order to avoid unnecessary administrative and financial burdens, and thereby making available resources to research, product development and market expansion, the authorisation of feed additives should be granted for an unlimited period of time, except for additives belonging to the categories of zootechnical additives, coccidiostats and histomonostats which should remain under the ten-year authorisation regime due to their antimicrobial nature and their derived higher risk profile. |
| 10 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj). | 10 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj). |
| Text proposed by the Commission | Amendment |
|---|---|
| (39) Regulation (EC) No 1831/200310 sets out the grounds and procedures for authorisation of feed additives in the Union. It provides that authorisations of feed additives are valid for ten years and are renewable for ten-year periods upon submission of an application in due time. This renewal requirement has proved to generate high administrative and regulatory burden and financial costs for businesses, in particular SMEs, but also for the Authority, the Member States and the Commission involved in the renewal procedure. In addition, the implementation of Regulation (EC) No 1831/2003 has so far led to only very few withdrawals or denials of authorisation for safety reasons, in particular on the occasion of the renewal of authorisations. In order to avoid unnecessary administrative and financial burdens, and thereby making available resources to research, product development and market expansion, the authorisation of feed additives should be granted for an unlimited period of time, except for additives belonging to the category of coccidiostats and histomonostats which should remain under the ten-year authorisation regime due to their antimicrobial nature and their derived higher risk profile. | (39) Regulation (EC) No 1831/200310 sets out the grounds and procedures for authorisation of feed additives in the Union. It provides that authorisations of feed additives are valid for ten years and are renewable for ten-year periods upon submission of an application in due time. This renewal requirement has proved to generate high administrative and regulatory burden and financial costs for businesses, in particular microenterprises and SMEs, but also for the Authority, the Member States and the Commission involved in the renewal procedure. In addition, the implementation of Regulation (EC) No 1831/2003 has so far led to only very few withdrawals or denials of authorisation for safety reasons, in particular on the occasion of the renewal of authorisations In order to avoid unnecessary administrative and financial burdens, and thereby making available resources to research, product development and market expansion, the authorisation of feed additives should be granted for an unlimited period of time, except for additives belonging to the category of coccidiostats and histomonostats which should remain under the ten-year authorisation regime due to their antimicrobial nature and their derived higher risk profile. |
| 10 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj). | 10 Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition (OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj). |
Anja Hazekamp, Per Clausen, Valentina Palmisano, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
| Text proposed by the Commission | Amendment |
|---|---|
| (40) Alternative measures to the option of authorisations valid for an unlimited period of time, such as longer authorisation periods for some or all feed additives or different authorisation periods according to the type of additives, were not considered as satisfactory due to a lack of objective criteria to differentiate between additives’ categories or functional groups in terms of safety or efficacy or due to the risk of absence of applicants for the renewal of non-holder specific authorisations. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (41) Modifications, suspensions or revocations of existing authorisations should continue to be adopted anytime where such authorisations no longer meet the safety or efficacy conditions set out in Regulation (EC) No 1831/2003, taking into account scientific and technological developments. The high safety level of protection pursued by the Regulation should continue to be ensured, considering in particular the supervision and monitoring requirements on holders of authorisations, including implementation of post-market monitoring required in authorisations granted before this Regulation, the Authority’s possible scientific reassessment of authorisations on its own initiative or on Member States’ or Commission’s request or upon submission of applications for modification of authorisations or for the authorisation of new uses of feed additives. In view of a scientific reassessment of authorisations, the Authority’s powers should include possible requests of information to applicants and authorisation-holders and the accomplishment of any relevant tasks provided by Regulation (EC) No 178/2002 of the European Parliament and of the Council11, such as data collection, commissioning of scientific studies and use of information identified from monitoring of emerging risks. The application of these safeguards should ensure that the authorisation of feed additives for an unlimited period of time does not pose a risk to safety. Article 9 and Article 14 of Regulation (EC) No 1831/2003 should therefore be amended accordingly. | (41) Modifications, suspensions or revocations of existing authorisations should continue to be adopted anytime where such authorisations no longer meet the safety or efficacy conditions set out in Regulation (EC) No 1831/2003, taking into account scientific and technological developments, after a 30-day notice period. The high safety level of protection pursued by the Regulation should continue to be ensured, considering in particular the supervision and monitoring requirements on holders of authorisations, including implementation of post-market monitoring required in authorisations granted before this Regulation, the Authority’s possible scientific reassessment of authorisations on its own initiative or on Member States’ or Commission’s request or upon submission of applications for modification of authorisations or for the authorisation of new uses of feed additives. In view of a scientific reassessment of authorisations, the Authority’s powers should include possible requests of information to applicants and authorisation-holders and the accomplishment of any relevant tasks provided by Regulation (EC) No 178/2002 of the European Parliament and of the Council11, such as data collection, commissioning of scientific studies and use of information identified from monitoring of emerging risks. The application of these safeguards should ensure that the authorisation of feed additives for an unlimited period of time does not pose a risk to safety. Article 9 and Article 14 of Regulation (EC) No 1831/2003 should therefore be amended accordingly. |
| 11 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1, ELI: http://data.europa.eu/eli/reg/2002/178/oj). | 11 Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1, ELI: http://data.europa.eu/eli/reg/2002/178/oj). |
Anja Hazekamp, Per Clausen, Valentina Palmisano, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
| Text proposed by the Commission | Amendment |
|---|---|
| (42) In order to provide legal certainty and to ensure a smooth transition to the new rules, it should be clarified that authorisations of feed additives already granted before the entry into force of this Regulation, and which are still in force, are deemed unlimited in time, except for additives belonging to the category of coccidiostats and histomonostats, urgent authorisations granted under Article 15, authorisations for which no application for renewal has been submitted on time before the entry into force of the new rules or for which such application has been submitted but subsequently withdrawn, and authorisations for which an application for renewal of authorisation has been submitted before the entry into force of the new rules and for which no decision has been taken by that date. | deleted |
Anja Hazekamp, Per Clausen, Valentina Palmisano, Sebastian Everding, Catarina Martins, Arash Saeidi, Emma Fourreau
| Text proposed by the Commission | Amendment |
|---|---|
| (43) Applications for renewal of authorisation submitted before the date of entry into force of the present Regulation and for which no decision on that renewal has been taken yet at that date, should continue to be treated in accordance with the rules set out in Article 14 as applicable at the time of their submission. However, authorisations renewed after the entry into force of this Regulation should be valid for an unlimited period of time. Furthermore, the new rule of authorisation for an unlimited period of time should not affect the processing of existing procedures concerning applications submitted pursuant to Article 10(2) of Regulation (EC) No 1831/2003. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (45) In addition, it would be appropriate to allow interested parties to submit an application to modify a non-holder specific authorisation, as it is already provided for holder-specific authorisations, with a view to possibly expanding the specifications or conditions included in that authorisation. The current absence of such procedure requires operators wishing to modify a non-holder specific authorisation to resubmit a full application for a new authorisation, which generates unnecessary burden. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (50a) In order to ensure legal safety and fair competition conditions for operators in the Union, it is worth specifying that feed additives or feed containing such additives not authorised for use in the Union may be manufactured, held, stored, packaged, transferred and transported within the Union and exported wherever they are exclusively intended for export to third countries. These products must be clearly identified as being intended for export and should not be used in the animal food chain in the Union. |
| Text proposed by the Commission | Amendment |
|---|---|
| (51) Regulation (EC) No 1099/200918 establishes minimum rules for the protection of animals at the time of slaughter or killing. Under Article 18(4) of Regulation (EC) No 1099/2009 , the competent authorities of Member States are currently required to submit specific annual reports to the Commission on depopulation operations carried out the previous year in addition to the annual reports submitted in accordance with Regulation (EU) 2017/625 on official controls and other official activities19 The objective of Regulation (EC) No 1099/2009 is, however, to protect animals at the time of killing. The annual compliance reports under Regulation (EU) 2017/625 cover animal welfare during killing, including during depopulation activities, and are sufficient to ensure that the objective of Regulation (EC) No 1099/2009 is met. This overlap of two separate reports provides limited added value and inefficiently diverts the resources of competent authorities from risk management. In addition, the information provided under Regulation (EC) No 1099/2009 has proven to be of limited value since that Regulation lacks provisions ensuring a thorough analysis and comparability of the reported information, when compared to the administrative burden of preparing the report. This additional reporting obligation should therefore be removed with a view to simplifying the requirements and reducing the administrative burden on Member State competent authorities. | deleted |
| 18 Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (OJ L 303, 18.11.2009, pp. 1–30, ELI: http://data.europa.eu/eli/reg/2009/1099/oj ) | |
| 19 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, pp. 1–142, ELI: http://data.europa.eu/eli/reg/2017/625/oj) |
| Text proposed by the Commission | Amendment |
|---|---|
| (51) Regulation (EC) No 1099/200918 establishes minimum rules for the protection of animals at the time of slaughter or killing. Under Article 18(4) of Regulation (EC) No 1099/2009 , the competent authorities of Member States are currently required to submit specific annual reports to the Commission on depopulation operations carried out the previous year in addition to the annual reports submitted in accordance with Regulation (EU) 2017/625 on official controls and other official activities19 The objective of Regulation (EC) No 1099/2009 is, however, to protect animals at the time of killing. The annual compliance reports under Regulation (EU) 2017/625 cover animal welfare during killing, including during depopulation activities, and are sufficient to ensure that the objective of Regulation (EC) No 1099/2009 is met. This overlap of two separate reports provides limited added value and inefficiently diverts the resources of competent authorities from risk management. In addition, the information provided under Regulation (EC) No 1099/2009 has proven to be of limited value since that Regulation lacks provisions ensuring a thorough analysis and comparability of the reported information, when compared to the administrative burden of preparing the report. This additional reporting obligation should therefore be removed with a view to simplifying the requirements and reducing the administrative burden on Member State competent authorities. | (51) Regulation (EC) No 1099/200918 establishes minimum rules for the protection of animals at the time of slaughter or killing. Under Article 18(4) of Regulation (EC) No 1099/2009 , the competent authorities of Member States are currently required to submit specific annual reports to the Commission on depopulation operations carried out the previous year in addition to the annual reports submitted in accordance with Regulation (EU) 2017/625 on official controls and other official activities19 The annual reports under Regulation (EC) No 1099/2009 systematically record reasons, species/volumes, emergency methods, non-compliances, difficulties, corrective actions or derogations for each depopulation event. The annual compliance reports under Regulation (EU) 2017/625 cover animal welfare during killing, including during depopulation activities, however these reports do not capture a comparable level of detail as the elements reported under Regulation (EC) No 1099/2009. Depopulation operations carried out for disease control purposes may affect large numbers of animals and give rise to significant animal welfare concerns. Transparent and comparable information on such operations is necessary to assess compliance with the animal welfare requirements laid down in Union legislation, identify challenges and improve future disease control measures. The reporting obligations set out in Regulation (EC) No 1099/2009 should therefore be maintained to ensure that such information remains available to competent authorities and the Commission. However, the Commission should prepare a harmonised reporting template for depopulation operations to simplify data collection and ensure that the information provided by Member States is complete, consistent, comparable and proportionate, with a view to simplifying the requirements and reducing the administrative burden on Member State competent authorities. |
| 18 Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (OJ L 303, 18.11.2009, pp. 1–30, ELI: http://data.europa.eu/eli/reg/2009/1099/oj ) | 18 Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (OJ L 303, 18.11.2009, pp. 1–30, ELI: http://data.europa.eu/eli/reg/2009/1099/oj ) |
| 19 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, pp. 1–142, ELI: http://data.europa.eu/eli/reg/2017/625/oj) | 19 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, pp. 1–142, ELI: http://data.europa.eu/eli/reg/2017/625/oj) |
| Text proposed by the Commission | Amendment |
|---|---|
| (51) Regulation (EC) No 1099/200918 establishes minimum rules for the protection of animals at the time of slaughter or killing. Under Article 18(4) of Regulation (EC) No 1099/2009 , the competent authorities of Member States are currently required to submit specific annual reports to the Commission on depopulation operations carried out the previous year in addition to the annual reports submitted in accordance with Regulation (EU) 2017/625 on official controls and other official activities19 The objective of Regulation (EC) No 1099/2009 is, however, to protect animals at the time of killing. The annual compliance reports under Regulation (EU) 2017/625 cover animal welfare during killing, including during depopulation activities, and are sufficient to ensure that the objective of Regulation (EC) No 1099/2009 is met. This overlap of two separate reports provides limited added value and inefficiently diverts the resources of competent authorities from risk management. In addition, the information provided under Regulation (EC) No 1099/2009 has proven to be of limited value since that Regulation lacks provisions ensuring a thorough analysis and comparability of the reported information, when compared to the administrative burden of preparing the report. This additional reporting obligation should therefore be removed with a view to simplifying the requirements and reducing the administrative burden on Member State competent authorities. | (51) Regulation (EC) No 1099/200918 establishes minimum rules for the protection of animals at the time of slaughter or killing. Under Article 18(4) of Regulation (EC) No 1099/2009 , the competent authorities of Member States are currently required to submit specific annual reports to the Commission on depopulation operations carried out the previous year in addition to the annual reports submitted in accordance with Regulation (EU) 2017/625 on official controls and other official activities19 The annual reports under Regulation (EC) No 1099/2009 systematically record reasons, species, volumes, emergency methods, non-compliances, difficulties, corrective actions or derogations for each depopulation event. The annual compliance reports under Regulation (EU) 2017/625 cover animal welfare during killing, including during depopulation activities, however these reports do not capture a comparable level of detail as the elements reported under Regulation (EC) No 1099/2009. This overlap of two separate reports inefficiently diverts the resources of competent authorities from risk management. Therefore, the specific information relating to depopulation operations currently covered by Regulation (EC) No 1099/2009 should be integrated in Regulation (EC) 2017/625 with a view to simplifying the requirements and reducing the administrative burden on Member State competent authorities. |
| 18 Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (OJ L 303, 18.11.2009, pp. 1–30, ELI: http://data.europa.eu/eli/reg/2009/1099/oj ) | 18 Council Regulation (EC) No 1099/2009 of 24 September 2009 on the protection of animals at the time of killing (OJ L 303, 18.11.2009, pp. 1–30, ELI: http://data.europa.eu/eli/reg/2009/1099/oj ) |
| 19 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, pp. 1–142, ELI: http://data.europa.eu/eli/reg/2017/625/oj) | 19 Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, pp. 1–142, ELI: http://data.europa.eu/eli/reg/2017/625/oj) |
| Text proposed by the Commission | Amendment |
|---|---|
| (52) Regulation (EC) No 999/200120 lays down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies in the Union. Article 6 of Regulation (EC) No 999/2001 requires each Member State to carry out an annual monitoring programme for transmissible spongiform encephalopathies based on active and passive surveillance in accordance with Annex III and it also specifies the minimum animal subpopulations to be covered by such monitoring programme in respect of bovine spongiform encephalopathy (BSE). During its General Session in May 2023, the World Organisation for Animal Health (WOAH) revised Chapter 11.4 “Bovine Spongiform Encephalopathy” of the Terrestrial Animal Health Code21 and updated the international standards as regards the bovine populations and the age of such populations to be covered by BSE surveillance. While Article 6 of Regulation (EC) No 999/2001 already provides that, after consultation of the appropriate scientific committee, the age laid down for certain bovine categories may be adapted according to scientific progress under the procedure referred to in Article 24(3), the updated international standards also require adaptation of the minimum bovine subpopulations covered by the monitoring programme. In order to ensure alignment with evolving scientific knowledge and international standards, Article 6 should therefore be amended so that both the age thresholds and the bovine subpopulations covered by the monitoring programme may be adapted under the procedure referred to in Article 24(3). | deleted |
| 20 Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, OJ L 147, 31.5.2001, http://data.europa.eu/eli/reg/2001/999/oj | |
| 21 World Organisation for Animal Health (WOAH), Terrestrial Animal Health Code, Chapter 11.4 Codes and Manuals - WOAH - World Organisation for Animal Health |
| Text proposed by the Commission | Amendment |
|---|---|
| (52) Regulation (EC) No 999/200120 lays down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies in the Union. Article 6 of Regulation (EC) No 999/2001 requires each Member State to carry out an annual monitoring programme for transmissible spongiform encephalopathies based on active and passive surveillance in accordance with Annex III and it also specifies the minimum animal subpopulations to be covered by such monitoring programme in respect of bovine spongiform encephalopathy (BSE). During its General Session in May 2023, the World Organisation for Animal Health (WOAH) revised Chapter 11.4 “Bovine Spongiform Encephalopathy” of the Terrestrial Animal Health Code21 and updated the international standards as regards the bovine populations and the age of such populations to be covered by BSE surveillance. While Article 6 of Regulation (EC) No 999/2001 already provides that, after consultation of the appropriate scientific committee, the age laid down for certain bovine categories may be adapted according to scientific progress under the procedure referred to in Article 24(3), the updated international standards also require adaptation of the minimum bovine subpopulations covered by the monitoring programme. In order to ensure alignment with evolving scientific knowledge and international standards, Article 6 should therefore be amended so that both the age thresholds and the bovine subpopulations covered by the monitoring programme may be adapted under the procedure referred to in Article 24(3). | (52) Regulation (EC) No 999/200120 lays down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies in the Union. Article 6 of Regulation (EC) No 999/2001 requires each Member State to carry out an annual monitoring programme for transmissible spongiform encephalopathies based on active and passive surveillance in accordance with Annex III and it also specifies the minimum animal subpopulations to be covered by such monitoring programme in respect of bovine spongiform encephalopathy (BSE). During its General Session in May 2023, the World Organisation for Animal Health (WOAH) revised Chapter 11.4 “Bovine Spongiform Encephalopathy” of the Terrestrial Animal Health Code21 and updated the international standards as regards the bovine populations and the age of such populations to be covered by BSE surveillance. While international standards constitute an important reference for the development of Union measures, the Union shall ensure that any adaptation of bovine spongiform encephalopathy (BSE) surveillance requirements maintains at least an equivalent level of protection of human and animal health and reflects the latest scientific knowledge. In particular, adaptations of surveillance requirements should be based on scientific opinions of the European Food Safety Authority (EFSA) and should not result in a reduction of surveillance sensitivity unless EFSA concludes that such reduction would not adversely affect the Union's capability to detect and monitor classical and atypical BSE. |
| 20 Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, OJ L 147, 31.5.2001, http://data.europa.eu/eli/reg/2001/999/oj | 20 Regulation (EC) No 999/2001 of the European Parliament and of the Council of 22 May 2001 laying down rules for the prevention, control and eradication of certain transmissible spongiform encephalopathies, OJ L 147, 31.5.2001, http://data.europa.eu/eli/reg/2001/999/oj |
| 21 World Organisation for Animal Health (WOAH), Terrestrial Animal Health Code, Chapter 11.4 Codes and Manuals - WOAH - World Organisation for Animal Health | 21 World Organisation for Animal Health (WOAH), Terrestrial Animal Health Code, Chapter 11.4 Codes and Manuals - WOAH - World Organisation for Animal Health |
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European Parliament (2026). “AMENDMENTS 76 - 267 - Draft report on the proposal for a regulation of the European Parliament and of the Council Amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements”. Text, 28 July 2026. docId CJ14-AM-790946. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/CJ14-AM-790946 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/CJ14-AM-790946 (CC BY 4.0).
BibTeX
@misc{epw-text-cj14-am-790946,
author = {{European Parliament}},
title = {{AMENDMENTS 76 - 267 - Draft report on the proposal for a regulation of the European Parliament and of the Council Amending Regulations (EC) No 999/2001, (EC) No 1829/2003, (EC) No 1831/2003, (EC) No 852/2004, (EC) No 853/2004, (EC) No 396/2005, (EC) No 1099/2009, (EC) No 1107/2009, (EU) No 528/2012, (EU) 2017/625 as regards the simplification and strengthening of food and feed safety requirements}},
year = {2026},
date = {2026-07-28},
howpublished = {\url{https://news.eu-parl.st-solutions.dev/texts/CJ14-AM-790946}},
url = {https://news.eu-parl.st-solutions.dev/texts/CJ14-AM-790946},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. docId CJ14-AM-790946. Data: EP Open Data API: document record (CC BY 4.0)}
}