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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-791047 · COM(2025)1030 – C100359/2025 – 2025/0410(COD)
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- Amendment list CJ14-AM-791047
- Date
- 28 July 2026
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- 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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| Text proposed by the Commission | Amendment |
|---|---|
| (53) As part of the measures aiming to prevent BSE, Article 8 of Regulation (EC) No 999/2001 requires that tissues with the greatest BSE infectivity, defined as specified risk material, be removed and disposed of in accordance with Annex V. This Article also specify the minimum list of tissues to be removed from bovine animals and the age limit of the animals affected by such removal. During its General Session in May 2023, the World Organisation for Animal Health revised Chapter 11.4 “Bovine Spongiform Encephalopathy” of the Terrestrial Animal Health Code and updated the international standards as regards the commodities harbouring the greatest BSE infectivity based on the BSE risk category of the country where such commodities are originating. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (55) Article 16 of Regulation (EC) No 999/2001 lays down the rules on placing certain products of animal origin on the market, including restrictions on gelatine and collagen derived from ruminant bones. The revised Chapter 11.4 “Bovine Spongiform Encephalopathy” of the Terrestrial Animal Health Code adopted in 2023 confirms, however, that gelatine and collagen derived from ruminant bones are safe commodities. This conclusion was further supported by the 2024 scientific opinion of the Authority on the BSE risk posed by ruminant collagen and gelatine derived from bones22 . To reflect both the international standards mentioned as well as the latest scientific evidence in this regard, the provisions of Article 16 should therefore be amended to include these products, i.e. collagen and gelatine, in the scope of products not subject to restrictions for the placing on the market. | deleted |
| 22 the Authority BIOHAZ Panel, Scientific Opinion on the potential BSE risk posed bythe use of ruminant collagen and gelatine in feed for non-ruminant farmed animals. the Authority Journal2020;18(10):6267, 68 pp. https://doi.org/10.2903/j.efsa.2020.6267ISSN: 1831-4732© 2020 European Food Safety Authority |
| Text proposed by the Commission | Amendment |
|---|---|
| (57) Article 23 and 23a of Regulation (EC) No 999/2001 currently empower the Commission to amend non-essential elements of this Regulation, including by supplementing it, through the regulatory procedure with scrutiny referred to in Article 24(3). In order to achieve the objectives of Regulation (EC) No 999/2001 and ensure the timely adaptation to evolving epidemiological situations, scientific knowledge and international standards, it is appropriate to replace these empowerments with delegated acts in accordance with Article 290 of the Treaty. The Commission should therefore be empowered to amend the annexes and to supplement that Regulation. In particular, regarding the approval of rapid and alternative tests, the adaptation of requirements for bovine spongiform encephalopathy monitoring and surveillance, the list of specified risk materials, and the conditions for placing on the market or, where appropriate, export of products of animal origin derived from healthy ruminants. Regulation (EU) 2017/62523 establishes rules on the performance of official controls by the competent authorities of the Member States, among others, on animals and goods entering the Union in order to verify compliance with Union agri-food chain legislation. Article 50(3) of Regulation (EU) 2017/625 allows the splitting of consignments only after the completion of official controls and the finalisation of the Common Health Entry Document (CHED), which implies that a consignment cannot be released until all the necessary checks for that consignment have been completed. | (57) Article 23 and 23a of Regulation (EC) No 999/2001 currently empower the Commission to amend non-essential elements of this Regulation, including by supplementing it, through the regulatory procedure with scrutiny referred to in Article 24(3). The list of specified risk material constitutes one of the most significant safeguards in EU food law, determining which animal tissues are removed from the human food chain before beef enters the food supply. Any attempt to change its scope carries direct implications for public health and consumer confidence. The highest standards of scientific scrutiny and transparency are essential conditions for maintaining the integrity of the specified risk material framework and public trust in the safety of beef products on the Union market. Regulation (EU) 2017/62523 establishes rules on the performance of official controls by the competent authorities of the Member States, among others, on animals and goods entering the Union in order to verify compliance with Union agri-food chain legislation. Article 50(3) of Regulation (EU) 2017/625 allows the splitting of consignments only after the completion of official controls and the finalisation of the Common Health Entry Document (CHED), which implies that a consignment cannot be released until all the necessary checks for that consignment have been completed. |
| 23 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) | 23 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 |
|---|---|
| (58) Regulation (EU) 2017/625 establishes rules on the performance of official controls by the competent authorities of the Member States, among others, on animals and goods entering the Union in order to verify compliance with Union agri-food chain legislation. Article 50(3) of Regulation (EU) 2017/625 allows the splitting of consignments only after the completion of official controls and the finalisation of the Common Health Entry Document (CHED), which implies that a consignment cannot be released until all the necessary checks for that consignment have been completed. | (58) Regulation (EU) 2017/625 establishes rules on the performance of official controls by the competent authorities of the Member States, among others, on animals and goods entering the Union in order to verify compliance with Union agri-food chain legislation. Article 50(3) of Regulation (EU) 2017/625 allows the splitting of consignments only after the completion of official controls and the finalisation of the Common Health Entry Document (CHED), which implies that a consignment cannot be released until all the necessary checks for that consignment have been completed. The requirement that consignments are not released until all applicable official controls have been completed constitutes an essential safeguard for the protection of human and animal health and consumer interests. It ensures that food and feed entering the Union are verified as complying with the relevant requirements of Union legislation before being released for distribution or placed on the market. The principle that compliance must be established prior to granting access to the Union market is a fundamental element of the Union’s border control framework and contributes to the effective functioning of the system of official controls. |
| Text proposed by the Commission | Amendment |
|---|---|
| (58a) To ensure a high level of consumer protection, food of animal origin placed on the EU market should meet requirements equivalent to those applicable to EU producers as regards certain production and processing methods prohibited on health grounds. Where such practices do not leave detectable residues, controls based solely on an analysis of the end products may be inadequate. It is therefore necessary to take account of the production and processing methods and to put in place appropriate safeguards, which would also prevent distortions of competition to the detriment of Union operators. |
| Text proposed by the Commission | Amendment |
|---|---|
| (60) To ensure that official controls are carried out at border control posts without causing unnecessary delay or financial loss for the operators, and without compromising the level of phytosanitary protection of the Union territory, Article 50(3) of Regulation (EU) 2017/625 should be amended to allow the competent authorities of the border control posts to split consignments of plant and plant products before completing the official controls on the entirety of the consignment, in order to enable the release of the parts for which official controls have been finalised. | (60) To ensure that official controls are carried out at border control posts without causing unnecessary delay or financial loss for the operators, and without compromising the level of phytosanitary protection of the Union territory, Article 50(3) of Regulation (EU) 2017/625 should be amended to allow the competent authorities of the border control posts to split consignments of plant and plant products before completing the official controls on the entirety of the consignment, in order to enable the release of the parts for which official controls have been finalised. However, the prevention of harm to the health of consumers must remain the overarching principle governing any such flexibility, and no portion of a consignment may be released before all controls on that specific portion are completed. |
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 |
|---|---|
| (60a) The simplification of official controls should not reduce the frequency or effectiveness of physical controls where these are required on the basis of risk, scientific evidence or new information affecting compliance with Union legislation. |
| Text proposed by the Commission | Amendment |
|---|---|
| (61a) Official control laboratories may hold a flexible accreditation, allowing the incorporation of new methods based on a technology or measurement principle that has already been accredited. |
Flexible accreditation already exists as an official form of accreditation in mandatory document EA-2/15 (issued by European Accreditation), as flexibility based on the analytical principle, internationally recognised as: 'flexibility with regard to the introduction of new methods based on an already accredited measurement principle (technology)'
| Text proposed by the Commission | Amendment |
|---|---|
| (61a) Official control laboratories may hold a flexible accreditation, allowing the incorporation of new methods based on a technology or measurement principle that has already been accredited. |
The term "flexible accreditation" is the official accreditation terminology used in the mandatory EA-2/15 document of the European co-operation for Accreditation (EA). It refers to "flexibility with regard to the introduction of new methods based on an already accredited measurement principle (technology)", a concept that is internationally recognised.
| Text proposed by the Commission | Amendment |
|---|---|
| (63a) In order to optimize the operational efficiency and responsiveness of official control laboratories, it is necessary to provide for the possibility of maintaining a flexible scope of accreditation. Such flexible accreditation allows laboratories to quickly integrate new testing or diagnostic methods within their verified capabilities, provided that these methods are based on an existing technology, matrix, or measurement principle already covered by their current accreditation scope. This mechanism ensures that official controls can swiftly adapt to emerging risks and shifting analytical realities without being hindered by lengthy, iterative administrative reappraisal processes. |
The proposed amendment introduces the concept of a "flexible scope of accreditation" for official control laboratories, aligning Union legislation with international standards and the mandatory EA-2/15 binding document issued by the European Co-operation for Accreditation. The proposal formalizes "flexibility based on the analytical principle," which is internationally recognized as the ability to introduce new methods based on a measurement principle or technology that is already accredited. This measure eliminates administrative red tape and redundant bureaucratic delays caused by iterative auditing cycles for minor methodological updates. Consequently, it delivers controlled operational agility, enabling official laboratories to swiftly adopt scientific innovations and respond effectively to emerging risks within the agri-food chain.
| Text proposed by the Commission | Amendment |
|---|---|
| (63a) In order to ensure that simplification measures deliver real benefits for farmers and competent authorities, Member States should be allowed to adapt certain administrative requirements relating to plant protection products to farm size, production type, digital readiness and the level of risk. Such flexibility should not lower food and feed safety standards, but should prevent disproportionate burdens. |
| Present text | Amendment |
|---|---|
| (-1) In Article 1, paragraph 1 is replaced by the following: | |
| 1. This Regulation lays down rules for the authorisation of plant protection products in commercial form and for their placing on the market, use and control within the Community. | "1. This Regulation lays down rules for the authorisation of plant protection products in commercial form and for their placing on the market, use and control within the Community, and for the trade in plant protection products. " |
| Present text | Amendment |
|---|---|
| Article 1 is replaced by the following | |
| Article 1 Subject matter and purpose | "Article 1 Subject matter and purpose |
| 1. This Regulation lays down rules for the authorisation of plant protection products in commercial form and for their placing on the market, use and control within the Community. | 1. This Regulation lays down rules for the authorisation of plant protection products in commercial form and for their placing on the market, use and control within the Community. |
| 2. This Regulation lays down both rules for the approval of active substances, safeners and synergists, which plant protection products contain or consist of, and rules for adjuvants and co-formulants. | 2. This Regulation lays down both rules for the approval of active substances, safeners and synergists, which plant protection products contain or consist of, and rules for adjuvants and co-formulants. |
| 3. The purpose of this Regulation is to ensure a high level of protection of both human and animal health and the environment and to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production. | 3. The purpose of this Regulation is to ensure: |
| a) a high degree of self-sufficiency in primary agricultural production in the Union as agricultural land is primarily be used for the production of food, feed and raw materials and active substances and plant protection products shall contribute to ensuring and safeguarding this objective; and | |
| b) a high level of protection of both human and animal health and the environment; and | |
| c) to improve the functioning of the internal market through the harmonisation of the rules on the placing on the market of plant protection products, while improving agricultural production. | |
| 4. The provisions of this Regulation are underpinned by the precautionary principle in order to ensure that active substances or products placed on the market do not adversely affect human or animal health or the environment. In particular, Member States shall not be prevented from applying the precautionary principle where there is scientific uncertainty as to the risks with regard to human or animal health or the environment posed by the plant protection products to be authorised in their territory. | 4. The provisions of this Regulation are underpinned by the precautionary principle in order to ensure that active substances or products placed on the market do not adversely affect human or animal health or the environment. In particular, Member States shall not be prevented from applying the precautionary principle where there is scientific uncertainty as to the risks with regard to human or animal health or the environment posed by the plant protection products to be authorised in their territory." |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) paragraph 1, point (b) is replaced by the following: | deleted |
| ‘(b) ‘disrupting life processes of plants, such as substances regulating their growth, other than as a nutrient or a plant biostimulant’ |
The terms “disrupting” and “regulating” would narrow the scope of the provision to substances that are already known to affect plant life processes. Maintaining the current phrasing is consistent with the precautionary principle
| Present text | Amendment |
|---|---|
| (1a) Article 2 is amended as follows: | |
| (a) in paragraph 1, point (a) is replaced by the following: | |
| (a) protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products; | ‘(a) protecting plants or plant products against all harmful organisms or preventing the action of such organisms, unless the protective function of such products results solely from a barrier effect or the main purpose of these products is considered to be for reasons of hygiene rather than for the protection of plants or plant products;’ |
| (b) point 1(b) is replaced by the following: | |
| (b) influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient; | ‘(b) influencing the life processes of plants, such as substances that regulate their growth, other than by acting as a plant nutrient or biostimulant;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) ‘disrupting life processes of plants, such as substances regulating their growth, other than as a nutrient or a plant biostimulant | deleted |
It is important to maintain the wording ‘influencing’, rather than ‘disrupting’ and ‘regulating’. Words such as ‘disrupting’ and ‘regulating’ would narrow the scope of the substances meant in paragraph (b) to those of which it is already known they disrupt life processes of plants.
| Text proposed by the Commission | Amendment |
|---|---|
| (b) ‘disrupting life processes of plants, such as substances regulating their growth, other than as a nutrient or a plant biostimulant | (b) ‘influencing the life processes of plants, such as substances regulating their growth, other than as a nutrient or a plant biostimulant |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) ‘disrupting life processes of plants, such as substances regulating their growth, other than as a nutrient or a plant biostimulant | (b) ‘influencing life processes of plants, such as substances influencing their growth, other than as a nutrient or a plant biostimulant |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) ‘disrupting life processes of plants, such as substances regulating their growth, other than as a nutrient or a plant biostimulant | (b) ‘influencing life processes of plants, such as substances influencing their growth, other than as a nutrient or a plant biostimulant |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) ‘disrupting life processes of plants, such as substances regulating their growth, other than as a nutrient or a plant biostimulant | (b) ‘regulating life processes of plants, such as substances regulating their growth, other than as a nutrient or a plant biostimulant |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) ‘disrupting life processes of plants, such as substances regulating their growth, other than as a nutrient or a plant biostimulant | (b) ‘regulating life processes of plants, such as substances regulating their growth, other than as a nutrient or a plant biostimulant |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) ‘disrupting life processes of plants, such as substances regulating their growth, other than as a nutrient or a plant biostimulant | (b) ‘regulating life processes of plants, such as substances regulating their growth, other than as a nutrient or a plant biostimulant |
The term “disrupting” implies that the substances have exclusively negative effects on plant growth and development. In contrast, a plant regulator can exert both positive and negative effects. The term regulating is more neutral and is therefore proposed.
| Text proposed by the Commission | Amendment |
|---|---|
| (b) ‘disrupting life processes of plants, such as substances regulating their growth, other than as a nutrient or a plant biostimulant | (b) ‘regulating life processes of plants, such as substances regulating their growth, other than as a nutrient or a plant biostimulant |
| Present text | Amendment |
|---|---|
| (1b) Article 2 is amended as follows: | |
| (c) paragraph 2 is replaced by the following: | |
| 2. This Regulation shall apply to substances, including micro-organisms having general or specific action against harmful organisms or on plants, parts of plants or plant products, referred to as ‘active substances’. | ‘2. This Regulation shall apply to substances, including biocontrol substances having general or specific action other than a barrier effect against harmful organisms or on plants, parts of plants or plant products, referred to as ‘active substances’.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. This Regulation shall apply to substances, including biocontrol substances having general or specific action against harmful organisms or on plants, parts of plants or plant products, referred to as ‘active substances.; | 2. This Regulation shall apply to substances, including biocontrol substances and micro-organisms having general or specific action against harmful organisms or on plants, parts of plants or plant products, referred to as ‘active substances.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. This Regulation shall apply to substances, including biocontrol substances having general or specific action against harmful organisms or on plants, parts of plants or plant products, referred to as ‘active substances.; | 2. This Regulation shall apply to substances, including biocontrol substances and micro-organisms having general or specific action against harmful organisms or on plants, parts of plants or plant products, referred to as ‘active substances. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) In Article 2, a new paragraph 3a is added: | |
| (3a) Where a product had been placed on the market in a Member State for at least three years prior to the date of entry into force of this Regulation, on the basis of the Commission’s working documents aimed at harmonising the approach of Member States, the positions of the competent authorities of Member States, or other established regulatory or interpretative practice, pursuant to which the product was not considered to fall within the scope of Regulation 1107/2009, and subsequently, as a result of a change to those guidelines, documents, positions or practices, it was deemed in that Member State to be subject to Regulation 1107/2009, Member States, acting in response to an application from a manufacturer or distributor, shall authorise the continued placing on the market and use of that product during a transitional period, where this is justified by a substantial economic interest of the users of the product, in particular the need to allow sufficient time to adapt to the amended classification, to ensure continuity of production or to avoid disproportionate disruption to economic activity, unless the competent authority determines that at least one of the grounds for exclusion set out in Annex I to this Regulation applies. | |
| An application may be submitted at any time, but no later than six months from the date of: | |
| (1) the entry into force of this Regulation, where the change to the guidelines, documents, positions or practice occurred before that date; or | |
| (2) from the date on which the Member State communicated or made available information on a change to the classification or interpretation, where the change to the classification or interpretation took place after the date of entry into force of this Regulation, | |
| The transitional period shall be five years and shall run from the date of submission of the application. If, within this period, a manufacturer or distributor submits, in accordance with the requirements, an application for the approval of an active substance, a safener or synergist, where required, or an application for authorisation to place a plant protection product on the market and for its use, the transitional period may be extended until the relevant procedure is completed, but for no longer than ten years from the date on which the application for the product to be covered by the transitional period was submitted. If the application submitted by the manufacturer or distributor is withdrawn, rejected or not submitted within the required time limit, the Member State concerned shall withdraw authorisation to benefit from the transitional period. Article 46 of Regulation 1107/2009 shall apply mutatis mutandis. |
| Text proposed by the Commission | Amendment |
|---|---|
| 17. ´zone´ means a group of Member States as defined in Annex I. | deleted |
| For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order 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 and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I.; |
The current division into three geographical zones does not always reflect agronomic and climatic realities. Member States within the same zone may face different conditions, while similar production conditions may exist across different zones. A more harmonised Union-wide authorisation framework could reduce administrative burdens, improve legal certainty and equal access to plant protection products, while maintaining a high level of protection of human and animal health and the environment.
| Text proposed by the Commission | Amendment |
|---|---|
| 17. ´zone´ means a group of Member States as defined in Annex I. | deleted |
| For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order 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 and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I.; |
EU a single zone approach should be implemented for all types of applications. Differences in climatic conditions are changing in due time (climatic change) significantly and it is not reasonable to continue with zonal approach. Differences amongst different localities within some MS are so huge, that zonal system including very different territories does not have any logic reason (mountain areas, lowlands, different soil types, ect.). Evaluation for different conditions should be carried out by Authority (EFSA) and/or rapporteur MS with possible assistance of other MS´s. Proposed model further reduce the present workload and unify farmers access to crop protection tools across EU.
Carmen Crespo Díaz, Juan Ignacio Zoido Álvarez, Susana Solís Pérez, Esther Herranz García, Dolors Montserrat
| Text proposed by the Commission | Amendment |
|---|---|
| ´zone´ means a group of Member States as defined in Annex I. | ´zone´ means a group of Member States as defined in Annex I. For the purpose of applications concerning plant protection products to be applied by unmanned aircraft systems in accordance with Directive 2009/128/EC, the zone shall comprise all areas defined in Annex I, provided that the requested use is based on comparable agricultural practices and a harmonised risk assessment; |
| Text proposed by the Commission | Amendment |
|---|---|
| For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order 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 and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I.; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order 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 and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I.; | For the purpose of use in open spaces, greenhouses, for all minor crops, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order 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, for plant protection products to be used for application by such unmanned aircraft systems in accordance with Directive 2009/128/EC and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I. |
| Text proposed by the Commission | Amendment |
|---|---|
| For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order 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 and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I.; | For the purpose of use in greenhouses, for all minor crops, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order 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, for plant protection products to be used for application by such unmanned aircraft systems in accordance with Directive 2009/128/EC, and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I.; |
| Text proposed by the Commission | Amendment |
|---|---|
| For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order 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 and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I.; | For the purpose of use in greenhouses, for all minor crops, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order 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, for plant protection products to be used for application by such unmanned aircraft systems in accordance with Directive 2009/128/EC, and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I.; |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez, Juan Ignacio Zoido Álvarez
| Text proposed by the Commission | Amendment |
|---|---|
| For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order 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 and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I.; | For the purpose of use in greenhouses, for all minor crops, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order 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 for plant protection products to be used for application by such unmanned aircraft systems in accordance with Directive 2009 128 EC and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I. |
| Text proposed by the Commission | Amendment |
|---|---|
| For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order 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 and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I.; | For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order 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, for plant protection products to be used for application by such unmanned aircraft systems in accordance with Directive 2009/128/EC and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I.’; |
PPP to be used for unmanned aircraft systems should be authorized the same at EU level or at less, at “zone” level, preventing an excessive fragmentation of the EU market. • A specific authorisation system should be established for drones.. • The EC Directive 128/2009 should be adapted accordingly
| Text proposed by the Commission | Amendment |
|---|---|
| For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order 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 and for plant protection products containing as active substances only biocontrol or low-risk active substances, the zone means all zones defined in Annex I.; | For the purpose of use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order 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, and for plant protection products containing low risk biocontrol active substances, the zone means all zones defined in Annex I.; |
| Present text | Amendment |
|---|---|
| (aa) Point 27 is replaced by the following: | |
| ‘greenhouse’ means a walk-in, static, closed place of crop production with a usually translucent outer shell, which allows controlled exchange of material and energy with the surroundings and prevents release of plant protection products into the environment. | ‘greenhouse’ means a walk-in, static, sealed place of crop production with a usually translucent outer shell, which allows controlled exchange of material and energy with the surroundings, with strictly no release of plant protection products into the environment, including through the soil. |
| For the purpose of this Regulation, closed places of plant production where the outer shell is not translucent (for example, for production of mushrooms or witloof) are also considered as greenhouses; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) point 34 is replaced by the following: | deleted |
| '34. ‘plant biostimulant’ means a product having at least one of the following actions: | |
| (1) stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: | |
| (a) nutrient use efficiency; | |
| (b) quality traits; | |
| (c) availability of confined nutrients in soil or rhizosphere; | |
| (2) stimulating life processes of crops to improve their tolerance to abiotic stress. | |
| Substances disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are active substances covered by this Regulation.’; |
. The rewording of the definition of biostimulant proposed by the Commission is deleted. This amendment is linked to the next one: it should be replaced by a single, conclusive definition, identical to the one in Regulation (EU) 2019/1009.
Carmen Crespo Díaz, Juan Ignacio Zoido Álvarez, Susana Solís Pérez, Esther Herranz García, Dolors Montserrat
| Text proposed by the Commission | Amendment |
|---|---|
| 34. ‘plant biostimulant’ means a product having at least one of the following actions: | 34. ‘plant biostimulant’ means a product that stimulates plant nutrition or physiological processes with the aim of improving one or more of the following characteristics of the plant, soil or rhizosphere irrespective of its nutrient content: |
| (1) stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: | |
| (a) nutrient use efficiency; | (a) nutrient use efficiency; |
| (b) quality traits; | (b) tolerance to abiotic stress; |
| (c) availability of confined nutrients in soil or rhizosphere; | (c) crop quality; |
| (d) availability of confined nutrients in soil or rhizosphere. | |
| (2) stimulating life processes of crops to improve their tolerance to abiotic stress. | |
| Substances disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are active substances covered by this Regulation; | Products whose primary function is to interfere with vital plant processes to control, inhibit or modify their growth for plant protection purposes shall be subject to this Regulation as plant protection products. |
| Text proposed by the Commission | Amendment |
|---|---|
| 34. ‘plant biostimulant’ means a product having at least one of the following actions: | 34. ‘plant biostimulant’ means a product stimulating plant nutrition processes or life processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: |
| (1) stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: | |
| (a) nutrient use efficiency; | (a) nutrient use efficiency; |
| (b) quality traits; | (b) quality traits; |
| (c) availability of confined nutrients in soil or rhizosphere; | (c) availability of confined nutrients in soil or rhizosphere; |
| (d) tolerance to abiotic stress | |
| (2) stimulating life processes of crops to improve their tolerance to abioticstress. | |
| Substances disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are active substances covered by this Regulation.’; | Products disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are plant protection products covered by this Regulation;’; |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| 34. ‘plant biostimulant’ means a product having at least one of the following actions: | 34. ‘plant biostimulant’ means a means an EU fertilising product stimulating plant nutrition or life processes independently of the product’s nutrient content, with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: |
| (1) stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: | |
| (a) nutrient use efficiency; | (a) nutrient use efficiency; |
| (b) quality traits; | (b) quality traits; |
| (c) availability of confined nutrients in soil or rhizosphere; | (c) availability of confined nutrients in soil or rhizosphere; |
| (d) tolerance to abiotic stress. |
| Text proposed by the Commission | Amendment |
|---|---|
| 34. ‘plant biostimulant’ means a product having at least one of the following actions: | 34. ‘plant biostimulant’ means a product: |
| Text proposed by the Commission | Amendment |
|---|---|
| 34. ‘plant biostimulant’ means a product having at least one of the following actions: | 34. ‘plant biostimulant’ means a product: |
| Text proposed by the Commission | Amendment |
|---|---|
| 34. ‘plant biostimulant’ means a product having at least one of the following actions: | 34. ‘plant biostimulant’ means a product: |
| Text proposed by the Commission | Amendment |
|---|---|
| 34. ‘plant biostimulant’ means a product having at least one of the following actions: | 34. ‘plant biostimulant’ means a product capable of: |
| Text proposed by the Commission | Amendment |
|---|---|
| (1) stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: | deleted |
| (a) nutrient use efficiency; | |
| (b) quality traits; | |
| (c) availability of confined nutrients in soil or rhizosphere; |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| (1) stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: | deleted |
| (a) nutrient use efficiency; | |
| (b) quality traits; | |
| (c) availability of confined nutrients in soil or rhizosphere; |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Viktória Ferenc, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (1) stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: | (1) stimulating plant nutrition processes or their life processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: |
| Text proposed by the Commission | Amendment |
|---|---|
| (1) stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: | (1) stimulating plant nutrition processes or life processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: |
| Text proposed by the Commission | Amendment |
|---|---|
| (1) stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: | (1) stimulating plant nutrition processes or life processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: |
| Text proposed by the Commission | Amendment |
|---|---|
| (1) stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: | (1) stimulating plant nutrition processes or life processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: |
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) tolerance to abiotic stress |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) tolerance to abiotic stress; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) tolerance to abiotic stress; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) tolerance to abiotic stress; |
| Text proposed by the Commission | Amendment |
|---|---|
| stimulating life processes of crops to improve their tolerance to abiotic stress. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| stimulating life processes of crops to improve their tolerance to abiotic stress. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| stimulating life processes of crops to improve their tolerance to abiotic stress. | deleted |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| stimulating life processes of crops to improve their tolerance to abiotic stress. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| stimulating life processes of crops to improve their tolerance to abiotic stress. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Substances disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are active substances covered by this Regulation.; | Products disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are plant protection products covered by this Regulation.; |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| Substances disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are active substances covered by this Regulation.; | Products disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are plant protection products covered by this Regulation.; |
| Text proposed by the Commission | Amendment |
|---|---|
| Substances disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are active substances covered by this Regulation.; | Products disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are plant protection products covered by this Regulation.; |
| Text proposed by the Commission | Amendment |
|---|---|
| Substances disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are active substances covered by this Regulation.; | Products disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are plant protection products covered by this Regulation; |
| Text proposed by the Commission | Amendment |
|---|---|
| Substances disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are active substances covered by this Regulation.; | Substances influencing the life processes of crops which are not fulfilling the definition of plant biostimulants are active substances covered by this Regulation.; |
| Text proposed by the Commission | Amendment |
|---|---|
| Substances disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are active substances covered by this Regulation.’; | Products disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are plant protection products covered by this Regulation.’; |
| Text proposed by the Commission | Amendment |
|---|---|
| Substances disrupting life processes of crops which are not fulfilling the definition of plant biostimulants are active substances covered by this Regulation.; | Substances regulating life processes of crops which are not fulfilling the definition of plant biostimulants are active substances covered by this Regulation.; |
The term “disrupting” implies that the substances have exclusively negative effects on plant growth and development. In contrast, a plant regulator can exert both positive and negative effects. The term regulating is more neutral and is therefore proposed.
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) ‘plant biostimulant’ means a product stimulating plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere: | |
| (a) nutrient use efficiency; | |
| (b) quality traits; | |
| (c) availability of confined nutrients in soil or rhizosphere; | |
| (d) tolerance to abiotic stress; |
A single definition is inserted with four purposes (a-d), which reads the same as the one in the Fertilising Products Regulation. A single, identical definition in both regulations prevents the same product from being considered as a biostimulant under one framework and not under another; the distinction is based on what the product does. (This replaces the sunset clause that is currently included there erroneously)
| Text proposed by the Commission | Amendment |
|---|---|
| 35. ‘biocontrol substance’ means: | 35. ‘biocontrol substance’ means an active substance having general or specific action against harmful organisms or on plants, parts of plants or plant products, excluding genetically modified organisms within the meaning of Directive 2001/18/EC which can be : |
| Text proposed by the Commission | Amendment |
|---|---|
| 35. ‘biocontrol substance’ means: | 35. ‘biocontrol substance’ means an active substance having general or specific action against harmful organisms or on plants, parts of plants or plant products, which can be: |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) micro-organisms, | (a) micro-organisms, not being genetically modified micro-organisms, |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim
| Text proposed by the Commission | Amendment |
|---|---|
| (a) micro-organisms, | (a) micro-organisms excluding genetically modified organisms, |
It is important that the biocontrol definition does not include genetically modified organisms. Without these clarifications, there is a risk of widening the category to synthetically produced substances or organisms that may have unknown or harmful effects.
| Text proposed by the Commission | Amendment |
|---|---|
| (a) micro-organisms, | (a) micro-organisms, viable and non-viable |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) semiochemicals, |
Semiochemicals have a distinct mode of action, such as mating disruption, attraction or repellence, rather than direct control of pests. They should therefore be recognised as a separate category of biocontrol substances, reflecting their specific characteristics and ensuring greater legal clarity.
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) Semio chemicals |
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) semiochemicals |
| Text proposed by the Commission | Amendment |
|---|---|
| (ab) extracts from natural sources, in particular plants and algae, and substances produced by microorganisms |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) inorganic substances as occurring in nature, with the exception of heavy metals and their salts or | (b) inorganic substances as occurring in nature, with the exception of heavy metals (to be precisely indicated) and their salts or |
Biljana Borzan, Gheorghe Cârciu, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim
| Text proposed by the Commission | Amendment |
|---|---|
| (b) inorganic substances as occurring in nature, with the exception of heavy metals and their salts or | (b) inorganic substances as occurring in nature, |
The exclusion of "heavy metals and their salts" should be removed, as the European Parliament has previously supported deleting this wording from the definition of biocontrol substances. Maintaining it could undermine the objective of facilitating access to biocontrol solutions for sustainable and organic agriculture. Any concerns related to toxicity are already addressed through the existing scientific risk assessment
| Text proposed by the Commission | Amendment |
|---|---|
| (b) inorganic substances as occurring in nature, with the exception of heavy metals and their salts or | (b) inorganic substances as occurring in nature or |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) inorganic substances as occurring in nature, with the exception of heavy metals and their salts or | (b) inorganic substances as occurring in nature or |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) inorganic substances as occurring in nature, with the exception of heavy metals and their salts or | (b) inorganic substances as occurring in nature (excluding heavy metals and their salts) or |
Greater clarity and scope are needed for the definition of biocontrol substances to reflectscientific and commercial practices. The Commission’s proposal does not specifically includeplant extracts, metabolites, or enzymes, all of which are important in biocontrols. By explicitlylisting them and their functionally identical synthetic equivalents, the definition captures the fullrange of biocontrol options and excludes ambiguity, enhancing regulatory certainty for bothapplicants and authorities.
| Text proposed by the Commission | Amendment |
|---|---|
| (c) substances of biological origin or produced synthetically that are functionally identical and structurally similar to them.; | (c) substances of biological origin or produced synthetically that are functionally identical and structurally identical to them. Identical requires that the substance only contains naturally occurring amino-acids or nucleotides, that its sequence and three-dimensional molecular structure is identical to the natural substance, that its function is identical, and that it is biologically degraded through predictable, natural pathways; |
It is necessary to ensure that biocontrol remainsrestricted to substances that are truly natural, and therefore, “identical”must be clearly defined. It should require that the substance containsnaturally and unmodified occurring amino acids or nucleotides, that itssequence and three-dimensional molecular structure is identical to the naturalsubstance, that its function is identical, and that it is biologically onlydegraded through predictable, natural pathways.
| Text proposed by the Commission | Amendment |
|---|---|
| (c) substances of biological origin or produced synthetically that are functionally identical and structurally similar to them.; | (c) substances of biological origin or produced synthetically that are functionally and structurally identical to them, consisting exclusively of naturally occurring amino acids or nucleotides, having the same sequence and three-dimensional molecular configuration as the corresponding natural substance, performing the same biological function, and being degraded through predictable natural biological pathways.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) substances of biological origin or produced synthetically that are functionally identical and structurally similar to them.; | (c) substances of biological origin or produced synthetically that are functionally identical and structurally similar to them, as determined in accordance with the relevant EFSA guidance on structural similarity, and that cumulatively fulfil the criteria for low-risk active substances laid down in point 5 of Annex II.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) substances of biological origin or produced synthetically that are functionally identical and structurally similar to them.; | (c) substances of biological origin or produced synthetically that are functionally identical and structurally identical to the naturally occurring substance and which do not present different relevant hazard, environmental fate or risk characteristics compared with the corresponding substance of biological origin.; |
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 |
|---|---|
| (c) substances of biological origin or produced synthetically that are functionally identical and structurally similar to them.; | (c) substances of biological origin or produced synthetically that are functionally identical and structurally similar to them. The Commission shall develop guidance to clarify “functionally identical and structurally similiar” based on recommendations from the Authority.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) substances of biological origin or produced synthetically that are functionally identical and structurally similar to them.; | (c) substances of biological origin, including but not limited to plant extracts, metabolites, enzymes, or their synthetic, functionally identical equivalents.; |
Greater clarity and scope are needed for the definition of biocontrol substances to reflectscientific and commercial practices. The Commission’s proposal does not specifically includeplant extracts, metabolites, or enzymes, all of which are important in biocontrols. By explicitlylisting them and their functionally identical synthetic equivalents, the definition captures the fullrange of biocontrol options and excludes ambiguity, enhancing regulatory certainty for bothapplicants and authorities.
| Text proposed by the Commission | Amendment |
|---|---|
| (c) substances of biological origin or produced synthetically that are functionally identical and structurally similar to them.; | (c) substances of biological origin or identical to them if syntetised |
Biljana Borzan, 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 |
|---|---|
| (c) substances of biological origin or produced synthetically that are functionally identical and structurally similar to them.; | (c) substances that are structurally similar and functionally identical to natural substances of biological origin or produced synthetically |
The diversity of nature-identical substances should be fully reflected in the definition of biocontrol substances to ensure legal clarity and avoid the unintended exclusion of substances with equivalent characteristics and functions.
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) substances of biological origin or produced synthetically that are functionally identical and structurally similar to them. Specific guidance on what is considered ‘structurally similar and functionally identical’ substances shall be developed by the European Commission and the Authority before the entry into force of this Regulation. The conditions established in the guidance for ‘structurally similar and functionally identical’ shall be formally confirmed during the pre-submission meeting process. |
| Text proposed by the Commission | Amendment |
|---|---|
| 36. ´basic substances´ means active substances that are not predominantly used for plant protection purposes, including foodstuffs and substances evaluated in accordance with other Union legislation, but are nevertheless useful in plant protection.; | 36. ´basic substances´ means active substances that are not predominantly used for plant protection purposes, including foodstuffs and substances evaluated in accordance with other Union legislation, provided that such evaluation is relevant to their use as plant protection products.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 36. ´basic substances´ means active substances that are not predominantly used for plant protection purposes, including foodstuffs and substances evaluated in accordance with other Union legislation, but are nevertheless useful in plant protection.’; | 36. ´basic substances´ means active substances that are not predominantly used for plant protection purposes, including foodstuffs and substances evaluated in accordance with other Union legislation, but can, in some cases, be useful in plant protection.’; |
| Text proposed by the Commission | Amendment |
|---|---|
| (da) the following point 36a is added: | |
| ‘36a. ‘barrier effect’ shall mean a mechanism of action of a product or substance in which the intended protective effect results solely from the creation, on a plant, part of a plant, plant product, harmful organism or in the space between them, of a physical barrier, a coating, film, trapping surface or other physical structure that prevents the harmful organism from coming into contact with the plant, or that leads solely to its mechanical trapping, immobilisation, restriction of movement or isolation, without exerting any direct physiological, biochemical or microbiological effect on that organism.’ |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (da) The following point 36a is added: | |
| '36a. 'nursery production’: means the activity of multiplication, grafting, and rearing of plants, including plant reproductive material, ornamental plants, cut flowers, young fruit trees, and vegetable seedlings, whether in open fields or under protected conditions. This activity is characterized by a high planting density per unit area and by plant biometric and phenological parameters that substantially differ from those of crops intended for food, fruit, or industrial production in their adult stage.' |
| Text proposed by the Commission | Amendment |
|---|---|
| (da) the following point 36a is inserted: | |
| 36a. ‘low-risk biocontrol products’ means: | |
| (a) natural substances of strictly biological origin, with the exception of biomimetic synthesis; | |
| (b) chemical mediators such as pheromones and kairomones; | |
| (c) these substances leave no residues in marketed products, |
The creation of a specific category of low-risk biocontrol products should allow the products to be placed on the market more quickly and therefore enable simplified access for operators when their use does not actually present any chronic risk.
| Text proposed by the Commission | Amendment |
|---|---|
| (db) the following point 33b is added: | |
| ‘33b. The Commission may, in accordance with the advisory procedure referred to in Article 79(2), adopt or amend technical and other guidance documents such as explanatory notes or guidance documents on the content of the application concerning micro-organisms, pheromones and biological products, for the implementation of this Regulation. The Commission may ask the Authority to prepare or to contribute to such guidance documents. 2. When adopting or amending the documents referred to in paragraph 1, the Commission shall ensure a transparent and impartial review procedure, with the participation of the Member States and the European Food Safety Authority, to the extent necessary in view of the scientific or technical nature of the assessment, and the operators concerned. A significant reclassification of a product or category of products which have been placed on the market in at least one Member State in accordance with existing regulatory or interpretative practice, including on the basis of guidelines, Commission working documents or other positions of the competent authorities aimed at harmonising the approach of Member States, and whose regulatory status had not previously been challenged by those authorities, should be based on available scientific and technical data, take into account the function of the product and its mode of action, and include a justification identifying the grounds for the reclassification. 3. Before adopting a document or an amendment to a document which may result in a product or category of products being considered to fall within the scope of this Regulation, the Commission shall ensure that the operators concerned have the opportunity to submit information, data or a position regarding the classification of the product or category of products in question. 4. Within twelve months of the date of entry into force of Regulation [insert title], the Commission shall carry out a review of the applicable technical guidelines or other guidelines in so far as they relate to products or categories of products which, during the five-year period preceding the date of entry into force of Regulation [insert number], following a change in regulatory classification or a change in the interpretative approach at Union level, were deemed to fall within the scope of this Regulation. This review shall be carried out in accordance with the principles set out in paragraphs 2 and 3, taking into account the intended use of the product, its mode of action, the available scientific and technical data, and the views of the operators concerned.’ |
| Present text | Amendment |
|---|---|
| (3a) in Article 4, paragraph 1, subparagraph 1 is replaced by the foloowing: | |
| 1. An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3. | 1. An active substance shall be approved in accordance with Annex II where, in the light of current scientific and technical knowledge, including the availability of the alternatives to secure the production and considering risk managament measures with particular regard to application techniques, it can be expected that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance will satisfy the requirements referred to in paragraphs 2 and 3. |
| Present text | Amendment |
|---|---|
| (2a) In Article 4, paragraph 1, the first subparagraph is replaced by the following | |
| 1. An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3. | “1. An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, including the availability of the alternatives to secure the production and considering risk managament measures with particular regard to application techniques, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3. |
| Present text | Amendment |
|---|---|
| (2a) In Article 4, paragraph 1, the first subparagraph is replaced by the following: | |
| An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3. The assessment of the active substance shall first establish whether the approval criteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are satisfied. If these criteria are satisfied the assessment shall continue to establish whether the other approval criteria set out in points 2 and 3 of Annex II are satisfied. | "An active substance shall be approved in accordance with Annex II where, in the light of current scientific and technical knowledge, including a risk assessment based on the availability of risk management measures with particular regard to application techniques, it can be expected that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance will satisfy the requirements referred to in paragraphs 2 and 3. " |
goods practices and new application techniques can contribute to a considerable extent to mitigating the risks associated with the use of plant protection products (PPPs) and should therefore be explicitly taken into consideration.
| Present text | Amendment |
|---|---|
| (2d) In Article 4, paragraph 1, the first subparagraph, is replaced by the following: | |
| 1. An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3. | '1. An active substance, or a group of structurally or functionally related active substances, may only be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substances meet the requirements provided for in paragraphs 2 and 3.' |
Adds "or a group of structurally or functionally related active substances," ... NB 2nd subpara "The assessment of the active substance ... points 2 and 3 of Annex II are satisfied" is untouched.
| Present text | Amendment |
|---|---|
| (2a) in Article 4, paragraph 1, subparagraph is replaced by the following: | |
| 1. An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3. The assessment of the active substance shall first establish whether the approvalcriteria set out in points 3.6.2 to 3.6.4 and 3.7 of Annex II are satisfied. If these criteria are satisfied the assessment shall continue to establish whether the other approval criteria set out in points 2 and 3 of Annex II are satisfied. | “1. An active substance shall be approved in accordance to risks evaluation in the light of current scientific and technical knowledge, including a risk assessment based on the availability of risk management measures. An active substance shall be approved if not approving the active substance would have a disproportionate negative impact on the viability of agriculture compared to the risks to human health, animal health, or the environment arising from the use of the substance. |
| Annex II need to be modified into list of risks, what need to be evaluated." |
Present sytem for active ingredients approval in EU do not allow sustainable production of agricultural crops. When new system started in 2009, it was expected, that about 20% of active ingredients will be excluded from the sytem, but in fact 75 % of active substances do not pass re-evaluation. This situation can not be accepted any more and significant re-design of system need to be introduced.In the present situation in crop protection is not acceptable to loose highly effective active substances due to theoretical risks and without evaluation of role of active substances in crop protection systems and agricultural needs.Present situation with very limited crop protection tools box is not comaparable to the situation when hazzard-bazed approach ( “cut off criteria” ) have been introduced (hundereds of active substances were available and their pre-selection according to theoretical risks (withou evaluation of any possibilities for these risks elimination) might be reasonable that time).Nowdays it is not acceptable to allow to exclude any active substance without real risks evaluation.At least cut-off “criteria set in appendix II 3.6.2., 3.6.3., 3.6.4. , 3.6.5. and 3.7.) need to be changed to real risks evaluation. Cut-off principle is not compliant with the risk assessment in other areas (e.g. directly carcinogenic food – alcohol, tobacco, every day-used chemicals – e.g. petrol). Present situation with limited crop protection tools differs substantially from the situation when “cut off” have been introduced (the pre-selection could seem rational at that time due to higher availability of active substances). Nowdays there are already many new tools how to minimize or avoid risks using new and precise application technologies, techniques and machinery.
| Present text | Amendment |
|---|---|
| (2a) In Article 4, paragraph 1, subparagraph 1 is replaced by the following: | |
| 1. An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3. | 1. An active substance shall be approved in accordance with Annex II where, in the light of current scientific and technical knowledge, including a risk assessment based on the availability of risk management measures with particular regard to application techniques, it can be expected that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance will satisfy the requirements referred to in paragraphs 2 and 3. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Present text | Amendment |
|---|---|
| (2a) in Article 4, paragraph 1 is replaced by the following: | |
| An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3. | ‘An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, based in particular on a methodology prioritising the assessment of actual risks rather than potential hazards, thereby taking into account the available risk mitigation measures and application techniques, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3.’ |
| Present text | Amendment |
|---|---|
| (2a) in Article 4, paragraph 1, the first subparagraph is replaced by the following: | |
| 1. An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3. | 1. An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, including a risk assessment based on the availability of risk management measures with particular regard to application techniques, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3. |
Application techniques can contribute to a considerable extent to mitigating the risks associated with the use of plant protection products (PPPs) and should therefore be explicitly taken into consideration.
| Present text | Amendment |
|---|---|
| (2a) In Article 4, paragraph 1, subparagraph 1 is replaced by the following: | |
| 1. An active substance shall be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substance meet the requirements provided for in paragraphs 2 and 3. | 1. An active substance, or a group of structurally or functionally related active substances, may only be approved in accordance with Annex II if it may be expected, in the light of current scientific and technical knowledge, that, taking into account the approval criteria set out in points 2 and 3 of that Annex, plant protection products containing that active substances meet the requirements provided for in paragraphs 2 and 3. |
| Present text | Amendment |
|---|---|
| (-3) In Article 4, paragraph 2, point (a) is replaced by: | |
| (a) they shall not have any harmful effects on human health, including that of vulnerable groups, or animal health, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available, or on groundwater; | (a) they shall not have any immediate or delayed harmful effects on human health, including that of vulnerable groups, or animal health either directly or through drinking water, food, feed or air, or consequences in the workplace, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Authority to assess such effects are available and where no such methods exist a precautionary assessment factor shall be applied to account for potential combined effects, or on groundwater; |
| Text proposed by the Commission | Amendment |
|---|---|
| (2b) In Article 4, paragraph 2, a new subparagraph is added after point (b): | |
| ‘With regard to release into environment, they shall not have any unacceptable effect on the environment, including release of living organisms acting as pesticides that are genetically modified, or parts thereof, that are able to modify genomes or interfere with genomic/genetic expression; such organisms may not be released in the environment though inter alia agricultural use;’ |
| Present text | Amendment |
|---|---|
| (2b) Article 4, paragraph 3 is amended as follows: | |
| 3. A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements: | "3. A plant protection product, following application in accordance with good plant protection practice and taking into account realistic conditions of use, including a risk assessment based on the availability of risk management measures with particular regard to application techniques, shall meet the following requirements: |
| (a) it shall be sufficiently effective; | (a) it shall ensure a sufficiently high level of efficacy; " |
| Text proposed by the Commission | Amendment |
|---|---|
| (2b) In article 4, paragraph 3, the intruductory sentence is replaced by the following: | |
| 3. A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements: | 3. A plant protection product, following application in accordance with good plant protection practice and taking into account realistic conditions of use, including a risk assessment based on the availability of risk management measures with particular regard to application techniques, shall meet the following requirements: |
| Present text | Amendment |
|---|---|
| (2c) in Article 4, paragraph 3, point e) is replaced by the following: | |
| e) it shall have no unacceptable effects on the environment, having particular regard to the following considerations where the scientific methods accepted by the Authority to assess such effects are available: i. its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters. | e) it shall have no unacceptable effects on the environment, having particular regard to the following considerations where the scientific methods accepted by the Authority to assess such effects are available: |
| i. its fate and distribution in the environment, particularly contamination of surface waters, including estuarine and coastal waters, groundwater, air and soil taking into account locations distant from its use following long-range environmental transportation; | |
| ii. its impact on non-target species, including on the ongoing behaviour of those species; | |
| iii. its impact on biodiversity and the ecosystem. " |
• good practices and new Application techniques can contribute to a considerable extent to mitigating the risks associated with the use of plant protection products and should therefore be explicitly taken into consideration.
• The requirement for Member States to consider ‘all available risk mitigation measures’ in the context of substance/products assessment/authorization should not give place to divergent interpretation among Member State, diverging outcomes of risk assessments, and, consequently, unequal access to plant protection products for farmers. The implementation of all available risk mitigation measures by all Member States should be harmonised.
• Any plant protection product should ensure the highest level of efficacy, both at the stage of first approval and renewal.
| Present text | Amendment |
|---|---|
| (2b) in Article 4, paragraph 3, the intoductory sentence is replaced by the following: | |
| 3. A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements: | '3. A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, including a risk assessment based on the availability of risk management measures with particular regard to application techniques, shall meet the following requirements:' |
Application techniques can contribute to a considerable extent to mitigating the risks associated with the use of plant protection products (PPPs) and should therefore be explicitly taken into consideration.
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Present text | Amendment |
|---|---|
| (2a) in Article 4, the introductory wording of paragraph 3 is replaced by the following: | |
| A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements: | ‘A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, that is to say, based on actual risks, taking into account the specific application contexts in which the risks can be mitigated, shall meet the following requirements:’ |
| Present text | Amendment |
|---|---|
| (2a) in Article 4, paragraph 3, the introductory sentence is replaced by the following: | |
| A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, shall meet the following requirements: | "A plant protection product, consequent on application consistent with good plant protection practice and having regard to realistic conditions of use, including a risk assessment based on the availability of risk management measures with particular regard to application techniques shall meet the following requirements: " |
• good practices and new Application techniques can contribute to a considerable extent to mitigating the risks associated with the use of plant protection products and should therefore be explicitly taken into consideration.
• The requirement for Member States to consider ‘all available risk mitigation measures’ in the context of substance/products assessment/authorization should not give place to divergent interpretation among Member State, diverging outcomes of risk assessments, and, consequently, unequal access to plant protection products for farmers. The implementation of all available risk mitigation measures by all Member States should be harmonised.
• Any plant protection product should ensure the highest level of efficacy, both at the stage of first approval and renewal.
| Present text | Amendment |
|---|---|
| (2b) in Article 4, paragraph 3, point a) is replaced by the following: | |
| a) it shall be sufficiently effective; | a) it shall ensure a sufficiently high level of efficacy |
• good practices and new Application techniques can contribute to a considerable extent to mitigating the risks associated with the use of plant protection products and should therefore be explicitly taken into consideration.
• The requirement for Member States to consider ‘all available risk mitigation measures’ in the context of substance/products assessment/authorization should not give place to divergent interpretation among Member State, diverging outcomes of risk assessments, and, consequently, unequal access to plant protection products for farmers. The implementation of all available risk mitigation measures by all Member States should be harmonised.
• Any plant protection product should ensure the highest level of efficacy, both at the stage of first approval and renewal.
| Text proposed by the Commission | Amendment |
|---|---|
| (2c) In Article 4, a new paragraph 6a is added: | |
| '6a. Studies carried out to demonstrate that the approval criteria laid down in paragraphs 1, 2 and 3 are fulfilled shall be commissioned and coordinated independently by the European Food Safety Authority (EFSA) or another competent public authority. The costs of such studies shall be borne by the applicant.' |
| Text proposed by the Commission | Amendment |
|---|---|
| (3) in Article 4, paragraph 7 is replaced by the following: | deleted |
| ‘7. By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | |
| The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. | |
| Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health or plant production in their territory identified pursuant to the first subparagraph.’; |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of a strictly exceptional derogation from paragraph 1, where it has been independently demonstrated on the basis of documented evidence included in the application or information provided in the course of the approval procedure and verified by EFSA, that an active substance is necessary to control a serious and demonstrable 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 methods, such active substances may be approved once for a limited period strictly necessary to control that serious and verified danger but not exceeding one year, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. This paragraph shall not be interpreted as modifying or derogating from the approval criteria laid down in paragraphs 1 to 6 or from the hazard-based exclusion criteria established by this Regulation, except to the extent expressly provided for in this paragraph. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to effectively control a serious danger to plant health, human health or plant production and/or its role is essential within crop protection strategies, including anti-resistant strategies, which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| The application referred to in the first subparagraph shall be submitted during the approval process by the applicant for approval and/or by official or scientific bodies involved in agricultural activities and/or by professional agricultural organizations. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application an active substance is necessary to effectively control a serious danger to plant health, human health, plant production, and its role is essential within crop protection strategies, including anti-resistant strategies and, consequently, to safeguard food security which cannot be effectively contained by other reasonable means in a way that is sufficiently efficient and economically viable for primary producers including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding ten years. |
| The notion of 'serious danger to plant production' within the meaning of this paragraph includes recurrent and structural damage caused by endemic soil pests in specific biogeographical regions of the Union, where pest densities systematically exceed the Economic Damage Threshold and no effective alternative plant protection methods are available, as demonstrated by multi-annual phytosanitary monitoring data. |
| Present text | Amendment |
|---|---|
| (3) in Article 4, paragraph 7 is replaced by the following : | |
| 7. By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | "7. By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to effectively control a serious danger to plant health, human health or plant production and/or its role is essential within crop protection strategies, including anti-resistant strategies, which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding 10 years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| The application referred to in the first subparagraph shall be submitted during the approval process by the applicant for approval and/or by official or scientific bodies involved in agricultural activities and/or by professional agricultural organizations." |
Simple approach, that active ingredient do not have alternative can be explained in different ways.It is not acceptable to exclude from the system substances having having specific role in crop protection system, especially in anti-rezistant strategies (including human health area regarding elimination of mycotoxines and long-term strorability of agricultural products).EC proposal is in this respect insufficient to keep long-term sustainable production in EU.We propose the limits should not be set for Article 4(7). The the decision making shall be based on single risk evaluation and possible risk-management. Article 4/7 never been use in practise since 1107/2009 – in this respect necessary changes in the paragraph need to be done. The 10-year derogation would be givenwhen a PPP with no agronomicallyeffective and economically viable alternative can not be reauthorised.
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, an active substance which does not meet the criteria set out in Annex II point 3.6.2 to 3.6.5 or 3.8.2, may be approved if, on the basis of a socio-economic assessment in line with Article 60(4) of Regulation (EC) No 1907/2006 ('REACH') it is demonstrated, that: |
| a) there is a serious risk to plant health or plant production; | |
| b) this risk cannot be contained by other means using qualified alternative testing (agronomic effectiveness, economic viability, practicability at the level of the application concerned); | |
| c) justify the socio-economic consequences of discontinuation, in particular for security of supply, production costs and competitiveness; | |
| d) for active substances below the CMR-1A threshold, with proven negligible exposure and lack of viable alternatives, differentiation of substance exclusion remains possible. | |
| The period of validity shall be up to five years and may be extended as long as the conditions outlined above are met. Risk mitigation measures are to be applied. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production or its role is essential within crop protection strategies, including anti-resistant strategies which cannot be contained by other available reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding seven years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. An application under the first subparagraph may be submitted, at any stage of the approval procedure, by the applicant for approval, by official or scientific bodies active in the field of agriculture, or by professional agricultural organisations. |
The amendment helps ensure that useful substances remain available to farmers where no suitable alternatives exist. As manufacturers may not always have an incentive to apply under Article 4(7), official and scientific bodies as well as professional agricultural organisations should also be able to initiate the procedure. This will allow a more objective assessment of agricultural needs.
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, even if it does not satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5 or 3.8.2 of Annex II provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| The evidence referred to in the first subparagraph shall be submitted during the approval process, by the applicant or the Member States and, where relevant, supported by official or scientific bodies involved in agricultural activities. |
The proposed wording from the Commission in art. 4(7) would imply that active substances with proven unacceptable risk to human health and environment can be approved for five years. This would seriously affect the level of protection and lead to the creation of new health and clean-up related costs. We suggest to include existing criteria in art. 4(7) in line with the current regulation.
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to effectively control a serious danger to plant health or plant production, human health or plant production, and its role is essential in crop protection strategies, including resistance management strategies, in order to safeguard food security, which cannot be effectively contained by other reasonable means, including non-chemical methods, in a way that is sufficiently efficient and economically viable for primary producers, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding 10 years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to effectively control a serious danger to plant health or plant production, or to human health, and its role is essential in crop protection strategies and strategies to combat uncontrolled proliferation, and, consequently, in safeguarding food security, which cannot be contained by other reasonable, effective and operational means, including non-chemical methods, such active substance may be approved, re-approved or the subject of an application submitted at any point during its approval period, for a period necessary to control that serious danger, limited to 10 years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application, an active substance is necessary to effectively address a serious danger to plant health, human health or plant production and plays a key role in the context of crop protection strategies, including resistance management strategies and therefore in ensuring food security, and this danger cannot be effectively addressed by other reasonable means that are sufficiently effective and viable from an agronomic point of view, including non-chemical methods, that active substance may be approved for a limited period necessary to address that serious danger but shall not exceed ten years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is reduced to a minimum. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application an active substance is necessary to effectively control a serious danger to plant health, human health, plant production, including where such danger is confined to a specific part of the territory of a Member State and results from specific climatic, agroecological, pedoclimatic or phytosanitary conditions, which cannot be effectively contained by other reasonable means in a way that is sufficiently efficient and economically viable for primary producers including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding ten years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application an active substance is necessary to effectively control a serious danger to plant health, human health, plant production, and its role is essential within crop protection strategies, including anti-resistant strategies and, consequently, to safeguard food security which cannot be effectively contained by other reasonable means in a way that is sufficiently efficient and economically viable for primary producers including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding ten years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure, within 3 months of the EFSA conclusion, an active substance is necessary to control a serious danger to plant health or plant production, demonstrated in an agroeconomic assessment or based on agroeconomic considerations, which cannot be contained by any other economically and agronomically reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure, within 3 months of EFSA conclusion, an active substance is necessary to control a serious danger to plant health or plant production, demonstrated in an agroeconomic assessment or based on agroeconomic consideration, which cannot be contained by any other economically and agronomically reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
The system should be more workable and take agronomic considerations into account, ensuring that indispensable crop protection solutions that can be used safely are not removed from the market. Further clarifications should be provided in guidance documents reflecting these principles.
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure, within 3 months of EFSA conclusion, an active substance is necessary to control a serious danger to plant health or plant production, demonstrated in an agroeconomic assessment or based on agroeconomic consideration, which cannot be contained by any other economically and agronomically reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means or alternatives including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, which can be extended in case no alternatives has been found, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production, demonstrated in an agroeconomic assessment or based on agroeconomic consideration, which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health, human health or plant production and its role is essential in crop protection strategies, which cannot be effectively contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or renewal of the approval, or provided by one or more Member States at any stage in the course of the approval or renewal procedure, an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production, including where such a danger is confined to a specific part of the territory of a Member State and stems from specific climate, agro-ecological, pedo-climatic or plant protection conditions, which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. |
Uses of plant protection products can vary greatly from one region to another, particularly for crops grown in the outermost regions that have to contend with a very different climate and environmental hazards from mainland Europe. These differences should therefore be taken into account in the assessments and authorisations, particularly when it comes to alternatives to conventional plant protection products.
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means with comparable costs and efficiency including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health which cannot be contained by other reasonable means including crop-rotation and non-chemical methods, such active substance may be approved once for a limited period necessary to control that serious danger but not exceeding three years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans, animals and the environment is minimised. For such substances maximally protective maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
Article 4(7) is intended to remain an exceptional derogation. Its scope should not be broadened beyond serious dangers to plant health, nor should it apply to the most hazardous substances. Maintaining phasing-out plans ensures that derogations remain temporary and supports the transition to safer alternatives.
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means including non-chemical methods, such active substance may be approved for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. | By way of derogation from paragraph 1, where on the basis of documented evidence included in the application or information provided in the course of the approval procedure an active substance is necessary to control a serious danger to plant health which cannot be contained by other available means including non-chemical methods, such active substance may be approved once for a limited period necessary to control that serious danger but not exceeding five years, provided that the use of the active substance is subject to risk mitigation measures to ensure that exposure of humans and the environment is minimised. For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
The proposal does to specify how risks to plant production would be assessed, as it provides neither objective criteria nor a methodology for determining when such risks are sufficiently serious to justify a derogation. Likewise, the notion of "reasonable means" remains undefined. This creates a risk that decisions will become politically driven rather than based on scientific evidence. The proposal would significantly broaden the scope of this derogation, thereby undermining its exceptional character.
| Text proposed by the Commission | Amendment |
|---|---|
| The notion of "serious danger to plant production" shall include recurrent and structural damage caused by endemic soil pests in specific biogeographical regions of the Union where, on the basis of multi-annual phytosanitary monitoring data, pest densities consistently exceed the Economic Damage Threshold and no effective alternative plant protection methods are available to maintain pest densities below that threshold. | |
| An application under the first subparagraph shall be submitted during the approval procedure by the applicant for approval or by official or scientific bodies involved in agricultural activities or by professional agricultural organizations |
| Text proposed by the Commission | Amendment |
|---|---|
| For the purposes of this paragraph, a ‘serious danger to plant production’ shall include cases of recurrent and structural crop damage caused by endemic soil pests within specific biogeographical regions of the Union. Such danger is deemed established where multi-annual phytosanitary monitoring data demonstrates that pest densities systematically exceed the Economic Damage Threshold and that no viable alternative plant protection methods are available. |
The proposed amendment ensures legal certainty and clarifies the application of Article 4(7) of Regulation (EC) No 1107/2009 by explicitly defining "serious danger to plant production" to include documented endemic pressures (e.g., the pest Tanymecus dilaticollis in the steppe region). The measure does not alter EU safety criteria; instead, it provides a predictable framework for Member States facing specific structural risks demonstrated by multi-annual monitoring and the absence of viable alternatives, eliminating the legal vulnerability of repeated emergency derogations.
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from paragraph 1, an active substance may be approved or its approval renewed where the non-approval or non-renewal of that active substance would have a disproportionate negative impact on agricultural viability, food production or food security, compared to the risks to human health, animal health or the environment arising from the use of the substance, in particular where effective alternatives are not available, provided that appropriate risk mitigation measures are applied. Such disproportionate negative impact shall be considered to exist, in particular, where: | |
| (a) endemic soil pests cause structural and recurrent crop losses that systematically exceed the Economic Damage Threshold in specific pedoclimatic regions of the Union; | |
| (b) no effective alternative plant protection means are available, as demonstrated by multi-annual phytosanitary monitoring data and field efficacy assessments conducted in accordance with EPPO guidance; and | |
| (c) seed treatment constitutes the only technically viable preventive measure under the specific agronomic and environmental conditions of those regions |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| Decisions on derogations should be taken on the base of a socio-economic and agro-economic assessment including efficacy, impact of pests on farmers yield and risks for cross-resistance, in particular: | |
| (a) endemic soil pests cause structural and recurrent crop losses systematically exceeding the Economic Damage Threshold in specific pedoclimatic regions of the Union; | |
| (b) no effective alternative plant protection means are available, as demonstrated by multi-annual phytosanitary monitoring data and field efficacy assessments conducted in accordance with EPPO guidance; and | |
| (c) seed treatment constitutes the only technically viable preventive measure under the specific agronomic and environmental conditions of those regions. |
| Text proposed by the Commission | Amendment |
|---|---|
| In Article 4(7), the following subparagraph is inserted after the first subparagraph: | |
| The notion of ‘serious danger to plant production’, for the purposes of this paragraph, includes recurrent and structural damage caused by soil endemic pests in certain biogeographical regions of the Union, where their density systematically exceeds the economic threshold for pests and where no effective and affordable alternative methods of plant protection are available, as demonstrated by multiannual phytosanitary monitoring data. |
| Text proposed by the Commission | Amendment |
|---|---|
| For the purposes of the first subparagraph, the existence of other reasonable means shall be assessed with regard to the use concerned, the crop, the pest or undesirable plant concerned, and the relevant local or regional conditions, notably the climatic, agro-ecological, pedo-climatic and plant protection conditions. Scientific or technical data from areas with comparable conditions may be taken into account where relevant for the assessment of the hazard and the effectiveness of the available control methods. |
The uses of plant protection products can vary greatly from one region to another, particularly for crops grown in the outermost regions, which have to contend with a climate and environmental hazards that are very different from those in mainland Europe. These differences should therefore be taken into account in the assessments and authorisations, particularly when it comes to alternatives to conventional plant protection products.
Raffaele Stancanelli, Silvia Sardone, Isabella Tovaglieri, Anne-Sophie Frigout, Marie-Luce Brasier-Clain, Gilles Pennelle
| Text proposed by the Commission | Amendment |
|---|---|
| The evidence referred to in the first subparagraph may be submitted at any stage of the approval or renewal procedure and may be supported, where relevant, by official or scientific bodies involved in agricultural activities. In the course of the assessment of these evidences, the Commission may request technical support to the Agency. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| This paragraph shall also apply to active substances for which an application for renewal of approval has been submitted before [date of entry into force of this Regulation]. |
| Text proposed by the Commission | Amendment |
|---|---|
| For such substances maximum residue levels shall be set in accordance with Regulation (EC) No 396/2005. |
| Text proposed by the Commission | Amendment |
|---|---|
| The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. | deleted |
Risk analysis should be cerried out in these exeptional cases instead of preventive exclusion of these active substances categories if there are no any other effective alternatives. There should not be set any limits for this derogation, if risks will be evaluated as acceptable.Vast majority of the most dangerous active ingredients were eliminated from the system, in case of remaining onces risks evaluation need to be done in any cases die to significant lack of crop protection tools at all.All cutt off criteria should be deleted in all cases of aprovals as any other chemicals used in every-day human life do not face similar limitations (cosmetics, household chemicals, fuels and fuel aditives, tobacco, alcohol, ect.
| Text proposed by the Commission | Amendment |
|---|---|
| The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. | The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. without appropriate risk assessment. |
| Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health, human health or plant production in their territory identified pursuant to the first subparagraph.’; | |
| The notion of 'serious danger to plant production' within the meaning of this paragraph includes recurrent and structural damage caused by endemic soil pests in specific biogeographical regions of the Union, where pest densities systematically exceed the Economic Damage Threshold and no effective alternative plant protection methods are available, as demonstrated by multi-annual phytosanitary monitoring data. | |
| An application under the first subparagraph shall be submitted during the approval procedure by the applicant for approval or by official or scientific bodies involved in agricultural activities or by professional agricultural organizations. |
| Text proposed by the Commission | Amendment |
|---|---|
| The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. | The derogation provided for in the first subparagraph shall not apply to: |
| - active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B, or toxic for reproduction category 1A or 1B, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), Persistent, Mobile and Toxic (PMT), very persistent and very mobile (vPvM) or that have endocrine-disrupting properties for humans or non-target organisms according to the criteria set out in points 3.6.5 and 3.8.2, 3.8.3, or 3.10 of Annex II, or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. | |
| - active substance which meets the OECD definition of poly- and per- fluoroalkyl substances. | |
| - cases where the concentration of the active substance or of relevant metabolites, degradation or reaction products in groundwater, may be expected to exceed, as a result of use of the plant protection product under the proposed conditions of use, the maximum permissible concentration laid down by Directive 2006/118/EC of the European Parliament and of the Council. | |
| - active substances identified as priority substances under Directive 2000/60/EC. |
Additional substances of concern should be excluded from the scope of the derogation, notably toxic to reproduction 1B, endocrine disruptors and Persistent Mobile and Toxic (i.e. PFAS substances).
| Text proposed by the Commission | Amendment |
|---|---|
| The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. | The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), Persistent, Mobile and Toxic (PMT), very persistent and very mobile (vPvM) or substances that have endocrine-disrupting properties for humans, non-target organisms or the environment according to the criteria set out in points 3.6.5 and 3.8.2, 3.8.3, or 3.10 of Annex II, or that contain PFAS or are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II, or to active substances designated as priority substances pursuant to Directive 2000/60/EC. |
| The derogation provided for in the first subparagraph shall not apply if it can reasonably be expected to lead to exceedances of the maximum permissible concentration established under Directive 2006/118/EC. |
| Text proposed by the Commission | Amendment |
|---|---|
| The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. | The derogation provided for in the first subparagraph shall not apply to: |
| (a) active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), Persistent, Mobile and Toxic (PMT), very persistent and very mobile (vPvM) or endocrine-disrupting substances, or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. | |
| (b) poly- and per- fluoroalkyl substances. | |
| At the same time, they shall draw up a phasing out plan concerning the control of the serious danger by other means, including non-chemical methods, and shall without delay transmit that plan to the Commission. |
| Text proposed by the Commission | Amendment |
|---|---|
| The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. | The derogation provided for in the first subparagraph shall not apply to active substances meeting the exclusion criteria laid down in points 3.6.5, 3.6.4, 3.7.1, 3.7.2, 3.8.2, 3.8.3 and 3.10 of Annex II, including substances classified as mutagenic category 1A or 1B, carcinogenic category 1A or 1B, toxic for reproduction category 1A or 1B, endocrine disruptors, persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent and very mobile (vPvM), persistent organic pollutants (POPs), or active substances containing per- or polyfluoroalkyl substances (PFAS) that, due to their chemical structure, meet the persistence criteria laid down in point 3.7 or the mobility criteria laid down in point 3.8 of Annex II. |
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 |
|---|---|
| The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. | The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008 as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, toxic for reproduction category 1A, endocrine disruptors, or which meet the criteria for persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT), very persistent and very mobile (vPvM), persistent organic pollutants (POP) according to the criteria set out in point 3.7.1 of Annex II, or per- and polyfluoroalkyl substances (PFAS). |
The derogation under Article 4(7) should not apply to substances with the most hazardous intrinsic properties. Endocrine disruptors, PMT and vPvM substances, together with the other excluded hazard classes, present significant and potentially irreversible risks to human health and the environment, particularly to groundwater and drinking water resources. Their inclusion among the exclusion criteria ensures that the derogation remains exceptional and consistent with the precautionary principle.
| Text proposed by the Commission | Amendment |
|---|---|
| The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. | The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A and 1B, or with endocrine-disrupting properties or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile and toxic (PMT) and very persistent and very mobile (vPvM), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1, 3.8 and 3.10 of Annex II. |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. | The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A or 1B, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II, or endocrine disrupting properties according to criteria set out in points 3.6.5 and 3.8.2 of Annex II. |
| Text proposed by the Commission | Amendment |
|---|---|
| The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. | The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II, unless an appropriate risk assessment has been carried out. |
| Text proposed by the Commission | Amendment |
|---|---|
| The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. | The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as endocrine disrupters category 1 (without a threshold), as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. |
The proposed wording from the Commission in art. 4(7) would imply that active substances with proven unacceptable risk to human health and environment can be approved for five years. This would seriously affect the level of protection and lead to the creation of new health and clean-up related costs. We suggest to exclude active substances with endocrine disrupters category 1 in line with the current regulation.
| Text proposed by the Commission | Amendment |
|---|---|
| The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. | The derogation provided for in the first subparagraph shall not apply to active substances which are or have to be classified in accordance with Regulation (EC) No 1272/2008, as mutagenic category 1A or 1B, carcinogenic category 1A, carcinogenic category 1B without a threshold, or toxic for reproduction category 1A, or persistent, bioaccumulative and toxic (PBT), very persistent and very bioaccumulative (vPvB), or that are a persistent organic pollutant (POP) according to the criteria set out in point 3.7.1 of Annex II. without appropriate risk assessment. |
| Text proposed by the Commission | Amendment |
|---|---|
| Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health or plant production in their territory identified pursuant to the first subparagraph.; | Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health identified in the approval decision and only for the crops, target organisms, geographical areas and duration specified therein. |
| Approvals granted pursuant to this paragraph shall be reviewed annually. The approval holder shall submit updated information demonstrating that the conditions laid down in this paragraph continue to be fulfilled, including evidence that no effective and reasonably available non-chemical or lower-risk alternatives have become available. The approval holder shall submit, together with the application, a substitution and transition plan setting out measures to develop, assess and deploy sustainable alternatives with the objective of replacing the active substance before the expiry of the approval period. | |
| The Agency shall publish annually a report listing all approvals granted under this paragraph, the crops and pests concerned, the evidence supporting the derogation, the risk mitigation measures imposed, the progress made towards substitution, and the reasons for any renewal. |
| Text proposed by the Commission | Amendment |
|---|---|
| Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health or plant production in their territory identified pursuant to the first subparagraph. | Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health or to plant production or human health in their territory identified pursuant to the first subparagraph. |
| The notion of ‘serious danger to plant production’, within the meaning of this paragraph, shall also cover recurrent and structural damage caused by endemic soil pests in certain biogeographical regions of the Union where pest populations systematically exceed the economic injury threshold and no other effective plant protection methods are available, as demonstrated by plant health monitoring data collected over several years. | |
| An application under the first subparagraph may be submitted during the approval procedure by the applicant for approval, by official or scientific bodies involved in agricultural activities or by professional agricultural organisations. |
Carmen Crespo Díaz, Susana Solís Pérez, Juan Ignacio Zoido Álvarez, Esther Herranz García, Dolors Montserrat
| Text proposed by the Commission | Amendment |
|---|---|
| Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health or plant production in their territory identified pursuant to the first subparagraph. | Member States may authorise plant protection products containing active substances approved in accordance with this paragraph when it is necessary to control the serious danger to plant health or plant production in their territory identified pursuant to the first subparagraph. |
| Where a serious phytosanitary risk or a serious risk to plant production concerns several Member States or crops under comparable agronomic, climatic or phytosanitary conditions, the Commission shall promote coordinated and harmonised implementation of exceptional and temporary authorisations, including those granted pursuant to Article 53, in order to prevent unjustified divergences between Member States and to ensure a level playing field for farmers. |
| Text proposed by the Commission | Amendment |
|---|---|
| Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health or plant production in their territory identified pursuant to the first subparagraph.; | Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health or plant production in their territory identified pursuant to the first subparagraph. At the same time, they shall draw up a phasing out plan concerning the control of the serious danger by other means, including non-chemical methods, and shall without delay transmit that plan to the Commission. |
Reintroducing the phasing out plans concerning the control of the serious danger from existing legislation.
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 |
|---|---|
| Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health or plant production in their territory identified pursuant to the first subparagraph.; | Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health in their territory identified pursuant to the first subparagraph. Member States shall establish a phasing-out plan identifying suitable alternatives and measures to progressively replace those active substances.; |
Article 4(7) is intended to remain an exceptional derogation. Its scope should not be broadened beyond serious dangers to plant health, nor should it apply to the most hazardous substances. Maintaining phasing-out plans ensures that derogations remain temporary and supports the transition to safer alternatives.
| Text proposed by the Commission | Amendment |
|---|---|
| Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health or plant production in their territory identified pursuant to the first subparagraph.; | Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health or plant production within their territory or within the part of the territory concerned, identified pursuant to the first subparagraph.; |
| Text proposed by the Commission | Amendment |
|---|---|
| Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health or plant production in their territory identified pursuant to the first subparagraph.; | Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health or plant production in their territory or in the relevant part of their territory identified pursuant to the first subparagraph.; |
The uses of plant protection products can vary greatly from one region to another, particularly for crops grown in the outermost regions, which have to contend with a climate and environmental hazards that are very different from those in mainland Europe. These differences should therefore be taken into account in the assessments and authorisations, particularly when it comes to alternatives to conventional plant protection products.
| Text proposed by the Commission | Amendment |
|---|---|
| Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health or plant production in their territory identified pursuant to the first subparagraph.’; | Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health, human health or plant production in their territory identified pursuant to the first subparagraph.’; |
| Text proposed by the Commission | Amendment |
|---|---|
| Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health or plant production in their territory identified pursuant to the first subparagraph.; | Member States may authorise plant protection products containing active substances approved in accordance with this paragraph only when it is necessary to control the serious danger to plant health in their territory identified pursuant to the first subparagraph.; |
Carmen Crespo Díaz, Juan Ignacio Zoido Álvarez, Susana Solís Pérez, Esther Herranz García, Dolors Montserrat
| Text proposed by the Commission | Amendment |
|---|---|
| For the purposes of this paragraph, the determination of whether other reasonable means exist shall be based on an agronomic and economic assessment that takes into account real production conditions, the effectiveness of available alternatives, the technical and economic viability of those alternatives, commercial availability, resistance management, scale of use needed and potential impact on plant production and food security. Implementation of this Regulation shall take into account the productive function of agricultural land, food security, the resilience of plant production and the competitiveness of the Union agricultural sector, without diminishing the high level of protection of human health, animal health and the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| The notion of 'serious danger to plant production' within the meaning of this paragraph includes recurrent and structural damage caused by endemic soil pests in specific biogeographical regions of the Union, where pest densities systematically exceed the Economic Damage Threshold and no effective alternative plant protection methods are available, as demonstrated by multi-annual phytosanitary monitoring data. | |
| An application under the first subparagraph shall be submitted during the approval procedure by the applicant for approval or by official or scientific bodies involved in agricultural activities or by professional agricultural organizations. |
| Text proposed by the Commission | Amendment |
|---|---|
| For the purposes of this paragraph, the notion of ‘serious danger to plant production’ includes recurrent and structural damage caused by soil endemic pests in certain biogeographical regions of the Union, where their density systematically exceeds the economic threshold for pests and where no effective and affordable alternative methods of plant protection are available, as demonstrated by multiannual phytosanitary monitoring data. |
| Text proposed by the Commission | Amendment |
|---|---|
| At the same time, they shall draw up a phasing out plan concerning the control of the serious danger by other means, including non-chemical methods, and shall without delay transmit that plan to the Commission. |
Restores the current legal provision to ensure that the derogation to use banned substances shall be as limited in time as possible.
| Text proposed by the Commission | Amendment |
|---|---|
| At the same time, they shall draw up a phasing out plan concerning the control of the serious danger by other means, including non-chemical methods, and shall without delay transmit that plan to the Commission. |
If the possibility of a further five-year renewal remains available as proposed by the Commission, there is no justification for dispensing with the phase-out plan, as the derogation could in practice become a pathway for the continued use of highly harmful substances.
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall prepare guidance for applicants regarding justification and for authorities concerning agronomic assessment. |
| Text proposed by the Commission | Amendment |
|---|---|
| The application referred to in the first subparagraph can be submitted by the applicant for approval, at any stage of the approval process for active substances. |
| Text proposed by the Commission | Amendment |
|---|---|
| An application under the first paragraph shall be submitted during the approval process by the applicant for approval, by official or scientific bodies involved in agricultural activities or by professional agricultural organisations. |
| Text proposed by the Commission | Amendment |
|---|---|
| Decisions on derogations shall be based on documented evidence demonstrating that the serious danger cannot be contained by other reasonable means. Where relevant, efficacy and resistance management may be taken into account: |
| Text proposed by the Commission | Amendment |
|---|---|
| In Article 4, a new paragraph 3d is added: | |
| By way of derogation from paragraph (1), an active substance may be approved, or its approval may be renewed, where the non-approval of the active substance or the non-renewal of its approval would have a disproportionate negative impact on the viability of agriculture, food production or food security, when weighed against the risks to human health, animal health or the environment arising from the use of that substance, in particular where no affordable and at least equally effective alternatives are available, provided that appropriate risk mitigation measures are applied. | |
| Such disproportionate negative impact shall be considered to exist, in particular where: | |
| (a) endemic soil pests cause structural and recurrent crop losses, which systematically exceed the economic threshold for pests in certain pedoclimatic regions of the Union; | |
| (b) there are no available plant protection alternatives that are affordable and at least equally effective, as demonstrated by multiannual phytosanitary monitoring data and field efficacy evaluations carried out in accordance with EPPO guidelines; and | |
| (c) seed treatment is the only technically viable preventive measure given the specific agronomic and environmental conditions of the regions concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| (3a) in Article 4, a new paragraph 7a is inserted: | |
| 7a. By way of derogation from paragraph 1, an active substance may be approved or its approval renewed where not approving or renewing the active substance would have a disproportionate negative impact on the viability of agriculture, food production or food security, compared to the risks to human health, animal health or the environment arising from the use of the substance, in particular where effective alternatives are not available, provided that appropriate risk mitigation measures are applied. | |
| Such disproportionate negative impact shall be considered to exist in particular where: | |
| (a) endemic soil pests cause structural and recurrent crop losses systematically exceeding the Economic Damage Threshold in specific pedoclimatic regions of the Union; | |
| (b) no effective alternative plant protection means are available, as demonstrated by multi-annual phytosanitary monitoring data and field efficacy assessments conducted in accordance with EPPO guidance; and | |
| (c) seed treatment constitutes the only technically viable preventive measure under the specific agronomic and environmental conditions of those regions. |
| Text proposed by the Commission | Amendment |
|---|---|
| 7a. By way of derogation from paragraph 1, an active substance may be approved, or its approval renewed, if its non-approval or non-renewal would inflict a disproportionate negative impact on agricultural viability, food production, or food security relative to the identified risks to human health, animal health, or the environment. This derogation may only be granted in the absence of effective alternatives, provided that appropriate risk mitigation measures are implemented to ensure a high level of protection. A disproportionate negative impact shall be deemed to exist, inter alia, where: | |
| (a) endemic soil pests cause structural and recurrent crop losses that systematically exceed the Economic Damage Threshold in specific pedoclimatic regions of the Union; | |
| (b) no effective alternative plant protection means are available, as demonstrated by multi-annual phytosanitary monitoring data and field efficacy assessments conducted in accordance with EPPO guidance; and | |
| (c) seed treatment constitutes the only technically viable preventive measure under the specific agronomic and environmental conditions of those regions. |
The proposed amendment addresses a legislative gap in Regulation (EC) No 1107/2009 by introducing a new Article 4(8), establishing an explicit proportionality assessment mechanism within the renewal and review procedures of active substances. Rooted in the principle of proportionality (Art. 5 TEU) and food security objectives (Art. 39 TFEU), this mechanism evaluates the medium- and long-term disproportionate impacts of non-approval on the viability of agricultural production. Distinct from Art. 4(7), which applies to initial approvals under immediate danger, the proposed Art. 4(8) provides a predictable framework to assess structural life-cycle impacts, balancing phytosanitary standards with the strategic stability of the agri-food sector.
| Text proposed by the Commission | Amendment |
|---|---|
| (3a) The following paragraph7a is inserted: | |
| 7a. By way of derogation from paragraph 1, an active substance may be approved where no suitable and economically viable alternatives are available and where non-approval would result in serious adverse effects on agricultural production or food security that are disproportionate to the risks arising from the use of that active substance under realistic conditions of use, provided that appropriate risk mitigation measures are applied to ensure that exposure of humans, animals and the environment is minimised. |
| Text proposed by the Commission | Amendment |
|---|---|
| (3a) In Article 4, the following paragraph 7a is added: | |
| 7a. By way of derogation from paragraph 1, in case of serious danger to plant and/or human health, active substance may be approved or renewed if not approving the active substance would have a disproportionate negative impact on the viability of agriculture, forestry, public green areas, natural areas, ect. compared to the risks to human health, animal health, or the environment arising from the use of the substance. |
Present Regulation in fact do not include any measure to allow to activate extraordinary tools for extraordinary cases (e.g. liquidation of invasive populations, quarantine pests, ect. , what can seriously damage or completely damage not only agricultural and forestry areas, but also public green areas, natural areas, including natural protected areas).A special statement should be introduced that would allow, in the event of such an extraordinary need, to allow highly effective active substances in the EU even in the case of their negative eco-toxicological properties, if the benefits of treatment outweigh the negative effects resulting from the use of such substances (this will also make it legally possible to distribute these substances within the EU).
| Text proposed by the Commission | Amendment |
|---|---|
| (3a) The following Article is inserted: | |
| 'Article 4a | |
| Banned subtances | |
| An active substance which failed to receive an approval, or whose approval has been withdrawn or not renewed pursuant to this Regulation shall not be produced, stored, transported, or placed on the market within the Union. |
Ban of export of banned substances: to ensure level playing field for EU agricultural producers, it is essential to ensure ban on export of banned substances, as export of banned substances has a detrimental effect on the competitiveness of Union´s food sector. The amendment further improves health protection of people, animals and of environment in third countries and in the Union.
| Text proposed by the Commission | Amendment |
|---|---|
| (3a) The following Article is inserted: | |
| ‘Article 4a | |
| Risk-based essential use extension | |
| By way of derogation from article 4(7) subparagraph 1, an active substance may be approved or its approval renewed where not approving or renewing the active substance would have a disproportionate negative impact on the viability of agriculture, food production or food security, compared to the risks to human health, animal health or the environment arising from the use of the substance, in particular where effective alternatives are not available, provided that appropriate risk mitigation measures are applied. | |
| Such disproportionate negative impact shall be considered to exist in particular where: | |
| (a) endemic soil pests cause structural and recurrent crop losses systematically exceeding the Economic Damage Threshold in specific pedoclimatic regions of the Union; | |
| (b) no effective alternative plant protection means are available, as demonstrated by multi-annual phytosanitary monitoring data and field efficacy assessments conducted in accordance with EPPO guidance; and | |
| (c) seed treatment constitutes the only technically viable preventive measure under the specific agronomic and environmental conditions of those regions.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (4) Article 5 is replaced by the following: | deleted |
| ‘Article 5 | |
| First approval | |
| The first approval shall be for an unlimited period except for: | |
| (a) active substances that are identified as candidates for substitution in accordance with Article 24; | |
| (b) active substances that are approved under Article 4(7); or | |
| (c) active substances for which a limited period of approval is set in accordance with Article 6 (j) in particular in the light of relevant uncertainties emerging from the risk assessment, including as a result of data gaps.; ’ |
Unlimited approval periods would remove the systematic periodic reassessment of active substances. Such reassessment is necessary to take account of new toxicological and ecotoxicological evidence, updated scientific guidance, cumulative exposure, monitoring results and changes in environmental conditions. Administrative backlogs should be addressed by strengthening the human and technical resources of EFSA and the competent national authorities, not by abandoning a fundamental safety guarantee. Time-limited approvals also provide legal certainty by ensuring that all active substances are reviewed according to predictable and transparent procedures.
| Text proposed by the Commission | Amendment |
|---|---|
| (4) Article 5 is replaced by the following: | deleted |
| ‘Article 5 | |
| First approval | |
| The first approval shall be for an unlimited period except for: | |
| (a) active substances that are identified as candidates for substitution in accordance with Article 24; | |
| (b) active substances that are approved under Article 4(7); or | |
| (c) active substances for which a limited period of approval is set in accordance with Article 6 (j) in particular in the light of relevant uncertainties emerging from the risk assessment, including as a result of data gaps.; ’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (4) Article 5 is replaced by the following: | deleted |
| ‘Article 5 | |
| First approval | |
| The first approval shall be for an unlimited period except for: | |
| (a) active substances that are identified as candidates for substitution in accordance with Article 24; | |
| (b) active substances that are approved under Article 4(7); or | |
| (c) active substances for which a limited period of approval is set in accordance with Article 6 (j) in particular in the light of relevant uncertainties emerging from the risk assessment, including as a result of data gaps.; ’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (4) Article 5 is replaced by the following: | deleted |
| ‘Article 5 | |
| First approval | |
| The first approval shall be for an unlimited period except for: | |
| (a) active substances that are identified as candidates for substitution in accordance with Article 24; | |
| (b) active substances that are approved under Article 4(7); or | |
| (c) active substances for which a limited period of approval is set in accordance with Article 6 (j) in particular in the light of relevant uncertainties emerging from the risk assessment, including as a result of data gaps.; ’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (4) Article 5 is replaced by the following: | (4) In Article 5 the following sub-paragraphs are added: |
| Text proposed by the Commission | Amendment |
|---|---|
| First approval | Approval |
| Text proposed by the Commission | Amendment |
|---|---|
| The first approval shall be for an unlimited period except for: | The first approval shall be for a period not exceeding 10 years, except for biocontrol active substances and basic substances for which the first approval shall be for an unlimited period. |
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 |
|---|---|
| The first approval shall be for an unlimited period except for: | The first approval shall be granted for a period not exceeding 15 years and shall be subject to renewal in accordance with the review procedure set out in this Regulation. |
Periodic renewal is a core safeguard ensuring that approvals continue to reflect the latest scientific and technical knowledge. Longer approval periods may be appropriate for low-risk active substances, but unlimited approvals would undermine the preventive, science-based approach established by this Regulation.
| Text proposed by the Commission | Amendment |
|---|---|
| The first approval shall be for an unlimited period except for: | The first approval shall not be restricted in time and shall therefore be for a period not defined by an expiry date, except for: |
| Text proposed by the Commission | Amendment |
|---|---|
| The first approval shall be for an unlimited period except for: | The first approval shall be for a period of not exceeding 15 years except for: |
| Text proposed by the Commission | Amendment |
|---|---|
| The first approval shall be for an unlimited period except for: | The first approval shall be for a period not exceeding 10 years, except for: |
Keeping the status quo for plant protection products on the market (pesticides and biocidal products)
Gerben-Jan Gerbrandy, Martin Hojsík, Pascal Canfin, Sigrid Friis, Stine Bosse, Michal Wiezik, Yvan Verougstraete
| Text proposed by the Commission | Amendment |
|---|---|
| The first approval shall be for an unlimited period except for: | The first approval shall be for a period not exceeding 10 years except for: |
| Text proposed by the Commission | Amendment |
|---|---|
| The first approval shall be for an unlimited period except for: | The first approval shall be for a period not exceeding 10 years. |
| Text proposed by the Commission | Amendment |
|---|---|
| The first approval shall be for an unlimited period except for: | First approval shall be for a period not exceeding 10 years. |
Unlimited approvals of both active substances for pesticides and biocides will significantly reduce the current level of protection for human health and environment. In addition, risks to human health and the environment may be overlooked, as there will no longer be generated new studies for the renewal process by the industry. Independent science cannot be expected to finance such targeted studies. Unlimited approvals would also increase the long-term clean-up costs of contaminated water bodies, at a time when Europe is already facing widespread water pollution, ultimately affecting access to clean water and European competitiveness across sectors. Approvals should instead be restricted in time as they are today.
| Text proposed by the Commission | Amendment |
|---|---|
| The first approval shall be for an unlimited period except for: | The approval shall be for an unlimited period except for: |
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 |
|---|---|
| (a) active substances that are identified as candidates for substitution in accordance with Article 24; | deleted |
Experience shows that periodic review 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. Notably, 31 of these substances had not previously been identified as candidates for substitution, meaning they were not initially considered among the most hazardous pesticides requiring heightened scrutiny. Periodic reassessment also ensures that the responsibility for demonstrating safety remains with the companies placing substances on the market.
| Text proposed by the Commission | Amendment |
|---|---|
| (a) active substances that are identified as candidates for substitution in accordance with Article 24; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) active substances that are identified as candidates for substitution in accordance with Article 24; | deleted |
Unlimited approvals of both active substances for pesticides and biocides will significantly reduce the current level of protection for human health and environment. In addition, risks to human health and the environment may be overlooked, as there will no longer be generated new studies for the renewal process by the industry. Independent science cannot be expected to finance such targeted studies. Unlimited approvals would also increase the long-term clean-up costs of contaminated water bodies, at a time when Europe is already facing widespread water pollution, ultimately affecting access to clean water and European competitiveness across sectors. Approvals should instead be restricted in time as they are today.
| Text proposed by the Commission | Amendment |
|---|---|
| (a) active substances that are identified as candidates for substitution in accordance with Article 24; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) active substances that are approved under Article 4(7); or | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) active substances that are approved under Article 4(7); or | deleted |
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 |
|---|---|
| (b) active substances that are approved under Article 4(7); or | deleted |
Experience shows that periodic review 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. Notably, 31 of these substances had not previously been identified as candidates for substitution, meaning they were not initially considered among the most hazardous pesticides requiring heightened scrutiny. Periodic reassessment also ensures that the responsibility for demonstrating safety remains with the companies placing substances on the market.
| Text proposed by the Commission | Amendment |
|---|---|
| (b) active substances that are approved under Article 4(7); or | deleted |
Unlimited approvals of both active substances for pesticides and biocides will significantly reduce the current level of protection for human health and environment. In addition, risks to human health and the environment may be overlooked, as there will no longer be generated new studies for the renewal process by the industry. Independent science cannot be expected to finance such targeted studies. Unlimited approvals would also increase the long-term clean-up costs of contaminated water bodies, at a time when Europe is already facing widespread water pollution, ultimately affecting access to clean water and European competitiveness across sectors. Approvals should instead be restricted in time as they are today.
| Text proposed by the Commission | Amendment |
|---|---|
| (c) active substances for which a limited period of approval is set in accordance with Article 6 (j) in particular in the light of relevant uncertainties emerging from the risk assessment, including as a result of data gaps.; | deleted |
Unlimited approvals of both active substances for pesticides and biocides will significantly reduce the current level of protection for human health and environment. In addition, risks to human health and the environment may be overlooked, as there will no longer be generated new studies for the renewal process by the industry. Independent science cannot be expected to finance such targeted studies. Unlimited approvals would also increase the long-term clean-up costs of contaminated water bodies, at a time when Europe is already facing widespread water pollution, ultimately affecting access to clean water and European competitiveness across sectors. Approvals should instead be restricted in time as they are today.
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 |
|---|---|
| (c) active substances for which a limited period of approval is set in accordance with Article 6 (j) in particular in the light of relevant uncertainties emerging from the risk assessment, including as a result of data gaps.; | deleted |
Experience shows that periodic review 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. Notably, 31 of these substances had not previously been identified as candidates for substitution, meaning they were not initially considered among the most hazardous pesticides requiring heightened scrutiny. Periodic reassessment also ensures that the responsibility for demonstrating safety remains with the companies placing substances on the market.
| Text proposed by the Commission | Amendment |
|---|---|
| (c) active substances for which a limited period of approval is set in accordance with Article 6 (j) in particular in the light of relevant uncertainties emerging from the risk assessment, including as a result of data gaps.; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) active substances for which a limited period of approval is set in accordance with Article 6 (j) in particular in the light of relevant uncertainties emerging from the risk assessment, including as a result of data gaps.; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) active substances for which a limited period of approval is set in accordance with Article 6 (j) in particular in the light of relevant uncertainties emerging from the risk assessment, including as a result of data gaps.; | (c) active substances for which a period of approval is set on the basis of an expiry date in accordance with Article 6 (j) in particular in the light of relevant uncertainties emerging from the risk assessment, including as a result of gaps in the data provided by the authorisation holder.; |
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Pascal Canfin, Olivier Chastel, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| in Article 5, the following paragraph 1a is inserted: | |
| '1a. By way of derogation to paragraph 1, the first approval for biocontrol substances and low-risk active substances shall be unlimited except in the cases referred to in points (a) to (c) of paragraph 1.' |
Biljana Borzan, 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 |
|---|---|
| An application for the approval of an active substance, for an amendment of the conditions of approval, or for a change of status for an active substance as identified in the regulation referred to in Article 13(4), shall be submitted by the producer of the active substance to a Member State (the “rapporteur Member State”) together with a summary and a complete dossier as provided for in Articles 8(1) and (2) this Regulation or a scientifically reasoned justification for not providing certain parts of those dossiers. The application shall demonstrate that the active substance fulfils the approval criteria provided for in Article 4 of this Regulation or, where applicable, that the change of status of the active substance is justified. The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002 of the European Parliament and of the Council, which shall apply mutatis mutandis. | An application for the approval of an active substance, for an amendment of the conditions of approval, or for a change of status for an active substance as identified in the regulation referred to in Article 13(4), shall be submitted by the producer of the active substance to a Member State (the “rapporteur Member State”) together with a summary and a complete dossier as provided for in Articles 8(1) and (2) this Regulation or a scientifically reasoned justification for not providing certain parts of those dossiers. Applications shall only be considered admissible where the dossier contains all information required under this Regulation that is necessary to enable the scientific assessment of the application. The application shall demonstrate that the active substance fulfils the approval criteria provided for in Article 4 of this Regulation or, where applicable, that the change of status of the active substance is justified. The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002 of the European Parliament and of the Council, which shall apply mutatis mutandis. |
Delays in the assessment process are often caused by incomplete applications requiring repeated requests for additional information. Clarifying the conditions for admissibility will improve the efficiency and timeliness of scientific assessments without lowering regulatory standards.
| Text proposed by the Commission | Amendment |
|---|---|
| An application for the approval of an active substance, for an amendment of the conditions of approval, or for a change of status for an active substance as identified in the regulation referred to in Article 13(4), shall be submitted by the producer of the active substance to a Member State (the “rapporteur Member State”) together with a summary and a complete dossier as provided for in Articles 8(1) and (2) this Regulation or a scientifically reasoned justification for not providing certain parts of those dossiers. The application shall demonstrate that the active substance fulfils the approval criteria provided for in Article 4 of this Regulation or, where applicable, that the change of status of the active substance is justified. The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002 of the European Parliament and of the Council, which shall apply mutatis mutandis. | A complete and scientifically up-to-date application for the approval of an active substance, for an amendment of the conditions of approval, or for a change of status for an active substance as identified in the regulation referred to in Article 13(4), shall be submitted by the producer of the active substance to a Member State (the “rapporteur Member State”) together with a summary and a complete dossier as provided for in Articles 8(1) and (2) this Regulation or a scientifically reasoned justification for not providing certain parts of those dossiers. The application shall demonstrate that the active substance fulfils the approval criteria provided for in Article 4 of this Regulation or, where applicable, that the change of status of the active substance is justified. The application shall be submitted in accordance with standard data formats, where they exist pursuant to Article 39f of Regulation (EC) No 178/2002 of the European Parliament and of the Council, which shall apply mutatis mutandis. |
| Text proposed by the Commission | Amendment |
|---|---|
| Member States shall only consider applications complying with Commission Regulation (EU) 283/2013 and with Article 8(5) as admissible. | |
| Any application submitted with a dossier that is incomplete or fails to meet the required quality standards shall be rejected. | |
| By way of implementing acts, the Commission shall establish detailed criteria for dossier completeness and quality to ensure consistency and transparency across Member States. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 79. |
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Pascal Canfin, Olivier Chastel, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from the first subparagraph, applications for the approval of biocontrol substances may be submitted to the Authority which shall assume the duties of the rapporteur Member State.; | By way of derogation from the first subparagraph, applications for the approval of biocontrol and low-risk substances may be submitted to the Authority which shall assume the duties of the rapporteur Member State.; |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from the first subparagraph, applications for the approval of biocontrol substances may be submitted to the Authority which shall assume the duties of the rapporteur Member State.; | By way of derogation from the first subparagraph, applications for the approval of biocontrol and low-risk substances may be submitted to the Authority which shall assume the duties of the rapporteur Member State.; |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from the first subparagraph, applications for the approval of biocontrol substances may be submitted to the Authority which shall assume the duties of the rapporteur Member State.; | By way of derogation from the first subparagraph, applications for the approval of active substances may be submitted to the Authority which shall assume the duties of the rapporteur Member State.; |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from the first subparagraph, applications for the approval of biocontrol substances may be submitted to the Authority which shall assume the duties of the rapporteur Member State.’; | By way of derogation from the first subparagraph, applications for the approval of substances may be submitted to the Authority which shall assume the duties of the rapporteur Member State.’; |
In some other cases (not only in case of biocontrols) should be allowed, that EFSA should assist to Rapporteur MS too, or act instead of rapporteur MS.
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from the first subparagraph, applications for the approval of biocontrol substances may be submitted to the Authority which shall assume the duties of the rapporteur Member State.; | By way of derogation from the first subparagraph, applications for the approval of active substances may be submitted to the Authority which shall assume the duties of the rapporteur Member State.; |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from the first subparagraph, applications for the approval of biocontrol substances may be submitted to the Authority which shall assume the duties of the rapporteur Member State.; | By way of derogation from the first subparagraph, applications for the approval of substances may be submitted to the Authority which shall assume the duties of the rapporteur Member State.; |
| Text proposed by the Commission | Amendment |
|---|---|
| By way of derogation from the first subparagraph, applications for the approval of biocontrol substances may be submitted to the Authority which shall assume the duties of the rapporteur Member State.’; | By way of derogation from the first subparagraph, applications for the approval of active substances may be submitted to the Authority which shall assume the duties of the rapporteur Member State.’; |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (5a) In Article 7, the following paragraph is added: | |
| 1a. The evaluation of the application for the approval of an active substance shall be completed within a period not exceeding 18 months from the date of submission of a complete dossier. |
| Text proposed by the Commission | Amendment |
|---|---|
| (5a) In Article 7, the following paragraph is added: | |
| 5a. Member States shall only consider applications complying with Regulation (EU) 283/2013 and with Article 8(5) as admissible. Any application submitted with a dossier that is incomplete or fails to meet the required quality standards shall be rejected. The Commission shall establish detailed criteria for dossier completeness and quality to ensure consistency and transparency across Member States. | |
| The Commission shall provide start-up and SMR applicants with pre-submission advice to help them implementing the drafting criteria and make sure files are complete and appropriately filled out. |
Most of the current delays in authorisation and approval are because of incomplete dossiers with data gaps or omissions, which cost the relevant administrations' time and effort to correct them and wait for the appropriate evidence, or find mitigating solutions. By improving the quality of submissions, with advice services, the delays and backlogs should diminish.
| Text proposed by the Commission | Amendment |
|---|---|
| (5b) In Article 8, the following paragraph 1a is added after paragraph 1: | |
| ‘1a. By way of derogation from paragraph 1, applications for the approval of biocontrol active substances shall be accompanied by data and information that are proportionate and scientifically adapted to their biological origin, mode of action and expected exposure. | |
| The data requirements, assessment methodologies and risk assessment principles applicable to biocontrol active substances shall ensure the same high level of protection of human health, animal health and the environment as required under Article 4, while avoiding studies or testing requirements that are not scientifically justified for the category of biocontrol active substance concerned.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (5c) In Article 8, the following parapraph shall be added: | |
| '1b. The Commission shall, by means of implementing acts by category of biocontrol active substances and micro organisms adopted in accordance with the examination procedure referred to in Article 79(3), after consulting the European Food Safety Authority, establish and periodically update the data requirements, assessment methodologies and risk assessment principles applicable to biocontrol active substances. The first implementing act shall be adopted no later than 12 months after the entry into force of this Regulation.' |
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 |
|---|---|
| (5a) in Article 8, the following paragraph is added: | |
| '5a. The Authority shall, at the request of a potential applicant, provide advice on the content of the application, prior to its submission, including the rules applicable to and the required content thereof as well as on the design of the studies and testing strategies to support such application. Such advice provided by the Authority shall be without prejudice and non-committal as to any subsequent assessment of application by the Authority' |
| Text proposed by the Commission | Amendment |
|---|---|
| In Article 8, the following paragraph is added: | |
| '5a. The Authority shall, at the request of a potential applicant, provide advice on the content of the application, prior to its submission, including the rules applicable to and the required content thereof as well as on the design of the studies and testing strategies to support such application. Such advice provided by the Authority shall be without prejudice and non-committal as to any subsequent assessment of application by the Authority' |
| Present text | Amendment |
|---|---|
| (-a) Paragraph 1 is replaced by the following: | |
| 1. Within 12 months of the date of the notification provided for in the first subparagraph of Article 9(3), the rapporteur Member State shall prepare and submit to the Commission, with a copy to the Authority, a report, referred to as the ‘draft assessment report’, assessing whether the active substance can be expected to meet the approval criteria provided for in Article 4. | ‘1. Within 12 months of the date of the notification provided for in the first subparagraph of Article 9(3), the rapporteur Member State shall carry out a comprehensive literature review and prepare and submit to the Commission, with a copy to the Authority, a report, referred to as the ‘draft assessment report’, assessing whether the active substance can be expected to meet the approval criteria provided for in Article 4.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| ‘1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.’; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| ‘1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.’; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | deleted |
| Present text | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances. | deleted |
the Omnibus proposal opens 3 risks:1.to inflation the application for biocontrol substances, with all the limitations today affecting this category of a.s.2.to further reduce the number of applications for new but “chemical” a..s.,more reliable and efficient in controlling pest proliferation3.Resources allocated to the evaluation/renewal of active substances and conventional PPPs should not be allocated to biological control products only. Instead, a specialized unit should be established with its own human and financial resources, ensuring that the procedures for the authorization and reauthorization of “conventional” active substances and PPPs maintain their quality and operational capacity.
| Text proposed by the Commission | Amendment |
|---|---|
| (1a) The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.’; | (1a) Where the intended use of an active substance includes biogeographical regions with specific pedoclimatic conditions that are not covered by the standard test conditions of the rapporteur Member State, the rapporteur Member State shall coordinate with the Member States where those regions are located to ensure that: |
| (a) efficacy evaluations reflect the full range of conditions under which the product is intended to be used within the Union; | |
| (b) gaps in the data on regional conditions are identified and remedied before the assessment is finalised; and; | |
| (c) the competent authorities and research institutes of the Member States hosting biogeographical regions present in only one Member State of the Union shall be consulted as part of the assessment procedure, given the specific scientific expertise and long-term monitoring data they may have at their disposal. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | 1a. The rapporteur Member State shall give priority to the assessment of applications for approval or renewal of approval of substances necessary to control a serious danger to plant health or plant production. Where the intended use of an active substance concerns biogeographical regions with specific pedoclimatic conditions not covered by the rapporteur Member State, the rapporteur Member State shall coordinate with the Member States whose territory includes those biogeographical regions to ensure that: |
| (a) efficacy assessments reflect the full range of conditions under which the product is intended to be used within the Union; | |
| (b) region-specific data gaps are identified and addressed before completion of the peer review; | |
| (c) competent authorities and research institutes from Member States hosting unique biogeographical regions are consulted as part of the assessment procedure. |
However acceleration of biocontrol approvals is generally welcome, but priority in evaluation has to be given to the all cases when there is serious danger to plant health or plant production regardless it is biocontrol or classical tool concerned.
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; Where the intended use of an active substance concerns biogeographical regions with specific pedoclimatic conditions not covered by the rapporteur Member State, the rapporteur Member State shall coordinate with the Member States whose territory includes those biogeographical regions to ensure that: |
| (a) efficacy assessments reflect the full range of conditions under which the product is intended to be used within the Union; | |
| (b) competent authorities and research institutes from Member States hosting unique biogeographical regions are consulted as part of the assessment procedure.; |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | 1a. Where the intended use of an active substance concerns biogeographical regions with specific pedoclimatic conditions not covered by the rapporteur Member State, the rapporteur Member State shall coordinate with the Member States whose territory includes those biogeographical regions to ensure that: |
| (a) efficacy assessments reflect the full range of conditions under which the product is intended to be used within the Union; | |
| (b) region-specific data gaps are identified and addressed before completion of the peer review; | |
| (c) competent authorities and research institutes from Member States hosting unique biogeographical regions are consulted as part of the assessment procedure. |
Carmen Crespo Díaz, Juan Ignacio Zoido Álvarez, Susana Solís Pérez, Esther Herranz García, Dolors Montserrat
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances. That priority shall be provided by way of additional technical, human and financial resources and shall not lead to unjustified delays to the assessment of other active substances necessary for effective crop protection, integrated pest management or resistance prevention. Where the intended use of an active substance concerns biogeographical regions with specific pedo-climatic conditions not present in the rapporteur Member State, the rapporteur Member State shall coordinate with the Member States whose territory includes such biogeographical regions to ensure that the assessment takes those conditions into account; |
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 |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances, without reducing the applicable scientific data requirements, risk assessment standards or post-market monitoring obligations. Member States shall establish 'green lanes' 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.; |
Biocontrol substances should benefit from faster assessment procedures, provided that the level of scientific scrutiny and protection of human health and the environment is fully maintained.
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 |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances and thereafter, low-risk active substances by allocating adequate scientific, technical and human resources to their national competent authority and to ensure that such priority assessment does not delay excessively the assessment of applications for approval of other active substances and does not affect the compliance with the time limits laid down in paragraph 1. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | 1a. Where the intended use of an active substance includes biogeographical regions with pedoclimatic conditions not covered by the standard test conditions of the rapporteur Member State, the rapporteur Member State shall coordinate with the Member States whose territory includes those regions, in order to ensure that efficacy assessments reflect the full range of conditions under which the product is intended to be used within the Union.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | 1a. The rapporteur Member State shall give priority to the assessment of applications for approval or renewal of approval of substances necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means, on the basis of the evidence referred to in Article 4, paragraph 7, subparagraph 1. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of substances intended to prevent or control an urgent or serious danger to plant health or plant production. |
The amendment replaces the reference to biological substances with a broader urgency-based criterion. Priority should be determined by the seriousness of the plant health risk rather than by the type of active substance concerned.
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | 1a. The rapporteur Member State shall allocate dedicated resources and establish dedicated pathways to the assessment of applications for approval of biocontrol substances.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | 1a. The rapporteur Member State shall allocate dedicated resources and establish dedicated pathways to the assessment of applications for approval of biocontrol substances; |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | 1a. The rapporteur Member State shall give priority to the assessment of applications for first approval of new substances, including biocontrol substances.; |
Biocontrol substances complement rather than replace conventional plant protection substances. Creating a priority lane for biocontrol substances risks further slowing down the assessment of conventional substances. Instead, all new substances should benefit from a prioritised assessment in order to ensure that farmers have access to the most effective solutions.
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of low-risk biocontrol substances.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | 1a. The rapporteur Member State shall give priority to the assessment of applications for first approval of new substances.’; |
Biocontrol is an important field of innovation, but it complements rather than replaces other crop protection innovations. Prioritising the first approval of new substances supports the full spectrum of innovation and helps ensure that farmers have timely access to the innovative tools needed for effective pest control.
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The rapporteur Member State shall give priority to the assessment of applications for approval of biocontrol substances.; | 1a. The rapporteur Member State shall give priority to the assessment of applications for first approval of new substances.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) the following paragraph is added: | |
| '1aa. Where the intended use of an active substance extends to biogeographical regions with pedoclimatic conditions that are not adequately represented by the standard testing parameters of the rapporteur Member State, the rapporteur Member State shall act in coordination with the Member States encompassing those regions. This cooperation shall be established to ensure that: | |
| (a) efficacy assessments reflect the full range of conditions under which the product is intended to be used within the Union; | |
| (b) data gaps relating to regional conditions are identified and addressed before the peer review is completed; and | |
| (c) competent authorities and research institutes in Member States hosting biogeographical regions present in only one Member State of the Union are consulted as part of the assessment procedure, in the view of specific scientific expertise and long-term monitoring data they may hold.' |
The proposed amendment converts the option provided under Article 11(3) of Regulation (EC) No 1107/2009 into a binding procedural obligation for the Rapporteur Member State whenever the intended uses cover specific biogeographical regions of the Union not represented by standard testing parameters. This is highly relevant for Romania, which holds the Steppe region—a zone unique to the EU, yet entirely unaddressed in current authorization dossiers. The measure enables the formal utilization and institutional integration of the unique data and monitoring expertise held by Romanian national institutes (INCDPP, INCDA Fundulea, SCDA/ASAS units), ensuring a complete scientific assessment tailored to the specific pedoclimatic realities of all Union territories.
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Pascal Canfin, Olivier Chastel, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) the following paragraph is added: | |
| '1aa. The implementation of the priority lane established in paragraph 1a shall not excessively affect the timely assessment of application for first approval or renewal of approval of active substances that have been approved for more than 10 years.' |
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) The following paragraph is added: | |
| '1aa. Where the intended use of an active substance includes biogeographical regions with specific pedoclimatic conditions not covered by the standard test conditions of the rapporteur Member State, the rapporteur Member State shall coordinate with the Member States whose territory includes those biogeographical regions to ensure that: | |
| (a) efficacy assessments reflect the full range of conditions under which the product is intended to be used within the Union; | |
| (b) data gaps relating to specific regional conditions are identified and addressed prior to the completion of the peer review; and | |
| (c) competent authorities and research institutes in Member States hosting biogeographical regions present in only one Member State of the Union are consulted as part of the assessment procedure, given the unique scientific expertise and long-term monitoring data they may hold for those regions.' |
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) the following paragraph is added: | |
| '1aa. Member States shall ensure that all assessment lanes or units referred to in paragraph 1a shall be equipped with sufficient and appropriate resources to ensure that all applications submitted under Chapter II, Section I, subsection 2 are processed within the applicable time-limits.' |
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) the following paragraph is added: | |
| '1aa. Assessment of applications for approval of active substances shall be carried out in the order in which they are received by the competent authority;' |
| Present text | Amendment |
|---|---|
| (ab) In Paragraph 2, subparagraph 2 is replaced by the following: | |
| The rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge. | ‘The rapporteur Member State shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge, using the fundamental principles of systematic review.' |
| Text proposed by the Commission | Amendment |
|---|---|
| The rapporteur Member State may ask the Authority to provide technical and scientific support during the assessment required for the preparation and delivery of the draft assessment report, during the assessment of the additional information referred to in Article 12(3), and for the preparation of necessary updates of the draft assessment report after its initial submission.; | The Member States shall create dedicated lanes with additional and specialized resources for the the assessment of applications for approval of biocontrol substances submitted under Chapter II, Section I, subsection 2.; |
Carmen Crespo Díaz, Juan Ignacio Zoido Álvarez, Susana Solís Pérez, Esther Herranz García, Dolors Montserrat
| Text proposed by the Commission | Amendment |
|---|---|
| (6a) the following paragraph 3a is inserted: | |
| ‘3a. The conclusion of the competent authority shall include information on the assessment procedure, the properties of the active substance and, where relevant, safe uses that can be established through risk mitigation measures. Those measures may include precision application technologies, drift-reducing equipment, localised applications, specific usage conditions and other available techniques that reduce exposure or risk.’ |
| Present text | Amendment |
|---|---|
| (6a) In Article 13, the introductory part of paragraph 2 is amended as follows | |
| 2. On the basis of the review report, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, a Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), providing that: | "2. On the basis of the review report, other factors legitimate to the matter under consideration and the precautionary principle where the conditions laid down in Article 7(1) of Regulation (EC) No 178/2002 are relevant, a Regulation shall be adopted in accordance with the regulatory procedure referred to in Article 79(3) within 6 months after the draft Regulation is presented to the Committee, providing that:" |
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- Licensed CC BY 4.0.
- Retrieved
- 25 September 2026
Cite as
European Parliament (2026). “AMENDMENTS 268 - 532 - 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-791047. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/CJ14-AM-791047 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/CJ14-AM-791047 (CC BY 4.0).
BibTeX
@misc{epw-text-cj14-am-791047,
author = {{European Parliament}},
title = {{AMENDMENTS 268 - 532 - 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-791047}},
url = {https://news.eu-parl.st-solutions.dev/texts/CJ14-AM-791047},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. docId CJ14-AM-791047. Data: EP Open Data API: document record (CC BY 4.0)}
}