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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-791049 · COM(2025)1030 – C100359/2025 – 2025/0410(COD)
- Kind
- Amendment list CJ14-AM-791049
- Date
- 28 July 2026
- Committee
- Committee on the Environment, Climate and Food Safety Committee on Agriculture and Rural Development
- Dossier
- 2025-0410
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- Official page PDF Word
- Reference
- COM(2025)1030 – C100359/2025 – 2025/0410(COD)
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| Present text | Amendment |
|---|---|
| (6a) In Article 13, paragraph 2, the introductory part is replaced by : | |
| 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, providing that:' |
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. Where the approval of an active substance is refused, the Commission Regulation adopted pursuant to paragraph 3 shall provide that the active substance shall not be produced, stored, transported, or placed on the market within the Union. |
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 |
|---|---|
| (9) Article 14 is replaced by the following: | deleted |
| ‘Article 14 | |
| Renewal of approval | |
| 1. Upon application, the approval of an active substance with a limited approval period shall be renewed where it is established that the approval criteria provided for in Article 4 are satisfied. | |
| Article 4 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance. | |
| Such renewal of the approval may include conditions and restrictions, as referred to in Article 6. | |
| 2. The renewal of approval of active substances shall be for an unlimited period, except for: | |
| (a) active substances that are approved as candidates for substitution in accordance with Article 24, | |
| (b) active substances whose approvals are renewed under Article 4(7); or | |
| (c) active substances for which a limited period of renewal 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 |
|---|---|
| (9) Article 14 is replaced by the following: | deleted |
| ‘Article 14 | |
| Renewal of approval | |
| 1. Upon application, the approval of an active substance with a limited approval period shall be renewed where it is established that the approval criteria provided for in Article 4 are satisfied. | |
| Article 4 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance. | |
| Such renewal of the approval may include conditions and restrictions, as referred to in Article 6. | |
| 2. The renewal of approval of active substances shall be for an unlimited period, except for: | |
| (a) active substances that are approved as candidates for substitution in accordance with Article 24, | |
| (b) active substances whose approvals are renewed under Article 4(7); or | |
| (c) active substances for which a limited period of renewal 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 |
|---|---|
| Article 14 | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Upon application, the approval of an active substance with a limited approval period shall be renewed where it is established that the approval criteria provided for in Article 4 are satisfied. | Upon application, the approval of an active substance with an approval period defined by an expiry date shall be renewed where it is established that the approval criteria provided for in Article 4 are satisfied. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 4 shall be deemed to be satisfied where this has been established with respect to one or more representative uses of at least one plant protection product containing that active substance. | Article 4 shall be deemed to be satisfied only where the conditions of that article have been met in full without data gaps or omissions, with respect to one or more representative uses of at least one plant protection product containing that active substance. Dossiers where data gaps or omissions still exist, or where full protection of human health and the environment cannot be assured shall not be granted reapproval. |
| Text proposed by the Commission | Amendment |
|---|---|
| Such renewal of the approval may include conditions and restrictions, as referred to in Article 6. | Such renewal of the approval shall include conditions and restrictions, as referred to in Article 6. |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The renewal of approval of active substances shall be for an unlimited period, except for: | 2. The renewal of approval of active substances shall be granted for a period not exceeding 15 years. By way of derogation from the first subparagraph, the renewal of approval of low-risk active substances approved in accordance with Article 22 may be granted for a period not exceeding 20 years, provided that the approval criteria continue to be fulfilled. Renewals shall continue to be based on a comprehensive scientific assessment in accordance with this Regulation. |
Periodic renewal is a fundamental safeguard to ensure that approvals continue to reflect the latest scientific and technical knowledge. Longer renewal periods may be justified for low-risk active substances, but unlimited renewals would weaken the preventive, science-based approach established by Regulation (EC) No 1107/2009.
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The renewal of approval of active substances shall be for an unlimited period, except for: | 2. The renewal of approval of active substances shall be for a period not exceeding 15 years. Shorter reapproval periods shall apply in line with art.4(7) for no longer than 5 years. Active substances for which there are still data gaps shall not be renewed. Unlimited reapproval shall only apply to low risk active substances as per art 22. and low risk biocontrol substances as per art.22a. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The renewal of approval of active substances shall be for an unlimited period, except for: | 2. The renewal of approval of active substances covered by Article 4(7) shall be for a period not exceeding five years. The renewal of approval of active substances shall be for a period not exceeding 15 years, except for: |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The renewal of approval of active substances shall be for an unlimited period, except for: | 2. The renewal of the approval shall be for a period not exceeding 15 years. The renewal of approval of active substances covered by Article 4(7) shall be for a period not exceeding five years. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The renewal of approval of active substances shall be for an unlimited period, except for: | 2. The renewal of the approval shall be for a period not exceeding 15 years. The renewal of approval of active substances covered by Article 4(7) shall be for a period not exceeding five years |
Gerben-Jan Gerbrandy, Martin Hojsík, Pascal Canfin, Sigrid Friis, Stine Bosse, Michal Wiezik, Yvan Verougstraete
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The renewal of approval of active substances shall be for an unlimited period, except for: | 2. The renewal of approval of active substances shall be for an a limited period, not exceeding 15 years, except: |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The renewal of approval of active substances shall be for an unlimited period, except for: | 2. The renewal of approval of active substances shall be for an undefined period, except for: |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The renewal of approval of active substances shall be for an unlimited period, except for: | 2. The renewal of approval of active substances shall be for a period of 10 years, except for: |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The renewal of approval of active substances shall be for an unlimited period, except for: | 2. The renewal of approval of active substances shall be for 20 years, except for: |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| (a) active substances that are approved as candidates for substitution in accordance with Article 24, | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) active substances that are approved as candidates for substitution in accordance with Article 24, | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) active substances whose approvals are renewed under Article 4(7); or | deleted |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| (b) active substances whose approvals are renewed under Article 4(7); or | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) active substances for which a limited period of renewal 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 |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| (c) active substances for which a limited period of renewal 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 |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Present text | Amendment |
|---|---|
| (10a) Article 14(2) is amended as follows: | |
| 2. The renewal of the approval shall be for a period not exceeding 15 years. The renewal of approval of active substances covered by Article 4(7) shall be for a period not exceeding five years. | ‘2. The renewal of the approval shall be for a period not exceeding 15 years. The renewal of approval of active substances covered by Article 4(7) shall be for a period not exceeding 10 years. In order to apply for the derogation referred to in Article 4(7), the applicant shall not be required to wait for the renewal of approval procedure. ’ |
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Olivier Chastel, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. By way of derogation to paragraph 2, the renewal of approval of biocontrol substances and low-risk active substances shall be for an unlimited period except in the cases referred to in points (a) to (c) of paragraph 2. |
| Text proposed by the Commission | Amendment |
|---|---|
| (9a) in Article 15, the following paragraph is added: | |
| '2a. 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.' |
| Text proposed by the Commission | Amendment |
|---|---|
| (9a) In Article 15, a new paragraph is added: | |
| '2a. Member States shall only consider applications for renewal 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.' |
| Present text | Amendment |
|---|---|
| (9a) Article 17 is deleted. | |
| Article 17 | |
| Extension of approval period for the duration of the procedure | |
| Where for reasons beyond the control of the applicant it appears that the approval is likely to expire before a decision has been taken on renewal, a decision shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), postponing the expiry of the approval period for that applicant for a period sufficient to examine the application. | |
| A Regulation postponing the expiry for a period sufficient to examine the application shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 79(5) where an applicant could not give the three years’ notice required under Article 15(1) because the active substance was included in Annex I to Directive 91/414/EEC for a duration which expired before 14 June 2014. | |
| The length of that period shall be established on the basis of the following: | |
| (a) the time needed to provide the information requested; | |
| (b) the time needed to complete the procedure; | |
| (c) where appropriate, the need to ensure the establishment of a coherent work programme, as provided for in Article 18. |
The possibility to extend the approval period for the duration of the procedure should be deleted. This possibility has been overused, leading to a situation where active substances that present a considerable risk to the health of humans, animals and the environment have been available on the market for years and years after their original approval has expired.
| Present text | Amendment |
|---|---|
| (9b) In Article 17, the first subparagraph is replaced by: | |
| Where for reasons beyond the control of the applicant it appears that the approval is likely to expire before a decision has been taken on renewal, a decision shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), postponing the expiry of the approval period for that applicant for a period sufficient to examine the application. | 'Where for reasons beyond the control of the applicant it appears that the approval is likely to expire before a decision has been taken on renewal, a decision shall be adopted in accordance with the regulatory procedure referred to in Article 79(3), postponing the expiry of the approval period for that applicant for a period strictly necessary to examine the application. Such extensions shall be exceptional, temporary in nature, and not applied systematically, and shall be tailored to the concrete progress the risk assessment.' |
| Text proposed by the Commission | Amendment |
|---|---|
| (9c) In Article 17, the following subparagraph is added at the end: | |
| 'The Commission shall have the discretion not to grant an extension where it can be established that delays result from gaps, deficiencies, or insufficient quality of the submitted dossier.' |
| Text proposed by the Commission | Amendment |
|---|---|
| (10) Article 18 is replaced by the following: | deleted |
| ‘Article 18 | |
| Work programme for renewal of approval of active substances with unlimited approval periods | |
| 1. The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | |
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | |
| The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. | |
| 2. The implementing acts referred to in paragraph 1 shall: | |
| (a) list the active substances concerned; | |
| (b) list the rapporteur and co-rapporteur Member States; | |
| (c) set deadlines for the submission of applications for renewal of the approval of the active substances concerned that allow sufficient time for the generation of the necessary data and the submission of the said applications; and | |
| (d) set expiry dates for the approvals of the active substances concerned that allow sufficient time for the submission and evaluation of the applications and for the adoption of decisions on the renewal of the approval of the active substances concerned. | |
| 3. Articles 14, 15(2), 16, 17 and 20 shall apply.; ’ |
| Text proposed by the Commission | Amendment |
|---|---|
| Work programme for renewal of approval of active substances with unlimited approval periods | Work programme for renewal of approval of active substances with approval periods which, not calendar based, have no specified expiry date: |
| Text proposed by the Commission | Amendment |
|---|---|
| Work programme for renewal of approval of active substances with unlimited approval periods | Work programme for renewal of approval of low-risk active substances with unlimited approval periods |
| Text proposed by the Commission | Amendment |
|---|---|
| Work programme for renewal of approval of active substances with unlimited approval periods | Work programme for renewal of approval of active substances with limited approval periods |
| Text proposed by the Commission | Amendment |
|---|---|
| Work programme for renewal of approval of active substances with unlimited approval periods | Work programme for renewal of approval of active substances |
| Text proposed by the Commission | Amendment |
|---|---|
| Work programme for renewal of approval of active substances with unlimited approval periods | Targeted reassessment of active substances with unlimited approval periods |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | The Commission shall, on an annual basis, based on the work programme prepared by the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances structurally or functionally related with unlimited approval periods for which a renewal procedure shall be conducted. |
| For the purpose of the first subparagraph the Authority shall, on an annual basis, propose a work programme to the Commission for the identification of active substances or groups of active substances structurally or functionally related with unlimited approval periods for which a renewal procedure shall be conducted. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | The Commission shall on an annual basis after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or a groups of structurally or functionally related active substances with unlimited approval periods for which a renewal procedure shall be conducted. The identification of such groups shall trigger a joint assessment, which may result in restrictions or non-approval for all substances in the group. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | The Commission shall every 2 years, after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances structurally or functionally related with unlimited approval periods for which a renewal procedure shall be conducted. The identification of such groups shall trigger a joint assessment, which may result in restrictions or non-approval for all substances in the group. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | The Commission shall periodically and at least every year after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances structurally or functionally related with unlimited approval periods for which a renewal procedure shall be conducted. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | The Commission may, if necessary and after consulting the Authority, periodically adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with approval periods having no specified expiry date and for which a renewal procedure shall be conducted. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | On an exceptional basis, the Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | On an exceptional basis, the Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. |
Benoit Cassart, Gerben-Jan Gerbrandy, Martin Hojsík, Olivier Chastel, Michal Wiezik, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | The Commission shall periodically and at least every year after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | The Commission shall at least every three years after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | The Commission shall, each year, after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances for which a renewal procedure shall be conducted. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with limited approval periods for which a renewal procedure shall be conducted. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | The Commission shall after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. |
Deleting the word "periodically" ensures that the Commission launches a renewal programme only where there are justified concerns that an approved substance may no longer meet the approval criteria. Monitoring data should guide this decision. Otherwise, regular renewals would undermine the purpose of granting approvals for an indefinite period.
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall periodically after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. | The Commission may after consulting the Authority, adopt implementing acts in accordance with the procedure referred to in Article 79(3), identifying active substances or groups of active substances with unlimited approval periods for which a renewal procedure shall be conducted. |
word periodically should be skipped, as the timing of activities should be based onto new information's, findings ect.
| Text proposed by the Commission | Amendment |
|---|---|
| Inclusion in a work programme pursuant to this Article shall be limited to cases where broad scientific evidence indicates the need for a comprehensive reassessment of the active substance. Targeted reassessment pursuant to Article 18a shall be the standard approach for the review of approved active substances. |
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall take into account, inter alia, indications of concerns for human or animal health or the environment, new scientific or technical knowledge, available monitoring data, gaps identified by the Authority during previous assessments, and requests from Member States, including those based on scientific peer-reviewed open literature.Where a Member State submits such a request, the Commission shall act within 6 months of receipt thereof. Where the Commission rejects the request, it shall provide a duly justified and reasoned decision. |
| For each low-risk plant protection product and biocontrol approved for an unlimited duration, the Authority shall, in cooperation with the Commission and the Member States, develop a product-specific detection protocol, accompanied by monitoring parameters including relevant indicators, trigger values and follow-up criteria, in order to ensure that risk-based follow-up measures are triggered on the basis of post-registration data and safety signals. The development of such protocols shall be carried out in accordance with the relevant work programmes. |
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall be based on objective criteria, and be triggered when any of the following conditions are met: indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge including those originating from scientific peer-review open literature, and available monitoring data gaps identified by the Authority during previous assessment, and shall act on requests from Member States. Where a Member State submits a request, the Commission shall act within 6 months. In case the Commission rejects the request by a Member State, it shall provide a reasoned decision duly justified with verifiable evidence. |
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall be based on objective criteria, and be triggered when any of the following conditions are met: indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge, including those originating from scientific peer-review open literature, and available monitoring data, gaps identified by the Authority during previous assessment, and shall act on requests from Member States. Where a Member State submits a request, the Commission shall act within 6 months. In case the Commission rejects the request by a Member State, it provides a duly justified and reasoned decision. |
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. |
| Inclusion in a work programme shall be limited to cases where robust scientific evidence suggests the need for a reassessment of the active substance. Targeted reassessment according to Article 18a of this Regulation shall be the standard approach for the review of active substances that have already been approved. |
The current system allocates excessive regulatory capacity to the repetitive assessment of previously reviewed data, which delays the evaluation of new scientific evidence and emerging risks. By adopting a targeted approach to reassessments, the Commission can optimize resource allocation, enhance procedural efficiency, and ensure that active substances on the market remain in strict compliance with safety standards.
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned take into account one or more of the following: indications on safety concerns for human or animal health or the environment, new scientific or technical knowledge, including from open literature, and available monitoring data, gaps identified by the Authority during previous assessment, and requests from Member States. Where a Member State submits a request, the Commission shall act on that request within a year. |
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall be based on, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge, including peer-reviewed open scientific literature, available monitoring data and uncertainties or data gaps identified by the Authority during previous evaluations, and shall include within 6 months all requests from Member States. |
Benoit Cassart, Gerben-Jan Gerbrandy, Olivier Chastel, Charles Goerens, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, including those based on scientific peer-reviewed open literature and information provided by the authorisation holders under Article 56. It shall take into account requests from Member States. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall take into account, among others, indications coming exclusively from the scientific sphere of safety concerns for human or animal health or the environment, new scientific or technical knowledge brought to the attention of the EFSA and available monitoring data and may take into account requests from Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data, gaps identified by the Authority during previous assessment and may take into account requests from Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall take into account broad indications of significant safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account applications from Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall take into account, broad-ranging indications of significant safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall take into account, among others, indications of significant safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall take into account broad-ranging indications of significant safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall take into account broad-ranging indications of significant safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall take into account broad-ranging indications of significant safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and may take into account requests from Member States. | The identification of the active substances concerned shall take into account, among others, indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data and shall take into account requests from Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. | The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 6 months after amendments to the approval criteria set out in Annex II relevant for these active substances , in case indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data or safety gaps were identified, or when updated data requirements or guidance documents relevant for these active substances become applicable. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. | The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 6 months after amendments to the approval criteria set out in Annex II relevant for these active substances, in case indications of safety concerns for human or animal health or the environment, new scientific or technical knowledge and available monitoring data or safety gaps were identified or when updated data requirements or guidance documents relevant for these active substances become applicable. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. | The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable if, as a result of the update, doubts arise as to whether the approval criteria are still met. |
The amendment clarifies the purpose of the update of the guidance. An update of methodologies should not automatically trigger the adoption of an implementing act. Such action should be considered only where the updated methodology raises doubts as to whether the approval criteria continue to be fulfilled. This ensures a proportionate and evidence-based approach while providing legal certainty for all parties concerned.
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. | The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable in case of the indication of safety concerns. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. | The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable in case of indication of safety concerns. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. | The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable in case of indication of safety concerns. |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. | The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable in case of indication of safety concerns. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. | The Commission may adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. | The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest one year after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. | The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 1 year after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 3 years after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. | The Commission shall adopt an implementing act identifying all relevant active substances, as referred to in the first subparagraph, at the latest 1 year after amendments to the approval criteria set out in Annex II relevant for these active substances, or when updated data requirements or guidance documents relevant for these active substances become applicable. |
| Text proposed by the Commission | Amendment |
|---|---|
| Inclusion in a work programme pursuant to this Article shall be limited to cases where broad scientific evidence indicates the need for a comprehensive reassessment of the active substance. Targeted reassessment pursuant to Article 18a shall be the standard approach for the review of approved active substances. |
The current review system dedicates substantial regulatory resources to the repeated assessment of previously evaluated information, limiting the capacity to address new scientific evidence and emerging concerns in a timely manner. Making targeted reassessments the standard approach enables resources to be focused where they are most relevant, improving efficiency and effectively ensuring that active substances placed on the market continue to meet the required safety standards.
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 |
|---|---|
| (b) list the rapporteur and co-rapporteur Member States; | (b) list the rapporteur and co-rapporteur Member States or the Authority if applicable; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) set deadlines for the submission of applications for renewal of the approval of the active substances concerned that allow sufficient time for the generation of the necessary data and the submission of the said applications; and | (c) set deadlines for the submission of applications for renewal of the approval of the active substances concerned applications for renewal shall be submitted by a producer of the active substance to a Member State, with a simultaneous copy to the Commission, to all other Member States and to the Authority, no later than three years after the adoption of the implementing act. Applications submitted after that deadline shall be deemed inadmissible and. approval shall expire immediately; and |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) set deadlines for the submission of applications for renewal of the approval of the active substances concerned that allow sufficient time for the generation of the necessary data and the submission of the said applications; and | (c) set deadlines for the submission of applications for renewal of the approval of the active substances concerned that allow sufficient time for the generation of the necessary data and the submission of the said applications; |
| Applications for renewal shall be submitted by a producer to a Member State, with a copy to the Commission, to the other Member States and to the Authority, no later than three years after implementing act is adopted. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) set deadlines for the submission of applications for renewal of the approval of the active substances concerned that allow sufficient time for the generation of the necessary data and the submission of the said applications; and | (c) set deadlines for the submission of applications for renewal of the approval of the active substances concerned. |
| Applications for renewal shall be submitted by a producer of the active substance to a Member State, with a simultaneous copy to the Commission, to all other Member States and to the Authority, no later than three years after the adoption of the implementing act. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) set deadlines for the submission of applications for renewal of the approval of the active substances concerned that allow sufficient time for the generation of the necessary data and the submission of the said applications; and | (c) set deadlines for the submission of applications for renewal of the approval of the active substances concerned that allow sufficient time for the generation of the necessary data and the submission of the said applications, but not exceeding 12 months; and |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) specify which guidance documents are to be considered by applicants at the time of submission; and |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) specify which guidance documents are to be considered by applicants at the time of submission; and |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) specify which guidance documents are to be considered by applicants at the time of submission; and |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) specify which guidance documents are to be considered by applicants at the time of submission; and |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) set expiry dates for the approvals of the active substances concerned that allow sufficient time for the submission and evaluation of the applications and for the adoption of decisions on the renewal of the approval of the active substances concerned. | (d) set expiry dates for the approvals of the active substances concerned that allow sufficient time for the submission and evaluation of the applications and for the adoption of decisions on the renewal of the approval of the active substances concerned. Applications for renewal shall be submitted by a producer of the active substance to a Member State, with a simultaneous copy to the Commission, to all other Member States and to the Authority. |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) set expiry dates for the approvals of the active substances concerned that allow sufficient time for the submission and evaluation of the applications and for the adoption of decisions on the renewal of the approval of the active substances concerned. | (d) set expiry dates for the approvals of the active substances concerned that allow sufficient time for the submission and evaluation of the applications and for the adoption of decisions on the renewal of the approval of the active substances concerned, but not exceeding 18 months. |
| Text proposed by the Commission | Amendment |
|---|---|
| (11) A new Article 18a is inserted: | deleted |
| ‘Article 18a | |
| Work programme for targeted reassessment of active substances | |
| 1. The Commission may initiate a targeted reassessment of the approval of active substances at any time, to verify whether certain approval criteria or specific aspects thereof are, in light of current scientific and technical knowledge, still met. | |
| It may, after consulting the Authority, and in accordance with the procedure referred to in Article 79(3), adopt implementing acts identifying active substances or groups of active substances with limited or unlimited approval periods for targeted reassessment. | |
| The identification of the active substances concerned shall be based on the same criteria as laid down in Article 18(1). | |
| 2. The implementing acts referred to in paragraph 1 shall: | |
| (a) list the active substances concerned; | |
| (b) list the rapporteur and co-rapporteur Member States; | |
| (c) set out the scope of the targeted reassessment for the active substances concerned, and indicate the specific data requirements that apply and, where relevant, the guidance documents and/or scientific opinions that shall be used; and | |
| (d) set deadlines for the submission of the required information for the active substances concerned that allow sufficient time for the generation of the necessary data and the submission of the information. | |
| 3. Where the Commission concludes that compliance with the relevant approval criteria covered by the targeted reassessment is demonstrated, it shall adopt an implementing act, confirming the approval, where applicable with conditions and restrictions in accordance with Article 6, in accordance with the procedure referred to in Article 79(3). | |
| 4. Where the information referred to in paragraph 2 point (d) has not been provided within the time period established, the Commission shall adopt an implementing act withdrawing the approval in accordance with the procedure referred to in Article 79(3). | |
| Where the Commission concludes that the approval criteria covered by the targeted reassessment are no longer satisfied, it shall adopt an implementing act withdrawing the approval in accordance with the procedure referred to in Article 79(3). In case the derogation set out in Article 4(7) applies, that implementing act may amend the approval. | |
| 5. Articles 13(4), 17 and 20(2) shall apply.; ’ |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may initiate a targeted reassessment of the approval of active substances at any time, to verify whether certain approval criteria or specific aspects thereof are, in light of current scientific and technical knowledge, still met. | The Commission shall initiate a targeted reassessment of the approval of active substances at any time, where new scientific evidence relevant to the approval criteria that has not previously been assessed indicates that one or more approval criteria, or specific aspects thereof, may no longer be fulfilledto verify whether certain approval criteria or specific aspects thereof are, in light of relevant scientific and technical knowledge, still met. |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may initiate a targeted reassessment of the approval of active substances at any time, to verify whether certain approval criteria or specific aspects thereof are, in light of current scientific and technical knowledge, still met. | The Commission may initiate a targeted reassessment of the approval of active substances at any time, to verify whether certain approval criteria or specific aspects thereof are, in light of current scientific and technical knowledge, still met. A targeted reassessment shall also be initiated at any time following a duly justified request from one or more Member States, or by the Authority. |
Decisions on targeted reassessment should not depend solely on the Commission's initiative. Member States should be able to request a reassessment where new scientific evidence gives rise to concerns, while the European Food Safety Authority should be able to formally alert the Commission where scientific developments indicate that an active substance may no longer meet the approval criteria. This strengthens the independence, transparency and scientific basis of the reassessment process.
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may initiate a targeted reassessment of the approval of active substances at any time, to verify whether certain approval criteria or specific aspects thereof are, in light of current scientific and technical knowledge, still met. | The Commission shall initiate a targeted reassessment without undue delay where there are reasonable grounds, based on scientific or technical knowledge, to conclude that the approval criteria may no longer be satisfied, and may in other cases initiate such reassessment after consulting the Authority. |
Benoit Cassart, Gerben-Jan Gerbrandy, Martin Hojsík, 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 |
|---|---|
| The Commission may initiate a targeted reassessment of the approval of active substances at any time, to verify whether certain approval criteria or specific aspects thereof are, in light of current scientific and technical knowledge, still met. | The Commission or following a request of a Member State may initiate a targeted reassessment of the approval of active substances at any time, to verify whether certain approval criteria or specific aspects thereof are, in light of current scientific and technical knowledge, still met. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Viktória Ferenc, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may initiate a targeted reassessment of the approval of active substances at any time, to verify whether certain approval criteria or specific aspects thereof are, in light of current scientific and technical knowledge, still met. | The Commission may initiate a targeted reassessment of the approval of active substances at any time, to verify whether certain approval criteria or specific aspects thereof are, in light of current scientific and technical knowledge brought to the attention of the EFSA, still met. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may initiate a targeted reassessment of the approval of active substances at any time, to verify whether certain approval criteria or specific aspects thereof are, in light of current scientific and technical knowledge, still met. | The Commission shall initiate targeted reassessments of the approval of active substances, and may do so at any time, to verify whether certain approval criteria or specific aspects thereof are, in light of current scientific and technical knowledge, still met. |
| Text proposed by the Commission | Amendment |
|---|---|
| It may, after consulting the Authority, and in accordance with the procedure referred to in Article 79(3), adopt implementing acts identifying active substances or groups of active substances with limited or unlimited approval periods for targeted reassessment. | It may, after consulting the Authority, and in accordance with the procedure referred to in Article 79(3), adopt implementing acts identifying active substances or groups of active substances with approval periods having a defined or undefined expiry date for targeted reassessment. |
| Text proposed by the Commission | Amendment |
|---|---|
| It may, after consulting the Authority, and in accordance with the procedure referred to in Article 79(3), adopt implementing acts identifying active substances or groups of active substances with limited or unlimited approval periods for targeted reassessment. | It may, after consulting the Authority, and in accordance with the procedure referred to in Article 79(3), adopt implementing acts identifying low-risk active substances or groups of active substances with limited or unlimited approval periods for targeted reassessment. |
| Text proposed by the Commission | Amendment |
|---|---|
| It may, after consulting the Authority, and in accordance with the procedure referred to in Article 79(3), adopt implementing acts identifying active substances or groups of active substances with limited or unlimited approval periods for targeted reassessment. | It shall, after consulting the Authority, and in accordance with the procedure referred to in Article 79(3), adopt implementing acts identifying active substances or groups of active substances with limited or unlimited approval periods for targeted reassessment. |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| It may, after consulting the Authority, and in accordance with the procedure referred to in Article 79(3), adopt implementing acts identifying active substances or groups of active substances with limited or unlimited approval periods for targeted reassessment. | The Commission may, after consulting the Authority, and in accordance with the procedure referred to in Article 79(3), adopt implementing acts identifying active substances or groups of active substances for targeted reassessment. |
| Text proposed by the Commission | Amendment |
|---|---|
| It may, after consulting the Authority, and in accordance with the procedure referred to in Article 79(3), adopt implementing acts identifying active substances or groups of active substances with limited or unlimited approval periods for targeted reassessment. | It shall, after consulting the Authority or at the request of Member States, and in accordance with the procedure referred to in Article 79(3), adopt implementing acts identifying active substances or groups of active substances for targeted reassessment. |
| Text proposed by the Commission | Amendment |
|---|---|
| It may, after consulting the Authority, and in accordance with the procedure referred to in Article 79(3), adopt implementing acts identifying active substances or groups of active substances with limited or unlimited approval periods for targeted reassessment. | It may, after consulting the Authority, and in accordance with the procedure referred to in Article 79(3), adopt implementing acts identifying active substances or groups of active substances with limited approval periods for targeted reassessment. |
| Text proposed by the Commission | Amendment |
|---|---|
| The targeted reassessment shall only look at the aspects identified by the scientific evidence. |
| Text proposed by the Commission | Amendment |
|---|---|
| The identification of the active substances concerned shall be based on the same criteria as laid down in Article 18(1). | The identification of the active substances concerned shall take into account the following: information notified by authorisation holders in accordance with Article 56; any other indications of safety concerns for human health, animal health or the environment; new scientific or technical knowledge; available monitoring data; and requests from Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. The targeted reassessment of an active substance shall be limited to the specific approval criteria, scientific concerns or new technical knowledge identified in the implementing act referred to in paragraph 1. Applicants shall only be required to submit data relevant to the scope of that reassessment. No comprehensive resubmission of data previously assessed shall be required unless duly justified on scientific grounds. |
The purpose of targeted reassessment is to focus regulatory resources on identified safety concerns and new scientific developments. Requiring applicants to resubmit complete dossiers would undermine the objective of simplification and create unnecessary administrative burden for authorities and applicants alike. The amendment therefore clarifies that data requests should be proportionate and limited to the specific issues under review, while fully preserving the possibility to request additional information where scientifically justified.
| Text proposed by the Commission | Amendment |
|---|---|
| (a) list the active substances concerned; | (a) list the active substances concerned ensuring that all relevant hazard and exposure pathways are covered in accordance with current scientific knowledge; |
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 |
|---|---|
| (b) list the rapporteur and co-rapporteur Member States; | (b) list the rapporteur and co-rapporteur Member States, or the Authority if applicable; |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| (c) set out the scope of the targeted reassessment for the active substances concerned, and indicate the specific data requirements that apply and, where relevant, the guidance documents and/or scientific opinions that shall be used; and | (c) set out the scope of the targeted reassessment for the active substances concerned, and indicate the specific data requirements that apply and, where relevant, the guidance documents and/or scientific opinions that shall be exclusively used; and |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) set out the scope of the targeted reassessment for the active substances concerned, and indicate the specific data requirements that apply and, where relevant, the guidance documents and/or scientific opinions that shall be used; and | (c) set out the scope of the targeted reassessment for the active substances concerned, and indicate the specific data requirements that apply and, where relevant, the guidance documents and/or scientific opinions that shall be used exclusively; and |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) set out the scope of the targeted reassessment for the active substances concerned, and indicate the specific data requirements that apply and, where relevant, the guidance documents and/or scientific opinions that shall be used; and | (c) set out the scope of the targeted reassessment for the active substances concerned, and indicate the specific data requirements that apply and, where relevant, the guidance documents and/or scientific opinions that shall be exclusively used; and |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) set deadlines for the submission of the required information for the active substances concerned that allow sufficient time for the generation of the necessary data and the submission of the information. | (d) set deadlines for the submission of the required information for the active substances concerned that allow sufficient time for the generation of the necessary data and the submission of the information, but not exceeding 12 months. |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) set deadlines for the submission of the required information for the active substances concerned that allow sufficient time for the generation of the necessary data and the submission of the information. | (d) set deadlines for the submission of the required information for the active substances concerned that allow sufficient time for the generation of the necessary data and the submission of the information, the cost of which shall be borne by the applicant. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. Active substances, safeners and synergists may not be subject to concurrent targeted reviews at the same time. |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. Active substances, safeners and synergists may not be subject to concurrent targeted reviews at the same time. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the information referred to in paragraph 2 point (d) has not been provided within the time period established, the Commission shall adopt an implementing act withdrawing the approval in accordance with the procedure referred to in Article 79(3). | Where the information referred to in paragraph 2 point (d) has not been provided within the time period established, the Commission shall within 6 months adopt an implementing act withdrawing the approval in accordance with the procedure referred to in Article 79(3) within 6 months. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the information referred to in paragraph 2 point (d) has not been provided within the time period established, the Commission shall adopt an implementing act withdrawing the approval in accordance with the procedure referred to in Article 79(3). | Where the information referred to in paragraph 2 point (d) has not been provided within the time period established, the Commission shall adopt an implementing act within 6 months withdrawing the approval in accordance with the procedure referred to in Article 79(3). |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the information referred to in paragraph 2 point (d) has not been provided within the time period established, the Commission shall adopt an implementing act withdrawing the approval in accordance with the procedure referred to in Article 79(3). | Where the information referred to in paragraph 2 point (d) has not been provided within the time period established, the Commission shall adopt an implementing act within 6 months withdrawing the approval in accordance with the procedure referred to in Article 79(3). |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the information referred to in paragraph 2 point (d) has not been provided within the time period established, the Commission shall adopt an implementing act withdrawing the approval in accordance with the procedure referred to in Article 79(3). | Where the information referred to in paragraph 2 point (d) has not been provided within the time period established, the Commission shall without delay adopt an implementing act withdrawing the approval in accordance with the procedure referred to in Article 79(3). |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the Commission concludes that the approval criteria covered by the targeted reassessment are no longer satisfied, it shall adopt an implementing act withdrawing the approval in accordance with the procedure referred to in Article 79(3). In case the derogation set out in Article 4(7) applies, that implementing act may amend the approval. | Where the Commission concludes that the approval criteria covered by the targeted reassessment are no longer satisfied, it shall within 6 months adopt an implementing act withdrawing the approval in accordance with the procedure referred to in Article 79(3) within 6 months. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the Commission concludes that the approval criteria covered by the targeted reassessment are no longer satisfied, it shall adopt an implementing act withdrawing the approval in accordance with the procedure referred to in Article 79(3). In case the derogation set out in Article 4(7) applies, that implementing act may amend the approval. | Where the Commission concludes that the approval criteria covered by the targeted reassessment are no longer satisfied, it shall adopt an implementing act withdrawing the approval in accordance with the procedure referred to in Article 79(3) within 6 months. In case the derogation set out in Article 4(7) applies, that implementing act may amend the approval. |
| Text proposed by the Commission | Amendment |
|---|---|
| Where the Commission concludes that the approval criteria covered by the targeted reassessment are no longer satisfied, it shall adopt an implementing act withdrawing the approval in accordance with the procedure referred to in Article 79(3). In case the derogation set out in Article 4(7) applies, that implementing act may amend the approval. | Where the Commission concludes that the approval criteria covered by the targeted reassessment are no longer satisfied, it shall without delay adopt an implementing act withdrawing the approval in accordance with the procedure referred to in Article 79(3). In case the derogation set out in Article 4(7) applies, that implementing act may amend the approval. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. No later than one year after the entry into force of this Regulation, and every year thereafter, the Commission shall submit a report to the European Parliament and to the Council stating whether the average time needed to complete procedures for the approval and authorisation of biocontrol substances and plant protection products containing such substances, completed during the previous calendar year under Regulation (EC) No 1107/2009, is three years or less. | |
| If the report concludes that the average time needed to complete those approval and authorisation procedures exceeds three years, the Commission shall identify the main remaining obstacles and set out in its next annual work programme the measures it intends to take to reduce the average time needed to complete those procedures to three years or less. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. The prioritisation of work programmes shall be based on transparent, scientifically sound criteria. Re-evaluations of individual active substances must not be carried out unless justified by new scientific evidence or changes in exposure conditions. The prioritisation must be disclosed to Member States and stakeholders. Synthetic and biological active substances shall be treated on an equal footing. |
The Commission’s proposal does not establish clear requirements for the re-evaluation process. As a result, it fails to provide regulatory certainty and may give rise to inconsistent decision-making. To reduce administrative burden and promote harmonisation, it is therefore essential to establish a clear and transparent framework for the re-evaluation of individual active substances.
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. In Article 18a the following paragraph 5a is added: | |
| The prioritisation of the work programme is carried out according to transparent and scientifically comprehensible criteria. Re-evaluations of individual active substances must not be carried out unless new scientific evidence or changing exposure conditions are duly justifying such actions. The prioritisation shall be disclosed to Member States and relevant stakeholders. Chemically synthetic and biological active ingredients are to be treated on equal footing. |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. Article 43 shall apply from the date of the adoption of the implementing act following targeted reassessment for plant protection product containing the active substance, safener, or synergist concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5a. Article 43 shall apply from the date of the adoption of the implementing act following targeted reassessment for plant protection product containing the active substance, safener, or synergist concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| An implementing act, adopted in accordance with the procedure referred to in Article 79(3), shall set out the provisions necessary for the implementation of the renewal procedure and of the targeted reassessment procedure, as provided for in this Subsection 3.; | The Commission shall adopt an implementing act in accordance with the procedure referred to in Article 79(3), setting out the provisions necessary for the implementation of the renewal procedure and of the targeted reassessment procedure, as provided for in this Subsection 3.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (13) in Article 20, paragraph 2 is replaced by the following: | deleted |
| ‘2. The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | |
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.;’ |
Gerben-Jan Gerbrandy, Martin Hojsík, Sigrid Friis, Karin Karlsbro, Michal Wiezik, Yvan Verougstraete
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period. |
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 |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. The Member States may consult the European Food Safety Authority for its opinion on the granting of a grace period as part of the risk assessment process. |
Decisions on granting grace periods should be supported by the best available scientific evidence. Allowing Member States to consult the European Food Safety Authority where appropriate strengthens the scientific basis of risk assessments while preserving flexibility in the decision-making process.
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a minimum and maximum grace periods that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That minimum grace period shall not be less than 12 months. That maximum grace period shall normally not exceed 2 years for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. |
Justification:The period of grace should be extended to 3 years in all cases when withdrawing or amending authorisations for PPP as a result of the Regulation., avoiding vague definition as “reasonable means” and for finding adequate effective alternative solution thus preventing losses of revenue for farmers and ensuring food security for consumers.To avoid fragmentation of the EU market due to unequal access to PPP for farmers depending on the Member State, Member States shall set and apply the same maximum grace period as set out by the Regulation adopted by the Commission.
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed two years for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of 18 months for the disposal, storage, and use of existing stocks of the plant protection products concerned. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed two years for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed two year for the sale and distribution, and in addition a maximum of one years for the disposal, storage, and use of existing stocks of the plant protection products concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 1 year for the sale and distribution, and in addition a maximum of 18 months for the disposal, storage, and use of existing stocks of the plant protection products concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 2 years for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 2 years for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. |
In line with the announcement in the Vision for Agriculture and Food, increasing the maximum overall length of grace periods to 3 years would allow for an alternative plant protection product to be authorized, if necessary, thus preventing losses of revenue for farmers and ensuring food security for consumers. Therefore, this grace period should not only be extended for cases where there are no other available reasonable, but in all cases in general (when withdrawing or amending authorisations for PPP as a result of the Regulation).
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed one year for the sale and distribution, and in addition a maximum of 18 months for the disposal, storage, and use of existing stocks of the plant protection products concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed one year for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall not exceed 3 months for the sale and distribution, and in addition a maximum of 6 months for the disposal, storage, and use of existing stocks of the plant protection products concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall normally not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. | The Regulation referred to in paragraph 1 shall provide for a maximum grace period that the Member States may set when withdrawing or amending authorisations for plant protection products as a result of that Regulation. That maximum grace period shall not exceed 6 months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| For the purposes of this paragraph, the lack of adequate alternatives shall be assessed by the Member State taking into account: | |
| a) the number of authorised plant protection products available for the same use (per specific crop and active substance); | |
| b) the characteristics of the crops concerned, including whether they are secondary crops; and | |
| c) the time required to obtain an approval for alternative products. | |
| Member States shall inform the Commission of their assessment. At the request of the Member States, the Commission shall promote a harmonised assessment. |
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | deleted |
The Commission proposal would allow grace periods of up to one year for sale and distribution and a further two years for disposal, storage and use where alternatives are considered unavailable. A total period of three years is excessive after the non-renewal or withdrawal of an active substance and could prolong exposure of farmers, consumers and ecosystems to products that no longer satisfy Union approval requirements. The existing maximum period of six months for sale and distribution and one additional year for disposal, storage and use already provides sufficient time to manage stocks and identify alternatives. Where a substance raises health or environmental concerns, the grace period should remain as short as technically necessary.
Carmen Crespo Díaz, Esther Herranz García, Juan Ignacio Zoido Álvarez, Susana Solís Pérez, Dolors Montserrat
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period. | The Regulation referred to in paragraph 1 shall provide for a minimum and maximum grace period to apply when withdrawing or amending authorisations for plant protection products as a result of that Regulation. |
| Where there are no other available reasonable, authorised, effective, commercially obtainable or economically viable means are available for the affected crop or to control the pest or disease concerned in the relevant Member States, the minimum grace period shall be 12 months for the sale and distribution of existing stocks and shall be mandatory for all Member States. | |
| The Regulation may also provide for a grace period of up to two years for the disposal, storage, and use of existing stocks. | |
| Within those limits, Member States may grant periods longer than the mandatory minimum, but may not provide for a grace period that is shorter than the mandatory minimum. | |
| Where there are immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non-renewal of the approval, the Regulation shall provide that no grace period may be granted. Assessment of the existence of alternatives shall take into account alternatives’ agronomic effectiveness, commercial availability, economic viability, cost to the farmer, suitability for climate and regional conditions, usability for resistance management and capacity to prevent severe production losses. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | The Regulation referred to in paragraph 1 shall lay down a minimum and a maximum grace period applicable where authorisations for plant protection products are withdrawn or amended as a result of that Regulation. |
| In case there are no other reasonable, authorised, effective, commercially available and economically viable means are available for the crop concerned or for the control of the pest or disease in question in the Member State concerned, the minimum grace period shall be twelve months for the sale and distribution of existing stocks and shall be mandatory for all Member States. | |
| The Regulation may also provide for a grace period of up to two years for the disposal, storage and use of existing stocks. | |
| Within these limits, Member States may grant periods longer than the mandatory minimum, but may not set a grace period shorter than that minimum. | |
| In case of immediate and serious risks to human or animal health or to the environment which have led to the withdrawal or non-renewal of authorisation, the Regulation shall provide that no grace period may be granted. The assessment of the availability of alternatives must take into account their agronomic efficacy, commercial availability, economic viability, cost to the farmer, suitability to climatic and regional conditions, usefulness for resistance management and ability to prevent serious production losses. |
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; |
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; |
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non-renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States shall not set a grace period. |
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non-renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States shall not set a grace period.; |
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States shall not set a grace period.; |
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | In case the reasons for not renewing the approval are that the substance does not satisfy the criteria set out in points 3.6.3, 3.6.4, 3.6.5, 3.8, 3.7 or 3.10 of Annex II, the Regulation referred to in paragraph 1 shall provide that the Member States shall not set a grace period.’; |
The amendment accompanies the proposal to ban the 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 |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | Where the reasons for not renewing the approval do not concern the protection of health or the environment, the Regulation referred to in paragraph 1 shall provide for a grace period not exceeding six months for the sale and distribution, and in addition a maximum of one year for the disposal, storage, and use of existing stocks of the plant protection products concerned. The grace period for the sale and distribution shall take into account the normal period of use of the plant protection product but the total grace period shall not exceed 18 months. |
| In the case of a withdrawal of the approval or if the approval is not renewed because of the immediate concerns for human health or animal health or the environment, the plant protection products concerned shall be withdrawn from the market immediately. |
Extending the maximum grace period from 18 months to 3 years significantly prolongs potential citizen exposure to substances whose approval has not been renewed. The amendment restores the existing 18-month maximum framework, which already provides operators and Member States with sufficient time to adapt.
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | In case there are no other effective, viable and available alternatives to plant protection products containing the active substance concerned, the maximum grace period shall not exceed an initial period of one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period. In the absence of effective and viable alternatives at the end of the initial grace period, that period may be renewed once. |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | In case there are no other available reasonable means other than the plant protection products containing the active substance concerned, and provided that the continued use of the active substance does not pose unacceptable or immediate risks to human health, animal health or the environment, the maximum grace period shall not exceed six months for the sale and distribution, and, in addition, one year for the disposal, storage and use of existing stocks of the plant protection products concerned. In case of immediate or long-term concerns for human health, animal health or the environment that led to a withdrawal or non-renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; |
Grace periods should remain strictly limited and should not prolong the use of active substances where this could compromise the protection of human health, animal health or the environment. Any derogation should be genuinely exceptional, limited in duration and subject to clear safety conditions.
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall normally not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States set shorter grace periods or that member states may not set a grace period; |
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | In case the authorisation of active substance is not renewed, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; |
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | In case the authorisation of active substance is not renewed, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; |
| Text proposed by the Commission | Amendment |
|---|---|
| In case there are no other available reasonable means to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; | In case there are no other available reasonable means or alternatives to plant protection products containing the active substance concerned, the maximum grace period shall not exceed one year for the sale and distribution, and in addition a maximum of two years for the disposal, storage, and use of existing stocks of the plant protection products concerned. In case of immediate and serious concerns for human health or animal health or the environment that led to a withdrawal or non -renewal of the approval, the Regulation referred to in paragraph 1 shall provide that the Member States may not set a grace period.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. The following paragraph 2a (new) is added: | |
| ‘2a. Where the plant protection product concerned is used for secondary crops within the meaning of Article 51 and no alternative product has been authorised for the same use, the maximum transitional period for the disposal, storage and use of existing stocks referred to in this paragraph shall be at least three years, unless there are direct and serious concerns relating to human health, animal health or the environment.’ |
| Present text | Amendment |
|---|---|
| (13a) Article 21 paragraph 1 is replaced by the following: | |
| 1. The Commission may review the approval of an active substance at any time. It shall take into account the request of a Member State to review, in the light of new scientific and technical knowledge and monitoring data, the approval of an active substance, including where, after the review of the authorisations pursuant to Article 44(1), there are indications that the achievement of the objectives established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC is compromised. | ‘The Commission may review the approval of an active substance at any time. It shall act within 3 months on the request of one or several Member States to review, in the light of new scientific and technical knowledge and monitoring data, the approval of an active substance, including where, after the review of the authorisations pursuant to Article 44(1), there are indications that the achievement of the objectives established in accordance with Article 4(1)(a) and (b) and Article 7(2) and (3) of Directive 2000/60/EC is compromised. |
| The Authority shall be mandated in any case to provide scientific and technical assistance on the review of the approval. | |
| Where, in the light of new scientific and technical knowledge it considers that there are indications that the substance no longer satisfies the approval criteria provided for in Article 4, or further information required in accordance with Article 6(f) has not been provided, it shall inform the Member States, the Authority and the producer of the active substance, setting a period for the producer to submit its comments. | Where, in the light of new scientific, technical knowledge and monitoring data it considers that there are indications that the substance no longer satisfies the approval criteria provided for in Article 4, or further information required in accordance with Article 6(f) has not been provided, it shall inform the Member States, the Authority and the producer of the active substance, setting a period for the producer to submit its comments.’ |
Original text refers specifically to Articles 4(1)(a)(iv) and (b)(i); these are now broadened to 4(1)(a) and (b) to strengthen compliance with the WFD and to ensure that action must be taken when an active substance breaches WFD norms.
| Present text | Amendment |
|---|---|
| (13a) In Article 21, paragraph 1, subparagraph 1 is replaced by the following: | |
| 1. The Commission may review the approval of an active substance at any time. It shall take into account the request of a Member State to review, in the light of new scientific and technical knowledge and monitoring data, the approval of an active substance, including where, after the review of the authorisations pursuant to Article 44(1), there are indications that the achievement of the objectives established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC is compromised. | "1. The Commission may review the approval of an active substance at any time, and shall immediately do so when there are indications that approval criteria provided for in Article 4 are no longer met. It shall without delay act on a request of a Member State to review, in the light of new scientific and technical knowledge and monitoring data, the approval of an active substance, including where, after the review of the authorisations pursuant to Article 44(1), there are indications that the achievement of the objectives established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC and Articles 7, 8, 9 and 13 (8) of Directive 2020/2184 EU is compromised. For the purpose of this paragraph, the Commission shall take into account peer-reviewed scientific literature and monitoring data." |
| Present text | Amendment |
|---|---|
| (13a) in Article 21, paragraph 1, subparagraph 1 is amended as follows: | |
| 1. The Commission may review the approval of an active substance at any time. It shall take into account the request of a Member State to review, in the light of new scientific and technical knowledge and monitoring data, the approval of an active substance, including where, after the review of the authorisations pursuant to Article 44(1), there are indications that the achievement of the objectives established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC is compromised. | "1. The Commission may review the approval of an active substance at any time. The Commission shall review the approval of an active substance at the request of a Member State where, in the light of new scientific and technical knowledge and monitoring data, including where, after the review of the authorisations pursuant to Article 44(1), there are indications that the achievement of the objectives established in accordance with Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC is compromised. |
| Present text | Amendment |
|---|---|
| (13b) In Article 21, paragraph 3 is replaced by the following: | |
| 3. Where the Commission concludes that the approval criteria provided for in Article 4 are no longer satisfied, or the further information required in accordance with Article 6(f) has not been provided, a Regulation to withdraw or amend the approval shall be adopted in accordance with the regulatory procedure referred to in Article 79(3). | "3. Where the Commission concludes that the approval criteria provided for in Article 4 are no longer satisfied, or the further information required in accordance with Article 6(f) has not been provided, a Regulation to withdraw or amend the approval shall be adopted without delay in accordance with the regulatory procedure referred to in Article 79(3)." |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Sakis Arnaoutoglou, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| 1. An active substance complying with the criteria provided for in Article 4 and in point 5 of Annex II shall be approved as a low-risk active substance. | 1. An active substance complying with the criteria provided for in Article 4 and in point 5 of Annex II shall be approved for a period not exceeding 20 years by way of derogation from Article 5, where it is considered a low-risk active substance and where it may be expected that plant protection products containing that substance will pose only a low risk to human and animal health and the environment as provided for in Article 47(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. An active substance complying with the criteria provided for in Article 4 and in point 5 of Annex II shall be approved as a low-risk active substance. | 1. An active substance complying with the criteria provided for in Article 4 shall be approved for a period not exceeding 15 years by way of derogation from Article 5, where it is considered a low-risk active substance where it may be expected that plant protection products containing that substance will pose only a low risk to human and animal health and the environment as provided for in Article 47(1). |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Articles 4 to 21 shall apply. Low-risk active substances shall be listed separately in the Regulation referred to in Article 13(4).; | 2. Articles 4 to 21 shall apply. Low-risk active substances shall be listed separately in the Regulation referred to in Article 13(4), indicating, where appropriate, whether they also constitute biocontrol active substances in addition to being low-risk substances. The list shall also continue to specifically identify, in line with Commission Implementing Regulation (EU) No 540/2011 and the format currently used in the EU Pesticides Database, low-risk active substances, basic substances and substances considered candidates for substitution. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Articles 4 to 21 shall apply. Low-risk active substances shall be listed separately in the Regulation referred to in Article 13(4).; | 2. Articles 4 and 6 to 21 and point 5 of Annex II shall apply. Low-risk active substances active substances shall be listed separately in the Regulation referred to in Article 13(4).; |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. An active substance complying with the criteria provided for in Article 4 shall be approved for an unlimited period by way of derogation from Article 5 where it is considered a low-risk active substance. |
| Text proposed by the Commission | Amendment |
|---|---|
| (14a) A new Article 22a is added : | |
| Article 22a (new) | |
| Low risk biocontrol | |
| 1. Biocontrol active substances shall be assessed using data requirements, assessment methodologies and risk assessment principles that are proportionate and scientifically adapted to their biological origin, mode of action and expected exposure. | |
| 2. The assessment referred to in paragraph 1 shall ensure a high level of protection of human and animal health and the environment, while taking into account the specific characteristics of biocontrol active substances and avoiding unnecessary testing requirements that are not scientifically justified. | |
| 3. A biocontrol active substance that, following the assessment referred to in paragraph 1, fulfils the criteria laid down in Article 22 may be classified as a low-risk active substance and shall benefit from the approval regime provided for in Article 5(a). | |
| 4. The Commission shall, by means of implementing acts adopted in accordance with the examination procedure referred to in Article 79(3), in consultation with the European Food Safety Authority, establish and periodically update detailed technical guidelines, data requirements and assessment methodologies referred to in paragraph 1. The first set of implementing acts shall be adopted within 12 months of the entry into force of this Regulation. | |
| 5. The Commission shall, within 12 months of the entry into force of this Regulation, by means of implementing acts, adopted in accordance with the examination procedure referred to in Article 79(3), in consultation with the European Food Safety Authority define the subcategory of low-risk biocontrol substances. A low riks bicontrol substance should be supported by scientific evidence demonstrating that, under its intended conditions of use, it presents negligible risk to human health, non-target organisms, and the environment, while providing effective pest or disease control. The substance should also exhibit characteristics consistent with a low-risk profile, such as limited persistence, high target specificity where relevant, and no unacceptable adverse ecological effects. | |
| 6. An active substance complying with the criteria provided for in Article 4 shall be approved for an unlimited period by way of derogation from Article 5 where it is considered a low-risk biocontrol active substance. |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the use of the basic substance in a product consisting of the basic substance and of, as applicable, a simple diluent, other basic substances or substances necessary to stabilise the product. | (b) the use of the basic substance in a product consisting of the basic substance and of, as applicable, a simple diluent, other basic substances or substances necessary to stabilise the product. Such products shall not contain any co-formulants listed in Annex III; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the use of the basic substance in a product consisting of the basic substance and of, as applicable, a simple diluent, other basic substances or substances necessary to stabilise the product. | (b) the use of the basic substance in a product consisting of the basic substance and of, as applicable, a simple diluent, or substances necessary solely to preserve the physical stability of the product and which do not modify its hazard profile or efficacy. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) Any product containing a basic substance with a composition not complying with point (b) of the first subparagraph shall be considered as a plant protection product and shall require an authorisation in accordance with Chapter III. | (c) If a registered active substance qualifies by definition as a basic substance, it shall be included in the catalogue of basic substances and simultaneously removed from the list of active substances. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the basic substance is not a substance of concern or the hazard classification of the substance in accordance with Regulation (EC) No 1272/2008 does not apply to the product in which it is approved for use; | (a) the basic substance is not a substance of concern; |
Restores the current Article 23 standard and avoids allowing hazardous substances merely because the final formulation is not classified.
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the basic substance is not a substance of concern or the hazard classification of the substance in accordance with Regulation (EC) No 1272/2008 does not apply to the product in which it is approved for use; | (a) the basic substance is not a substance of concern; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the basic substance or the product in which it is used does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects; | (b) the basic substance does not have an inherent capacity to cause endocrine disrupting, neurotoxic or immunotoxic effects; |
The concept of "inherent capacity" relates to the intrinsic properties of the active substance. Extending it to the product creates legal ambiguity and is inconsistent with the substance-based hazard assessment underpinning Regulation (EC) No 1107/2009.
| Text proposed by the Commission | Amendment |
|---|---|
| (c) is not an approved active substance for use in plant protection products at the time of the submission of the application for approval as basic substance and no application for an approval as an active substance is under assessment at that moment; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) is not an approved active substance for use in plant protection products at the time of the submission of the application for approval as basic substance and no application for an approval as an active substance is under assessment at that moment; | (c) is not predominantly used for plant protection purposes but nevertheless is useful in plant protection either directly or in a product consisting of the substance and a simple diluent; and |
this change from the Commission looks only at the regulatory status of the substance, not what it is actually used for; corrected here
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (c) is not an approved active substance for use in plant protection products at the time of the submission of the application for approval as basic substance and no application for an approval as an active substance is under assessment at that moment; | (c) if a registered active substance qualifies by definition as a basic substance, it shall be included in the catalogue of basic substances and simultaneously removed from the list of active substances; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) is not an approved active substance for use in plant protection products at the time of the submission of the application for approval as basic substance and no application for an approval as an active substance is under assessment at that moment; | (c) if a registered active substance qualifies by definition as a basic substance, it shall be included in the catalogue of basic substances and simultaneously removed from the list of active substances; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) If a registered active substance qualifies by definition as a basic substance, it shall be included in the catalogue of basic substances and simultaneously removed from the list of active substances |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) the basic substance or the product in which it is used has neither immediate or delayed harmful effects in human health, including that of vulnerable groups, or animal health, nor unacceptable effects on the environment, arising from its use(s) for plant protection purposes.; | (d) the basic substance or the product in which it is used has neither immediate or delayed harmful effects in human health, including that of vulnerable groups, or animal health, nor unacceptable effects on the environment.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (da) the approval of the basic substance shall not circumvent the authorisation requirements applicable to plant protection products under Chapter III. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. For the purpose of this Regulation, an active substance which fulfils the criteria of a ‘foodstuff’ as defined in Article 2 of Regulation (EC) No 178/2002 shall be considered as a basic substance. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Commission shall ask the Authority for an opinion or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within 3 months of the date of the request. | 2. The Commission shall ask the Authority for an opinion or for scientific or technical assistance. The Authority shall provide its opinion or the results of its work to the Commission within a maximum of 60 days of the date of the request. |
Timely access to safe and effective biocontrols is critical for farmers and mitigation of pest risks. Reducing the opinion period from three months to 60 days ensures swift regulatory processing without compromising scientific rigour, provided adequate resources are allocated. This facilitates faster market access and aligns with stakeholder calls for accelerated procedures
Gheorghe Cârciu, Biljana Borzan, Dan Nica, Ştefan Muşoiu, Vasile Dîncu, Andi Cristea, Dragoş Benea, Gabriela Firea
| Text proposed by the Commission | Amendment |
|---|---|
| 4. The approval shall cover all approved uses of the basic substances and any product containing it as specified under Article 23a without being limited by the uses applied for. The approval shall be for an unlimited period and Articles 59 to 62 shall not apply. | 4. The approval shall cover all approved uses of the basic substances and any product containing it as specified under Article 23a without being limited by the uses applied for. The approval shall be for an unlimited period and Articles 59 to 62 shall not apply. The Commission shall publish and update a publicly accessible register of all approved uses covered by each basic substance approval. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. The approval shall cover all approved uses of the basic substances and any product containing it as specified under Article 23a without being limited by the uses applied for. The approval shall be for an unlimited period and Articles 59 to 62 shall not apply. | 4. The approval shall cover all approved uses of the basic substances and any product containing it as specified under Article 23a without being limited by the uses applied for. The approval shall be for a period without a defined expiry date and Articles 59 to 62 shall not apply. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. The approval shall cover all approved uses of the basic substances and any product containing it as specified under Article 23a without being limited by the uses applied for. The approval shall be for an unlimited period and Articles 59 to 62 shall not apply. | 4. The approval shall cover all approved uses of the basic substances and any product containing it as specified under Article 23a. The approval shall be for an unlimited period and Articles 59 to 62 shall not apply. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. The approval shall cover all approved uses of the basic substances and any product containing it as specified under Article 23a without being limited by the uses applied for. The approval shall be for an unlimited period and Articles 59 to 62 shall not apply. | 4. The approval shall cover only the uses of the basic substances evaluated and approved pursuant to paragraphs 1 to 3, as specified under Article 23(1). The approval shall be for an unlimited period and Articles 59 to 62 shall not apply. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where a substance approved as a basic substance is subsequently also approved as an active substance that is not a basic substance, that approval shall not affect the existing approval as a basic substance, as well as the placing on the market and use as basic substance or product as refer to in Article 23(1). | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where a substance approved as a basic substance is subsequently also approved as an active substance that is not a basic substance, that approval shall not affect the existing approval as a basic substance, as well as the placing on the market and use as basic substance or product as refer to in Article 23(1). | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may review the approval of a basic substance at any time. It may take into account the request of a Member State to review the approval. | The Commission may review the approval of a basic substance at any time. It shall take into account the request of a Member State to review the approval. |
| Text proposed by the Commission | Amendment |
|---|---|
| The Commission may review the approval of a basic substance at any time. It may take into account the request of a Member State to review the approval. | The Commission may review the approval of a basic substance at any time. It shall take into account the request of a Member State to review the approval. |
| Text proposed by the Commission | Amendment |
|---|---|
| 8. Basic substances and products referred to in Article 23(1) may be labelled as “Products containing (a) basic substance(s) for plant protection”. In such case the label shall contain clear indications about their allowed use for plant protection. | 8. Basic substances and products referred to in Article 23(1) may be labelled as “Products containing (a) basic substance(s) for plant protection”. In such case the label shall contain clear indications about their allowed use for plant protection including any restrictions and conditions laid down in the approval. |
| Text proposed by the Commission | Amendment |
|---|---|
| 8. Basic substances and products referred to in Article 23(1) may be labelled as “Products containing (a) basic substance(s) for plant protection”. In such case the label shall contain clear indications about their allowed use for plant protection. | 8. Basic substances and products referred to in Article 23(1) should be labelled as “Products containing (a) basic substance(s) for plant protection”. In such case the label shall contain clear indications about their allowed use for plant protection. |
| Text proposed by the Commission | Amendment |
|---|---|
| (16a) a new Article 23b is inserted: | |
| Article 23b | |
| Evaluation and reporting | |
| No later than one year after the entry into force of this Regulation, and every year thereafter, the Commission shall submit a report to the European Parliament and to the Council stating whether the average time needed to complete procedures for the approval and authorisation of biocontrol substances and plant protection products containing such substances, completed during the previous calendar year under Regulation (EC) No 1107/2009, is three years or less. | |
| If the report concludes that the average time needed to complete those approval and authorisation procedures exceeds three years, the Commission shall identify the main remaining obstacles and set out in its next annual work programme the measures it intends to take to reduce the average time needed to complete those procedures to three years or less. |
| Present text | Amendment |
|---|---|
| (16a) in Article 24, the title and the first paragraph are replaced by the following: | |
| Article 24 | Article 24 |
| Candidates for substitution | Extension of approval of candidates for substitution |
| 1. An active substance complying with the criteria provided for in Article 4 shall be approved, for a period not exceeding seven years, as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II. By way of derogation from Article 14(2), the approval may be renewed once or more for periods not exceeding seven years. | 1. An active substance complying with the criteria provided for in Article 4 shall be approved, for a period not exceeding fifteen years, as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II. By way of derogation from Article 14(2), the approval may be renewed once or more for periods not exceeding fifteen years. |
| Present text | Amendment |
|---|---|
| (16a) Article 24(1) is amended as follows: | |
| 1. An active substance complying with the criteria provided for in Article 4 shall be approved, for a period not exceeding seven years, as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II. By way of derogation from Article 14(2), the approval may be renewed once or more for periods not exceeding seven years. | ‘1. An active substance complying with the criteria provided for in Article 4 shall be approved, for a period not exceeding seven years, as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II. By way of derogation from Article 14(2), the approval may be renewed once or more for periods not exceeding seven years. Any withdrawal or non-renewal of the authorisation of a substance under this substitution scheme will first have been justified by the presence of viable and effective alternatives, taking into account the impact on agricultural production.’ |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Present text | Amendment |
|---|---|
| (16a) In Article 24, paragraph 1 is replaced by the following: | |
| An active substance complying with the criteria provided for in Article 4 shall be approved, for a period not exceeding seven years, as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II. By way of derogation from Article 14(2), the approval may be renewed once or more for periods not exceeding seven years. | "An active substance complying with the criteria provided for in Article 4 shall be approved, for a period not exceeding fifteen years, as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II. By way of derogation from Article 14(2), the approval may be renewed once or more for periods not exceeding fifteen years on the basis of a socio-economic and agro-economic assessment including for instance efficacy, impact of pests on farmers yield, and risks for cross- resistance." |
| Present text | Amendment |
|---|---|
| (16a) In Article 24, paragraph 1 is replaced by the following: | |
| 1. An active substance complying with the criteria provided for in Article 4 shall be approved, for a period not exceeding seven years, as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II. By way of derogation from Article 14(2), the approval may be renewed once or more for periods not exceeding seven years. | "1. An active substance complying with the criteria provided for in Article 4 shall be approved, for a period not exceeding three years, as a candidate for substitution if it meets one or more of the additional criteria laid down in point 4 of Annex II. By way of derogation from Article 14(2), the approval may be renewed once for a period not exceeding two years." |
| Text proposed by the Commission | Amendment |
|---|---|
| (16a) In Article 24, the following paragraph is added: | |
| '2a. When assessing alternatives, particular account shall be taken of integrated pest management, biological control methods and non-chemical alternatives.' |
| Present text | Amendment |
|---|---|
| (16a) in Article 24, following paragraph 2a is inserted: | |
| ‘2a. When assessing alternatives, particular account shall be taken of integrated pest management, biological control methods and non-chemical alternatives.’ |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (16b) In Article 24, the following paragraph 2a is added: | |
| '2a. Before withdrawing or not renewing the approval of an active substance approved as a candidate for substitution, the Commission shall assess whether alternative substances or methods are available that provide an equivalent level of effectiveness and are economically viable for farmers. Such an assessment shall take into account agronomic needs, the availability of alternatives across different climatic zones, and the potential impacts on agricultural production.' |
| Present text | Amendment |
|---|---|
| (16a) In Article 27, the following paragraph is added: | |
| '4a. Substances of natural origin whose approval as active substances has not been renewed for reasons other than unacceptable risks to human or animal health or to the environment shall not be precluded from being used as co-formulants solely on the basis of such non-renewal, provided that they: (a) are not classified as carcinogenic, mutagenic or toxic for reproduction pursuant to Regulation (EC) No 1272/2008; (b) do not meet the criteria for being persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB); and (c) are not included in the list of unacceptable co-formulants referred to in paragraph 2.' |
Not all non-renewed active substances were withdrawn because of safety concerns. Some natural substances lost approval for procedural, data-related or other reasons but are today treated the same as substances found to pose unacceptable risks. For instance, natural repellents based on fish oil or sheep fat remain available, whereas crude tall oil and tall oil pitch are excluded despite no final finding of unacceptable risk. The amendment would allow a case-by-case assessment while maintaining existing safety standards.
| Text proposed by the Commission | Amendment |
|---|---|
| (16b) In Article 27, a new paragraph 5a is added: | |
| Within one year of the entry into force of this Regulation, the Commission shall, in accordance with the regulatory procedure referred to in Article 79(3), establish data requirements for co-formulants. These data requirements shall be equivalent in scope and rigour to those applicable to active substances, adapted as appropriate to the specific properties and uses of co-formulants. |
| Text proposed by the Commission | Amendment |
|---|---|
| (17) a new Article 27a is inserted: | deleted |
| ‘Article 27a | |
| Approval periods of already granted approvals | |
| 1. For all active substances approved at the latest on (…) [OP please insert the date of entry into force of this Regulation], approvals shall be deemed unlimited in time, except for: | |
| (a) active substances identified as candidates for substitution in accordance with Article 24; | |
| (b) active substances approved under Article 4(7); | |
| (c) active substances for which the submission of an application for renewal under Article 15(1) was required before [OP: please insert the date of entry into force of this Regulation] but was not submitted before the deadline referred to in Article 15(1); | |
| (d) active substances for which a procedure for the renewal of approval is ongoing on [OP: please insert the date of entry into force of this Regulation]. | |
| 2. The Commission shall amend the Regulation referred to in Article 78(3) in accordance with the first paragraph.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (17) a new Article 27a is inserted: | deleted |
| ‘Article 27a | |
| Approval periods of already granted approvals | |
| 1. For all active substances approved at the latest on (…) [OP please insert the date of entry into force of this Regulation], approvals shall be deemed unlimited in time, except for: | |
| (a) active substances identified as candidates for substitution in accordance with Article 24; | |
| (b) active substances approved under Article 4(7); | |
| (c) active substances for which the submission of an application for renewal under Article 15(1) was required before [OP: please insert the date of entry into force of this Regulation] but was not submitted before the deadline referred to in Article 15(1); | |
| (d) active substances for which a procedure for the renewal of approval is ongoing on [OP: please insert the date of entry into force of this Regulation]. | |
| 2. The Commission shall amend the Regulation referred to in Article 78(3) in accordance with the first paragraph.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (17) a new Article 27a is inserted: | deleted |
| ‘Article 27a | |
| Approval periods of already granted approvals | |
| 1. For all active substances approved at the latest on (…) [OP please insert the date of entry into force of this Regulation], approvals shall be deemed unlimited in time, except for: | |
| (a) active substances identified as candidates for substitution in accordance with Article 24; | |
| (b) active substances approved under Article 4(7); | |
| (c) active substances for which the submission of an application for renewal under Article 15(1) was required before [OP: please insert the date of entry into force of this Regulation] but was not submitted before the deadline referred to in Article 15(1); | |
| (d) active substances for which a procedure for the renewal of approval is ongoing on [OP: please insert the date of entry into force of this Regulation]. | |
| 2. The Commission shall amend the Regulation referred to in Article 78(3) in accordance with the first paragraph.;’ |
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 |
|---|---|
| (17) a new Article 27a is inserted: | deleted |
| ‘Article 27a | |
| Approval periods of already granted approvals | |
| 1. For all active substances approved at the latest on (…) [OP please insert the date of entry into force of this Regulation], approvals shall be deemed unlimited in time, except for: | |
| (a) active substances identified as candidates for substitution in accordance with Article 24; | |
| (b) active substances approved under Article 4(7); | |
| (c) active substances for which the submission of an application for renewal under Article 15(1) was required before [OP: please insert the date of entry into force of this Regulation] but was not submitted before the deadline referred to in Article 15(1); | |
| (d) active substances for which a procedure for the renewal of approval is ongoing on [OP: please insert the date of entry into force of this Regulation]. | |
| 2. The Commission shall amend the Regulation referred to in Article 78(3) in accordance with the first paragraph.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (17) a new Article 27a is inserted: | deleted |
| ‘Article 27a | |
| Approval periods of already granted approvals | |
| 1. For all active substances approved at the latest on (…) [OP please insert the date of entry into force of this Regulation], approvals shall be deemed unlimited in time, except for: | |
| (a) active substances identified as candidates for substitution in accordance with Article 24; | |
| (b) active substances approved under Article 4(7); | |
| (c) active substances for which the submission of an application for renewal under Article 15(1) was required before [OP: please insert the date of entry into force of this Regulation] but was not submitted before the deadline referred to in Article 15(1); | |
| (d) active substances for which a procedure for the renewal of approval is ongoing on [OP: please insert the date of entry into force of this Regulation]. | |
| 2. The Commission shall amend the Regulation referred to in Article 78(3) in accordance with the first paragraph.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (17) a new Article 27a is inserted: | deleted |
| ‘Article 27a | |
| Approval periods of already granted approvals | |
| 1. For all active substances approved at the latest on (…) [OP please insert the date of entry into force of this Regulation], approvals shall be deemed unlimited in time, except for: | |
| (a) active substances identified as candidates for substitution in accordance with Article 24; | |
| (b) active substances approved under Article 4(7); | |
| (c) active substances for which the submission of an application for renewal under Article 15(1) was required before [OP: please insert the date of entry into force of this Regulation] but was not submitted before the deadline referred to in Article 15(1); | |
| (d) active substances for which a procedure for the renewal of approval is ongoing on [OP: please insert the date of entry into force of this Regulation]. | |
| 2. The Commission shall amend the Regulation referred to in Article 78(3) in accordance with the first paragraph.;’ |
Automatically converting existing time-limited approvals into approvals of unlimited duration would exempt a large number of substances from systematic reassessment and create a two-tier system between substances already on the market and future applicants. Existing substances must continue to be assessed against evolving scientific standards, particularly where their original evaluation did not cover current criteria concerning endocrine disruption, cumulative exposure, effects on pollinators, biodiversity or water resources. Transitional provisions should ensure legal certainty for pending procedures, but should not result in the permanent extension of existing approvals.
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 |
|---|---|
| 1. For all active substances approved at the latest on (…) [OP please insert the date of entry into force of this Regulation], approvals shall be deemed unlimited in time, except for: | deleted |
| (a) active substances identified as candidates for substitution in accordance with Article 24; | |
| (b) active substances approved under Article 4(7); | |
| (c) active substances for which the submission of an application for renewal under Article 15(1) was required before [OP: please insert the date of entry into force of this Regulation] but was not submitted before the deadline referred to in Article 15(1); | |
| (d) active substances for which a procedure for the renewal of approval is ongoing on [OP: please insert the date of entry into force of this Regulation]. |
This approach preserves legal certainty for existing approvals while ensuring a smooth transition to the renewed approval system. It avoids automatically converting existing approvals into unlimited approvals and maintains periodic scientific reassessment in line with the precautionary principle.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. For all active substances approved at the latest on (…) [OP please insert the date of entry into force of this Regulation], approvals shall be deemed unlimited in time, except for: | 1. For low-risk active substances and low-risk biocontrol active substances approved at the latest on (…) [OP please insert the date of entry into force of this Regulation], approvals shall be deemed unlimited in time. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. For all active substances approved at the latest on (…) [OP please insert the date of entry into force of this Regulation], approvals shall be deemed unlimited in time, except for: | 1. For all basic substances and biocontrol active substances approved at the latest on (…) [OP please insert the date of entry into force of this Regulation], approvals shall be deemed unlimited in time. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. For all active substances approved at the latest on (…) [OP please insert the date of entry into force of this Regulation], approvals shall be deemed unlimited in time, except for: | 1. For all active substances approved at the latest on (…) [OP please insert the date of entry into force of this Regulation], approvals shall be deemed to have an undefined expiry date, except for: |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) active substances identified as candidates for substitution in accordance with Article 24; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) active substances approved under Article 4(7); | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) active substances for which the submission of an application for renewal under Article 15(1) was required before [OP: please insert the date of entry into force of this Regulation] but was not submitted before the deadline referred to in Article 15(1); | deleted |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (d) active substances for which a procedure for the renewal of approval is ongoing on [OP: please insert the date of entry into force of this Regulation]. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) active substances for which a procedure for the renewal of approval is ongoing on [OP: please insert the date of entry into force of this Regulation]. | (d) active substances for which a procedure for the renewal of approval is ongoing on [OP: please insert the date of entry into force of this Regulation] and the draft assessment report or the previous approval decision suggest possible non-compliance with Article 14 (2) (a-c) as amended by [OP: please insert the reference of this Regulation]. |
| If these conditions are not met, approval for an unlimited period shall be granted and the active substances shall be considered with priority for the work programmes according to Articles 18 and 18a as amended by [OP: please insert the reference of this Regulation]. |
Persistent backlogs in renewal procedures continue to impede farmers' access to essential innovations and will take years to resolve, despite the welcomed move toward unlimited approvals . This amendment optimizes regulatory oversight by prioritising finalized assessments for substances where concerns are identified, while managing other cases through the existing work programme. This approach ensures a comprehensive safety overview while focusing finite resources on substantiated, science-based risks.
| Text proposed by the Commission | Amendment |
|---|---|
| (d) active substances for which a procedure for the renewal of approval is ongoing on [OP: please insert the date of entry into force of this Regulation]. | (d) active substances for which a procedure for the renewal of approval is ongoing on [OP: please insert the date of entry into force of this Regulation]. |
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 |
|---|---|
| 1. Active substances approved before [OP: please insert the date of entry into force of this Regulation] shall remain approved until the expiry date laid down in their current approval. | |
| 2. Upon renewal, the approval periods referred to in Articles 5 and 14 shall apply. | |
| 3. Active substances for which a procedure for the renewal of approval is ongoing on [OP: please insert the date of entry into force of this Regulation] shall continue to be assessed and renewed in accordance with the provisions applicable before that date until the renewal procedure has been completed. |
This approach preserves legal certainty for existing approvals while ensuring a smooth transition to the renewed approval system. It avoids automatically converting existing approvals into unlimited approvals and maintains periodic scientific reassessment in line with the precautionary principle.
| Present text | Amendment |
|---|---|
| Article 2a | |
| Article 28 is replaced by the following: | |
| Article 28 Authorisation for placing on the market and use 1. A plant protection product shall not be placed on the market or used unless it has been authorised in the Member State concerned in accordance with this Regulation. 2. By way of derogation from paragraph 1, no authorisation shall be required in the following cases: (a) use of products containing exclusively one or more basic substances; (b) placing on the market and use of plant protection products for research or development purposes in accordance with Article 54; (c) production, storage or movement of a plant protection product intended for use in another Member State, provided that the product is authorised in that Member State and that the Member State of production, storage or movement has put in place inspection requirements to ensure that the plant protection product is not used in its territory; (d) production, storage or movement of a plant protection product intended for use in a third country provided that the Member State of production, storage or movement has put in place inspection requirements to ensure that the plant protection product is exported from its territory; (e) placing on the market and use of plant protection products for which a parallel trade permit has been granted in accordance with Article 52. | ‘Article 28 Authorisation for placing on the market and use 1. A plant protection product shall not be placed on the market or used unless it has been authorised in the zone concerned in accordance with this Regulation. 2. By way of derogation from paragraph 1, no authorisation shall be required in the following cases: |
| (a) use of products containing exclusively one or more basic substances; | |
| (b) placing on the market and use of plant protection products for research or development purposes in accordance with Article 54; | |
| (c) production, storage or movement of a plant protection product intended for use in another zone, provided that the product is authorised in another zone and that the Member States of the respective zone of production, storage or movement have put in place inspection requirements to ensure that the plant protection product is not used in the respective territories; | |
| (d) production, storage or movement of a plant protection product intended for use in a third country provided that the Member States of the respective zone of production, storage or movement have put in place inspection requirements to ensure that the plant protection product is exported from the respective territory; | |
| (e) placing on the market and use of plant protection products for which a parallel trade permit has been granted in accordance with Article 52.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) placing on the market and use of basic substances or products referred to in Article 23(1).; | (a) use of products containing exclusively basic substances approved in accordance with Article 23(1).; |
| Text proposed by the Commission | Amendment |
|---|---|
| (aa) point (d) is deleted. |
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 |
|---|---|
| (b) the following point (f) is added: | deleted |
| ‘(f) placing on the market and use of seeds and other plant reproductive material treated with plant protection products authorised for that use in at least one Member State.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the following point (f) is added: | deleted |
| ‘(f) placing on the market and use of seeds and other plant reproductive material treated with plant protection products authorised for that use in at least one Member State.;’ |
Coating of seeds and other material, and its subsequent emission in the environment can have detrimental effect on the quality and health of soil, on soil organisms and pollinators nesting in the ground. It also influences water quality. Member States should therefore retain their discretion to decide on the placing on the market and use of seeds and other material treated with coating, especially when synthetic products are used.
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 |
|---|---|
| (f) placing on the market and use of seeds and other plant reproductive material treated with plant protection products authorised for that use in at least one Member State.; | deleted |
Seed treatment may pose risks to human health and the environment that depend on national agronomic and environmental conditions. Exempting treated seeds from the authorisation requirement where the plant protection product has been authorised in only one Member State would weaken national risk management and could undermine the high level of protection required by this Regulation.
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (f) placing on the market and use of seeds and other plant reproductive material treated with plant protection products authorised for that use in at least one Member State.; | (f) treatment of seeds, placing on the market and use of treated seeds and other plant reproductive material treated with plant protection products authorised for that use in at least one Member State.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) the following point (fa) is added: | |
| '(fa) the introduction and use of a plant protection product for the purpose of the treatment of seeds or other plant reproductive material in the professional treatment facilities of that Member State, provided that such plant protection product is authorised for such use in at least one Member State and is not placed on the market or used for any other purpose in the Member State of introduction.' |
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) the following point (fa) is added: | |
| '(fa) the introduction and use of a plant protection product for the purpose of the treatment of seeds or other plant reproductive material in the professional treatment facilities of that Member State, provided that such plant protection product is authorised for such use in at least one Member State and is not placed on the market or used for any other purpose in the Member State of introduction.' |
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) The following point (fa) is added: | |
| '(fa) the introduction and use of a plant protection product for the purpose of the treatment of seeds or other plant reproductive material in the professional treatment facilities of that Member State, provided that such plant protection product is authorised for such use in at least one Member State and is not placed on the market or used for any other purpose in the Member State of introduction.' |
| Present text | Amendment |
|---|---|
| (18a) In Article 29, paragraph 3 is replaced by the following: | |
| 3. Compliance with the requirements set out in point (b) and points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used. | '3. Compliance with the requirements referred to in paragraph 1, point (b) and points (e) to (h), shall be established by means of official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product concerned, and representative of the conditions prevailing in the area where the product is to be used, including a risk assessment based on the availability of risk management measures with particular regard to application techniques. |
| Member States shall take into account all available risk mitigation measures when assessing whether the requirements are met. Where the intended area of use of a plant protection product includes biogeographical regions with specific pedoclimatic conditions not represented in the tests conducted by the rapporteur Member State, supplementary efficacy and risk data collected under the conditions of those regions shall be required as part of the authorisation dossier. Such supplementary data shall be taken into account in the authorisation decision and in any mutual recognition procedure under Article 40. | |
| This requirement applies in particular to biogeographical regions present in only one Member State of the Union, where specific pedoclimatic stress conditions, including elevated temperatures, drought periods or endemic soil pest pressure, may significantly affect product performance and efficacy compared to the conditions under which the standard tests were conducted.' |
| Present text | Amendment |
|---|---|
| (18a) Article 29, paragraph 3 is replaced by the following: | |
| 3. Compliance with the requirements set out in point (b) and points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used. | 3. Compliance with the requirements set out in point (b) and points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used. |
| Where the intended area of use of a plant protection product includes biogeographical regions with specific pedoclimatic conditions not represented in the tests conducted by the rapporteur Member State, supplementary efficacy and risk data collected under the conditions of those regions shall be required as part of the authorisation dossier. | |
| Such supplementary data shall be taken into account in the authorisation decision and in any mutual recognition procedure under Article 40. This requirement applies in particular to biogeographical regions present in only one Member State of the Union, where specific pedoclimatic stress conditions — including elevated temperatures, drought periods or pressure from endemic soil pests — may significantly affect product performance and efficacy compared to the conditions under which the standard tests were conducted. |
| Present text | Amendment |
|---|---|
| (18a) Article 29, paragraph 3 is replaced by the following | |
| 3. Compliance with the requirements set out in point (b) and points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used. | "3. Compliance with the requirements referred to in paragraph 1, point (b) and points (e) to (h), shall be established by means of official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product concerned, and representative of the conditions prevailing in the area where the product is to be used, including a risk assessment based on the availability of risk management measures with particular regard to application techniques. |
| Member States shall take into account all available risk mitigation measures when assessing whether the requirements are met. | |
| Where the intended area of use of a plant protection product includes biogeographical regions with specific pedoclimatic conditions not represented in the tests conducted by the rapporteur Member State, supplementary efficacy and risk data collected under the conditions of those regions shall be required as part of the authorisation dossier. Such supplementary data shall be taken into account in the authorisation decision and in any mutual recognition procedure under Article 40. | |
| This requirement applies in particular to biogeographical regions present in only one Member State of the Union, where specific pedoclimatic stress conditions — including elevated temperatures, drought periods or endemic soil pest pressure — may significantly affect product performance and efficacy compared to the conditions under which the standard tests were conducted." |
| Present text | Amendment |
|---|---|
| (18a) In Article 29, paragraph 3 is replaced by the following: | |
| 3. Compliance with the requirements set out in point (b) and points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used. | 3. Compliance with the requirements referred to in paragraph 1, point (b) and points (e) to (h), shall be established by means of official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product concerned, and representative of the conditions prevailing in the area where the product is to be used, including a risk assessment based on the availability of risk management measures with particular regard to application techniques. |
| Present text | Amendment |
|---|---|
| In article 29, paragraph 3 is replaced by the following: | |
| 3. Compliance with the requirements set out in point (b) and points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used. | ‘3. Compliance with the requirements set out in point (b) and points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used, including a risk assessment based on the availability of risk management measures with particular regard to application techniques.’ |
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 |
|---|---|
| (18a) in Article 29, paragraph 3 is replaced by the following: | |
| 3. Compliance with the requirements set out in point (b) and points (e) to (h) of paragraph 1 shall be established by official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product in question and representative of the conditions prevailing in the zone where the product is intended to be used. | "3. Compliance with the requirements referred to in paragraph 1, point (b) and points (e) to (h), shall be established by means of official or officially recognised tests and analyses carried out under agricultural, plant health and environmental conditions relevant to the use of the plant protection product concerned, and representative of the conditions prevailing in the area where the product is to be used, including a risk assessment based on the availability of risk management measures with particular regard to application techniques.” |
the good practices and the 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.The requirement for Member States to consider ‘all available risk mitigation measures’ in the context of substance/products assessments should not give place to divergent interpretation among Member States, diverging outcomes of risk assessments, and unequal access to plant protection products for farmers among Member State. The implementation of all available risk mitigation measures by Member States should be harmonised
| Text proposed by the Commission | Amendment |
|---|---|
| In article 29, paragraph 3, a new subparagraph 1a is inserted: | |
| 1a. Where the intended area of use of a plant protection product includes biogeographical regions with specific pedoclimatic conditions, the applicant shall be required to submit supplementary efficacy data collected under the conditions of those regions as part of the authorisation dossier. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3a In Article 29, the following paragraph 3a is added: | |
| '3a. Where the intended area of use of a plant protection product includes biogeographical regions with specific pedoclimatic conditions not represented in the tests conducted by the rapporteur Member State, supplementary efficacy and risk data collected under the conditions of those regions shall be required as part of the authorisation dossier. Such supplementary data shall be taken into account in the authorisation decision and in any mutual recognition procedure under Article 40. This requirement applies in particular to biogeographical regions present in only one Member State of the Union, where specific pedoclimatic stress conditions — including elevated temperatures, drought periods or endemic soil pest pressure — may significantly affect product performance and efficacy compared to the conditions under which the standard tests were conducted. ' |
The proposed amendment corrects a structural flaw in the zonal authorization framework (Annex I and Art. 3(17) of Regulation No 1107/2009), which artificially groups Member States with radically different pedoclimatic conditions, such as Romania and Germany, into the same Zone B. Although Art. 29(3) mandates "representative" testing, internal macro-zone heterogeneity leaves unique ecosystems, like the Romanian Steppe, unrepresented in standard dossiers. This measure safeguards the principle of evidence-based substitution within Integrated Pest Management (IPM): a substance cannot be validly substituted if its alternative has not been evaluated under specific local conditions.
| Text proposed by the Commission | Amendment |
|---|---|
| In article 29, the following paragraph 6a is added: | |
| '6a. By way of derogation from paragraph 1, in case of serious danger to plant and/or human health, active substance may be autorised if not approving the active substance would have a disproportionate negative impact on the viability of agriculture, forestry, public green areas, natural areas, etc. compared to the risks to human health, animal health, or the environment arising from the use of the substance.' |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| In Article 29 the following paragraph 6a is added: | |
| 6a. By way of derogation from paragraph 1, a plant protection product may be authorised where not authorising the product would result in disproportionate negative impacts on the viability of agriculture, compared to the risks to human health, animal health or the environment arising from the use of the plant protection product under the conditions set out in the authorisation. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (18a) In Article 29, the following paragraph 6a is added: | |
| '6a. By way of derogation from paragraph 1, a plant protection product may be authorised where not authorising the product would result in disproportionate negative impacts on the viability of agriculture, compared to the risks to human health, animal health or the environment arising from the use of the plant protection product under the conditions set out in the authorisation.' |
| Text proposed by the Commission | Amendment |
|---|---|
| (18b) in Article 29 the folowwing paragraph 6a is added: | |
| 6a. By way of derogation from paragraph 1, a plant protection product may be authorised where not authorising the product would result in disproportionate negative impacts on the viability of agriculture, compared to the risks to human health, animal health or the environment arising from the use of the plant protection product under the conditions set out in the authorisation." |
| Text proposed by the Commission | Amendment |
|---|---|
| (18b) in Article 29 a new paragraph 6a is inserted: | |
| Agriculture viability requirement to authorisation | |
| By way of derogation from paragraph 1, a plant protection product may be authorised where not authorising the product would result in disproportionate negative impacts on the viability of agriculture, compared to the risks to human health, animal health or the environment arising from the use of the plant protection product under the conditions set out in the authorisation. |
| Present text | Amendment |
|---|---|
| Article 30 is replaced by the following: | |
| Article 30 Provisional authorisations 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding 3 years, the placing on the market of plant protection products containing an active substance not yet approved, provided that: (a) the decision on approval could not be finalised within a period of 30 months from the date of admissibility of the application, extended by any additional period set in accordance with Article 9(2), Article 11(3) or Article 12(2) or (3); and (b) pursuant to Article 9 the dossier on the active substance is admissible in relation to the proposed uses; and (c) the Member State concludes that the active substance can satisfy the requirements of Article 4(2) and (3) and that the plant protection product may be expected to satisfy the requirements of Article 29(1)(b) to (h); and (d) maximum residue levels have been established in accordance with Regulation (EC) No 396/2005. (2) In such cases the Member State shall immediately inform the other Member States and the Commission of its assessment of the dossier and of the terms of the authorisation, giving at least the information provided for in Article 57(1). | ‘Article 30 Provisional authorisations 1. By way of derogation from Article 29(1)(a), the respective zones may authorise for a provisional period not exceeding 3 years, the placing on the market of plant protection products containing an active substance not yet approved, provided that: |
| (a) the decision on approval could not be finalised within a period of 30 months from the date of admissibility of the application, extended by any additional period set in accordance with Article 9(2), Article 11(3) or Article 12(2) or (3); and | |
| (b) pursuant to Article 9 the dossier on the active substance is admissible in relation to the proposed uses; and | |
| (c) the Member State of a zone concludes that the active substance can satisfy the requirements of Article 4(2) and (3) and that the plant protection product may be expected to satisfy the requirements of Article 29(1)(b) to (h); and | |
| (d) maximum residue levels have been established in accordance with Regulation (EC) No 396/2005. | |
| (2) In such cases the examining Member State shall immediately inform the other Member States of the same and other zone and the Commission of its assessment of the dossier and of the terms of the authorisation, giving at least the information provided for in Article 57(1).’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (19) Article 30 is replaced by the following: | (19) Article 30 is deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Provisional authorisations for plant protection products containing biocontrol active substances | Provisional authorisations for low-risk biocontrol products and plant protection products containing biocontrol active substances |
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 |
|---|---|
| Provisional authorisations for plant protection products containing biocontrol active substances | Provisional authorisations for plant protection products containing low-risk biocontrol active substances |
| Text proposed by the Commission | Amendment |
|---|---|
| Provisional authorisations for plant protection products containing biocontrol active substances | Provisional authorisations for plant protection products containing low risk biocontrol active substances |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| Provisional authorisations for plant protection products containing biocontrol active substances | Provisional authorisations for plant protection products |
| Text proposed by the Commission | Amendment |
|---|---|
| Provisional authorisations for plant protection products containing biocontrol active substances | Provisional authorisations for plant protection products |
Carmen Crespo Díaz, Juan Ignacio Zoido Álvarez, Susana Solís Pérez, Esther Herranz García, Dolors Montserrat
| Text proposed by the Commission | Amendment |
|---|---|
| Provisional authorisations for plant protection products containing biocontrol active substances | Provisional authorisations for plant protection products containing active substances not yet approved |
| Text proposed by the Commission | Amendment |
|---|---|
| Provisional authorisations for plant protection products containing biocontrol active substances | Provisional authorisations for plant protection products containing new active substances |
Biocontrol substances complement rather than replace conventional plant protection substances. In order to ensure that farmers have access to innovative solutions, the authorisation procedures, including provisional authorisation, for all innovative active substances, including biocontrols, should be accelerated.
| Text proposed by the Commission | Amendment |
|---|---|
| Provisional authorisations for plant protection products containing biocontrol active substances | Provisional authorisations for plant protection products containing active substances not yet approved |
The heading of the article on provisional authorisations changes from ‘products containing biocontrol active substances’ to ‘products containing active substances not yet approved’. The title thus reflects the broadening of scope set out in the subsequent amendment.
| Text proposed by the Commission | Amendment |
|---|---|
| Provisional authorisations for plant protection products containing biocontrol active substances | Provisional authorisations for plant protection products containing active substances |
To ensure the broadest availability of plant protection products, biocontrol or otherwise, provisional authorisations cannot be limited to PPPs containing biocontrol active substances.
| Text proposed by the Commission | Amendment |
|---|---|
| Provisional authorisations for plant protection products containing biocontrol active substances | Provisional authorisations for plant protection products containing active substances |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that | 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more active substances not yet approved, provided that the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); |
| The implementation of paragraph 1 shall not undermine the provisional authorisations for plant protection products containing an active substance not yet approved. |
Carmen Crespo Díaz, Dolors Montserrat, Esther Herranz García, Juan Ignacio Zoido Álvarez, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that | 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or several active substances not yet approved at the time authorisation was granted, provided that the dossier has been declared admissible, the draft assessment report has not identified any critical areas of concern and the conditions laid down in this Article are met: |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that | 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding 18 months from the approval of the active substance, the placing on the market of plant protection products containing one or more active substances not yet approved at the time when the authorization is granted, provided that: |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that | 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances or conventional plant protection products not yet approved, provided that |
Justificare:Extinderea perioadei autorizațiilor provizorii la cinci ani pentru produsele care conțin substanțe active de control biologic este binevenită. Totuși, limitarea acestei măsuri exclusiv la aceste produse poate crea un tratament inechitabil în cazul produselor convenționale aflate în proceduri de reînnoire prelungite la EFSA. În situațiile în care dosarul de reînnoire este complet depus, nu există dovezi științifice noi privind riscuri inacceptabile și nu sunt disponibile alternative eficiente, acordarea unei autorizații provizorii contribuie la asigurarea continuității protecției culturilor și la evitarea unor efecte negative asupra producției agricole și securității alimentare.
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that | 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more active substances not yet approved at the time when the authorization is granted, provided that |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that | 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more active substances which have not yet been approved at the time the authorisation is granted, provided that |
Een lidstaat mag een middel voorlopig toelaten zodra de werkzame stof de beoordeling van de rapporterende lidstaat positief heeft doorstaan, terwijl het definitieve EU-goedkeuringsbesluit nog loopt — en dat voor álle nieuwe stoffen, niet alleen biocontrole en laag-risico. De gevaarsgebaseerde uitsluitingen (CMR, hormoonverstoorders, POP/PBT) blijven onverkort gelden; twee identieke situaties zonder objectieve reden verschillend behandelen verhoudt zich slecht tot het gelijkheidsbeginsel en de evenredigheid, en botst met de technologieneutraliteit die de Commissie zelf nastreeft.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that | 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products not yet approved, provided that |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that | 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol or low-risk active substances not yet approved, provided that |
The limitation of provisional authorisations to biocontrol plant protection products may create an imbalance, given that certain low-risk substances may remain subject to lengthy renewal procedures at EFSA, potentially resulting in a lack of viable plant protection solutions for farmers. Therefore, it was proposed that the five-year provisional authorisation mechanism should also be available for low-risk substances where the renewal application has been duly submitted and is complete, no new scientific evidence indicating a risk has emerged, and no effective alternatives are available for the relevant uses.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that | 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding three years, the placing on the market of plant protection products containing one or more low-risk biocontrol active substances not yet approved, provided that |
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 |
|---|---|
| 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that | 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more low-risk biocontrol active substances not yet approved, provided that |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that | 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing active substances not yet approved, provided that |
Biocontrol substances complement rather than replace conventional plant protection substances. In order to ensure that farmers have access to innovative solutions, the authorisation procedures, including provisional authorisation, for all innovative active substances, including biocontrols, should be accelerated.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that | 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more active substances not yet approved, provided that |
Justification: the extension to 5 years of the provisional authorization period is proposed only for “biocontrol” a.s.. In the current 1107 Regulation it is 3 years for all the a.s.5 years should include all the a.s. otherwise the “conventional” PPPs would be excluded from the provisional authorization option
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that | 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more active substances not yet approved, provided that |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one or more biocontrol active substances not yet approved, provided that | 1. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period not exceeding five years, the placing on the market of plant protection products containing one low-risk substance not yet approved, provided that |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved biocontrol active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved biocontrol active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); | (a) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved low risk biocontrol active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); |
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) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved biocontrol active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); | (a) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved low-risk biocontrol active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); |
Mireia Borrás Pabón, Gilles Pennelle, Raffaele Stancanelli, Anne-Sophie Frigout, Jorge Buxadé Villalba
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved biocontrol active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); | (a) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved biocontrol active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); | (a) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved biocontrol active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); | (a) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved biocontrol active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); | (a) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved biocontrol active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); | (a) the dossier is admissible in accordance with Article 9 and the Rapporteur Member State has finalised the draft assessment report in accordance with Article 11 concluding that the not yet approved active substances in the plant protection product are expected to satisfy the requirements of Article 4(2) and Article 4(3); |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the Member State concludes that all active substances in the plant protection product comply with the criteria of point 5 of Annex II or qualify as biocontrol active substance and that the uses of the plant protection product for which provisional authorisations are granted satisfy the requirements of Article 29(1)(b) to (h); | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the Member State concludes that all active substances in the plant protection product comply with the criteria of point 5 of Annex II or qualify as biocontrol active substance and that the uses of the plant protection product for which provisional authorisations are granted satisfy the requirements of Article 29(1)(b) to (h); | (b) the Member State concludes that all active substances in the plant protection product comply with the criteria of point 5 of Annex II or qualify as low-risk biocontrol active substance in accordance with the criteria established under this Regulation and that the uses of the plant protection product for which provisional authorisations are granted satisfy the requirements of Article 29(1)(b) to (h); |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the Member State concludes that all active substances in the plant protection product comply with the criteria of point 5 of Annex II or qualify as biocontrol active substance and that the uses of the plant protection product for which provisional authorisations are granted satisfy the requirements of Article 29(1)(b) to (h); | (b) the Member State concludes that all active substances in the plant protection product comply with the criteria of point 5 of Annex II that the uses of the plant protection product for which provisional authorisations are granted satisfy the requirements of Article 29(1)(b) to (h); |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the Member State concludes that all active substances in the plant protection product comply with the criteria of point 5 of Annex II or qualify as biocontrol active substance and that the uses of the plant protection product for which provisional authorisations are granted satisfy the requirements of Article 29(1)(b) to (h); | (b) the Member State concludes that all active substances in the plant protection product comply with the criteria of point 5 of Annex II and qualify as biocontrol active substance and that the uses of the plant protection product for which provisional authorisations are granted satisfy the requirements of Article 29(1)(b) to (h); |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the Member State concludes that all active substances in the plant protection product comply with the criteria of point 5 of Annex II or qualify as biocontrol active substance and that the uses of the plant protection product for which provisional authorisations are granted satisfy the requirements of Article 29(1)(b) to (h); | (b) the Member State concludes that all active substances in the plant protection product comply with the criteria of point 5 of Annex II or qualify as and that the uses of the plant protection product for which provisional authorisations are granted satisfy the requirements of Article 29(1)(b) to (h); |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (c) where relevant, maximum residue levels have been established in accordance with Regulation (EC) No 396/2005. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) Provisional authorisations pursuant to this Article shall not be granted for plant protection products containing biocontrol active substances which have not been demonstrated to meet the criteria for low-risk biocontrol active substances, or where scientific evidence indicates that the substance may pose unacceptable risks to human or animal health or the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. By way of derogation from Article 29(1)(a), Member States may authorise for a provisional period of a minimum of three years, renewable for a period of two years at the end of the first provisional period of authorisation, the placing on the market of low-risk biocontrol products (hereinafter ‘the product’) not yet approved, provided that: | |
| (a) no CMR classification has been identified for the product; | |
| (b) no residue is left by the product in the marketed products; | |
| (c) the dossier has been submitted to and deemed complete by the Member State; | |
| (d) data on the toxicological and ecotoxicological profiles of the product and its substances are available; | |
| (e) the product does not present an unacceptable risk to human health and the environment in view of the available data and complies with the criteria set out in point 5 of Annex II, or can be considered a low-risk biocontrol product, and that the uses of the product for which provisional authorisations are granted satisfy the requirements of Article 29(1)(b) to (h); |
The 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 |
|---|---|
| 2a. The Member State shall process applications for provisional authorisation of low-risk biocontrol products within a maximum period of three months from the date of receipt of the complete dossier; after that period the provisional authorisation shall be deemed to have been approved. |
Connections
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Sources & citation
Where the facts on this page come from, and how to cite it.
- Data source
- Licensed CC BY 4.0.
- Retrieved
- 25 September 2026
Cite as
European Parliament (2026). “AMENDMENTS 533 - 826 - 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-791049. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/CJ14-AM-791049 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/CJ14-AM-791049 (CC BY 4.0).
BibTeX
@misc{epw-text-cj14-am-791049,
author = {{European Parliament}},
title = {{AMENDMENTS 533 - 826 - 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-791049}},
url = {https://news.eu-parl.st-solutions.dev/texts/CJ14-AM-791049},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. docId CJ14-AM-791049. Data: EP Open Data API: document record (CC BY 4.0)}
}