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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-791050 · COM(2025)1030 – C100359/2025 – 2025/0410(COD)
- Kind
- Amendment list CJ14-AM-791050
- 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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| Text proposed by the Commission | Amendment |
|---|---|
| 4. Following the approval of an active substance contained in a plant protection product for which a Member State has granted a provisional authorisation in accordance with this Article, the Member States may transform the provisional authorisation into an authorisation granted in accordance with Article 36, unless the conditions set in the approval require amendment of the provisional authorisation.; | 4. Following the approval of an active substance contained in a plant protection product for which a Member State has granted a provisional authorisation in accordance with this Article, the Member States may transform the provisional authorisation into an authorisation granted in accordance with Article 36, unless the conditions set in the approval require amendment of the provisional authorisation and provided that the approved active substance continues to fulfil the criteria for low-risk biocontrol active substances.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. Following the approval of an active substance contained in a plant protection product for which a Member State has granted a provisional authorisation in accordance with this Article, the Member States may transform the provisional authorisation into an authorisation granted in accordance with Article 36, unless the conditions set in the approval require amendment of the provisional authorisation. | 4. Following the approval of a low-risk biocontrol product or an active substance contained in a plant protection product for which a Member State has granted a provisional authorisation in accordance with this Article, the Member States may transform the provisional authorisation into an authorisation granted in accordance with Article 36, unless the conditions set in the approval require amendment of the provisional authorisation. |
The specific category of low-risk biocontrol products must allow products to be placed on the market more quickly and thus allow easier access for operators where the use of such products does not in effect present any chronic risk.
Carmen Crespo Díaz, Juan Ignacio Zoido Álvarez, Susana Solís Pérez, Esther Herranz García, Dolors Montserrat
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. Where the provisional authorisation expires before a definitive decision has been made on approval of the active substance at Union level, the Member State that granted that authorisation may extend it until such decision has been made, provided that no new risk or critical concern has been identified to human health, animal health or the environment. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. In Article 30 paragraph 4a (new) is added: | |
| 4a. Where the period of provisional authorisation for the relevant plant protection product has expired and a decision on the approval of the active substance has not yet been adopted, the Member States, which granted the provisional authorisation, may extend the provisional authorisation until an authorisation is granted as provided in paragraph 4. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. Where, upon expiry of the period of provisional authorisation for the plant protection product concerned, no decision has yet been adopted on the approval of the active substance, the Member State that granted the provisional authorisation may extend that authorisation until the plant protection product is authorised pursuant to paragraph 4. |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. Where a decision on the approval of the active substance has not yet been adopted when the period of provisional authorisation for the relevant plant protection product has expired, the Member States which granted the provisional authorisation may extend it until an authorisation is granted as provided in the paragraph 4 above. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4a. If, upon expiry of the provisional authorisation for the plant protection product concerned, no decision has yet been made on the approval of the active substance, the Member States that granted the provisional authorisation may extend it until authorisation as set out in paragraph 4 has been granted. |
If the provisional authorisation expires before the EU has made a decision on the substance, the Member State may extend that authorisation until such a decision has been reached. This will prevent situations in which a product disappears in the middle of the production season through no fault of the applicant; the decision remains discretionary.
| Text proposed by the Commission | Amendment |
|---|---|
| (19a) In Article 31, a new paragraph 3a is added: | |
| 3a. Plant protection products containing an active substance identified as a candidate for substitution pursuant to article 24 shall not be authorised for non-professional or non-agricultural uses. The requirements referred to in paragraph 2 shall set out those restrictions and such restrictions shall be indicated on the label. |
| Text proposed by the Commission | Amendment |
|---|---|
| (19a) in Article 31, paragraph 4, a new point (ia) is inserted: | |
| “(ia) where applicable, the specific conditions, application methods, and dosages for nursery production, ensuring that such parameters are proportionate to planting density and plant size, clearly distinguishing them from dosages for open-field crops.” |
The transition to digital farm records requires consistency between label instructions and field application. This amendment ensures legal certainty and avoids inappropriate dosages by distinguishing nursery-specific application methods and dosages from those for open-field crops.
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (19a) in Article 31, paragraph 4, a new point (ia) is inserted: | |
| "(ia) where applicable, the specific conditions, application methods, and dosages for nursery production, ensuring that such parameters are proportionate to planting density and plant size, clearly distinguishing them from dosages for open-field crops. " |
| Text proposed by the Commission | Amendment |
|---|---|
| (20) Article 32 is replaced by the following: | deleted |
| ‘Article 32 | |
| Duration | |
| 1. The period of authorisation shall be laid down in the authorisation. | |
| Without prejudice to Article 44, the duration of an authorisation shall be set for a period: | |
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | |
| (b) not exceeding 1 year from the earliest date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned. | |
| This period shall allow the examination as provided for in Article 43 to be carried out. | |
| 2. Authorisations may be granted for shorter periods to synchronise the re-evaluation of similar products for the purposes of a comparative assessment of products containing candidates for substitution as provided for in Article 50.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The period of authorisation shall be laid down in the authorisation. | deleted |
| Without prejudice to Article 44, the duration of an authorisation shall be set for a period: | |
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | |
| (b) not exceeding 1 year from the earliest date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned. | |
| This period shall allow the examination as provided for in Article 43 to be carried out. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The period of authorisation shall be laid down in the authorisation. | 1. The period of authorisation shall be laid down in the authorisation. Authorisations shall be valid for an unlimited time if the plant protection product concerned contains only active substances, safeners and synergists that have been approved for an unlimited time, and it has been assessed according to this Regulation considering the latest assessments underlying the approvals of the active substances, safeners and synergists contained in the product. Without prejudice to Article 44, the duration of an authorisation shall be set for a period not exceeding one year from the date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned and thereafter for as long as the active substances, safeners and synergists contained in the plant protection product are approved. This period shall allow the examination as provided for in Article 43 to be carried out. Where no expiry date is set for an active substance (approval for an unlimited time), the re-evaluation of the plant protection product shall take place no later than one year after the re-evaluation of the active substance. |
An authorisation will apply for an unlimited time if all components have been approved for an unlimited time and the product has been assessed on the basis of the most recent data; if the approval of a component expires, there will be a short bridging period before the re-evaluation. This avoids the need to periodically re-grant authorisations unnecessarily and ensures that the re-evaluation of safety remains linked to the re-evaluation of the substance.
| Text proposed by the Commission | Amendment |
|---|---|
| The period of authorisation shall be laid down in the authorisation. | The period of authorisation shall be laid down in the authorisation. |
| Authorizations shall be for an unlimited time if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval period, and it has been assessed according to this Regulation. considering the latest assessments underlying the approvals of the active substances, safeners, and synergists contained in the product. | |
| Without prejudice to Article 44, the duration of an authorisation shall be set for a period |
Justification: the authorization period for a PPP should be the same as set under art. 5 and 14 when it contains substances approved for unlimited time.It can facilitate the Chemical companies to submit authorization or re-authorization dossiers.Member States should dedicate their resources to evaluating applications for products and not to renewal procedures, as is currently the case. Therefore, not only approvals of active substances but also authorizations of plant protection products containing those active substances should be for unlimited in time.
| Text proposed by the Commission | Amendment |
|---|---|
| The period of authorisation shall be laid down in the authorisation. | The period of authorisation shall be laid down in the authorisation. Authorisations shall be set for unlimited time if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval period, and it has been assessed according to this Regulation considering the latest assessments underlying the approvals of the active substances, safeners, and synergists contained in the product. |
The limitation of (national) authorisations for plant protection products (PPPs) runs counter to the idea of reducing the administrative burden. If an active substance receives unlimited approval, a product containing said substance should also receive unlimited authorisation. Further, this doesn't infringe on the member states' recourse, as established in Article 1(4) of this Regulation 1107/2009. The suggested amendment would genuinely contribute to reducing bureaucracy and increasing efficiency for all Member States.
| Text proposed by the Commission | Amendment |
|---|---|
| The period of authorisation shall be laid down in the authorisation. | The period of authorisation shall be laid down in the authorisation. Authorisations shall be for an unlimited time if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval period, and it has been assessed according to this Regulation considering the latest assessments underlying the approvals of the active substances, safeners, and synergists contained in the product. |
| Text proposed by the Commission | Amendment |
|---|---|
| The period of authorisation shall be laid down in the authorisation. | The period of authorisation shall be laid down in the authorisation. Authorisations shall be for an unlimited time if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval period, and it has been assessed according to this Regulation considering the latest assessments underlying the approvals of the active substances, safeners, and synergists contained in the product. |
It would be inconsistent that, under the proposed framework, while active substances would be re-assessed on a risk-based basis, plant protection products would remain subject to mandatory periodic re-assessment at national level. That approach unnecessarily risks an inefficient use of the limited capacity of national authorisation authorities and may create practical implementation challenges. As a result, it could undermine the effective functioning of the system and, counterintuitively, risk lowering the overall level of protection.
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 |
|---|---|
| Without prejudice to Article 44, the duration of an authorisation shall be set for a period: | Without prejudice to Article 44, the duration of an authorisation shall be set for a period not exceeding 1 year from the date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product and thereafter for as long as the active substances, safeners and synergists contained in the plant protection product are approved. |
The Commission's amendment is a direct consequence of introducing unlimited approval periods for active substances. As approvals should remain time-limited and subject to periodic renewal, the existing rules on the duration of product authorisations should be maintained to ensure legal consistency with Articles 5 and 14.
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Pascal Canfin, Olivier Chastel, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| Without prejudice to Article 44, the duration of an authorisation shall be set for a period: | Without prejudice to Article 44, the duration of an authorisation shall be set for: |
| Text proposed by the Commission | Amendment |
|---|---|
| Without prejudice to Article 44, the duration of an authorisation shall be set for a period: | Without prejudice to Article 44, the duration of an authorisation shall be set for. |
The limitation of (national) authorisations for plant protection products (PPPs) runs counter to the idea of reducing the administrative burden. If an active substance receives unlimited approval, a product containing said substance should also receive unlimited authorisation. Further, this doesn't infringe on the member states' recourse, as established in Article 1(4) of this Regulation 1107/2009. The suggested amendment would genuinely contribute to reducing bureaucracy and increasing efficiency for all Member States.
| Text proposed by the Commission | Amendment |
|---|---|
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | deleted |
The limitation of (national) authorisations for plant protection products (PPPs) runs counter to the idea of reducing the administrative burden. If an active substance receives unlimited approval, a product containing said substance should also receive unlimited authorisation. Further, this doesn't infringe on the member states' recourse, as established in Article 1(4) of this Regulation 1107/2009. The suggested amendment would genuinely contribute to reducing bureaucracy and increasing efficiency for all Member States.
| Text proposed by the Commission | Amendment |
|---|---|
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | deleted |
It would be inconsistent that, under the proposed framework, while active substances would be re-assessed on a risk-based basis, plant protection products would remain subject to mandatory periodic re-assessment at national level. That approach unnecessarily risks an inefficient use of the limited capacity of national authorisation authorities and may create practical implementation challenges. As a result, it could undermine the effective functioning of the system and, counterintuitively, risk lowering the overall level of protection.
| Text proposed by the Commission | Amendment |
|---|---|
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, 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 |
|---|---|
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists, except for products containing solely low-risk active substances exerting biological control which authorisation shall be indefinite in time , or, |
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) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | (a) unlimited if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, and it has been assessed according to this Regulation considering the latest assessments underlying their approvals or, |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | (a) not exceeding 20 years if the plant protection product concerned contains only active substances, safeners, and synergists with approval periods that have no expiry date, or, |
Benoit Cassart, Gerben-Jan Gerbrandy, Pascal Canfin, Olivier Chastel, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | (a) an unlimited period only if the plant protection product concerned contains biocontrol or low-risk active substances and safeners with unlimited approval period. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | (a) not exceeding 30 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, |
A maximum authorisation period of 15 years is disproportionate where the active substance is approved for an indefinite period. However, unlimited product authorisations would not allow for periodic review of product-specific aspects. Extending the maximum period to 30 years strikes a balanced approach by reducing unnecessary administrative burden while ensuring periodic reassessment where appropriate.
| Text proposed by the Commission | Amendment |
|---|---|
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | (a) not exceeding 5 years if the plant protection product concerned contains only active substances, safeners, and synergists with limited approval periods, or, |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) not exceeding 15 years if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | (a) unlimited if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, |
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) not exceeding 1 year from the earliest date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) not exceeding 1 year from the earliest date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned. | (b) not exceeding 1 year from the date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned and thereafter for as long as the active substances, safeners and synergists contained in the plant protection product are approved |
| This period shall allow the examination as provided for in Article 43 to be carried out. |
Justification: PPP to be used for unmanned aircraft systems should be authorized the same at EU level or at less, at “zone” level, preventing an excessive fragmentation of the EU market.
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) not exceeding 1 year from the earliest date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned. | (b) not exceeding 1 year from the date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned and thereafter for as long as the active substances, safeners and synergists contained in the plant protection product are approved . |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) not exceeding 1 year from the earliest date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned. | (b) not exceeding 1 year from the date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned and thereafter for as long as the active substances, safeners and synergists contained in the plant protection product are approved. |
The limitation of (national) authorisations for plant protection products (PPPs) runs counter to the idea of reducing the administrative burden. If an active substance receives unlimited approval, a product containing said substance should also receive unlimited authorisation. Further, this doesn't infringe on the member states' recourse, as established in Article 1(4) of this Regulation 1107/2009. The suggested amendment would genuinely contribute to reducing bureaucracy and increasing efficiency for all Member States.
| Text proposed by the Commission | Amendment |
|---|---|
| (b) not exceeding 1 year from the earliest date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned. | (b) not exceeding 1 year from the date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned and thereafter for as long as the active substances, safeners and synergists contained in the plant protection product are approved. |
It would be inconsistent that, under the proposed framework, while active substances would be re-assessed on a risk-based basis, plant protection products would remain subject to mandatory periodic re-assessment at national level. That approach unnecessarily risks an inefficient use of the limited capacity of national authorisation authorities and may create practical implementation challenges. As a result, it could undermine the effective functioning of the system and, counterintuitively, risk lowering the overall level of protection.
Benoit Cassart, Gerben-Jan Gerbrandy, Pascal Canfin, Olivier Chastel, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (b) not exceeding 1 year from the earliest date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned. | (b) not exceeding 1 year from the earliest date of expiry of the approval of the active substances, safeners and synergists contained in the plant protection product concerned as long as the active substance is approuved. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) unlimited in duration for low-risk biocontrol products, subject to re-assessment if any risks to health or the environment are identified. |
The specific category of low-risk biocontrol products must allow products to be placed on the market more quickly and thus allow easier access for operators where the use of such products does not in effect present any chronic risk.
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Where no expiry date is set for an active substance (unlimited approval), the re-evaluation of the plant protection product should take place no later than one year after the re-evaluation of the active substance. |
The limitation of (national) authorisations for plant protection products (PPPs) runs counter to the idea of reducing the administrative burden. If an active substance receives unlimited approval, a product containing said substance should also receive unlimited authorisation. Further, this doesn't infringe on the member states' recourse, as established in Article 1(4) of this Regulation 1107/2009. The suggested amendment would genuinely contribute to reducing bureaucracy and increasing efficiency for all Member States.
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. Where no expiry date is set for an active substance (unlimited approval), the re-evaluation of the plant protection product should take place no later than one year after the re-evaluation of the active substance. |
It would be inconsistent that, under the proposed framework, while active substances would be re-assessed on a risk-based basis, plant protection products would remain subject to mandatory periodic re-assessment at national level. That approach unnecessarily risks an inefficient use of the limited capacity of national authorisation authorities and may create practical implementation challenges. As a result, it could undermine the effective functioning of the system and, counterintuitively, risk lowering the overall level of protection.
Carmen Crespo Díaz, Juan Ignacio Zoido Álvarez, Susana Solís Pérez, Esther Herranz García, Dolors Montserrat
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. Where a plant protection product contains only active substances, safeners or synergists with unlimited approval periods, authorisation of the product may be granted for an unlimited period, provided that the product has been assessed in accordance with this Regulation. Such authorisation may be reviewed where there are new relevant scientific or technical data that may have a significant impact on the risk assessment. Where the active substance is reviewed, the file for the re-assessment of the plant protection product must be submitted no later than one year after the end of that review. |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 32a | |
| Union authorisation of plant protection products containing only biocontrol substances | |
| 1. By way of derogation from Article 28(1), an applicant may apply for a Union authorisation for a plant protection product containing as active substances only biocontrol substances. | |
| 2. The application shall be submitted to the Authority and shall be accompanied by the information referred to in Article 33(3). The Authority shall assess the application and deliver its conclusion to the Commission within 12 months of the date on which it establishes that the application is admissible. | |
| 3. The Commission shall, by means of implementing acts adopted in accordance with the procedure referred to in Article 79(3), grant or refuse the Union authorisation on the basis of the conclusion referred to in paragraph 2 and of the requirements set out in Article 29(1). | |
| 4. A Union authorisation shall confer, in each Member State, the same rights and obligations as an authorisation granted by that Member State in accordance with Article 29. It shall be valid for an unlimited period. |
| Present text | Amendment |
|---|---|
| (21) Article 33 is replaced by the following: | |
| Article 33 Application for authorisation or amendment of an authorisation (1) An applicant who wishes to place a plant protection product on the market shall apply for an authorisation or amendment of an authorisation himself, or through a representative, to each Member State where the plant protection product is intended to be placed on the market. | ‘Article 33 Application for authorisation or amendment of an authorisation (1) An applicant who wishes to place a plant protection product on the market shall apply for an authorisation or amendment of an authorisation himself, or through a representative, to each zone where the plant protection product is intended to be placed on the market. |
| (2) The application shall include the following: | (2) The application shall include the following: |
| (a) a list of intended uses in each zone as indicated in Annex I and the Member States where the applicant has made or intends to make an application; | (a) a list of intended uses in each zone as indicated in Annex I; |
| (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request; | (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request; |
| (c) where relevant, a copy of any authorisations already granted for that plant protection product in a Member State; | (c) where relevant, a copy of any authorisations already granted for that plant protection product in another zone; |
| (d) where relevant, a copy of any conclusion of the Member State assessing equivalence as referred to in Article 38(2). | (d) where relevant, a copy of any conclusion of the Member State assessing equivalence as referred to in Article 38(2). |
| (3) The application shall be accompanied by the following: | (3) The application shall be accompanied by the following: |
| (a) for the plant protection product concerned, a complete and a summary dossier for each point of the data requirements of the plant protection product; | (a) for the plant protection product concerned, a complete and a summary dossier for each point of the data requirements of the plant protection product; |
| (b) for each active substance, safener and synergist contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist; 02009R1107 — DE — 21.11.2022 — 008.001 — 26 ▼ B | (b) for each active substance, safener and synergist contained in the plant protection product, a complete and a summary dossier for each point of the data requirements of the active substance, safener and synergist; 02009R1107 — DE — 21.11.2022 — 008.001 — 26 ▼ B |
| (c) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals; | (c) for each test or study involving vertebrate animals, a justification of the steps taken to avoid animal testing and duplication of tests and studies on vertebrate animals; |
| (d) the reasons why the test and study reports submitted are necessary for first authorisation or for amendments to the conditions of the authorisation; | (d) the reasons why the test and study reports submitted are necessary for first authorisation or for amendments to the conditions of the authorisation; |
| (e) where relevant a copy of the application for a maximum residue level as referred to in Article 7 of Regulation (EC) No 396/2005 or a justification for not supplying such information; | (e) where relevant a copy of the application for a maximum residue level as referred to in Article 7 of Regulation (EC) No 396/2005 or a justification for not supplying such information; |
| (f) where relevant for an amendment of an authorisation an assessment of all information submitted in accordance with point (h) of Article 8(1); | (f) where relevant for an amendment of an authorisation an assessment of all information submitted in accordance with point (h) of Article 8(1); |
| (g) a draft label. | (g) a draft label. |
| (4) When submitting the application, the applicant may pursuant to Article 63, request certain information, including certain parts of the dossier, to be kept confidential and shall physically separate that information. The applicant shall at the same time submit the complete list of studies submitted pursuant to Article 8(2) and a list of test and study reports for which any claims for data protection pursuant to Article 59 are requested. Upon a request for access to information the Member State examining the application shall decide what information is to be kept confidential. | (4) Upon a request for access to information the Member State in the respective zone examining the application shall decide what information is to be kept confidential. |
| (5) Where requested by the Member State the applicant shall submit his application in the national or official languages of that Member State or one of those languages. | (5) Where requested by the Member State in the respective zone the applicant shall submit his application in the national or official languages of that Member State or one of those languages. |
| (6) On request, the applicant shall provide the Member State with samples of the plant protection product and analytical standards of its ingredients. | (6) On request, the applicant shall provide the Member State in the respective zone with samples of the plant protection product and analytical standards of its ingredients.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (21) in Article 33, paragraph 2, point (b) is replaced by the following: | deleted |
| ‘(b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3) and 37(2) of Regulation (EU) 2016/2031 and for a plant protection product containing as active substances only biocontrol or low-risk active substances, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3) and 37(2) of Regulation (EU) 2016/2031 and for a plant protection product containing as active substances only biocontrol or low-risk active substances, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request.; | (b) a proposal as to which Member State the applicant expects to evaluate the application taking account of all zones. The applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request.; |
Carmen Crespo Díaz, Esther Herranz García, Dolors Montserrat, Juan Ignacio Zoido Álvarez, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3) and 37(2) of Regulation (EU) 2016/2031 and for a plant protection product containing as active substances only biocontrol or low-risk active substances, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request. | (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3) and 37(2) of Regulation (EU) 2016/2031 for plant protection products to be applied by unmanned aircraft systems in accordance with Directive 2009/128/EC or for a plant protection product containing as active substances only biocontrol or low-risk active substances, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request. |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3) and 37(2) of Regulation (EU) 2016/2031 and for a plant protection product containing as active substances only biocontrol or low-risk active substances, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request.; | (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, all minor crops, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3) and 37(2) of Regulation (EU) 2016/2031, for plant protection products to be applied by such unmanned aircraft systems in accordance with Directive 2009/128/EC, and for a plant protection product containing as active substances only biocontrol or low-risk active substances, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3) and 37(2) of Regulation (EU) 2016/2031 and for a plant protection product containing as active substances only biocontrol or low-risk active substances, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request.; | (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3) and 37(2) of Regulation (EU) 2016/2031,for plant protection products to be used for application by such unmanned aircraft systems in accordance with Directive 2009/128/EC and for a plant protection product containing as active substances only biocontrol or low-risk active substances, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3) and 37(2) of Regulation (EU) 2016/2031 and for a plant protection product containing as active substances only biocontrol or low-risk active substances, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request.; | (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3) and 37(2) of Regulation (EU) 2016/2031, for plant protection products to be applied by such unmanned aircraft systems in accordance with Directive 2009/128/EC, and for a plant protection product containing as active substances only biocontrol or low-risk active substances, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3) and 37(2) of Regulation (EU) 2016/2031 and for a plant protection product containing as active substances only biocontrol or low-risk active substances, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request.; | (b) a proposal as to which Member State the applicant expects to evaluate the application in the zone concerned. In the case of an application for use in greenhouses, as post-harvest treatment, for treatment of empty storage rooms and for seed treatment, for uses that are solely and explicitly needed in order to prevent the entry into, and spread within, the Union, of pests listed in accordance with Articles 5(2), 30(1), 32(3) and 37(2) of Regulation (EU) 2016/2031 and for a plant protection product containing as active substances only low risk biocontrol substances or low-risk active substances, only one Member State shall be proposed, which evaluates the application taking account of all zones. In this case the applicant shall send the summary or complete dossier as referred to in Article 8 to other Member States on request.; |
| Present text | Amendment |
|---|---|
| (21a) Article 34 is replaced by the following: | |
| Article 34 Exemption from the submission of studies | ‘Article 34 Exemption from the submission of studies |
| (1) Applicants shall be exempted from supplying the test and study reports referred to in Article 33(3) where the Member State to which an application is made has the test and study reports concerned and the applicants demonstrate that they have been granted access in accordance with Article 59, 61 or 62 or that any data protection period has expired. | (1) Applicants shall be exempted from supplying the test and study reports referred to in Article 33(3) where the Member State in the respective zone by which an application is reviewed has the test and study reports concerned and the applicants demonstrate that they have been granted access in accordance with Article 59, 61 or 62 or that any data protection period has expired. |
| (2) However, applicants to whom paragraph 1 applies shall provide the following information: | (2) However, applicants to whom paragraph 1 applies shall provide the following information: |
| (a) all necessary data for the identification of the plant protection product including its complete composition as well as a declaration that no unacceptable co-formulants are used; | (a) all necessary data for the identification of the plant protection product including its complete composition as well as a declaration that no unacceptable co-formulants are used; |
| (b) the information needed to identify the active substance, safener or synergist, where they have been approved, and to establish whether the conditions for approval are met and comply with point (b) of Article 29(1), where appropriate; | (b) the information needed to identify the active substance, safener or synergist, where they have been approved, and to establish whether the conditions for approval are met and comply with point (b) of Article 29(1), where appropriate; |
| (c) on the request of the concerned Member State, the data needed to demonstrate that the plant protection product has comparable effects to the plant protection product for which they show access to the protected data. | (c) on the request of the concerned Member State, the data needed to demonstrate that the plant protection product has comparable effects to the plant protection product for which they show access to the protected data.’ |
| Present text | Amendment |
|---|---|
| (21b) Article 35 is replaced by the following: | |
| Article 35 Member State examining the application The application shall be examined by the Member State proposed by the applicant, unless another Member State in the same zone agrees to examine it. The Member State which will examine the application shall inform the applicant. At the request of the Member State examining the application, the other Member States in the same zone to which an application has been submitted shall cooperate to ensure a fair division of the workload. The other Member States within the zone to which an application has been submitted shall refrain from proceeding with the file pending assessment by the Member State examining the application. Where an application has been made in more than one zone, Member States evaluating the application shall agree on the evaluation of data which are not related to the environmental and agricultural conditions. | ‘Article 35 Member State examining the application The application shall be examined by the Member State proposed by the applicant, unless another Member State in the same zone agrees to examine it, or the Member State proposed by the applicant, after prior consultation, appoints another Member State in the same zone to examine it. The Member State which will examine the application shall inform the applicant. At the request of the Member State examining the application, the other Member States in the same zone shall cooperate to ensure a fair division of the workload. Where an application has been made in more than one zone, data which are not related to the environmental and agricultural conditions shall be evaluated.’ |
| Present text | Amendment |
|---|---|
| (21a) Article 35 is replaced by the following: | |
| Article 35 Member State examining the application | ‘Article 35 Member State examining the application |
| The application shall be examined by the Member State proposed by the applicant, unless another Member State in the same zone agrees to examine it. The Member State which will examine the application shall inform the applicant. | The application shall be examined by the Member State proposed by the applicant, unless another Member State in the same zone agrees to examine it. The Member State which will examine the application shall inform the applicant. |
| At the request of the Member State examining the application, the other Member States in the same zone to which an application has been submitted shall cooperate to ensure a fair division of the workload. The other Member States within the zone to which an application has been submitted shall refrain from proceeding with the file pending assessment by the Member State examining the application. | At the request of the Member State examining the application, the other Member States in the same zone to which an application has been submitted shall cooperate to ensure a fair division of the workload. The other Member States within the zone to which an application has been submitted shall refrain from proceeding with the file pending assessment by the Member State examining the application. |
| Where an application has been made in more than one zone, Member States evaluating the application shall agree on the evaluation of data which are not related to the environmental and agricultural conditions. | Where an application has been made in more than one zone, Member States evaluating the application shall agree on the evaluation of data which are not related to the environmental and agricultural conditions. |
| The Commission shall, within a period of two years, submit a report to the European Parliament and to the Council, accompanied where relevant by appropriate draft legislation, with a view to moving towards authorisation of plant protection products at European level.’ |
| Present text | Amendment |
|---|---|
| (21c) Article 36 is replaced by the following: | |
| Article 36 Examination for authorisation | ‘Article 36 Examination for authorisation |
| (1) The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge using guidance documents available at the time of the application. It shall give all Member States in the same zone the opportunity to submit comments to be considered in the assessment. It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6), to establish, as far as possible, whether the plant protection product meets the requirements provided for in Article 29 in the same zone, where used in accordance with Article 55, and under realistic conditions of use. The Member State examining the application shall make available its assessment to the other Member States within the same zone. The format of the assessment report shall be established in accordance with the advisory procedure referred to in Article 79(2). | (1) The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge using guidance documents available at the time of the application. It shall give all Member States in the same zone the opportunity to submit comments to be considered in the assessment. It shall apply the uniform principles for evaluation and authorisation of plant protection products, referred to in Article 29(6), to establish, as far as possible, whether the plant protection product meets the requirements provided for in Article 29 in the same zone, where used in accordance with Article 55, and under realistic conditions of use. The Member State examining the application shall make available its assessment to the other Member States within the same zone. The format of the assessment report shall be established in accordance with the advisory procedure referred to in Article 79(2). |
| (2) The Member States concerned shall grant or refuse authorisations accordingly on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 31 and 32. | (2 new) The Member State examining the application shall grant an authorisation with effect for the relevant zone. |
| (3) By way of derogation from paragraph 2 and subject to Community law, appropriate conditions may be imposed with respect to the requirements referred to in Article 31(3) and (4) and other risk mitigation measures deriving from specific conditions of use. Where the concerns of a Member State relating to human or animal health or the environment cannot be controlled by the establishment of the national risk mitigation measures referred to in the first subparagraph, a Member State may refuse authorisation of the plant protection product in its territory if, due to its specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment. That Member State shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefor. Member States shall provide for the possibility of challenging a decision refusing the authorisation of such products before national courts or other instances of appeal. | (3) Subject to Community law, appropriate conditions may be imposed by a Member State in exceptional cases with respect to the requirements referred to in Article 31(3) and (4) and other risk mitigation measures deriving from specific conditions of use. Where the concerns of a Member State relating to human or animal health or the environment cannot be controlled by the establishment of the national risk mitigation measures referred to in the first subparagraph, a Member State may refuse authorisation of the plant protection product in its territory if, due to its specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment. That Member State shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefor. The challenging of a decision refusing the authorisation of such products shall take place before the national court or other instance of appeal in the Member State which granted the authorisation.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (22) in Article 36, paragraph 1, first subparagraph is replaced by the following: | deleted |
| ‘1. The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge using guidance documents available at the time of the application. It shall give all Member States in the same zone the opportunity to submit comments to be considered in the assessment. | |
| For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level unless it considers that an update is necessary in the light of the current scientific and technical knowledge. In this case the Member State shall request the Commission to act under Articles 18, 18a or 21.;’ |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The Member State examining the application shall make an independent, objective and transparent assessment in the light of current scientific and technical knowledge using guidance documents available at the time of the application. It shall give all Member States in the same zone the opportunity to submit comments to be considered in the assessment. | deleted |
| For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level unless it considers that an update is necessary in the light of the current scientific and technical knowledge. In this case the Member State shall request the Commission to act under Articles 18, 18a or 21.; |
This proposal would freeze the science at the time of approval, which may be years or even decades old if a substance is granted unlimited approval. Such an approach contradicts both EU and national case law, which consistently established that Member States are obliged to consider the most up-to-date scientific evidence when assessing the authorisation of pesticide products. This could also unduly undermine national authorities’ power to to fully assess product toxicity and to regulate the placing of products on the market.
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 |
|---|---|
| For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level unless it considers that an update is necessary in the light of the current scientific and technical knowledge. In this case the Member State shall request the Commission to act under Articles 18, 18a or 21.; | deleted |
The proposed provision creates legal uncertainty regarding the respective responsibilities of Member States and the Union in product authorisations. Existing provisions already ensure that Member States rely on Union-level assessments while allowing the Commission to review active substance approvals where justified by new scientific evidence. This additional provision is therefore unnecessary and risks complicating the authorisation process.
| Text proposed by the Commission | Amendment |
|---|---|
| For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level unless it considers that an update is necessary in the light of the current scientific and technical knowledge. In this case the Member State shall request the Commission to act under Articles 18, 18a or 21.; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level unless it considers that an update is necessary in the light of the current scientific and technical knowledge. In this case the Member State shall request the Commission to act under Articles 18, 18a or 21.; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level unless it considers that an update is necessary in the light of the current scientific and technical knowledge. In this case the Member State shall request the Commission to act under Articles 18, 18a or 21.; | deleted |
With this proposal that limits Member States (MS) and limits use of latest scientific data, the Commission contradicts EU case law and national rulings, which established that MS are obliged to consider the most up-to-date scientific evidence when assessing authorisations.
| Text proposed by the Commission | Amendment |
|---|---|
| For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level unless it considers that an update is necessary in the light of the current scientific and technical knowledge. In this case the Member State shall request the Commission to act under Articles 18, 18a or 21.; | For the active substances, safeners and synergists contained in the plant protection product, Member States shall take due account of the latest assessment conducted at Union level. Where current scientific and technical knowledge, monitoring data or specific agronomic, climatic, environmental or exposure conditions indicate a concern not adequately addressed in that assessment, the Member State may require additional information, impose appropriate risk-mitigation measures, restrict the authorisation or refuse it. The Member State shall inform the Commission and the other Member States without undue delay and provide the scientific grounds for its decision.; |
Union-level assessments provide the common scientific basis of the authorisation system, but they cannot always address emerging evidence or every local condition. Soil characteristics, climatic conditions, water scarcity, proximity to protected ecosystems, dietary patterns and exposure pathways differ considerably across the Union. This is particularly relevant in Mediterranean Member States, where high temperatures, drought and intensive irrigation may affect the behaviour and environmental fate of active substances. Member States must therefore retain the ability to act promptly and proportionately on scientifically substantiated concerns, while informing the Commission and ensuring transparency and Union-wide follow-up.
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level unless it considers that an update is necessary in the light of the current scientific and technical knowledge. In this case the Member State shall request the Commission to act under Articles 18, 18a or 21.; | For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level, in particular on EFSA Conclusions and agreed List of Endpoints supporting the (renewal of) approval. When a Member State considers that an update is necessary in the light of the current scientific and technical knowledge, the Member State shall request the Commission to act under Articles 18, 18a or 21. However, such request will follow a separate procedure and shall not suspend, postpone or withdraw the examination of the application for authorization of the plant protection product.; |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level unless it considers that an update is necessary in the light of the current scientific and technical knowledge. In this case the Member State shall request the Commission to act under Articles 18, 18a or 21.; | For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level. When a Member State considers that an update is necessary in the light of the current scientific and technical knowledge, the Member State shall request the Commission to act under Articles 18, 18a or 21. Such request shall follow a separate procedure and shall not suspend, postpone or withdraw the examination of the application for authorization of the plant protection product.; |
| Text proposed by the Commission | Amendment |
|---|---|
| For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level unless it considers that an update is necessary in the light of the current scientific and technical knowledge. In this case the Member State shall request the Commission to act under Articles 18, 18a or 21.; | For the active substances, safeners and synergists contained in the plant protection product, Member States shall consider the most up-to-date scientific evidence when assessing the authorisation of pesticide products..; |
| Text proposed by the Commission | Amendment |
|---|---|
| For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level unless it considers that an update is necessary in the light of the current scientific and technical knowledge. In this case the Member State shall request the Commission to act under Articles 18, 18a or 21.; | For the active substances, safeners and synergists contained in the plant protection product, Member States shall take due account of the last assessment conducted at EU level. This shall not prevent the Member State examining the application from taking into account relevant scientific and technical knowledge. Where such information indicates that the EU-level assessment may need to be updated, the Member State shall request the Commission to act under Articles 18, 18a or 21.; |
Benoit Cassart, Gerben-Jan Gerbrandy, Martin Hojsík, Christine Singer, Pascal Canfin, Olivier Chastel, Michal Wiezik, Charles Goerens, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU level unless it considers that an update is necessary in the light of the current scientific and technical knowledge. In this case the Member State shall request the Commission to act under Articles 18, 18a or 21.; | For the active substances, safeners and synergists contained in the plant protection product, Member States shall rely on the last assessment conducted at EU or national level unless it considers that an update is necessary in the light of the current scientific and technical knowledge. In this case the Member State shall request the Commission to act under Articles 18, 18a or 21.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (22a) in Article 36, a new suparagraph 2a is added: | |
| A Member State may impose risk mitigation measures that go beyond the conditions laid down under the zonal authorisation only if it has reached the scientifically justified conclusion that the conditions laid down do not ensure the level of protection on the basis of demonstrable Member State-specific environmental or agricultural circumstances not taken into account in the zonal assessment. The justification shall be submitted to the Commission and the other Member States of the zone and shall be made public.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (22a) in Article 36, paragraph 3 is amended as follows: | |
| Where the concerns of a Member State relating to human or animal health or the environment cannot be controlled by the establishment of the national risk mitigation measures referred to in the first subparagraph, a Member State may refuse authorisation of the plant protection product in its territory if, due to its specific environmental, climatic or agricultural circumstances, it has substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Present text | Amendment |
|---|---|
| (22a) Article 36(2) is replaced by the following text: | |
| 2. The Member States concerned shall grant or refuse authorisations accordingly on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 31 and 32. | ‘2. The Member States concerned shall grant or refuse authorisations accordingly on the basis of the conclusions of the assessment of the Member State examining the application as provided for in Articles 31 and 32. |
| All refusals must be reasoned and justified by the conditions laid down in subparagraphs 1 and 2 of paragraph 3 of this Article.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (22a) in Article 36, paragraph 3, a new subparagraph 3a is added: | |
| 'Local extinction of non-target invertebrates shall constitute an unacceptable risk to food security and the environment. A terrestrial ecotoxicology guidance document updated to contemporary needs shall be published by the Commission by 2029, and the Commission shall update its regulation 546/2011 on uniform principles for risk assessment for plant protection products accordingly, in line with article 84 of this regulation.' |
Regarding the update of the Terrestrial Ecotoxicology guidance document, the Commission already mandated EFSA in 2024, and EFSA has announced that the revised document will be published in 2028/29: https://efsa.onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2025.EN-9216. Outline for the revision of the terrestrial ecotoxicology guidance document and for the development of an approach on indirect effects, EFSA, April 2026.
Mireia Borrás Pabón, Gilles Pennelle, Raffaele Stancanelli, Anne-Sophie Frigout, Jorge Buxadé Villalba
| Present text | Amendment |
|---|---|
| (22a) in Article 36, paragraph 3 is replaced by the following: | |
| Art. 36.3. By way of derogation from paragraph 2 and subject to Community law, appropriate conditions may be imposed with respect to the requirements referred to in Article 31(3) and (4) and other risk mitigation measures deriving from specific conditions of use. | "Art. 36.3. By way of derogation from paragraph 2 and subject to Community legislation, Member States shall take into account all available risk mitigation measures in order to impose specific conditions of use appropriateto the requirements referred to in Article 31(3) and (4). That Member State shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefor. Member States shall provide for the possibility of challenging a decision refusing the authorisation of such products before national courts or other instances of appeal. " |
| Where the concerns of a Member State relating to human or animal health or the environment cannot be controlled by the establishment of the national risk mitigation measures referred to in the first subparagraph, a Member State may refuse authorisation of the plant protection product in its territory if, due to its specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment. | |
| That Member State shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefor. | |
| Member States shall provide for the possibility of challenging a decision refusing the authorisation of such products before national courts or other instances of appeal. |
The requirement for Member States to consider ‘all available risk mitigation measures’ in the context of product authorisations should not give place to divergent interpretation among Member State, diverging outcomes of risk assessments, and, as a consequence, unequal access to plant protection products for farmers depending on the Member State of their establishment. The implementation of all available risk mitigation measures by all Member States should be harmonised.
| Present text | Amendment |
|---|---|
| (22a) Article 36, paragraph 3 is replaced by the following | |
| 3. By way of derogation from paragraph 2 and subject to Community law, appropriate conditions may be imposed with respect to the requirements referred to in Article 31(3) and (4) and other risk mitigation measures deriving from specific conditions of use. | "3. By way of derogation from paragraph 2 and subject to Community law, Member States must take into account all available risk mitigation measures in order to impose specific conditions of use appropriate to the requirements referred to in Article 31(3) and (4). |
| Where the concerns of a Member State relating to human or animal health or the environment cannot be controlled by the establishment of the national risk mitigation measures referred to in the first subparagraph, a Member State may refuse authorisation of the plant protection product in its territory if, due to its specific environmental or agricultural circumstances, it has substantiated reasons to consider that the product in question still poses an unacceptable risk to human or animal health or the environment. | That Member State shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefor. |
| That Member State shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefor. | Member States shall provide for the possibility of challenging a decision refusing the authorisation of such products before national courts or other instances of appeal. " |
| Member States shall provide for the possibility of challenging a decision refusing the authorisation of such products before national courts or other instances of appeal. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Present text | Amendment |
|---|---|
| (22b) In Article 36, the third subparagraph of paragraph 3 is amended as follows: | |
| That Member State shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefor. | ‘That Member State shall immediately inform the applicant and the Commission of its decision and provide a technical or scientific justification therefor. Before reporting a refusal decision under the first and second subparagraphs of this paragraph, the Member State shall give the applicant the opportunity to supplement the file by providing the additional data or information necessary for the authorisation application within a reasonable time limit.’ |
| Present text | Amendment |
|---|---|
| Article 37 is replaced by the following: | |
| Article 37 Period for examination | ‘Article 37 Period for examination |
| (1) The Member State examining the application shall decide within 12 months of receiving it whether the requirements for authorisation are met. Where the Member State needs additional information, it shall set a time limit for the applicant to supply it. In that case, the 12-month period shall be extended by the additional period granted by the Member State. That additional period shall be a maximum of 6 months and shall cease at the moment when the additional information is received by the Member State. Where at the end of that period the applicant has not submitted the missing elements, the Member State shall inform the applicant that the application is inadmissible. | (1) The Member State examining the application shall decide within 12 months of receiving it whether the requirements for authorisation are met. Where the Member State needs additional information, it shall set a time limit for the applicant to supply it. In that case, the 12-month period shall be extended by the additional period granted by the Member State. That additional period shall be a maximum of 6 months and shall cease at the moment when the additional information is received by the Member State. Where at the end of that period the applicant has not submitted the missing elements, the Member State shall inform the applicant that the application is inadmissible. |
| (2) The time limits provided for in paragraph 1 shall be suspended during the application of the procedure set out in Article 38. | (2) The time limits provided for in paragraph 1 shall be suspended during the application of the procedure set out in Article 38. |
| (3) For an application for authorisation of a plant protection product containing an active substance not yet approved, the Member State examining the application shall start the evaluation as soon as it has received the draft assessment report referred to in Article 12(1). In case the application concerns the same plant protection product and the same uses as contained in the dossier referred to in Article 8, the Member State shall decide on the application at the latest within six months of the active substance being approved. | (3) For an application for authorisation of a plant protection product containing an active substance not yet approved, the Member State examining the application shall start the evaluation as soon as it has received the draft assessment report referred to in Article 12(1). In case the application concerns the same plant protection product and the same uses as contained in the dossier referred to in Article 8, the Member State shall decide on the application at the latest within six months of the active substance being approved. |
| (4) The other Member States concerned shall at the latest within 120 days of the receipt of the assessment report and the copy of the authorisation of the Member State examining the application decide on the application as referred to in Article 36(2) and (3). | (4) The other Member States in the zone shall at the latest within 120 days of the receipt of the assessment report and the copy of the authorisation of the Member State examining the application decide on the application as referred to in Article 36(3).’ |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Present text | Amendment |
|---|---|
| (23a) The second subparagraph of Article 37(1) is replaced by the following text: | |
| Where the Member State needs additional information, it shall set a time limit for the applicant to supply it. In that case, the 12-month period shall be extended by the additional period granted by the Member State. That additional period shall be a maximum of 6 months and shall cease at the moment when the additional information is received by the Member State. Where at the end of that period the applicant has not submitted the missing elements, the Member State shall inform the applicant that the application is inadmissible. | ‘Where the Member State needs additional information, it must give the requester the opportunity to supplement the file that is being assessed, and set a reasonable time limit for the applicant to supply it. In that case, the 12-month period shall be extended by the additional period granted by the Member State. That additional period shall be a maximum of 6 months and shall cease at the moment when the additional information is received by the Member State. Where at the end of that period the applicant has not submitted the missing elements, the Member State shall inform the applicant that the application is inadmissible.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. | deleted |
Biljana Borzan, Christophe Clergeau, Annalisa Corrado, Romana Jerković, Maria Noichl, Tiemo Wölken, Delara Burkhardt, Kristian Vigenin, Thomas Bajada, Mohammed Chahim, Heléne Fritzon
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. | deleted |
The authorisation of a plant protection product should always result from an explicit decision by the competent authority following a complete scientific assessment. Administrative simplification should accelerate procedures, not replace regulatory scrutiny with tacit approval.
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. | 5. Where the application concerns a plant protection product and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. Any refusal of an application for mutual recognition must be based on Article 36(3) of Regulation (EC) No 1107/2009 and especially justified. The decision shall identify the agronomic, phytosanitary or environmental circumstances, including climate-related circumstances, particular to the national territory of the Member State or the risk-reduction measures that were not taken into account by the reference Member State, thus demonstrating that one of the circumstances set out in Article 36(3) justifies the rapporteur Member State in refraining from recognising the authorisation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. | 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision within 120 days, they shall inform the applicant and the Commission of the reasons for the delay and of the timetable for completing the assessment. A reasoned decision shall be adopted as soon as possible and no later than 60 days thereafter. The absence of a decision shall not constitute an authorisation. |
Faster access to biocontrol and low-risk products is necessary to support farmers and reduce dependence on more hazardous chemical substances. Nevertheless, an authorisation must remain the outcome of an explicit scientific and administrative decision. Even products based on biocontrol or low-risk substances may present product-specific risks linked to formulation, application rate, non-target organisms, local ecosystems or conditions of use. Regulatory silence should therefore trigger accountability and a short final deadline, but should not be treated as proof that all authorisation criteria have been satisfied. The amendment accelerates decision-making without introducing authorisation by default.
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. | 5. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 180 days, the authorisation shall be deemed as having been granted by the Member State. The decision includes any reasoned procedural response issued by the competent authority within this period, not only a final grant or refusal, particularly relevant for Member States with limited administrative resources |
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. | 5. Where the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. | 5. Where the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. | 5. Where the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. | 5. Where the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. |
the automatic authorization procedure should include all the PPPs. Limiting the facilitation only to the bioproducts leaves all the problems affecting the “conventional” PPPs as they stand today, increasing the risk of having more “less effective” PPPs and less “highly effective” PPPs in the toolbox.
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. | 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision which for the purpose of this paragraph, may be under the form of a resoned procedural response, after 180 days, the authorisation shall be deemed as having been granted by the Member States. |
This clarification is critically relevant for Member States facing administrative and technical resource constraints, eliminating legal vulnerabilities when strict evaluation deadlines are challenged by dossier complexity. By permitting national competent authorities to formally issue interim stances or reasoned notifications, the amendment replaces a rigid framework with an inclusive, predictable administrative process tailored to institutional realities, while fully preserving the scientific rigor of risk assessments.
| Text proposed by the Commission | Amendment |
|---|---|
| 5. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. | 5. Where the application concerns a plant protection product containing as active substances only low-risk biocontrol or low-risk active substances and the Member States concerned have not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member States. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | deleted |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | deleted |
(see art. 11.1) : the Omnibus proposal opens 3 risks:1.the proliferation of applications for biocontrol substances, with all the limitations today affecting this category of a.s.2.to further reduce the number of applications for new but “chemical” a..s., more reliable and efficient in controlling pests3.Resources allocated to the evaluation/renewal of active substances and conventional PPPs should not be taken away from EFSA and Member States and allocated to biological control products. Instead, a specialized unit should be established with its own human and financial resources, ensuring that the procedures for the authorization/renewal of “conventional” active substances and PPPs maintain their quality and operational capacity.
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Pascal Canfin, Olivier Chastel, Charles Goerens, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as biocontrol or thereafter low-risk active substances by allocating adequate scientific, technical and human resources to their national competent authority and to ensure that such priority assessment does not delay excessively the assessment of applications for authorisation of other plant protection products containing other active substances. |
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 |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. Dedicated 'green lanes' shall be established for biocontrol products, allowing risk assessments to be conducted in a manner adapted to the specific characteristics of this class of substances, so as to accelerate their availability to farmers as lower-risk alternatives to synthetic substances. |
Biocontrol products generally present a different and more favourable risk profile than conventional chemical plant protection products. Their assessment should therefore be prioritised and organised through dedicated procedures adapted to their specific characteristics, while fully maintaining the scientific standards and level of protection required under this Regulation.
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing active substances necessary to control a serious danger to plant health or plant production which cannot be contained by other reasonable means, on the basis of the evidence referred to in Article 4, paragraph 7, subpara 1. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | 6. The Member State examining the application shall give, where feasible and does not disproportionately hinder the processing of applications of other essential plant protection products, priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only substances intended to prevent or control an urgent or serious danger to plant health or plant production. |
The amendment replaces the reference to biological substances with a broader urgency-based criterion. Priority should be determined by the seriousness of the plant health risk rather than by the type of active substance concerned.
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | 6. The Member State examining the application shall give, where feasible, priority to the processing of applications for plant protection products containing as active substances necessary to control a serious danger to plant health or plant production. |
However acceleration of biocontrol approvals is generally welcome, priority has to be done to the cases when there is serious danger to plant health or plant production regardless it is biocontrol or classical tool concerned.
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | 6. The Member State examining the application shall create dedicated lane with additional specialized resources for the processing of applications for plant protection products containing as active substances only biocontrol substances. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | 6. The Member State examining the application shall allocate dedicated resources and establish dedicated pathways to the processing of applications for plant protection products containing as active substances only biocontrol substances. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | 6. The Member State examining the application shall allocate dedicated resources and establish dedicated pathways to the processing of applications for plant protection products containing as active substances only biocontrol substances. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing new active substances, including biocontrol substances. |
Biocontrol substances complement rather than replace conventional plant protection substances. Creating a priority lane for biocontrol substances risks further slowing down the assessment of conventional substances. Instead, all new substances should benefit from a prioritised assessment in order to ensure that farmers have access to the most effective solutions.
| Text proposed by the Commission | Amendment |
|---|---|
| 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing as active substances only biocontrol substances. | 6. The Member State examining the application shall give priority to the processing of applications for plant protection products containing new active substances. |
Biocontrol is an important field of innovation, but it complements rather than replaces other crop protection innovations. Prioritising the first approval of new substances supports the full spectrum of innovation and helps ensure that farmers have timely access to the innovative tools needed for effective pest control.
| Present text | Amendment |
|---|---|
| ‘Article 40 The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under the comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases: (a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone; (b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone; (c) the authorisation was granted by a Member State for use in greenhouses, or as post-harvest treatment, or for treatment of empty rooms or containers used for storing plant or plant products, or for seed treatment, regardless of the zone to which the reference Member State belongs. 2. Where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply, with the consent of the authorisation holder, for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1. In that case the applicant must demonstrate that the use of such a plant protection product is of general interest for the Member State of introduction. Where the authorisation holder refuses its consent, the competent authority of the Member State concerned may accept the application, on grounds of public interest. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (24) Article 40 is replaced by the following: | deleted |
| ‘Article 40 | |
| Mutual recognition | |
| 1. The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases: | |
| (a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone and the authorised plant protection product is placed on the market in the reference Member State; | |
| (b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone and the authorised plant protection product is placed on the market in the reference Member State; | |
| (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only biocontrol active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. | |
| 2. Where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1.; ’ |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Article 40 is replaced by the following: | |
| 1.The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under the comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases. | 1. An authorisation granted in accordance with Article 29 by a reference Member State shall automatically be effective in all other Member States which belong to the same zone, as defined in Annex I, for the same use and under the comparable agricultural practices, with no need to submit a further application or conduct a national mutual recognition procedure. |
| If the use or agricultural practices are different, the holder of the authorisation may apply for authorisation of the plant protection product by way of the mutual recognition procedure provided for in this subsection. | |
| The provisions of this paragraph shall not prevent a Member State from applying Article 36(3) where there are special circumstances in relation to human or animal health or the environment that justify limiting or refusing automatic application of the authorisation. | |
| (2) Where a plant protection product is not available in a Member State because the automatic authorisation referred to in paragraph 1 is not applicable or because different conditions of use are necessary, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply for an authorisation for the same plant protection product, with the same use and under the same agricultural practices, under the mutual recognition procedure provided for in this Article. |
An additional administrative procedure for Member States in the same zone is dispensed with, and mutual recognition applies only where the use is different or where the exceptions already provided for in Regulation (EC) No 1107/2009, including those in Article 36(3), apply. This approach is more closely aligned with the objective of the internal market and that of reducing administrative burdens.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases: | 1. The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under comparable agricultural practices in another Member State under the mutual recognition procedure provided for in this subsection, where the receiving Member State concludes, following an assessment in accordance with Article 29, that the conditions for authorisation are fulfilled, in the following cases: |
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. The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases: | 1. Where an authorisation is granted to an applicant by a Member State in accordance with Article 29, such authorisation for the same plant protection product, the same use and under comparable agricultural practices shall be automatically grantes to all Member States in the same zone under the mutual recognition procedure. By way of derogation, automatic mutual recognition is also granted in the following cases: |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases: | 1. The holder of an authorisation granted in accordance with Article 29 shall be entitled to automatic mutual recognition of that authorisation in all other Member States, for the same plant protection product and the same use under comparable agricultural practices, without the need for a separate application, in accordance with the single zone system established under this Regulation, in the following cases: |
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Pascal Canfin, Olivier Chastel, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Charles Goerens, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases: | 1. The holder of an authorisation granted in accordance with Article 29 may be granted an authorisation for the same plant protection product, the same use and under comparable agricultural practices in another Member State under the mutual recognition procedure, without the need to submit a separate application in another Member State, provided for in this subsection, in the following cases: |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases: | 1. The holder of an authorisation granted in accordance with Article 29: shall be entitled to automatic mutual recognition of that authorisation in all other Member States, for the same plant protection product and the same use under comparable agricultural practices, without the need for a separate application, in accordance with the single zone system established under this Regulation: |
This intelligent tool, which theoretically allows synergies between Member States to facilitate (without duplicating efforts or deadlines) the availability of the same plant protection product in different territories with similar situations, has failed. Due to a lack of trust between Member State administrations, Member States continue to re-evaluate the plant protection product instead of accepting the evaluation already carried out by the neighbouring Member State as their own! We therefore propose requiring Member States to automatically "validate" evaluations and proceed directly to the registration of the plant protection product when requested, provided that it is already listed in the register of a Member State in the same area.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases: | 1. An authorisation granted in accordance with Article 29 in one Member State shall be recognised by other Member States for the same plant protection product, the same use and under the comparable agricultural practices, in the following cases: |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under the comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases: | 1. The holder of an authorisation granted in accordance with Article 29 shall be entitled to benefit from automatic mutual recognition of that authorisation in another Member State, for the same use and in comparable agricultural practices, as provided for in this subsection, in the following cases: |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The holder of an authorisation granted in accordance with Article 29 may apply for an authorisation for the same plant protection product, the same use and under comparable agricultural practices in another Member State under the mutual recognition procedure, provided for in this subsection, in the following cases: | 1. When an authorisation is granted to an applicant by a Member State in accordance with Article 29, such authorisation for the same plant protection product, the same use and under comparable agricultural practices is automatically granted to all Member State under the mutual recognition procedure. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone and the authorised plant protection product is placed on the market in the reference Member State; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone and the authorised plant protection product is placed on the market in the reference Member State; | (a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone and the authorised plant protection product is placed on the market in the reference Member State and the receiving Member State concludes that the conditions of use, including agricultural, environmental and climatic conditions, are comparable, in order to do so, the receiving Member State may require additional information where necessary to establish that the conditions of use are comparable and that the risks to human health, animal health or the environment are acceptable.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone and the authorised plant protection product is placed on the market in the reference Member State; | (a) the authorisation has been granted by any Member State acting as (reference Member State)whithin the single Union zone and the authorised plant protection product is placed on the market in the reference Member State; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone and the authorised plant protection product is placed on the market in the reference Member State; | (a) the authorisation has been granted by any Member State acting as reference Member State within the single Union zone, and the authorised plant protection product is placed on the market in that Member State; |
Carmen Crespo Díaz, Susana Solís Pérez, Esther Herranz García, Dolors Montserrat, Juan Ignacio Zoido Álvarez
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone and the authorised plant protection product is placed on the market in the reference Member State; | (a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone and the authorised plant protection product is to be placed on the market throughout the European Union; |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the authorisation was granted by a Member State (reference Member State) which belongs to the same zone and the authorised plant protection product is placed on the market in the reference Member State; | (a) the authorisation was granted by a Member State (reference Member State) and the authorised plant protection product is placed on the market in the reference Member State; |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone and the authorised plant protection product is placed on the market in the reference Member State; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone and the authorised plant protection product is placed on the market in the reference Member State; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone and the authorised plant protection product is placed on the market in the reference Member State; | (b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone and the authorised plant protection product is placed on the market in the reference Member State and the receiving Member State has verified that the relevant conditions of use are comparable and that the authorisation does not result in unacceptable risks taking into account the specific environmental, agricultural and climatic conditions of the receiving Member State. Where the receiving Member State concludes that the conditions laid down in Article 29 or the criteria established in Article 4 are not fulfilled, it may refuse the application or impose appropriate risk mitigation measures ; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone and the authorised plant protection product is placed on the market in the reference Member State; | (b) the authorisation shall apply uniformly across the single Union zone to all uses, including use in greenhouses, post-harvest treatment, treatment of empty rooms or containers used for storing plants or plant products, seed treatment, uses required for the application of Regulation (EU) 2016/2031, and plant protection products without distinction based on geographical zones; |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone and the authorised plant protection product is placed on the market in the reference Member State; | (b) the authorisation shall apply uniformly across the single Union zone to all uses, including use in greenhouses, post-harvest treatment, treatment of empty rooms or containers used for storing plants or plant products, seed treatment, uses required for the application of Regulation (EU) 2016/2031, and plant protection products without distinction based on geographical zones |
Carmen Crespo Díaz, Susana Solís Pérez, Esther Herranz García, Dolors Montserrat, Juan Ignacio Zoido Álvarez
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone and the authorised plant protection product is placed on the market in the reference Member State; | (b) the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made is not used for the purpose of mutual recognition in another Member State within the same zone and the authorised plant protection product is to be placed on the market throughout the European Union; |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only biocontrol active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only biocontrol active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only biocontrol active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only biocontrol active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. | (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only low-risk biocontrol active substances demonstrated to fulfil the criteria established under this Regulation, regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only biocontrol active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. | (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for low-risk biocontrol products or plant protection products containing as active substances only biocontrol active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. |
The specific category of low-risk biocontrol products must allow products to be placed on the market more quickly and thus allow easier access for operators where the use of such products does not in effect present any chronic risk.
| Text proposed by the Commission | Amendment |
|---|---|
| (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only biocontrol active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. | (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only biocontrol or low-risk active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only biocontrol active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. | (c) the authorisation was granted by a Member State for use in open spaces, in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only biocontrol active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. |
Carmen Crespo Díaz, Susana Solís Pérez, Esther Herranz García, Dolors Montserrat, Juan Ignacio Zoido Álvarez
| Text proposed by the Commission | Amendment |
|---|---|
| (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only biocontrol active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. | (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only biocontrol active substances regardless of the zone to which the reference Member State belongs and the plant protection product is to be placed on the market throughout the European Union; |
Benoit Cassart, Gerben-Jan Gerbrandy, Christine Singer, Pascal Canfin, Olivier Chastel, Billy Kelleher, Barry Cowen, Jérémy Decerle, Elsi Katainen, Asger Christensen, Katri Kulmuni
| Text proposed by the Commission | Amendment |
|---|---|
| (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing as active substances only biocontrol active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. | (c) the authorisation was granted by a Member State for use in greenhouses, as post-harvest treatment, for treatment of empty rooms or containers used for storing plant or plant products, for seed treatment, for uses that are solely and explicitly needed in order to apply the provisions of Regulation (EU) 2016/2031 or for plant protection products containing biocontrol or low-risk active substances regardless of the zone to which the reference Member State belongs and the authorised plant protection product is placed on the market in the reference Member State. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) in case of seed treatment, automatic mutual recognition will be granted if the plant protection product is authorised in at least one EU Member State for seed treatment in professional facilities. |
Carmen Crespo Díaz, Esther Herranz García, Dolors Montserrat, Susana Solís Pérez, Juan Ignacio Zoido Álvarez
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. Member States may not refuse an application for mutual recognition on purely administrative, trade-related or formal grounds where the plant protection product is authorised in the reference Member State. Any refusal must be properly reasoned and based on a specific, objective, verifiable and proportionate risk to human or animal health. The file submitted and accepted for the first authorisation shall be deemed to be valid, complete and up to date for the purposes of mutual recognition. Requests for additional information or an update to the file shall be the exception rather than the rule and must be restricted to properly justified cases. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1.; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1.; | 2. Where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply, with the consent of the authorisation holder, for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1. In such cases, the applicant shall demonstrate that the authorisation of the plant protection product is justified on grounds of public interest in the Member State of introduction. Where the authorisation holder refuses to give its consent, the competent authority of the Member State concerned may nevertheless accept the application where it considers that such public interest has been demonstrated.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1.; | 2. Where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply, with the consent of the authorisation holder, for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1. In that case the applicant must demonstrate that the use of such a plant protection product is of general interest for the Member State of introduction. Where the authorisation holder refuses its consent, the competent authority of the Member State concerned may accept the application, on grounds of public interest; |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1.; | 2. Where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1. In that case the applicant must demonstrate that the use of such a plant protection product is of general interest for the Member State of introduction. Where the authorisation holder refuses its consent, the competent authority of the Member State concerned may accept the application, on grounds of public interest. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a plant protection product is not authorised in a Member State because no application for an authorisation has been submitted in that Member State, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1.; | 2. Where a plant protection product is not authorised in a Member State because the authorisation was granted by a Member State (reference Member State) which belongs to a different zone provided that the authorisation for which the application was made, official or scientific bodies involved in agricultural activities or professional agricultural organisations may apply for an authorisation for the same plant protection product, the same use and under the same agricultural practices in that Member State under the mutual recognition procedure referred to in paragraph 1. The application should be supported by the competent authority of the Member State to the maximum extent practicable. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. The application should be supported by the official authority of the Member State. |
| Text proposed by the Commission | Amendment |
|---|---|
| 24a. A new Article 40a is inserted: | |
| Article 40a | |
| Review of zones and subzones for the authorisation of plant protection products | |
| 1. The Commission shall regularly assess the appropriateness of the allocation of Member States to zones, as provided for in Annex I, having regard to changes in climatic, agronomic, soil and environmental conditions, as well as scientific and technical advances. | |
| 2. The assessment referred to in paragraph 1 shall be carried out [1 year after this Regulation enters into force] and at least once every five years thereafter. | |
| 3. If this assessment shows that the division into zones no longer accurately reflects comparable conditions of use of plant protection products, the Commission shall be empowered to adopt delegated acts, under Article 78a, in order to amend Annex I. | |
| 4. The delegated acts referred to in paragraph 3 may provide for redefinition of existing zones, the creation of subzones, or the allocation of certain regions of Member States to different zones, as appropriate, where this is justified by comparable agronomic, climatic and environmental conditions. |
| Present text | Amendment |
|---|---|
| Article 41 Authorisation | deleted |
| (1) The Member State to which an application under Article 40 is submitted shall, having examined the application and the accompanying documents referred to in Article 42(1), as appropriate with regard to the circumstances in its territory, authorise the plant protection product concerned under the same conditions as the Member State examining the application, except where Article 36(3) applies. | |
| (2) By way of derogation from paragraph 1, the Member State may authorise the plant protection product where: | |
| (a) an authorisation under point (b) of Article 40(1) was applied for; | |
| (b) it contains a candidate of substitution; | |
| (c) Article 30 has been applied; or | |
| (d) it contains a substance approved in accordance with Article 4(7). |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| (c) a complete or summary dossier as required in Article 33(3) when requested by the Member State; | (c) a complete or summary dossier as required in Article 33(3) when requested by the Member State, which, in the event that any information is missing, must always ensure that it gives the applicant the opportunity to provide the additional information for the dossier before reaching a definitive decision; |
| Text proposed by the Commission | Amendment |
|---|---|
| Points (c) and (d) shall not apply to applications submitted under Article 40(2) and Article 51(7). | deleted |
For applications submitted by official or scientific bodies involved in agricultural activities, professional agricultural organisations, or for minor uses, the proposal removes the requirement to provide the complete dossier and the assessment report prepared by the reference Member State. As a result, other Member States would no longer have access to the information necessary to verify whether the assessment has been carried out correctly and comprehensively.
| Text proposed by the Commission | Amendment |
|---|---|
| Points (c) and (d) shall not apply to applications submitted under Article 40(2) and Article 51(7). | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Points (c) and (d) shall not apply to applications submitted under Article 40(2) and Article 51(7). | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Member State to which an application under Article 40 is submitted shall decide on the application within 120 days. | 2. The Member State to which an application under Article 40 is submitted shall aim to decide on the application within 120 days. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. The Member State to which an application under Article 40 is submitted shall decide on the application within 120 days. | 2. The Member State to which an application under Article 40 is submitted shall decide on the application within 180 days. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Where it assesses an application under Article 40, the Member State’s assessment shall be limited to verifying whether any appropriate conditions or risk-management measures are necessary in accordance with Article 36(3), taking account of the specific environmental or agricultural conditions. Any refusal and any supplementary condition or requirement must be properly justified by scientific or technical reasons and communicated to the applicant by the deadline referred to in paragraph 2. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | 3. Where the application concerns a plant protection product and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. Any refusal of an application for mutual recognition must be based on Article 36(3) of Regulation (EC) No 1107/2009 and specifically justified. The decision shall identify the agronomic, phytosanitary or environmental circumstances, including climate-related circumstances, particular to the national territory of the Member State that were not taken into account by the reference Member State, thus demonstrating that one of the circumstances set out in Article 36(3) justifies refraining from recognising the authorisation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | 3. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member State has not adopted a decision within 120 days, it shall inform the applicant, the reference Member State and the Commission of the reasons for the delay and of the timetable for completing the assessment. A reasoned decision shall be adopted as soon as possible and no later than 60 days thereafter. The absence of a decision shall not constitute an authorisation. |
Mutual recognition should facilitate the availability of sustainable crop-protection products throughout the internal market, particularly in smaller markets where applicants may otherwise have limited commercial incentives. However, mutual recognition must still take account of the agricultural, climatic and environmental conditions of the receiving Member State. Deemed authorisation could permit a product to enter the market without confirmation that the conditions for mutual recognition have been met. A mandatory explanation and an additional, strictly limited decision period offer a proportionate response to administrative delays while preserving legal responsibility and public confidence in the authorisation procedure.
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 180 days, the authorisation shall be deemed as having been granted by the Member State. The decision includes any reasoned procedural response issued by the competent authority within this period, not only a final grant or refusal, particularly relevant for Member States with limited administrative resources |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | 3. Where the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | 3. Where the application concerns a plant protection product containing as active substances only biocontrol or low-risk active substances and the Member State has not adopted a decision within 120 days, the Member State shall inform the applicant of the reasons for the delay and of the expected date of adoption of the decision. The Member State shall adopt a decision as soon as possible. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | 3. Where the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | 3. Where the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | 3. Where the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | 3. Where the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. |
Justification (see art. 37.5) : the automatic authorization procedure should include all the PPPs. Limiting the facilitation only to the bioproducts leaves all the problems affecting the “conventional” PPPs as they stand today, broadening the risk of having more “less effective” PPPs and less “effective” PPPs in the PPPs toolbox. If the purpose of this proposal is to simplify and accelerate certain procedures, Member States should dedicate their resources to evaluating applications for new active substances and products and not to renewal procedures, as is currently the case. Therefore, authorizations of plant protection products containing those active substances should be unlimited in time. And PPP contains only active substances, safeners, and synergists with unlimited approval periods must be renewed when these active substances are reevaluated and their authorization conditions have changed.
Michele Picaro, Carlo Fidanza, Antonella Sberna, Nicola Procaccini, Pietro Fiocchi, Sergio Berlato, Paolo Inselvini, Stefano Cavedagna
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | 3. Where the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | 3. Where the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | 3. Where the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | "3. Where the application concerns active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State." |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision, which for the purpose of this paragraph, may be under the form of a resoned procedural response, after 180 days, the authorisation shall be deemed as having been granted by the Member State. |
This clarification is critically relevant for Member States facing administrative and technical resource constraints, eliminating legal vulnerabilities when strict evaluation deadlines are challenged by dossier complexity. By permitting national competent authorities to formally issue interim stances or reasoned notifications, the amendment replaces a rigid framework with an inclusive, predictable administrative process tailored to institutional realities, while fully preserving the scientific rigor of risk assessments.
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | 3. Where the application concerns a low-risk biocontrol product or a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. |
The specific category of low-risk biocontrol products must allow products to be placed on the market more quickly and thus allow easier access for operators where the use of such products does not in effect present any chronic risk.
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 120 days, the authorisation shall be deemed as having been granted by the Member State. | 3. Where the application concerns a plant protection product containing as active substance only biocontrol or low-risk active substances and the Member State has not adopted a decision after 180 days, the authorisation shall be deemed as having been granted by the Member State. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. No later than one year after the entry into force of this Regulation, and every year thereafter, the Commission shall present a report to the European Parliament and the Council on the efficiency of the approval and authorization timelines under this Regulation. This report shall verify whether the average timeframe to finalize procedures for biocontrol substances, and products containing them, was maintained at or below three years during the previous calendar year. If the average timeframe exceeds three years, the Commission shall outline the underlying causes of the delay in the report. Consequently, the Commission shall integrate into its next Annual Work Programme an action plan detailing the corrective measures designed to align the average procedure duration with the three-year target. |
| Present text | Amendment |
|---|---|
| (26) Article 43 is replaced by the following: | |
| Article 43 Renewal of authorisations | ‘Article 43 Renewal of authorisations |
| (1) An authorisation shall be renewed upon application by the authorisation holder, provided that the requirements referred to in Article 29 are still met. | (1) An authorisation shall be renewed upon application by the authorisation holder, provided that the requirements referred to in Article 29 are still met. |
| (2) Within 3 months from the renewal of the approval of an active substance, safener or synergist contained in the plant protection product, the applicant shall submit the following information: | (2) Within 3 months from the renewal of the approval of an active substance, safener or synergist contained in the plant protection product, the applicant shall submit the following information: |
| (a) a copy of the authorisation of the plant protection product; | (a) a copy of the authorisation of the plant protection product; |
| (b) any new information required as a result of amendments in data requirements or criteria; | (b) any new information required as a result of amendments in data requirements or criteria; |
| (c) evidence that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of approval; | (c) evidence that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of approval; |
| (d) any information required to demonstrate that the plant protection product meets the requirements set out in the Regulation on the renewal of the approval of the active substance, safener or synergist contained therein; | (d) any information required to demonstrate that the plant protection product meets the requirements set out in the Regulation on the renewal of the approval of the active substance, safener or synergist contained therein; |
| (e) a report on the monitoring information, where the authorisation was subject to monitoring. | (e) a report on the monitoring information, where the authorisation was subject to monitoring. |
| (3) Member States shall check compliance of all plant protection products containing the active substance, safener or synergist concerned with any conditions and restrictions provided for in the Regulation renewing the approval under Article 20. | (3) Zones shall check compliance of all plant protection products containing the active substance, safener or synergist concerned with any conditions and restrictions provided for in the Regulation renewing the approval under Article 20. |
| The Member State referred to in Article 35 within each zone shall coordinate the compliance check and assessment of the information submitted for all Member States within that zone. | The Member State referred to in Article 35 within each zone shall coordinate the compliance check and assessment of the information submitted within that zone. |
| (4) Guidelines on the organisation of compliance checks may be established in accordance with the advisory procedure referred to in Article 79(2). | (4) Guidelines on the organisation of compliance checks may be established in accordance with the advisory procedure referred to in Article 79(2). |
| (5) Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the renewal of the approval of the active substance, safener or synergist contained therein. | (5) Zones shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the renewal of the approval of the active substance, safener or synergist contained therein. |
| (6) Where, for reasons beyond the control of the holder of the authorisation, no decision is taken on the renewal of the authorisation before its expiry, the Member State in question shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal. | (6) Where, for reasons beyond the control of the holder of the authorisation, no decision is taken on the renewal of the authorisation before its expiry, the coordinating Member State for the respective zone shall extend the authorisation for the period necessary to complete the examination and adopt a decision on the renewal.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) paragraph 2 is replaced by the following: | deleted |
| ‘2. That application for renewal shall be submitted: | |
| (a) No later than nine months before the expiry of an authorisation, if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or | |
| (b) Within 3 months from the renewal of the approval of an active substance, safener or synergist contained in the plant protection product.’ |
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. That application for renewal shall be submitted: | 2. That application shall be submitted no later than three months from the renewal of the approval of the active substance, safener or synergist contained in the plant protection product. |
Since approvals of active substances remain time-limited and subject to periodic renewal, applications for the renewal of plant protection product authorisations should continue to be linked to the renewal of the active substances they contain. This ensures consistency with the approval and renewal system established by this Regulation.
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) No later than nine months before the expiry of an authorisation, if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) No later than nine months before the expiry of an authorisation, if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or, | (a) No later than nine months before the expiry of an authorisation, if the plant protection product concerned contains only active substances, safeners, and synergists with approval periods that do not have a defined expiry date, or, |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) No later than nine months before the expiry of an authorisation, if the plant protection product concerned contains only active substances, safeners, and synergists with unlimited approval periods, or | (a) No later than nine months before the expiry of an authorisation, if the plant protection product concerned contains only active substances, safeners, and synergists with limited approval periods, or |
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) Within 3 months from the renewal of the approval of an active substance, safener or synergist contained in the plant protection product. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) in Article 43, a newparagraph 2a is added: | |
| Within 3 months from the renewal of the approval of an active substance, safener or synergist contained in the plant protection product, the applicant shall submit the following information: | |
| (a) a copy of the authorisation of the plant protection product; | |
| (b) any new information required as a result of amendments in data requirements or criteria; | |
| (c) evidence that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of approval; | |
| (d) any information required to demonstrate that the plant protection product meets the requirements set out in the Regulation on the renewal of the approval of the active substance, safener or synergist contained therein; | |
| (e) a report on the monitoring information, where the authorisation was subject to monitoring. |
Keep current article 43.2// If the purpose of this proposal is to simplify and accelerate certain procedures, Member States should dedicate their resources to evaluating applications for new active substances and products and not to renewal procedures, as is currently the case. Therefore, authorizations of plant protection products containing those active substances should be unlimited in time. And PPP contains only active substances, safeners, and synergists with unlimited approval periods must be renewed when these active substances are reevaluated and their authorization conditions have changed.
| Text proposed by the Commission | Amendment |
|---|---|
| (27) The applicant shall provide the following information: | deleted |
| ‘(a) a copy of the authorisation of the plant protection product; | |
| (b) any new information required as a result of amendments in data requirements or criteria; | |
| (c) evidence that the new data submitted are the result of data requirements or criteria which were not in force when the authorisation of the plant protection product was granted or necessary to amend the conditions of approval; | |
| (d) any information required to demonstrate that the plant protection product meets the requirements set out in the Regulation on the renewal of the approval of the active substance, safener or synergist contained therein; | |
| (e) a report on the monitoring information, where the authorisation was subject to monitoring.; ’ | |
| (b) in Article 43, paragraph 5 is replaced by the following: |
| Text proposed by the Commission | Amendment |
|---|---|
| (28) ‘Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the submission of the application;’; | (28) ‘Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the renewal of the authorisation of the active substance, safener or synergist contained therein. If no decision is taken within this period, the authorisation shall be deemed to have been granted provisionally. ;’; |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| (28) ‘Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the submission of the application;’; | (28) ‘Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the renewal of the authorization of the active substance, safener or synergist contained therein. If no decision is taken within this period, the authorization shall be deemed to have been granted provisionally ’; |
| Text proposed by the Commission | Amendment |
|---|---|
| (28) ‘Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the submission of the application;’; | (28) ‘Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the renewal of the authorisation of the active substance, safener or synergist contained therein. If no decision is taken within this period, the authorisation shall be deemed to have been granted provisionally. |
| Text proposed by the Commission | Amendment |
|---|---|
| (28) ‘Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the submission of the application;’; | (28) ‘Member States shall decide on the renewal of the authorisation of a plant protection product at the latest 12 months after the submission of the application. If no decision is taken within this period, the authorisation shall be deemed to have been granted on a provisional basis.;’; |
| Present text | Amendment |
|---|---|
| (29) Article 44 is replaced by the following | |
| Article 44 Withdrawal or amendment of an authorisation | ‘Article 44 Withdrawal or amendment of an authorisation |
| (1) Member States may review an authorisation at any time where there are indications that a requirement referred to in Article 29 is no longer satisfied. A Member State shall review an authorisation where it concludes that the objectives of Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may not be achieved. | (1) Each zone may review an authorisation at any time where there are indications that a requirement referred to in Article 29 is no longer satisfied. The authorisation shall be reviewed if a Member State in the respective zone concludes that the objectives of Article 4(1)(a)(iv) and (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may not be achieved. |
| (2) Where a Member State intends to withdraw or amend an authorisation, it shall inform the authorisation holder and give him the possibility to submit comments or further information. | (2) Where a Member State in a zone has information which makes it necessary to amend or review an authorisation under paragraph 1, it shall inform the Member State which granted the authorisation. |
| (2b) The Member State which granted the authorisation, | |
| (a) shall inform the authorisation holder and give him the possibility to submit comments or further information, | |
| (b) shall inform the other Member States in the same zone and give them the possibility to submit comments, | |
| (c) shall review the available information in order to determine whether an authorisation needs to be amended or reviewed. To this end it shall carry out an independent, objective and transparent assessment, taking into account the comments of the holder of the authorisation and those of the Member States. It shall make its assessment available in full to the Member States in the same zone. | |
| (2c) The Member State which granted the authorisation shall withdraw or amend the authorisation with effect for the entire zone. | |
| (3) The Member State shall withdraw or amend the authorisation, as appropriate, where: | (3) The authorisation shall be withdrawn or amended for the respective zone, where: |
| (a) the requirements referred to in Article 29 are not or are no longer satisfied; | (a) the requirements referred to in Article 29 are not or are no longer satisfied; |
| (b) false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted; | (b) false or misleading information was supplied concerning the facts on the basis of which the authorisation was granted; |
| (c) a condition included in the authorisation has not been met; | (c) a condition included in the authorisation has not been met; |
| (d) on the basis of developments in scientific and technical knowledge, the manner of use and amounts used can be modified; or | (d) on the basis of developments in scientific and technical knowledge, the manner of use and amounts used can be modified; or |
| (e) the authorisation holder fails to comply with the obligations resulting from this Regulation. | (e) the authorisation holder fails to comply with the obligations resulting from this Regulation. |
| (4) Where a Member State withdraws or amends an authorisation in accordance with paragraph 3, it shall immediately inform the holder of the authorisation, the other Member States, the Commission and the Authority. The other Member States belonging to the same zone shall withdraw or amend the authorisation accordingly taking into account national conditions and risk mitigation measures except for cases where the second, third or fourth subparagraphs of Article 36(3) have been applied. Article 46 shall apply where appropriate. | (4) Where an authorisation in accordance with paragraph 3 is withdrawn or amended, the reviewing Member State shall immediately inform the holder of the authorisation, the Member States in the same zone and in the other zone, the Commission and the Authority. Article 36(3) shall apply. Article 46 shall apply where appropriate.’ |
| Text proposed by the Commission | Amendment |
|---|---|
| Article 46 | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| Period of grace | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Where a Member State withdraws or amends an authorisation or does not renew it, as a result of a Regulation adopted pursuant to Article 20(1) or as a result of a Regulation adopted pursuant to Article 21(3), Member States shall set a grace period within the limits of the maximum grace period set by the Commission on the basis of Article 20(2), unless the Commission has prohibited the setting of such a grace period on the basis of Article 20(2) . | deleted |
Gerben-Jan Gerbrandy, Martin Hojsík, Sigrid Friis, Stine Bosse, Karin Karlsbro, Michal Wiezik, Yvan Verougstraete
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Where a Member State withdraws or amends an authorisation or does not renew it, as a result of a Regulation adopted pursuant to Article 20(1) or as a result of a Regulation adopted pursuant to Article 21(3), Member States shall set a grace period within the limits of the maximum grace period set by the Commission on the basis of Article 20(2), unless the Commission has prohibited the setting of such a grace period on the basis of Article 20(2) . | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. Where a Member State withdraws or amends an authorisation or does not renew it, as a result of a Regulation adopted pursuant to Article 20(1) or as a result of a Regulation adopted pursuant to Article 21(3), Member States shall set a grace period within the limits of the maximum grace period set by the Commission on the basis of Article 20(2), unless the Commission has prohibited the setting of such a grace period on the basis of Article 20(2) . | 1. Where a Member State withdraws or amends an authorisation or does not renew it, as a result of a Regulation adopted pursuant to Article 20(1) or as a result of a Regulation adopted pursuant to Article 21(3), Member States shall set the maximum grace period set by the Commission on the basis of Article 20(2), unless the Commission has prohibited the setting of such a grace period on the basis of Article 20(2) . |
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 |
|---|---|
| 1a. The maximum grace period referred to in Article 20(2) shall not exceed 3 months for the sale and distribution and an additional maximum of 6 months for the disposal, storage and use of existing stocks of the plant protection products concerned. |
Grace periods should be strictly limited to what is necessary to manage existing stocks and should not undermine regulatory decisions taken to protect human health and the environment. The amendment also ensures consistency between Articles 20 and 46 by maintaining a clear link between the Commission decision setting the maximum grace period and the subsequent national implementation.
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned ). | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (31) Article 46 is replaced by the following: | (31) Article 46(2) is replaced by the following: |
| 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, and where the use is recognised as a minor use or where there is a phytosanitary dead end for a given use, it may set a grace period that shall not exceed two years for sale and distribution and one additional year for the disposal, storage and use of existing stocks of the plant protection products concerned.; |
Gerben-Jan Gerbrandy, Martin Hojsík, Sigrid Friis, Stine Bosse, Karin Karlsbro, Michal Wiezik, Yvan Verougstraete
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned ).; | deleted |
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 |
|---|---|
| 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned ).; | 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned, provided that the continued use of the plant protection product does not pose unacceptable risks to human health, animal health or the environment. |
Grace periods should remain exceptional and should not prolong the use of plant protection products where their withdrawal or non-renewal is based on concerns for human health, animal health or the environment. Any grace period should therefore be subject to clear safety conditions and remain strictly limited in duration.
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned ). | 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, and where the crop is recognised as a minor crop or where there is a phytosanitary dead end for a given use, it may set a grace period that shall not exceed two years for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned ). |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned ).; | 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not be below 12 months and shall not exceed 2 years for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned. |
The period of grace for the PPPs (commercial formulation) should be the same granted for the active substances as set in the art. 20.2
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned).; | 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall normally not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned).; |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned).; | 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 6 months for the sale and the distribution and an additional 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 |
|---|---|
| 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned).; | 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 3 months for the sale and the distribution and an additional maximum of 6 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 |
|---|---|
| 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned ).; | 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 2 years for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned ).; |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned ).; | 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 2 years for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned ).; |
The period of grace for the PPPs (commercial formulation) should be the same granted for the active substances.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.
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned).; | 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 12 months for the sale and the distribution and an additional maximum of 2 years for the disposal, storage, and use of existing stocks of the plant protection products concerned).; |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 6 months for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned ). | 2. Where a Member State withdraws or amends an authorisation or does not renew it for other reasons than those referred to in paragraph 1, it may set a grace period that shall not exceed 1 year for the sale and the distribution and an additional maximum of 1 year for the disposal, storage, and use of existing stocks of the plant protection products concerned. ). |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. The grace periods laid down in Article 20(2) and in this Article shall cover at least one complete cultivation or vegetation cycle of the crops principally concerned. When assessing the availability of adequate alternatives, agronomic effectiveness, economic viability and practicability at the scale of agricultural practice are crucial. Only mechanical, biological or arable methods shall be considered as adequate alternatives if their effectiveness and economic viability have been demonstrated on the crops concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Plant protection products lawfully manufactured before the date on which the withdrawal, amendment or non-renewal of the relevant authorisation becomes applicable may continue to be placed on the market, stored and used only within the grace period established in accordance with paragraphs 1 or 2. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Where the withdrawal, amendment or non-renewal is based on the criteria referred to in points 3.6.3, 3.6.4, 3.6.5, 3.7, 3.8 or 3.10 of Annex II, no grace period shall be set. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Products for agricultural input produced using such active substances before the entering into force of the new provisions, can be marketed up to the end of the stocks. |
This is an important provision for product stocked for longer periods, such as apples or wine, for instances where MRLs are changed retroactively/while they are in storage/stock
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Products for agricultural input produced using such active substances before the entering into force of the new provisions can be marketed up to the end of the stocks. |
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 |
|---|---|
| 2a. No grace period shall be granted where the withdrawal, amendment or non-renewal is based on concerns for human health, animal health or the environment.; |
Grace periods should remain exceptional and should not prolong the use of plant protection products where their withdrawal or non-renewal is based on concerns for human health, animal health or the environment. Any grace period should therefore be subject to clear safety conditions and remain strictly limited in duration.
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Products for human consumption produced using such active substances before the entering into force of the new provisions, can be marketed up to the end of the stocks. |
In the case of “not renewal” of an a.s. (or a modification of specific parameters like ARfD and MRL), what was produced respecting the rules and laws in place during the producing season can be fully traded if not unacceptable health and/or environmental risks are present (in this case art. 69-71 emergency measures apply)
| Text proposed by the Commission | Amendment |
|---|---|
| 2b. If the purpose of this proposal is to simplify and accelerate certain procedures, Member States should dedicate their resources to evaluating applications for new active substances and products and not to renewal procedures, as is currently the case. Therefore, authorizations of plant protection products containing those active substances should be unlimited in time. And PPP contains only active substances, safeners, and synergists with unlimited approval periods must be renewed when these active substances are reevaluated and their authorization conditions have changed. |
In the case of “not renewal” of an a.s. (or a modification of specific parameters like ARfD and MRL), what was produced respecting the rules and laws in place during the producing season can be fully traded if not unacceptable health and/or environmental risks are present (in this case art. 69-71 emergency measures apply)
| Text proposed by the Commission | Amendment |
|---|---|
| Placing on the market of treated seeds and plant reproductive material | Placing on the market of treated seeds |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | deleted |
Under the Commission’s proposed amendment to Article 49, paragraph 1, sowing is classified as the application of a plant protection product. However, paragraph 7 clarifies that seed drills are not to be regarded as plant protection application equipment. While this removes the explicit requirements relating to operator competence and equipment inspection, the new classification of sowing as an "application" may nevertheless trigger other regulatory obligations.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 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 |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. Treated seeds and plant reproductive material as well as the sowing of the treated seeds and plant reproductive material are not to be considered a plant protection product. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a precision application use of a plant protection product. |
Carmen Crespo Díaz, Esther Herranz García, Dolors Montserrat, Juan Ignacio Zoido Álvarez, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. Treated seeds and treated plant reproductive material are not to be considered as plant protection products. The treatment of seeds or plant reproductive material with plant protection products shall constitute use of a plant protection product. The sowing of treated seeds and the planting of treated plant reproductive material shall not in themselves constitute use of a plant protection product. |
Katri Kulmuni, Elsi Katainen, Benoit Cassart, Emma Wiesner, Jan-Christoph Oetjen, Christine Singer, Stefan Köhler, Asger Christensen, Andreas Glück
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. The treatment of seeds and plant reproductive material with plant protection products is a use of a plant protection product. |
Defining the sowing of treated seeds and the planting of treated plant reproductive material as the use of plant protection products would create an excessive administrative burden for authorities, users, and control bodies.If the definition of use is broadened as proposed, all individuals who sow or plant treated seeds or reproductive material would be considered professional users. As a result, they would be required to obtain certification, in accordance with Article 5 of Directive 2009/128/EC, which mandates certification for all professional users of plant protection products.In practice, this would significantly expand the scope of certification requirements. It would mean that every person on farms who sows or plants, all individuals working in gardening and greenhouse operations who perform these tasks, and everyone involved in planting forest reproductive material would need to be certified.Therefore, it is proposed that the proposed new wording of the provision be deleted, and the provision remain unchanged.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. The treatment of seeds and plant reproductive material with plant protection products constitutes a use of a plant protection product. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. The treatment of seeds and plant reproductive material with plant protection products constitutes a use of a plant protection product. |
We disagree that sowing treated seeds and planting material is considered as use of plant protection product. This interpretation would lead to further increase of administrative and organizational burden for farmers.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. The treatment of seeds and plant reproductive material with plant protection products constitutes a use of a plant protection product. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. The treatment of seeds and plant reproductive material with plant protection products constitutes a use of a plant protection product. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. The treatment of seeds and plant reproductive material with plant protection products constitutes a use of a plant protection product. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. The treatment of seeds and plant reproductive material with plant protection products as well constitutes a use of a plant protection product. |
Treating the sowing of treated seeds or other plant reproductive material as a use of a plant protection product would create unnecessary administrative burdens without clear added value. As seeds are often treated in another country, it should be clarified whether Article 53 permits the import, distribution and use of seeds treated in third countries. If not, an appropriate legal basis should be introduced to avoid disruptions to seed supply and agricultural production.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. The treatment of seeds and plant reproductive material with plant protection products as well constitutes a use of a plant protection product. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material does not constitutes a use of a plant protection product. |
The use of treated seeds is a common farming practice that protects newly emerging plants from specific fungi or pests with a very low PPP concentration. Often a few grams per hectare protects better than later use of PPPs where much more active ingredient is needed. Therefore, treated seeds constitutes a more environmentally friendly approach, and often with better results for the crop and the farmer.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material does not constitute a use of a plant protection product. |
Seed treatment allows for a highly precise application of active substances at reduced quantities, substantially reducing operator exposure and delivering a smaller environmental footprint than equivalent foliar treatments. For some Member States, this practice remains an essential tool for controlling populations of Tanymecus dilaticollis in order to protect certain ecosystems and the production of specific crops in the Union. Imposing further requirements would create an additional legal and administrative burden for a tool that is already tightly regulated under Regulations (EU) 2018/783, 2018/784, and 2018/785.
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material does not constitute a use of a plant protection product. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material does not constitute a use of a plant protection product. |
Anne-Sophie Frigout, Gilles Pennelle, Marie-Luce Brasier-Clain, Mireia Borrás Pabón, Mathilde Androuët
| Text proposed by the Commission | Amendment |
|---|---|
| 1. The treatment of seeds and plant reproductive material with plant protection products as well as the sowing of the treated seeds and plant reproductive material constitutes a use of a plant protection product. | 1. The sowing of seeds, treated seeds and plant reproductive material are not to be considered as plant protection products. Treatment of the seeds constitutes a use of a plant protection product. |
| Text proposed by the Commission | Amendment |
|---|---|
| 1a. Seeds and plant reproductive material treated with plant protection products, the authorisation of which has been withdrawn or amended after the time of treatment, may be used for sowing or planting as long as such seeds and plant reproductive material comply with the requirements of Union legislation on plant reproductive material, unless a different period for sowing or planting has been laid down in the withdrawal or amendment of the authorisation |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Placing on the market and use of seeds and plant reproductive material treated with a plant protection product which is not authorised in any Member State is prohibited. | 2. Placing on the market and use of seeds and plant reproductive material treated with a plant protection product which is not authorised in any Member State is prohibited and Member States shall ensure appropriate controls and traceability measures to verify compliance with this requirement. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Placing on the market and use of seeds and plant reproductive material treated with a plant protection product which is not authorised in any Member State is prohibited. | 2. Placing on the market and use of seeds and plant reproductive material treated with a plant protection product which is not authorised in any Member State is prohibited. Derogation is possible according Article 53 |
Seeds is not necessarily treated in the same country where it is intended to be sown. Cases of emergency authorization under Article 53 allows the competent authority of a Member State to authorize the distribution and sowing of seeds treated in a third country if the product is not authorized in any EU country under the new wording of Article 49(2). If the authorization under Article 53 does not allow authorizing the import from the third country of the seeds treated with a product not authorized in any Member State, such competence should be added.
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Member States may allow seeds or other plant reproductive material treated with plant protection products whose authorisation has been withdrawn or amended after the time of treatment to be used for sowing or planting provided that such seeds and plant reproductive material comply with the requirements of Union legislation on plant reproductive material, unless specific provisions regarding such continued use have been laid down in the withdrawal or amendment of the authorisation |
| Text proposed by the Commission | Amendment |
|---|---|
| 2a. Member States may allow seeds or other plant reproductive material treated with plant protection products whose authorisation has been withdrawn or amended after the time of treatment to be used for sowing or planting provided that such seeds and plant reproductive material comply with the requirements of Union legislation on plant reproductive material, unless specific provisions regarding such continued use have been laid down in the withdrawal or amendment of the authorisation. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Member States can only prohibit the placing on the market or the use of seeds and plant reproductive material treated with plant protection product authorised for that use in at least one Member State if there are substantial concerns that treated seeds are likely to constitute a serious risk to human or animal health or to the environment and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned. | 3. Member States can only prohibit the placing on the market or the use of seeds and plant reproductive material treated with plant protection product authorised for that use in at least one Member State if there are substantial concerns that treated seeds are likely to constitute a serious risk to human or animal health or to the environment, including risks to biodiversity, non-target organisms and ecosystem functions, and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Member States can only prohibit the placing on the market or the use of seeds and plant reproductive material treated with plant protection product authorised for that use in at least one Member State if there are substantial concerns that treated seeds are likely to constitute a serious risk to human or animal health or to the environment and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned. | 3. Member States can prohibit the placing on the market or the use of seeds and plant reproductive material treated with plant protection product authorised for that use in at least one Member State, and shall immediately do so if there are substantial concerns that treated seeds are likely to constitute a serious risk to human or animal health or to the environment. |
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 |
|---|---|
| 3. Member States can only prohibit the placing on the market or the use of seeds and plant reproductive material treated with plant protection product authorised for that use in at least one Member State if there are substantial concerns that treated seeds are likely to constitute a serious risk to human or animal health or to the environment and that such risk cannot be contained satisfactorily by means of measures taken by the Member State(s) concerned. | 3. Member States may prohibit the placing on the market or the use of seeds and plant reproductive material treated with a plant protection product authorised for that use in another Member State where, in the light of current scientific and technical knowledge, they conclude that the treated seeds are likely to constitute a risk to human or animal health or the environment that cannot be adequately addressed under the conditions of use in their territory. |
Member States should retain the ability to take proportionate risk management measures where national agricultural, environmental or climatic conditions justify a different assessment. This ensures that the principle of mutual recognition does not undermine a high level of protection of human health, animal health and the environment.
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. By way of derogation from paragraph 3, Member States shall not prohibit the placing on the market or use of seeds treated with a plant protection product where such treatment has been authorised under a derogation granted under Article 2 of an implementing regulation that restricts the use of an active substance, provided that the derogation is based on documented and systematic exceedance of the Economic Threshold Level (ETL) for endemic soil pests in officially demarcated areas and that appropriate risk mitigation measures are applied. |
În absența art. 49(3)(b), noul art. 49(3)(a) rămâne inaplicabil, întrucât Regulamentele de punere în aplicare (UE) 2018/783, 2018/784 și 2018/785 restricționează în prezent tratamentul semințelor la utilizări în sere permanente și nu pot fi adaptate prin simpla modificare a Regulamentului (CE) nr. 1107/2009. Integrarea modificării acestor regulamente de punere în aplicare prin art. 49(3)(b) constituie, prin urmare, consecința juridică necesară și directă a introducerii art. 49(3)(a), în conformitate cu principiul effet utile, consacrat în jurisprudența Curții de Justiție a Uniunii Europene. Modificarea Regulamentelor de punere în aplicare (UE) 2018/783, 2018/784 și 2018/785 este integrată ca propunere în art. 49(3)(b), și nu ca inițiativă separată, pentru a reflecta faptul că aceasta reprezintă o consecință juridică directă a introducerii art. 49(3)(a), necesară pentru asigurarea aplicabilității efective a acestuia
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. By way of derogation from paragraph 3, Member States shall not prohibit the placing on the market or the use of seeds treated with a plant protection product where such treatment has been authorised pursuant to a derogation granted under Article 2 of an implementing regulation restricting the use of an active substance, provided that the derogation is based on documented and systematic exceedance of the Economic Damage Threshold for endemic soil pests in officially delimited areas and that appropriate risk mitigation measures are applied. |
Esther Herranz García, Gabriel Mato, Raúl de la Hoz Quintano, Carmen Crespo Díaz, Dolors Montserrat, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. By way of derogation from paragraph 3, Member States shall not prohibit the placing on the market or the use of seeds treated with a plant protection product where such treatment has been authorised pursuant to a derogation granted under Article 2 of an implementing regulation restricting the use of an active substance, provided that the derogation is based on documented and systematic exceedance of the Economic Damage Threshold for endemic soil pests in officially delimited areas and that appropriate risk mitigation measures are applied. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. By way of derogation from paragraph 3, Member States shall not prohibit the placing on the market or the use of seeds treated with a plant protection product where such treatment has been authorised pursuant to a derogation granted under Article 2 of an implementing regulation restricting the use of an active substance, provided that the derogation is based on documented and systematic exceedance of the Economic Damage Threshold for endemic soil pests in officially delimited areas and appropriate risk mitigation measures are applied. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3a. By way of derogation from paragraph 3, Member States shall not prohibit the placing on the market or the use of seeds treated with a plant protection product where such treatment has been authorised pursuant to a derogation granted under Article 2 of an implementing regulation restricting the use of an active substance, provided that the derogation is based on documented and systematic exceedance of the Economic Damage Threshold for endemic soil pests in officially delimited areas and appropriate risk mitigation measures are applied. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3b. For the purpose of implementing the derogation provided for in paragraph 3a, Implementing Regulations (EU) 2018/783, 2018/784 and 2018/785 are all amended by inserting the following point (c) into Article 2: (c) the seeds are intended for use in areas officially demarcated by the competent authority of the Member State where, on the basis of multi-year plant protection monitoring and relevant scientific data, systematic exceedance of the Economic Threshold Level (ETL) for endemic soil pests has been found to have occurred and no affordable and at least equally effective alternative means of plant protection is available, provided that use is limited solely to seed treatment and that appropriate risk mitigation measures are applied. |
În absența art. 49(3)(b), noul art. 49(3)(a) rămâne inaplicabil, întrucât Regulamentele de punere în aplicare (UE) 2018/783, 2018/784 și 2018/785 restricționează în prezent tratamentul semințelor la utilizări în sere permanente și nu pot fi adaptate prin simpla modificare a Regulamentului (CE) nr. 1107/2009. Integrarea modificării acestor regulamente de punere în aplicare prin art. 49(3)(b) constituie, prin urmare, consecința juridică necesară și directă a introducerii art. 49(3)(a), în conformitate cu principiul effet utile, consacrat în jurisprudența Curții de Justiție a Uniunii Europene. Modificarea Regulamentelor de punere în aplicare (UE) 2018/783, 2018/784 și 2018/785 este integrată ca propunere în art. 49(3)(b), și nu ca inițiativă separată, pentru a reflecta faptul că aceasta reprezintă o consecință juridică directă a introducerii art. 49(3)(a), necesară pentru asigurarea aplicabilității efective a acestuia
| Text proposed by the Commission | Amendment |
|---|---|
| 3b. For the purposes of implementing the derogation provided for in Article 49(3)(a)(new), Implementing Regulations (EU) 2018/783, 2018/784 and 2018/785 shall each be amended by inserting the following point (c) in Article 2: (c) the seeds are intended for use in areas officially delimited by the competent authority of the Member State, in which, on the basis of multi-annual phytosanitary monitoring and relevant scientific data, a systematic exceedance of the economic damage threshold for endemic soil pests has been established and effective alternative plant protection means are not available, provided that the use is limited exclusively to seed treatment and that appropriate risk mitigation measures are applied. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3b. For the purposes of implementing the derogation provided for in paragraph (3a new), Implementing Regulations (EU) 2018/783, 2018/784 and 2018/785 shall each be amended by inserting the following point (c) in Article 2: | |
| (c) the seeds are intended for use in areas officially delimited by the competent authority of the Member State in which, on the basis of multi-annual phytosanitary monitoring and relevant scientific data, a systematic exceedance of the Economic Damage Threshold for endemic soil pests has been established and effective alternative plant protection means are not available, provided that the use is limited exclusively to seed treatment and that appropriate risk mitigation measures are applied |
The proposed amendment introducing Article 49(3)(b new) constitutes the direct and necessary legal consequence of introducing subparagraph (a new), rendering it indispensable for ensuring its effective implementation in line with the CJEU principle of "effet utile." Following the CJEU judgment in Case C-162/21 (Pesticide Action Network), the use of the Article 53 emergency mechanism was ruled out for substances restricted at Union level. The proposed Article 49(3)(a) establishes an alternative, structural legal pathway to temporary emergency derogations. However, without subparagraph (b), this pathway would remain ineffective, as Implementing Regulations (EU) 2018/783, 2018/784, and 2018/785 currently restrict seed treatments strictly to permanent greenhouses. Integrating the amendment of these secondary acts directly into this proposal ensures legislative coherence and resolves the current regulatory impasse.
| Text proposed by the Commission | Amendment |
|---|---|
| 4. In the cases referred under paragraph 3 above, the Commission may take measures to restrict or prohibit the use and/or sale of such treated seeds and plant reproductive material in accordance with the procedure referred to in Article 79(3). Before taking such measures, the Commission shall examine the evidence and may request an opinion from the Authority. The Commission may set a time limit within which such an opinion shall be provided. | 4. In the cases referred under paragraph 3 above, the Commission shall take measures to restrict or prohibit the use and/or sale of such treated seeds and plant reproductive material in accordance with the procedure referred to in Article 79(3). Before taking such measures, the Commission shall examine the evidence and may request an opinion from the Authority. The Commission may set a time limit within which such an opinion shall be provided. |
| Text proposed by the Commission | Amendment |
|---|---|
| 4. In the cases referred under paragraph 3 above, the Commission may take measures to restrict or prohibit the use and/or sale of such treated seeds and plant reproductive material in accordance with the procedure referred to in Article 79(3). Before taking such measures, the Commission shall examine the evidence and may request an opinion from the Authority. The Commission may set a time limit within which such an opinion shall be provided. | 4. In the cases referred under paragraph 3 above, the Commission shall take measures to restrict or prohibit the use and/or sale of such treated seeds and plant reproductive material in accordance with the procedure referred to in Article 79(3). Before taking such measures, the Commission shall examine the evidence and may request an opinion from the Authority. The Commission may set a time limit within which such an opinion shall be provided. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Without prejudice to other Union legislation concerning the labelling of seeds and plant reproductive material, the label and documents accompanying the treated seeds and plant reproductive material shall include the name of the plant protection product with which they were treated, its authorisation number and the Member State which authorised it, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and, where applicable, risk mitigation measures set out in the authorisation for that product. | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Without prejudice to other Union legislation concerning the labelling of seeds and plant reproductive material, the label and documents accompanying the treated seeds and plant reproductive material shall include the name of the plant protection product with which they were treated, its authorisation number and the Member State which authorised it, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and, where applicable, risk mitigation measures set out in the authorisation for that product. | deleted |
The amendment to paragraph 6 also introduces a new requirement to state the national authorisation number of the plant protection product used in seed treatment on the seed label. As authorisation numbers are issued at national level, in the case of cross-border marketing the label would have to be physically adapted for each Member State of destination, which would effectively bring an end to the free trade in seeds within the single market. This additional bureaucratic burden will result solely in extra costs, which will be passed on down the supply chain to the end user.
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Without prejudice to other Union legislation concerning the labelling of seeds and plant reproductive material, the label and documents accompanying the treated seeds and plant reproductive material shall include the name of the plant protection product with which they were treated, its authorisation number and the Member State which authorised it, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and, where applicable, risk mitigation measures set out in the authorisation for that product. | 6. Without prejudice to other Union legislation concerning the labelling of seeds and plant reproductive material, the label and documents accompanying the treated seeds and plant reproductive material shall include the name of the plant protection product with which they were treated, its authorisation number and the Member State which authorised it, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and, where applicable, risk mitigation measures set out in the authorisation for that product and information on restrictions concerning use in areas of particular environmental sensitivity, where applicable. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Without prejudice to other Union legislation concerning the labelling of seeds and plant reproductive material, the label and documents accompanying the treated seeds and plant reproductive material shall include the name of the plant protection product with which they were treated, its authorisation number and the Member State which authorised it, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and, where applicable, risk mitigation measures set out in the authorisation for that product. | 6. Without prejudice to other Union legislation concerning the labelling of seeds and plant reproductive material, the label and documents accompanying the treated seeds and plant reproductive material shall include the name of the plant protection product with which they were treated, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and, risk mitigation measures relating to the handling and sowing of treated seed, shall be used. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Without prejudice to other Union legislation concerning the labelling of seeds and plant reproductive material, the label and documents accompanying the treated seeds and plant reproductive material shall include the name of the plant protection product with which they were treated, its authorisation number and the Member State which authorised it, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and, where applicable, risk mitigation measures set out in the authorisation for that product. | 6. Without prejudice to other Union legislation concerning the labelling of seeds, the label and documents accompanying the treated seeds shall include the name of the plant protection product with which the seeds were treated, its authorisation number and the Member State which authorised it, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and any risk mitigation measures relating to the handling and sowing of treated seed, shall be used. |
The text should be clarified to avoid legal uncertainty. It is currently unclear which risk mitigation measures are covered. The provision should therefore refer specifically to risk mitigation measures relating to the handling and sowing of treated seed, rather than to all measures contained in the product authorisation.
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Without prejudice to other Union legislation concerning the labelling of seeds and plant reproductive material, the label and documents accompanying the treated seeds and plant reproductive material shall include the name of the plant protection product with which they were treated, its authorisation number and the Member State which authorised it, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and, where applicable, risk mitigation measures set out in the authorisation for that product. | 6. Without prejudice to other Union legislation concerning the labelling of seeds and plant reproductive material, the label and documents accompanying the treated seeds and plant reproductive material shall include the name of the plant protection product with which they were treated, the Member State which authorised it, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and, where applicable, risk mitigation measures set out in the authorisation for that product. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Without prejudice to other Union legislation concerning the labelling of seeds and plant reproductive material, the label and documents accompanying the treated seeds and plant reproductive material shall include the name of the plant protection product with which they were treated, its authorisation number and the Member State which authorised it, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and, where applicable, risk mitigation measures set out in the authorisation for that product. | 6. Without prejudice to other Union legislation concerning the labelling of seeds and plant reproductive material, the label and documents accompanying the treated seeds and plant reproductive material shall include the name of the plant protection product with which they were treated and the Member State which authorised it, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and, where applicable, risk mitigation measures set out in the authorisation for that product. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6. Without prejudice to other Union legislation concerning the labelling of seeds and plant reproductive material, the label and documents accompanying the treated seeds and plant reproductive material shall include the name of the plant protection product with which they were treated, its authorisation number and the Member State which authorised it, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and, where applicable, risk mitigation measures set out in the authorisation for that product. | 6. Without prejudice to other Union legislation concerning the labelling of seeds and plant reproductive material, the label and documents accompanying the treated seeds and plant reproductive material shall include the name of the plant protection product with which they were treated and the Member State which authorised it, the name(s) of the active substance(s) in that product, standard phrases for safety precautions as provided for in Regulation (EC) No 1272/2008 and, where applicable, risk mitigation measures set out in the authorisation for that product. |
| Text proposed by the Commission | Amendment |
|---|---|
| 6a. The placing on the market and use of treated seeds and plant reproductive material shall not undermine the objectives of Union legislation on biodiversity protection, including by causing unacceptable risks to pollinators, beneficial organisms or other non-target organisms. |
| Text proposed by the Commission | Amendment |
|---|---|
| 7. Machinery used to sow treated seeds shall not be considered pesticide application equipment in the context of Article 8 of Directive 2009/128/EC.; | deleted |
This is a deregulation measure. Dust emissions from treated seed sowing are a known exposure pathway (especially for pollinators). Excluding machinery from pesticide application equipment rules could reduce requirements for training, inspection and risk mitigation.
| Text proposed by the Commission | Amendment |
|---|---|
| 7. Machinery used to sow treated seeds shall not be considered pesticide application equipment in the context of Article 8 of Directive 2009/128/EC.; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 7. Machinery used to sow treated seeds shall not be considered pesticide application equipment in the context of Article 8 of Directive 2009/128/EC.; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 7a. By way of derogation from paragraph 3, Member States shall not prohibit the placing on the market or use of seeds treated with a plant protection product where the treatment is authorised for officially demarcated areas in which there is documented endemic pressure from soil pests, as demonstrated by multi-year plant protection monitoring and relevant scientific data, in the absence of any affordable and at least equally effective alternatives, provided that appropriate risk mitigation measures are applied. |
Carmen Crespo Díaz, Esther Herranz García, Dolors Montserrat, Juan Ignacio Zoido Álvarez, Susana Solís Pérez
| Text proposed by the Commission | Amendment |
|---|---|
| 7a. Member States shall facilitate the use of treated seeds and other treated plant reproductive material by means of clear, harmonised and proportionate procedures. They may not lay down any additional requirements that might unjustifiably impede their marketing, movement or use where the plant protection product used is authorised for that use in at least one Member State and the labelling, traceability and risk-management conditions laid down in this Article are fulfilled. |
| Text proposed by the Commission | Amendment |
|---|---|
| 2. Member States shall extend the authorisation provided that all the following conditions are met: | 2. Member States shall decide on applications for renewal of the authorisation for minor uses submitted in accordance with this Article within 120 days of receipt of the application. If the Member States do not take a decision within that period, the extension shall be deemed to have been granted under the same conditions as the initial authorisation. |
| Text proposed by the Commission | Amendment |
|---|---|
| (a) the intended use is minor in nature; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (b) the conditions provided for in Article 4(3)(b), (d) and (e) and Article 29(1)(i) are fulfilled; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) the extension is in the public interest |
The Commission proposal aims to increase the availability of pesticides for minor uses, namely by removing the public interest requirement and obliging Member States to facilitate or encourage extensions for minor uses. These changes raise concerns that they would weaken the requirements for minor uses without addressing the underlying problem of an inconsistent, non-harmonised definition and the ongoing misuse of minor-uses.
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) the extension is in the public interest |
| Text proposed by the Commission | Amendment |
|---|---|
| (c) the documentation and information to support the extension of use has been submitted by the persons or bodies referred to in paragraph 1 or is available otherwise, in particular data on the of residues and where necessary on the risk assessment as regards the operators, workers and bystanders. | 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 |
|---|---|
| (ca) The competent authorities shall support the bodies referred to in paragraph 1, other than the authorisation holder, in obtaining the documents and data necessary for the authorisation. In these cases, derogation should be allowed for the generation of data required for authorisation. In particular, reduced requirements for residue data should apply for minor crops and minor uses (e.g. fewer trial repetitions and the possibility to conduct analyses in non-GLP-certified laboratories). | |
| To strengthen the cultivation of minor crops, the costs and administrative burden for procedures under Article 51 should be reduced to a minimum. | |
| The Commission shall establish a Union programme to support the generation of data and the authorisation of plant protection products for minor crops and minor uses. |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) The competent authorities shall support the bodies referred to in paragraph 1, other than the authorisation holder, in obtaining the documents and data necessary for the authorisation. In these cases, derogation should be allowed for the generation of data required for authorisation. in particular, reduced requirements for residue data should apply for minor crops and minor uses (e.g. fewer trial repetitions and the possibility to conduct analyses in non-GLP-certified laboratories). |
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) the extension is justified in the public interest |
Gheorghe Cârciu, Biljana Borzan, Dan Nica, Ştefan Muşoiu, Vasile Dîncu, Andi Cristea, Dragoş Benea, Gabriela Firea
| Text proposed by the Commission | Amendment |
|---|---|
| (ca) the extension is in the public interest |
| Text proposed by the Commission | Amendment |
|---|---|
| (cb) To strengthen the cultivation of minor crops, the costs and administrative burden for procedures under Article 51 should be reduced to a minimum. The Commission shall establish a Union programme to support the generation of data and the authorisation of plant protection products for minor crops and minor uses. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Member States shall take measures to facilitate or encourage the submission of applications to extend the authorisation of already authorised plant protection products to minor uses.; | 3. Member States shall take measures to facilitate or encourage the submission of applications to extend the authorisation of already authorised plant protection products containing low-risk active substances and low-risk biocontrol substances to minor uses.’; |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Member States shall take measures to facilitate or encourage the submission of applications to extend the authorisation of already authorised plant protection products to minor uses.; | 3. Member States shall take measures to facilitate or encourage the submission of applications to extend the authorisation of already authorised plant protection products to minor uses and also do the applications therefore by the competent authorities.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Member States shall take measures to facilitate or encourage the submission of applications to extend the authorisation of already authorised plant protection products to minor uses.; | 3. Member States shall take measures to facilitate or encourage the submission of applications to extend the authorisation of already authorised plant protection products containing low-risk active substances to minor uses.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Member States shall take measures to facilitate or encourage the submission of applications to extend the authorisation of already authorised plant protection products to minor uses.; | 3. Member States shall take measures to facilitate or encourage the submission of applications to extend the authorisation of already authorised plant protection products containing only biocontrol substances to minor uses. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Member States shall take measures to facilitate or encourage the submission of applications to extend the authorisation of already authorised plant protection products to minor uses.; | 3. Member States shall take measures to facilitate or encourage the submission of applications to extend the authorisation of already authorised plant protection products containing low-risk substances to minor uses. |
| Text proposed by the Commission | Amendment |
|---|---|
| 3. Member States shall take measures to facilitate or encourage the submission of applications to extend the authorisation of already authorised plant protection products to minor uses.; | 3. Member States shall take measures to facilitate or encourage the submission of applications to extend the authorisation of already biocontrol authorised plant protection products to minor uses.; |
| Text proposed by the Commission | Amendment |
|---|---|
| (ba) Article 51(3) is supplemented by the following new subparagraph: | |
| “Member States shall maintain a register of pending applications for the extension of authorisations for minor uses and of extensions of authorisations for minor uses granted pursuant to this Article, which shall be updated at least once a year, and shall make this register publicly available. The Commission shall facilitate the exchange of this information between Member States through the Union Register of Plant Protection Products." |
The European Minor Uses Coordination Facility is chronically underfunded. Member States share very little data on outstanding gaps and ongoing activities, yet the visibility of existing authorisations in other Member States is a prerequisite for mutual recognition to function effectively.
| Text proposed by the Commission | Amendment |
|---|---|
| 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) even if the uses in the reference Member State are not minor uses. Member States shall authorise such uses in accordance with Article 41.; | deleted |
| Text proposed by the Commission | Amendment |
|---|---|
| 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) even if the uses in the reference Member State are not minor uses. Member States shall authorise such uses in accordance with Article 41. | 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) on the basis of an authorisation in force in another Member State for the major use with which the minor use is associated in one or another of the Member States, even if the uses in the reference Member State are not minor uses and even if the product in question is not yet authorised in the Member State that receives the application. Member States shall authorise such uses in accordance with Article 41, taking account of the identity of the product, the usages applied for, and the comparability of the agricultural and phytosanitary conditions. Member States may, in accordance with Article 51, extend the authorisation of the plant health product that has already been authorised for major use to cover minor uses associated with that major use, where the product is already authorised in another Member State in the same zone or where the agricultural and phytosanitary conditions are comparable. |
| Applications submitted under this paragraph, in particular those relating to crops or uses affected by a phytosanitary dead end resulting from specific climate, agri-economic or phytosanitary conditions, shall be subject to a fast-track procedure. Member States shall decide on such applications at the latest two years after receipt of a complete dossier. |
| Text proposed by the Commission | Amendment |
|---|---|
| 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) even if the uses in the reference Member State are not minor uses. Member States shall authorise such uses in accordance with Article 41.’; | 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) on the basis of an authorisation in force in another Member State for the major crop with which the minor crop is associated in one or another of the Member States, even if the uses in the reference Member State are not minor uses and even if the product in question is not yet authorised in the Member State that receives the application. Member States shall authorise such uses in accordance with Article 41, taking account of the identity of the product, the usages applied for, and the comparability of the agricultural and phytosanitary conditions. Member States may, in accordance with Article 51, extend the authorisation of the plant health product that has already been authorised for a major crop to cover minor crops associated with that major crop, where the product is already authorised in another Member State in the same zone or where the agricultural and phytosanitary conditions are comparable. |
| Text proposed by the Commission | Amendment |
|---|---|
| 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) even if the uses in the reference Member State are not minor uses. Member States shall authorise such uses in accordance with Article 41.; | 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) even if the uses in the reference Member State are not minor uses. Member States shall authorise such uses in accordance with Article 41. |
| Competent authorities shall help officials or scientific bodies involved in agricultural activities, professional agricultural organisations or professional users to do the applications for authorisation of minor uses. |
| Text proposed by the Commission | Amendment |
|---|---|
| 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) even if the uses in the reference Member State are not minor uses. Member States shall authorise such uses in accordance with Article 41.; | 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product containing low- risk active substances and low-risk biocontrol substances for minor uses in accordance with Article 40(1) even if the uses in the reference Member State are not minor uses. Member States shall authorise such uses in accordance with Article 41.’; |
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 |
|---|---|
| 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) even if the uses in the reference Member State are not minor uses. Member States shall authorise such uses in accordance with Article 41.; | 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product containing only biocontrol active substances for minor uses in accordance with Article 40(1) even if the uses in the reference Member State are not minor uses. Member States shall authorise such uses in accordance with Article 41.; |
Simplified procedures for extending authorisations to minor uses should be targeted at biocontrol products, thereby promoting access to safer alternatives while maintaining the existing level of scientific scrutiny for other plant protection products.
| Text proposed by the Commission | Amendment |
|---|---|
| 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) even if the uses in the reference Member State are not minor uses. Member States shall authorise such uses in accordance with Article 41.; | 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product containing only biocontrol substances for minor uses in accordance with Article 40(1) even if the uses in the reference Member State are not minor uses. Member States shall authorise such uses in accordance with Article 41.; |
| Text proposed by the Commission | Amendment |
|---|---|
| 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product for minor uses in accordance with Article 40(1) even if the uses in the reference Member State are not minor uses. Member States shall authorise such uses in accordance with Article 41.; | 7. The applicants referred to in paragraph 1 may also apply for authorisation of a plant protection product containing low-risk substances for minor uses in accordance with Article 40(1) even if the uses in the reference Member State are not minor uses. Member States shall authorise such uses in accordance with Article 41. |
| Text proposed by the Commission | Amendment |
|---|---|
| 7a. Competent authorities shall help officials or scientific bodies involved in agricultural activities, professional agricultural organisations or professional users to do the applications for authorisation of minor uses. |
| Text proposed by the Commission | Amendment |
|---|---|
| (d) paragraph 9 is replaced by the following: | (d) In paragraph 9 the following suparagraph is added: |
| "Member States shall keep and make publicly available a list of pending applications for the extension of the authorisation for minor use and the extensions of the authorisation for minor use granted in accordance with this Article, which shall be updated at least once a year. The Commission shall encourage the exchange of such information between Member States through the Union Plant Protection Products Register." |
| Text proposed by the Commission | Amendment |
|---|---|
| 9. Detailed rules for the implementation of this Article 51 may be established in accordance with the procedure referred to in Article 79(3).; | deleted |
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European Parliament (2026). “AMENDMENTS 827 - 1123 - 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-791050. EU Parl Watch Research. https://news.eu-parl.st-solutions.dev/texts/CJ14-AM-791050 (retrieved 25 September 2026). Data: EP Open Data API: document record, https://data.europarl.europa.eu/api/v2/documents/CJ14-AM-791050 (CC BY 4.0).
BibTeX
@misc{epw-text-cj14-am-791050,
author = {{European Parliament}},
title = {{AMENDMENTS 827 - 1123 - 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-791050}},
url = {https://news.eu-parl.st-solutions.dev/texts/CJ14-AM-791050},
urldate = {2026-09-25},
publisher = {EU Parl Watch Research},
note = {Text. docId CJ14-AM-791050. Data: EP Open Data API: document record (CC BY 4.0)}
}