Commission Implementing Regulation (EU) No 1037/2012 of 7 November 2012 approving the active substance isopyrazam, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011 Text with EEA relevance
Modified by
  • Commission Implementing Regulation (EU) 2015/1106of 8 July 2015amending Implementing Regulations (EU) No 540/2011 and (EU) No 1037/2012 as regards the conditions of approval of the active substance isopyrazam(Text with EEA relevance), 32015R1106, July 9, 2015
  • Commission Implementing Regulation (EU) 2022/782of 18 May 2022withdrawing the approval of the active substance isopyrazam in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, amending Commission Implementing Regulation (EU) No 540/2011 and repealing Implementing Regulation (EU) No 1037/2012(Text with EEA relevance), 32022R0782, May 19, 2022
Commission Implementing Regulation (EU) No 1037/2012of 7 November 2012approving the active substance isopyrazam, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011(Text with EEA relevance)
Article 1Approval of active substanceThe active substance isopyrazam, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Article 2Re-evaluation of plant protection products1.Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing isopyrazam as an active substance by 30 September 2013.By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.2.By way of derogation from paragraph 1, for each authorised plant protection product containing isopyrazam as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 March 2013 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.Following that determination Member States shall:(a)in the case of a product containing isopyrazam as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2014 at the latest; or(b)in the case of a product containing isopyrazam as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2014 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or substances, whichever is the latest.
Article 3Amendments to Implementing Regulation (EU) No 540/2011The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 4Entry into force and date of applicationThis Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.It shall apply from 1 April 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX I
Further details on identity and specification of active substance are provided in the review report.
Common Name, Identification NumbersIUPAC NamePurityDate of approvalExpiration of approvalSpecific provisions
IsopyrazamCAS No 881685-58-1(syn-isomer: 683777-13-1/anti-isomer: 683777-14-2)CIPAC No 963A mixture of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide(syn-isomer – 50:50 mix of two enantiomers)and3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide(anti-isomer– 50:50 mix of two enantiomers)In a range of 78:15 % to 100:0 % syn to anti.≥ 920 g/kgIn a range of 78:15 % to 100:0 % syn- to anti-isomers1 April 201331 March 2023For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on isopyrazam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to aquatic organisms;(b)the risk to earthworms if the substance is applied in the framework of no cultivation/minimum cultivation practices;(c)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, like the exclusion of no cultivation/minimum cultivation practices, and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate.The applicant shall submit confirmatory information as regards the relevance of the metabolites CSCD 459488 and CSCD 459489 for groundwater.The applicant shall submit to the Commission, the Member States and the Authority this information by 31 July 2017.
ANNEX IIIn Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Further details on identity and specification of active substance are provided in the review report.
NumberCommon Name, Identification NumbersIUPAC NamePurityDate of approvalExpiration of approvalSpecific provisions
"27IsopyrazamCAS No 881685-58-1(syn-isomer: 683777-13-1/anti-isomer: 683777-14-2)CIPAC No 963A mixture of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide(syn-isomer – 50:50 mix of two enantiomers)and3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide(anti-isomer– 50:50 mix of two enantiomers)In a range of 78:15 % to 100:0 % syn to anti.≥ 920 g/kgIn a range of 78:15 % to 100:0 % syn- to anti-isomers1 April 201331 March 2023For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on isopyrazam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to aquatic organisms;(b)the risk to earthworms if the substance is applied in the framework of no cultivation/minimum cultivation practices;(c)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, like the exclusion of no cultivation/minimum cultivation practices, and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate.The applicant shall submit confirmatory information as regards the relevance of the metabolites CSCD 459488 and CSCD 459489 for groundwater.The applicant shall submit to the Commission, the Member States and the Authority this information by 31 July 2017."
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Further details on identity and specification of active substance are provided in the review report.
Article 1Approval of active substanceThe active substance isopyrazam, as specified in Annex I, is approved subject to the conditions laid down in that Annex.
Article 2Re-evaluation of plant protection products1.Member States shall in accordance with Regulation (EC) No 1107/2009, where necessary, amend or withdraw existing authorisations for plant protection products containing isopyrazam as an active substance by 30 September 2013.By that date they shall in particular verify that the conditions in Annex I to this Regulation are met, with the exception of those identified in the column on specific provisions of that Annex, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to Directive 91/414/EEC in accordance with the conditions of Article 13(1) to (4) of that Directive and Article 62 of Regulation (EC) No 1107/2009.2.By way of derogation from paragraph 1, for each authorised plant protection product containing isopyrazam as either the only active substance or as one of several active substances, all of which were listed in the Annex to Implementing Regulation (EU) No 540/2011 by 31 March 2013 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles, as referred to in Article 29(6) of Regulation (EC) No 1107/2009, on the basis of a dossier satisfying the requirements of Annex III to Directive 91/414/EEC and taking into account the column on specific provisions of Annex I to this Regulation. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 29(1) of Regulation (EC) No 1107/2009.Following that determination Member States shall:(a)in the case of a product containing isopyrazam as the only active substance, where necessary, amend or withdraw the authorisation by 30 September 2014 at the latest; or(b)in the case of a product containing isopyrazam as one of several active substances, where necessary, amend or withdraw the authorisation by 30 September 2014 or by the date fixed for such an amendment or withdrawal in the respective act or acts which added the relevant substance or substances to Annex I to Directive 91/414/EEC or approved that substance or substances, whichever is the latest.
Article 3Amendments to Implementing Regulation (EU) No 540/2011The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 4Entry into force and date of applicationThis Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.It shall apply from 1 April 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.ANNEX I
Further details on identity and specification of active substance are provided in the review report.
Common Name, Identification NumbersIUPAC NamePurityDate of approvalExpiration of approvalSpecific provisions
IsopyrazamCAS No 881685-58-1(syn-isomer: 683777-13-1/anti-isomer: 683777-14-2)CIPAC No 963A mixture of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide(syn-isomer – 50:50 mix of two enantiomers)and3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide(anti-isomer– 50:50 mix of two enantiomers)In a range of 78:15 % to 100:0 % syn to anti.≥ 920 g/kgIn a range of 78:15 % to 100:0 % syn- to anti-isomers1 April 201331 March 2023For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on isopyrazam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to aquatic organisms;(b)the risk to earthworms if the substance is applied in the framework of no cultivation/minimum cultivation practices;(c)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, like the exclusion of no cultivation/minimum cultivation practices, and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate.The applicant shall submit confirmatory information as regards the relevance of the metabolites CSCD 459488 and CSCD 459489 for groundwater.The applicant shall submit to the Commission, the Member States and the Authority this information by 31 July 2017.
ANNEX IIIn Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Further details on identity and specification of active substance are provided in the review report.
NumberCommon Name, Identification NumbersIUPAC NamePurityDate of approvalExpiration of approvalSpecific provisions
"27IsopyrazamCAS No 881685-58-1(syn-isomer: 683777-13-1/anti-isomer: 683777-14-2)CIPAC No 963A mixture of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide(syn-isomer – 50:50 mix of two enantiomers)and3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide(anti-isomer– 50:50 mix of two enantiomers)In a range of 78:15 % to 100:0 % syn to anti.≥ 920 g/kgIn a range of 78:15 % to 100:0 % syn- to anti-isomers1 April 201331 March 2023For the implementation of the uniform principles as referred to in Article 29(6) of Regulation (EC) No 1107/2009, the conclusions of the review report on isopyrazam, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 September 2012 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the risk to aquatic organisms;(b)the risk to earthworms if the substance is applied in the framework of no cultivation/minimum cultivation practices;(c)the protection of groundwater, when the substance is applied in regions with vulnerable soil and/or climatic conditions.Conditions of use shall include risk mitigation measures, like the exclusion of no cultivation/minimum cultivation practices, and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate.The applicant shall submit confirmatory information as regards the relevance of the metabolites CSCD 459488 and CSCD 459489 for groundwater.The applicant shall submit to the Commission, the Member States and the Authority this information by 31 July 2017."
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Further details on identity and specification of active substance are provided in the review report.