Commission Implementing Regulation (EU) No 820/2011 of 16 August 2011 approving the active substance terbuthylazine, 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 and Commission Decision 2008/934/EC Text with EEA relevance
Modified by
  • Commission Implementing Regulation (EU) 2021/824of 21 May 2021amending Implementing Regulations (EU) No 540/2011 and (EU) No 820/2011 as regards the conditions of approval of the active substance terbuthylazine(Text with EEA relevance), 32021R0824, May 25, 2021
Commission Implementing Regulation (EU) No 820/2011of 16 August 2011approving the active substance terbuthylazine, 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 and Commission Decision 2008/934/EC(Text with EEA relevance)
Article 1Approval of active substanceThe active substance terbuthylazine, 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 terbuthylazine as an active substance by 30 June 2012.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 Part B of 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 terbuthylazine 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 December 2011 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 Part B of 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 terbuthylazine as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or(b)in the case of a product containing terbuthylazine as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 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 4Amendments to Decision 2008/934/ECThe line concerning terbuthylazine in the Annex to Decision 2008/934/EC is deleted.
Article 5Entry into force and date of applicationThis Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.It shall apply from 1 January 2012.
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
TerbuthylazineCAS No 5915-41-3CIPAC No 234N2-tert-butyl-6-chloro-N4-ethyl-1,3,5-triazine-2,4-diamine≥ 950 g/kgThe following impurities are of toxicological concern and must not exceed the following levels in the technical material:Propazine: maximum of 9 g/kgAtrazine: maximum of 1 g/kgSimazine: maximum of 9 g/kg1 January 201231 December 2024PART AOnly uses as herbicide may be authorised.Use shall be limited to one application every three years on the same field at a maximum dose of 850 g terbuthylazine per hectare.PART BFor 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 terbuthylazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 and updated by the Standing Committee on Plants, Animals, Food and Feed on 24 March 2021 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the consumer risk assessment from exposure to metabolites of terbuthylazine,the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,the risk to mammals and earthworms.Conditions of use shall include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate
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
"16TerbuthylazineCAS No 5915-41-3CIPAC No 234N2-tert-butyl-6-chloro-N4-ethyl-1,3,5-triazine-2,4-diamine≥ 950 g/kgImpurities:Propazine not more than 10 g/kgAtrazine not more than 1 g/kgSimazine not more than 30 g/kg1 January 201231 December 2021PART AOnly uses as herbicide may be authorised.PART BFor 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 terbuthylazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;(b)the risk to mammals and earthworms.Conditions of use shall include risk mitigation measures 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:(1)the specification of the technical material, as commercially manufactured, by appropriate analytical data, including information on the relevance of the impurities;(2)the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies;(3)groundwater exposure assessment for the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6;(4)the relevance of the metabolites MT1 (N-tert-butyl-6-chloro-1,3,5-triazine-2,4-diamine), MT 13 (4-(tert-butylamino)-6-(ethylamino)-1,3,5-triazin-2-ol or 6-hydroxy-N2-ethyl-N4-tert-butyl-1,3,5-triazine-2,4-diamine), MT14 (4-amino-6-(tert-butylamino)-1,3,5-triazin-2-ol or N-tert-butyl-6-hydroxy-1,3,5-triazine-2,4-diamine), and of the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6 with respect to cancer, if terbuthylazine is classified under Regulation (EC) No 1272/2008 as "suspected of causing cancer".The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012, the information set out in point (3) by 30 June 2013 and the information set out in point (4) within six months from the notification of the classification decision concerning that substance."
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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 terbuthylazine, 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 terbuthylazine as an active substance by 30 June 2012.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 Part B of 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 terbuthylazine 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 December 2011 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 Part B of 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 terbuthylazine as the only active substance, where necessary, amend or withdraw the authorisation by 31 December 2015 at the latest; or(b)in the case of a product containing terbuthylazine as one of several active substances, where necessary, amend or withdraw the authorisation by 31 December 2015 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 4Amendments to Decision 2008/934/ECThe line concerning terbuthylazine in the Annex to Decision 2008/934/EC is deleted.
Article 5Entry into force and date of applicationThis Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.It shall apply from 1 January 2012.
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
TerbuthylazineCAS No 5915-41-3CIPAC No 234N2-tert-butyl-6-chloro-N4-ethyl-1,3,5-triazine-2,4-diamine≥ 950 g/kgThe following impurities are of toxicological concern and must not exceed the following levels in the technical material:Propazine: maximum of 9 g/kgAtrazine: maximum of 1 g/kgSimazine: maximum of 9 g/kg1 January 201231 December 2024PART AOnly uses as herbicide may be authorised.Use shall be limited to one application every three years on the same field at a maximum dose of 850 g terbuthylazine per hectare.PART BFor 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 terbuthylazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 and updated by the Standing Committee on Plants, Animals, Food and Feed on 24 March 2021 shall be taken into account.In this overall assessment Member States shall pay particular attention to:the consumer risk assessment from exposure to metabolites of terbuthylazine,the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions,the risk to mammals and earthworms.Conditions of use shall include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential groundwater contamination in vulnerable zones, where appropriate
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
"16TerbuthylazineCAS No 5915-41-3CIPAC No 234N2-tert-butyl-6-chloro-N4-ethyl-1,3,5-triazine-2,4-diamine≥ 950 g/kgImpurities:Propazine not more than 10 g/kgAtrazine not more than 1 g/kgSimazine not more than 30 g/kg1 January 201231 December 2021PART AOnly uses as herbicide may be authorised.PART BFor 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 terbuthylazine, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 17 June 2011 shall be taken into account.In this overall assessment Member States shall pay particular attention to:(a)the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;(b)the risk to mammals and earthworms.Conditions of use shall include risk mitigation measures 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:(1)the specification of the technical material, as commercially manufactured, by appropriate analytical data, including information on the relevance of the impurities;(2)the equivalence between the specifications of the technical material, as commercially manufactured, and the specifications of the test material used in the toxicity studies;(3)groundwater exposure assessment for the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6;(4)the relevance of the metabolites MT1 (N-tert-butyl-6-chloro-1,3,5-triazine-2,4-diamine), MT 13 (4-(tert-butylamino)-6-(ethylamino)-1,3,5-triazin-2-ol or 6-hydroxy-N2-ethyl-N4-tert-butyl-1,3,5-triazine-2,4-diamine), MT14 (4-amino-6-(tert-butylamino)-1,3,5-triazin-2-ol or N-tert-butyl-6-hydroxy-1,3,5-triazine-2,4-diamine), and of the unidentified metabolites LM1, LM2, LM3, LM4, LM5 and LM6 with respect to cancer, if terbuthylazine is classified under Regulation (EC) No 1272/2008 as "suspected of causing cancer".The applicant shall submit to the Commission, the Member States and the Authority the information set out in points (1) and (2) by 30 June 2012, the information set out in point (3) by 30 June 2013 and the information set out in point (4) within six months from the notification of the classification decision concerning that substance."
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Further details on identity and specification of active substance are provided in the review report.