
Article 1 
The approval of the active substance acibenzolar-S-methyl, as specified in Annex I, is renewed subject to the conditions laid down in that Annex.
Article 2 
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with Annex II to this Regulation.
Article 3 
This 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 2016.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 17 March 2016.
For the Commission
The President
Jean-Claude JUNCKER
ANNEX I

Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
Acibenzolar-S-methylCAS No 135158-54-2CIPAC No 597 S-methyl benzo[1,2,3]thiadiazole-7-carbothioate 970 g/kgToluene: max. 5 g/kg 1 April 2016 31 March 2031 For 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 acibenzolar-S-methyl, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:
((a)) the risk for consumers via food intake;
((b)) the protection of operators and workers;
((c)) the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall by 1 June 2017 submit to the Commission, the Member States and the Authority confirmatory information as regards the relevance and reproducibility of the morphometric changes observed in the cerebellum of foetuses linked to exposure to acibenzolar-S-methyl and whether these changes may be produced via an endocrine mode of action. The information to be submitted shall include a systematic review of the available evidence assessed on the basis of available guidance (e.g. EFSA GD on Systematic Review methodology, 2010).

ANNEX II

The Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:

((1)) in Part A, entry 20 on acibenzolar-S-methyl is deleted;
((2)) in Part B, the following entry is added:

Number Common Name, Identification Numbers IUPAC Name Purity Date of approval Expiration of approval Specific provisions
‘98 Acibenzolar-S-methylCAS No 135158-54-2CIPAC No 597 S-methyl benzo[1,2,3]thiadiazole-7-carbothioate 970 g/kgToluene: max. 5 g/kg 1 April 2016 31 March 2031 For 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 acibenzolar-S-methyl, and in particular Appendices I and II thereof, shall be taken into account.In this overall assessment Member States shall pay particular attention to:
((a)) the risk for consumers via food intake;
((b)) the protection of operators and workers;
((c)) the risk to aquatic organisms.Conditions of use shall include risk mitigation measures, where appropriate.The applicant shall by 1 June 2017 submit to the Commission, the Member States and the Authority, confirmatory information as regards the relevance and reproducibility of the morphometric changes observed in the cerebellum of foetuses linked to exposure to acibenzolar-S-methyl and whether these changes may be produced via an endocrine mode of action. The information to be submitted shall includea systematic review of the available evidence assessed on the basis of available guidance (e.g. EFSA GD on Systematic Review methodology, 2010).’

