
COMMISSION IMPLEMENTING REGULATION (EU) No 91/2014 of 31 January 2014 approving S-methoprene as an existing active substance for use in biocidal products for product-type 18 (Text with EEA relevance) 

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012 concerning the making available on the market and use of biocidal products, and in particular the third subparagraph of Article 89(1) thereof,
Whereas:

(1) Commission Regulation (EC) No 1451/2007 establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC of the European Parliament and of the Council. That list includes S-methoprene.

(2) S-methoprene has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive, which corresponds to product-type 18 as defined in Annex V to Regulation (EU) No 528/2012.

(3) Ireland was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 29 October 2010 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

(4) The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 13 December 2013, in an assessment report.

(5) It appears from that report that biocidal products used for product-type 18 and containing S-methoprene may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.

(6) It is therefore appropriate to approve S-methoprene for use in biocidal products for product-type 18.

(7) Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.

(8) A reasonable period should be allowed to elapse before an active substance is approved, in order to permit Member States, interested parties, and the Commission where appropriate, to prepare themselves to meet the new requirements entailed.

(9) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Biocidal Products,
HAS ADOPTED THIS REGULATION:

Article 1 
S-methoprene shall be approved as an active substance for use in biocidal products for product-type 18, subject to the specifications and conditions set out in the Annex.
Article 2 
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.Done at Brussels, 31 January 2014.
For the Commission
The President
José Manuel BARROSO
ANNEX

Common Name IUPAC NameIdentification Numbers Minimum degree of purity of the active substance Date of approval Expiry date of approval Product type Specific conditions
S-methoprene IUPAC Name:Isopropyl-(2E,4E,7S)-11-methoxy-3,7,11-trimethyl-2,4-dodecadienoateEC No: N/ACAS No: 65733-16-6 950 g/kg 1 September 2015 31 August 2025 18 The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any uses covered by an application for authorisation, but not addressed in the Union level risk assessment of the active substance.Authorisations are subject to the following condition:For products that may lead to residues in food or feed, the need to set new or to amend existing maximum residue levels (MRLs) in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.



