
COMMISSION IMPLEMENTING REGULATION (EU) 2016/2289 of 16 December 2016 approving epsilon-Momfluorothrin as an active substance for use in biocidal products of 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 Article 90(2) thereof,
Whereas:

(1) The United Kingdom received on 29 May 2013 an application, in accordance with Article 11(1) of Directive 98/8/EC of the European Parliament and of the Council, for the inclusion of the active substance epsilon-Momfluorothrin, in Annex I to that Directive for use in products of product-type 18, insecticides, acaricides and products to control other arthropods, as described in Annex V to that Directive, which correspond to product-type 18 as described in Annex V to Regulation (EU) No 528/2012.

(2) The United Kingdom submitted the assessment report together with its recommendations on 6 October 2015 in accordance with Article 90(2) of Regulation (EU) No 528/2012.

(3) The opinion of the European Chemicals Agency was formulated on 16 June 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.

(4) According to that opinion, biocidal products of product-type 18 and containing epsilon-Momfluorothrin may be expected to satisfy the criteria of Article 19(1)(b) of Regulation (EU) No 528/2012, provided that certain specifications and conditions concerning their use are complied with.

(5) It is therefore appropriate to approve epsilon-Momfluorothrin for use in biocidal products of product-type 18, subject to compliance with certain specifications and conditions.

(6) A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.

(7) 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 
epsilon-Momfluorothrin is approved as an active substance for use in biocidal products of 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, 16 December 2016.
For the Commission
The President
Jean-Claude JUNCKER
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
epsilon-Momfluorothrin IUPAC Name:
 All isomers: 2,3,5,6-tetrafluoro-4-(methoxymethyl)benzyl (EZ)-(1RS,3RS;1SR,3SR)-3-(2-cyanoprop-1-enyl)-2,2-dimethylcyclopropanecarboxylate
 RTZ isomer: 2,3,5,6-Tetrafluoro-4-(methoxymethyl)benzyl (Z)-(1R,3R)-3-(2-cyanoprop-1-enyl)-2,2-dimethylcyclopropanecarboxylateEC No: noneCAS No:
 All isomers: 609346-29-4
 RTZ isomer: 1065124-65-3 All isomers: 93 % w/wRTZ isomers: 82,5 % w/w 1 July 2017 30 June 2027 18 The authorisations of biocidal products are subject to the following conditions:
1.. The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.
2.. In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to surface water, sediment and soil for products used (i) indoors as a space spray; and (ii) outdoors as a surface spray.
3.. 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.


