LegalizeCommission Implementing Regulation (EU) No 1036/2013 of 24 October 2013 approving etofenprox as an existing active substance for use in biocidal products for product-type 18 Text with EEA relevance
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| 25.10.2013 | EN | Official Journal of the European Union | L 283/35 |
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 1, and in particular the third subparagraph of Article 89(1) thereof,
Whereas:
- (1) Commission Regulation (EC) No 1451/2007 2 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 3. That list includes etofenprox.
- (2) Etofenprox 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) Austria was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 9 August 2011 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 27 September 2013, in an assessment report.
- (5) It appears from that report that biocidal products used for product-type 18 and containing etofenprox may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC.
- (6) It also appears from the reports that the characteristics of etofenprox render it liable to bioaccumulate (B) and toxic (T), in accordance with the criteria laid down in Annex XIII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council 4. The period of approval should be 10 years in consistency with the current practice under Directive 98/8/EC, since the conditions of Article 90(2) of Regulation (EU) No 528/2012 are not met. However, for the purpose of authorising products in accordance with Article 23 of Regulation (EU) No 528/2012, etofenprox shall be considered as a candidate for substitution pursuant to Article 10(1)(d) of that Regulation.
- (7) It is therefore appropriate to approve etofenprox for use in biocidal products for product-type 18.
- (8) 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.
- (9) 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.
- (10) 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
Etofenprox 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, 24 October 2013.
For the Commission
The President
José Manuel BARROSO
Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3).
Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (OJ L 123, 24.4.1998, p. 1).
Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
ANNEX
| Common Name | IUPAC Name Identification Numbers | Minimum degree of purity of the active substance5 | Date of approval | Expiry date of approval | Product type | Specific conditions6 |
|---|---|---|---|---|---|---|
| Etofenprox | IUPAC Name: 3-phenoxybenzyl-2-(4-ethoxyphenyl)-2-methylpropylether EC No: 407-980-2 CAS No: 80844-07-1 | 970 g/kg | 1 July 2015 | 30 June 2025 | 18 | Etofenprox is considered a candidate for substitution in accordance with article 10(1)(d) of Regulation (EU) No 528/2012. 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 conditions: (1) For industrial or professional users, safe operational procedures and appropriate organizational measures shall be established. Where exposure cannot be reduced to an acceptable level by other means, products shall be used with appropriate personal protective equipment. (2) 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 Council7 or Regulation (EC) No 396/2005 of the European Parliament and of the Council8 shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded. |
The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in accordance with Article 8 of Regulation (EU) No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been proven technically equivalent with the evaluated active substance.
For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
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