EN EN
EUROPEAN
COMMISSION
Brussels, XXX
CA-July13-Doc.3.5
[…](2013) XXX draft
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
to approve etofenprox as an existing active substance for use in biocidal products for 
product -type 18
(Text with EE A relevance)EN 2 ENCOMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
to approve etofenprox as an existing active substance for use in biocidal products for 
product -type 18
(Text with EEA relevance)
THE EUROPEAN COMMI SSION,
Having regard to the Treaty on the Functioni ng of the European Union ,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Counc il of 22 May 2012 concerning the making available on the market and use of biocidal 
products1, and in particular the third subparagraph of Article 89(1) thereof ,
Whereas:
(1) 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 market2establishes 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. That list 
includes etofenprox .
(2) Pursuant to Regulation (EC) No 1451/2007, etofenp rox 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 defin ed in Annex 
V to that Directive, which corresponds to product -type 18 as def ined 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 recomm endation, to the Commission on 9 August 
2011 in accordance with Article 14(4) and (6) of R egulation (EC) No 1451/2007.
(4) The competent authority report was reviewed by the Member States and the 
Commission. I n 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 the evaluations that biocidal products used for product -type 18 and 
containing etofenprox maybe expected to satisfy the requirements laid down in 
Article 5 of Directive 98/8/EC . Italso appears from the report that such biocidal 
products maybe expected to satisfy the requirements laid down in Article 19 of 
Regulation (EU) No 528/2012, provided that the conditions specified in the Annex to 
this Regulation are satisfied.
(6) In addition, in view of its characteristics which render it liable to bioaccumulate (B)
and toxic (T), in accordance with the criteria laid down in Annex XIII to Regulation 
  
1OJ L 167, 27. 6.2012, p. 1.
2OJ L 325, 11.12.2007, p. 3.EN 3 EN(EC) No 1907/2006 of the European Parliament and of the Council of 18 December 
2006 co ncerning 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, 93/6 7/EEC, 93/105/EC and 2000/21/EC3, 
etofenprox should be considered acandidate for substitution in accordance with 
Article 10(1) of Regulation (EU) No 528/2012. 
(7) It is therefore appropriate to approve etofenprox for use in biocidal products for 
product -type 18.This approval should be limited to seven y ears onl y in accordance 
with Article 10(4) of Regulation (EU) No 528/2012.
(8) Since the evaluation did not a ddress nanomaterials, th e 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 Commis sion 
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 to this Regulation .
Article 2
This Regulation shall enter into force on the twentieth dayfollowing 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, 
For the Commission
The President
José Manuel BARROSO
  
3OJ L 396, 30.12.2006, p. 1.EN 4 ENANNEX 
Common 
Nam eIUPAC Name
Identification NumbersMinimum 
degree of 
purity of 
the active 
substance4Date of 
approvalExpiry date 
of approvalProduct 
typeSpecific condit ions5
Etofenpr
oxIUPAC Name : 
3-phenoxybenzyl -2-(4-ethoxyphenyl) -2-
methylpropylet her
EC No: 407-980-2
CAS No: 80844 -07-1970 g/kg 1 July 
2015 30 June 
202218Etofenprox is considered a candidate for 
substitution in accordance w ith article 
10(1) 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 
condition s:
1)For industrial or professional 
users, safe operational procedures 
and appropriate organizational 
measures shall be established. 
Only where exposure cannot be 
reduced to an acceptable level by 
other means, products shall be 
used with appropriate personal 
protective equipm ent..
2)For products that may lead to 
residues in food or feed, the need 
  
4The 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 mar ket can be of equal or different purity if it has been proven technically equivalent with the evaluated 
active substance.
5For the implementation of the common principles of Annex VI of Regulation (EU) No 528/2012 , the content and conclusions of assessmen t reports are available on the 
Commission website: http://ec.europa.eu/comm/environment/biocides/index.htmEN 5 ENCommon 
Nam eIUPAC Name
Identification NumbersMinimum 
degree of 
purity of 
the active 
substance4Date of 
approvalExpiry date 
of approvalProduct 
typeSpecific condit ions5
to set new or to am end existing 
maximum residue levels (MRLs) 
in accordance with Regulation 
(EC) No 470/2009 ofthe 
European Parliament and of the 
Council6or Regulation (EC) No 
396/200 5 of the European 
Parliament and of the Counci l7
shall be verified, and any 
appropriate risk mitigation 
measures shall be taken to ensure 
that the applicable MRLs are not 
exceeded.
  
6OJ L 152, 16.6.2009, p. 11.
7OJ L 70, 16.3.2005, p. 1 .