EN    EN  
 EUROPEAN 
COMMISSION  
Brussels, XXX   
CA-Sept13-Doc.4.3 
[…](2013) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving transfluthrin as an existing active substance for use in biocidal products for 
product-type 18 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving transfluthrin 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 av ailable on the market and use of biocidal 
products
1, and in particular the third subpa ragraph of Article 89(1) thereof, 
Whereas: (1) Commission Regulati on (EC) No 1451/2007
2 establishes a list of active substances to 
be assessed, with a view to their possible in clusion in Annex I, IA or IB to Directive 
98/8/EC of the European Parliament and of the Council3. That list includes 
transfluthrin. 
(2) Transfluthrin has been evaluated in acco rdance 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 Anne x V to Regulation (EU) No 528/2012. 
(3) The Netherlands was designated as Rapporteur Member State and submitted the 
competent authority report, together with a recommendation, to the Commission on 13 July 2010 in accordance with Article 14(4)  and (6) of Regulation (EC) No 1451/2007. 
(4) The competent authority report was re viewed 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 in  an assessment report reviewed within the 
Standing Committee on Biocidal  Products on date SCB. 
(5) According to that assessment report, bioc idal products used for product-type 18 and 
containing transflurthin may be expected to satisfy the requirements laid down in 
Article 5 of Directive 98/8/EC, provided that certain specifications and conditions relating to its use are satisfied. 
(6) It is therefore appropriate to approve tran sfluthrin for use in biocidal products for 
product-type 18 subject to compliance w ith such specifications and conditions. 
                                                
 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Regulation (EC) No 1451/2007 of 4 Decem ber 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). 
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) .  
EN 3   EN (7) Since the evaluation did not a ddress nanomaterials, the appr oval 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 interested pa rties to take the preparatory measures 
necessary to meet the ne w requirements laid down.  
(9) The measures provided for in this Regulati on are in accordance with the opinion of the 
Standing Committee on Biocidal Products, 
HAS ADOPTED THIS REGULATION: 
Article 1 
Transfluthrin shall be approved as an active substance for use in bi ocidal products for 
product-type 18, subject to th e specifications and conditi ons 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, 
 For the Commission 
 The President  José Manuel BARROSO 
EN 4   EN ANNEX  
Common 
Name IUPAC Name 
Identification Numbers Minimum 
degree of 
purity of 
the active substance
4  Date of 
approval Expiry date 
of approval Product 
type Specific conditions5 
Transfluthri
n IUPAC Name :  
2,3,5,6-tetrafluorobenzyl (1R,3S)-3-(2,2-
dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate 
or 
2,3,5,6-tetrafluorobenzyl (1R)-trans-3-(2,2-
dichlorovinyl)-2,2-
dimethylcyclopropanecarboxylate  
 
EC n° : 405-060-5  
CAS n° : 1187712-89-3 960 g/kg of 
1R trans 
configuratio
n 1 
November 
2015 31 October 
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 : 
In view of the risks for water, sediment and 
soil compartments, transfluthrin shall not be used in battery-operated fan vaporisers 
or insecticidal coils unless it can be 
demonstrated in the application for product authorisation that risks can be reduced to 
an acceptable level. 
 
                                                 
4 The purity indicated in this column was the minimum degree of purity of the active substance used for the evaluation made in a ccordance 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. 
5 For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of ass essment reports are available on the 
Commission website: http://ec.europa.eu/comm/environment/biocides/index.htm