EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SCBP41-Doc.xx 
[…](2014) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving dinotefuran as an 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 dinotefuran as an active substan ce 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 Article 90(2) thereof, 
Whereas: (1) The United Kingdom received on 29 March 2012 an applica tion, in accordance with 
Article 11(1) of Directive 98/8/EC  of the European Parliament and of the Council
2, for 
the inclusion of the active substance dinotefuran in its Annex I for use in product-type 
18, insecticides, acaricides and products to control other arthropods, as defined in 
Annex V to that Directive.  
(2) Dinotefuran  was not on the market on 14 Ma y 2000 as an active substance of a 
biocidal product.  
(3) The United Kingdom submitted an assessment report, together with its 
recommendations, to the European Ch emicals Agency on 15 October 2013 in 
accordance with Article 8(1) of Regulation (EU) No 528/2012. 
(4) The opinion of the European Chemicals Agency was formulated on 17 June 2014 by 
the Biocidal Product Committee, having regard  to the conclusions of the evaluating 
competent authority.  
(5) According to that opinion, biocidal products used for product-type 18 and containing 
dinotefuran may be expected to satisfy the requirements laid down in Article 19(1)(b) 
of Regulation (EU) No 528/2012, provided that  certain specifications and conditions 
relating to its use are satisfied.  
(6) It also appears from that opinion that the ch aracteristics of dinotef uran render it very 
persistent (vP) and toxic (T) in accordance w ith the criteria laid down in Annex XIII to 
Regulation (EC) No 1907/2006 of the Euro pean Parliament and of the Council3. 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 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) . 
3 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).  
EN 3   EN Therefore, dinotefuran should be considered as a candidate for substitution pursuant to 
Article 10(1)(d) of Regulation (EU) No  528/2012 for the purpose of authorising 
products in accordance with Ar ticle 23 of that Regulation. 
(7) It is therefore appropriate to approve di notefuran for use in biocidal products for 
product-type 18 subject to compliance with  certain specifications and conditions.  
(8) Since the evaluations did not address nanom aterials, the approvals should not cover 
such materials in accordance with Arti cle 4(4) of Regula tion (EU) No 528/2012. 
(9) Since the conditions of the first subparagra ph of Article 90(2) of Regulation (EU) No 
528/2012 are met, the provisions of that Re gulation should apply. Dinotefuran should 
be approved for a period not exceeding 7 years in accordance with Article 10(4) of that Regulation. 
(10) 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 
Dinotefuran shall be approved as an active subs tance for use in biocidal products for product-
type 18, subject to the sp ecifications and condition s 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