EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SCBP41-Doc.xx 
[…](2014) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving tolylfluanid as an active substance for use in biocidal products for product-
type 21 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) No …/.. 
of XXX  
approving tolylfluanid as an active substan ce for use in biocidal products for product-
type 21 
(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 Delegated Regul ation (EU) No XX/20142 establishes a list of active 
substances to be evaluated with a view to  their possible approval for use in biocidal 
products or inclusion into A nnex I to Regulation (EU) No  528/2012. That list includes 
tolylfluanid. 
(2) Tolylfluanid has been evaluated in accordan ce with Article 90(2) of Regulation (EU) 
No 528/2012 for use in biocidal products fo r product-type 21, an tifouling products, as 
defined in Annex V to Regulation (EU) No 528/2012. 
(3) The United Kingdom was designated as eval uating competent authority and submitted 
an assessment report, together with its  recommendations, to the Commission on 18 
September 2012 in accordance with paragraphs  4 and 6 of Article 14 of Commission 
Regulation (EC) No 1451/20073. 
(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 21 and containing 
tolylfluanid may be expected to satisfy th e requirements laid down in Article 5 of 
Directive 98/8/EC of the European  Parliament and of the Council4 provided that 
certain specifications an d conditions relating to its use are satisfied.  
(6) Nevertheless, the acceptability of the risks re lated to the use of antifouling products, as 
well as the suitability of th e proposed risk mitigation measures, need to be further 
                                                 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Delegated Regulation (EU) No XX/2014 of XXXX on the work programme for the 
systematic examination of all existing active substances contained in biocidal products referred to in 
Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L XX, XXX, p. X). 
3 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). 
4 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 confirmed. In order to facilitate, at the time of the renewal of the approvals of existing 
antifouling active substances, the review and comparison of the risks and benefits of 
these substances as well as of the risk mitigation measures applied, the expiry date of approval of these substances should be the same. 
(7) It is therefore appropriate to approve toly lfluanid for use in biocidal products for 
product-type 21 subject to compliance with  certain specifications and conditions.  
(8) Since the evaluations did not address nanom aterials, the approva l should not cover 
such materials in accordance with Arti cle 4(4) of Regula tion (EU) No 528/2012. 
(9) 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 th e new requirements.  
(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 
Tolylfluanid shall be approved as an active substance for use in biocidal products for product-
type 21, 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