EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/10790/2016 
(POOL/E4/2016/10790/10790-EN.doc) […](2016) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving coco alkyltrimethylammonium ch loride (ATMAC/TMAC) as an existing 
active substance for use in biocid al products of product-type 8 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving coco alkyltrimethylammonium chloride (ATMAC/TMAC) as an existing 
active substance for use in bioc idal products of product-type 8 
(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 avai lable 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 Re gulation (EU) No 1062/2014
2 establishes a list of existing 
active substances to be evaluated for thei r possible approval for use in biocidal 
products. That list includes coco alkyltrimethylammonium chloride 
(ATMAC/TMAC). 
(2) Coco alkyltrimethylammonium chloride (ATMAC/TMAC) has been evaluated in 
accordance with Article 16(2) of Directive 98/ 8/EC of the European Parliament and of 
the Council3 for use in products of product-type 8,  wood preservatives, as described in 
Annex V to that Directive, which corres ponds to product-type 8 as described in 
Annex V to Regulati on (EU) No 528/2012. 
(3) Italy was designated as evaluating compet ent authority and submitted the assessment 
reports together with its recommenda tions on 20 November 2007 and 10 June 2010. 
(4) In accordance with Article 7(2) of De legated Regulation (EU) No 1062/2014, the 
opinion of the European Chemicals Agency was formulated on 14 April 2016 by the Biocidal Products Committee, having regard  to the conclusions of the evaluating 
competent authority. 
(5) According to that opinion, biocidal produc ts of product-type 8 containing coco 
alkyltrimethylammonium chloride (ATMAC/T MAC) may be expected to satisfy the 
requirements of Article 5 of Directive 98/ 8/EC, provided that certain specifications 
and conditions concerning their use are complied with. 
(6) It is therefore appropriate to approve  coco alkyltrimethyl ammonium chloride 
(ATMAC/TMAC) for use in biocidal pr oducts of product-type 8, subject to 
compliance with certain sp ecifications and conditions. 
                                                
 
1 OJ L 167, 27.6.2012, p. 1. 
2 Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for 
the systematic examination of all existing active substan ces contained in biocidal products referred to in 
Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1). 
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) A reasonable period should be allowed to elapse before an active substance is 
approved in order to permit interested parties to take the preparatory measures 
necessary to meet th e new requirements. 
(8) 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 
Coco alkyltrimethylammonium chloride (ATMAC /TMAC) is approved as an active substance 
for use in biocidal products of  product-type 8, 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, 
 For the Commission 
 The President  Jean-Claude JUNCKER