EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11236/2017 CIS 
(POOL/E4/2017/11236/11236-EN 
CIS.doc) […](2017) XXX  draft 
  
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
of XXX  
approving cyanamide as an existin g active substan ce for use in biocidal products of 
product-types 3 and 18 
(Text with EEA relevance) 
  
EN 2   EN COMMISSION IMPLEMENTING  REGULATION (EU) …/... 
of XXX  
approving cyanamide as an existing active substance for use in biocidal products of 
product-types 3 and 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 Pa rliament and of the 
Council of 22 May 2012 concerning the making available on the m arket and use of biocidal 
products1, and in particular the third subpa ragraph of Article 89(1) the reof, 
Whereas: (1) Commission Delegated Regulation (EU) No 1062/2014
2 establishes a list of existing 
active substances to be evaluated for their possible approval f or use in biocidal 
products. That list includes cyanamide. 
(2) Cyanamide has been evaluated in accordance with Article 16(2) o f Directive 98/8/EC 
of the European Parliament and of the Council3 for use in product-type 3, veterinary 
hygiene biocidal products, and pr oduct-type 18, insecticides, a caricides and products 
to control other arthropods, as d efined in Annex V to that Dire ctive, which correspond 
to product-types 3 and 18 as defi ned in Annex V to Regulation ( EU) No 528/2012. 
(3) Germany was designated as evaluating competent authority and su bmitted the 
assessment reports together with its recommendations on 30 July  2013. 
(4) In accordance with Article 7(2) of Delegated Regulation (EU) No  1062/2014, the 
opinions of the European Chemicals Agency ("the opinions") were  formulated on 16 
June 2016 by the Biocidal Products Committee, having regard to the conclusions of 
the evaluating competent authority. 
(5) According to the opinions, biocidal products of product-types 3  and 18 containing 
cyanamide may be expected to satisfy the requirements laid down  i n  A r t i c l e  5  o f  
Directive 98/8/EC, provided that  certain specifications and con ditions concerning their 
use are complied with. 
(6) It is therefore appropriate to approve cyanamide for use in bio cidal products of 
product-types 3 and 18, subject to  compliance with certain spec ifications 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 substances co ntained in biocidal products referred to in 
Regulation (EU) No 528/2012 of the European Parliament and of t he Council (OJ L 294, 10.10.2014, 
p. 1). 
3 Directive 98/8/EC of the European Parliament and of the Counci l 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) The opinions conclude that cyanamide meets the criteria for cla ssification as 
carcinogenic category 2 and toxi c for reproduction category 2 i n accordance with 
Regulation (EC) No 1272/2008 of the  European Parliament and of the Council4.  
(8) Pending the adoption of scientific criteria for the determinati on of endocrine-
disrupting properties, active subs tances that meet the criteria  to be classified as 
carcinogenic category 2 and as toxi c for reproduction category 2 are to be considered 
as having endocrine-disrupting pr operties. Cyanamide is therefo re to be considered as 
having endocrine-disrupting properties, and as meeting the excl usion criterion set in 
Article 5(1)(d) of Regulation (EU) No 528/2012. 
(9) Pursuant to Article 90(2) of Regulation (EU) No 528/2012, subst ances for which the 
Member States' evaluation has been completed by 1 September 201 3 are to be 
approved in accordance with Directive 98/8/EC. The period of ap proval should be 
restricted to 5 years in accordan ce with the practice establish ed under that Directive.  
(10) For the purposes of Article 23 of Regulation (EU) No 528/2012 h owever, cyanamide 
meets the conditions of Article 10(1)(a) of that Regulation and  should therefore be 
considered a candida te for substitution. 
(11) Furthermore, pursuant to point 10 of Annex VI to Regulation (EU ) No 528/2012, the 
competent authorities are require d to evaluate whether the cond itions of Article 5(2) of 
that Regulation can be satisfied to decide if a biocidal produc t containing cyanamide 
can be authorised or not. 
(12) Since cyanamide is to be considered as having endocrine-disrupt ing properties, and 
meets the criteria for classification as skin sensitiser catego ry 1 as defined in Annex I 
to Regulation (EC) No 1272/2008, tr eated articles treated with or incorporating 
cyanamide should be appropriately labelled when placed on the m arket. 
(13) A reasonable period should be allowed to elapse before an activ e substance is 
approved, in order to permit interested parties to take the pre paratory measures 
necessary to meet the new requirements. 
(14) 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 
Cyanamide is approved as an active substance for use in biocida l products of product-types 3 
and 18, subject to the specificati ons and conditions set out in  the Annex. 
Article 2 
This Regulation shall enter into force on the twentieth day fol lowing that of its publication in 
the Official Journal of  the European Union . 
                                                 
4 Regulation (EC) No 1272/2008 of the European Parliament and of  the Council of 16 December 2008 on 
classification, labelling and packaging of substances and mixtu res, amending and repealing Directives 
67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907 /2006 (OJ L 353, 31.12.2008, 
p. 1).  
EN 4   EN This Regulation shall be binding i n its entirety and directly a pplicable in all Member States. 
Done at Brussels, 
 For the Commission 
 The President  Jean-Claude JUNCKER