EN    EN  
 EUROPEAN  
COMMISSION 
Brussels, XXX   
SANTE/11236/2017 ANNEX CIS 
(POOL/E4/2017/11236/11236-EN 
ANNEX CIS.doc) 
[…](2017) XXX  draft 
ANNEX 1 
  
ANNEX 
to the 
COMMISSION IMPLEMENTING REGULATION (EU) …/... 
approving cyanamide as an existin g active substan ce for use in biocidal products of 
product-types 3 and 18 
  
EN 2   EN ANNEX  
Common Name IUPAC Name 
Identification Numbers Minimum degree 
of purity of the 
active substance1 Date of 
approval Expiry 
date of 
approval Product 
type Specific conditions 
Cyanamide IUPAC Name: Cyanamide 
 
EC No: 206-992-3 CAS No: 420-04-2 96,8% w/w (dry 
weight), 
manufactured as an 
aqueous solution 
with 50,5% w/w.  1 October 
2019 30 
September 
2024 3 Cyanamide is considered a candidate for substitution in 
accordance with Article 10(1)(a) of Regulation (EU) 
No 528/2012. 
The authorisations of biocidal  products are subject to the 
following conditions: 
1) 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. In addition, pursuant to point 10 of 
Annex VI to Regulation (EU) No 528/2012, the product 
assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) 
No 528/2012 can be satisfied. 
2) Products shall only be authorised for use in Member 
States where at least one of the conditions set in Article 5(2) of Regulation (EU) No 528/2012 is met. 
3) In view of the risks identified for the uses assessed, the 
product assessment shall pay particular attention to professional users. 
4) For products that may lead to residues in food or feed, 
the need to set new or to amend existing maximum 
residue levels (MRLs) in accordance with Regulation 
(EC) No 470/2009 of the European Parliament and of 
the Council
2 or Regulation (EC) No 396/2005 of the 
                                                 
1 The purity indicated in this column was the minimum degree of purity of the active substance ev aluated. The active substance in the product placed on the market can be of 
equal or different purity if it has been proven to be technical ly equivalent to the evaluated active substance. 
2 Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of 
pharmacologically active substances in foodstuffs of animal ori gin, repealing Council Regulation (EEC) No 2377/90 and amending  Directive 2001/82/EC of the European 
Parliament and of the Council and Regulation (EC) No 726/2004 o f the European Parliament and o f the Council (OJ L 152, 16.6.20 09, p. 11).  
EN 3   EN European Parliament and of the Council3 shall be 
verified, and any appropriate risk mitigation measures shall be taken to ensure tha t the applicable MRLs are 
not exceeded. 
The placing on the market of treat ed articles is subject to the  
following condition:  
The person responsible for the placing on the market of a 
treated article treated with or incorporating cyanamide shall 
ensure that the label of that treated article provides the 
information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012. 
18 Cyanamide is considered a candidate for substitution in 
accordance with Article 10(1)(a) of Regulation (EU) No 528/2012. 
The authorisations of biocidal  products are subject to the 
following conditions: 
1) 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. In addition, pursuant to point 10 of 
Annex VI to Regulation (EU) No 528/2012, the product 
assessment shall include an evaluation as to whether the conditions of Article 5(2) of Regulation (EU) 
No 528/2012 can be satisfied. 
2) Products shall only be authorised for use in Member 
States where at least one of the conditions set in Article 5(2) of Regulation (EU) No 528/2012 is met. 
3) In view of the risks identified for the uses assessed, the 
product assessment shall pay particular attention to 
professional users. 
4) For products that may lead to residues in food or feed, 
the need to set new or to amend existing MRLs in 
                                                 
3 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pe sticides in or on food and feed of plant 
and animal origin and amending Council Directive 91/414/EEC (OJ  L 70, 16.3.2005, p. 1).  
EN 4   EN accordance with Regulation (EC) No 470/2009 or 
Regulation (EC) No 396/2005 shall be verified, and any appropriate risk mitigation measures shall be taken to 
ensure that the applicable  MRLs are not exceeded. 
The placing on the market of treat ed articles is subject to the  
following condition:  
The person responsible for the placing on the market of a 
treated article treated with or incorporating cyanamide shall 
ensure that the label of that treated article provides the 
information listed in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.