EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/1833  
(POOL/E4/2022/1833/1833 -EN.docx)  
[…](2022) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving cyanamide as an existing active substance for use in biocidal products of 
product -types 3 and 18 in accordance with Regulation (EU) No 528/2012 of the 
European Parliament and of the Council  
(Text with EEA relevance)    
EN 1  EN COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving cyanamide as an existing active substance for use in biocidal products of 
product -types 3 and 18 in accordance with Regulation (EU) No 528/2012 of the 
European Parliament and of the Council  
(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 available on the market and use of biocidal 
products1, and in particular  Article 89(1), third subparagraph,  thereof,  
Whereas:  
(1) Commission Delegate d Regulation (EU) No 1062/20142 establishes a list of e xisting 
active substa nces to be evaluated for their possible approval for use in biocidal 
products. That list includes cyanamide (EC No: 206-992-3; CAS No: 420-04-2). 
(2) Cyanamide  has been evaluated for use in  biocidal products of product -type 3, 
veter inary hygiene biocidal products , and product -type 18, insecticides, acaricides and 
products to control other arthropods , as described in Annex V to Directive 98/8/EC of 
the European Parliament and of the Cou ncil3, which correspond respectively to 
product -types 3 and 18  as described  in Annex V to Regulation (EU) No  528/2012.  
(3) Germany  was designated as the rapporteur Member State  and its evaluating competent 
authority submitted the assessment report together with its conclusions to the 
Commission  on 30 July 2013 . After the submission of the assessment report, 
discussions took place in technical meetings organised by the European Chemicals 
Agency (‘the Agency’).  
(4) It follo ws from  Article 90(2) of Regulation (EU) No 528/2012 that substances for 
which the Member States’ evaluation has been completed by 1 September 2013 should 
be evaluated in accordance with the provisions of Directive 98/8/EC.   
(5) In accordance with Article 75(1 ), point (a),  of Regulation (EU) No 528/2012, the 
Biocidal Products Committee is responsible for preparing  the opinion of the Agency 
regarding applications for approval of active substances. In accordance with Article 
7(2) of Delegated Regulation (EU) No  1062/2014, the Biocidal  Products Committee 
                                                 
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 contained in biocidal products referred to in 
Regulation (EU) No 528/2012 of the European Parliament a nd of the Co uncil (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 2  EN adopted the opinion s of the Agency on 16 June 2016  (“the opinions of 16 June 
2016 ”)4, having regard to the conclusions of the evaluating competent authority.  
(6) According to the opinions  of 16 June 2016 , cyanamide met the criteria to be classified 
as carcinogen category 2 and toxic for reproduction category 2  in accordance with 
Regulation (EC) No 1272/2008  of the European Parliament and of the Council5, and 
was therefore  considered as also having endocrine -disrupting p roperties in accordance 
with Article 5(3) of Regulation (EU) No 528/2012 , pending the adoption of delegated 
acts specifying the scientific criteria for the determination of endocrine -disrupting 
properties.  The opinions of 16 June 2016 also con sidered that the risks to human 
health and the environment of using the representative biocidal products presented in 
the application for approval of cyanamide for product -types 3 and 18 were acceptable  
subject to appropriate  risk mitigation measures . However, the risk  assessment 
presented in th ose opinions did not take into ac count the risks resulting from the 
endocrine -disrupting properties of cyanamide . 
(7) Commission Delegated Regulation (EU) 2017/21006 setting out scientific criteria for 
the determination of endocrine -disrupting properties pursuant to Regulation (EU) No 
528/2012 entered into force on  7 December 2017  and came into effect on 7 June 2018 .  
(8) In anticipation of the application of the new scientific criteria set out in  Delegated 
Regulation  (EU) 2017/2100 , and to provide clarity as regards the hazard properties 
and the risks  resulting from the use of cyanamide , on 26 April 2018, p ursuant to 
Article 75(1), point (g), of Regulation (EU) No 528/2012, the Commission requested 
the Agency7 to revise its opinion s of 16 June 2016 and to clarify whether cyanamide 
has also endocrine -disrupting properties on the  basis of the scientific criteria  laid down 
in that Delegated Regulation . The Agency was  requested to update only th at part of 
the opinions  relati ng to the asse ssment of the endocrine -disrupting properties, unless 
the conclusion of th at assessment affect ed the results of the risk assessment already 
performed or the recommendations for approval. In the latter case, such assessment 
and recommendations were also to be updated.  For the preparation of the revised 
opinions of the Agency, t he evaluating competent authority  of Germany invited the 
applicant to submit additional information as regards the assessment of the endocrine -
disrupting properties  of cyanamide  in accordance with  the criteria laid down in 
Delegated Regulation (EU) 2017/2100 . 
(9) The Biocidal  Products Committee adopted the revised opinion s of the Agency on 10 
December 2019  (“the opinions of 10 December 201 9”)8, having regard to the 
conclusions of the evaluating competent authority.  
                                                 
4 Biocidal Products Committee  Opinion on the application for approval of the active substance : 
Cyanamide , Product type: 3, ECHA/BPC/ 116/2016 , adopted on 16 June 2016 ; Biocidal Products 
Committee  Opinion on the application for approval of the active substance : Cyanamide, Product type: 
18, ECHA/BPC/ 117/2016 , adopted on 16 June 2016 . 
5 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 mixtures, 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). 
6 Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria 
for the determination of endocrine -disrupting properties pursu ant to Regulation (EU) No 528/2012 of 
the European Parliament and Council (OJ L 301, 17.11.2017, p. 1).  
7 Mandate requesting ECHA opinions under Article 75(1)(g) of the BPR - "Evaluation of the Endocrine 
disrupting properties of certain biocidal actives substances according to the new scientific criteria"  
8 Biocidal Products Committee  Opinion on the application for approval of the active substance : 
Cyanamide, Product type: 3, ECHA/BPC/ 230/2019 , adopted on 10 December 2019 ; Biocidal Products  
EN 3  EN (10) According to the opinion s of 10 December 201 9, cyanamide ha s endocrine -disrupting 
properties that may cause adverse effects in humans and the environment (non -target 
organisms) on the basis of  the criteria laid down in Deleg ated Regulation (EU) 
2017/2100 . The opinions remarked that there is no agreed methodology for 
undertaking a risk assessment of endocrine -disrupting properties  and that, g iven the 
exposure of cyanamide to humans and the environment, a  risk related to endocr ine-
disrupting properties cannot be excluded.  
(11) The opinions  of 10 December 201 9 did not contain any information as to whether a 
safe threshold can be derived in relation to endocrine -disrupting  properties  of 
cyanamide,  and, if so, whether the risks of using  the representative biocidal products 
presented in the application for approval of cyanamide  for product -types 3 and 18  
could be considered acceptable or not , in relation to the endocrine -disrupting 
properties of cyanamide .  
(12) On 2 September 2020, p ursuant t o Article 75(1), point (g), of Regulation (EU)  No 
528/2012, the Commission requested the Agency9 to revise its opinions  of 10 
December 2019  and to clarify whether a safe threshold may be derived in relation to 
the endocrine -disrupting  properties of cyanami de, and to conclude whether the risks 
for human health and for the environment  could be consid ered acceptable or not . 
(13) The Biocidal  Products Committee adopted the new revised opinion s of the Agency on 
30 November 2021  (“the opinions of 30 November 2021”)10, having regard to the 
conclusions of the evaluating competent authority.  According to those opinion s, since 
it was not possible to derive a safe threshold with respect to the endocrine -disrupting  
properties of cyanamide, it is not possible to conclude wheth er risks for both  human 
health  for the general public  and the environment for the representative biocidal 
product used for product -type 3 (for the disinfection by professional  users again st 
Brachyspira hyodysenteriae  of the liquid manure stored underneath the slatted floor in 
pig stables in order to protect fattening pigs against the pig disease dysenteria) and 
product -type 18 (for the control by professional users of Musca domestica  in liquid 
manure in pig stables) ar e acceptable or not.  Therefore, no conclusion could be drawn 
whether  cyanamide fulfils the approval conditions . 
(14) Therefore , given that the opinions of 30 November 2021 of the Agency  do not provide 
either a positive or a negative conclusion on whether cyanam ide fulfils the approval 
conditions , the Commission considers that it has ultimately  not been demonstrated 
based on the data available in the application submitted for the approval that the 
representative biocidal product containing cyanamide for product -types 3 and 18 may 
be expected to not have unacceptable effects itself, or as a result of its residues, on 
human  health  and on the environment .  
(15) Taking into account the opinion s of 30 November 2021 , it has not been demonstrated 
that biocidal products of product -types 3 and 18 containing cyanamide meet the 
criteria laid down in Article 5(1), points (b) (iii) and (iv), read in conjunction with 
                                                                                                                                                         
Committee  Opin ion on the application for approval of the active substance : Cyanamide, Product type: 
18, ECHA/BPC/ 231/2019 , adopted on 10 December 2019 . 
9 Mandate requesting ECHA opinions under Article 75(1)(g) of the BPR - "Evaluation of the level of the 
risks for human  health and for the environment of cyanamide used in biocidal products of product types 
3 and 18” .  
10 Biocidal Products Committee  Opinion on the application for approval of the active substance : 
Cyanamide, Product type: 3, ECHA/BPC/ 116/2016 , adopted on 30 November 2021; Biocidal Products 
Committee  Opinion on the application for approval of the active substance : Cyanamide, Product type: 
18, ECHA/BPC/302 /2021 , adopted on 30 November 2021.   
EN 4  EN Article 10(1) of Directive 98/8/EC. It is therefore appropriate not to approve 
cyanamide for use in biocidal products of product -types 3 and 18.  
(16) The measures provided for in this Decision are in accordance with the opinion of the 
Standing Committee  on Biocidal Products , 
HAS ADOPTED THIS DECISION:  
Article 1  
Cyanamide  (EC No: 206-992-3; CAS No: 420-04-2) is not approved as an active substance 
for use in biocidal products of product -types 3 and 18 . 
Article 2 
This Decision shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European  Union . 
Done at Brussels,  
 For the Commission  
 The President  
 Ursula VON DER LEYEN