EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
PLAN/2022/1832  
(POOL/E4/2022/1832/1832 -EN.docx)  
[…](2022) XXX  draft  
 
COMMISSION IMPLEMENTING DECISION (EU) …/…  
of XXX  
not approving 2,2 -Dibromo -2-cyanoacetamide (DBNPA) as an existing active substance 
for use in biocidal products of product -type 4 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 2,2 -Dibromo -2-cyanoacetamide (DBNPA) as an existing active substance 
for use in biocidal products of product -type 4 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 Delegated 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 2,2-Dibromo -2-cyanoacetamide (DBNPA)  (EC No: 233-
539-7; CAS No: 10222 -01-2). 
(2) DBNPA  has been evaluated for use in  biocidal products of product -type 4, food and 
feed area , as described in Annex V to Regulation (EU) No  528/2012.  
(3) Denmark  was designated as the rapporteur Member State  and its evaluating competent 
authority submitted the assessment report together with its conclusions to the 
European Chemicals Agency (‘the Agency’)  on 27 December 2016. After the 
submission of the assessment report, discussions took place in technical meetings 
organised by the Agency.  
(4) 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 
adopted the opinion  of the Agency on 25 June 2019  (“the opinion of 25 June 2019”)3, 
having regard to the conclusions of the evaluating competent authority .  
(5) According to the opinion of 25 June 2019, DBNPA has endocrine -disrupting 
properties that may cause adverse effects in humans and the environment (non -target 
organi sms) on the basis of the criteria laid down in Commission Delegated Regulation 
                                                 
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 528/201 2 of the European Parliament and of the Co uncil (OJ L 294, 10.10.2014, 
p. 1). 
3 Biocidal Products Committee Opinion on the application for approval of the active substance: 2,2 -
Dibromo -2-cyanoacetamide (DBNPA), Product type: 4, ECHA/BPC/225/2019, adopted on 25 June 
2019.   
EN 2  EN (EU) 2017/21004. DBNPA therefore  meets the exclusion criteria set out in Article 
5(1), point (d),  of Regulation (EU) No  528/2012 . The opinion of 25 June 2019 also 
considered tha t the risks to human health and the environment of using the 
representative biocidal product  presented in the application for approval of DBNPA 
for product -type 4 were acceptable  subject to appropriate risk mitigation measures, but 
also concluded that, given the exposure of humans and the environment  to DBNPA , a 
risk related to endocrine -disrupting properties cannot be excluded.  
(6) Pursuant to Article 5(2) of Regulation (EU) No 528/2012,  an active substance meeting 
the exclusion criteria may only be approved if it is shown that at least one of the 
conditions for derogation set out in that Article is met. When deciding whether an 
active substance may be approved on that basis , the availability of suitable and 
sufficient alternative substances or technologies is to be a key consideration . 
(7) The Commission, with the support of the Agency, carried out a public consultation 
between 11 October 2019 and 10 December 2019 (“the public consultation”) in order 
to gather information as to whether the conditions set out in Art icle 5(2) of Regulation 
(EU) No 528/2012  were satisfied.  
(8) The opinion of 25 June 2019 and the contributions to the  public consultation were  
discussed by the Commission with the Member States representatives in the meeting 
of the Standing Committee on Biocidal Products of February 2020 . The Commission 
asked the Member States to indicate whether they consider that at least one of the 
conditions set out in Article 5(2) of Regulation (EU) No 528/2012  would be met in 
their respective territory, and to provi de justification . It was concluded that there  was a 
need to further analyse the information provided by the applicant during the 
consultation to assess whether the condition in Article 5(2) , point (a), could be 
considered met. On 8 July 2020, pursuant to A rticle 75(1), point (g), of Regulation 
(EU) No 528/2012, the Commission requested the Agency5 to revise its opinion and 
clarify whether a safe threshold may be derived in relation to the endocrine -disrupting 
properties of DBN PA, to assess the contribution of the use of DBNPA as a biocid al 
active substance to the average daily bromide consumption and to the environmental 
background, and to conclude whether the risks for human health and for the 
environment  could be consid ered acceptable or not . 
(9) The Biocidal  Products Committee adopted the revised opinion  of the Agency on 30 
November 2021  (“the opinion of 30 November 2021”)6, having regard to the 
conclusions of the evaluating competent authority . 
(10) According to the opinion of 30 November 2021, the risks associate d with the exposure 
to DBNPA -derived bromide use in product -type 4, including the risks resulting from 
its endocrine -disrupting effects , are considered acceptable for humans and the 
environment for the representative biocidal product presented in the application for 
approval , subject to appropriate risk mitigation measures . Therefore, w ithout prejudice 
to the provisions of Article 5(2) of Regulation (EU) No 528/2012, biocidal products of 
                                                 
4 Commission Delegated Regulation (EU) 2017/2100 of 4 September 2017 setting out scientific criteria 
for the determination of endocrine -disrupting properties pursuant to Regulation (EU) No 528/2012 of 
the European Parliament and Council (O J L 301, 17.11.2017, p. 1).  
5 Mandate requesting ECHA  an opinion  under Article 75(1)(g) of the BPR , "Evaluation of the level of the 
risks for human health and for the environment of  DBNPA used in biocidal products of product type 4"   
6 Biocidal Products C ommittee  Opinion on the application for approval of the active substance : 2,2-
Dibromo -2-cyanoacetamide (DBNPA) , Product type: 4, ECHA/BPC/300/ 2021 , adopted on 30 
November 2021.   
EN 3  EN product -type 4 containing DBNPA  may be expected to satisfy the re quirements laid 
down in  Article 19(1), point (b), of that Regulation.  
(11) The opinion of 30 November 2021 and the contributions to the  public consultation 
were  discussed by the Commission with the Member States representatives in the 
meetings of the Standing C ommittee on Biocidal Products  of March 2022 and June 
2022 . The Commission  again asked the Member States to indicate whether they 
consider that at least one of the conditions set out in Article 5(2) of Regulation (EU) 
No 528/2012  would be met in their respe ctive territory, and to provide justification . 
No Member State indicated that th ose conditions would be met in its territory , in the 
light of the availability of alternatives, which is a key consideration in the context of 
Article 5(2)  of Regulation  (EU) No 528/2012 . 
(12) In fact, b ased on the information collected and the views expressed by Member States,  
suitable and sufficient alternative substances or technologies are available. The 
representative  biocidal product presented by the applicant in the applicati on for 
approval is a product used for the disinfection of food processing vessels by 
professional/industrial users (such as  industrial mayonnaise or yogurt producing 
facilities, fermenters for beer or other fermented products). The opinion of 30 
November 2 021 lists several active substance s as potential alternatives7. 26 active 
substances are already  approved for use in biocidal products of product -type 4 , while  
another 37 active substances are  still under examination within the work programme 
for the systematic examination of existing active substances pursuant to Article 89 of 
Regulation (EU) No 528/2012 . Moreover, o ther active substances have been approved 
under Regulation (EU) No 528/2012 followin g the assessment of representative 
biocidal products similar to the representative biocidal product presented in the 
application for the approval of DBNPA8. No evidence has been submitted by the  
applicant show ing that any of those  active substance s could n ot be used for the same 
purpose as DBNPA . Lastly, s everal Member States representatives indicated during 
the discussions  in the Standing  Committee on Biocidal Products that no biocidal 
products containing DBNPA for product -type 4 were registered under thei r national 
rules or placed on their market  despite the presence of food processing industries on 
their territory , and that alternative active substances and biocidal products were  
available on their territory  for the same or similar use , like biocidal prod ucts 
containing peracetic acid or hydrogen peroxide.  
(13) Furthermore, t he representative biocidal product presented by the applicant cannot be 
considered as a product used in closed systems or under other conditions which aim at 
excluding contact with humans a nd release into the environment,  as, according to the 
opinion of 30 November 2021 , its use may lead to the presence of residues in 
disinfected bottles even after rinsing and may  lead to releases into the environment via 
waste water. Although the opinion of 30 November 2021  concludes that the risks to 
humans and to the environment could be considered acceptable, in view of the 
positions expressed by Member States representatives in the  Standing Committee on 
                                                 
7 Biocidal Products Committee  Opinion on the application for approval of the active substance : 2,2-
Dibromo -2-cyanoacetamide (DBNPA) , Product type: 4, ECHA/BPC/300/ 2021 , adopted on 30 
November 2021, on page 16: 2 -phenoxy ethanol, Active chlorine (generated from sodium chloride by 
elect rolysis or released from hypochlorous acid), Active chlorine (released from calcium hypochlorite), 
Active chlorine (released from sodium hypochlorite), Bromoacetic acid, C(M)IT/MIT, Decanoic acid, 
Glutaraldehyde, Hydrogen peroxide, Iodine, L(+) lactic acid , Octanoic acid, Peracetic acid, Peracetic 
acid generated from tetraacetylethylenediamine (TAED) and sodium percarbonate, PHMB (1415;4.7), 
PHMB (1600;1.8), Polyvinyl -pyrrolidone iodine, Propan -1-ol, Propan -2-ol, Salicylic acid.  
8 For instance : lactic acid,  octanoic acid, decanoic acid, peracetic acid or glutaraldehyde .  
EN 4  EN Biocidal Products, it is not concluded that the risks could be considered negligible. 
Considering in addition that suitable and sufficient alternative substances or 
technologies are available, the condition in Article 5(2), point (a) , of Regulation (EU) 
No 528/2012 is therefore not met.  
(14) No specific information or justification has been submitted  by the applicant  to 
demonstrate that DBNPA would be essential to prevent or control a serious danger to 
human health, animal health or the en vironment. Considering in addition that suitable 
and sufficient alternative substances or technologies are available, the condition in 
Article 5(2), point (b), of Regulation (EU) No 528/2012 is therefore not met.  
(15) No information  has been submitted  by the ap plicant  that demonstrates that the non-
approval of DBN PA would have disproportionate negative impact s on society when 
compared to the risks to human health, animal health or  the environment arising from 
the use of the substance. Considering in addition tha t suitable and sufficient alternative 
substances or technologies are available, the condition in Article 5(2), point (c), of 
Regulation (EU) No 528/2012 is therefore not met.  
(16) Consequently,  the applicant has not shown that any of the conditions in Article 5 (2), 
first subparagraph,  of Regulation (EU) No 528/2012  is met. It is therefore appropriate 
not to approve DBNPA  for use in biocidal products of product -type 4. 
(17) 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  
2,2-Dibromo -2-cyanoacetamide (DBNPA)  (EC No: 233-539-7; CAS No: 10222 -01-2) is not 
approved as an active substance for use in biocidal products of product -type 4. 
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