Commission Implementing Regulation (EU) 2025/937 of 21 May 2025 approving 2,2-Dibromo-2-cyanoacetamide (DBNPA) as an existing active substance for use in biocidal products of product-type 6 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Date: 2025-05-21
Institutions: Directorate-General for Health and Food Safety, European Commission
Subjects: biocide, chemical product, health risk, market approval, preservative, storage








L_202500937EN.000101.fmx.xml












Official Journal of the European Union


EN
L series













2025/937


22.5.2025







            COMMISSION IMPLEMENTING REGULATION (EU) 2025/937
of 21 May 2025
         
approving 2,2-Dibromo-2-cyanoacetamide (DBNPA) as an existing active substance for use in biocidal products of product-type 6 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 products (1), and in particular Article 89(1), third subparagraph, thereof,

Whereas:







(1)


Annex II to Commission Delegated Regulation (EU) No 1062/2014 (2) establishes a list of existing active substances 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) for product-type 6.












(2)


DBNPA has been evaluated for use in biocidal products of product-type 6 (in-can preservatives), as described in Annex V to Directive 98/8/EC of the European Parliament and of the Council (3), which corresponds to product-type 6 (preservatives for products during storage), 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 16 December 2022. After the submission of the assessment report, discussions took place in technical meetings organised by the Agency.












(4)


In accordance with Article 75(1), second subparagraph, point (a), of Regulation (EU) No 528/2012, the Biocidal Products Committee prepares the opinion of the Agency regarding the applications for approval of active substances. In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, read in conjunction with Article 75(1) and (4) of Regulation (EU) No 528/2012, the Biocidal Products Committee adopted the opinion of the Agency on 12 September 2023 (4), having regard to the conclusions of the evaluating competent authority.












(5)


In that opinion, the Agency concluded that biocidal products of product-type 6 containing DBNPA may be expected to satisfy the criteria laid down in Article 19(1), point (b), of Regulation (EU) No 528/2012, provided that certain conditions concerning their use are complied with.












(6)


According to the opinion of the Agency, DBNPA is considered as having endocrine-disrupting properties that may cause adverse effects in humans, and therefore meets the exclusion criterion set out in Article 5(1), point (d), of Regulation (EU) No 528/2012, and it is considered as having endocrine-disrupting properties that may cause adverse effects in non-target organisms, and therefore it is a candidate for substitution in accordance with Article 10(1), point (e), of that Regulation.












(7)


Pursuant to Regulation (EU) No 528/2012, active substances meeting an exclusion criterion may only be approved if they meet the conditions laid down in Article 4(1), and at least one of the conditions set out in Article 5(2), first subparagraph, of that Regulation.












(8)


From 3 November 2023 to 4 January 2024, the Commission, with the support of the Agency, carried out a public consultation in order to contribute to gathering information as to whether the conditions set out in Article 5(2), first subparagraph, of Regulation (EU) No 528/2012 were satisfied.












(9)


The opinion of the Agency and the contributions to the public consultation have been discussed with Member State representatives in the Standing Committee on Biocidal Products. Member States’ representatives have also been requested to indicate whether they considered that at least one of the conditions set out in Article 5(2) of Regulation (EU) No 528/2012 would be met, and to provide justifications for their answer.












(10)


The analysis of all data collected from the application dossier, the public consultation and the views expressed by Member States indicates that DBNPA is currently needed in all Member States for certain uses.












(11)


DBNPA is needed for short-term preservation of mineral slurries and other additives (e.g., starch, fillers, binders, defoamers, polymer solutions, barrier products, coatings, pigments) for use in paper production by industrial users. Several active substances were investigated as potential alternatives to DBNPA for such use: 2-methyl-2,3-dihydro-1,2-thiazol-3-one hydrochloride, 2-Phenoxyethanol, (benzyloxy)methanol, 2-butyl-benzo[d]isothiazol-3-one (‘BBIT’), benzyl alcohol, biphenyl-2-ol, 1,2-benzisothiazol-3(2H)-one (‘BIT’), bronopol, chlorocresol, 5-chloro-2-methyl-2H-isothiazol-3-one (‘CIT’), mixture of 5-chloro-2-methyl-2H-isothiazol-3-one (Einecs 247-500-7) and 2-methyl-2H-isothiazol-3-one (Einecs 220-239-6) (‘mixture of CMIT/MIT’), 2-bromo-2-(bromomethyl)pentanedinitrile (‘DBDCB’), didecyldimethylammonium chloride (‘DDAC (C8-10)’), didecyldimethylammonium chloride (‘DDAC’), 1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione (‘DMDMH’), dodecylguanidine monohydrochloride, 2,2′-dithiobis[N-methylbenzamide] (‘DTBMA’), (ethylenedioxy)dimethanol (Reaction products of ethylene glycol with paraformaldehyde (‘EGForm’)), ethanol, formaldehyde released from the reaction products of paraformaldehyde and 2-hydroxypropylamine (‘RP 1:1’), formaldehyde released from the reaction products of paraformaldehyde and 2-hydroxypropylamine (‘RP 3:2’), formic acid, glutaral (‘glutaraldehyde’), hexa-2,4-dienoic acid (‘sorbic acid’), 2,2′,2′′-(hexahydro-1,3,5-triazine-1,3,5-triyl)triethanol (‘HHT’), hydrogen peroxide, 3-iodo-2-propynylbutylcarbamate (‘IPBC’), L-(+)-lactic acid, MBIT, 2-methyl-2H-isothiazol-3-one (‘MIT’), monochloramine generated from ammonium carbamate and a chlorine source, N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine (‘diamine’), N-(trichloromethylthio)phthalimide (‘Folpet’), 2-octyl-2H-isothiazol-3-one (‘OIT’), p-[diiodomethyl]sulphonyl]toluene, peracetic acid, potassium sorbate, pyridine-2-thiol 1-oxide sodium salt (‘sodium pyrithione’), pyrithione zinc (‘zinc pyrithione’), silver chloride, sulfur dioxide released from sodium metabisulfite, tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione (‘TMAD’), tetrakis(hydroxymethyl)phosphonium sulphate (2:1) (‘THPS’). However, according to the analysis of the information collected, none of those active substances could be a suitable substitute of DBNPA for the examined use due to their use for long-term preservation, technical compatibility issues or hazard issues.












(12)


DBNPA is needed for short-term preservation of paints and coatings (including pigments, varnishes and inks) and of raw materials (e.g., starch, fillers, binders, defoamers, pigments) used for paints and coatings production, by industrial users. The same active substances as those listed in recital 11 were investigated as potential alternatives to DBNPA for such use. However, according to the analysis of the information collected, none of those active substances could be a suitable substitute of DBNPA for such use due to their use for long-term preservation, technical compatibility issues or hazard issues.












(13)


DBNPA is needed for short-term preservation of polymer dispersions (e.g., polymer dispersions used in adhesives, non-woven fabrics, carpet-making compounds, premix plasters, wall fillers), by industrial users. The same active substances as those listed in recital 11 were investigated as potential alternatives to DBNPA for such use. However, according to the analysis of the information collected, none of those active substances could be a suitable substitute of DBNPA for such use due to their use for long-term preservation, technical compatibility issues or hazard issues.












(14)


Alternative methods to the use of biocidal products for the short-term preservation of mineral slurries and other additives for use in paper production are currently under research (thermal or irradiation techniques) but they have not yet reached a sufficient technology readiness level and can therefore not currently be considered as suitable alternatives to the use of DBNPA. Concerning the short-term preservation of paints and coatings and of raw materials used for their production, and the short-term preservation of polymer dispersions, non-chemical alternative methods could present technical compatibility issues (e.g., corrosion, destabilization, limited efficacy), economical burdens (energy intense processes) and safety issues (e.g., risk of burning for the operators, gamma radiation).












(15)


Therefore, the analysis of the information collected shows that the non-approval of DBNPA as an active substance for use in biocidal products of product-type 6 would have a disproportionate negative impact on society in comparison to the risks arising from the use of the substance for short-term preservation of mineral slurries and other additives for use in paper production, for short-term preservation of paints and coatings and of raw materials used for their production, and for short-term preservation of polymer dispersions. The condition set out in Article 5(2), point (c), of Regulation (EU) No 528/2012 is thus satisfied for those uses.












(16)


Therefore, the conditions set out in Article 4(1) of Regulation (EU) No 528/2012, in conjunction with the conditions set out in Article 5(2), point (c), of that Regulation, are considered to be satisfied.












(17)


It is therefore appropriate to approve DBNPA for use in biocidal products of product-type 6, subject to compliance with certain conditions.












(18)


As DBNPA meets the exclusion criterion laid down in Article 5(1), point (d), of Regulation (EU) No 528/2012, the approval should be for a period not exceeding 5 years as set out in the second sentence of Article 4(1) of that Regulation.












(19)


Pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the biocidal product assessment should include an evaluation as to whether the condition of Article 5(2), point (c), of that Regulation is satisfied in the respective Member State territory. It should be provided that biocidal products of product-type 6 containing DBNPA may only be authorised for use in Member States where the condition set out in Article 5(2), point (c), of Regulation (EU) No 528/2012 is satisfied.












(20)


Furthermore, pursuant to Article 4(3), points (d) and (g), and Article 58(2), of Regulation (EU) No 528/2012, to ensure a high level of safety for human health, animal health and the environment and to ensure equal treatment between treated articles manufactured in the Union and imported treated articles, the placing on the market of treated articles treated with or intentionally incorporating DBNPA should be subject to restrictions and conditions. In particular, in line with the conditions set out in the approval for the authorisation of biocidal products of product-type 6 containing DBNPA, the only treated articles treated with or incorporating DBNPA that may be placed on the market are mineral slurries and other additives used in paper production, paints and coatings and raw materials used for their production, and polymer dispersions, while the DBNPA has been used in those treated articles only to ensure their short-term preservation.












(21)


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 the new requirements.












(22)


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
2,2-Dibromo-2-cyanoacetamide (DBNPA) is approved as an active substance for use in biocidal products of product-type 6, subject to the 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, 21 May 2025.


For the Commission


The President

Ursula VON DER LEYEN
            





(1)  
            OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.

(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 and of the Council (OJ L 294, 10.10.2014, p. 1, ELI: http://data.europa.eu/eli/reg_del/2014/1062/oj).

(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, ELI: http://data.europa.eu/eli/dir/1998/8/oj).

(4)  Biocidal Products Committee Opinion on the application for approval of the active substance 2,2-Dibromo-2-cyanoacetamide (DBNPA); Product-type: 6; ECHA/BPC/388/2023, adopted on 12 September 2023.




ANNEX











Common Name


IUPAC Name
Identification Numbers


Minimum degree of purity of the active substance (1)



Date of approval


Expiry date of approval


Product type


Specific conditions




DBNPA


IUPAC name:
2,2-Dibromo-2-cyanoacetamide
EC No: 233-539-7
CAS No: 10222-01-2


Minimum purity of the active substance evaluated: 98,0 %


1 November 2026


31 October 2031


6


2,2-Dibromo-2-cyanoacetamide (‘DBNPA’) is a candidate for substitution in accordance with Article 10(1), points (a) and (e), of Regulation (EU) No 528/2012.
The authorisation of biocidal products using DBNPA as an active substance is subject to the following conditions:






(a)


the product assessment pays 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 assessment of the active substance;










(b)


pursuant to point 10 of Annex VI to Regulation (EU) No 528/2012, the product assessment includes an evaluation as to whether the condition set out in Article 5(2), point (c), of Regulation (EU) No 528/2012 is satisfied;










(c)


products may only be authorised for use in Member States where the condition set out in Article 5(2), point (c), of Regulation (EU) No 528/2012 is satisfied;










(d)


products may only be authorised for the short-term preservation by industrial users of:






i)


mineral slurries and of other additives (e.g., starch, fillers, binders, defoamers, polymer solutions, barrier products, coatings, pigments) used in paper production;










ii)


paints and coatings (including pigments, varnishes and inks) and of raw materials (e.g., starch, fillers, binders, defoamers, pigments) used for paints and coatings production;










iii)


polymer dispersions (e.g., polymer dispersions used in adhesives, non-woven fabrics, carpet making compounds, premix plasters, wall fillers);














(e)


the product assessment pays particular attention to industrial users;










(f)


for products that may lead to residues in food or feed, Member States’ competent authorities assess whether new maximum residue levels or maximum residue limits need to be set or the existing maximum residue levels or maximum residue limits need to be amended 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 European Parliament and of the Council (3), and any appropriate risk mitigation measures are taken to ensure that such maximum residue levels or maximum residue limits are not exceeded;










(g)


Member States’ competent authorities specify in the summary of the biocidal product characteristics of a biocidal product containing DBNPA the relevant instructions for use and precautions to be indicated on the label of the treated articles under Article 58(3), second subparagraph, point (e), of Regulation (EU) No 528/2012.




The placing on the market of treated articles treated with or incorporating DBNPA is subject to the following conditions:






(a)


treated articles treated with or intentionally incorporating DBNPA may be placed on the market only for use as:






i)


mineral slurries and other additives used in paper production;










ii)


paints and coatings (including pigments, varnishes and inks) and raw materials used for their production;










iii)


polymer dispersions;














(b)


DBNPA has been used in the treated articles referred in point (a) only to ensure a short-term preservation;










(c)


the person responsible for the placing on the market of a treated article treated with or incorporating DBNPA ensures that the label of that treated article provides the information listed in Article 58(3), second subparagraph, of Regulation (EU) No 528/2012.










(1)  The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product made available on the market can be of equal or different purity if it has been proven to be technically 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 origin, 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 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11, ELI: http://data.europa.eu/eli/reg/2009/470/oj).

(3)  Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides 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, ELI: http://data.europa.eu/eli/reg/2005/396/oj).



ELI: http://data.europa.eu/eli/reg_impl/2025/937/oj
ISSN 1977-0677 (electronic edition)