EN EN
EUROPEAN
COMMISSION
Brussels, XXX
CA-July13-Doc.3.7
[…](2013) XXX draft
COMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
to approve bromoacetic acid as an existing active substance for use in biocidal products 
for product -type 4
(Text wi th EEA relevance)EN 2 ENCOMMISSION IMPLEMENTING REGULATION (EU) No …/..
of XXX
to approve bromoacetic acid as an existing active substance for use in biocidal products 
for product -type 4
(Text with EEA relevance)
THE EUROPEAN COMMI SSION,
Having regard to the Treaty on the Func tioning of the European Union ,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the 
Counc il of 22 May 2012 concerning the making available on the market and use of biocidal 
products1, and in particular the third subparagraph o f Article 89(1) thereof ,
Whereas:
(1) Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase 
of the 10 -year work programme referred to in Article 16(2) of Directive 98/8/EC of 
the European Parliament and of the Council concerning the pl acing of biocidal 
products on the market2establishes a list of active substances to be assessed, with a 
view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list 
includes bromoacetic acid .
(2) Pursuant to Regulation (EC) No 1451/20 07, bromoacetic acid has been evaluated in 
accordance with Article 11(2) of Directive 98/8/EC for use in product -type 4, food and 
feed area disinfectants , as defined in Annex V to that Directive, which corresponds to 
product -type 4as defined in Annex V to Regulation (EU) No 528/2012.
(3) Spain was designated as Rapporteur Member State and submitted the competent 
authority report, together with a recommendation, to the Commission on 22nd January 
2011 in accordance with Article 14(4) and (6) of Regulation (EC) N o1451/2007.
(4) The competent authority report was reviewed by the Member States and the 
Commission. I n accordance with Article 15(4) of Regulation (EC) No 1451/2007, the 
findings of the review were incorporated, within the Standing Committee on Biocidal 
Prod ucts on 27 September 2013 , inan assessment report.
(5) It appears from the evaluations that biocidal products used for product -type 4and 
containing bromoacetic acid maybe expected to satisfy the requirements laid down in 
Article 5 of Directive 98/8/EC . Italso appears from the report that such biocidal 
products maybe expected to satisfy the requirements laid down in Article 19 of 
Regulation (EU) No 528/2012, provided that the conditions specified in the Annex to 
this Regulation are satisfied .
(6) Itis therefor e appropriate to approve bromoacetic acid for use in biocidal products for 
product -type 4.
  
1OJ L 167, 27. 6.2012, p. 1.
2OJ L 325, 11.12.2007, p. 3.EN 3 EN(7) Since the evaluation did not ad dress nanomaterials, the approval should not cover such 
materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.
(8) The evaluat ion did not adress the incorporation of biocidal products containing
bromoacetic acid in materials and articles intended to come into contact directly or 
indirectly with food within the meaning of Article 1(1) of Regulation (EC) No 
1935/2004 of the Europea n Parliament and of the Council of 27 October 2004 on 
materials and articles intended to come into contact with food and repealing Directives 
80/590/EEC and 89/109/EEC3. Such materials may require the establishment of 
specific limits on the migration into food, as referred to in Article 5(1)(e) of
Regulation (EC) No 1935/2004 . The approval sh ould therefore not cover such use
unless the Commission has established such limits or it has been established pursuant 
to that Regulation that such limits are not nece ssary . 
(9) A reasonable period should be allowed to elapse before an active substance is 
approved , in order to permit Member States , interested parties , and the Commission 
where appropriate, to prepare themselves to meet the new requirements entailed .
(10) The me asures provided for in this Regulation are in accordance with the opinion of the 
Standing Committee on Biocidal Products ,
HAS ADOPTED THIS REGULATION:
Article 1
Bromoacetic acid shall be approved as an active substance for use in biocidal products for 
product-type 4, subject to the specifications and conditions set out in the Annex to this 
Regulation .
Article 2
This Regulation shall enter into force on the twentieth dayfollowing that of its publication in 
the Official Journal of the European Union .
This Re gulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 
For the Commission
The President
José Manuel BARROSO
  
3OJ L 338, 13.11.2004 , p.4.EN 4 ENANNEX 
Common 
Nam eIUPAC Name
Identification NumbersMinimum 
degree of 
purity of 
the acti ve 
substance4Date of 
approvalExpiry date 
of approvalProduct 
typeSpecific condit ions5
Brom oac
etic acidIUPAC Name : 
2-brom o-ethanoic acid 
EC No : 201-175-8
CAS No: 79-08-3800 g/kg 1 July 
2015 30 June
20254The product assessment shall pay part icular 
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 .
Authorisations are subject to the following 
conditio n:
1)For industrial or professional 
users, safe operational procedures 
and appropriate organizational 
measures shall be established. 
Only where exposure cannot be 
reduced to an acceptable level by 
other means, products shall be 
used with appropriate personal
protective equipment. .
2)For products that may lead to 
residues in food or feed, the need 
to set new or to am end existing 
maximum residue levels (MRLs) 
in accordance with Regulation 
  
4The purity indicated in this column was the minimum degree of purity of the active sub stance used for the evaluation made in accordance with Article 8 of Regulation (EU) 
No 528/2012. The active substance in the product placed on the market can be of equal or different purity if it has been prov en technically equivalent with the evaluated 
active substance.
5For the implementation of the common principles of Annex VI of Regulation (EU) No 528/2012, the content and conclusions of as sessment reports are available on the 
Commission website: http://ec.europa.eu/comm/environment/biocides/index.htmEN 5 ENCommon 
Nam eIUPAC Name
Identification NumbersMinimum 
degree of 
purity of 
the acti ve 
substance4Date of 
approvalExpiry date 
of approvalProduct 
typeSpecific condit ions5
(EC) No 470/2009 ofthe 
European Parliament and of the 
Council6or Regulati on (EC) No 
396/2005 of the European 
Parliament and of the Counci l7
shall be verified, and any 
appropriate risk mitigation 
measures shall be taken to ensure 
that the applicable MRLs are not 
exceeded.
3)Products containing b romoacetic 
acid shall not be incorpo ratedin 
materials and articles intended to 
come into contact with food 
within the meaning of Article 1(1) 
of Regulation (EC) No 1935/2004 , 
unless the Commission has 
established specific limits on the 
migration of bromoacetic acid into 
food or it has been established 
pursuant to that Regulation that 
such limits are not necessary .
  
6OJ L 152, 16.6.2009, p. 11.
7OJ L 70, 16.3.2005, p. 1 .