HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 283/22
EN
Official Journal of the European Union
25.10.2013
COMMISSION IMPLEMENTING REGULATION (EU) No 1032/2013
of 24 October 2013
approving bromoacetic acid as an existing active substance for use in biocidal products for product-
type 4
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
the findings of the review were incorporated, within the
Standing Committee on Biocidal Products on
27 September 2013, in an assessment report.
Having regard to the Treaty on the Functioning of the European
Union,
(5)
It appears from that report that biocidal products used
for product-type 4 and containing bromoacetic acid may
be expected to satisfy the requirements laid down in
Having regard to Regulation (EU) No 528/2012 of the
Article 5 of Directive 98/8/EC.
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 the third subparagraph
of Article 89(1) thereof,
(6) It
is
therefore
appropriate
to
approve
bromoacetic
acid
for use in biocidal products for product-type 4.
Whereas:
(7) Since
the
evaluation
did
not
address
nanomaterials,
the
approval should not cover such materials pursuant to
(1) Commission
Regulation
(EC)
No
1451/2007
( 2 ) estab
Article 4(4) of Regulation (EU) No 528/2012.
lishes 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 of the European Parliament and of the
Council ( 3 ). That list includes bromoacetic acid.
(8) The
evaluation
did
not
address
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
(2) Bromoacetic
acid
has
been
evaluated
in
accordance
with
Article 11(2) of Directive 98/8/EC for use in product-
Article 1(1) of Regulation (EC) No 1935/2004 of the
type 4, food and feed area disinfectants, as defined in
European Parliament and of the Council
( 4 ). Such
Annex V to that Directive, which corresponds to
materials may require the establishment of specific
product-type 4 as defined in Annex V to Regulation
limits on the migration into food, as referred to in
(EU) No 528/2012.
Article 5(1)(e) of Regulation (EC) No 1935/2004. The

approval should 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 necessary.
(3) Spain
was
designated
as
rapporteur
Member
State
and
submitted the competent authority report, together
with a recommendation, to the Commission on
22 January 2011 in accordance with Article 14(4) and
(6) of Regulation (EC) No 1451/2007.
(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
(4) The
competent
authority
report
was
reviewed
by
the
new requirements entailed.
Member States and the Commission. In accordance
with Article 15(4) of Regulation (EC) No 1451/2007,
( 1 ) OJ L 167, 27.6.2012, p. 1.
(10) The
measures
provided
for
in
this
Regulation
are
in
( 2 ) Commission Regulation (EC) No 1451/2007 of 4 December 2007
accordance with the opinion of the Standing
on the second phase of the 10-year work programme referred to in
Committee on Biocidal Products,
Article 16(2) of Directive 98/8/EC of the European Parliament and
of the Council concerning the placing of biocidal products on the
market (OJ L 325, 11.12.2007, p. 3).
( 4 ) Regulation (EC) No 1935/2004 of the European Parliament and of
( 3 ) Directive 98/8/EC of the European Parliament and of the Council of
the Council of 27 October 2004 on materials and articles intended
16 February 1998 concerning the placing of biocidal products on
to come into contact with food and repealing Directives 80/590/EEC
the market (OJ L 123, 24.4.1998, p. 1).
and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).

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EN
25.10.2013 Official
Journal
of
the
European
Union L
283/23
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.
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, 24 October 2013.
For the Commission
The President
José Manuel BARROSO

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L 283/24
ANNEX
Common Name
IUPAC Name
Minimum degree of purity
Identification Numbers
of the active substance (1 )
Date of approval Expiry
date
of
approval Product
type Specific
conditions
(2 )
Bromoacetic
IUPAC Name:
946 g/kg 1
July
2015 30
June
2025
4 The
product
assessment
shall
pay
particular
attention
to
the
exposures,
the
acid
risks and the efficacy linked to any uses covered by an application for
EN
2-bromo-ethanoic acid
authorisation, but not addressed in the Union level risk assessment of the

EC No: 201-175-8
active substance.
CAS No: 79-08-3
Authorisations are subject to the following condition:
(1) For industrial or professional users, safe operational procedures and
appropriate organisational measures shall be established. 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 amend existing maximum residue levels (MRLs) in
Off
accordance with Regulation (EC) No 470/2009 of the European
icial
Parliament and of the Council (3 ) or Regulation (EC) No 396/2005
of the European Parliament and of the Council (4 ) shall be verified, and
Jour
any appropriate risk mitigation measures shall be taken to ensure that
the applicable MRLs are not exceeded.
nal
of
(3) Products containing bromoacetic acid shall not be incorporated in
the
materials and articles intended to come into contact with food
within the meaning of Article 1(1) of Regulation (EC) No 1935/2004,
European
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.
Union
Where a treated article has been treated with or intentionally incorporates
bromoacetic acid, and where necessary due to the possibility of skin
contact as well as the release of bromoacetic acid under normal conditions
of use, the person responsible for placing the treated article on the market
shall ensure that the label provides information on the risk of skin sensiti
sation, as well as the information referred to in the second subparagraph
of Article 58(3) of Regulation (EU) No 528/2012.
(1 ) The purity indicated in this column was the minimum degree of purity of the active substance 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 proven technically equivalent with the evaluated active substance.
(2 ) For the implementation of the common principles of Annex VI to Regulation (EU) No 528/2012, the content and conclusions of assessment reports are available on the Commission website: http://ec.europa.eu/comm/environment/
biocides/index.htm
(3 ) 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).
(4 ) 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).
25.10.2013

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Document Outline

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