# 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), Annex

Extent: E+W+S+N.I.

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.
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
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).
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).
Common Name
IUPAC NameIdentification Numbers
Minimum degree of purity of the active substance
Date of approval
Expiry date of approval
Product type
Specific conditions
Bromoacetic acid
IUPAC Name:
2-bromo-ethanoic acid
EC No: 201-175-8
CAS No: 79-08-3
946 g/kg
1 July 2015
30 June 2025
4
The product assessment shall pay 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 risk assessment of the active substance.
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 accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council or Regulation (EC) No 396/2005 of the European Parliament and of the Council shall be verified, and any appropriate risk mitigation measures shall be taken to ensure that the applicable MRLs are not exceeded.
(3) Products containing bromoacetic acid shall not be incorporated in 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.
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 sensitisation, as well as the information referred to in the second subparagraph of Article 58(3) of Regulation (EU) No 528/2012.

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Source: https://www.legislation.gov.uk/eur/2013/1032/annex (the official version)
Page: https://openlegislation.uk/eu-regulation-2013-1032/annex
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.