
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,
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, and in particular the third subparagraph of Article 89(1) thereof,
Whereas:

(1) Commission Regulation (EC) No 1451/2007 establishes 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. That list includes bromoacetic acid.

(2) 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 4 as 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 22 January 2011 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

(4) The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 27 September 2013, in an assessment report.

(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 Article 5 of Directive 98/8/EC.

(6) It is therefore appropriate to approve bromoacetic acid for use in biocidal products for product-type 4.

(7) Since the evaluation did not address nanomaterials, the approval should not cover such materials pursuant to Article 4(4) of Regulation (EU) No 528/2012.

(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 Article 1(1) of Regulation (EC) No 1935/2004 of the European Parliament and of the Council. 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 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.

(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 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 
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
ANNEX

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 acidEC No: 201-175-8CAS 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.



