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
Commission Implementing Regulation (EU) No 1032/2013of 24 October 2013approving 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 productsOJ L 167, 27.6.2012, p. 1., and in particular the third subparagraph of Article 89(1) thereof,Whereas:(1)Commission Regulation (EC) No 1451/2007Commission 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 placing of biocidal products on the market (OJ L 325, 11.12.2007, p. 3). 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 CouncilDirective 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).. 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 CouncilRegulation (EC) No 1935/2004 of the European 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/EEC (OJ L 338, 13.11.2004, p. 4).. 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 1Bromoacetic 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 2This 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 CommissionThe PresidentJosé Manuel BarrosoANNEX
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.htmRegulation (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 NameIUPAC NameIdentification NumbersMinimum degree of purity of the active substanceDate of approvalExpiry date of approvalProduct typeSpecific conditions
Bromoacetic acidIUPAC Name:2-bromo-ethanoic acidEC No: 201-175-8CAS No: 79-08-3946 g/kg1 July 201530 June 20254The 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.