Commission Implementing Regulation (EU) 2017/1276 of 14 July 2017 approving peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate as an existing active substance for use in biocidal products of product-types 2, 3 and 4 (Text with EEA relevance. )
Commission Implementing Regulation (EU) 2017/1276of 14 July 2017approving peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate as an existing active substance for use in biocidal products of product-types 2, 3 and 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 Delegated Regulation (EU) No 1062/2014Commission Delegated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (OJ L 294, 10.10.2014, p. 1). establishes a list of existing active substances to be evaluated for their possible approval for use in biocidal products. That list includes peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate.(2)Peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate has been evaluated in accordance with Article 16(2) of 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). for use in products of product-type 2, private area and public health area disinfectants and other biocidal products; product-type 3, veterinary hygiene biocidal products; and product-type 4, food and feed area disinfectants, as defined in Annex V to that Directive, which correspond respectively to product-types 2, 3 and 4 as defined in Annex V to Regulation (EU) No 528/2012.(3)Finland was designated as evaluating competent authority and submitted the assessment reports together with its recommendations on 16 January 2013.(4)In accordance with Article 7(2) of Delegated Regulation (EU) No 1062/2014, the opinions of the European Chemicals Agency were formulated on 13 December 2016 by the Biocidal Products Committee, having regard to the conclusions of the evaluating competent authority.(5)According to those opinions, biocidal products of product-types 2, 3 and 4 based on peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate may be expected to satisfy the requirements of Article 5 of Directive 98/8/EC, provided that certain specifications and conditions concerning its use are complied with.(6)It is therefore appropriate to approve peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate for use in biocidal products of product-types 2, 3 and 4, subject to compliance with certain specifications and conditions.(7)A reasonable period should be allowed to elapse before an active substance is approved in order to permit interested parties to take the preparatory measures necessary to meet the new requirements.(8)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 1Peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate is approved as an active substance for use in biocidal products of product-types 2, 3 and 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, 14 July 2017.For the CommissionThe PresidentJean-Claude JunckerANNEX
The purity indicated in this column was the minimum degree of purity of the active substance evaluated. The active substance in the product placed on the market can be of equal or different purity if it has been proven to be technically equivalent to the evaluated active substance.
Common NameIUPAC NameIdentification NumbersMinimum degree of purity of the active substanceDate of approvalExpiry date of approvalProduct typeSpecific conditions
Peracetic acid generated from tetraacetylethylenediamine and sodium percarbonateIUPAC Name:Peroxyethanoic acidEC No: 201-186-8CAS No: 79-21-0Precursors:IUPAC Name: N,N′-ethane-1,2-diylbis(N-acetylacetamide)EC No: 234-123-8CAS No: 10543-57-4IUPAC Name: Sodium percarbonateEC No: 239-707-6CAS No: 15630-89-4The specification for peracetic acid generated in situ is based on the precursors tetraacetylethylenediamine and sodium percarbonate.The minimum degree of purity of tetraacetylethylenediamine is 99,0 % and the minimum degree of purity of the sodium percarbonate is 85,1 %1 January 201931 December 20282The authorisations of biocidal products are subject to the following conditions:(1)The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.(2)In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:(a)industrial and professional users;(b)surface water for products used in laundry disinfection in closed washing machines in households.
3The authorisations of biocidal products are subject to the following conditions:(1)The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.(2)In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to industrial and professional users.
4The authorisations of biocidal products are subject to the following conditions:(1)The product assessment shall pay particular attention to the exposures, the risks and the efficacy linked to any use covered by an application for authorisation, but not addressed in the Union-level risk assessment of the active substance.(2)In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to industrial and professional users.