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)

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 products1, and in particular the third subparagraph of Article 89(1) thereof,

Whereas:

(1)
Commission Delegated Regulation (EU) No 1062/20142 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 Council3 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 1

Peracetic 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 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, 14 July 2017.

For the Commission

The President

Jean-Claude Juncker

ANNEX

Common Name

IUPAC NameIdentification Numbers

Minimum degree of purity of the active substance4

Date of approval

Expiry date of approval

Product type

Specific conditions

Peracetic acid generated from tetraacetylethylenediamine and sodium percarbonate

IUPAC Name:

Peroxyethanoic acid

EC No: 201-186-8

CAS No: 79-21-0

Precursors:

  • IUPAC Name: N,N′-ethane-1,2-diylbis(N-acetylacetamide)

    EC No: 234-123-8

    CAS No: 10543-57-4

  • IUPAC Name: Sodium percarbonate

    EC No: 239-707-6

    CAS No: 15630-89-4

The 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 2019

31 December 2028

2

The authorisations of biocidal products are subject to the following conditions:

  1. (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. (2)

    In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to:

    1. (a)

      industrial and professional users;

    2. (b)

      surface water for products used in laundry disinfection in closed washing machines in households.

3

The authorisations of biocidal products are subject to the following conditions:

  1. (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. (2)

    In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to industrial and professional users.

4

The authorisations of biocidal products are subject to the following conditions:

  1. (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. (2)

    In view of the risks identified for the uses assessed, the product assessment shall pay particular attention to industrial and professional users.

4

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.