Address https://gelex.eu/eli/EU/decision/2010/169@2010-03-19/en

Contents

1. Preamble
2. 1. Article 1
   2. Article 2
   3. Article 3

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (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, and in particular Article 11(3) thereof,

Whereas:

(1) Annex III to Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs establishes a Union list of additives which may be used for the manufacture of plastic materials and articles. According to Article 4a(1) of that Directive, following submission of an application and its scientific evaluation by the European Food Safety Authority, a new additive may be added to that list.

(2) On 23 March 1998 RCC Registration Consulting submitted data for the evaluation of the safety of 2,4,4’-trichloro-2’-hydroxydiphenyl ether on behalf of Ciba Inc. for use as an additive in the manufacture of plastic materials and articles intended to come into contact with foodstuffs.

(3) In accordance with Article 4a(5) of Directive 2002/72/EC 2,4,4’-trichloro-2’-hydroxydiphenyl ether was included in the provisional list of additives provided for in Article 4a(3) thereof.

(4) In its opinion of 15 March 2004, the European Food Safety Authority came to the conclusion that the requested use of 2,4,4’-trichloro-2’-hydroxydiphenyl ether could be accepted, provided the substance is not migrating into food more than 5 mg per kg of food.

(5) On 21 April 2009 Ciba Inc. informed the Commission of its decision to withdraw the application for the authorisation of the substance as an additive in the manufacture of plastic materials and articles intended to come into contact with foodstuffs. The company does not consider the use of the substance in plastics intended to come into contact with food appropriate any more.

(6) As there is no longer a valid application for the use of 2,4,4’-trichloro-2’-hydroxydiphenyl ether as an additive in plastics intended to come into contact with food, the substance should not be included in Annex III to Directive 2002/72/EC.

(7) Therefore, pursuant to point (b) of Article 4a(6) of Directive 2002/72/EC, the substance should be removed from the provisional list of additives.

(8) Taking into account that 2,4,4’-trichloro-2’-hydroxydiphenyl ether may have been used in the manufacture of plastic materials and articles intended to come into contact with foodstuffs, a transitional period should be introduced for the marketing of plastic materials and articles containing that substance.

(9) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,

HAS ADOPTED THIS DECISION:

Article 1

2,4,4’-trichloro-2’-hydroxydiphenyl ether (CAS No 0003380-34-5, ref. No 93930) shall not be included in Annex III to Directive 2002/72/EC.

Article 2

Plastic materials and articles manufactured with 2,4,4’-trichloro-2’-hydroxydiphenyl ether and placed on the market before 1 November 2010, may continue to be marketed until 1 November 2011, subject to national law.

Article 3

This Decision is addressed to the Member States.

Done at Brussels, 19 March 2010. For the Commission John Dalli Member of the Commission

Versions

1. 2010-03-19

Cited by

• Council Decision (EU) 2017/1391 of 17 July 2017 on the position to be adopted, on behalf of the European Union, within the Sanitary and Phytosanitary Management Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part, as regards the modification of Annex V to that Agreement Decision · Grade B

  Ukraine undertakes to approximate its legislation to the following Union legislation within the timeframes listed below, in accordance with Article 64(4) of this Agreement. Union legislation Deadline for approximation Chapter I — General legislation (public health) Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organisation of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC 2016 Council Directive 97/78/EC of 18 December 1997 laying down the principles governing the orga

• Council Decision 2019/1748 of 7 October 2019 on the position to be taken on behalf of the European Union within the Sanitary and Phytosanitary Management Sub-Committee established by the Association Agreement between the European Union and the European Atomic Energy Community and their Member States, of the one part, and Ukraine, of the other part, as regards the modification of Annex V to Chapter 4 of that Agreement Act · Grade B

  Ukraine undertakes to approximate its legislation to the following Union legislation with the deadlines for adoption as listed below, in accordance with Article 64(4) of this Agreement. Union legislation Deadline for adoption Chapter I – General legislation (public health) Council Directive 91/496/EEC of 15 July 1991 laying down the principles governing the organization of veterinary checks on animals entering the Community from third countries and amending Directives 89/662/EEC, 90/425/EEC and 90/675/EEC 2018 Council Directive No 97/78/EC of 18 December 1997 laying down the principles governi