COMMISSION DECISION  
of 19 March 2010  
concerning the non-inclusion of 2,4,4’-trichloro-2’-hydroxydiphenyl ether in the Union list of 
additives which may be used in the manufacture of plastic materials and articles intended to 
come into contact with foodstuffs under Directive 2002/72/EC  
(notified under document C(2010) 1613)  
(Text with EEA relevance)  
(2010/169/EU)  
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 (  1 ), 
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 (  2 ) estab ­
lishes 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 au- 
thorisation of the substance as an additive in the manu ­
facture 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’-hydroxy ­
diphenyl 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.EN 23.3.2010 Official Journal of the European Union L 75/25  
( 1 ) OJ L 338, 13.11.2004, p. 4.  
( 2 ) OJ L 220, 15.8.2002, p. 18.Article 3  
This Decision is addressed to the Member States.  
Done at Brussels, 19 March 2010.  
For the Commission  
John DALLI  
Member of the CommissionEN L 75/26 Official Journal of the European Union 23.3.2010