EN    EN EN 
SANCO/10750/2009 (POOL/E3/ 2009/10750/10750-EN.doc)  
EN    EN  EUROPEAN COMMISSION 
Brussels, 
C(2010) final 
Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of 2,4,4’-tric hloro-2’-hydroxydiphenyl ether in the 
Community list of additives which may be us ed in the manufacture of plastic materials 
and articles intended to come into contac t with foodstuffs under Directive 2002/72/EC 
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION DECISION 
of 
concerning the non-inclusion of 2,4,4’-tric hloro-2’-hydroxydiphenyl ether in the 
Community list of additives which may be us ed in the manufacture of plastic materials 
and articles intended to come into contac t with foodstuffs under Directive 2002/72/EC 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION 
Having regard to the Treaty on the Functioning of the European Union, Having regard to Commission Regulation (E C) No 1935/2004 of the European Council and 
the Parliament of 27 October 2004 on materials and articles intended to come into contact 
with food and repealing Dir ectives 80/590/EEC and 89/109/EEC
1, and in particular 
Article 11 (3) thereof, 
Whereas: (1) Annex III to Commission Dir ective 2002/72/EC of 6 August 2002 relating to plastic 
materials and articles intended to co me into contact with foodstuffs
2 establishes a 
Community list of additives which may be used for the manufacture of plastic 
materials and articles. According to Artic le 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 Artic le 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 Eur opean Food Safety Authority, came to the 
conclusion that the requested use of 2,4,4’-trichloro-2’-hydroxydiphenyl ether could 
be accepted, provided the substa nce is not migrating into food  at a level of 5 mg/kg of 
food. 
                                                
 
1 OJ L 338, 13.11.2004, p. 4.  
2 OJ L 220, 15.8.2002, p. 18.  
EN 3   EN (5) On 21 April 2009 Ciba Inc informed the Com mission of its decisi on 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 s ubstance in plastics intended to come into 
contact with food appropriate any more. 
(6) As there is no longer a valid applica tion 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 include d in Annex III to Directive 2002/72/EC. 
(7) Therefore, pursuant to point (b) of Ar ticle 4a(6) of Dire ctive 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 pl astic materials and articles in tended 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 Anim al 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 [date of pub lication of the decision + 6 months], may 
continue to be marketed until [date of publication of  the decision + 18 months], subject to 
national law.  
Article 3 
This Decision is addressed to the Member States. 
Done at Brussels, 
 For the Commission 
 Androulla VASSILIOU  Member of the Commission