COMMISSION DIRECTIVE 2005/79/EC
of 18 November 2005
amending Directive 2002/72/EC relating to plastic materials and articles intended to come into contact with food
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
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 5(2) thereof,
After consulting the European Food Safety Authority,
Whereas:
(1)
Commission Directive 2002/72/EC (2) establishes a list of monomers and other starting substances, which may be used for the manufacture of plastic materials and articles. On the basis of new information related to the risk assessment of such substances, certain monomers provisionally admitted at national level as well as new monomers should be included in the Community list of permitted substances in that Directive.
(2)
Directive 2002/72/EC also contains an incomplete list of additives which may be used in the manufacture of plastic materials and articles. That list should be amended so as to include other additives evaluated by the European Food Safety Authority (the Authority).
(3)
For certain substances, the restrictions already established at Community level should be amended on the basis of the new information available. In particular for epoxidised soybean oil (ESBO) the Authority recommended to decrease its specific migration limit (SML) for PVC gaskets containing that substance which are used to seal glass jars containing infant formulae and follow-on formulae or containing processed cereal-based foods and baby foods for infants and young children. In fact the Authority noted that the exposure of infants who regularly eat such foods may exceed the TDI. Therefore the SML for ESBO is decreased for these particular applications from 60 to 30 mg/kg of food or food simulant while it remains unchanged for all other applications.
(4)
A transitional period should be provided for in respect of PVC gaskets containing epoxidised soybean oil, used to seal glass jars, which are brought into contact with food before the 19 November 2006.
(5)
Directive 2002/72/EC should therefore be amended accordingly.
(6)
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Annexes II, III, V and VI of Directive 2002/72/EC are amended in accordance with Annexes I to IV to this Directive.
Article 2
PVC gaskets containing epoxidised soybean oil, with reference number 88640 in section A of Annex III to Directive 2002/72/EC, which are used to seal glass jars containing infant formulae and follow-on formulae as defined by Commission Directive 91/321/EEC (3) or containing processed cereal-based foods and baby foods for infants and young children as defined by Commission Directive 96/5/EC (4), filled before 19 November 2006 and which comply with the restrictions and/or specifications provided for in Section A of Annex III to Directive 2002/72/EC as amended by Directive 2004/19/EC, may continue to be placed on the market provided that the date of filling appears on the materials and articles.
The date of filling may be replaced by another indication, provided that that indication permits the identification of the date of filling. Upon request the date of filling shall be made available to the competent authorities and any person enforcing the requirements of this Directive.
The first and second subparagraphs shall apply without prejudice to Directive 2000/13/EC of the European Parliament and of the Council (5).
Article 3
1. Member States shall adopt and publish, by 19 November 2006 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
They shall apply those provisions in such a way as to:
(a)
permit the trade in and use of plastic materials and articles intended to come into contact with food and complying with this Directive, from 19 November 2006;
(b)
prohibit the manufacture and importation into the Community of plastic materials and articles intended to come into contact with food and which do not comply with this Directive, from 19 November 2007.
When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 4
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 5
This Directive is addressed to the Member States.
Done at Brussels, 18 November 2005.