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of 30 March 2007
amending Directive 2002/72/EC relating to plastic materials and articles intended to come into
contact with food and Council Directive 85/572/EEC laying down the list of simulants to be
used for testing migration of constituents of plastic materials and articles intended to come into
contact with foodstuffs
(Text with EEA relevance)
Having regard to the Treaty establishing the European
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 5(2) thereof,
After consulting the European Food Safety Authority (the
Commission Directive 2002/72/EC (
) is a specific
Directive within the meaning of the framework Regu-
lation (EC) No 1935/2004, harmonising the rules for
the plastics materials and articles intended to come into
contact with food.
Directive 2002/72/EC establishes a list of authorised
substances for the manufacture of those materials and
articles, in particular additives and monomers, the
restrictions on their use, rules on labelling as well as
the information to be given to consumers or to food
business operators concerning correct use of those
materials and articles.
Information provided to the Commission demonstrates
that the plasticizers used e.g. in polyvinyl chloride (PVC)
gaskets in lids may migrate into fatty foods in quantities
that could endanger human health or bring about an
unacceptable change in the composition of the foods.
It should therefore be made clear that, even if they are
part of e.g. metal lids, gaskets fall under the scope of
Directive 2002/72/EC. At the same time, specific rules
should be laid down as regard the use of additives for the
manufacture of those gaskets. It is appropriate to take
account of the need of lid manufacturers to have
sufficient time to adapt to some of the provisions of
Directive 2002/72/EC. In particular, taking into account
the time needed to prepare an application for the
evaluation of specific additives used for the manufacture
of gaskets of lids, it is not yet possible to establish a
timetable for their evaluation. Therefore, in a first stage,
the positive list of authorised additives that will be
adopted in the future for plastic materials and articles
should not apply for the manufacture of gaskets in
lids, so that the use of other additives will remain
possible, subject to national law. This situation should
be reassessed at a later stage.
On the basis of new information related to the risk
assessment of substances evaluated by the Authority
and the need to adapt to technical progress the existing
rules for calculating migration, Directive 2002/72/EC
should be updated. For reasons of clarity definitions of
technical terms used should be introduced.
The rules for overall migration and specific migration
should be based on the same principle and should
therefore, be aligned.
Specific rules should be introduced to improve the
protection of infants, since infants ingest more food in
proportion to their body weight than adults.
The verification of compliance with the specific
migration limits (SML) in simulant D for additives
listed in Annex III, Section B, to Directive 2002/72/EC
should be applied at the same time as the other
provisions for calculating migration introduced in this
Directive for better estimation of the real exposure of
the consumer to those additives. Therefore, the deadline
for application of the abovementioned verification of
compliance should be extended.
Official Journal of the European Union
L 91/17
) OJ L 338, 13.11.2004, p. 4.
) OJ L 220, 15.8.2002, p. 18. Directive as last amended by Directive
2005/79/EC (OJ L 302, 19.11.2005, p. 35).