- Practical Guide -
Page 50 of 153
This limit must not be exceeded for plastic materials and articles intended to come in
contact with foodstuffs. For the method of determination of the overall migration limit, see
in this Section, paragraph 11. "Enforcement of legislation and methods of analysis"
and "Analytical info" in JRC website:
The limits are expressed in different units in accordance with the different volumes of the
articles. In fact, the articles having a capacity less than 0.5 litre normally contain foods
consumed in low quantity and therefore result in a low exposure to the consumer. As the
migration of a low amount into a low volume result in a relatively high concentration, the
migration expressed in mg/dmē provides a more appropriate indication of the contamination
and avoids that articles are rejected in the absence of an appreciable risk for the consumer.
The opposite refers to articles having a capacity greater than 10 litres, since even the
migration of a large amount results in a low concentration. Moreover, foodstuffs contained in
these articles during their storage or transport are transferred into other articles for sale and
hence are subject to additional contamination by migrants. Therefore, to stop the manufacture
of articles of poor quality, the units chosen in these cases are mg/dmē.
Specific migration limits
Specific migration limits (SML) are specified for some of the substances in the lists for
monomers and additives. They are based on the opinions expressed by the SCF and are
obtained by multiplying the ADI/TDI values by a factor of 60 This factor is derived from
the convention that a person of 60 kg daily could ingest up to 1 kg of foodstuffs in contact
with a plastic article always containing the considered substance at a concentration
corresponding to the SML. The Council of Europe adopted this convention in '60. Recently
the Commission examined the possibility of changing this convention, since European
professional organisations consider them as excessively severe. See Chapter I, Section 3,
paragraph 10.1. "Fat (Consumption) Reduction Factors". For the method of
determination of the SML see in this Section, paragraph 11. "Enforcement of legislation
and methods of analysis" (and annexes), Chapter III "CEN" and "Analytical info" in
Implementation of the legislation (Directives 82/711/EEC and 85/572/EEC)
8.1. Verification of compliance with the migration limits
An incomplete list of additives, which may be used for the manufacture of plastic materials and articles, together with
the restrictions and/or specifications on their use, is set out in Annex III, Sections A and B.
For the substances in Annex III, Section B, the specific migration limits are applied as from 1 January 2004 when the
verification of compliance is carried out in simulant D or in test media of substitute tests as laid down in Directives
82/711/EEC and 85/572/EEC.
Verification of compliance with the migration limits shall be carried out in accordance with the rules laid down in Directives
82/711/EEC [A6] and 85/572/EEC [A9] and the further provisions set out in Annex I.
Verification of compliance with the specific migration limits provided for in paragraph 1 shall not be compulsory, if it can be
established that compliance with the overall migration limit laid down in Article 2 implies that the specific migration limits
are not exceeded.