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- Practical Guide -
Page 17 of 153
Specific Directives applicable to one group of materials and articles
Individual Directives relating to individual substances.
Moreover a certain number of Guidelines are given in this document and, even though they
are not legally binding, the Commission services invite the interested parties to follow them.
The Framework Directive of the Commission establishes:
General principles applicable to all materials and articles, such as 'purity' of foodstuffs,
'inertness' of the materials and articles in food contact, 'good manufacturing practice',
Criteria and procedures to be followed in drafting specific directives, i.e. directives for
individual sectors (plastics, ceramics) or substances (vinyl chloride, nitrosamines,
BADGE, ...);
Criteria for adopting new rules, directives, provisions and for revising the existing ones,
including the limited and conditional delegation of power upon the Commission by the
Council in the legislating area (see above, 'simplified procedure').
The Specific Directives concern materials and articles (often globally referred to as products)
mentioned in Annex I of Directive 89/109/EEC.
The Individual Directives refer to single substances or groups of substances used in the
fabrication of the above-mentioned materials and articles or their components. They usually
come into being as a result of an urgent need, but might also address a specific issue.
Practical Guide, Note for Guidance, Synoptic document and other documents contained in
the JRC website (
) provide guidance to the enforcement laboratories
and professional organisations for a correct application of the legislation or to assist them in
areas not clearly described in the legislation.
Relations with other international organisms
In the past, considerable effort has been devoted to the development and validation of test
methods. This is all the more true for migration tests, which are complex by the great number
of parameters involved and the need for simplifications. The Commission has supported the
development and standardisation of a certain number of methods for the determination of
substances for which an SML or QM was established in EU Directives. Later the
Commission mandated CEN (European Committee for Standardisation) to establish validated
method of analysis for the determination of overall and specific migration limits. See
Chapter III for further information.
Due to the lack of human resources, it was agreed that the Council of Europe establishes
Resolutions in the areas not covered by an EC activity. See Chapter IV for further