COUNCIL OF EUROPE
COMMITTEE OF MINISTERS

Framework Resolution ResAP(2004)1
on coatings intended to come into contact with foodstuffs

(Adopted by the Committee of Ministers on 1 December 2004
at the 907th meeting of the Ministers’ Deputies)
(replacing Resolution AP (96) 5)

The Committee of Ministers, in its composition restricted to Representatives of the States members of the Partial Agreement in the Social and Public Health Field,¹

Recalling Resolution No. R (59) 23 of 16 November 1959 concerning the extension of the activities of the Council of Europe in the social and cultural fields;

Having regard to Resolution No. R (96) 35 of 2 October 1996, whereby it revised the structures of the
Partial Agreement and resolved to continue, on the basis of revised rules replacing those set out in
Resolution No. R (59) 23, the activities hitherto carried out and developed by virtue of that resolution; these being aimed in particular at:

a. raising the level of health protection of consumers in its widest application: constant contribution to harmonising – in the field of products having a direct or indirect impact on the human food chain as well as in the field of pesticides, pharmaceuticals and cosmetics – legislation, regulations and practices governing, on the one hand, quality, efficiency and safety controls for products and, on the other hand, the safe use of toxic or noxious products;

b. integrating people with disabilities into the community: defining – and contributing to its implementation at European level – a model coherent policy for people with disabilities, which takes account simultaneously of the principles of full citizenship and independent living; contributing to the elimination of barriers to integration, whatever their nature, whether psychological, educational, family-related, cultural, social, professional, financial or architectural;

Having regard to the action carried out for several years for the purposes of harmonising legislation in the public health field and, in particular, with regard to materials and articles intended to come into contact with foodstuffs;

Considering that coatings intended to come into contact with foodstuffs may, through migration of constituents to the foodstuffs, pose under certain conditions a risk to human health;

Noting that certain issues expressed in general terms in the Appendix to the present Framework Resolution need further analysis, input from other scientific projects currently carried out and appropriate innovative solutions;

Taking the view that each member state, faced with the need to introduce regulations governing this matter, would find it beneficial to harmonise such regulations at European level,

Recommends to the governments of the States members of the Partial Agreement in the Social and Public Health Field to take into account in their national laws and regulations on coatings intended to come into contact with foodstuffs the principles set out hereafter.

Appendix to Framework Resolution ResAP(2004)1
on coatings intended to come into contact with foodstuffs

1. Field of application

Framework Resolution ResAP(2004)1 on coatings intended to come into contact with foodstuffs applies to coatings which in the finished state are intended to come into contact or which are brought into contact with foodstuffs and are designed for that purpose. The following types of coating are covered:

a. coatings for metal packaging;

b. flexible packaging coatings;

c. heavy-duty coatings.

2. Definition

For the purpose of the Framework Resolution, “coatings” mean the finished material prepared mainly from organic materials applied to form a layer/film on a substrate in such a way as to create a protective layer and/or to impart certain technical performance.

3. Specifications

Coatings intended to come into contact with foodstuffs under normal or foreseeable conditions of use should meet the following conditions:

3.1. they should not transfer their constituents to foodstuffs in quantities, which could endanger human health, or bring about an unacceptable change in the composition of the foodstuffs or a deterioration in the organoleptic characteristics thereof;

3.2. they should be manufactured in accordance with guidelines on good manufacturing practice for coatings intended to come into contact with foodstuffs and using substances of “Technical document No. 1 - List of substances to be used in the manufacture of coatings intended to come into contact with foodstuffs” as well as aids to polymerisation as set out in Resolution AP (92) 2 on control of aids to polymerisation (technological coadjuvants) for plastics materials and articles intended to come into contact with foodstuffs or substances of relevant national regulations, and prepared, applied and cured in strict adherence to the manufacturer’s specifications, according to the conditions specified;

3.3. they should not transfer their constituents to foodstuffs in quantities exceeding 10mg/dm² of surface area of material or article (mg/dm²) (overall migration limit). However, this limit should be 60 mg of the constituents released per kg of foodstuff (mg/kg) in the following cases:

a. articles which are containers or are comparable to containers or which can be
filled, with a capacity of not less than 500 ml and not more than 10 litres;

b. articles which can be filled and for which it is impracticable to estimate the surface
area in contact with foodstuffs;

c. caps, gaskets, stoppers or other similar devices for sealing;

3.4. they should not transfer migrating components not listed in “Technical document No. 1 – List of substances to be used in the manufacture of coatings intended to come into contact with foodstuffs” which have MW < 1000 D in quantities which could endanger human health. These non listed substances of MW < 1000 D should be subjected to appropriate risk assessment, taking into account dietary exposure as well as toxicological and structure activity considerations.