COUNCIL OF EUROPE
COMMITTEE OF MINISTERS
________
RESOLUTION AP (96) 5
ON SURFACE COATINGS INTENDED
TO COME INTO CONTACT WITH FOODSTUFFS
(Adopted by the Committee of Ministers on 2 October 1996
at the 574th meeting of the Ministers' Deputies)
The Representatives on the Committee of Ministers of Belgium, France, Germany, Italy, Luxembourg, the Netherlands and the United Kingdom of Great Britain and Northern Ireland, these states being parties to the Partial Agreement in the social and public health field, and the Representatives of Austria, Denmark, Finland, Ireland, Spain and Switzerland, states which have participated in the public health activities carried out within the above-mentioned Partial Agreement since 1 October 1974, 2 April 1968, 20 June 1991, 23 September 1969, 21 April 1988 and 5 May 1964 respectively,
Considering that the aim of the Council of Europe is to achieve greater unity between its members and that this aim may be pursued by common action in the social and the public health field;
Having regard to the provisions of the Brussels Treaty, signed on 17 March 1948, by virtue of which Belgium, France, Luxembourg, the Netherlands, the United Kingdom of Great Britain and Northern Ireland declared themselves resolved to strengthen the social ties by which they were already united;
Having regard to the protocol modifying and completing the Brussels Treaty, signed on 23 October 1954 by the signatory states of the Brussels Treaty, on the one hand, and the Federal Republic of Germany and Italy, on the other hand;
Observing that the seven states parties to the Partial Agreement which have continued within the Council of Europe the social work hitherto undertaken by the Brussels Treaty Organisation and then by the Western European Union, which derived from the Brussels Treaty as modified by the protocol mentioned in the fourth paragraph above, as well as Austria, Denmark, Finland, Ireland, Spain and Switzerland, which participate in Partial Agreement activities in the public health field, have always endeavoured to be in the forefront of progress in social matters and also in the associated field of public health, and have for many years undertaken action towards harmonisation of their legislation;
Having regard to the fact that a wide variety of materials, containers, conduits and other articles intended for packaging, handling, preparation, baking, transportation or storage of foodstuffs are provided with a surface coating;
Considering that surface coatings used in food contact applications may, by reason of migration of surface coating constituents into foodstuffs, pose, under certain conditions, a risk to health;
Observing that the lists of Appendix 2 hereafter represent an inventory of substances used for the manufacture of surface coatings intended to come into contact with foodstuffs;
Observing that the date specified in Appendix 2 hereafter represents the state of the art of substances used for the manufacture of surface coatings intended to come into contact with foodstuffs at that date;
Observing that the substances of List 1 of Appendix 2 hereafter have been evaluated by an international body and have been considered as toxicologically acceptable, taking into consideration their restrictions of use;
Observing that the substances of List 2 of Appendix 2 hereafter have not been fully evaluated nor evaluated at all by an international body due to lack of data, and that these substances should be subject to further toxicological studies;
Observing that if new data on substances of Appendix 2 hereafter or on substances not included in Appendix 2 hereafter will be available, the lists will be updated;
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,
Recommend to the governments of the seven states parties to the Partial Agreement, as well as those of Austria, Denmark, Finland, Ireland, Spain and Switzerland, that they take into account in their national laws and regulations on surface coatings intended to come into contact with foodstuffs the principles and the inventory lists set out in the appendices hereafter.
Appendix 1 to Resolution AP (96) 5
on surface coatings intended to come into contact with foodstuffs
General principles
Definitions
Surface coatings are organic materials applied in the form of a continuous film on a substrate in such a way as to form a protective layer and/or a functional barrier See footnote 1 between the food and the substrate.
They may be applied to the substrate in the form of solutions, dispersions, powders or solvent-free preparations.
They are composed of:
- thermoplastic polymers, where the continuous layer is formed for instance by simple evaporation of the solvent or dispersing medium, or by thermal treatment of the polymers; or
- a mixture of resins, polymers and curing resins, where formation of a thermosetting continuous layer is achieved, for instance after a series of chemical reactions, often induced by heat or any other source of energy.
They may also contain additives and/or pigments and fillers.
The main types of starting polymers used are, for example, phenolic resins, epoxy resins, aminoplastics, vinyl resins, acrylics, polyesters and perfluorinated resins.
Specifications
Surface coatings should meet the following requirements:
Under normal or foreseeable conditions of use they should not pose a risk to health or bring about either a deterioration in the organoleptic characteristics or an unacceptable change in the nature, composition or quality of the foodstuffs with which they come into contact.
They should be manufactured in accordance with good manufacturing practice using monomers, starting substances and additives listed in Appendix 2 to this resolution, as well as aids to polymerisation listed in Resolution AP (92) 2 on control of aids to polymerisation (technological coadjuvants) for plastic materials
and articles intended to come into contact with foodstuffs, and prepared, applied and cured in strict adherence to manufacturers' specifications.
They should not transfer their constituents to foodstuffs in quantities > 10 mg/dm2 of the surface area of the final varnished material or article (mg/dm2) (overall migration limit).
However, this limit is set at 60 mg of components transferred per kg of foodstuffs (mg/kg) in the following cases:
a. articles which are containers or comparable to containers or which can be filled with a volume between 500 ml and 10 l;
b. articles which can be filled and for which it is not possible to determine the surface area in contact with the foodstuffs;
c. caps, gaskets, stoppers or other devices for sealing.
Migration tests should be conducted according to Directives 82/711/EEC, 85/572/EEC, 90/128/EEC, 93/8/EEC and their future amendments, as appropriate, unless technically impracticable due to the nature of the material and the migration tests. Labelling should mention the limit of conditions of use of the finished product.
If more severe methods of analysis prove that the demands of the resolution are fulfilled then no migration tests will be required.
Using currently available methods of analysis, specific constituents can generally be detected in foodstuffs or food simulants at the level of 0.01 mg/kg. This should be taken as the limit of detection.
"Not-detectable" means that the substance can not be determined with reasonable statistical certainty by a validated analytical method. The method should have a specified determination limit. When the validated method is used to test for the substance and the substance is below the limit of determination, the substance is considered "not-detectable". If a validated analytical method does not exist, then the level of 0.01 mg/kg should be taken as a conventionally agreed and temporary value.
Where for a group of constituents a specific migration limit or residual quantity limit has been assigned to a common chemical function in the various constituents in that group (for example, the NCO or epoxy function), there should be a mechanism whereby constituents belonging to the group can be individually assessed.
References:
Council Directive 82/711/EEC, laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, as amended.
Council Directive 85/572/EEC, laying down the list of simulants to be used for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs, as amended.
Council Directive 90/128/EEC, concerning plastic materials and articles intended to come into contact with foodstuffs.
Commission Directive 93/8/EEC, amending Council Directive 82/711/EEC laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs.
Appendix 2 to Resolution AP (96) 5
on surface coatings intended to come into contact with foodstuffs
Inventory list of substances used for the manufacture of surface coatings
intended to come into contact with foodstuffs
(state of the art: June 1996)
The full list, comprising 128 pages, is contained in "related documents"
Footnote: 1
1. A functional barrier is any integral layer, which under normal or foreseeable conditions of use, reduces all possible material transfers (permeation and migration) from any layer beyond the barrier into food to a toxicologically and organoleptically insignificant, and to a technologically unavoidable, level.