684 Meeting, 13 [-14] October]1999
6 Social and Economic questions
6.2 Public Health Committee
(CD-P-SP) - Addendum to the meeting report
CM(99)130 Addendum17 September 1999
Strasbourg, 1st July 1999
draft resolution on silicones used for
food contact applications
AS APPROVED BY THE CD-P-SP
RESOLUTION AP ( ) ...
ON SILICONES USED FOR FOOD CONTACT APPLICATIONS
(adopted by the Committee of Ministers on
at the ...meeting of the Ministers Deputies)
The Representatives, on the Committee of Ministers, of Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, The Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom, member states of the Partial Agreement in the Social and Public Health Field,
Recalling Resolution AP (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 AP (96) 35 of 2 October 1996, whereby they revised the structures of the Partial Agreement and resolved to continue, on the basis of revised rules replacing those set out in Resolution AP (59) 23, the activities hitherto carried out and developed by virtue of that resolution; these being in particular aimed at:
Having regard to the action carried out for several years for the purposes of harmonising their legislation in the public health field and, in particular, in the food sector;
Having regard to the fact that silicones are used in a wide variety of food contact applications;
Considering that silicones used in food contact applications may, by reason of the migration of their components to the foodstuffs, pose a risk to human health;
Observing that the lists of Appendix 2 hereafter represent an inventory of substances used for the manufacture of silicones used for food contact applications, but not a positive list;
Observing that the date specified in Appendix 2 hereafter represents the state of the art of substances used for the manufacture of silicones 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 account their restrictions of use;
Observing that the substances of List 2 of Appendix 2 hereafter have not been fully evaluated, or evaluated at all, by an international body due to lack of data and that these substances should be subject to toxicological studies;
Observing that the restrictions of use in Appendix 2 are those set by the Commission of the European Communities in its directives relating to plastic materials and articles intended to come into contact with foodstuffs;
Observing that the lists will be updated if new data on substances of Appendix 2 hereafter or on substances not included become available;
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 member states of the Partial Agreement in the Social and Public Health field to take into account in their national laws and regulations on silicones used for food contact applications the principles and the inventory list set out in the appendices hereafter.
Appendix 1 to Resolution AP (..) ..
Silicones constitute a group of polymeric chemical substances and preparations, all containing polysiloxanes. Polysiloxanes are characterised by Si-O-Si and Si-C bonds. They are prepared from chlorosilanes which are subjected to hydrolysis. Polysiloxanes such as fillers, emulsifiers, solvents etc. are also covered by the definition. Furthermore, copolymers or polymer-blends of polysiloxanes with organic polymers are comprised in the term silicones, provided siloxane monomer units predominate by weight over each of the other monomer units present. Silicones used as food additives are not covered by the definition.
Description of the silicone product group
Silicones include a range of products with a variety of properties and applications:
Silicones used for food contact applications, hereafter called silicones, should meet the following requirements:
They should be manufactured in accordance with a certified Quality Assurance System (e.g. ISO 9002 or CEN 29-004) and under the conditions specified in Appendix 2.
Interactions between starting substances or between starting substances and any other substance used in the manufacturing process of silicones should not lead to the formation of compounds which pose a risk to human health.
Linear siloxanes containing methyl- and phenyl- groups attached to the same silicone atom and also containing two methyl- groups attached to one silicon atom (siloxanes and silicones, Me-, Ph-, di-Me-) should not be used as starting substances, in order to prevent the formation of certain phenyl-substituted cyclic polydimethylsiloxanes.
The release of any substance from silicones to foodstuffs should be as low as technologically possible. The total of all substances migrating into food from silicone materials or articles should not exceed 10 mg/dm2 of the surface area of the final material or article or 60 mg/kg of food, this being considered as the overall migration limit.
The migration limits set out in Appendix 2 should be met.
Migration tests should be conducted according to Directives 82/711/EEC, 85/572/EEC, 90/128/EEC, 93/8/EEC, 97/48/EEC and their future amendments, as appropriate, unless technically impracticable due to the nature of the material and the migration tests.
Silicones should not release to or form in the foodstuffs any substance in a quantity that poses a risk to human health or that adversely effects the organoleptic properties in the food in accordance with Article 2 of Directive 89/109/EEC.
Appropriate labelling for the materials or articles should be assured, if pre-washing by the user is necessary.
Appendix 2 to Resolution AP (..) ..
Inventory list of substances used in the manufacture of
silicones used for food contact applications
(State of the art: May 1999)
Appendix 2 contains the inventory of substances (starting substances, polymerisation aids and additives) which are used in the manufacture of silicones used for food contact applications and which, due to their non-reactive groups, are likely to be present in the final material or article and which may therefore be found in the overall migrate.
Precursors and other substances, which contain reactive groups and which due to their reactivity are incorporated into a solid macromolecular structure and which therefore are not likely to be found in the overall migrate, are not included in the inventory list, as they disappear during the manufacturing process.
As regards the list of starting substances:
As regards the list of additives:
The lists contain the following information:
If any of the above methods of analysis does not currently exist, an analytical method with appropriate performance characteristics at the specified limit level may be used, pending development of a validated method.
Theses appendix are only available in word .
Substances evaluated by an international body (Substances classified in SCF Lists 0-4)
1. Substances not fully evaluated by an international body (Substances classified in SCF Lists 6-8)
2. Substances not evaluated by an international body (Substances classified in SCF List 9 or not at all classified)