SILICONES USED for FOOD CONTACT APPLICATIONS Version 1 Œ 10.06.2004
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PUBLIC HEALTH COMMITTEE COMMITTEE OF EXPERTS ON MATERIALS COMING INTO CONTACT WITH FOOD POLICY STATEMENT CONCERNING SILICONES USED FOR FOOD CONTACT APPLICATIONS Version 1 œ 10.06.2004 NOTE TO THE READER The following documents are part of the Policy statement concerning silicones used for food contact applications: Resolution ResAP (2004) 5 on silicones to be used for food contact applications Technical document No. 1 œ List of substances to be used in the manufacture of silicones used for food contact applications The documents are available on the Internet website of the Partial Agreement Division in the Social and Public Health Field: www.coe.int/soc-sp 2 TABLE OF CONTENTS Page Resolution ResAP (2004) 5 on silicones to be used for food contact applications ……………………………………………………………………….……. 4 Technical document No. 1 œ List of substances to be used in the manufacture of silicones used for food contact applications ……………………… 8 3 RESOLUTION RESAP (2004) 5 ON SILICONES USED FOR FOOD CONTACT APPLICATIONS 4 RESOLUTION RESAP (2004) 5 ON SILICONES USED FOR FOOD CONTACT APPLICATIONS (adopted by the Committee of Ministers on 1st December 2004 at the 907 th meeting of the Ministers‘ Deputies) (superseding Resolution AP AP (99) 3) The Committee of Ministers, in its composition restricted to the Representatives of Austria, Belgium, Cyprus, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, The Netherlands, Norway, Portugal, Slovenia, Spain, Sweden, Switzerland and the United Kingdom, member states of the Partial Agreement in the Social and Public Health Field, Recalling Resolution (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 (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 (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, including constant contribution to harmonising œ 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 œ 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 œ and contributing to its implementation at European level œ 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 silicones used for food contact applications may, by reason of the migration of their components to the foodstuffs, pose a risk to human health; 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 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 set out hereafter. 5 APPENDIX 1 TO RESOLUTION RESAP (2004) 5 1. Definition 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. 2. Description of the silicone product group Silicones include a range of products with a variety of properties and applications: 2.1. silicone elastomers: coatings, sealants, etc.; 2.2. silicone liquids: additives to plastics and coatings, release agents for moulding plastic articles, impregnating agents for textiles, etc.; 2.3. silicone pastes: lubricants for food processing machinery etc.; 2.4. silicone resins: heat-resistant coatings, release coatings in food production such as bakery, etc. 3. Specifications Silicones used for food contact applications, hereafter called silicones, should meet the following requirements: 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 deterioration in the organoleptic characteristics thereof; 3.2. they should be manufactured in accordance with a certified Quality Assurance System (for example, ISO 9002 or CEN 29-004) and under the conditions specified in —Technical document No. 1 œ List of substances used in the manufacture of silicones used for food contact applications “; 3.3. 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; 3.4. 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; 6 3.5. 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/dm 2 of the surface area of the final material or article or 60 mg/kg of food, this being considered as the overall migration limit; 3.6. the migration limits set out in —Technical document No. 1 œ List of substances used in the manufacture of silicones used for food contact applications “ should be met; 3.7. 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; 3.8. appropriate labelling for the materials or articles should be assured, if pre-washing by the user is necessary. 7 TECHNICAL DOCUMENT No. 1 LIST OF SUBSTANCES USED IN THE MANUFACTURE OF SILICONES USED FOR FOOD CONTACT APPLICATIONS Version 1 œ 10.06.2004 8 1. CLASSIFICATION SYSTEM OF SUBSTANCES TO BE USED FOR MATERIALS AND ARTICLES INTENDED TO COME INTO CONTACT WITH FOODSTUFFS General specifications List 1 - Substances approved for the use of materials and articles intended to come into contact with food 1. Substances evaluated by SCF, classified in list 0-4, and used in compliance with specific migration limits or other restrictions, if any; 2. Substances evaluated and approved by the Committee of expert on materials coming into contact with food; 3. Substances approved in Partial Agreement member states or by FDA, based on an evaluation of a toxicological dossier, which meets the present SCF criteria; 4. Substances authorised as direct food additives in compliance with specific migration limits or other restrictions; 5. The substances which have been approved by Partial Agreement member states or by FDA applying scientific evaluation criteria of the time of their approval will be listed in a Temporary Appendix to List 1. List 2 œ Substances not approved for the use of materials and articles intended to come into contact with food Substances which do not meet the criteria set for List 1 substances. Complementary specifications 1. The substances of the Temporary Appendix should be integrated in List 1 or List 2 not later than five years after adoption of the List of substances. 2. Lists 1 and List 2 will be updated in principle once a year in order to take into account newly evaluated substances, new submissions by industry or substances to be deleted. 9 2. Introduction 2.1. The lists contain the substances (starting substances, polymerisation aids and additives) to be 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. 2.2. 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 present list, as they disappear during the manufacturing process. 2.3. As regards the list of starting substances: • the majority of substances listed are polymers with functional groups from which the polymeric macro-network is formed after reaction with cross-linking agents; • many of the polymers are groups of products with their assigned CAS registration number, as for example: - siloxanes and silicones, di-Me, me-vinyl (CAS No. 67762-94-1) are a group comprising linear polymeric molecules with a wide variation in chain length and content of vinyl groups; - silsesquioxanes, Me-Ph (CAS No. 67763-03-5) and siloxanes and silicones, di-Me, polymers with Me-Ph-silsesquioxanes (CAS No. 68440- 81-3) each describe a group of branched polymeric siloxanes with wide variations in molecular weight, degree of branching and ratio Me : Ph.