Ministers' Deputies
CM Documents



684 Meeting, 13 [-14] October]1999
6 Social and Economic questions

6.2 Public Health Committee

CM(99)130 Addendum 17 September 1999

PUBLIC HEALTH COMMITTEE

63^rd session

Strasbourg, 1^st July 1999

ADDENDUM TO THE MEETING REPORT

 

draft resolution on silicones used for

food contact applications

AS APPROVED BY THE CD-P-SP

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:

a. raising the level of health protection of consumers in its widest sense, including a 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; the definition – and contribution to implementation at European level – of 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 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.

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.

Silicones include a range of products with a variety of properties and applications:

– Silicone elastomers: coatings, sealants, etc.;

– Silicone liquids: additives to plastics and coatings, release agents for moulding plastic articles, impregnating agents for textiles, etc.;

– Silicone pastes: lubricants for food processing machinery etc.;

– Silicone resins: heat-resistant coatings, release coatings in food production such as bakery, etc.;

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 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:

– 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) is 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.

As regards the list of additives:

– it contains polymeric substances with names ‘siloxanes and silicones…’.

- the additives entries of ‘siloxanes and silicones…’ describe true additives. The
substances are used for a technical effect and do not participate in the
formation of the macro-network. Thus, as example, silicone fluids (polydimethylsiloxanes (CAS No. 63148-62-9) are used as softening agents in some silicone elastomer formulations.

The lists contain the following information:

– SCF	Scientific Committee for Food of the European Commission;
– SCF Lists 0-4 SCF Lists 6-8 SCF List 9	As defined in "A practical guide for users of EC Directives on materials and articles intended to come into contact with foodstuffs";
– NAME	The chemical name of the substance or the substance group;
– PM/REF	The EU packaging material reference number of the substance;
– CAS	The Chemical Abstracts Service Registry Number of the substance;
– RESTRICTIONS	They may include : – Specific migration limit (SML) – Residual quantity of the substance in the material (QM) – Any other restriction specifically mentioned;
– ADI/TDI	Acceptable daily intake or tolerable daily intake as defined in the reports of the Scientific Committee for Food.

 

A number of abbreviations are used under RESTRICTIONS and ADI/TDI, the meanings of which are as follows:

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 .

Inventory list

List 1

Substances evaluated by an international body (Substances classified in SCF Lists 0-4)

List 2

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)