FSA Consultation Letter, 16 March 2004
The European Commission has made a proposal for a so-called superdirective for plastic materials and articles intended to come into contact with food.
Negotiations with the Commission and other European Union Member States are
currently expected to continue at meetings planned for June and September 2004
Summary of proposal
The aim of the proposal is to bring together all the existing harmonised EU rules on food contact plastics into one document and, simultaneously, to bring them into line with other EU-harmonised food law. A codification of the original Directive on food contact plastics, 90/128/EEC, and its seven amendments was adopted in 2002. This proposal goes much further by adding to those rules three others on vinyl chloride, three more on methods for migration testing and one on simulants that may be used in the migration test.
As well as bringing these disparate existing rules together, the proposal extends the rules to multi-layer plastics that are composed of different materials, makes provision for 'functional barriers', specifies a reduction factor that may be used with lipophilic substances, clarifies manufacturers obligations for having supporting documentation for substances that migrate into the food that are not listed in the Community lists of substances and havent been evaluated by the authorities, conversion of other measures of substances into specific migration limits. Currently, this proposal is made as a directive, but it may become a proposal for a regulation in time.
Detail of proposal
The proposal to extend the rules to cover multilayer materials composed of layers of different materials recognises that, at present there are no specific rules governing this type of material. Currently, articles composed of more than one layer, even if one or more layers is plastic, must meet the general requirements of Article 2 of the framework Directive, Council Directive 89/109/EEC. The new concept being proposed recognises that glass and metal are fully functioning barriers that may be generally used.
The proposal also recognises that the use of other materials as functional barriers may be effective under specific conditions in which they either reduce the migration of authorised substances below the specific migration level (SML) or reduce the migration of non-authorised substances into food or food simulants to a not detectable level. Under the proposal, the layer acting as a functional barrier may be authorised and listed together with the conditions of its validity. If used without authorisation, the manufacturer will be required to provide a written declaration of compliance.
The proposals introduces a new provision of the fat (consumption) reduction factor for the lipophilic substances. This provides the formula for measuring migration when comparing specific migration limits and it gives recognition to the fact that the European consumer does not eat more than 200 grams of fat, current assumptions are based on the consumption of 1000 grams of fat consumed daily. New rules are proposed to clarify the problem of substances not listed at present in the finished material or article.
These would oblige the manufacturer to indicate that the substances used in the manufacture comply with the general safety and food quality requirements of Article 2 of the framework Directive, Council Directive 89/109/EEC. The proposal also includes a provision on the labelling of food contact materials that are not in contact with food at the time they are sold to consumers. This requires that they be accompanied by a written declaration of compliance, clarifies the need for record keeping by the industry. The proposal will apply to imports into the Community as well goods manufactured in the Community.
This is a complex proposal and we should like to know whether there are particular
difficulties or overbearing costs for anyone likely to be affected by it. If
you find any weaknesses in the proposal please let me know what they are and,
if you can, say how you think these might be overcome.
To see a copy of the working document, go to: http://www.food.gov.uk/multimedia/pdfs/plasticmaterialsfoodstuffs.pdf