The Food Standards Agency is consulting on new regulations on plastics intended to come into contact with food.

• The Regulations implement Commission Directive 1999/91/EC in England and must be in place by 31 December 2000. They extend controls on substances used to make plastics intended to come into contact with food.

• The Regulations will apply in England only. Separate but parallel regulations will be introduced simultaneously by the relevant authorities to apply in Scotland, Wales and Northern Ireland.

• The new Regulations amend Statutory Instrument 1998 No 1376 which implements all previous Directives in this area.

• The deadline for comments on the consultation package is 15 July.

The Food Standards Agency (FSA) has taken over responsibility for food contact materials legislation from MAFF and now has the responsibility of implementing all new EC Directives in this area.

The draft Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2000 have been drawn-up to implement Directive 1999/91/EC. You are invited to comment on these by 14 July 2000.

These regulations will only apply in England. The relevant regulatory bodies in Scotland, Wales and Northern Ireland will be introducing separate legislation.

The use of food contact plastics in Great Britain is controlled by the Plastic Materials and Articles in Contact with Food Regulations 1998 (SI 1998 No.1376). These implement Directive 90/128/EEC (as amended), which restricts the substances used to make food contact plastics and sets overall and specific limits on their migration into food and Directives 82/711/EEC (as amended) and 85/572/EEC, which lay down rules for testing compliance with the migration limits.

In November last year, Directive 1999/91/EC, the Fifth Amendment to Directive 90/128/EEC, was adopted, with an implementation deadline for Member States of 31 December 2000. Implementation of 1999/91/EEC will require an amendment to be made to the 1998 Regulations.

Consumers will benefit from the improved controls that these new Regulations will bring with regard to the protection of public health. The primary business sector affected will be the manufacturers of food contact plastics.

Submitting comments on the draft Regulations

We would welcome comments on:

• The draft Regulations themselves; and
• Any issues raised by the draft Regulations including the draft Regulatory Impact Assessment (see particularly the requests in sections 9, 10 and 12).

Please send your responses in writing to arrive no later than Friday 14 July 2000.

Candice Olsen
Room 211, Food Standards Agency
PO Box 31037, SW1P 3WG.
Fax: 020 7238 6124
Email: candice.olsen@foodstandards.gsi.gov.uk

To comply with the Food Standards Agency's openness procedures, it is intended that all responses to the consultation be made available through the main library, Whitehall Place (West Block), London SW1A 2HH. The library will supply copies on request, to telephone and personal callers (although personal callers should give 24 hours notice of their visit). A small charge will be made to cover photocopying and administrative costs.

If you feel that we have omitted to consult an interested party we would be grateful if you would let us know, as soon as possible. Please note that this consultation will be announced in a Press Release and in the Food Safety Information Bulletin published by the Food Standards Agency. These consultation papers will be made available on the FSA website and can also be obtained from the above address.

These regulations will implement EC Directive 1999/91/EC, which amends, for the fifth time, Directive 90/128/EEC relating to plastic materials and articles intended to come into contact with foodstuffs. This amendment updates the list of substances permitted for use in food contact plastics. It reflects assessment of migration and toxicity data by the EC Scientific Committee on Food. The Directive serves the dual purpose of protecting consumer health from harmful chemical migration and of harmonising technical and legislative standards in the European Union.

Directive 90/128/EEC, and its previous four amendments (Directives 92/39/EEC, 93/9/EEC, 95/3/EC and 96/11/EC) have been implemented by means of a consolidated Statutory Instrument (SI 1998 No. 1376). These regulations will amend SI 1998 No.1376 by

• Amending the list of monomers (Schedule 1 Part I Section A to 1998 Regulations)
  
  
• Amending the list of additives (Schedule 2 Part I to 1998 Regulations)
  
  
• Adding new, or new parts of, schedules on:

3. Risk Assessment

Many different chemicals are used in the manufacture of plastic food contact materials. These chemicals may migrate into food or drink and therefore specific migration and toxicity data have to be assessed by the relevant expert committee. In the EU the Scientific Committee on Food (SCF) is the authoritative source of advice in the context of this Directive. The contents of Directive 1999/91/EC take forward the advice of the SCF into the legislative framework.

4. Options

Business is already complying with the legislation into which this Directive fits. Business has already incurred costs in assembling the migration and toxicity data. Costs associated with compliance with SI 1998 No.1376 are already being met. Business generally tests its products for the purposes of demonstrating compliance with the Food Safety Act 1990 in the event of prosecution. The listing of additional substances in the Directive increases the choice of safe raw materials. There are no costs for charities or voluntary organisations.

Business sectors affected

The primary business sector affected will be the manufacturers of food contact plastics. Users of such materials will not be affected to the same extent. It is not possible to estimate the number of businesses affected by these regulations because we cannot be sure if they use the substances in Directive 1999/91/EC as there may be alternatives.

Compliance costs for a ‘typical’ business

Not quantifiable but estimated to be negligible, based on previous similar measures.

Total Compliance costs

Not quantifiable but estimated to be negligible.

The primary business sector affected will be the manufacturers of food contact plastics. Users of such materials will not be affected to the same extent. It is not possible to estimate the number of businesses affected by these regulations because we cannot be sure if they use the substances in Directive 1999/91/EC as there may be alternatives.

Not quantifiable but estimated to be negligible, based on previous similar measures.

Not quantifiable but estimated to be negligible.

All relevant industry organisations including small businesses, and in particular the Small Business Service, have had the opportunity to comment on the draft Regulations. Prior to this there have been consultations on the draft Directive through the usual channels maintained by the Commission and industry organisations. SCF opinions on individual substances are routinely published before these are incorporated in the relevant Directive. The individual businesses responsible for presenting migration and toxicity data to the SCF will have been made aware of their opinion, directly through the EC Commission services.

10. Results of consultation

11. Summary and recommendations

This is a routine technical amendment primarily to update lists of chemicals used in the manufacture of food contact plastics in existing legislation. Data on these chemicals have been provided by industry to the relevant independent expert committee. The outcome of the assessment of the data by this committee is being codified in the Directive. Industry and consumers benefit from more extensive lists of approved substances which provide more choice and greater confidence in the safety of the plastic materials and articles. Compliance costs for industry are negligible.

Directive 1999/91/EC should be implemented by Statutory Instrument. The recommendation also takes into account Community obligations.

Enforcement is carried out by local authorities. Amendments to Directive 90/128/EEC will continue to be adopted at periodic intervals. A sixth amendment is already under discussion.

Contact point

Ms C Olsen
Rm 211
Food Standards Agency
PO Box 31037
SW1P 3WG

Tel: 020-7238-6225
Fax: 020-7238-6124
Email: candice.olsen@foodstandards.gsi.gov.uk