Materials and Articles in Contact with Food (England) Regulations 2005

The new Regulations made in England, the Materials and Articles in Contact with Food (England) Regulations 2005 will:

• revoke The Materials and Articles in Contact with Food Regulations 1987 and all subsequent amendments
• re-enact the provisions on regenerated cellulose film and implement the amending provisions of Directive 2004/14/EC, where necessary and include the removal of three substances in the phthalates group from the positive list of substances that may be used in manufacturing these materials and articles
• permit the use ofa new type of regenerated cellulose film with a food contact coating consisting of plastics, which is compostable and biodegradable, with appropriate controls to protect consumers
• re-enact without amendment, the provisions on vinyl chloride monomer
• provide for the enforcement of the new European Regulation by the enforcement authorities
• revise penalties for offences that are required under the new EC Regulation 1935/2004 so that a person found guilty of an offence under the Regulations is liable on conviction to a fine or imprisonment of up to two years, or both

This guidance is aimed primarily at companies that manufacture, use or sell materials and articles made from regenerated cellulose film and all other materials and articles that are intended for use in contact with food, including materials and articles using vinyl chloride monomer. It may also be of use to others with an interest in the legislation, such as enforcement authorities. These guidance notes provide a short summary of the changes proposed by the new Regulations and relate to England only. The devolved administrations, Scotland, Wales and Northern Ireland, will make separate parallel legislation.

Within the European Union (EU) it is the responsibility of the manufacturer, importer or distributor of food contact materials and articles, or those who place them in contact with food prior to sale, to ensure that their products comply with the appropriate legislation. Unlike the system administered by the Food and Drug Administration (FDA) in the United States of America, which many businesses will be familiar with, there is no harmonised system of prior approval or authorisation of food contact materials within the EU. It is possible that, in the event of prosecution for an alleged offence under these Regulations, defendants might avail themselves of the defence of due diligence provided for in the Food Safety Act 1990, as amended. In order to succeed, such a defence would most likely require evidence that the defendant had taken all reasonable precautions to avoid committing the alleged offence, probably including documentary evidence that the material or article complied with the law.

The European Commission and the Member States of the EU are working towards a fully harmonised set of rules that will apply to food contact materials and articles across the EU. The aim is to protect consumers from harmful effects of eating food contaminated by chemicals that might have migrated from materials and articles with which the food had been in contact. This harmonisation will provide businesses with one set of rules to comply with throughout the EU, instead of a plethora of national rules in different EU Member States.

A new Regulation (EC) No. 1935/2004 on materials and articles intended to come into contact with food came into force on 3 December 2004. The new European Regulation replaces the original Council Directive 89/109/EEC and Directive 80/590/EEC (the directive containing the official symbol).

The regulations that are the subject of this guidance, The Materials and Articles in Contact with Food (England) Regulations 2005, will revise the penalties that have been in place since 1987. This will ensure that we comply with the requirements of Article 25 of the new EC Regulation. They will also revoke The Materials and Articles in Contact with Food Regulations 1987 (SI No. 1987/1523) and all subsequent amendments in so far as they apply to England, as the EC Directives these Regulations implemented have been revoked by the new European Regulation.

The English Regulations will also re-enact, with amendments where necessary, certain provisions contained in those 1987 regulations that have to remain in force. These latter provisions will, therefore, continue to implement Council Directive 78/142/EEC, 80/766/EEC, 85/432/EEC on materials and articles which contain vinyl chloride monomer, and Commission Directive 2004/14/EC on regenerated cellulose film.

The Materials and Articles in Contact with Food (England) Regulations 2005 provide for the enforcement of the European Regulation in England by the Food Authorities as defined by the Food Safety Act 1990, as amended. This ensures that enforcement of the European Regulation is the same as the enforcement of other elements of the food law as it applies in England.

The Regulations also contain new levels of penalty that will apply in future, in cases of infringement of the provisions of the European Regulation. These new penalties are in line with those of the Food Safety Act 1990, which apply elsewhere in our food law. The 1987 Regulations, which are replaced by the new European Regulation, contained lesser penalties. The older penalties were no longer sustainable, given that they were put in place nearly 16 years ago and that the European Regulation requires that penalties be effective, proportionate and dissuasive. The penalties that now apply are that a person found guilty of an offence under these and other regulations dealing with materials and articles in contact with food is liable on conviction to a fine or imprisonment ip to two years, or both; on summary conviction to a fine not exceeding the statutory maximum or to a term of imprisonment up to 6 months, or both.

Commission Directive 93/10/EEC, amended by Directive 93/111/EC, established a positive list of substances that can be used in the manufacture of coated and uncoated regenerated cellulose film. Some of the substances have conditions or restrictions on their use. In particular, uncoated film must not transfer ethylene glycol or di(ethylene) glycol, by themselves or together, in quantities exceeding 30 milligrams per kilogram of food. Synthetic casings made of regenerated cellulose and cellulose films that have coatings on the food contact side of greater than 50 milligrams per square decimetre of film are, at present, excluded from the scope of the legislation. The Materials and Articles in Contact with Food Regulations 1987 and the 1994 amendment Regulations implemented these directives.

Commission Directive 2004/14/EC amends Directive 93/10/EEC. This amendment provides that the uncoated, coated cellulose and plastic coated regenerated cellulose film may also be manufactured from the substances listed. It also applies the provisions of EC Directive 2002/72/EC (on plastic materials and articles intended to come into contact with foodstuffs), as implemented by the Plastic Materials and Articles in Contact with Food Regulations 1998 (as amended) to those regenerated cellulose films coated with plastics.

The 2005 Regulations also re-enact the provisions on vinyl chloride monomer that were contained in The Materials and Articles in Contact with Food Regulations 1987. These provisions are a straightforward re-enactment of those provisions, which had implemented Council Directive 78/142/EEC and Commission Directives 80/766/EEC and 81/432/EEC that remain in force.

If you have any questions about these or any other regulations governing food contact materials and articles, please contact:

Nasreen Shah
Food Standards Agency
Food Contact Materials Unit,
Room 515C, Aviation House,
125 Kingsway
London WC2B 6NH

Tel: 020 7276 8553
Fax: 020 7276 8514

E-mail: nasreen.shah@foodstandards.gsi.gov.uk