Food contact materials and articles guidance notes (Scotland)

Friday 11 February 2005

This guidance is aimed primarily at businesses that, in Scotland, manufacture, use by way of filling with foodstuff for sale or sell, plastic materials and articles that are intended for use in contact with food. It may also be of use to others with an interest in the legislation, such as enforcement authorities.

Similar provisions are being made by the other administrations in England, Wales and Northern Ireland and those provisions should be consulted regarding the law in those jurisdictions.

Why you should read this note - compliance
Within the European Union 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 that many businesses will be familiar with, there is no harmonised system of prior approval or authorisation of food contact materials within the EU. Instead of approving the product, constituents of the materials, such as monomers and other starting substances, are subject to authorisation at EC level. It is likely 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, including, probably, documentary evidence that the goods complied with the law.

Purpose of the changes to legislation
The European Commission and the Member States of the European Union 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 any harmful effects of eating food contaminated by chemicals that might have migrated from materials and articles with which the food had been in intentional contact. In addition to protecting consumers, 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. Since the principal legislation on plastic food contact materials and articles was introduced in 1990, it has been regularly amended as better scientific understanding has developed about the nature and detection of chemical migrants from food contact materials and articles.

The Plastic Materials and Articles in Contact with Food Amendment (Scotland) Regulations 2005, which are the subject of this guidance, implement one EC Directive that contains the latest of these regular amendments by amending, in Scotland, the Plastic Materials and Articles in Contact with Food Regulations 1998. These new amending regulations are the first to be made in Scotland in 2005 to amend those 1998 Regulations. They will come into force on 24 March 2005.

The main changes brought about by the amending Regulations:

• Change the definition of 'additive' used in the manufacture of food contact plastics. (Regulation 3(a)(i))
• Place a restriction on the use of additives to the plastic material or article when that additive is also used as a food additive. (Regulation 5)
• Provide for the procedure by which authorisation may be sought when anybody wants to have a new additive added to the Community list of authorised additives. (Regulation 6)
• Require changes to the labelling provisions for food contact plastics so as to include more information attesting compliance with the law before at the stages before products are placed on retail sale. (Regulation 7)
• Provide for a defence against an alleged breach of the 1998 regulations for plastic materials and articles made or brought into the EU before 1 March 2006. (Regulation 8(b))
• Make amendments to the technical lists of monomers and plastics additives that may be used in the manufacture of food contact plastics. These amendments include changes to the conditions of use of some substances, for example changes to the amount of a substance that is permitted to migrate adventitiously into food, changes to the dates up to which some substances may be used, adding newly authorised substances to the lists, and deleting substances whose authorisations have expired. (Regulation 9(a) and Schedules 1 & 2, Regulation 9 (b), Regulation 10, Regulation 11 and Schedules 3 & 4, Regulation 12 and Schedule 5, Regulation 13, Regulation 14, Regulation 15 and Schedule 6, Regulation 16)

Further information
If you have any questions about these or any other Regulations governing food contact materials and articles, please contact:
Fiona Bruce
Food Standards Agency Scotland
Contaminants, Hygiene, Additives & Shellfish Branch
6th Floor, St Magnus House
25 Guild Street
Aberdeen
AB11 6NJ
Tel No: 01224 285170
Fax No: 01224 285168
E-mail: fiona.bruce@foodstandards.gsi.gov.uk

Other information about food contact materials is available from the link at the foot of this page.

The information that is available includes explanatory notes on all food contact material legislation, including European Council resolutions and policy statements, European Regulations and European Commission Directives, United Kingdom research and development and chemical surveillance. The results of completed surveillance can be viewed from this point, although work predating the formation of the Agency can be accessed from the site archive. You can also access information about the work of The Working Party on Chemical Contaminants from Food Contact Materials in determining and reviewing work on research and development in this area.