Last updated on 14 February 2006
Plastic Materials and Articles in Contact with Food (England) Regulations 2006: Guidance notes
This guidance provides a short summary of the changes proposed by the new regulations in so far as they relate to England only. It is aimed primarily at companies that manufacture, use or sell materials and articles made from food contact plastics, and those plastics, adhesives and coatings containing BADGE (2,2,-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether and its derivatives.
It is also aimed at enforcement authorities. It may also be relevant to others with an interest in the legislation.
The devolved administrations, Scotland, Wales and Northern Ireland will make separate but parallel legislation.
This guidance has been prepared to provide information about the regulations. It should not be taken as an interpretation of the law.
It is not a substitute for the regulations nor should it be read in isolation from, but in conjunction with, them.
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 that 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, including, probably, documentary evidence that the material of article complied with the law.
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 harmful effects of eating food contaminated by chemicals that might have migrated from materials and articles with which the food had been in 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 Member States.
The European Regulation (EC) No 1895/2005 on the restriction of use certain epoxy derivatives in materials and articles intended to come into contact with food, came into force on 9 December 2005 and is directly applicable throughout the European Union.
The European regulation consolidates most of the provisions contained in Commission Directives 2002/16/EC and 2004/13/EC that it now replaces.
However, one significant change that arises from this regulation is a relaxation in the limit of migration from packaging into food for BADGE and its hydrolysed derivatives.
The European regulation now permits the use of BADGE in food contact plastics, adhesives and coatings, providing any migration is within a specific migration limit of 9 milligrams per kilogram of food of food simulant, including its hydrolysed derivatives.
This limit can be taken as 9 milligrams per six decimetres squared in certain cases.
This applies where articles are containers, or are comparable to containers, which can be filled with a capacity of less than 500 millilitres or more than 10 litres.
It also applies to sheet film or other material, which cannot be filled, or for which it is impracticable to estimate the relationship between the surface area and the quantity of food with which the material is in contact.
Where BADGE migration occurs with particular chlorohydrins the sum of their migration may not exceed 1 milligram per kilogram of food or food simulant or I milligram per six decimetres squared in the specific cases above.
The EC Regulation permits trade in the use of materials and articles containing BADGE throughout the EU from 1 January 2006 and re-affirms the ban on the use of BFDGE (Bis(4-hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers) and NOGE (Novolac glycidyl ethers).
The EC Regulation also requires that, at the marketing stages but not the retail stage, materials and articles containing BADGE and its derivatives shall be accompanied by a written declaration in accordance with Regulation (EC) No. 1935/2004 (Article 16).
Compliance must be documented and that documentation has to be made available to the competent authorities on demand.
Purpose of the England Regulations
The regulations that are the subject of this guidance, The Plastic Materials and Articles in Contact with Food (England) Regulations 2006 will provide for the enforcement, in England, of Regulation (EC) No. 1895/2005 by the food authorities and for certain necessary provisions consequent upon action that may be taken by the enforcement authorities.
The regulations will also revoke older legislation that they replace and, at the same time, re-enact provisions that should remain in force, but in one set of regulations rather than six.
This should make it easier for businesses to comply with the rules and for enforcement authorities to carry out their responsibilities.
Implementing provisions for enforcing 1895/2005
The Plastic Materials and Articles in Contact with Food (England) Regulations 2006 will provide for the enforcement, in England, of Regulation (EC) No 1895/2005 by the food authorities, as defined by the Food Safety Act 1990.
They will also provide for offences where products subject to the provisions in the European regulation are in breach of them, for defences against alleged breaches of the European regulation and for penalties to apply upon conviction for an offence under them.
Changes to the rules on food contact plastics in England
The Plastic Materials and Articles in Contact with Food (England) Regulations 2006 will revoke in their entirety The Plastic Materials and Articles in Contact with Food Regulations 1998 (SI 1998 No 1376) and their five sets of amending regulations in so far as they apply in relation to England.
However, at the same time, they will re-enact all the provisions contained within them.
This is the start of work that will simplify and consolidate those six current sets of regulations into one.
This has been done to make it easier for businesses to understand and comply with the law and for food authorities and enforcement laboratories to enforce the law.
In addition to the 1998 regulations, the following five sets of amending regulations have therefore also been revoked:
- The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2000 (SI 2000 No 3162)
- The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2002 (SI 2002 No 2364)
- The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2002 (SI 2002 No 3008)
- The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2004 (SI 2004 No 3113)
- The Plastic Materials and Articles in Contact with Food (Amendment) (England) Regulations 2005 (SI 2005 No 325)
The new regulations made in England, The Plastic Materials and Articles in Contact with Food (England) Regulations 2006 will:
- provide for the enforcement by the Food Authorities in England of Regulation (EC) No. 1895/2005 and The Plastic Materials and Articles in Contact with Food (England) Regulations 2006;
- provide for defences against alleged breaches of the EC Regulation and for penalties to apply upon conviction for an offence against them;
- revoke existing national provisions in our Regulations governing these derivatives;
- simplify the rules on food contact plastics by revoking The Plastic Materials and Articles in Contact with Food Regulations 1998 and all five existing amendments to those regulations by consolidating them into one set of comprehensive Regulations on food contact plastics
If you have any questions about these or any other regulations governing food contact materials and articles, please contact:
Food Standards Agency
Room 515C, Aviation House
London WC2B 6NH
Tel: 020 7276 8553
Fax: 020 7276 8514