European Regulations and Directives

Within the EC (European Community), matters pertaining to the marketing/sale of products and materials in the European market as well as testing requirements for them are stated in directives which are permanently updated via the use of amendments. European regulations for articles and materials coming in contact with foodstuffs are based on a framework directive stating the basic requirements that must be met for all food-contact materials.

It is supplemented by directives (and their respective amendments) related to material groups that include:

• Positive lists of substances authorized
• Purity standards for these substances
• Special conditions for use of these substances
• Basic rules for checking compliance
• Overall migration limit of constituents into foodstuffs
• Specific migration limits of certain constituents into foodstuffs

Furthermore, EC-Directive 76/769/EEC – relating to restrictions on the marketing and use of certain dangerous substances and preparations--and its amendments shall be applied to all articles and materials coming in contact with foodstuffs.

German Law

Within Germany, EC directives regarding contact with foodstuffs have been incorporated into:

• German Food and Commodity Goods Law, Lebensmittel und Bedarfsgegenständegesetz (LMBG), dated 09.09.1999
• Commodities Ordinance, Bedarfsgegenständeverordnung (BGVO), dated 07.01.1998

The LMBG provides a framework of mandatory requirements controlling commodities coming in contact with foodstuffs.

• § 30 LMBG
  Prohibits the manufacturing, marketing and treatment of commodities coming in contact with
  foodstuffs as well as human skin or mucus membranes, which endanger human health through
  transmission of toxic substances or impurities.
  
  
• § 31 LMBG
  Prohibits the marketing of commodities coming in contact with foodstuffs as well as human skin
  or mucus membranes, and releasing substances into foodstuffs or on their surfaces, except at
  physical and sensorial levels that are harmless and technically unavoidable.
  
  
• BfR (Bundesinstitut für Risikobewertung)
  Germany’s BfR (Bundesinstitut für Risikobewertung - the Federal Institute for Risk Assessment) is regarded as the leading authority in Germany for evaluating plastic materials. Their recommendations represent the present state of the art wherever the LMBG is not specific enough, e.g. for silicone materials.

Examination of synthetic materials coming in contact with foodstuffs

Confirmation of compliance with EC regulations or national regulations should be made available by manufacturers of raw materials. It should however be noted that the attestation given by the manufacturer is limited in scope, i.e. to specific requirements which have been applied to the final product. For example, it is difficult to check limits with regard to the migration of certain substances in raw materials and compliance with requirements.
As to random and final testing undertaken in order to ensure the suitability of plastic products coming in contact with foodstuffs in the sense of § 30 and §31 LMBG, we consider the following examination procedures to be necessary:

1. Check of general manufacturing process and materials
2. Sensorial examination: transfer of taste and smell
3. Plastics – global migration / specific migration / heavy-metal content
4. Silicones – migration / volatile organic compounds
5. Metal – composition / extractable heavy metals
6. Other – other materials or application for specific requirements