Regulations

European Union EU

• The Packaging and packaging waste Directive 2004/12/EC (amending Directive 94/62/EC) http://eur-lex.europa.eu/legal-content/EN/TXT/?qid=1432287283191&uri=URISERV:l21207
• Practical and scientific guidelines and methods for use by companies and authorities when setting up systems for compliance with the European Packaging and Packaging Waste Directive (EU/94/62) and the 6 harmonised CEN Standards (EN 13427-13432). Developed by Scandinavian companies, business associations, and institutes in a number of national projects from Denmark, Finland, Iceland, Norway and Sweden. http://www.opti-pack.org
• Food contact materials and articles are regulated by:
  • Framework Regulation EC 1935/2004 - general requirements for all food contact materials
  • Legislation on specific materials - groups of materials and articles listed in the Framework Regulation
  • Directives on Individual Substances or groups of substances used in the manufacture of materials and articles intended for food contact
  • National legislation covering groups of materials and articles for which EU legislation is not yet in place
• Principles for EU legislation
  • Harmonising legislation on food contact materials at EU level aims to:
    • Protect consumers' health;
    • Remove technical barriers to trade.
• Safety and migration of food contact materials
  • Food contact materials must not transfer their components into the foods in unacceptable quantities (migration).
  • Migration limits for plastic materials:
    • Overall Migration Limit - 10mg of substances/dm² of the food contact surface for all substances that can migrate from food contact materials to foods;
    • Specific Migration Limit (SML) for individual authorised substances fixed on the basis of a toxicological evaluation.
• SML is set according to the Acceptable Daily Intake or the Tolerable Daily Intake established by the Scientific Committee on Food.
• The limit is set on the assumption that every day throughout lifetime, a person weighing 60kg eats 1kg of food packed in plastics containing the substance in the maximum permitted quantity.
• http://ec.europa.eu/food/food/chemicalsafety/foodcontact/index_en.htm