5.1. Regulatory Authorities
5.1.1. International Standards Organization
5.1.2. Federal Food and Drugs Administration
5.1.3. EU REGULATIONS FOR FOOD PACKAGING (CEPE)
5.1.4. Sri Lanka Food, Costmetic and Drug Authority
5.1.5. Central Environamental Authority
5.1.8. CALIFORNIA PROPOSITION 65
5.1.9. 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: o Framework Regulation EC 1935/2004 - general requirements for all food contact materials o Legislation on specific materials - groups of materials and articles listed in the Framework Regulation o Directives on Individual Substances or groups of substances used in the manufacture of materials and articles intended for food contact o National legislation covering groups of materials and articles for which EU legislation is not yet in place
• Principles for EU legislation o 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 o Food contact materials must not transfer their components into the foods in unacceptable quantities (migration). o 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.