5.1. Regulatory Authorities

5.1.1. International Standards Organization

5.1.2. Federal Food and Drugs Administration

https://www.fda.gov/Food/IngredientsPackagingLabeling/PackagingFCS/default.htm

5.1.3. EU REGULATIONS FOR FOOD PACKAGING (CEPE)

https://dfl.di.dk/sitecollectiondocuments/klassificeringsregler/cepe%20m%C3%A6rkningsguide%202%20del.pdf

5.1.4. Sri Lanka Food, Costmetic and Drug Authority

http://203.94.76.60/DRA/home.htm

5.1.5. Central Environamental Authority

http://www.cea.lk/

5.1.6. EN71

https://www.tuv-sud.com/home-com/resource-centre/publications/e-ssentials-newsletter/consumer-products-e-ssentials/vol.-82/eu-toy-standard-en-71-1-2011a3-2014-is-published

http://www.toy-icti.org/info/toysafetystandards.html

5.1.7. REACH

https://echa.europa.eu/regulations/reach/legislation

5.1.8. CALIFORNIA PROPOSITION 65

https://www.toms.com/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.

• http://ec.europa.eu/food/food/chemicalsafety/foodcontact/index_en.htm

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