Packaging legislation

Main legal or regulatory requirements for packaging design

     
Life cycle step Principles to comply with Legal or regulatory texts
     
Packaging conception Requirements and authorised materials intended to come into contact with food Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC
  Commission Directive 2008/39/EC amending Directive 2002/72/EC relating to plastic materials and articles,
Council Directive 84/500/EE relating to ceramic articles,
Commission Directive 2007/42/EC relating to materials and articles made of regenerated cellulose film.
  Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food.
Commission Regulation (EC) No 1895/2005 on the restriction of use of certain epoxy derivatives in materials and articles intended to come into contact with food.
Council Directive 78/142/EEC relating to materials and articles which contain vinyl chloride monomer and are intended to come into contact with foodstuffs.
Council Directive 82/711/EEC laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs
Commission Regulation (EC) No 450/2009  on active and intelligent materials and articles intended to come into contact with food.
  Commission Regulation (EC) No 450/2009 on active and intelligent materials and articles intended to come into contact with food.
Packaging for pharmaceutical products and medical devices Directive 2009/53/EC  (on the Community code relating to medicinal products for human use) as regards variations to the terms of marketing authorisations for medicinal products, amending Directive 2001/82/EC and 2001/83/EC
Packaging for transportation of dangerous products Regulation (EC) No 1272/2008 "CLP" on classification, labelling and packaging of substances and mixtures, effective on 1 June 2015 and amending and repealing Directives 67/548/EEC and 1999/45/EC. ddStandard ISO 16104:2003 on transport packaging for dangerous goods
Aerosol packaging Commission Directive 2008/47/EC relating to aerosol dispensers
Essential requirements on environment Council Directive 94/62/EC on packaging and packaging waste amended by Council Directive 2004/12/EC and 2005/20/EC.
Decision 97/129/CE on the identification system for packaging materials.
     
Raw material transformation; packaging manufacturing Autorisations and restrictions applying to chemical substances used in packaging COUNCIL REGULATION (EC) No 440/2008 of 30 May 2008
laying down test methods pursuant to Regulation (EC) No 1907/2006 of on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)
Control, inspection of materials and manufacturing of packaging Commission Directive 2003/94/EC laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use. Standard ISO 15378:2006  join in one document the requirements of quality management ISO 9001:2000 and Good Manufacturing Practices (GMP) for the design, manufacture and supply of primary packaging materials for drugs.
Traceability of materials and packaging intended to come into contact with food Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC
Regulation (EC) No 178/2002  laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety
Recycled plastic material intended to come into contact with food Commission Regulation (EC) No 282/2008 on recycled plastic materials and articles intended to come into contact with foods and amending Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food.Commission Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food
Labelling of primary packaging Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC
     
Packaging filling Hygiene of foodstuf packaging Regulation (EC) No 852/2004 on the hygiene of foodstuffs.   
Directive 1993/43 concerning hygiene of foodstuffs Standard ISO 22000: Management systems of food safety - Requirements for any organization in the food chain. Standard EN 15593: Management of hygiene in the production of packaging for foodstuffs
Several private standars (BRC, BRC/IOP, IFS, AIB...)
Packaging of medical devices Council Directive 93/42/EEC concerning medical devices ISO 11607 standard: Packaging for terminally sterilized medical devices
Compliance of prepackaged products Council Directive 76/211/EEC relating to the making-up by weight or by volume of certain prepackaged products.
Directive 2007/45/EC laying down rules on nominal quantities for prepacked products, repealing Council Directives 75/106/EEC and 80/232/EEC, and amending Council Directive 76/211/EEC
Council Directive 89/396/EEC on indications or marks identifying the lot to which a foodstuff belongs.
Products labelling Directive 2000/13/EC relating to the labelling, presentation and advertising of foodstuffs. Regulation (EC) No 1830/2003 concerning the traceability and labelling of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC, Regulation No 41/2009 concerning the composition and labelling of foodstuffs suitable for people intolerant to gluten, Regulation No 90/496/EEC on nutrition labelling for foodstuffs. Regulation (EC) No 1223/2009 on cosmetic products, Directive 2004/27/EC on the Community code relating to medicinal products for human use and amending Directive 2001/83/EC. Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures. Council Directive 67/548/EEC relating to the classification, packaging and labelling of dangerous substances. Regulation (EC) No 648/2004 on detergents.
     
Valorisation and recycling packaging waste   Directive 94/62/EC on Packaging and Packaging Waste, as amended by Directive 2004/12/EC