Quick Guide to Food Contact Regulation


Regulation


Description


Regulation (EC) No 1935/2004 

Full text

It is EU's framework regulation and sets out general requirements for all food contact materials (FCMs):
- FCMs shall not release their constituents into food at levels harmful to human health or change food composition, taste and odour in an unacceptable way;
- EU may set specific measures for certain groups of materials and articles (i.e, plastics). When a specific measure is adopted, business operators must provide written declaration of compliance (DOC) ;
- Business operators must establish a traceability system for FCMs from production to distribution;
- Labelling: Materials and articles, which are not yet in contact with food when they are placed on the market shall be labelled with the words ‘for food contact’, or a specific indication as to their use or the symbol below:

Regulation (EC) No 2023/2006 on GMP

Full text

- FCMs should be manufactured in compliance with general and detailed rules on good manufacturing practice (GMP);
- Business operators shall establish and implement both quality assurance system and quality control system, and maintain documentation system.

Specific Measures for Materials
- Only applicable to specific materials with special requirements on the positive list of food contact substanes, specification and restrictions.
- Regulation (EU) No 10/2011 on plastic materials
- Regulation (EC) No 450/2009 on active and intelligent materials
- Regulation (EC) No 282/2008 on recycled plastic materials
- Directive 84/500/EEC for ceramics
- Directive 2007/42/EC for regenerated cellulose film
- Resolution CM/Res(2013)9 on metals and alloys and its Technical Guide , for material like stainless steel, aluminum and other alloys, more detail can be found here

For above materials, declaration of compliance (DOC) is required.
Note: For FCMs with no specific EU measures, Member States may adopt their own national provisions on food contact materials.


Specific Measures for Substances

- Regulation 1895/2005/EC - restricting use of certain epoxy derivatives in FCMs;
- Regulation EU No 284/2011 for kitchenware made of melamine or polyamide originating or consigned from China or Hong Kong.
- Directive 93/11/EEC - release of N-nitrosamines and N-nitrosatable substances from rubber teats and soothers