Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food
Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food (“new” Plastics Regulation) is a specific measure within the meaning of Article 5 of Regulation (EC) No 1935/2004.
It consolidates previous EU Regulations and Directives with respect to plastics in food contact, repeals the previous Plastics Directive (2002/72/EC and its amendments), and incorporates a number of technical requirements dealing with migration testing.
This regulation applies to plastic materials and articles intended to come into contact with food. These materials and articles and parts thereof may be composed exclusively of plastics, of several layers of plastics, or of plastics combined with other materials. This regulation does not apply to ion exchange resins, rubber, or silicones.
- additives (excluding colorants);
- polymer production aids (excluding solvents); and
- macromolecules obtained from microbial fermentation.
An overview of this list is provided in the Annex I Table of the regulation, with reference to specific restrictions, group restrictions, and verification on compliance notes. By way of derogation, substances other than those included in the EU list may be used as polymer production aids, solvents or colorants in the manufacture of plastic layers in plastic materials and articles subject to national law. Polymerization aids and non-intentionally added substances are not included in the EU list, but may be present in the plastic layers of plastic materials or articles provided they meet the safety requirement of the Article 3 of the Framework Regulation (EC) No 1935/2004. Compliance shall be assessed in accordance with internationally recognized scientific principles on risk assessment (Article 19).
The composition shall be known to the manufacturer of the substance and made available to the competent authorities on request.
- exceed the restrictions provided for in Regulations (EC) No 1333/2008 or No 1334/2008 or in Annex I to this regulation for foods for which their use is authorized as food additive or flavoring substances; or
- exceed the restrictions set out in Annex I to this regulation in foods for which their use is not authorized as food additive or flavoring substances.
- Specific migration limit (SML) - the maximum permitted amount of a given substance released from a material or article into food or food simulants.
- Overall migration limit (OML) - the maximum permitted amount of non-volatile substances released from a material or article into food simulants. In principle, the OML is a maximum 10 mg of substances/dm² of the food contact surface for all substances that can migrate from food contact materials to foods.
Information on the content of the declaration of compliance is provided in Annex IV of the regulation.
Appropriate documentation to demonstrate that the materials and articles, products from intermediate stages of their manufacturing as well as the substances intended for the manufacturing of those materials and articles comply with the requirements of this Regulation shall be made available to the national competent authorities on request.
In this section
- GHS of classification and labeling
- The OECD chemicals safety program
- Chemical management programs
- VOC regulations
- Transport regulations
Food contact regulations
European food contact legislation
- EU Member States laws
- EC Framework Regulation (EC) No 1935/2004
- Regulation (EC) No 2023/2006 on Good Manufacturing Practice for materials and articles intended to come into contact with food
- Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food
- Directive 2009/32/EC on extraction solvents used in the production of foodstuffs and food ingredients
- ExxonMobil fluids and plasticizers for food contact in Europe
- US food contact legislation
- Food contact regulations in Asia
- European food contact legislation
- Other regulations
- Safety data sheets