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Plastic materials and articles
Plastic materials and articles coming into contact with food may transfer toxic substances to them. In order to prevent any danger to human health, the European Union (EU) establishes migration limits applicable to substances constituting the materials and articles in question and defines specific conditions of use to guarantee food safety.
Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food.
This Regulation establishes specific requirements applicable to the manufacture and marketing of plastic materials and articles intended to come into contact with food. These requirements supplement the general provisions laid down in Regulation (EC) No 1935/2004 on materials and articles used for the packaging of food.
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.
The provisions on printing inks, adhesives or coatings supplement the requirements laid down in this Regulation.
Placing on the market
Plastic materials and articles intended to come into contact with food must comply with:
- the requirements for use, labelling and traceability set out in Regulation (EC) No 1935/2004;
- the good manufacturing practice defined in Regulation (EC) No 2023/2006;
- the compositional and declaration requirements set out in this Regulation.
Only the substances included in the list set out in Annex I may be intentionally used in the manufacture of plastic materials and articles. The list includes:
- additives (excluding colorants);
- polymer production aids (excluding solvents); and
- macromolecules obtained from microbial fermentation.
By way of derogation, substances not included on this list may be authorised under certain conditions.
Requirements on substances
This Regulation lays down the conditions of use for authorised substances (see Annex II) and migration limits (see Annex I). These migration limits correspond to the maximum amount of substances that materials and articles may transfer to food. They are expressed in mg of substance per kg of food (mg/kg).
All plastic materials and articles must comply with specific migration limits and overall migration limits.
The composition of each plastic layer constituting a material or article must comply with this Regulation. However, a layer which is not in direct contact with food may:
- not comply with the restrictions and specifications of this Regulation (except for vinyl chloride monomer as provided in Annex I);
- be manufactured with substances not included on the list of authorised substances (these substances must nevertheless not be mutagenic, carcinogenic or toxic to reproduction, or be in nanoform).
Declaration of compliance
The manufacturer shall draw up a written declaration containing the information set out in Annex IV. The information provided shall identify the materials, articles and products from intermediate stages of their manufacturing as well as the substances themselves. This declaration shall be renewed when substantial changes in the composition or production occur.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
Regulation (EU) No 10/2011
OJ L 12, 15.1.2011
The successive amendments and corrections to Regulation (EC) No 10/2011 have been incorporated into the original text. This consolidated version is of documentary value only.