32011R0010

WHAT IS THE AIM OF THE REGULATION?

• Plastic materials and articles that come into contact with food may transfer toxic substances to them and may be a risk to human health.
• Regulation (EU) 10/2011 introduces migration limits¹ for substances used in such packaging and lays down conditions for their use to ensure food safety.
• The regulation sets out the requirements for the manufacture and marketing of plastic materials and articles intended to come into contact with food. These requirements supplement the general rules laid down in Regulation (EC) No 1935/2004 (see summary) on materials and articles used for food packaging.
• The plastic materials and articles, and parts thereof, may be composed:
  • exclusively of plastics;
  • of several layers of plastics; or
  • of plastics combined with other materials.
• The regulation does not apply to ion exchange resins, rubber or silicones.

KEY POINTS

Authorised substances

• The regulation lists the substances that may be intentionally used in the manufacture of plastic materials and articles. The list includes:
  • monomers;
  • additives (excluding colourants);
  • polymer production aids (excluding solvents); and
  • macromolecules obtained from microbial fermentation.
• New substances are added to the list if the European Food Safety Authority issues a favourable opinion following an application and approval procedure.

Following the amendments introduced by Regulation (EU) 2025/351, the regulation further clarifies the rules governing substances.

• Only substances included in the European Union (EU) list of authorised substances may be used in the manufacture of plastic materials and articles. Where there is doubt over the designated identity of a substance, the European Food Safety Authority may be consulted.
• The regulation also clarifies the use of substances of unknown or variable composition, complex reaction products or materials of biological or natural origin (UVCB substances), which may be used where they correspond to their designated identity.
• Substances used in the manufacture of plastic materials and articles, including those manufactured from waste, must be of a high degree of purity. Only limited amounts of non-intentionally added substances may be present, provided they do not endanger human health or lead to non-compliance with migration limits.

Placing on the market

• To be placed on the EU market, the plastic materials and articles in question 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 (see summary);
  • requirements regarding composition and the declaration on compliance (see below).
• The regulation’s annexes set out the conditions of use for authorised substances and migration limits. All plastic materials and articles must comply with specific migration limits and overall migration limits.
• The composition of each plastic layer of a material or article must comply with the regulation. However, a layer which is not in direct contact with food may:
  • not comply with the restrictions and specifications of the 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, however, must not be mutagenic², carcinogenic³ or toxic to reproduction, or be in nanoform⁴).
• The manufacturer must draw up a written declaration (Annex IV). This must identify the materials, articles and products from the intermediate stages of their manufacture, along with the substances themselves. It must be renewed when substantial changes in the composition or production occur.

Regulation (EU) 2025/351 further clarifies the conditions under which plastic materials and articles may be placed on the EU market.

• All plastic materials and articles must comply with applicable specific and overall migration limits. In multi-material or multi-layer articles, these requirements apply where the surface layer in contact with food is a plastic layer.
• Plastic materials and articles may contain reprocessed plastic from manufacturing by-products (offcuts and scraps from plastic materials and articles), provided that safety, purity and migration requirements are met and that no risk to human health arises.
• The declaration of compliance must include additional information necessary to demonstrate food safety, including, where relevant, information on non-intentionally added substances, on material intended for reprocessing and on the use of substances manufactured from waste. Supporting documentation must be made available to competent authorities on request.
• Plastic articles intended for repeated contact with food must be designed to prevent increased migration over successive uses and must be accompanied by appropriate information on safe use.

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 4 February 2011.

Regulation (EU) 2025/351 has applied since 16 March 2025. Transitional provisions allow existing materials and articles that comply with the previous rules and are first placed on the market before 16 September 2026 to continue to be placed on the market until stocks are exhausted.

BACKGROUND

For further information, see:

• Food contact materials (European Commission)
• Union guidance on Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food as regards information in the supply chain (European Commission).

KEY TERMS

1. Migration limits. The maximum amount of substances that materials and articles may transfer to food. They are expressed in milligrams of substance per kilogram of food (mg/kg).
2. Mutagenic. A physical or chemical agent that changes the genetic material of an organism and thus increases the frequency of mutations above the natural background level.
3. Carcinogenic. An agent directly involved in causing cancer.
4. Nanoform. Natural, incidental or manufactured substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimension(s) is in the size range 1 nanometre–100 nanometres (i.e. one billionth of a metre).

MAIN DOCUMENT

Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, pp. 1–89).

The successive amendments and corrections to Regulation (EU) No 10/2011 have been incorporated into the original text. This consolidated version is for reference only.

RELATED DOCUMENTS

Regulation (EC) No 1935/2004 on materials and articles intended to come into contact with food.

See consolidated version.

Regulation (EC) No 2023/2006 on good manufacturing practice for materials and articles intended to come into contact with food.

See consolidated version.