Plastic materials and articles in contact with food

SUMMARY OF:

Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food

SUMMARY

WHAT DOES THIS REGULATION DO?

• Plastic materials and articles that come into contact with food may transfer toxic substances to them and may be a risk to human health.
• The regulation introduces migration limits* for substances used in such packaging and lays down conditions for their use to ensure food safety.
• It 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 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 colorants);
  • 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.

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;
  • 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 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, however, must not be mutagenic*, carcinogenic* or toxic to reproduction, or be in nanoform*).
• 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, as well as the substances themselves. It must be renewed when substantial changes in the composition or production occur.

FROM WHEN DOES THE REGULATION APPLY?

It applies from 4 February 2011.

BACKGROUND

• Food Contact Materials - Introduction
• Union Guidelines on Regulation (EU) No 10/2011 on plastic materials and articles intended to come into contact with food

KEY TERMS

* 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).

* 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.

* Carcinogenic: an agent directly involved in causing cancer.

* 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 dimensions is in the size range 1 nanometre-100 nanometre (i.e. one billionth of a metre).

ACT

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 ACTS

Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, pp. 4–17). See consolidated version.

Commission Regulation (EC) No 2023/2006 of 22 December 2006 on good manufacturing practice for materials and articles intended to come into contact with food (OJ L 384, 29.12.2006, pp. 75–78). See consolidated version.

last update 24.11.2015