Plastic materials and articles in contact with food

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.