Regulation (EC) no. 1935/2004 provides rules relating to the quality of food packaging, described as 'materials and articles intended to come into contact with food'. This Regulation specifically provides due consideration to the development of active and intelligent packaging.

The objective of this Regulation is to realise a high level of protection in the EU of population health and consumer interests. It contains general provisions on the safety of materials and articles designed to come into contact with food, and special requirements relating to active and intelligent packaging. In addition, the Regulation includes rules on labelling, the authorisation of new substances and traceability.

For specific groups of materials and articles special measures can be taken, such as the adoption of a list of authorised raw materials, purity standards and additional labelling requirements. From Annex I it is evident that this concerns things such as active and intelligent materials and articles, ceramics (jugs), glass (bottles) and plastics (small tubs).

Active packaging is meant to extend the shelf-life or to maintain and improve the condition of the packaged foods, and release substances or absorb certain substances. Intelligent packaging monitors the condition of the packaged food or its surroundings. Regulation (EC) no. 450/2009 establishes special rules for active and intelligent materials and articles. This Regulation must be applied in addition to the requirements set out in Regulation (EC) no. 1935/2004 for its safe use. 

In the Netherlands, certain components from the Regulation are included in the Packaging and Consumer Items (Commodities Act) Decree. This Decree includes some general requirements, a number of penalisation provisions for requirements in European regulations and a provision that the Minister of Health, Welfare and Sport (VWS) can impose rules relating to the release of constituents of materials and articles. These additional rules are included in the Packaging and Consumer Items (Commodities Act) Regulation. In addition to references to EU rules, this Regulation contains conditions for materials for which there are fewer or no provisions in the EU. The Commodities Act Regulations contain a large number of composition requirements for packaging and consumer items. These requirements focus on safe products; anyone complying with these requirements, will supply safe packaging and consumer items, and will prevent foods that come into contact with them from becoming contaminated. 

Regulation (EU) 10/2011 is a special regulation in the sense of Regulation (EC) no. 1935/2004, and harmonises requirements for the authorisation of plastic materials and articles intended to come into contact with food, that are already in contact with food or that can be expected to come into contact with food. Various materials are excluded from the Regulation, such as rubber and silicones, for which separate measures must be established. Only substances that are on the EU List of Authorised Substances (see Annex I) may be used in the production of plastic materials and articles. Exceptions are described for various substances such as polymerisation production aids, colorants and solvents, mineral salts, mixtures of authorised substances and substances that are present on the provisional list for evaluation by the EFSA. The Regulation furthermore determines that the total migration of constituents of plastic materials and articles to food simulants may not be higher than 10 mg per dm2 of the surface that comes into contact with the food. A ‘food simulant’ means a test medium imitating food; in its behaviour the food simulant mimics migration from food contact materials. The company must be able to show evidence in the form of documents that contain the testing conditions and the test results and that demonstrate conformity with the Regulation to the competent authorities. These are the so-called Documents of Compliance (DoC).

New limits for PVC packaging that contains epoxidised soy oil used for sealing glass receptacles and that are brought into contact with foods are included in Directive 2005/79/ECRegulation (EC) no. 1895/2005 regulates the restriction of the use of certain epoxy derivatives in materials and articles intended to come into contact with food.

Other applicable legislation:

  • Regulation 2023/2006: Good Manufacturing Practices
  • Directive 2007/42: Regenerated Cellulose Film
  • Regulation 10/2011
  • Directive 82/711
  • Directive 85/572: Plastics
  • Regulation 282/2008: Recycled Plastics
  • Regulation 372/2007: Plasticisers in Gaskets in Lids
  • Directive 78/142
  • Regulation 1895/2005: Epoxy Derivatives
  • Directive 93/11: N-nitrosamines; rubber
Last modified: October 31, 2019 09:50