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Document 32009R0450

Active and intelligent materials and articles that come into contact with food

Active and intelligent materials and articles that come into contact with food

 

SUMMARY OF:

Regulation (EC) No 450/2009 — active and intelligent materials and articles intended to come into contact with food

WHAT IS THE AIM OF THE REGULATION?

  • It seeks to lay down specific rules for active* and intelligent* materials and articles, which supplement those set out in Regulation (EC) No 1935/2004, the general regulation on materials and articles intended to come into contact with food.
  • It establishes specific requirements for the marketing of these materials and articles and sets out the procedure for their authorisation at EU level.

KEY POINTS

Scope

The regulation applies to active or intelligent materials and articles intended to come into contact with food which are placed on the EU market.

Requirements for active and intelligent materials and articles

Active and intelligent materials and articles:

  • must be suitable and effective for the intended purpose of use;
  • must not release into the food any components* in sufficient quantity as to endanger human health or to bring about an unacceptable change in the composition, taste or smell of food;
  • must not mislead consumers through their labelling, presentation or advertising material.

These specific requirements are without prejudice to EU or national rules applicable to materials and articles to which active or intelligent components are added or into which they are incorporated. Those materials may be subject to other specific legislation, such as Regulation (EU) No 10/2011 on plastic food contact materials.

Composition

  • Once the regulation enters fully into force, only substances which are included in the Union list of authorised substances may be used in components of active and intelligent materials and articles. It will enter fully into force after the European Commission publishes a list of substances that may be used in the manufacture of active and intelligent components.
  • The following substances may be used in components of active and intelligent materials and articles without being included in the list:
    • released active substances, added or incorporated by techniques such as grafting or immobilisation which are used in full compliance with the relevant EU and national rules (for example, legislation on food additives and food enzymes);
    • substances used in the components which are not in direct contact with food or the environment surrounding the food; and are separated from the food by a functional barrier, and if they are not mutagenic, carcinogenic, or toxic to reproduction or substances produced deliberately in a particle size that exhibits chemical and physical properties that significantly differ from those at a larger scale.

Applications for authorisation of substances constituting the components of active and intelligent materials and articles

  • Applications for authorisation of substances constituting the components of active and intelligent materials and articles are to be made to the competent authorities of an EU country accompanied by a technical dossier containing the information described in the guide to safety assessment prepared by the European Food Safety Authority (EFSA).
  • The EU country sends the application to EFSA which is responsible for assessing whether the substance meets the above conditions.

Union list of authorised substances

To be included in the Union list, substances constituting the components of active and intelligent materials and articles must meet the requirements that apply to the said products (see above).

The Commission must adopt the Union list after EFSA has delivered its opinion on all substances for which a valid application for market authorisation has been submitted.

The Union list specifies:

  • the identity of the substance(s);
  • the function of the substance(s);
  • the reference number;
  • if necessary, the conditions of use of the substance(s) or component.

Labelling

Active and intelligent materials and articles:

  • in contact with food are to be labelled appropriately to allow the consumer to identify the non-edible parts. In this case the words ‘DO NOT EAT’ must be added to the label as well as (if possible) the symbol reproduced in Annex I;
  • must be labelled so that it is clear that they are active and/or intelligent.

Released active substances are considered as ingredients and must be labelled according to Regulation (EU) No 1169/2011 on the labelling of foodstuffs.

Packaging

It should also be noted that Regulation (EC) No 1935/2004 on the safe packaging of foods contains some rules directly applicable to active and intelligent materials, including definitions and labelling requirements. It authorises the use of active and intelligent packaging, which can extend the shelf-life of food and give information on its freshness, provided that the packaging does not adversely affect its composition.

Declaration of compliance

  • Businesses must issue at marketing stages other than at the point of sale to the final consumer, a written declaration of compliance containing the information set out in Annex II to the regulation, whether or not the active and intelligent materials and articles are in contact with food.
  • This declaration must also be issued for the components intended for the manufacturing of those materials and articles or the substances intended for the manufacturing of those components.

FROM WHEN DOES THE REGULATION APPLY?

It has applied since 19 December 2009.

BACKGROUND

For more information, see:

KEY TERMS

Active materials and articles: materials and articles intended to extend the shelf-life or to maintain or improve the condition of packaged food. They are designed to deliberately incorporate components that would release substances into or onto the packaged food or the environment surrounding the food.
Intelligent materials and articles: materials and articles which monitor the condition of packaged food or the environment surrounding the food.
A component: an individual substance or a combination of individual substances which cause the active and/or intelligent function of a material or article, including the products of an in situ reaction of those substances; it does not include the passive parts, such as the material they are added to or incorporated into.

MAIN DOCUMENT

Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food (OJ L 135, 30.5.2009, pp. 3-11)

RELATED DOCUMENTS

Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004 (OJ L 304, 22.11.2011, pp. 18-63)

Successive amendments to Regulation (EU) No 1169/2011 have been incorporated into the original document. This consolidated version is of documentary value only.

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)

See consolidated version.

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.

last update 11.07.2019

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