Active and intelligent materials and articles
This Regulation lays down specific provisions for active and intelligent materials and articles, which are to be added to those established by the general Regulation on materials and articles intended to come into contact with food.
Commission Regulation (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food.
This Regulation establishes specific requirements for the marketing of active * and intelligent * materials and articles intended to come into contact with food. It supplements the general principles defined in Regulation (EC) No 1935/2004 and describes the procedure for the authorisation of substances at Community level.
This Regulation shall apply to active or intelligent materials and articles which are placed on the Community 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 to food any components * in sufficient quantity as to endanger human health or to bring about an unacceptable change in the composition or organoleptic characteristics of food;
- must not mislead consumers through their labelling, presentation or advertising material.
These specific requirements are without prejudice to Community or national provisions applicable to materials and articles to which active or intelligent components are added or into which they are incorporated.
Only substances which are included in the Community list of authorised substances may be used in components of active and intelligent materials and articles.
However, the following substances may be used in components of active and intelligent materials and articles without being included in the Community list:
- released active substances, added or incorporated by techniques such as grafting or immobilisation which are used in full compliance with the relevant Community and national provisions (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 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 a Member State accompanied by a technical dossier containing the information described in the guide to safety assessment prepared by the European Food Safety Authority.
The Member State sends the application to the Authority which is responsible for assessing whether the substance meets the above conditions.
Community list of authorised substances
In order to be included in the Community 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 shall adopt the Community list after the Authority has delivered its opinion on all substances for which a valid application for market authorisation has been submitted.
The Community list shall specify:
- 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.
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;
- labelled so that it is clear that they are active and/or intelligent.
Released active substances are considered as ingredients and are to be labelled pursuant to the general rules for the labelling of foodstuffs.
The provisions relating to the composition of active and intelligent materials and articles apply from the date at which the Community list of substances that may be used in the composition of the said materials and articles enters into force.
The provisions on labelling apply from 19 December 2009.
|Act||Entry into force||Deadline for transposition in the Member States||Official Journal|
Regulation (EC) No 450/2009
OJ L 135 of 30.5.2009
- Chemical Safety of Food, Health & Consumers Directorate-General