30.5.2009 Official Journal of the European Union L 135/3 COMMISSION REGULATION (EC) No 450/2009 of 29 May 2009 on active and intelligent materials and articles intended to come into contact with food (Text with EEA relevance) THE COMMISSION OF THE EUROPEAN COMMUNITIES, Having regard to the Treaty establishing the European Community, Having regard to 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 (1), and in particular Article 5(1) (h), (i), (), (m) and (n) thereof, After consulting the European Food Safety Authority, Whereas: 1) Regulation (EC) No 1935/2004 establishes that active and intelligent food contact materials and articles (active and intelligent materials and articles) are included in its field of application and, therefore, all its provisions concerning materials and articles intended to come into contact with food (food contact materials) also apply to these materials and articles. Other Community measures, such as those provided for in Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety (%) and its implementing measures, and Council Directive 87/357/EEC of 25 June 1987 on the approx- imation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of the consumers (%), also apply, where appropriate, to such materials and articles. Regulation (EC) No 1935/2004 lays down the general principles for eliminating the differences between the laws of the Member States as regards food contact materials. Article 5(1) of that Regulation provides for the adoption of specific measures for groups of materials and articles and describes in detail the procedure for the authorisation of substances at Community level when a specific measure provides for a list of authorised substances. Certain rules applicable to active and intelligent materials and articles are set out in Regulation (EC) No 1935/2004. These include rules for released active 338, 13.11.2004, p. 4. 0] L 0] L 11, 15.1.2002, p. 4. 0J L 192, 11.7.1987, p. 49. substances that have to comply with Community and national provisions applicable to food and labelling rules. Specific rules should be laid down in a specific measure. This Regulation is a specific measure within the meaning of Article 5(1)(b) of Regulation (EC) No 1935/2004. This Regulation should establish the specific rules for active and intelligent materials and articles to be applied in addition to the general requirements established in Regu- lation (EC) No 1935/2004 for their safe use. Many different types of active and intelligent materials and articles exist. The substances responsible for the active andfor intelligent function can be contained in a separate container, for example, inclusion in a small paper sachet or, the substances can be directly incor- porated into the packaging material, for example, incor- poration in the plastic of a plastic bottle. Those substances, responsible for creating the active and/or intelligent function of those materials and articles (the components) should be evaluated in accordance with this Regulation. The passive parts, such as the container, the packaging into which that container is placed and the packaging material, in which the substance is incorporated, should be covered by the specific Community or national provisions applicable to those materials and articles. The active and intelligent materials and articles may be composed of one or more layers, or parts of different types of materials, such as plastics, paper and cardboard or coatings and varnishes. Requirements for those materials may be either fully harmonised, or only partially harmonised, or not yet harmonised at Community level. The rules laid down in this Regulation should apply without prejudice to Community or national provisions that regulate such materials. The individual substance or, if relevant, the combination of substances which constitute the components should be evaluated to guarantee that they are safe and comply with the requirements laid down in Regulation (EC) No 1935/2004. In some cases, it may be necessary to evaluate and authorise the combination of substances, when the active or intelligent function implies interaction between different substances leading to an enhancement of the function or the generation of new substances responsible for the active and intelligent function.