Guidelines on submission of a dossier for safety evaluation by the EFSA of active or intelligent substances present in active and intelligent materials and articles intended to come into contact with food
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Regulation (EC) No 450/2009 is a specific measure that lays down specific rules for active and intelligent materials and articles intended to be used in contact with foodstuffs to be applied in addition to the general requirements established in Regulation (EC) No 1935/2004 for their safe use. The substance(s) responsible for the active and/or intelligent function of the material should be evaluated under the regulation (EC) No 450/2009.
A community list of authorised substances, that can be used to manufacture an active or intelligent component of active and/or intelligent materials and articles, shall therefore be established after the European Food Safety Authority (EFSA) has performed a risk assessment and has issued an opinion on each substance. In some cases, restrictions may be proposed by the EFSA on a group of substances especially when the active or intelligent function implies interactions between different substances.
Substances deliberately incorporated into active materials and articles to be released into the food or the environment surrounding the food, do not need to be listed in the Community list. They shall be used in full compliance with the relevant Community and national provisions applicable to food, and shall comply with the provisions of Regulation (EC) No 1935/2004 and its implementing measures. The same shall apply to substances which are incorporated in active materials and articles by techniques such as grafting and immobilisation, in order to have a technological effect in the food. However, for these substances already approved in food legislation, their stability under the intended packaging manufacturing and processing conditions must be verified by the packaging manufacturer and a dossier for safety evaluation has to be submitted if chemical reaction, degradation or decomposition of these substances is likely to occur.
Passive parts should be covered by the specific community or national legislation applicable to those materials. These guidelines do not apply to substances used behind a functional barrier as defined by article 3 of Regulation (EC) No 450/2009. Substances behind such a barrier will not, by definition, migrate in amounts which could endanger human health or bring about unacceptable changes in the composition of the food or of its organoleptic properties. Consequently, these active and intelligent substances do not need a safety evaluation and are also outside the scope of Regulation (EC) No 450/2009. However, this functional barrier concept does not apply to substances in nanoparticulate form which should be assessed on a case by case basis (article 5(2)(c)ii of regulation No 450/2009).
The purpose of this document is to give guidance to applicants and other interested parties for the preparation and the submission of a dossier for the evaluation of the safety of active and/or intelligent substances responsible for active and/or intelligent functions of active and/or intelligent materials and articles intended to be used in contact with food. It gives guidance on the administrative and technical data required, and on the format of a submission (hereinafter referred to as “dossier”) for the evaluation by the EFSA.
guidelines, dossier for safety evaluation, active intelligent substances present in active and intelligent materials and articles intended to come into contact with food
