Guidance document on the submission of a dossier on a substance to be used in Food Contact Materials for evaluation by EFSA by the Panel on additives, flavourings, processing aids and materials in contact with food (AFC)
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Introductory remarks
The purpose of this document is to give guidance to petitioners and other interested parties wishing to present an application for the safety assessment of a substance prior to its authorisation according to European Parliament and Council Regulation 1935/2004 of 27 October 2004 on materials and articles intended to come into contact with food*. It gives guidance on the administrative and technical data required and on the format for formal submissions (hereafter referred to as “dossiers”) to the competent authority of a Member State for further transmission to the European Food Safety Authority (EFSA).
As stated in Regulation 1935/2004 a substance shall only be authorised for use in food contact materials if it is sufficiently demonstrated that it does not present risks to human health. A list of substances authorised to the exclusion of all others in the Community for use in the manufacturing of food contact materials shall therefore be established. For inclusion of a substance in the list a favourable opinion by the Authority is needed following the submission of an application. Applications shall be submitted in accordance with Article 9 of the Regulation. Petitioners wishing to make a submission are advised to consult this Guidance.
For petitioners’ convenience, models of letters to be used when asking for evaluation or re-evaluation of substances as well as a model of the summary data sheet they should provide are published in word format along with a check list of the required deliverables in pdf format.
Petitioners should note that the competent authorities in Member States and the Commission will have access in full form to any dossier submitted to the Authority (Art. 9.1c of the Regulation). It should also be noted that there will be general access to applications except for parts which are clearly marked as and accepted as being confidential (Art. 20 of the Regulation).
