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Note for Guidance for Food Contact Materials
Page 6 of 126
CHAPTER I
EFSA ADMINISTRATIVE GUIDANCE ON HOW TO PRESENT AN APPLICATION
FOR EVALUATION BY THE EFSA AFC PANEL AND FOLLOW UP.
(Called briefly "EFSA Administrative Guidance")


1. INTRODUCTION
The general procedure for the authorisation of substances in food contact materials is laid
down in Article 8 12 of Regulation (EC) 1935/2004
2
(Framework Regulation)

The aim of this document, prepared by EFSA in cooperation with the Commission, is to
explain:
a)
the practical aspects of the administrative procedure to be followed by a petitioner
requiring the evaluation or re-evaluation of a substance;

b)
the follow-up of the request.
In this document the term "petition" or "application" means the official request from a
company to obtain an evaluation, or a re-evaluation by the EFSA AFC Panel of a substance
for the purpose of introducing it into, or for a change of its classification/restriction in the
"Synoptic document" and subsequently in a EU Directive.

This document deals mainly with plastics used in food contact materials. However it may
also be used for the evaluation of a substance for other food contact materials (e.g.
regenerated cellulose films, rubber etc.).
A typical petition consists of the following separate documents described below:
a)
a letter requesting the evaluation or re-evaluation of the substance. For model letters,
see Chapter I, Annexes 2 & 3;

b)
a technical dossier compiled following the "SCF Guidelines" as well as the AFC-
FCM-Explanatory Guidance;

c)
a Petitioner Summary Data Sheet (P-SDS). See Chapter III, Annex 6.
Each document should be prepared as set out here in order to facilitate the examination of a
petition by the EFSA AFC Panel and to avoid delays.

2 Regulation (EC) No 1935/2004 of the European Parliament and the Council of 27 October 2004 on materials and
articles intended to come into contact with food, OJ No L 338/4, 13.11.2004