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Note for Guidance for Food Contact Materials
Page 4 of 126

The current table includes the main amendments to the previous version (dated 28.09.2005)
of the EFSA "Note for Guidance", available on the EFSA website. The amendments are
indicated in bold characters and a turquoise background. However, minor editorial
changes are not specified.

By technical dossier is meant the WHOLE TECHNICAL INFORMATION (also
summaries of studies) divided in technical annexes and submitted by the petitioner in
support of his request for evaluation of a substance by the EFSA.
The technical dossier has to be submitted by model letter No 1 or 2 to a Member State
competent Authority.
A document, called Petitioner Summary Data Sheet (P-SDS), containing the whole
information in summary and THE REFERENCES to the annexes has to be included in the
technical dossier.
Since EFSA is the competent Authority for the risk assessment in Europe while the risk
management decisions remain to the Commission it is clarified that:
The classification into a SCF_List is a tool used for tackling authorisation dossiers and do
not prejudice the management decisions that will be taken on the basis of the scientific
opinions of the AFC Panel and in the framework of the applicable legislation