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Note for Guidance for Food Contact Materials
Page 10 of 126
For petitions concerning re-evaluation of substances the following practical advises have to
be followed to avoid misunderstandings and delays in the evaluations:
a)
The petitioner should always prepare a new, complete Summary Data Sheet (P-SDS),
to replace the previous one. In this P-SDS the new data should be highlighted, e.g. by
the use of bold or coloured characters or background etc.
b)
The technical dossier should only include the new data to be considered by EFSA.
c)
In addition to the model letter n 2, another letter should accompany the petition to
explain briefly the reasons for the request for re-evaluation.
2.2. CHECK LIST WITH THE DOCUMENTS TO BE PROVIDED

For facilitating the petitioner in compiling a valid dossier for evaluation by the AFC Panel
the following check list of documents to be submitted is attached:
1
Model letter
No.1 for evaluation and No.2 for re-evaluation
2 Letter explaining the
background of the request
for evaluation (for re-
evaluations only
)
Alternatively the reasons for asking the re-evaluation can be
given in the model letter
3
P-SDS
Document summarising all data with marked appropriately
the confidential information and in the case of re-evaluation
the new data.
Reference to the technical annexes attached has to be
made in every section of the P-SDS.
Verifiable justification should be provided as to why the
disclosure of information marked as confidential would
significantly harm the petitioner's competitive position.
4
Technical
annexes
The necessary technical information, e.g. scientific
reasoning, full reports of experiments, bibliographic
references cited
5
Table of contents for the
annexes
A table which will give the contents of each Annex and the
relevant point on the SDS, e.g. Annex 1, Gene mutation in
bacteria, 8.1.1
6 CD-ROM
With the complete
information
All the information in hard copy should also be on the CD.
The P-SDS should be provided in Word format. The other
files may be either in Word format or in Adobe Acrobat
Reader.
Appropriate labels should be attached on the CD jewel case,
including the following information: Name of the substance,
REF No (when it is known), company, date of submission
and CD-ROM number (if more than one per dossier, eg disk
# of #).
Each CD-ROM should contain a file detailing the name of
the files contained in the disk and their contents. A print out
of this file should accompany the CD-ROM, clearly
indicating the different files and where they can be found.
7 CD-ROM
With only the non-
confidential information
Only the information which is not considered as confidential
by the petitioner should be on this CD-ROM. This
information will be readily available to anyone who might
so request, according to Regulation (EC) No. 1935/2004, art.
19