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Note for Guidance for Food Contact Materials
Page 9 of 126
services for further advice. Because it is highly probable that the secretariat will have to
consult the AFC-FCM-WG, it is recommended that the use of this option is restricted
entirely to cases where the substance or the group of substances require special
consideration. Some delay must be expected for this procedure (generally 2-6 months).

2.2. RE-EVALUATION OF A SUBSTANCE
The re-evaluation of substances can be requested in three different situations:
a)
During the evaluation of the dossier, EFSA may consider necessary to require further
information including additional studies. Such additional tests should be presented
by the original petitioner using the model letter n 2 related to a request of re-
evaluation.

b)
The petitioner has obtained further information on a substance currently classified in
SCF lists 0-5 and believes that the additional data might permit a different
classification or restriction for that substance.
c)
A new petitioner has obtained further information on a substance currently in the
Synoptic Document and believes that the additional data might permit a different
classification. In that case, the article 21 on data sharing of Regulation (EC) No
1935/2004 applies. The new applicant should enquire with the Commission and the
European professional organisations about an agreement on data sharing with the
original applicant. If such an agreement is reached the petitioner should include the
written agreement signed by all involved parties in the application and supply only
the new data using model letter n 2 related to a request of re-evaluation. If the
original and new applicant have not agreed on data sharing the new petitioner has to
submit a new petition including all data using model letter n 2.

In any case the petitioner has to check the dossier to be submitted against the requirements
of the latest version of the Note for Guidance. This is imperative if more than 4 years have
elapsed from the time of the last evaluation of the substance by the SCF or EFSA. It is
quite possible that the scientific approach to the safety evaluation of a substance has
changed in meanwhile and additional or different data may be needed or inversely some
data may no more be considered necessary. If in doubt the petitioner is invited to ask
EFSA.

For the re-evaluation of a substance the petitioner is invited to submit a request to the
national competent authority. The technical dossier should be submitted with the use of
the model letter n 2 and will always include the Petitioner Summary Data Sheet (P-
SDS), a document which will provide the full information in summary and make
reference to the technical annexes contained in the technical dossier.
The full
information should be submitted on paper and in electronic format on standard physical
media (CD-ROM).
3 paper and electronic copies of all documents should be held available to be sent to the
persons indicated by the Secretariat of the AFC Panel of EFSA or a Member State as
indicated in the model letter n 2.