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- Practical Guide -
Page 41 of 153
('EFSA') not later than 31 December 2004. For the submission of the required data the
applicant shall consult the "Guidelines of the Scientific Committee on Food for the
presentation of an application for safety assessment of a substance to be used in food
contact materials prior to its authorisation"12
The Commission will establish not later than 31 December 2005:
the date when the list of authorised additives will become a positive list;
a provisional list of additives which may continue to be used until the EFSA has
evaluated them. They shall fulfil the following conditions:
they are permitted in one or more of the Member States not later than
31 December 2004;
the data mentioned in paragraph 4 have been supplied in accordance
with EFSA requirements not later than 31 December 2004;
they shall be used in accordance with the national law.
If during the examination of the data the EFSA requires supplementary information,
these substances shall continue to be used subject to national law, even after the positive
list is established and until the EFSA has issued an opinion, provided that the
information is submitted within the time limits specified by the EFSA.
"New additives", i.e. additives never evaluated by the SCF or EFSA may always be
added to the list of substances authorised at Community level following the safety
evaluation by the EFSA."
The list is also subdivided in two lists:
Section A contains additives fully harmonised at EU level;
Section B contains additives not yet fully harmonised at EU level, because the SML
set out in the Directive should be not yet applied when the simulant D is used.
Section B has been provisionally introduced (until 31 December 2003, but now a deadline
of 31 December 2005 is under discussion)
because the discussion on Fat (consumption)
Reduction Factors is not yet finished and the application of the SML without these factors
may exclude some applications already authorised at national level.
As regards the impurities, reaction intermediates and decomposition products the same
considerations made for monomers apply.
3.2.3 There are several additives contained in the current list, which are also included in the
lists of additives or flavouring substances for food. The new ongoing amendment of
Directive 2002 establishes the general rule that the more severe restrictions should be
enforced in those foods for which the rules apply. Therefore, if an SML is more restrictive
than the maximum level allowed of this substance as food additive or flavouring for a
certain food, the SML applies. If the SML is less restrictive than the maximum authorised
The Guidelines of the Scientific Committee on food for the presentation of an application for safety
assessment of a substance to be used in food contact materials prior to its authorisation" is updated on 13
December 2001 and it is available on: