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(12)
The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health,
HAS ADOPTED THIS DIRECTIVE:
Article 1
Directive 2002/72/EC is amended as follows:
1. In Article 3, paragraphs 1 and 2 are replaced by the
following:
`1.
Only those monomers and other starting substances
listed in Annex II, section A may be used for the manufac-
ture of plastic materials and articles subject to the restric-
tions set out therein.
2.
By way of derogation from paragraph 1, the mono-
mers and other starting substances listed in Annex II,
section B may continue to be used until 31 December 2004
at the latest, pending their evaluation by the European Food
Safety Authority (hereinafter referred to as the Authority).'
2. Article 4 is replaced by the following:
`Article 4
1.
A list of additives which may be used for the manufac-
ture of plastic materials and articles, together with the
restrictions and/or specifications on their use, is set out in
Annex III.
That list of additives shall be considered to be an incomplete
list until the Commission decides, in accordance with
Article 4a, that it shall become a positive Community list of
authorised additives, to the exclusion of all others.
The Commission shall establish, by 31 December 2007 at
the latest, the date when that list shall become a positive
list.
2.
For the additives listed in Annex III, section B, the veri-
fication of compliance with the specific migration limits in
simulant D or in test media of substitute tests as laid down
in Article 3(1), second subparagraph of Directive 82/711/
EEC and Article 1 of Directive 85/572/EEC shall apply from
1 July 2006.
3.
The lists in Annex III, sections A and B do not yet
include the following additives:
(a) additives used only in the manufacture of:
-- surface coatings obtained from resinous or poly-
merised products in liquid, powder or dispersion
form, such as varnishes, lacquers, paints,
-- epoxy resins,
-- adhesives and adhesion promoters,
-- printing inks;
(b) colorants;
(c) solvents.'
3. The following Articles 4a and 4b are inserted:
`Article 4a
1.
A new additive may always be added to the list of
substances referred to in Article 4(1) following an evaluation
of its safety by the Authority.
2.
Member States shall provide that any person interested
in the inclusion in the list referred to in Article 4(1) of an
additive, which is already placed on the market in one or
more of the Member States, shall submit data for the evalua-
tion of its safety by the Authority by 31 December 2006 at
the latest.
For the submission of the required data, the applicant shall
consult the "Guidelines of the European Food Safety
Authority for the presentation of an application for safety
assessment of a substance to be used in food contact mate-
rials prior to its authorisation".
3.
If during the examination of the data referred to in
paragraph 2, the Authority calls for supplementary informa-
tion, the additive may continue to be used subject to
national law until the Authority has issued an opinion,
provided that the information is submitted within the time
limits specified by the Authority.
4.
The Commission shall establish, by 31 December
2007 at the latest, a provisional list of additives which may
continue to be used after 31 December 2007 subject to
national law until the Authority has evaluated them.
5.
The inclusion of an additive in the provisional list is
subject to the following conditions:
(a) the additive must be permitted in one or more of the
Member States no later than 31 December 2006;
(b) the data referred to in paragraph 2 concerning that addi-
tive must have been supplied in accordance with the
Authority requirements no later than 31 December
2006.
Article 4b
Without prejudice to Article 4 of Directive 89/109/EEC,
Member States may not authorise after 31 December 2006
additives referred to in Article 4(1) which were never evalu-
ated by the Scientific Committee on Food or the Authority.'
10.3.2004
L 71/9
Official Journal of the European Union
EN