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Article 3
1.
Only those monomers and other starting substances listed
in Annex II, Sections A and B, may be used for the manufacture
of plastic materials and articles subject to the restrictions
specified.
2.
By way of derogation from the first paragraph the mono-
mers and other starting substances listed in Annex II, Section B,
may continue to be used until 31 December 2004 at latest,
pending their evaluation by the Scientific Committee on Food.
3.
The list in Annex II, Section A, may be amended:
-- either by adding substances listed in Annex II, Section B,
according to the criteria in Annex II of Directive 89/109/
EEC, or
-- by including `new substances', i.e. substances which are
listed neither in Section A nor in Section B of Annex II,
according to Article 3 of Directive 89/109/EEC.
4.
No Member State shall authorise any new substance for
use within its territory except under the procedure in Article 4
of Directive 89/109/EEC.
5.
The lists appearing in Annex II, Sections A and B, do not
yet include monomers and other starting substances used only
in the manufacture of:
-- surface coatings obtained from resinous or polymerised
products in liquid, powder or dispersion form, such as
varnishes, lacquers, paints, etc.,
-- epoxy resins,
-- adhesives and adhesion promoters,
-- printing inks.
Article 4
An incomplete list of additives, which may be used for the
manufacture of plastic materials and articles, together with the
restrictions and/or specifications on their use, is set out in
Annex III, Sections A and B.
For the substances in Annex III, Section B, the specific migra-
tion limits are applied as from 1 January 2004 when the verifi-
cation of compliance is carried out in simulant D or in test
media of substitute tests as laid down in Directives 82/711/EEC
and 85/572/EEC.
Article 5
Only the products obtained by means of bacterial fermentation
listed in Annex IV may be used in contact with foodstuffs.
Article 6
1.
General specifications related to plastic materials and arti-
cles are laid down in Annex V, Part A. Other specifications
related to some substances appearing in Annexes II, III and IV
are laid down in Annex V, Part B.
2.
The meaning of the numbers between brackets appearing
in the column `Restrictions and/or specifications' is explained in
Annex VI.
Article 7
The specific migration limits in the list set out in Annex II are
expressed in mg/kg. However, such limits are expressed in mg/
dmē in the following cases:
(a) articles which are containers or are comparable to
containers or which can be filled, with a capacity of less
than 500 ml or more than 10 l;
(b) sheet, film or other materials which cannot be filled of for
which it is impracticable to estimate the relationship
between the surface area of such materials and the quantity
of foodstuffs in contact therewith.
In these cases, the limits set out in Annex II, expressed in mg/
kg shall be divided by the conventional conversion factor of 6
in order to express them in mg/dm
2
.
Article 8
1.
Verification of compliance with the migration limits shall
be carried out in accordance with the rules laid down in Direc-
tives 82/711/EEC and 85/572/EEC and the further provisions
set out in Annex I.
2.
The verification of compliance with the specific migration
limits provided for in paragraph 1 shall not be compulsory, if it
can be established that compliance with the overall migration
limit laid down in Article 2 implies that the specific migration
limits are not exceeded.
3.
The verification of compliance with the specific migration
limits provided for in paragraph 1 shall not be compulsory, if it
can be established that, by assuming complete migration of the
residual substance in the material or article, it cannot exceed
the specific limit of migration.
4.
The verification of compliance with the specific migration
limits provided for in paragraph 1 may be ensured by the deter-
mination of the quantity of a substance in the finished material
or article provided that a relationship between that quantity
and the value of the specific migration of the substance has
been established either by an adequate experimentation or by
the application of generally recognised diffusion models based
on scientific evidence. To demonstrate the non-compliance of a
material or article, confirmation of the estimated migration
value by experimental testing is obligatory.
Article 9
1.
At the marketing stages other than the retail stages, the
plastic materials and articles which are intended to be placed in
contact with foodstuffs shall be accompanied by a written
declaration in accordance with Article 6(5) of Directive 89/
109/EEC.
15.8.2002
L 220/20
Official Journal of the European Communities
EN