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(15)
On the basis of new information related to the risk
assessment of monomers and other starting substances
evaluated by the Authority (
1
), certain monomers provi-
sionally admitted at national level as well as new
monomers should be included in the Community list
of authorised substances. For others, the restrictions
and/or specifications already established at Community
level should be amended on the basis of the new infor-
mation available.
(16)
The incomplete list of additives which may be used in
the manufacture of plastic materials and articles should
be amended so as to include other additives evaluated by
the Authority. For certain additives, the restrictions
and/or specifications already established at Community
level should be amended on the basis of those new
evaluations available.
(17)
Commission Directive 2005/79/EC (
2
) introduced the
changes in the restrictions and/or specifications for
substance Ref. No 35760 in section A instead of
section B of Annex III to Directive 2002/72/EC and for
substance Ref. No 67180 the changes were introduced in
section B instead of section A of that Annex. In addition,
for substances Ref. No 43480, 45200, 81760 and
88640 the indication to the restrictions and/or specifi-
cations in Annex III to Directive 2002/72/EC is
ambiguous. Therefore, for legal certainty, there is a
need to place substances Ref. No 35760 and 67180 in
the appropriate section of the list of additives and re-
introduce
the
restrictions
and
specifications
for
substances Ref. No 43480, 45200, 81760 and 88640.
(18)
It has been shown that distilled water, which is used at
present is not an adequate simulant for some milk
products. It should be replaced by 50 % ethanol, which
better simulates their fatty character.
(19)
Epoxidised soybean oil (ESBO) is used as plasticizer in
gaskets. Taking into account the opinion of the Authority
adopted on 16 March 2006 (
3
) concerning exposure of
adults to ESBO used in food contact materials, it is
appropriate to set a shorter deadline for the compliance
of gaskets of lids with the restrictions of ESBO and its
substitutes set out in Directive 2002/72/EC. The same
deadline should apply as regards the prohibition of use
of azodicarbonamide.
(20)
Certain phthalates are used as plasticizers in gaskets and
in other plastic applications. In its opinions on certain
phthalates (
4
) published in September 2005 the Authority
set tolerable daily intakes (TDI) for certain phthalates and
estimated that the exposure of humans to certain
phthalates is in the same range as the TDI. Therefore,
it is appropriate to set a shorter deadline for the
compliance of plastic materials and articles with the
restrictions set in Directive 2002/72/EC for those
substances.
(21)
Council
Directive
85/572/EEC (
5
)
and
Directive
2002/72/EC should therefore be amended accordingly.
(22)
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. Article 1 is amended as follows:
(a) paragraph 2 is replaced by the following:
`2.
This Directive shall apply to the following
materials and articles which, in the finished product
state, are intended to come into contact or are
brought into contact with foodstuffs and are intended
for that purpose (hereafter referred to as
"plastic
materials and articles
"):
(a) materials and articles and parts thereof consisting
exclusively of plastics;
(b) plastic multi-layer materials and articles;
(c) plastic layers or plastic coatings, forming gaskets in
lids that together are composed of two or more
layers of different types of materials.
'
EN
31.3.2007
Official Journal of the European Union
L 91/19
(
1
) The EFSA Journal (2005) 218, 1-9.
The EFSA Journal (2005) 248, 1-16.
The EFSA Journal (2005) 273, 1-26.
The EFSA Journal (2006) 316 to 318, 1-10.
The EFSA Journal (2006) 395 to 401, 1-21.
(
2
) OJ L 302, 19.11.2005, p. 35.
(
3
) The EFSA Journal (2006) 332, 1-9.
(
4
) The EFSA Journal (2005) 244, 1-18.
The EFSA Journal (2005) 245, 1-14.
The EFSA Journal (2005) 243, 1-20.
The EFSA Journal (2005) 242, 1-17.
The EFSA Journal (2005) 241, 1-14.
(
5
) OJ L 372, 31.12.1985, p. 14.