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COMMISSION REGULATION (EC) No 1895/2005
of 18 November 2005
on the restriction of use of certain epoxy derivatives in materials and articles intended to come into
contact with food
(Text with EEA relevance)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European
Community,
Having regard to Regulation (EC) No 1935/2004 of the
European Parliament and of the Council of 27 October 2004
on materials and articles intended to come into contact with
food and repealing Directives 80/590/EEC and 89/109/EEC (
1
),
and in particular Article 5(1) thereof,
After consulting the European Food Safety Authority,
Whereas:
(1)
To avoid risks to human health and barriers to the free
movement of goods, Commission Directive 2002/16/EC
of 20 February 2002 on the use of certain epoxy deri-
vatives in materials and articles intended to come into
contact with food (
2
), lays down specific migration limits
for
2,2-bis(4-hydroxyphenyl)propane
bis(2,3-epoxy-
propyl) ether (
`BADGE' i.e. Bisphenol-A DiGlycidyl
Ether),
bis(hydroxyphenyl)methane
bis(2,3-epoxypro-
pyl)ethers (
`BFDGE' i.e. Bisphenol-F DiGlycidyl Ether)
and novolac glycidyl ethers (NOGE) and some of their
derivatives.
(2)
Directive 2002/16/EC provides that the use and/or the
presence of BFDGE and NOGE may only be continued
until 31 December 2004. For BADGE the transitional
period was extended until 31 December 2005 pending
the expected submission of new toxicological data and
their evaluation by the European Food Safety Authority
(the Authority).
(3)
The toxicological data required for BADGE have been
transmitted. The Authority concluded that BADGE,
BADGE.H
2
O and BADGE.2H
2
O do not raise concern
about carcinogenicity and genotoxicity
in vivo and that
a Tolerable Daily Intake of 0,15 mg/kg body weight can
be
established
for
BADGE,
BADGE.H
2
O
and
BADGE.2H
2
O. Therefore a higher specific migration
limit
SML(T)
can
be
established
for
BADGE
BADGE.H
2
O and BADGE.2H
2
O. As regards the BADGE
chlorohydrins, in view of the lack of data on genotoxicity
in vivo, the Authority considers that the current specific
migration limit of 1 mg/kg of food or food simulants
remains appropriate.
(4)
Trade in and use of materials and articles containing
BADGE in accordance with this Regulation shall
therefore be permitted throughout the Community as
from 1 January 2006.
(5)
The toxicological data required for NOGE and BFDGE
have not been transmitted on time to permit their
evaluation by the Authority and to continue their use.
Therefore the use and/or presence BFDGE and NOGE is
no longer permitted as from 1 January 2005 in
accordance with Directive 2002/16/EC. However the
exhaustion of existing stocks should be permitted.
(6)
For large containers, the use and/or presence of BADGE,
NOGE and BFDGE are permitted. The high volume/
surface area ratio, the repeated use over their long
lifetime which reduces migration and the fact that
contact with food usually occurs at ambient temperature
suggests that it is not necessary to set a migration limit
for BADGE, NOGE and BFDGE used in such containers.
(7)
Pursuant to Article 16 of Regulation (EC) No 1935/2004
materials and articles covered by specific measures are to
be accompanied by a written declaration stating that they
comply with the rules applicable to them. That
requirement has not yet been included in Directive
2002/16/EC. Therefore it is necessary to introduce this
obligation and to provide for a transitional period.
(8)
Having regard to the amendments required and in the
interest of clarity, Directive 2002/16/EC should be
replaced by a new Regulation.
EN
L 302/28
Official Journal of the European Union
19.11.2005
(
1
) OJ L 338, 13.11.2004, p. 4.
(
2
) OJ L 51 of 22.2.2002, p. 27. Regulation as amended by Directive
2004/13/EC (OJ L 27, 30.1.2004, p. 46).