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)
Date: 2005-11-18
Institutions: European Commission
Subjects: food safety, foodstuffs legislation, packaging product, plastics

L 302/28

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Official Journal of the European Union

19.11.2005

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
Community,

establishing the European

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)

(2)

(3)

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
bis(2,3-epoxy-
i.e. Bisphenol-A DiGlycidyl
propyl)
Ether),
bis(2,3-epoxypro-
i.e. Bisphenol-F DiGlycidyl Ether)
pyl)ethers
and novolac glycidyl ethers (NOGE) and some of their
derivatives.

ether
bis(hydroxyphenyl)methane

2,2-bis(4-hydroxyphenyl)propane

(‘BADGE’

(‘BFDGE’

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).

The toxicological data required for BADGE have been
transmitted. The Authority concluded that BADGE,
BADGE.H2O and BADGE.2H2O do not raise concern
about carcinogenicity and genotoxicity in vivo and that

(4)

(5)

(6)

(7)

for

SML(T)

BADGE,

established

a Tolerable Daily Intake of 0,15 mg/kg body weight can
BADGE.H2O and
be
specific migration
BADGE.2H2O. Therefore a higher
limit
BADGE
can
BADGE.H2O and BADGE.2H2O. 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.

established

for

be

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.

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
from 1 January 2005 in
no longer permitted as
accordance with Directive 2002/16/EC. However
the
exhaustion of existing stocks should be permitted.

For large containers, the use and/or presence of BADGE,
NOGE and BFDGE are permitted. The high volume/
long
surface area ratio,
their
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.

the repeated use over

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
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.

applicable

rules

(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).

(8)

Having regard to the amendments required and in the
interest of clarity, Directive 2002/16/EC should be
replaced by a new Regulation.

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Official Journal of the European Union

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(9)

its

that

requirements
Directive 2002/16/EC provides
concerning BADGE, BFDGE and NOGE do not apply
to materials and articles brought into contact with food
before 1 March 2003. Those materials and articles may
continue to be placed on the market provided that the
date of
filling appears on them. This date may be
replaced by the ‘best before’ date as provided for by
Directive 2000/13/EC of the European Parliament and
of the Council of 20 March 2000 on the approximation
of the laws of the Member States relating to the labelling,
presentation and advertising of food (1) or another indi-
cation, such as the lot number required by Council
Directive 89/396/EEC of 14 June 1989 on indications
or marks
to which a foodstuff
belongs (2) for the food packed in such materials and
articles, provided a link is established between this indi-
cation and the date of filling so that the latter can always
be identified.

identifying the lot

(10) Directive 2002/16/EC should therefore be repealed.

(11)

The measures provided for in this Regulation are in
accordance with
Standing
Committee on the Food Chain and Animal Health,

opinion

the

the

of

HAS ADOPTED THIS REGULATION:

Article 1

Scope

1.
This Regulation shall apply to materials and articles,
including active and intelligent
food contact materials and
referred to in Article 1(2) of Regulation (EC)
articles, as
No 1935/2004, which are manufactured with or contain one
or more of the following substances:

(b) materials and articles covered by surface coatings; and

(c) adhesives.

This Regulation shall not apply to containers or storage
3.
tanks having a capacity greater
to
pipelines belonging to or connected with them, covered by
special coatings called ‘heavy-duty coatings’.

than 10 000 litres or

Article 2

BADGE

Materials and articles shall not release the substances listed in
Annex I in a quantity exceeding the limits laid down in that
Annex.

Article 3

BFDGE

The use and/or presence of BFDGE in the manufacture of
materials and articles are prohibited.

Article 4

NOGE

The use and/or presence of NOGE in the manufacture of
materials and articles are prohibited.

Article 5

Written declaration

(a) 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether,
hereinafter referred to as ‘BADGE’ (CAS No 001675-54-3),
and some of its derivatives;

At the marketing stages other than the retail stages, materials
and articles containing BADGE and its derivatives shall be
accompanied by a written declaration in accordance with
Article 16 of Regulation (EC) No 1935/2004.

(b) bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers, here-
inafter referred to as ‘BFDGE’ (CAS No 039817-09-9);

(c) other novolac glycidyl ethers, hereinafter

‘NOGE’.

referred to as

For the purposes of this Regulation, ‘materials and articles’

2.
are:

(a) materials and articles made of any type of plastics;

Appropriate documentation shall be available to demonstrate
such compliance. That documentation shall be made available
to the competent authorities on demand.

Article 6

Transitional provisions

1.
Articles 2, 3 and 4 shall not apply to materials and articles
referred to in Article 1(2)(b) and (c) which are brought into
contact with food before 1 March 2003.

(1) OJ L 109, 6.5.2000, p. 29. Directive as last amended by Directive

2003/89/EC (OJ L 308, 25.11.2003, p. 15).

(2) OJ L 186, 30.6.1989, p. 21. Directive as last amended by Directive

91/11/EEC (OJ L 65, 11.3.1992, p. 32).

2.
Articles 3 and 4 shall not apply to materials and articles
which are in compliance with Directive 2002/16/EC and which
are brought into contact with food before 1 January 2005.

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Article 5 shall not apply to materials and articles referred
3.
to Article 1(2)(a)(b) and (c) which are brought into contact with
food before 1 January 2007.

Article 7

Repeal

4.
The materials and articles referred to in paragraphs 1, 2
and 3 may be placed on the market provided the date of filling
appears on the materials and articles. The date of filling may be
replaced by another indication, provided it permits the identifi-
cation of the date of filling. Upon request the date of filling
shall be made available to the competent authorities and any
person enforcing the requirements of this Regulation.

Directive 2002/16/EC is repealed.

References to the repealed Directive shall be construed as
references to this Regulation and be read in accordance with
the correlation table set out in Annex II.

Article 8

Entry into force

This Regulation shall enter into force on the twentieth day
following its publication in the Official Journal of the European
Union.

Paragraphs 1 to 4 shall apply without prejudice to the

5.
requirements of Directive 2000/13/EC.

It shall apply from 1 January 2006.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 18 November 2005.

For the Commission

Markos KYPRIANOU
Member of the Commission

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Official Journal of the European Union

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ANNEX I

Specific migration limit for BADGE and certain of its derivatives

1. The sum of the migrations of the following substances:

(a) BADGE [= 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether] (CAS No = 001675-54-3)

(b) BADGE.H2O (CAS No = 076002-91-0)

(c) BADGE.2H2O (CAS No = 005581-32-8)

shall not exceed the following limits:

— 9 mg/kg in food or food simulants, or

— 9 mg/6 dm2 in accordance with the cases provided by Article 7 of Commission Directive 2002/72/EC (1).

2. The sum of the migrations of the following substances:

(a) BADGE.HCl (CAS No = 013836-48-1)

(b) BADGE.2HCl (CAS No = 004809-35-2)

(c) BADGE.H2O.HCl (CAS No = 227947-06-0)

shall not exceed the following limits:

— 1 mg/kg in food or in food simulants, or

— 1 mg/6 dm2 in accordance with the cases provided by Article 7 of Directive 2002/72/EC.

3. The migration testing shall be carried out in accordance to the rules established in Council Directive 82/711/EEC (2)

and Directive 2002/72/EC.

(1) OJ L 39, 13.2.2003, p. 1.
(2) OJ L 297, 23.10.1982, p. 26.

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Official Journal of the European Union

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ANNEX II

Correlation table

Directive 2002/16/EC as amended by Directive 2004/13/EC

This Regulation

Article 1

Article 2

Article 3

Article 4

—

Article 5

Article 6

Article 7

Article 8

Article 9

Annex I

Annex II

Annex III

Article 1

Article 2

Article 3

Article 4

Article 5

Article 6

Article 7

Article 8

Article 8

—

Annex I

—

Annex II