Commission Directive 2002/16/EC of 20 February 2002 on the use of certain epoxy derivatives in materials and articles intended to come into contact with foodstuffs (Text with EEA relevance)
Date: 2002-02-20
Institutions: European Commission
Subjects: European standard, analytical chemistry, food inspection, foodstuff, packaging product, plastics

22.2.2002

EN

Official Journal of the European Communities

L 51/27

COMMISSION DIRECTIVE 2002/16/EC

of 20 February 2002

on the use of certain epoxy derivatives in materials and articles intended to come into contact with
foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Community,

Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws of
the Member States relating to materials and articles intended to come into contact with foodstuffs (1), and in
particular Article 3 thereof,

After consulting the Scientific Committee on Food,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

(7)

(8)

(9)

The use and/or presence of 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (‘BADGE’),
bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers
ethers
(‘NOGE’) in materials and articles intended to come into contact with foodstuffs has led to questions
about their safety, mainly when they are used as an additive.

(‘BFDGE’) and novolac glycidyl

Test results have shown significant levels of these substances and certain derivatives thereof in some
foodstuffs.

The Scientific Committee on Food has given an opinion that the specific migration limit for BADGE
and some of its derivatives can be extended for another three years pending the submission of
further toxicological data for evaluation.

Acceptance of the use and/or presence of BADGE may therefore be provisionally extended.

The Scientific Committee on Food has examined the data available on BFDGE, which are very similar
to the corresponding data obtained for BADGE.

Acceptance of the use and/or presence of BFDGE and some of its derivatives may therefore also be
continued pending the submission and evaluation of
further toxicological data, under certain
conditions.

The Scientific Committee on Food has stated that, in the absence of information about the potential
exposure and toxicological profile of NOGE components with more than two aromatic rings and
it is not in a position to evaluate the safety of use and/or the presence of
their derivatives,
corresponding products. The Committee is therefore of the opinion that at present,
it is not
appropriate to use NOGE as an additive in materials and articles intended to come into contact with
foodstuffs due to its tendency to migrate in this application.

The use and/or presence of NOGE components with more than two aromatic rings and their
derivatives in plastic materials and articles, surface coatings and adhesives intended to come into
contact with foodstuffs should be regulated through the establishment of a strict limit, which should,
in practice, provisionally rule out their use as additives. This provisional limit should apply pending
the submission of adequate data for a more complete scientific risk assessment, in accordance with
Article 5(7) of the World Trade Organisation Agreement on the Application of Sanitary and
Phytosanitary Measures, and the development of adequate methods for the determination of their
levels in foodstuffs.

The use and/or presence of NOGE and BFDGE as starting substances for the preparation of special
coatings used to cover the surfaces of very big containers should provisionally be allowed to
continue, pending the submission of further technical data. The large volume/surface area ratio of
these containers, their repeated use over their long lifetime which reduces migration, and their
contact with foodstuffs at ambient temperature in the majority of the applications suggest that it is
not necessary to set a migration limit for NOGE and BFDGE in such containers.

(1) OJ L 40, 11.2.1989, p. 38.

L 51/28

EN

Official Journal of the European Communities

22.2.2002

(10) Member States which have not yet authorised the use and/or the presence of BADGE and/or BFDGE
and/or NOGE in materials and articles intended to come into contact with foodstuffs should be able
to maintain their prohibition.

(11)

(12)

The use and/or presence of BADGE, BFDGE and NOGE in plastic materials and articles, surface
lacquers and paints, as well as adhesives, should be regulated at
coatings such as varnishes,
Community level to avoid risks to human health and barriers to the free movement of goods.

Errors due to the presence of other chemical substances may occur during analysis. Validated
methods of analysis are, therefore, necessary for correct verification of compliance with the restric-
tions set out in the Directive.

(13) A transitional period should be provided for in respect of materials and articles which are brought

into contact with foodstuffs before the deadline for implementation of this Directive.

(14)

(15)

This transitional period should also take into account the requirements of 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 foodstuffs (1), as amended
by Commission Directive 2001/101/EC (2).

In view of the new technical requirements, Commission Directive 2001/61/EC of 8 August 2001 on
the use of certain epoxy derivatives in materials and articles intended to come into contact with
foodstuffs (3) should be repealed for reasons of clarity.

(16)

The measures provided for in this Directive are in accordance with the opinion of the Standing
Committee on Foodstuffs,

HAS ADOPTED THIS DIRECTIVE:

Article 1

1.
This Directive shall apply to 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 and which
are manufactured with or contain one or more of the following substances:

(a) 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (hereinafter ‘BADGE’), and some of its

derivatives;

(b) bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers (hereinafter ‘BFDGE’), and some of their deriva-

tives;

(c) other novolac glycidyl ethers (hereinafter ‘NOGE’), and some of their derivatives.

For the purposes of this Directive,

‘materials and articles’ are:

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

(b) materials and articles covered by surface coatings;

(c) adhesives.

This Directive shall not apply to containers or storage tanks having a capacity greater than 10 000
2.
litres or to pipelines belonging to or connected with them, covered by special coatings called ‘heavy-duty
coatings’.

Article 2

The materials and articles referred to in Article 1(1) shall not release the substances listed in Annex I in a
quantity exceeding the limit laid down in that Annex.

The use and/or presence of BADGE in the manufacture of those materials and articles may only be
continued until 31 December 2004.

(1) OJ L 109, 6.5.2000, p. 29.
(2) OJ L 310, 28.11.2001, p. 19.
(3) OJ L 215, 9.8.2001, p. 26.

22.2.2002

EN

Official Journal of the European Communities

L 51/29

Article 3

The materials and articles referred to in Article 1(1) shall not release the substances listed in Annex II in a
quantity which, when added, to the sum of BADGE and its derivatives listed in Annex I, exceeds the limit
laid down in Annex II.

The use and/or presence of BFDGE in the manufacture of those materials and articles may only be
continued until 31 December 2004.

Article 4

As from 1 March 2003, the quantity of NOGE components with more than two aromatic rings and at least
one epoxy group as well as their derivatives containing chlorohydrin functions and having a molecular
mass less than 1 000 daltons shall not be detectable in the materials and articles referred to in Article 1(1)
at the detection limit of 0,2 mg/6 dm²,

including analytical tolerance.

For the purpose of this Directive, the detection limit specified in the first paragraph should be verified by a
validated method of analysis. If such a method does not exist, an analytical method with appropriate
performance characteristics may be used, pending the development of a validated method.

The use and/or presence of NOGE in the manufacture of those materials and articles may only be continued
until 31 December 2004.

Article 5

The requirements of this Directive shall not apply to materials and articles covered by surface coatings, and
adhesives, referred to in points (b) and (c) of the second subparagraph of Article 1(1), which are brought
into contact with foodstuffs before 1 March 2003. These materials and articles may continue to be placed
on the market provided that the date of filling appears on the materials and articles, taking into account the
requirements of Directive 2000/13/EC.

Directive 2001/61/EC is hereby repealed.

Article 6

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

Article 7

Member States shall bring into force the laws, regulations and administrative provisions necessary to
comply with this Directive by 28 February 2003 at latest. They shall forthwith inform the Commission
thereof.

When Member States adopt those provisions, they shall contain a reference to this Directive or be
accompanied by such a reference on the occasion of their official publication. Member States shall
determine how such reference is to be made.

This Directive shall enter into force on the 20th day following its publication in the Official Journal of the
European Communities.

Article 8

This Directive is addressed to the Member States.

Article 9

Done at Brussels, 20 February 2002.

For the Commission

David BYRNE

Member of the Commission

L 51/30

EN

Official Journal of the European Communities

22.2.2002

ANNEX I

Specific migration limit for BADGE and certain of its derivatives

1. The sum of the migration levels of the following substances:

(a) BADGE (= 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether;
(b) BADGE.H2
(c) BADGE.HCl;

O;

(d) BADGE.2HCl;
(e) BADGE.H2
shall not exceed the following limits:

O.HCl

— 1 mg/kg in foodstuffs or in food simulants (analytical tolerance excluded), or

— 1 mg/6 dm² in accordance with the cases provided by Article 4 of Commission Directive 90/128/EEC (1).

2. The migration testing shall be carried out in accordance to the rules established in Council Directive 82/711/EEC (2), as
well as in Directive 90/128/EEC. However in aqueous food simulants, this value should also include BADGE.2H
O
2
unless the material or article is labelled for use in contact only with those foods and/or beverages for which it has been
demonstrated that the sum of the migration levels of the five substances listed in paragraph 1(a), (b), (c), (d) and (e)
cannot exceed the limits provided in paragraph 1.

3. For the purpose of this Directive, the specific migration of the substances listed in paragraph 1(a), (b), (c), (d) and (e)
should be determined by a validated method of analysis. If such a method does not exist, an analytical method with
appropriate performance characteristics may be used, pending the development of a validated method.

(1) OJ L 75, 21.3.1990, p. 19.
(2) OJ L 297, 23.10.1982, p. 26.

22.2.2002

EN

Official Journal of the European Communities

L 51/31

ANNEX II

Specific migration limit for BFDGE and certain of its derivatives

1. The sum of the migration levels of the following substances:

(a) BFDGE (= bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers);
(b) BFDGE.H2
(c) BFDGE.HCl;

O;

(d) BFDGE.2HCl;
(e) BFDGE.H2
added to the sum of those listed in Annex I, shall not exceed the following limits:

O.HCl

— 1 mg/kg in foodstuffs or in food simulants (analytical tolerance excluded), or

— 1 mg/6 dm² in accordance with the cases provided by Article 4 of Directive 90/128/EEC.

2. The migration testing shall be carried out in accordance to the rules established in Directive 82/711/EEC, as well as in
Directive 90/128/EEC. However in aqueous food simulants, this value should also include BFDGE.2H
O unless the
2
material or article is labelled for use in contact only with those foods and/or beverages for which it has been
demonstrated that the sum of the migration levels of the five substances listed in paragraph 1(a), (b), (c), (d) and (e),
added to those listed in Annex I, cannot exceed the limits provided in paragraph 1.

3. For the purpose of this Directive, the specific migration of the substances listed in paragraph 1(a), (b), (c), (d) and (e)
should be determined by a validated method of analysis. If such a method does not exist, an analytical method with
appropriate performance characteristics may be used, pending the development of a validated method.

ANNEX III

Correlation table

Directive 2001/61/EC

This Directive

Article 1

Article 2

Article 3

Article 4

Article 5

—

Article 6

Article 7

Article 8

Annex I

Annex II

—

Article 1

Article 2

Article 3

Article 4

Article 5

Article 6

Article 7

Article 8

Article 9

Annex I

Annex II

Annex III