2002L0016 — EN — 19.02.2004 — 001.001 — 1
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►B COMMISSIONDIRECTIVE2002/16/EC
of20February2002
ontheuseofcertainepoxyderivativesinmaterialsandarticlesintendedtocomeintocontactwith
foodstuffs
(TextwithEEArelevance)
(OJ L 51, 22.2.2002, p. 27)
Amended by:
Official Journal
No page date
►M1Commission Directive 2004/13/EC of 29 January 2004 L 27 46 30.1.2004
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COMMISSIONDIRECTIVE2002/16/EC
of20February2002
on the use of certain epoxy derivatives in materials and articles
intendedtocomeintocontactwithfoodstuffs
(TextwithEEArelevance)
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 tomaterials 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)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 (‘BFDGE’) and novolacglycidyl ethers (‘NOGE’) in materials and articles intended tocome into contact with foodstuffs has led to questions abouttheir safety, mainly when they are used as an additive.
(2)Test results have shown significant levels of these substancesand certain derivatives thereof in some foodstuffs.
(3)The Scientific Committee on Food has given an opinion that thespecific migration limit for BADGE and some of its derivativescan be extended for another three years pending the submissionof further toxicological data for evaluation.
(4)Acceptance of the use and/or presence of BADGE may thereforebe provisionally extended.
(5)The Scientific Committee on Food has examined the data avail-able on BFDGE, which are very similar to the correspondingdata obtained for BADGE.
(6)Acceptance of the use and/or presence of BFDGE and some ofits derivatives may therefore also be continued pending thesubmission and evaluation of further toxicological data, under
certain conditions.
(7)The Scientific Committee on Food has stated that, in the absenceof information about the potential exposure and toxicological
profile of NOGE components with more than two aromatic ringsand their derivatives, it is not in a position to evaluate the safetyof use and/or the presence of corresponding products. TheCommittee is therefore of the opinion that at present, it is notappropriate 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.
(8)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 intocontact with foodstuffs should be regulated through the estab-lishment 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 withArticle 5(7) of the World Trade Organisation Agreement on theApplication of Sanitary and Phytosanitary Measures, and thedevelopment of adequate methods for the determination of theirlevels in foodstuffs.2002L0016 — EN — 19.02.2004 — 001.001 — 2
(1) OJ L 40, 11.2.1989, p. 38.
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(9)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 beallowed to continue, pending the submission of further technicaldata. The large volume/surface area ratio of these containers,their repeated use over their long lifetime which reduces migra-tion, 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.
(10)Member States which have not yet authorised the use and/or thepresence 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)The use and/or presence of BADGE, BFDGE and NOGE inplastic materials and articles, surface coatings such as varnishes,
lacquers and paints, as well as adhesives, should be regulated at
Community level to avoid risks to human health and barriers tothe free movement of goods.
(12)Errors due to the presence of other chemical substances may
occur during analysis. Validated methods of analysis are, there-
fore, necessary for correct verification of compliance with therestrictions set out in the Directive.
(13)A transitional period should be provided for in respect of mate-rials and articles which are brought into contact with foodstuffs
before the deadline for implementation of this Directive.
(14)This transitional period should also take into account the require-
ments of Directive 2000/13/EC of the European Parliament andof 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).
(15)In view of the new technical requirements, Commission Direc-
tive 2001/61/EC of 8 August 2001 on the use of certain epoxy
derivatives in materials and articles intended to come intocontact with foodstuffs(
3) should be repealed for reasons of
clarity.
(16)The measures provided for in this Directive are in accordancewith 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 andwhich are manufactured with or contain one or more of the followingsubstances:
(a) 2,2-bis(4-hydroxyphenyl)propane bis(2,3-epoxypropyl) ether (here-
inafter ‘BADGE’), and some of its derivatives;
(b) bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers (hereinafter
‘BFDGE’), and some of their derivatives;
(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;2002L0016 — EN — 19.02.2004 — 001.001 — 3
(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.
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(c) adhesives.
2. This Directive shall not apply to containers or storage tanks
having a capacity greater than 10 000 litres or to pipelines belongingto 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 mate-
rials and articles may only be continued until ►
M131 December
2005◄.
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, tothe sum of BADGE and its derivatives listed in Annex I, exceeds thelimit laid down in Annex II.
The use and/or presence of BFDGE in the manufacture of those mate-
rials 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 theirderivatives 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 appropriateperformance characteristics may be used, pending the development of avalidated method.
The use and/or presence of NOGE in the manufacture of those mate-
rials and articles may only be continued until 31 December 2004.
Article 5
1. Articles 2, 3 and 4 shall not apply to the materials and articles
referred to in points (b) and (c) of the second subparagraph of Article1(1) which are brought into contact with foodstuffs before 1 March2003.
Those materials and articles may be placed on the market provided that
the date of filling appears on the materials and articles. However, thedate of filling may be replaced by another indication, provided that
this indication permits the identification of the date of filling. Upon
request, the date of filling shall be made available to the competentauthorities and any person enforcing the requirements of this Directive.
2. Paragraph 1 shall apply without prejudice to the requirements of
Directive 2000/13/EC.
Article 6
Directive 2001/61/EC is hereby repealed.
References to the repealed Directive shall be construed as references to
this Directive and be read in accordance with the correlation table setout in Annex III.2002L0016 — EN — 19.02.2004 — 001.001 — 4
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Article 7
Member States shall bring into force the laws, regulations and admin-
istrative 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 refer-
ence to this Directive or be accompanied by such a reference on theoccasion of their official publication. Member States shall determinehow such reference is to be made.
Article 8
This Directive shall enter into force on the 20th day following its
publication in the Official Journal of the European Communities .
Article 9
This Directive is addressed to the Member States.2002L0016 — EN — 19.02.2004 — 001.001 — 5
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ANNEX I
Specific migrationlimitforBADGEandcertain ofitsderivatives
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.H2O;
(c) BADGE.HCl;
(d) BADGE.2HCl;
(e) BADGE.H2O.HCl
shall not exceed the following limits:
— 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 estab-
lished 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.2H2O 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 vali-
dated 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.2002L0016 — EN — 19.02.2004 — 001.001 — 6
(1) OJ L 75, 21.3.1990, p. 19.
(2) OJ L 297, 23.10.1982, p. 26.
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ANNEX II
Specific migrationlimitforBFDGEandcertain ofitsderivatives
1. The sum of the migration levels of the following substances:
(a) BFDGE (= bis(hydroxyphenyl)methane bis(2,3-epoxypropyl)ethers);
(b) BFDGE.H2O;
(c) BFDGE.HCl;
(d) BFDGE.2HCl;
(e) BFDGE.H2O.HCl
added to the sum of those listed in Annex I, shall not exceed the following
limits:
— 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 Direc-
tive 90/128/EEC.
2. The migration testing shall be carried out in accordance to the rules estab-
lished in Directive 82/711/EEC, as well as in Directive 90/128/EEC.
However in aqueous food simulants, this value should also include
BFDGE.2H2O 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), 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 vali-dated 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.2002L0016 — EN — 19.02.2004 — 001.001 — 7
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ANNEX III
Correlationtable
Directive 2001/61/EC This Directive
Article 1 Article 1
Article 2 Article 2
Article 3 Article 3
Article 4 Article 4
Article 5 Article 5
— Article 6
Article 6 Article 7
Article 7 Article 8
Article 8 Article 9
Annex I Annex I
Annex II Annex II
— Annex III2002L0016 — EN — 19.02.2004 — 001.001 — 8