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欧盟 EC 1935 CELEX-2004 R1935-en-TXT.pdf
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欧盟 EC 1935 CELEX_2004 R1935_en_TXT.pdf
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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
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EURO-
PEAN UNION,
Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and
Social Committee (
1
),
Acting in accordance with the procedure laid down in Article 251
of the Treaty (
2
),
Whereas:
(1) Council Directive 89/109/EEC of 21 December 1988 on
the approximation of the laws of the Member States relat-
ing to materials and articles intended to come into contact
with foodstuffs (
3
) established general principles for elimi-
nating the differences between the laws of the Member
States as regards those materials and articles and provided
for the adoption of implementing directives concerning
specific groups of materials and articles (specific directives).
This approach was successful and should be continued.
(2) The specific directives adopted under
Directive 89/109/EEC in general contain provisions which
leave little room for the exercise of discretion by the Mem-
ber States in their transposition besides being subject to
frequent amendments required to adapt them rapidly to
technological progress. It should therefore be possible for
such measures to take the form of regulations or decisions.
At the same time it is appropriate to include a number of
additional subjects. Directive 89/109/EEC should therefore
be replaced.
(3) The principle underlying this Regulation is that any mate-
rial or article intended to come into contact directly or
indirectly with food must be sufficiently inert to preclude
substances from being transferred to food in quantities
large enough to endanger human health or to bring about
an unacceptable change in the composition of the food or
a deterioration in its organoleptic properties.
(4) New types of materials and articles designed to actively
maintain or improve the condition of the food (active food
contact materials and articles) are not inert by their design,
unlike traditional materials and articles intended to come
into contact with food. Other types of new materials and
articles are designed to monitor the condition of the food
(intelligent food contact materials and articles). Both these
types of materials and articles may be brought into con-
tact with food. It is therefore necessary, for reasons of clar-
ity and legal certainty, for active and intelligent food con-
tact materials and articles to be included in the scope of
this Regulation and the main requirements for their use to
be established. Further requirements should be stated in
specific measures, to include positive lists of authorised
substances and/or materials and articles, which should be
adopted as soon as possible.
(5) Active food contact materials and articles are designed to
deliberately incorporate ‘active’ components intended to be
released into the food or to absorb substances from the
food. They should be distinguished from materials and
articles which are traditionally used to release their natural
ingredients into specific types of food during the process
of their manufacture, such as wooden barrels.
(6) Active food contact materials and articles may change the
composition or the organoleptic properties of the food
only if the changes comply with the Community provi-
sions applicable to food, such as the provisions of
Directive 89/107/EEC (
4
) on food additives. In particular,
substances such as food additives deliberately incorporated
into certain active food contact materials and articles for
release into packaged foods or the environment surround-
ing such foods, should be authorised under the relevant
Community provisions applicable to food and also be sub-
ject to other rules which will be established in a specific
measure.
(
1
) OJ C 117, 30.4.2004, p. 1.
(
2
) Opinion of the European Parliament of 31 March 2004 (not yet pub-
lished in the Official Journal) and Council Decision of 14 October
2004.
(
3
) OJ L 40, 11.2.1989, p. 38. Directive as amended by Regulation (EC)
No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).
(
4
) Council Directive 89/107/EEC of 21 December 1988 on the approxi-
mation of the laws of the Member States concerning food additives
authorised for use in foodstuffs intended for human consumption
(OJ L 40, 11.2.1989, p. 27). Directive as last amended by Regula-
tion (EC) No 1882/2003.
L 338/4 EN Official Journal of the European Union 13.11.2004
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In addition, adequate labelling or information should sup-
port users in the safe and correct use of active materials
and articles in compliance with the food legislation, includ-
ing the provisions on food labelling.
(7) Active and intelligent food contact materials and articles
should not change the composition or the organoleptic
properties of food or give information about the condition
of the food that could mislead consumers. For example,
active food contact materials and articles should not release
or absorb substances such as aldehydes or amines in order
to mask an incipient spoilage of the food. Such changes
which could manipulate signs of spoilage could mislead
the consumer and they should therefore not be allowed.
Similarly, active food contact materials and articles which
produce colour changes to the food that give the wrong
information concerning the condition of the food could
mislead the consumer and therefore should not be allowed
either.
(8) Any material or article intended to come into contact with
food which is placed on the market should comply with
the requirements of this Regulation. Nevertheless, materi-
als and articles supplied as antiques should be excluded as
they are available in restricted quantities and their contact
with food is therefore limited.
(9) Covering or coating materials forming part of the food and
possibly being consumed with it should not fall within the
scope of this Regulation. On the other hand, this Regula-
tion should apply to covering or coating materials which
cover cheese rinds, prepared meat products or fruit but
which do not form part of food and are not intended to be
consumed together with such food.
(10) It is necessary to lay down various types of restrictions and
conditions for the use of the materials and articles covered
by this Regulation and the substances used in their manu-
facture. It is appropriate to establish those restrictions and
conditions in specific measures having regard to the tech-
nological characteristics specific to each group of materi-
als and articles.
(11) Pursuant to Regulation (EC) No 178/2002 of the Euro-
pean Parliament and of the Council of 28 January 2002
laying down the general principles and requirements of
food law, establishing the European Food Safety Authority
and laying down procedures in matters of food safety (
1
),
the European Food Safety Authority (the Authority) should
be consulted before provisions liable to affect public health
are adopted under specific measures.
(12) When specific measures include a list of substances autho-
rised within the Community for use in the manufacture of
materials and articles intended to come into contact with
food, those substances should undergo a safety assessment
prior to their authorisation. The safety assessment and
authorisation of those substances should be without preju-
dice to the relevant requirements of the Community legis-
lation concerning the registration, evaluation, authorisa-
tion and restriction of chemicals.
(13) Differences between national laws, regulations and admin-
istrative provisions concerning the safety assessment and
authorisation of substances used in the manufacture of
materials and articles intended to come into contact with
food may hinder the free movement of those materials and
articles, creating conditions of unequal and unfair compe-
tition. An authorisation procedure should therefore be
established at Community level. In order to ensure harmo-
nised safety assessment of those substances, the Authority
should carry out such assessments.
(14) The safety assessment of substances should be followed by
a risk management decision as to whether those substances
should be entered on a Community list of authorised
substances.
(15) It is appropriate to provide for the possibility of an admin-
istrative review of specific acts or omissions on the part of
the Authority under this Regulation. This review should
be without prejudice to the role of the Authority as an
independent scientific point of reference in risk assessment.
(16) Labelling supports users in the correct use of the materials
and articles. Methods used for such labelling may vary
according to the user.
(17) Commission Directive 80/590/EEC (
2
) introduced a sym-
bol that may accompany materials and articles intended to
come into contact with foodstuffs. This symbol should, for
reasons of simplicity, be incorporated in this Regulation.
(18) The traceability of materials and articles intended to come
into contact with food should be ensured at all stages in
order to facilitate control, the recall of defective products,
consumer information and the attribution of responsibil-
ity. Business operators should at least be able to identify
the businesses from which, and to which, the materials and
articles are supplied.
(
1
) OJ L 31, 1.2.2002, p. 1. Regulation as amended by Regulation (EC) No
1642/2003 (OJ L 245, 29.9.2003, p. 4).
(
2
) Commission Directive 80/590/EEC of 9 June 1980 determining the
symbol that may accompany materials and articles intended to come
into contact with foodstuffs (OJ L 151, 19.6.1980, p. 21). Directive as
last amended by the 2003 Act of Accession
13.11.2004 EN Official Journal of the European Union L 338/5
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(19) In the control of the compliance of the materials and
articles with this Regulation, it is appropriate to take into
account the special needs of developing countries, and
in particular of the least developed countries. The Commis-
sion has been committed by Regulation (EC) No 882/2004
of the European Parliament and of the Council of
29 April 2004 on official controls performed to ensure the
verification of compliance with feed and food law, animal
health and animal welfare rules (
1
) to support develop-
ing countries with regard to food safety, including the
safety of the materials and articles in contact with food.
Special provisions have therefore been established in that
Regulation which should be applicable also to the food
contact materials and articles.
(20) It is necessary to establish procedures for the adoption of
safeguard measures in situations where a material or article
is likely to constitute a serious risk to human health.
(21) Regulation (EC) No 1049/2001 of the European Parlia-
ment and of the Council of 30 May 2001 regarding public
access to European Parliament, Council and Commis-
sion documents (
2
) applies to documents held by the
Authority.
(22) It is appropriate to protect the investment made by inno-
vators in gathering the information and data supporting an
application made under this Regulation. In order to avoid
unnecessary repetition of studies and in particular animal
testing, however, sharing of data should be permitted pro-
vided there is agreement between the interested parties.
(23) Community and national reference laboratories should be
designated to contribute to a high quality and uniformity
of analytical results. This objective will be achieved within
the framework of Regulation (EC) No 882/2004.
(24) The use of recycled materials and articles should be
favoured in the Community for environmental reasons,
provided that strict requirements are established to ensure
food safety and consumer protection. Such requirements
should be established taking also into account the techno-
logical characteristics of the different groups of materials
and articles mentioned in Annex I. Priority should be given
to the harmonisation of rules on recycled plastic material
and articles as their use is increasing and national laws and
provisions are lacking or are divergent. Therefore, a draft
of a specific measure on recycled plastic materials and
articles should be made available to the public as soon as
possible in order to clarify the legal situation in the
Community.
(25) The measures necessary for the implementation of this
Regulation and amendments to Annexes I and II hereto
should be adopted in accordance with Council
Decision 1999/468/EC of 28 June 1999 laying down the
procedures for the exercise of implementing powers con-
ferred on the Commission (
3
).
(26) Member States should lay down rules on sanctions appli-
cable to infringements of the provisions of this Regulation
and ensure that they are implemented. Such sanctions
must be effective, proportionate and dissuasive.
(27) It is necessary for business operators to have sufficient time
to adapt to some of the requirements established by this
Regulation.
(28) Since the objectives of this Regulation cannot be suffi-
ciently achieved by the Member States because of the dif-
ferences between the national laws and provisions and can
therefore be better achieved at Community level, the Com-
munity may adopt measures, in accordance with the prin-
ciple of subsidiarity as set out in Article 5 of the Treaty. In
accordance with the principle of proportionality, as set out
in that Article, this Regulation does not go beyond what is
necessary in order to achieve those objectives.
(29) Directives 80/590/EEC and 89/109/EEC should therefore
be repealed,
HAVE ADOPTED THIS REGULATION:
Article 1
Purpose and subject matter
1. The purpose of this Regulation is to ensure the effective
functioning of the internal market in relation to the placing on the
market in the Community of materials and articles intended to
come into contact directly or indirectly with food, whilst provid-
ing the basis for securing a high level of protection of human
health and the interests of consumers.
(
1
) OJ L 165, 30.4.2004, p. 1. Regulation as corrected in OJ L 191,
28.5.2004, p. 1.
(
2
) OJ L 145, 31.5.2001, p. 43. (
3
) OJ L 184, 17.7.1999, p. 23
L 338/6 EN Official Journal of the European Union 13.11.2004
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