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
Date: 2004-10-27
Institutions: Council of the European Union, European Parliament
Subjects: consumer protection, food safety, foodstuff, health control, marketing, packaging product

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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,

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.

Having regard to the proposal from the Commission,

(4)

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:

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.

(1)

(2)

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.

specific

adopted

directives

The
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

(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).

(5)

(6)

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.

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.

(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.

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(7)

(8)

(9)

(10)

(11)

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.

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.

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.

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.

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.

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)

(15)

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.

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)

(18)

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.

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

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(19)

the European Parliament and of

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
the Council of
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.

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).

(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.

(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.

(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.

(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,

(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.

HAVE ADOPTED THIS REGULATION:

(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

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

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This Regulation shall apply to materials and articles, includ-
2.
ing active and intelligent food contact materials and articles, (here-
inafter referred to as materials and articles) which in their finished
state:

(a) are intended to be brought into contact with food;

(b)

(c)

or

‘intelligent food contact materials and articles’ (hereinafter
referred to as intelligent materials and articles) means mate-
rials and articles which monitor the condition of pack-
aged food or the environment surrounding the food;

‘business’ means any undertaking, whether for profit or not
and whether public or private, carrying out any of the activi-
ties related to any stage of manufacture, processing and dis-
tribution of materials and articles;

(b) are already in contact with food and were intended for that

purpose;

or

(d)

‘business operator’ means the natural or legal persons respon-
sible for ensuring that the requirements of this Regulation are
met within the business under their control.

(c)

can reasonably be expected to be brought into contact with
food or to transfer their constituents to food under normal
or foreseeable conditions of use.

Article 3

General requirements

3.

This Regulation shall not apply to:

(a) materials and articles which are supplied as antiques;

(b) covering or coating materials, such as the materials covering
cheese rinds, prepared meat products or fruits, which form
part of the food and may be consumed together with this
food;

1. Materials and articles, including active and intelligent mate-
rials and articles, shall be manufactured in compliance with good
manufacturing practice so that, under normal or foreseeable con-
ditions of use, they do not transfer their constituents to food in
quantities which could:

(a)

endanger human health;

(c)

fixed public or private water supply equipment.

or

Article 2

Definitions

1.
For the purposes of this Regulation, the relevant definitions
laid down in Regulation (EC) No 178/2002 shall apply, with the
exception of the definitions of ‘traceability’ and ‘placing on the
market’, which shall have the following meanings:

(a)

(b)

‘traceability’: the ability to trace and follow a material or
article through all stages of manufacture, processing and
distribution;

‘placing on the market’: the holding of materials and articles
for the purpose of sale, including offering for sale or any
other form of transfer, whether free of charge or not, and the
sale, distribution and other forms of transfer themselves.

2.

The following definitions shall also apply:

(b) bring about an unacceptable change in the composition of

the food;

or

(c) bring about a deterioration in the organoleptic characteris-

tics thereof.

The labelling, advertising and presentation of a material or

2.
article shall not mislead the consumers.

Article 4

Special requirements for active and intelligent materials
and articles

(a)

(hereinafter
‘active food contact materials and articles’
referred to as active materials and articles) means materials
and articles that are intended to extend the shelf-life or to
maintain or improve the condition of packaged food. They
are designed to deliberately incorporate components that
would release or absorb substances into or from the pack-
aged food or the environment surrounding the food;

In the application of Article 3(1)(b) and 3(1)(c), active mate-
1.
rials and articles may bring about changes in the composition or
organoleptic characteristics of food on condition that the changes
comply with the Community provisions applicable to food, such
as the provisions of Directive 89/107/EEC on food additives and
related implementing measures, or, if no Community provisions
exist, with the national provisions applicable to food.

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Pending the adoption of additional rules in a specific mea-
2.
sure on active and intelligent materials and articles, substances
deliberately incorporated into active materials and articles to be
released into the food or the environment surrounding the food
shall be authorised and used in accordance with the relevant
Community provisions applicable to food, and shall comply with
the provisions of this Regulation and its implementing measures.

(b)

list(s) of authorised substances incorporated in active or intel-
ligent food contact materials and articles, or list(s) of active
or intelligent materials and articles and, when necessary, spe-
cial conditions of use for these substances and/or the mate-
rials and articles in which they are incorporated;

These substances shall be considered as ingredients within the
meaning of Article 6(4)(a) of Directive 2000/13/EC (1).

3.
Active materials and articles shall not bring about changes
in the composition or organoleptic characteristics of food, for
instance by masking the spoilage of food, which could mislead
consumers.

4.
Intelligent materials and articles shall not give information
about the condition of the food which could mislead consumers.

5.
Active and intelligent materials and articles already brought
into contact with food shall be adequately labelled to allow iden-
tification by the consumer of non-edible parts.

6.
Active and intelligent materials and articles shall be
adequately labelled to indicate that the materials or articles are
active and/or intelligent.

(c) purity standards for substances referred to in (a);

(d)

special conditions of use for substances referred to in (a)
and/or the materials and articles in which they are used;

(e)

specific limits on the migration of certain constituents or
groups of constituents into or on to food, taking due account
of other possible sources of exposure to those constituents;

(f)

an overall limit on the migration of constituents into or on
to food;

(g) provisions aimed at protecting human health against hazards

arising from oral contact with materials and articles;

(h) other rules to ensure compliance with Articles 3 and 4;

Article 5

Specific measures for groups of materials and articles

(i)

basic rules for checking compliance with points (a) to (h);

1.
For the groups of materials and articles listed in Annex I
and, where appropriate, combinations of those materials and
articles or recycled materials and articles used in the manufacture
of those materials and articles, specific measures may be adopted
or amended in accordance with the procedure referred to in
Article 23(2).

Those specific measures may include:

(j)

rules concerning the collection of samples and the methods
of analysis to check compliance with points (a) to (h);

(k)

specific provisions for ensuring the traceability of materials
and articles including provisions regarding the duration for
retention of records or provisions to allow, if necessary, for
derogations from the requirements of Article 17;

(a) a list of substances authorised for use in the manufacturing

of materials and articles;

(l)

additional provisions of labelling for active and intelligent
materials and articles;

(1) Directive 2000/13/EC of the European Parliament and of the Council
of 20 March 2000 on the approximation of the laws of the Mem-
ber States relating to the labelling, presentation and advertising of
foodstuffs (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).

(m) provisions requiring the Commission to establish and main-
tain a publicly available Community Register (Register) of
authorised substances, processes, or materials or articles;

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(n)

specific procedural rules adapting, as necessary, the proce-
dure referred to in Articles 8 to 12, or making it appropriate
for the authorisation of certain types of materials and articles
and/or processes used in their manufacture,
including,
where necessary, a procedure for an individual authorisation
of a substance, process, or material or article through a deci-
sion addressed to an applicant.

(ii) a technical dossier containing the information specified
in the guidelines for the safety assessment of a substance
to be published by the Authority;

(iii) a summary of the technical dossier;

Existing specific directives on materials and articles shall be
2.
amended in accordance with the procedure laid down in
Article 23(2).

(b)

the competent authority referred to in (a) shall:

Article 6

National specific measures

(i)

acknowledge receipt of the application in writing to the
applicant within 14 days of its receipt. The acknowl-
edgement
the
state the date of
application;

receipt of

shall

In the absence of specific measures referred to in Article 5, this
Regulation shall not prevent Member States from maintaining or
adopting national provisions provided they comply with the rules
of the Treaty.

Article 7

Role of the European Food Safety Authority

Provisions liable to affect public health shall be adopted after con-
sulting the European Food Safety Authority, hereinafter referred
to as ‘the Authority’.

Article 8

General requirements for the authorisation of substances

1. When a list of substances as referred to in points (a) and (b)
of the second subparagraph of Article 5(1) is adopted, anyone
seeking an authorisation for a substance not yet included in that
list shall submit an application in accordance with Article 9(1).

2.
No substance shall be authorised unless it has been
adequately and sufficiently demonstrated that, when used under
the conditions to be set in the specific measures, the final mate-
rial or article satisfies the requirements of Article 3 and, where
they apply, Article 4.

Article 9

Application for authorisation of a new substance

(ii)

inform the Authority without delay;

and

(iii) make the application and any supplementary informa-
tion supplied by the applicant available to the Authority;

(c)

the Authority shall without delay inform the other Member
States and the Commission of the application and shall make
the application and any supplementary information supplied
by the applicant available to them.

The Authority shall publish detailed guidelines concerning

2.
the preparation and the submission of the application (1).

Article 10

Opinion of the Authority

1.
The Authority shall give an opinion within six months of
the receipt of a valid application, as to whether, under the intended
conditions of use of the material or article in which it is used, the
substance complies with the safety criteria laid down in Article 3
and, where they apply, Article 4.

To obtain the authorisation referred to in Article 8(1), the

1.
following procedure shall apply:

(a) an application shall be submitted to the competent authority

of a Member State accompanied by the following:

(i)

the name and address of the applicant;

The Authority may extend the said period by a maximum period
of a further six months. In such a case it shall provide an expla-
nation for the delay to the applicant, the Commission and the
Member States.

(1) Pending such publication, applicants may consult the ‘Guidelines of
the Scientific Committee on Food for the presentation of an applica-
tion for safety assessment of a substance to be used in food contact
materials prior to its authorisation’. –
http://europa.eu.int/comm/food/fs/sc/scf/out82_en.pdf.

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The Authority may, where appropriate, request the appli-
2.
cant to supplement the particulars accompanying the application
within a time limit specified by the Authority. Where the Author-
ity requests supplementary information, the time limit laid down
in paragraph 1 shall be suspended until that information has been
provided. Similarly, the time limit shall be suspended for the time
allowed the applicant to prepare oral or written explanations.

3.

In order to prepare its opinion, the Authority shall:

The draft specific measure shall take into account the opin-
2.
ion of the Authority, relevant provisions of Community law and
other legitimate factors relevant to the matter under consider-
ation. Where the draft specific measure is not in accordance with
the opinion of the Authority, the Commission shall provide with-
out delay an explanation for the reasons for the differences. If the
Commission does not intend to prepare a draft specific measure
after a favourable opinion by the Authority, it shall inform the
applicant without delay and provide the applicant with an
explanation.

(a) verify that the information and documents submitted by the
applicant are in accordance with Article 9(1)(a), in which case
the application shall be regarded as valid, and examine
whether the substance complies with the safety criteria laid
down in Article 3 and, where they apply, Article 4;

(b)

inform the applicant, the Commission and the Member States
if an application is not valid.

In the event of an opinion in favour of authorising the

4.
evaluated substance, the opinion shall include:

(a)

the designation of the substance including its specifications;

and

(b) where appropriate, recommendations for any conditions or
restrictions of use for the evaluated substance and/or the
material or article in which it is used;

and

3.
Community authorisation in the form of a specific measure,
as referred to in paragraph 1, shall be adopted in accordance with
the procedure referred to in Article 23(2).

4.
After the authorisation of a substance in accordance with
this Regulation, any business operator using the authorised sub-
stance or materials or articles containing the authorised substance
shall comply with any condition or restriction attached to such
authorisation.

5.
The applicant or any business operator using the authorised
substance or materials or articles containing the authorised sub-
stance shall immediately inform the Commission of any new sci-
entific or technical information, which might affect the safety
assessment of the authorised substance in relation to human
health.
then review the
assessment.

the Authority shall

If necessary,

6.
The granting of an authorisation shall not affect the general
civil and criminal liability of any business operator in respect of
the authorised substance, the material or article containing the
authorised substance, and the food that is in contact with such
material or article.

(c) an assessment as to whether the analytical method proposed

is appropriate for the intended control purposes.

Article 12

Modification, suspension and revocation of authorisation

The Authority shall forward its opinion to the Commission,

5.
the Member States and the applicant.

6.
The Authority shall make its opinion public, after deletion
of any information identified as confidential, in accordance with
Article 20.

1.
The applicant or any business operator using the authorised
substance or materials or articles containing the authorised sub-
stance may,
in accordance with the procedure laid down in
Article 9(1), apply for modification of the existing authorisation.

2.

The application shall be accompanied by the following:

Article 11

Community authorisation

(a) a reference to the original application;

1.
The Community authorisation of a substance or substances
shall take place in the form of the adoption of a specific measure.
The Commission shall, where appropriate, prepare a draft of a
specific measure, as referred to in Article 5, to authorise the sub-
stance or substances evaluated by the Authority and specify or
change the conditions of its or their use.

(b) a technical dossier containing the new information in accor-

dance with the guidelines referred to in Article 9(2);

(c) a new complete summary of the technical dossier in a stan-

dardised form.

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On its own initiative or following a request from a Member
3.
State or the Commission, the Authority shall evaluate whether the
opinion or the authorisation is still in accordance with this Regu-
lation, in accordance with the procedure laid down in Article 10,
where applicable. The Authority may, where necessary, consult
the applicant.

The Commission shall examine the opinion of the Author-
4.
ity without delay and prepare a draft specific measure to be taken.

Article 15

Labelling

1. Without prejudice to the specific measures referred to in
Article 5, materials and articles, which are not yet in contact with
food when placed on the market, shall be accompanied by:

(a)

the words ‘for food contact’, or a specific indication as to
their use, such as coffee machine, wine bottle, soup spoon, or
the symbol reproduced in Annex II;

A draft specific measure modifying an authorisation shall
5.
specify any necessary changes in the conditions of use and, if any,
in the restrictions attached to that authorisation.

and

6.
A final specific measure on the modification, suspension or
revocation of the authorisation shall be adopted in accordance
with the procedure referred to in Article 23(2).

(b)

if necessary, special instructions to be observed for safe and
appropriate use;

and

Article 13

Competent authorities of Member States

(c)

the name or trade name and, in either case, the address or
registered office of the manufacturer, processor, or seller
responsible for placing on the market established within the
Community;

Each Member State shall notify to the Commission and to the
Authority the name and address, as well as a contact point, of the
national competent authority or authorities designated to be
responsible in its territory for receiving the application for autho-
risation referred to in Articles 9 to 12. The Commission shall pub-
lish the name and address of the national competent authorities
as well as the contact points notified in accordance with this
Article.

and

(d) adequate labelling or identification to ensure traceability of

the material or article, as described in Article 17;

and

Article 14

Administrative review

Any act adopted under, or failure to exercise, the powers vested
in the Authority by this Regulation may be reviewed by the Com-
mission on its own initiative or in response to a request from a
Member State or from any person directly and individually
concerned.

To this effect a request shall be submitted to the Commission
within two months from the day on which the party concerned
became aware of the act or omission in question.

(e)

in the case of active materials and articles, information on the
permitted use or uses and other relevant information such as
the name and quantity of the substances released by the active
component so as to enable food business operators who use
these materials and articles to comply with any other relevant
Community provisions or, in their absence, national provi-
sions applicable to food, including the provisions on food
labelling.

2.
The information referred to in paragraph 1(a) shall not,
however, be obligatory for any articles which, because of their
characteristics, are clearly intended to come into contact with
food.

The information required by paragraph 1 shall be conspicu-

3.
ous, clearly legible and indelible.

The Commission shall take a decision within two months requir-
ing, if appropriate, the Authority to undo its act or to remedy its
failure to act.

4.
Retail trade in materials and articles shall be prohibited if the
information required under paragraph (1)(a), (b) and (e) is not
given in a language easily understood by purchasers.

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5. Within its own territory, the Member State in which the
material or article is marketed may, in accordance with the rules
of the Treaty, stipulate that those labelling particulars shall be
given in one or more languages which it shall determine from
among the official languages of the Community.

Paragraphs 4 and 5 shall not preclude the labelling particu-

6.
lars from being indicated in several languages.

At the retail stage, the information required under para-

7.
graph 1 shall be displayed on:

(a)

the materials and articles or on their packaging;

or

(b)

labels affixed to the materials and articles or to their
packaging;

or

(c) a notice in the immediate vicinity of the materials and articles
and clearly visible to purchasers; for the information referred
to in paragraph 1(c), however, this option shall be open only
if, for technical reasons, that information or a label bearing it
cannot be affixed to the materials and articles at either the
manufacturing or the marketing stage.

At the marketing stages other than the retail stage, the infor-

8.
mation required by paragraph 1 shall be displayed on:

(a)

the accompanying documents;

or

(b)

the labels or packaging;

or

(c)

the materials and articles themselves.

The information provided for in paragraph 1(a), (b) and (e)

9.
shall be confined to materials and articles which comply with:

(a)

the criteria laid down in Article 3 and, where they apply,
Article 4;

and

Article 16

Declaration of compliance

The specific measures referred to in Article 5 shall require
1.
that materials and articles covered by those measures be accom-
panied by a written declaration stating that they comply with the
rules applicable to them.

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

2.
In the absence of specific measures, this Regulation shall not
prevent Member States from retaining or adopting national pro-
visions for declarations of compliance for materials and articles.

Article 17

Traceability

1.
The traceability of materials and articles shall be ensured at
all stages in order to facilitate control, the recall of defective prod-
ucts, consumer information and the attribution of responsibility.

2. With due regard to technological feasibility, business opera-
tors shall have in place systems and procedures to allow identifi-
cation of the businesses from which and to which materials or
articles and, where appropriate, substances or products covered
by this Regulation and its implementing measures used in their
manufacture are supplied. That information shall be made avail-
able to the competent authorities on demand.

3.
The materials and articles which are placed on the market
in the Community shall be identifiable by an appropriate system
which allows their traceability by means of labelling or relevant
documentation or information.

Article 18

Safeguard measures

1. When a Member State, as a result of new information or a
reassessment of existing information has detailed grounds for
concluding that the use of a material or article endangers human
health, although it complies with the relevant specific measures,
it may temporarily suspend or restrict application of the provi-
sions in question within its territory.

(b)

the specific measures referred to in Article 5 or, in their
absence, with any national provisions applicable to these
materials and articles.

It shall immediately inform the other Member States and the
Commission and give reasons for the suspension or restriction.

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The Commission shall examine as soon as possible, where
2.
appropriate after obtaining an opinion from the Authority, within
the Committee referred to in Article 23(1) the grounds adduced
by the Member State referred to in paragraph 1 and shall deliver
its opinion without delay and take appropriate measures.

The Commission, the Authority and the Member States shall
5.
take the necessary measures to ensure appropriate confidentiality
of the information received by them under this Regulation, except
for information which must be made public if circumstances so
require in order to protect human health.

3.
If the Commission considers that amendments to the rel-
evant specific measures are necessary in order to remedy the dif-
ficulties referred to in paragraph 1 and to ensure the protection
of human health, those amendments shall be adopted in accor-
dance with the procedure referred to in Article 23(2).

4.
The Member State referred to in paragraph 1 may retain the
suspension or restriction until the amendments referred to in
paragraph 3 have been adopted or the Commission has declined
to adopt such amendments.

Article 19

Public access

Applications for authorisation, supplementary information
1.
from applicants and opinions from the Authority, excluding con-
fidential information, shall be made accessible to the public in
accordance with Articles 38, 39 and 41 of Regulation (EC) No
178/2002.

2. Member States shall process applications for access to docu-
ments received under this Regulation in accordance with Article 5
of Regulation (EC) No 1049/2001.

Article 20

Confidentiality

1.
The applicant may indicate which information submitted
under Articles 9(1), 10(2) and 12(2) is to be treated as confiden-
tial on the ground that its disclosure might significantly harm its
competitive position. Verifiable justification must be given in such
cases.

6.
If an applicant withdraws or has withdrawn an application,
the Authority, the Commission and the Member States shall
respect the confidentiality of commercial and industrial informa-
tion provided, including research and development information
as well as information on which the Commission and the appli-
cant disagree as to its confidentiality.

Article 21

Sharing of existing data

Information given in an application submitted in accordance with
Articles 9(1), 10(2) and 12(2) may be used for the benefit of
another applicant, provided that the Authority considered that the
substance is the same as the one for which the original applica-
tion was submitted, including the degree of purity and the nature
of impurities, and that the other applicant has agreed with the
original applicant that such information may be used.

Article 22

Amendments to Annexes I and II

Amendments to Annexes I and II shall be adopted in accordance
with the procedure referred to in Article 23(2).

Article 23

Committee procedure

The Commission shall be assisted by the Standing Commit-
1.
tee on the Food Chain and Animal Health instituted by Article
58(1) of Regulation (EC) No 178/2002.

Information relating to the following shall not be consid-

2.
ered confidential:

2. Where reference is made to this paragraph, Articles 5 and 7
of Decision 1999/468/EC shall apply, having regard to the pro-
visions of Article 8 thereof.

(a)

the name and address of the applicant and the chemical name
of the substance;

The period laid down in Article 5(6) of Decision 1999/468/EC
shall be set at three months.

(b)

information of direct relevance to the assessment of the safety
of the substance;

3.

The Committee shall adopt its rules of procedure.

(c)

the analytical method or methods.

The Commission shall determine, after consultation with
3.
the applicant, which information should be kept confidential and
shall inform the applicant and the Authority of its decision.

The Authority shall supply the Commission and the Mem-

4.
ber States with all information in its possession on request.

Article 24

Inspection and control measures

1. Member States shall carry out official controls in order to
enforce compliance with this Regulation in accordance with rel-
evant provisions of Community law relating to official food and
feed controls.

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2. Where necessary and on the request of the Commission, the
Authority shall assist in developing technical guidance on sam-
pling and testing to facilitate a coordinated approach for the
application of paragraph 1.

3.
The Community reference laboratory for materials and
articles intended to come into contact with food and national ref-
erence laboratories established as laid down in Regulation (EC)
No 882/2004 shall assist Member States in the application of
paragraph 1 by contributing to a high quality and uniformity of
analytical results.

Article 26

Repeals

Directives 80/590/EEC and 89/109/EEC are repealed.

References to the repealed Directives shall be construed as refer-
ences to this Regulation and shall be read in accordance with the
correlation table in Annex III.

Article 27

Transitional arrangements

Article 25

Sanctions

Materials and articles that have been lawfully placed on the mar-
ket before 3 December 2004 may be marketed until the stocks are
exhausted.

Member States shall lay down the rules on sanctions applicable to
infringements of the provisions of this Regulation and shall take
all measures necessary to ensure that they are implemented. The
sanctions provided for must be effective, proportionate and dis-
suasive. Member States shall communicate the relevant provisions
to the Commission by 13 May 2005 and shall communicate to it
without delay any subsequent amendment affecting them.

Article 28

Entry into force

This Regulation shall enter into force on the 20 th day following
that of its publication in the Official Journal of the European Union.

Article 17 shall apply from 27 October 2006.

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

Done at Strasbourg, 27 October 2004.

For the European Parliament
J. BORRELL FONTELLES
For the Council

The President
A. NICOLAI
The President

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List of groups of materials and articles which may be covered by specific measures

ANNEX I

1. Active and intelligent materials and articles

2. Adhesives

3.

4.

5.

Ceramics

Cork

Rubbers

6. Glass

7.

Ion-exchange resins

8. Metals and alloys

9.

Paper and board

10. Plastics

11. Printing inks

12. Regenerated cellulose

13. Silicones

14. Textiles

15. Varnishes and coatings

16. Waxes

17. Wood

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ANNEX II

Symbol

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ANNEX III

Correlation table

Directive 89/109/EEC

This Regulation

Article 1

—

Article 2

—

Article 3

—

—

—

—

—

—

—

—

Article 4

Article 6

—

—

Article 5

Article 7

—

—

—

—

Article 8

Article 9

—

—

—

Article 10

—

Article 11

Article 12

Article 13

Annex I

Annex II

Annex III

Article 1

Article 2

Article 3

Article 4

Article 5

Article 7

Article 8

Article 9

Article 10

Article 11

Article 12

Article 13

Article 14

—

Article 15

Article 16

Article 17

Article 18

Article 6

Article 19

Article 20

Article 21

Article 22

—

Article 23

Article 24

Article 25

Article 26

Article 27

—

—

Article 28

Annex I

—

Annex III

Directive 80/590/EEC

Annex

This Regulation

Annex II