2004R1935 — EN — 07.08.2009 — 001.

001 — 1

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B 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
(OJ L 338, 13.11.2004, p. 4)

Amended by:

Official Journal

No page date
►M1 Regulation (EC) No 596/2009 of the European Parliament and of the L 188 14 18.7.2009
Council of 18 June 2009
 2004R1935 — EN — 07.08.2009 — 001.001 — 2

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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

EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, 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 relating to
materials and articles intended to come into contact with food-
stuffs (3) established general principles for eliminating 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 Member 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 material 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 compo-
sition 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 tradi-
tional 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 contact with food. It is therefore

(1) OJ C 117, 30.4.2004, p. 1.

(2) Opinion of the European Parliament of 31 March 2004 (not yet published 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).
 2004R1935 — EN — 07.08.2009 — 001.001 — 3

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necessary, for reasons of clarity and legal certainty, for active and
intelligent food contact 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 delib-
erately 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 tradi-
tionally 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 compo-
sition or the organoleptic properties of the food only if the
changes comply with the Community provisions applicable to
food, such as the provisions of Directive 89/107/EEC (1) 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
surrounding such foods, should be authorised under the relevant
Community provisions applicable to food and also be subject to
other rules which will be established in a specific measure.
In addition, adequate labelling or information should support
users in the safe and correct use of active materials and articles
in compliance with the food legislation, including 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, materials 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 Regulation
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 manufacture. It is
appropriate to establish those restrictions and conditions in

(1) Council Directive 89/107/EEC of 21 December 1988 on the approximation 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 Regulation (EC) No 1882/2003.
 2004R1935 — EN — 07.08.2009 — 001.001 — 4

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specific measures having regard to the technological character-
istics specific to each group of materials and articles.
(11) Pursuant to Regulation (EC) No 178/2002 of the
European 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 authorised
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 prejudice to the relevant
requirements of the Community legislation concerning the regis-
tration, evaluation, authorisation and restriction of chemicals.
(13) Differences between national laws, regulations and administrative
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 competition. An authorisation procedure
should therefore be established at Community level. In order to
ensure harmonised 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 administrative
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 symbol 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 infor-
mation and the attribution of responsibility. Business operators
should at least be able to identify the businesses from which, and
to which, the materials and articles are supplied.
(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 Commission 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

(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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ensure the verification of compliance with feed and food law,
animal health and animal welfare rules (1) to support
developing 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 Parliament and
of the Council of 30 May 2001 regarding public access to
European Parliament, Council and Commission documents (2)
applies to documents held by the Authority.
(22) It is appropriate to protect the investment made by innovators in
gathering the information and data supporting an application
made under this Regulation. In order to avoid unnecessary repe-
tition of studies and in particular animal testing, however, sharing
of data should be permitted provided 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 technological 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 conferred on the Commission (3).
(26) Member States should lay down rules on sanctions applicable to
infringements of the provisions of this Regulation and ensure that
they are implemented. Such sanctions must be effective, propor-
tionate 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 sufficiently
achieved by the Member States because of the differences
between the national laws and provisions and can therefore be
better achieved at Community level, the Community may adopt
measures, in accordance with the principle 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.

(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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(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 func-

tioning 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 providing the basis for
securing a high level of protection of human health and the interests of
consumers.
2. This Regulation shall apply to materials and articles, including
active and intelligent food contact materials and articles, (hereinafter
referred to as materials and articles) which in their finished state:
(a) are intended to be brought into contact with food;
or
(b) are already in contact with food and were intended for that purpose;
or
(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.
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;
(c) fixed public or private water supply equipment.

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) ‘traceability’: the ability to trace and follow a material or article
through all stages of manufacture, processing and distribution;
(b) ‘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:
(a) ‘active food contact materials and articles’ (hereinafter 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 incor-
porate components that would release or absorb substances into or
from the packaged food or the environment surrounding the food;
(b) ‘intelligent food contact materials and articles’ (hereinafter referred
to as intelligent materials and articles) means materials and articles
 2004R1935 — EN — 07.08.2009 — 001.001 — 7

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which monitor the condition of packaged food or the environment
surrounding the food;
(c) ‘business’ means any undertaking, whether for profit or not and
whether public or private, carrying out any of the activities
related to any stage of manufacture, processing and distribution of
materials and articles;
(d) ‘business operator’ means the natural or legal persons responsible
for ensuring that the requirements of this Regulation are met within
the business under their control.

Article 3
General requirements

1. Materials and articles, including active and intelligent materials

and articles, shall be manufactured in compliance with good manufac-
turing practice so that, under normal or foreseeable conditions of use,
they do not transfer their constituents to food in quantities which could:
(a) endanger human health;
or
(b) bring about an unacceptable change in the composition of the food;
or
(c) bring about a deterioration in the organoleptic characteristics
thereof.
2. The labelling, advertising and presentation of a material or article
shall not mislead the consumers.

Article 4
Special requirements for active and intelligent materials and articles

1. In the application of Article 3(1)(b) and 3(1)(c), active materials

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.
2. Pending the adoption of additional rules in a specific measure 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.
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.

(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 Member 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).
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5. Active and intelligent materials and articles already brought into
contact with food shall be adequately labelled to allow identification 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 intel-
ligent.

Article 5
Specific measures for groups of materials and articles

▼M1
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
by the Commission.
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Those specific measures may include:
(a) a list of substances authorised for use in the manufacturing of
materials and articles;
(b) list(s) of authorised substances incorporated in active or intelligent
food contact materials and articles, or list(s) of active or intelligent
materials and articles and, when necessary, special conditions of
use for these substances and/or the materials and articles in which
they are incorporated;
(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;
(i) basic rules for checking compliance with points (a) to (h);
(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;
(l) additional provisions of labelling for active and intelligent materials
and articles;
(m) provisions requiring the Commission to establish and maintain a
publicly available Community Register (Register) of authorised
substances, processes, or materials or articles;
(n) specific procedural rules adapting, as necessary, the procedure
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 decision addressed to an
applicant.
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The specific measures referred to in point (m) shall be adopted by the
Commission in accordance with the regulatory procedure referred to in
Article 23(2).
The specific measures referred to in points (f), (g), (h), (i), (j), (k), (l)
and (n), designed to amend non-essential elements of this Regulation,
shall be adopted in accordance with the regulatory procedure with
scrutiny referred to in Article 23(3).
The specific measures referred to in points (a) to (e), designed to amend
non-essential elements of this Regulation, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in
Article 23(4).
2. The Commission may amend the existing specific directives on
materials and articles. Those measures, designed to amend the non-
essential elements of this Regulation by supplementing it, shall be
adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 23(4).
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Article 6
National specific measures

In the absence of specific measures referred to in Article 5, this Regu-

lation 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 consulting

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 material or article satisfies the
requirements of Article 3 and, where they apply, Article 4.

Article 9
Application for authorisation of a new substance

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

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;
(ii) a technical dossier containing the information specified in the
guidelines for the safety assessment of a substance to be
published by the Authority;
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(iii) a summary of the technical dossier;
(b) the competent authority referred to in (a) shall:
(i) acknowledge receipt of the application in writing to the
applicant within 14 days of its receipt. The acknowledgement
shall state the date of receipt of the application;
(ii) inform the Authority without delay;
and
(iii) make the application and any supplementary information
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 appli-
cation and any supplementary information supplied by the applicant
available to them.
2. The Authority shall publish detailed guidelines concerning 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.
The Authority may extend the said period by a maximum period of a
further six months. In such a case it shall provide an explanation for the
delay to the applicant, the Commission and the Member States.
2. The Authority may, where appropriate, request the applicant to
supplement the particulars accompanying the application within a time
limit specified by the Authority. Where the Authority requests supple-
mentary 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:
(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.
4. In the event of an opinion in favour of authorising the 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;

(1) Pending such publication, applicants may consult the ‘Guidelines of the
Scientific Committee on Food for the presentation of an application 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.
 2004R1935 — EN — 07.08.2009 — 001.001 — 11

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and
(c) an assessment as to whether the analytical method proposed is
appropriate for the intended control purposes.
5. The Authority shall forward its opinion to the Commission, 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.

Article 11
Community authorisation

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 substance or
substances evaluated by the Authority and specify or change the
conditions of its or their use.
2. The draft specific measure shall take into account the opinion of
the Authority, relevant provisions of Community law and other
legitimate factors relevant to the matter under consideration. Where
the draft specific measure is not in accordance with the opinion of
the Authority, the Commission shall provide without delay an expla-
nation 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.
▼M1
3. Community authorisation in the form of specific measure, as
referred to in paragraph 1, shall be adopted by the Commission. That
measure, designed to amend non-essential elements of this Regulation
by supplementing it, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 23(4).
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4. After the authorisation of a substance in accordance with this
Regulation, any business operator using the authorised substance 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 substance
shall immediately inform the Commission of any new scientific or
technical information, which might affect the safety assessment of the
authorised substance in relation to human health. If necessary, the
Authority shall then review the assessment.
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.

Article 12
Modification, suspension and revocation of authorisation

1. The applicant or any business operator using the authorised

substance or materials or articles containing the authorised substance
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:
(a) a reference to the original application;
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(b) a technical dossier containing the new information in accordance
with the guidelines referred to in Article 9(2);

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

form.

3. On its own initiative or following a request from a Member State

or the Commission, the Authority shall evaluate whether the opinion or
the authorisation is still in accordance with this Regulation, in
accordance with the procedure laid down in Article 10,
where applicable. The Authority may, where necessary, consult the
applicant.

4. The Commission shall examine the opinion of the Authority

without delay and prepare a draft specific measure to be taken.

5. A draft specific measure modifying an authorisation shall specify

any necessary changes in the conditions of use and, if any, in the
restrictions attached to that authorisation.

▼M1
6. A final specific measure on the modification, suspension or revo-
cation of the authorisation shall be adopted by the Commission. That
measure, designed to amend non-essential elements of this Regulation
by supplementing it, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 23(4). On imperative
grounds of urgency, the Commission may have recourse to the
urgency procedure referred to in Article 23(5).

▼B

Article 13
Competent authorities of Member States

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 authorisation referred to in
Articles 9 to 12. The Commission shall publish the name and address
of the national competent authorities as well as the contact points
notified in accordance with this Article.

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 Commission 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.

The Commission shall take a decision within two months requiring, if

appropriate, the Authority to undo its act or to remedy its failure to act.

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:
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(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;
and
(b) if necessary, special instructions to be observed for safe and appro-
priate use;
and
(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;
and
(d) adequate labelling or identification to ensure traceability of the
material or article, as described in Article 17;
and
(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 provisions 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.
3. The information required by paragraph 1 shall be conspicuous,
clearly legible and indelible.
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.
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.
6. Paragraphs 4 and 5 shall not preclude the labelling particulars
from being indicated in several languages.
7. At the retail stage, the information required under paragraph 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.
8. At the marketing stages other than the retail stage, the information
required by paragraph 1 shall be displayed on:
(a) the accompanying documents;
or
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(b) the labels or packaging;
or
(c) the materials and articles themselves.
9. The information provided for in paragraph 1(a), (b) and (e) 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
(b) the specific measures referred to in Article 5 or, in their absence,
with any national provisions applicable to these materials and
articles.

Article 16
Declaration of compliance

1. The specific measures referred to in Article 5 shall require that

materials and articles covered by those measures be accompanied 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 provisions
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 products,
consumer information and the attribution of responsibility.
2. With due regard to technological feasibility, business operators
shall have in place systems and procedures to allow identification 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 available 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 reas-

sessment 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 provisions in question within its
territory.
It shall immediately inform the other Member States and the
Commission and give reasons for the suspension or restriction.
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2. The Commission shall examine as soon as possible, where appro-
priate 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.
3. If the Commission considers that amendments to the relevant
specific measures are necessary in order to remedy the difficulties
referred to in paragraph 1 and to ensure the protection of human
health, those amendments shall be adopted in accordance 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

1. Applications for authorisation, supplementary information from

applicants and opinions from the Authority, excluding confidential
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 documents
received under this Regulation in accordance with Article 5 of Regu-
lation (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 confidential on the
ground that its disclosure might significantly harm its competitive
position. Verifiable justification must be given in such cases.
2. Information relating to the following shall not be considered confi-
dential:
(a) the name and address of the applicant and the chemical name of the
substance;
(b) information of direct relevance to the assessment of the safety of the
substance;
(c) the analytical method or methods.
3. The Commission shall determine, after consultation with the
applicant, which information should be kept confidential and shall
inform the applicant and the Authority of its decision.
4. The Authority shall supply the Commission and the Member
States with all information in its possession on request.
5. The Commission, the Authority and the Member States shall take
the necessary measures to ensure appropriate confidentiality of the infor-
mation received by them under this Regulation, except for information
which must be made public if circumstances so require in order to
protect human health.
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 information provided,
including research and development information as well as information
on which the Commission and the applicant disagree as to its confiden-
tiality.
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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 application 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 infor-
mation may be used.
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Article 22

Amendments to Annexes I and II shall be adopted by the Commission.

Those measures, designed to amend non-essential elements of this
Regulation, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 23(3).
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Article 23
Committee procedure

1. The Commission shall be assisted by the Standing Committee on

the Food Chain and Animal Health instituted by Article 58(1) of Regu-
lation (EC) No 178/2002.
2. Where reference is made to this paragraph, Articles 5 and 7 of
Decision 1999/468/EC shall apply, having regard to the provisions of
Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.
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3. Where reference is made to this paragraph, Article 5a(1) to (4) and
Article 7 of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.
4. Where reference is made to this paragraph, Article 5a(1) to (4) and
(5)(b) and Article 7 of Decision 1999/468/EC shall apply, having regard
to the provisions of Article 8 thereof.
The time-limits laid down in Article 5a(3)(c), (4)(b) and (4(e) of
Decision 1999/468/EC shall be set at two months, one month and
two months respectively.
5. Where reference is made to this paragraph, Article 5a(1), (2), (4)
and (6) and Article 7 of Decision 1999/468/EC shall apply, having
regard to the provisions of Article 8 thereof.
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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 relevant provisions
of Community law relating to official food and feed controls.
2. Where necessary and on the request of the Commission, the
Authority shall assist in developing technical guidance on sampling
and testing to facilitate a coordinated approach for the application of
paragraph 1.
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3. The Community reference laboratory for materials and articles
intended to come into contact with food and national reference labora-
tories 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 25
Sanctions

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 dissuasive.
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 26
Repeals

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

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

Article 27
Transitional arrangements

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

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.
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ANNEX I
List of groups of materials and articles which may be covered by specific
measures
1. Active and intelligent materials and articles
2. Adhesives
3. Ceramics
4. Cork
5. 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 1
— Article 2
Article 2 Article 3
— Article 4
Article 3 Article 5
— Article 7
— Article 8
— Article 9
— Article 10
— Article 11
— Article 12
— Article 13
— Article 14
Article 4 —
Article 6 Article 15
— Article 16
— Article 17
Article 5 Article 18
Article 7 Article 6
— Article 19
— Article 20
— Article 21
— Article 22
Article 8 —
Article 9 Article 23
— Article 24
—
— Article 25
Article 10 Article 26
— Article 27
Article 11 —
Article 12 —

Article 13 Article 28
Annex I Annex I
Annex II —
Annex III Annex III

Directive 80/590/EEC This Regulation

Annex Annex II