02004R1935 — EN — 27.03.2021 — 002.

001 — 1

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►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
►M2 Regulation (EU) 2019/1381 of the European Parliament and of the L 231 1 6.9.2019
Council of 20 June 2019
 02004R1935 — EN — 27.03.2021 — 002.001 — 2

▼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

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.
 02004R1935 — EN — 27.03.2021 — 002.001 — 3

▼B
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
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 implemen­
ting measures, or, if no Community provisions exist, with the national
provisions applicable to food.
 02004R1935 — EN — 27.03.2021 — 002.001 — 4

▼B
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.

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.

▼B
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;

(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).
 02004R1935 — EN — 27.03.2021 — 002.001 — 5

▼B
(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.

▼M1
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).
 02004R1935 — EN — 27.03.2021 — 002.001 — 6

▼B
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;

(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;
 02004R1935 — EN — 27.03.2021 — 002.001 — 7

▼M2
(c) the Authority shall without delay:

(i) inform the Commission and the other Member States of the
application and shall make the application and any supple­
mentary information supplied by the applicant available to
them; and

(ii) make public the application, relevant supporting information

and any supplementary information supplied by the applicant,
in accordance with Articles 19 and 20.

2. The Authority shall publish detailed guidelines, following the

agreement with the Commission, concerning the preparation and the
submission of the application, taking into account standard data
formats, where they exist in accordance with Article 39f of Regulation
(EC) No 178/2002, which shall apply mutatis mutandis.

▼B

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;

and

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

appropriate for the intended control purposes.
 02004R1935 — EN — 27.03.2021 — 002.001 — 8

▼B
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).

▼B
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 auth­
orised 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.
 02004R1935 — EN — 27.03.2021 — 002.001 — 9

▼B
2. The application shall be accompanied by the following:

(a) a reference to the original application;

(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.
 02004R1935 — EN — 27.03.2021 — 002.001 — 10

▼B
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;

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
 02004R1935 — EN — 27.03.2021 — 002.001 — 11

▼B
(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

(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.
 02004R1935 — EN — 27.03.2021 — 002.001 — 12

▼B
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.

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

▼M2
1. The Authority shall make public the application for authorisation,
relevant supporting information and any supplementary information
supplied by the applicant, as well as its scientific opinions, in
accordance with Articles 38 to 39e of Regulation (EC) No 178/2002,
which shall apply mutatis mutandis, and with Article 20 of this Regu­
lation.

▼B
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.

▼M2
Article 20
Confidentiality

1. In accordance with the conditions and the procedures laid down in

Articles 39 to 39e of Regulation (EC) No 178/2002 and in this Article:

(a) the applicant may submit a request to treat certain parts of the
information submitted under this Regulation as confidential, accom­
panied by verifiable justification; and
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▼M2
(b) the Authority shall assess the confidentiality request submitted by
the applicant.

2. In addition to the items of information referred to in Article 39(2)

of Regulation (EC) No 178/2002 and pursuant to Article 39(3) thereof,
the Authority may also grant confidential treatment with respect to the
following items of information, where the disclosure of such
information is demonstrated by the applicant to potentially harm its
interests to a significant degree:

(a) any information provided in detailed descriptions of starting

substances and mixtures used to manufacture the substance
subject to the authorisation, the composition of mixtures, materials
or articles in which the applicant intends to use that substance, the
manufacturing methods of those mixtures, materials or articles,
impurities, and migration testing results, except for information
which is relevant to the assessment of safety;

(b) the trademark under which the substance shall be marketed as well
as the tradename of the mixtures, material or articles in which it
shall be used, where applicable; and

(c) any other information deemed confidential within the specific

procedural rules referred to in point (n) of Article 5(1) of this
Regulation.

3. This Article is without prejudice to Article 41 of Regulation (EC)

No 178/2002.

▼B

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
information may be used.

▼M1
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).

▼B

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

▼M1
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.

▼B

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.

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.
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▼B
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.
 02004R1935 — EN — 27.03.2021 — 002.001 — 16

▼B
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
 02004R1935 — EN — 27.03.2021 — 002.001 — 17

▼B
ANNEX II

Symbol
 02004R1935 — EN — 27.03.2021 — 002.001 — 18

▼B
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