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,

Whereas:

specific groups of materials and articles (specific directives).

This approach was successful and should be continued.

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.

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 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.

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.

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 the Official Journal) and Council Decision of 14 October 2004.

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.

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.

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.

they are available in restricted quantities and their contact with food is therefore limited.

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 appropriate to establish those restrictions and conditions in specific measures having regard to the technological characteristics specific to each group of materials and articles.

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 registration, evaluation, authorisation

and restriction of chemicals.

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.

Business operators should at least be able to identify the businesses from which, and to which, the materials and articles are supplied.

1642/2003 (OJ L 245, 29.9.2003, p. 4).

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

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 ensure the

verification of compliance with feed and food law, animal

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.

safeguard measures in situations where a material or article

is likely to constitute a serious risk to human health.

and of the Council of 30 May 2001 regarding public

access to European Parliament, Council and Commission

Authority.

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 provided

there is agreement between the interested parties.

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.

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.

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

to infringements of the provisions of this Regulation

and ensure that they are implemented. Such sanctions

must be effective, proportionate and dissuasive.

to adapt to some of the requirements established by this

Regulation.

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.

be repealed,

HAVE ADOPTED THIS REGULATION:

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 providing

the basis for securing a high level of protection of human

health and the interests of consumers.

28.5.2004, p. 1.

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.

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 incorporate 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.

1. Materials and articles, including active and intelligent materials

and articles, shall be manufactured in compliance with good

manufacturing 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.

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

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 intelligent.

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:

(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;

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).

(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.

2. Existing specific directives on materials and articles shall be

amended in accordance with the procedure laid down in

Article 23(2).

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.

Provisions liable to affect public health shall be adopted after consulting

the European Food Safety Authority, hereinafter referred

to as ‘the Authority’.

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.

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;

(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.

2. The Authority shall publish detailed guidelines concerning

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.

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.

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 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:

(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.

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.

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 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.

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 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.

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;

(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.

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).

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.

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.

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

appropriate 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

(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.

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.

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.

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 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

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.

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.

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 Regulation (EC) No 1049/2001.

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

confidential:

(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 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.

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 confidentiality.

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.

Amendments to Annexes I and II shall be adopted in accordance

with the procedure referred to in Article 23(2).

1. The Commission shall be assisted by the Standing Committee

on the Food Chain and Animal Health instituted by Article

58(1) of Regulation (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.

3. The Committee shall adopt its rules of procedure.

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

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.

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.

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.

Materials and articles that have been lawfully placed on the market

before 3 December 2004 may be marketed until the stocks are

exhausted.

This Regulation shall enter into force on the 20 th day following

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.

J. BORRELL FONTELLES

A. NICOLAI

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

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