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

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.

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

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.

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.

Article 3

General requirements

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.

Article 4

Special requirements for active and intelligent materials and articles

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

Article 5

Specific measures for groups of materials and articles

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.

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).

Article 6

National specific measures

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

Article 7

Role of the European Food Safety Authority

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

Article 8

General requirements for the authorisation of substances

Article 9

Application for authorisation of a new substance

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: (i) inform the Commission and the other Member States of the application and shall make the application and any supplementary 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.

Article 10

Opinion of the Authority

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.

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.

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.

Article 11

Community authorisation

Article 12

Modification, suspension and revocation of authorisation

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.

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

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.

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.

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.

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

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

Article 17

Traceability

Article 18

Safeguard measures

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

Article 19

Public access

Article 20

Confidentiality

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, accompanied by verifiable justification; and

(b) the Authority shall assess the confidentiality request submitted by the applicant.

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.

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.

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).

Article 23

Committee procedure

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

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.

Article 24

Inspection and control measures

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.

ANNEX I