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 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.

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:

1. are intended to be brought into contact with food;

   or

2. are already in contact with food and were intended for that purpose;

   or

3. 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:

1. materials and articles which are supplied as antiques;

2. 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;

3. fixed public or private water supply equipment.

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:

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

2. ‘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:

1. ‘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;

2. ‘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;

3. ‘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;

4. ‘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.

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:

1. endanger human health;

   or

2. bring about an unacceptable change in the composition of the food;

   or

3. bring about a deterioration in the organoleptic characteristics thereof.

The labelling, advertising and presentation of a material or article shall not mislead the consumers.

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.

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⁾.

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.

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

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.

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

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.

Those specific measures may include:

1. a list of substances authorised for use in the manufacturing of materials and articles;

2. 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;

3. purity standards for substances referred to in (a);

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

5. 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;

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

7. provisions aimed at protecting human health against hazards arising from oral contact with materials and articles;

8. other rules to ensure compliance with Articles 3 and 4;

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

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

11. 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;

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

13. provisions requiring the Commission to establish and maintain a publicly available Community Register (Register) of authorised substances, processes, or materials or articles;

14. 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).

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).