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 L338 13/11/2004), as amended, applies to materials and articles, including active and intelligent food contact 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.
Regulation (EC) No. 1935/2004, as amended requires that materials and articles, including active and intelligent materials and articles, are 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.
Annex I of the legislation lists those materials and articles for which specific measures may be adopted by the Commission. Legislation on specific measures for some of these materials and articles have been published. Where a specific measure has not yet been introduced for a given food contact material or article, then it must comply with the general provisions of the framework Regulation. In due course, it is proposed to introduce measures on paper and board, coatings, glass, metal and alloys, wood, including cork, textile products and microcrystalline waxes.
The labelling, advertising and presentation of a material or article must not mislead the consumers. Article 15 of Regulation (EC) No. 1935/2004, as amended sets out specific labelling requirements for materials and articles which are not yet in contact with food when placed on the market. It requires that they must be accompanied by:
1. 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 of Regulation (EC) No. 1935/2004, as amended; and
2. if necessary, special instructions to be observed for safe and appropriate use; and
3. 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
4. adequate labelling or identification to ensure traceability of the material or article, as described in Article 17 of Regulation (EC) No. 1935/2004, as amended; and
5. 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.
However, the information referred to in point (1) above is not obligatory for any articles which, because of their characteristics, are clearly intended to come into contact with food.
Regulation (EC) No. 2023/2006 of 22 December 2006 of good manufacturing practice for materials and articles intended to come into contact with food (OJ L384, 29/12/2006), as amended lays down the rules on good manufacturing practice (GMP) for the groups of materials and articles intended to come into contact with food listed in Annex I to Regulation (EC) No. 1935/2004, as amended and combinations of those materials and articles or recycled materials and articles used in those materials and articles. It applies to all sectors and to all stages of manufacture, processing and distribution of materials and articles, up to but excluding the production of starting substances.
European Union (Plastics and other materials) (Contact with food) Regulations 2017 (S.I. No. 49 of 2017). The amendments to this Regulation can found in the following Statutory Instruments (S.I. No. 257 of 2018, S.I. No. 278 of 2019)
In addition to giving full effect to Regulation (EC) No. 1935/2004, as amended, S.I. No. 587 of 2007 and its' amendments set out the requirements regarding the importation and sale of materials intended to come into contact with food, the descriptions which must accompany them and specifies labelling requirements when materials and articles are sold for food contact use but are not already in contact with food.
We have a range of resources available to help you comply with the requirements of the Food Contact Materials legislation.
- Factsheet on Food Contact Materials
- Diamond of Compliance: a quick check list developed by the FSAI to help you assess the compliance of a FCM with Regulation 1935/2004
- Use EASY DoC, a job aid created by the FSAI that will help you assess Declarations of Compliance (DoCs) for plastic FCMs
- Example of a Declaration of Compliance (DoC) for a plastic
- eLearning module on Food Contact Materials
European Commission website on FCMs - contains useful guidance documents and other resources
European Reference Laboratory for FCMs
European Food Safety Authority website on FCMs - contains useful documents and other resources
European Food Safety Authority webpage on FCM applications procedure