Presentation
Regulation (EC) no. 1935/2004 replaced directive no. 89/109/EEC and directive no. 80/590/EEC as of 3/12/2004. It applies to materials and articles which, in their finished state, are intended to be brought into contact or are brought into contact, in accordance with their intended purpose, with foodstuffs or with water intended for human consumption. It does not apply to fixed installations, public or private, used for the distribution of water, nor to antiques.
Regulation 1935/2004 introduces the principle of inertia (article 3): Materials and articles must be manufactured in accordance with good manufacturing practice so that, under normal or foreseeable conditions of use, they do not transfer to foodstuffs constituents in a quantity likely to:
- be hazardous to human health,
- lead to an unacceptable change in the composition of the foodstuffs or an alteration in their organoleptic characteristics.
The Regulation lists the inertness criteria which may apply to a category of materials, and which will be specified in specific directives or regulations (positive lists of authorized constituents, purity criteria applicable to some of these constituents, special conditions of use, specific migration limits, overall migration limits, measures concerning oral contact) as well as procedures relating to sampling and methods of analysis.
The groups of materials and objects subject to specific guidelines are as follows:
Plastics including varnishes and coatings
- Regenerated cellulose
- Elastomers and rubber
- Paper and cardboard
- Ceramics
- Glass
- Metals and alloys
- Wood, including cork
- Textile products
- Paraffin waxes and microcrystalline waxes
- Active materials and objects
- Glues
- Cork
- Ion-exchange resins
- Printing inks
- Silicone
- Varnishes and coatings
The Regulation also lays down rules concerning the authorization of substances in the manufacture of materials, inspection and control arrangements, the labeling of materials and articles and in particular a symbol, the written declaration of conformity, traceability and safeguard measures.
Substance authorization application guidelines
This guide, published by EFSA and dated 30/07/08, consists of the compilation of the following documents:
- The EFSA administrative guide on how to submit a request for assessment;
- The SCF guidelines for food contact materials;
- The CEF-FCM-WG explanatory guide to SCF guidelines for food contact materials;
- The Commission's explanatory guide for migration testing.
This document contains:
- guidelines on submitting an application for the safety assessment of a substance prior to its authorization and subsequent inclusion in the relevant European directives;
- guidelines for requesting the re-evaluation of a substance;
- guidelines for the presentation of technical dossiers accompanying applications;
- an explanation of the criteria used by the AFC Scientific Panel in classifying substances on one of the SCF lists.