PURPOSE : 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.
LEGISLATIVE ACT : Regulation 1935/2004/EC of the European Parliament and of the Council on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC.
CONTENT : this Regulation will apply to all materials and articles, including active and intelligent food contact materials, which are intended to be brought into contact with food, are already in contact with food and were intended for that purpose or can reasonable be expected to be brought into contact with food. It does not apply to the covering or coating materials of certain foodstuffs such as cheese rinds, prepared meat products or fruits, which may be part of the food. Nor does it apply to fixed public or private water supply equipment.
As far as the "General Requirements" are concerned materials and articles coming into contact with food must not endanger human health, bring about an unacceptable change in the composition of food or bring about deterioration in the organoleptic characteristics of the food. Changes may only be brought about in the composition of the food on condition that the changes comply with Community provisions.
Certain procedures are foreseen for certain groups of materials and articles. This includes, inter alia, a list of substances authorized for use in the manufacturing of materials and articles, purity standards for substances, or provisions aimed at protecting human health against hazards arising from oral contact with materials and articles.
Other provisions outlined in the Regulation include national specific measures, the role of the European Food Safety Authority, general requirements for the authorization of substances, applications for the authorization of new substances, the Opinion of the Authority, Community authorization, the modification, suspension and revocation of authorization, labeling, the declaration of compliance, safeguard measures, public access, confidentiality, the sharing of existing data, inspection and control measures and lastly sanctions and repeals.
There is also a provision regarding traceability, which states that all materials and articles must be traceable at all stages in order to control the recall of defective products. Business operators must have a system in place to allow for the identification of the businesses from which materials are coming into contact with food. Lastly, materials and articles that have been lawfully placed on the market before 3 December 2003 may be marketed until the stocks are exhausted.
ENTRY INTO FORCE: 03/12/2004. Article 17 (traceability) will be applicable as from 27/10/2006.