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This Regulation shall apply to materials and articles, includ-
ing active and intelligent food contact materials and articles, (here-
inafter referred to as materials and articles) which in their finished
(a) are intended to be brought into contact with food;
(b) are already in contact with food and were intended for that
(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
(c) fixed public or private water supply equipment.
Article 2
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
(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 pack-
aged food or the environment surrounding the food;
(b) `intelligent food contact materials and articles' (hereinafter
referred to as intelligent materials and articles) means mate-
rials and articles which monitor the condition of pack-
aged 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 activi-
ties related to any stage of manufacture, processing and dis-
tribution of materials and articles;
(d) `business operator' means the natural or legal persons respon-
sible 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 mate-
rials and articles, shall be manufactured in compliance with good
manufacturing practice so that, under normal or foreseeable con-
ditions of use, they do not transfer their constituents to food in
quantities which could:
(a) endanger human health;
(b) bring about an unacceptable change in the composition of
the food;
(c) bring about a deterioration in the organoleptic characteris-
tics thereof.
The labelling, advertising and presentation of a material or
article shall not mislead the consumers.
Article 4
Special requirements for active and intelligent materials
and articles
In the application of Article 3(1)(b) and 3(1)(c), active mate-
rials 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.
Official Journal of the European Union
L 338/7