are intended to be brought into contact with food;

or

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

or

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.

materials and articles which are supplied as antiques;

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;

fixed public or private water supply equipment.

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

‘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.

‘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;

‘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;

‘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;

‘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.

endanger human health;

or

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

or

bring about a deterioration in the organoleptic characteristics thereof.

an application shall be submitted to the competent authority of a Member State accompanied by the following:

the competent authority referred to in (a) shall:

the Authority shall without delay:

verify that the information and documents submitted by the applicant are in accordance with Article 9(1)(a), in which case the application shall be regarded as valid, and examine whether the substance complies with the safety criteria laid down in Article 3 and, where they apply, Article 4;

inform the applicant, the Commission and the Member States if an application is not valid.

the designation of the substance including its specifications;

and

where appropriate, recommendations for any conditions or restrictions of use for the evaluated substance and/or the material or article in which it is used;

and

an assessment as to whether the analytical method proposed is appropriate for the intended control purposes.

a reference to the original application;

a technical dossier containing the new information in accordance with the guidelines referred to in Article 9(2);

a new complete summary of the technical dossier in a standardised form.

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;

and

if necessary, special instructions to be observed for safe and appropriate use;

and

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

adequate labelling or identification to ensure traceability of the material or article, as described in Article 17;

and

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.

the materials and articles or on their packaging;

or

labels affixed to the materials and articles or to their packaging;

or

a notice in the immediate vicinity of the materials and articles and clearly visible to purchasers; for the information referred to in paragraph 1(c), however, this option shall be open only if, for technical reasons, that information or a label bearing it cannot be affixed to the materials and articles at either the manufacturing or the marketing stage.

the accompanying documents;

or

the labels or packaging;

or

the materials and articles themselves.

the criteria laid down in Article 3 and, where they apply, Article 4;

and

the specific measures referred to in Article 5 or, in their absence, with any national provisions applicable to these materials and articles.

the applicant may submit a request to treat certain parts of the information submitted under this Regulation as confidential, accompanied by verifiable justification; and

the Authority shall assess the confidentiality request submitted by the applicant.

any information provided in detailed descriptions of starting substances and mixtures used to manufacture the substance subject to the authorisation, the composition of mixtures, materials or articles in which the applicant intends to use that substance, the manufacturing methods of those mixtures, materials or articles, impurities, and migration testing results, except for information which is relevant to the assessment of safety;

the trademark under which the substance shall be marketed as well as the tradename of the mixtures, material or articles in which it shall be used, where applicable; and

any other information deemed confidential within the specific procedural rules referred to in point (n) of Article 5(1) of this Regulation.