ANNEX IV Declaration of compliance

The written declaration referred to in Article 15 shall contain the following information:

(1)

the identity and address of the business operator issuing the declaration of compliance;

(2)

the identity and address of the business operator which manufactures or imports the plastic materials or articles or products from intermediate stages of their manufacturing or the substances intended for the manufacturing of those materials and articles;

(3)

the identity of the materials, the articles, products from intermediate stages of manufacture or the substances intended for the manufacturing of those materials and articles;

(4)

the date of the declaration;

(5)

confirmation that the plastic materials or articles, products from intermediate stages of manufacture or the substances meet relevant requirements laid down in this Regulation and Regulation (EC) No 1935/2004;

(6)

adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annexes I and II to this Regulation to allow the downstream business operators to ensure compliance with those restrictions;

(7)

adequate information relative to the substances which are subject to a restriction in food, obtained by experimental data or theoretical calculation about the level of their specific migration and, where appropriate, purity criteria in accordance with Directives 2008/60/EC, 95/45/EC and 2008/84/EC to enable the user of these materials or articles to comply with the relevant EU provisions or, in their absence, with national provisions applicable to food;

(8)

specifications on the use of the material or article, such as:

(i)

type or types of food with which it is intended to be put in contact;

(ii)

time and temperature of treatment and storage in contact with the food;

(iii)

ratio of food contact surface area to volume used to establish the compliance of the material or article;

(9)

when a functional barrier is used in a multi-layer material or article, the confirmation that the material or article complies with the requirements of Article 13(2), (3) and (4) or Article 14(2) and (3) of this Regulation.