ANNEX VIISupplementary provisions
ANNEX VII ‘ANNEX VIa DECLARATION OF COMPLIANCE The written declaration referred to in Article 9 shall contain the following information: (1) the identity and address of the business operator which manufactures or imports the plastic materials or articles or the substances intended for the manufacturing of those materials and articles; (2) the identity of the materials, the articles or the substances intended for the manufacturing of those materials and articles; (3) the date of the declaration; (4) confirmation that the plastic materials or articles meet relevant requirements laid down in this Directive and Regulation (EC) No 1935/2004; (5) adequate information relative to the substances used for which restrictions and/or specifications are in place under this Directive to allow the downstream business operators to ensure compliance with those restrictions; (6) 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 95/31/EC, 95/45/EC and 96/77/EC to enable the user of these materials or articles to comply with the relevant Community provisions or, in their absence, with national provisions applicable to food; (7) 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; (8) when a plastic functional barrier is used in a plastic multi-layer material or article, the confirmation that the material or article complies with the requirements of Article 7a(2), (3) and 4 of this Directive. The written declaration shall permit an easy identification of the materials, articles or substances for which it is issued and shall be renewed when substantial changes in the production bring about changes in the migration or when new scientific data are available.’