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

1. (1)

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

2. (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. (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. (4)

   the date of the declaration;

5. (5)

   F1confirmation that the plastic materials or articles, products from intermediate stages of manufacture or the substances meet the relevant requirements laid down in this Regulation and in Article 3, 11(5), 15 and 17 of Regulation (EC) No 1935/2004;

6. (6)

   F2adequate information relative to the substances used or products of degradation thereof for which restrictions and/or specifications are set out in Annex I and II to the Regulation to allow the downstream business operators to ensure compliance with the Regulation.

   At intermediate stages, this information shall include the identification and amount of substances in the intermediate material,

   • that are subject to restrictions in Annex II, or

   • for which genotoxicity has not been ruled out, and which originate from an intentional use during a manufacturing stage of that intermediate material and which could be present in an amount that foreseeably gives rise to a migration from the final material exceeding 0,00015 mg/kg food or food simulant;

7. (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 F4... provisions applicable to food;

8. (8)

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

   1. (i)

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

   2. (ii)

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

   3. (iii)

      F3the highest food contact surface area to volume ratio for which compliance has been verified in accordance with Article 17 and 18 or equivalent information;

9. (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.