1.At the marketing stages other than at the retail stage, a written declaration in accordance with Article 16 of Regulation (EC) No 1935/2004 shall be available for plastic materials and articles, products from intermediate stages of their manufacturing as well as for the substances intended for the manufacturing of those materials and articles.
2.The written declaration referred to in paragraph 1 shall be issued by the business operator and shall contain the information laid down in Annex IV.
3.The written declaration shall permit an easy identification of the materials, articles or products from intermediate stages of manufacture or substances for which it is issued. It shall be renewed when substantial changes in the composition or production occur that bring about changes in the migration from the materials or articles or when new scientific data becomes available.
1.Appropriate documentation to demonstrate that the materials and articles, products from intermediate stages of their manufacturing as well as the substances intended for the manufacturing of those materials and articles comply with the requirements of this Regulation shall be made available by the business operator to the F1... competent authorities on request.
2.That documentation shall contain the conditions and results of testing, calculations, including modelling, other analysis, and evidence on the safety or reasoning demonstrating compliance. Rules for experimental demonstration of compliance are set out in Chapter V.
Textual Amendments
F1Word in Art. 16 omitted (31.12.2020) by virtue of The Materials and Articles in Contact with Food (Amendment) (EU Exit) Regulations 2019 (S.I. 2019/704), regs. 1, 73; 2020 c. 1, Sch. 5 para. 1(1)