In accordance with Article 16(1) of Regulation (EC) No 1935/2004, business operators shall ensure that varnished or coated materials and articles are accompanied by a written declaration of compliance containing the information laid down in Annex I to this Regulation. The declaration shall be available at all stages of manufacture, processing and distribution other than the retail stage.

The written declaration shall permit an easy identification of the varnished or coated materials and articles to which it applies. It shall be renewed to reflect any changes in migration levels from the varnish or coating that has been applied to materials and articles.

Business operators shall, upon request of a F1... competent authority, make available appropriate supporting documentation to demonstrate compliance with the written declaration referred to in paragraph 1. Such supporting documentation shall be provided without delay and in any event not later than 10 days following receipt of the request. The documentation shall contain the conditions and results of the testing, calculations, including modelling, other analysis and evidence on the safety or reasoning demonstrating compliance.