Labelling
12.—(1) At marketing stages other than the retail stage a person in possession of any plastic material or article shall ensure that it is accompanied by a written declaration which–
(a)accords with Article 16.1 of Regulation (EC) No. 1935/2004 of the European Parliament and of the Council repealing Directives 80/590/EEC and 89/109/EEC(1); and
(b)provides, in respect of substances that are subject to a restriction on quantities migrating into food, information obtained from experimental data or theoretical calculation concerning–
(i)the levels of migration specific to those substances; and
(ii)where appropriate, purity criteria in accordance with the purity Directives,
sufficient to enable the user to comply with food law.
(2) In establishing which descriptions of food a material or article may come into contact with, it is to be assumed until the contrary is proved that, for the purposes of these Regulations, if particulars are shown in relation to it in accordance with paragraph (1)(a) those particulars are accurate and that unless the particulars so indicate, there are no restrictions on the intended conditions of contact.
O.J. No. L 338, 13.11.04, p.4.