Commission Directive 93/10/EEC of 15 March 1993 relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs2 has been substantially amended several times3. In the interests of clarity and rationality the said Directive should be codified.

The Community measures envisaged by this Directive are not only necessary but also indispensable for the attainment of the objectives of the internal market. These objectives cannot be achieved by Member States individually. Furthermore, their attainment at Community level is already provided for by Regulation (EC) No 1935/2004.

In order to achieve the objective laid down in Article 3(1) of Regulation (EC) No 1935/2004 in the case of regenerated cellulose film, the suitable instrument was a specific directive within the meaning of Article 5 of that Regulation.

Synthetic casings of regenerated cellulose should be the subject of specific provisions.

The method for determining the absence of migration of colouring matters should be established at a later stage.

Until criteria of purity and methods of analysis have been drawn up, national provisions should remain in force.

The establishment of a list of approved substances, accompanied by limits to the quantities to be used, is sufficient in principle in this specific case to achieve the objective laid down in Article 3(1) of Regulation (EC) No 1935/2004.

However, the bis(2-hydroxyethyl)ether (= diethyleneglycol) and ethanediol (= monoethyleneglycol) can migrate extensively to certain foodstuffs and therefore in order to avoid this possibility, as a preventive measure, it is more appropriate to lay down definitively the maximum authorised quantity of such substances in foodstuffs which have been in contact with regenerated cellulose film.

To protect the health of the consumer, direct contact between foodstuffs and the printed surfaces of regenerated cellulose film should be avoided.

The written declaration referred to in Article 16(1) of Regulation (EC) No 1935/2004 should be provided for in the event of professional use of regenerated cellulose film for materials and articles intended to come into contact with foodstuffs, except those which are, by their nature, intended for this use.

The rules to be applied to the regenerated cellulose films should be specific to the nature of the layer in contact with the foodstuff. Accordingly, the requirements for regenerated cellulose films coated with coatings consisting of plastics should be different from those provided for regenerated cellulose films uncoated or coated with coatings derived from cellulose.

Only authorised substances should be used in the manufacture of all the types of regenerated cellulose films, including regenerated cellulose films coated with plastics.

In the case of regenerated cellulose films coated with coatings consisting of plastics, the layer in contact with foodstuffs consists of a material similar to plastic materials and articles intended to come into contact with foodstuffs. Therefore it is appropriate that the rules provided for in Commission Directive 2002/72/EC of 6 August 2002 relating to plastic materials and articles intended to come into contact with foodstuffs4 apply also to such films.

In the interest of consistency of Community legislation, the verification of compliance of plastic-coated regenerated cellulose films with the migration limits set by Directive 2002/72/EC should be carried out according to the rules laid down in Council Directive 82/711/EEC of 18 October 1982 laying down the basic rules necessary for testing migration of the constituents of plastic materials and articles intended to come into contact with foodstuffs5 and Council Directive 85/572/EEC of 19 December 1985 laying down the list of simulants to be used for testing migration of constituents of plastic materials and articles intended to come into contact with foodstuffs6.

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.

This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law and application of the Directives set out in Annex III, Part B,