30.6.2007 EN Official Journal of the European Union L 172/71
COMMISSION DIRECTIVE 2007/42/EC
of 29 June 2007
relating to materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs
(Text with EEA relevance)
(Codified version)
THE COMMISSION OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Community,
Having regard to Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (1), and in particular Article 5 thereof,
Whereas:
(1) 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 foodstuffs (2) has been substantially amended several times (3). In the interests of clarity and rationality the said Directive should be codified.
(2) 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.
(3) 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.
(4) Synthetic casings of regenerated cellulose should be the subject of specific provisions.
(5) The method for determining the absence of migration of colouring matters should be established at a later stage.
(6) Until criteria of purity and methods of analysis have been drawn up, national provisions should remain in force.
(7) 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.
(8) 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.
(9) To protect the health of the consumer, direct contact between foodstuffs and the printed surfaces of regenerated cellulose film should be avoided.
(10) 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.
(11) 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.
(12) Only authorised substances should be used in the manufacture of all the types of regenerated cellulose films, including regenerated cellulose films coated with plastics.
(13) 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 foodstuffs (4) apply also to such films.
(14) 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 foodstuffs (5) 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 foodstuffs (6).
(15) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.
(16) 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,
1.   This Directive is a specific directive within the meaning of Article 5 of Regulation (EC) No 1935/2004.
2.   This Directive shall apply to regenerated cellulose film within the meaning of the description given in Annex I which is intended to come into contact with foodstuffs or which, by virtue of its purpose, does come into such contact and which either:
(a) constitutes a finished product in itself; or
(b) forms part of a finished product containing other materials.
3.   This Directive shall not apply to synthetic casings of regenerated cellulose.
The regenerated cellulose films referred to in Article 1(2) shall belong to one of the following types:
(a) uncoated regenerated cellulose film;
(b) coated regenerated cellulose film with coating derived from cellulose; or
(c) coated regenerated cellulose film with coating consisting of plastics.
1.   Regenerated cellulose films referred to in Article 2(a) and (b) shall be manufactured using only substances or groups of substances listed in Annex II subject to the restrictions set out therein.
2.   By way of derogation from paragraph 1, substances other than those listed in Annex II may be used when these substances are employed as colouring matter (dyes and pigments) or as adhesives, provided that there is no trace of migration of the substances into or onto foodstuffs, detectable by a validated method.
1.   Regenerated cellulose film referred to in Article 2(c) shall be manufactured, prior to coating, using only substances or groups of substances listed in the first part of Annex II, subject to the restrictions set out therein.
2.   The coating to be applied to the regenerated cellulose film referred to in paragraph 1 shall be manufactured using only substances or groups of substances listed in Annexes II to VI to Directive 2002/72/EC, subject to the restrictions set out therein.
3.   Without prejudice to paragraph 1, materials and articles made of regenerated cellulose film referred to in Article 2(c) shall comply with Articles 2, 7 and 8 of Directive 2002/72/EC.
Printed surfaces of regenerated cellulose film shall not come into contact with the foodstuffs.
1.   At the marketing stages other than the retail stages, materials and articles made of regenerated cellulose film intended to come into contact with foodstuffs shall be accompanied by a written declaration in accordance with Article 16(1) of Regulation (EC) No 1935/2004.
2.   Paragraph 1 shall not apply to materials and articles made of regenerated cellulose film which by their nature are clearly intended to come into contact with foodstuffs.
3.   Where special conditions of use are indicated, the material or article made of regenerated cellulose film shall be labelled accordingly.
Directive 93/10/EEC, as amended by the Directives listed in Annex III, Part A, is repealed, 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.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex IV.
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
This Directive is addressed to the Member States.