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
THE  COMMISSION OF THE EUROPEAN COMMUNITIES
,
Having regard to the Treaty establishing the European Economic Community,
Having regard to Council Directive 89/109/EEC of 21 December 1988 on the approximation of the laws  of the Member States relating to materials and articles intended to come into contact with  foodstuffs  (1), and in particular Article 3 thereof,
After consulting the Scientific Committee for Food,
Whereas the number and nature of the changes that have had to be made and should now be made to  Council Directive 83/229/EEC of 25 April 1993 on the approximation of the laws of the Member States  relating to materials and articles made of regenerated cellulose film intended to come into contact  with foodstuffs  (2), as last amended by Commission Directive 92/15/EEC  (3), indicate the need for  the said Directive to be replaced;
Whereas the Community measures envisaged by this Directive are not only necessary but also  indispensable for the attainment of the objectives of the internal market; whereas these objectives  cannot be achieved by Member States individually; whereas, furthermore, their attainment at  Community level is already provided for by Directive 89/109/EEC;
Whereas Article 2 of Directive 89/109/EEC lays down that materials and articles, in their finished  state, must not transfer their constituents to foodstuffs in quantities which could endanger human  health or bring about an unacceptable change in the composition of the foodstuffs;
Whereas, in order to achieve this objective in the case of regenerated cellulose film, the suitable  instrument is a specific directive within the meaning of Article 3 of Directive 89/109/EEC;
Whereas synthetic casings of regenerated cellulose should be the subject of specific provisions;
Whereas the method for determining the absence of migration of colouring matters should be  established at a later stage;
Whereas, until criteria of purity and methods of analysis have been drawn up, national provisions  should remain in force;
Whereas 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 2 of Directive 89/109/EEC;
Whereas, 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 authorized quantity of such substances in foodstuffs which have been in contact with  regenerated cellulose film;
Whereas, to protect the health of the consumer, direct contact between foodstuffs and the printed  surfaces of regenerated cellulose film should be avoided;
Whereas the written declaration referred to in Article 6 (5) of Directive 89/109/EEC 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;
Whereas the measures provided for in this Directive are in accordance with the opinion of the  Standing Committee on Foodstuffs,
1.  This Directive is a specific directive within the meaning of  Article 3 of Directive 89/109/EEC.
2.  This Directive shall apply to regenerated cellulose film within the meaning of the description  given in Annex I which either:
(a)  constitutes a finished product in itself; or (b)  forms part of a finished product containing other materials,
and which is intended to come into contact with foodstuffs or which, by virtue of its purpose, does  come into such contact.
3.  This Directive does not apply to:
(a)  regenerated cellulose film which, on the side intended to come into contact with foodstuffs or  which, by virtue of its purpose does come into such contact, has a coating exceeding 50 mg/dm2;
(b)  synthetic casings of regenerated cellulose.
1.  Only those substances or groups of substances listed in Annex II may be used for  the manufacture of regenerated cellulose film and only under the conditions laid down 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.
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 6 (5) of Directive 89/109/EEC.
2.  Paragraph 1 does 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.
1.  Member States shall bring into force the laws, regulations and administrative  provisions necessary to comply with this Directive as from 1 January 1994. They shall immediately  inform the Commission thereof.
Member States shall:
-  permit, as from 1 January 1994, the trade in and use of regenerated cellulose film which is  intended to come into contact with foodstuffs complying with this Directive,
-  prohibit, as from 1 January 1994, the trade in and use of regenerated cellulose film which is  intended to come into contact with foodstuffs and which complies with neither this Directive nor  Directive 83/229/EEC,
-  prohibit, as from 1 January 1995, the trade in and use of regenerated cellulose film which is  intended to come into contact with foodstuffs and which does not comply with this Directive but did  comply with Directive 83/229/EEC.
2.  When Member States adopt the measures referred to in paragraph 1, these shall contain a  reference to this Directive or shall be accompanied by such reference at the time of their official  publication. The procedure for such reference shall be adopted by Member States.
1.  Directive 83/229/EEC is hereby repealed as from 1 January 1994.
2.  References to Directive 83/229/EEC shall be construed as references to this Directive and  should be read in accordance with the correlation table appearing in Annex III.
This Directive is addressed to the Member States.