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

KOMMISSIONENS DIREKTIV 93/10/EOEF af 15. marts 1993 om materialer og genstande af folie af celluloseregenerater, bestemt til at komme i beroering med levnedsmidler

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

KOMMISSIONEN FOR DE EUROPAEISKE FAELLESSKABER HAR - under henvisning til Traktaten om Oprettelse af Det Europaeiske OEkonomiske Faellesskab,

Having regard to the Treaty establishing the European Economic Community,

under henvisning til Raadets direktiv 89/109/EOEF af 21. december 1988 om indbyrdes tilnaermelse af medlemsstaternes lovgivning om materialer og genstande, bestemt til at komme i beroering med levnedsmidler (1), saerlig artikel 3,

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,

efter hoering af Det Videnskabelige Udvalg for Levnedsmidler, og ud fra foelgende betragtninger:

After consulting the Scientific Committee for Food,

Antallet og arten af de aendringer, der har maattet foretages, og som nu boer foretages i Raadets direktiv 83/229/EOEF af 25. april 1983 om indbyrdes tilnaermelse af medlemsstaternes lovgivning om materialer og genstande af folie af celluloseregenerater, bestemt til at komme i beroering med levnedsmidler (2), senest aendret ved Kommissionens direktiv 92/15/EOEF (3), viser, at der er behov for at erstatte naevnte direktiv med et nyt direktiv;

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;

de ved dette direktiv fastsatte EF-foranstaltninger er ikke blot noedvendige, men ogsaa uundvaerlige for at opfylde maalene for det indre marked; medlemsstaterne kan ikke opfylde disse maal enkeltvis; ved direktiv 89/109/EOEF er det desuden allerede fastsat, at maalene skal opfyldes paa EF-plan;

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;

ifoelge artikel 2 i direktiv 89/109/EOEF maa materialer og genstande ikke afgive bestanddele til levnedsmidler i et omfang, der kan frembyde en fare for menneskers sundhed eller medfoere en uacceptabel aendring af sammensaetningen af levnedsmidler;

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;

hvad angaar folie af celluloseregenerater er det bedste middel til at naa dette maal et saerdirektiv, jf. artikel 3 i direktiv 89/109/EOEF;

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;

der boer fastsaettes saerlige bestemmelser vedroerende syntetiske tarme af celluloseregenerater;

Whereas synthetic casings of regenerated cellulose should be the subject of specific provisions;

metoden til bestemmelse af farvestoffers migration boer fastlaegges senere;

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

indtil der er udarbejdet renhedskriterier og analysemetoder, finder de nationale bestemmelser fortsat anvendelse;

Whereas, until criteria of purity and methods of analysis have been drawn up, national provisions should remain in force;

opstilling af en liste over stoffer, som er godkendt til anvendelse med en begraensning angivet, er i det foreliggende tilfaelde principielt tilstraekkeligt til at naa det i artikel 2 i direktiv 89/109/EOEF fastsatte maal;

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;

bis(2-hydroxyethyl)ether (= diethylenglycol) og ethandiol (= monoethylenglycol) kan imidlertid i vidt omfang migrere til visse levnedsmidler, og for at forhindre denne mulighed boer der derfor som forebyggende foranstaltning fastsaettes et maksimalt indhold af saadanne stoffer i levnedsmidler, der kommer i beroering med folie af celluloseregenerater;

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;

med henblik paa at beskytte forbrugerens sundhed boer det undgaas, at de paatrykte dele af folie af celluloseregenerater kommer i direkte beroering med levnedsmidler;

Whereas, to protect the health of the consumer, direct contact between foodstuffs and the printed surfaces of regenerated cellulose film should be avoided;

den skriftlige erklaering, der omhandles i artikel 6, stk. 5, i direktiv 89/109/EOEF, boer foreligge i tilfaelde af erhvervsmaessig anvendelse af folie af celluloseregenerater til materialer og genstande, bestemt til at komme i beroering med levnedsmidler, med undtagelse af saadanne folier, som ifoelge deres art er bestemt til denne anvendelse;

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;

de i dette direktiv fastsatte foranstaltninger er i overensstemmelse med udtalelse fra Den Staaende Levnedsmiddelkomité - UDSTEDT FOELGENDE DIREKTIV:

Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Foodstuffs,

HAS ADOPTED THIS DIRECTIVE:

Artikel 1

1. Dette direktiv er et saerdirektiv efter artikel 3 i direktiv 89/109/EOEF.

Article 1

2. Dette direktiv finder anvendelse paa folier af celluloseregenerater som defineret i beskrivelsen i bilag I, der enten:

1. This Directive is a specific directive within the meaning of Article 3 of Directive 89/109/EEC.

a) i sig selv er et faerdigprodukt, eller b) udgoer en del af et faerdigprodukt, der indeholder andre materialer og som er bestemt til at komme i beroering med, eller som foelge af dets anvendelsesformaal kommer i beroering med levnedsmidler.

2. This Directive shall apply to regenerated cellulose film within the meaning of the description given in Annex I which either:

3. Dette direktiv finder ikke anvendelse paa:

(a) constitutes a finished product in itself; or (b) forms part of a finished product containing other materials,

a) folier af celluloseregenerater, der paa den side, som er beregnet til at komme i beroering med, eller som foelge af deres anvendelsesformaal kommer i beroering med levnedsmidler, har et lag lak paa over 50 mg/dm2 b) syntetiske tarme af celluloseregenerater.

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:

Artikel 2

(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;

1. Til fremstilling af folier af celluloseregenerater maa kun anvendes de stoffer eller stofgrupper, der er anfoert i bilag II, og udelukkende paa de deri fastsatte betingelser.

(b) synthetic casings of regenerated cellulose.

2. Uanset stk. 1 er anvendelse af andre stoffer end de i bilag II anfoerte tilladt, naar disse stoffer anvendes som farvestoffer (farvestoffer og pigmenter) eller som bindemiddel, saafremt migration af disse stoffer til eller paa levnedsmidlerne ikke kan spores efter en valideret metode.

Article 2

Artikel 3

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.

Paatrykte overflader paa folier af celluloseregenerater maa ikke komme i beroering med levnedsmidler.

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.

Artikel 4

Article 3

1. Ved anden markedsfoering end detailsalg skal materialer og genstande af folier af celluloseregenerater, som er bestemt til at komme i beroering med levnedsmidler, ledsages af en skriftlig erklaering efter artikel 6, stk. 5, i direktiv 89/109/EOEF.

Printed surfaces of regenerated cellulose film shall not come into contact with the foodstuffs.

2. Stk. 1 gaelder ikke for materialer og genstande af folier af celluloseregenerater, som paa grund af deres beskaffenhed klart er bestemt til at komme i beroering med levnedsmidler.

3. Hvor specielle anvendelsesbetingelser er angivet, skal materialet eller genstanden af folie af celluloseregenerater vaere maerket tilsvarende.

Article 4

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.

Artikel 5

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.

1. Medlemsstaterne saetter de noedvendige love og administrative bestemmelser i kraft for at efterkomme dette direktiv fra den 1. januar 1994. De underretter straks Kommissionen herom.

3. Where special conditions of use are indicated, the material or article made of regenerated cellulose film shall be labelled accordingly.

Medlemsstaterne:

- tillader handel med og brug af folier af celluloseregenerater, der er bestemt til at komme i beroering med levnedsmidler, og som er i overensstemmelse med bestemmelserne i dette direktiv fra den 1. januar 1994 - forbyder fra den 1. januar 1994 handel med og brug af folier af celluloseregenerater, der er bestemt til at komme i beroering med levnedsmidler, og som hverken er i overensstemmelse med naervaerende direktiv eller direktiv 83/229/EOEF - forbyder fra den 1. januar 1995 handel med og brug af folier af celluloseregenerater, der er bestemt til at komme i beroering med levnedsmidler, og som ikke er i overensstemmelse med bestemmelserne i naervaerende direktiv, men som er i overensstemmelse med bestemmelserne i direktiv 83/229/EOEF.

Article 5

2. Naar en medlemsstat vedtager de i stk. 1 naevnte love og administrative bestemmelser, skal disse indeholde en henvisning til dette direktiv, eller de skal ved offentliggoerelsen ledsages af en saadan henvisning. De naermere regler for denne henvisning fastsaettes af medlemsstaterne.

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:

Artikel 6

- 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,

1. Direktiv 83/229/EOEF ophaeves fra den 1. januar 1994.

- 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,

2. Henvisninger til direktiv 83/229/EOEF gaelder som henvisninger til naervaerende direktiv og laeses i overensstemmelse med sammenligningstabellen i bilag III.

- 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.

Artikel 7

Dette direktiv er rettet til medlemsstaterne.

Article 6

1. Directive 83/229/EEC is hereby repealed as from 1 January 1994.

Udfaerdiget i Bruxelles, den 15. marts 1993.

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.

Paa Kommissionens vegne Martin BANGEMANN Medlem af Kommissionen

Article 7

BILAG I

This Directive is addressed to the Member States.

BESKRIVELSE AF FOLIE AF CELLULOSEREGENERATER

Done at Brussels, 15 March 1993.

Folie af celluloseregenerater er en tynd film, der fremstilles af raffineret cellulose af ikke-genanvendt trae eller bomuld. Af teknologiske hensyn kan egnede stoffer vaere tilsat massen eller overfladen. Folier af celluloseregenerater kan vaere belagt (coated) paa en eller begge sider.

For the Commission Martin BANGEMANN Member of the Commission

ANNEX I

BILAG II

DESCRIPTION OF REGENERATED CELLULOSE FILM

LISTE OVER STOFFER, DER MAA ANVENDES VED FREMSTILLING AF FOLIER AF CELLULOSEREGENERATER

Regenerated cellulose film is a thin sheet material obtained from a refined cellulose derived from unrecycled wood or cotton. To meet technical requirements, suitable substances may be added either in the mass or on the surface. Regenerated cellulose film may be coated on one or both sides.

NB - Procentsatserne i dette bilag, foerste og anden del, udtrykkes i vaegt/vaegt (w/w) og beregnes i forhold til maengden af vandfri ulakeret folie af celluloseregenerat - de almindelige tekniske benaevnelser er anfoert i skarpe parenteser - de anvendte stoffer skal vaere af god teknisk kvalitet for saa vidt angaar renhedskriterier.

FOERSTE DEL

ANNEX II

ULAKEREDE FOLIER AF CELLULOSEREGENERATER

LIST OF SUBSTANCES AUTHORIZED IN THE MANUFACTURE OF REGENERATED CELLULOSE FILM

>TABELPOSITION>

NB - The percentages in this Annex, first and second parts, are expressed in weight/weight (w/w) and are calculated in relation to the quantity of anhydrous uncoated regenerated cellulose film.

- The usual technical denominations are given in square brackets.

ANDEN DEL

- The substances used shall be of good technical quality as regards the purity criteria.

LAKEREDE FOLIER AF CELLULOSEREGENERATER

FIRST PART

>TABELPOSITION>

UNCOATED REGENERATED CELLULOSE FILM

>TABLE>

BILAG III

SECOND PART

SAMMENLIGNINGSTABEL

>TABELPOSITION>

COATED REGENERATED CELLULOSE FILM

>TABLE>

ANNEX III

CORRELATION TABLE

>TABLE>