COUNCIL DIRECTIVE

RAADETS DIREKTIV

of 21 December 1988

af 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

om indbyrdes tilnaermelse af medlemsstaternes lovgivning om materialer og genstande, bestemt til at komme i beroering med levnedsmidler

(89/109/EEC)

(89/109/EOEF)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

RAADET FOR DE EUROPAEISKE FAELLESSKABER HAR-

Having regard to the Treaty establishing the European Economic Community, and in particular Article l00a thereof,

under henvisning til Traktaten om Oprettelse af Det Europaeiske OEkonomiske Faellesskab, saarlig artikel 100 A,

Having regard to the Proposal from the Commission,

under henvisning til forslag fra Kommissionen,

In cooperation with the European Parliament (1),

i samarbejde med Europa-Parlamentet (1),

Having regard to the opinion of the Economic and Social Committee (2),

under henvisning til udtalelse fra Det OEkonomiske og Sociale Udvalg (2), og

Whereas Council Directive 76/893/EEC of 23 November 1976 on the approximation of the laws of the Member States relating to materials and articles intended to come into contact with foodstuffs (3), as last amended by the act of Accession of Spain and Portugal (4), has been substantially amended on a number of occasions; whereas on making the new amendments to the said Directive, the opportunity should be taken to consolidate the provisions of the existing relevant texts with a view to ensuring legal clarity;

ud fra foelgende betragtninger:

Whereas Directive 76/893/EEC was adopted on the grounds that the differences that existed at that time between the national laws relating to the aforesaid materials and articles impeded the free movement thereof, could create unequal conditions of competition and could thereby directly affect the establishment or functioning of the common market;

Raadets direktiv 76/893/EOEF af 23. november 1976 om indbyrdes tilnaermelse af medlemsstaternes lovgivninger om materialer og genstande, bestemt til at komme i beroering med levnedsmidler (3), senest aendret ved akten vedroerende Spaniens og Portugals tiltraedelse (4), er blevet aendret talrige gange; i forbindelse med nye aendringer af naevnte direktiv boer der foretages en omredigering af de bestemmelser, der gaelder paa dette omraade med henblik at sikre den juridiske klarhed;

Whereas those laws had to be approximated if free movement was to be achieved for the aforesaid materials and articles, taking account primarily of human health requirements but also, within the limits required for the protection of health, of economic and technological needs;

vedtagelsen af direktiv 76/893/EOEF var begrundet i det forhold, at de davaerende forskelle mellem de nationale lovgivninger vedroerende de paagaeldende materialer og genstande haemmede den frie omsaetning heraf og kunne skabe ulige konkurrencevilkaar og saaledes indvirke direkte paa det faelles markeds oprettelse og funktion;

Whereas the chosen method was to lay down, in the first place, in a framework directive, general principles on the basis of which legal differences between certain groups of materials and articles had been and could subsequently be

med henblik paa at opnaa fri omsaetning af ovennaevnte materialer og genstande var det noedvendigt at foretage en indbyrdes tilnaermelse af lovgivningerne under hensyntagen foerst og fremmest til kravet om beskyttelse af menneskers sundhed, men ogsaa til oekonomiske og tekniske forhold i det omfang det var foreneligt med de sundhedsmaessige hensyn;

eliminated by means of specific directives; whereas this method has proved itself and should therefore be retained;

den valgte fremgangsmaade gik ud paa foerst ved et rammedirektiv at fastlaegge de almindelige principper, paa grundlag af hvilke man senere ved hjaelP af saerdirektiver kunne ophaeve ulighederne i lovgivningerne vedroerende visse grupper af materialer og genstande; denne fremgangsmaade har vist sig at vaere hensigtsmaessig og boer derfor fortsat anvendes;

(1) EFT nr. C 99 af 13. 4. 1987, s. 65, og EFT nr. C 12 af 16. 1. 1989.

(2) EFT nr. C 328 af 22. 12. 1986, s. 5.

(3) EFT nr. L 340 af 9. 12. 1976, s.19.

(4) EFT nr. L 302 af 15. 11. 1985, s. 216.

Whereas covering or coating substances, all or part of which form part of foodstuffs, could not be considered to be simply in contact with these foodstuffs: whereas, in that case, account had to be taken of possible direct consumption by consumers; whereas the rules laid down in this Directive are therefore inappropriate in such circumstances;

Whereas the principle underlying this Directive should be that any material or article intended to come into contact or which is intentionally in contact either directly or indirectly with foodstuffs, must be sufficiently stable not to transfer substances to the foodstuffs in quantities which could endanger human health or bring about an unacceptable change in the composition of the foodstuffs or a deterioration in the organoleptic properties thereof;

daeklags- og overtraeksmaterialer, som helt eller delvis udgoer en del af levnedsmidlerne, kan ikke anses som kun vaerende i beroering med disse levnedsmidler, idet muligheden for, at de indtages direkte af forbrugerne, i disse tilfaelde maa tages i betragtning; de i naervaerende direktiv fastsatte regler er uegnede under saadanne omstaendigheder;

Whereas, in order to achieve this objective, it may prove necessary to lay down various types of limitations, alone or in combination; whereas it is appropriate to retain in specific directives those limitations which are most appropriate to the desired objective, having regard to the technological characteristics peculiar to each group of materials and articles;

grundprincippet i naervaerende ordning boer vaere, at ethvert materiale og enhver genstand, der er bestemt til at komme eller i overensstemmelse med deres formaal kommer i direkte eller indirekte beroering med levnedsmidler, skal vaere saa neutral, at der ikke til de paagaeldende levnedsmidler afgives bestanddele i maengder, der kan frembyde en fare for menneskers sundhed eller medfoere en uacceptabel aendring af sammensaetningen af levnedsmidlerne eller en organoleptisk forringelse;

Whereas, in order to allow the informed use of the materials and articles, appropriate labelling should be provided for; whereas the methods used for such labelling may vary according to the user;

for at naa dette maal kan det vise sig noedvendigt at fastsaette forskellige former for begraensninger, som finder anvendelse hver for sig eller i forening, og det er formaalstjenligt i saerdirektiver at fastsaette de begraensninger, der er bedst egnede til at foere til det fastlagte maal, under hensyntagen til de saerlige teknologiske egenskaber hos hver gruppe materialer og genstande;

Whereas this Directive does not apply to the labelling of products which, by reason of their behaviour in the presence of foodstuffs, must not be designed to come into contact or be in contact with them;

for at muliggoere en korrekt anvendelse af materialer og genstande boer der foreskrives en passende maerkning; de naermere bestemmelser for, hvorledes denne maerkning skal foretages, kan afaenge af, hvem de paagaeldende materialer og genstande er bestemt for;

Whereas the drafting of specific directives implementing the basic principles and of amendments thereto constitute technical implementing measures; whereas, in order to simplify and expedite the procedure, the adoption of these measures should be entrusted to the Commission;

dette direktiv vedroerer ikke maerkning af produkter, som paa grund af deres indvirkning paa levnedsmidler ikke maa bringes i beroering med disse eller vaere bestemt hertil;

Whereas the Scientific Committee for Food, set up by Commission Decision 74/234/EEC (5), should be asked for its opinion before provisions liable to affect public health are adopted under specific directives;

udarbejdelsen af saerdirektiver til gennemfoerelse af ordningens grundprincipper samt aendringer af saadanne direktiver udgoer tekniske gennemfoerelsesforanstaltninger; for at forenkle og fremskynde proceduren boer vedtagelsen af disse foranstaltninger overlades til Kommissionen;

der boer indhentes udtalelse fra Den Videnskabelige Komité for Levnedsmidler, nedsat ved Kommissionens afgoerelse 74/234/EOEF (5), inden der ved saerdirektiver vedtages bestemmelser, som kan vaere af betydning for den offentlige sundhed;

Whereas it is desirable that in all cases where the Council empowers the Commission to implement rules relating to foodstuffs, provision should be made for a procedure establishing close cooperation between the Member States and the Commission within the Standing Committee on Foodstuffs set up by Council Decision 69/414/EEC (1)

HAS ADOPTED THIS DIRECTIVE:

i alle de tilfaelde, hvor Raadet overdrager Kommissionen befoejelser til at gennemfoere de regler, der er opstillet paa levnedsmiddelomraadet, boer der fastlaegges en fremgangsmaade, ved hvilken der etableres et snaevert samarbejde mellem medlemsstaterne og Kommissionen i Den Staaende Levnedsmiddelkomité, der blev nedsat ved Raadets afgoerelse 69/414/EOEF (1) -

UDSTEDT FOELGENDE DIREKTIV:

Article 1

1. This Directive shall apply to materials and articles which, in their finished state, are intended to be brought into contact with foodstuffs or which are brought into contact with foodstuffs and are intended for that purpose, hereinafter referred ro as 'materials and articles'.

Covering or coating substances, such as the substances convering cheese rinds, prepared meat products or fruit, which form part of foodstuffs and may be consumed together with those foodstuffs, shall not be subject to this Directive

Artikel 1

2. This Directive shall apply to materials and articles which are in contact with water which is intended for human consumption. It shall not, however, apply to fixed public or private water supply equipment.

1. Dette direktiv finder anvendelse paa materialer og genstande, der som faerdigvarer er bestemt til at blive bragt i beroering med eller i overensstemmelse med deres formaal bringes i beroering med levnedsmidler, i det foelgende benaevnt »materialer og genstande«.

3. This Directive shall not apply to antiques.

Overtraeks- og daeklagsmaterialer - saasom overtraeksmaterialer til skorpen paa ost, til charcuterivarer eller til frugt - der udgoer en del af levnedsmidlerne, og som vil kunne indtages sammen med disse, er ikke omfattet af dette direktiv

2. Dette direktiv anvendes paa materialer og genstande i beroering med drikkevand. Det finder dog ikke anvendelse paa faste installationeri offentlige eller private vandforsyningssystemer.

Article 2

3. Dette direktiv finder ikke anvendelse paa antikviteter.

Materials and articles must be manufactured in compliance with good manufacturing practice so that, under their normal or foreseeable conditions of use, they do not transfer their constituents to foodstuffs in quantities which could:

- endanger human health,

Artikel 2

- bring about an unacceptable change in the composition of the foodstuffs or a deterioration in the organoleptic characteristics thereof.

Materialerne og genstandene skal fremstilles i overensstemmelse med god fremstillingspraksis, saaledes at de under de for deres anvendelse normale eller forventelige forhold ikke afgiver bestanddele til levnedsmidlerne i et omfang der kan:

- frembyde en fare for menneskers sundhed

Article 3

- medfoere en uacceptabel aendring af sammensaetningen af levnedsmidlerne eller en organoleptisk forringelse deraf.

1. The groups of materials and articles listed in Amex I and, where appropriate, combinations of these materials and articles shall be subject to specific directives.

2. The specific directives, including amendments to existing specific directives, shall be adopted in accordance with the procedure laid down in Article 8.

Artikel 3

3. The specific directives may include:

1. De grupper af materialer og genstande, som er anfoert paa listen i bilag I, og i givet fald kombinationer af disse materialer og genstande, er undergivet saerdirektiver.

(a) a list of the substances the use of which is authorized to the exclusion of all others (positive list);

2. Saerdirektiverne, herunder aendringer af allerede gaeldende saerdirektiver, vedtages efter fremgangsmaaden i artikel 9.

3. Disse saerdirektiver kan blandt andet indeholde:

(b) purity standards for such substances;

a) en liste over de stoffer, hvis anvendelse er tilladt med udelukkelse af alle andre (positivliste)

(c) special conditions of use for these substances and/or the materials and articles in which they are used;

(d) specific limits on the migration of certain constituents or groups of constituents into or onto foodstuffs:

(e) an overall limit on the migration of constituents into or outo foodstuffs;

b) renhedskriterierne for disse stoffer

(f) if necessary, provisions aimed at protecting human health against any hazards which might arise through oral contact with materials and articles;

c) de saerlige betingelser for anvendelse af disse stoffer og/eller de materialer og genstande, i hvilke disse stoffer eranvendt

(g) other rules to ensure compliance with Article 2;

d) specifikke graenser for migration af visse bestanddele eller grupper af bestanddele til eIler paa levnedsmidler

(h) the basic rules necessary for checking compliance with the provisions of points (d), (e), (f) and (g);

e) en generel graense for migration af bestanddele til eller paa levnedsmidler

(i) detailed rles concerning sample taking and the methods of analysis required to check compliance with the provisions of points (a) to (g).

f) om fonmoedent forskrifter til beskyttelse af menneskers sundhed mod eventuelle farer, der kan opstaa som foelge af mundens beroering med materialerne og genstandene

provisions liable to affect public health shall be adopted after consulting the Scientific Committee for Food. They must fulfill the criteria set out in Annex II.

g) andre forskrifter til sikring af overholdelsen af bestemmelserne i artikel 2

h) de grundregler, der er noedvendige for kontrol med overholdelsen af bestemmelserne under litra d), e), f) og g)

Article 4

i) de naermere regler for proeveudtagning og analysemetoder, der er noedvendige for kontrollen med overholdelsen af bestemmelserne under litra a) til g)

1. Notwithstanding Article 3, a Member State may, where a list of substances has been drawn up in accordance with paragraph 3 (a) of that Article, authorize the use within its territory of a substance not included in the list, subject to compliance with the following conditions:

Forskrifter, der kan vaere af betydning for den offentlige sundhed, vedtages efter hoering af Den Videnskabelige Komité for Levnedsmidler. De skal vaere i overensstemmelse med de i bilag II anfoerte kriterier

(a) the authorization must be limited to a maximum period of two years;

(b) the Member State must carry out an official check on materials and articles manufactured from a substance of which it has authorized the use;

Artikel 4

(c) materials and articles thus manufactured must bear a distinctive indication which will be defined in the authorization.

1. Uanset de i artikel 3 fastsatte bestemmelser kan en medlemsstat, naar en liste over stoffer er fastsat i overensstemmelse med stk. 3, litra a), i naevnte artikel, inden for dens omraade tillade anvendelse af et stof, der ikke er optaget paa denne liste, hvis foelgende betingelser overholdes:

2. The Member State shall forward to the other Member States and to the Commission the text of any authorization drawn up pursuant to paragraph 1 within two months of the date of its taking effect.

a) tilladelsen skal vaere begraenset til en periode paa hoejst to aar

3. Before the expiry of the two-year period provided for in paragraph 1 (a), the Member State may submit to the Commission a request for the inclusion in the list referred to.

b) medlemsstaten skal foere officiel kontrol med de materialer og genstande, der er fremstillet ved hjaelp af det stof, som den har tilladt anvendt.

in Article 3 (3) (a) of the substance given national authorization in accordance with paragraph 1 of this Article. At the same time, it shall supply supporting documents setting out the grounds on which it deems such inclusion justified and shall indicate the uses for which this substance is ineended

c) de saaledes fremstillede materialer og genstande skal vaere forsynet med en saerlig angivelse, der skal beskrives i tilladelsen

Within 18 months of the submission of the request, a decision shall be taken on the basis of information relating to public health, after consulting the Scientific Committee for Food and in accordance with the procedure laid down in Article 9 as to whether the substance in question may be included in the list referred to in Article 3 (a) or whether the national authorization should be revoked. If provisions prove necessary pursuant to Article 3 (3) (b), (c) and (d), these shall be adopted in accordance with the same procedure. Notwithstanding paragraph 1 (a) of this Article, the national authorization shall remain in force until a decision is taken on the request for inclusion in the list.

2. Medlemsstaten meddeler de oevrige medlemsstater og Kommissionen teksten til enhver tilladelse, der udstedes i medfoer af stk. 1, inden for en frist af to maaneder fra den dato, Paa hvilken denne tilladelse faar virkning.

Should it be decided pursuant to the preceding subparagraph that the national authorization should be revoked, this decision shall apply to any other national authorization in respect of the substance in question. The decision may stipulate that the ban on the use of this substance shall extend to uses other than those referred to in the request for inclusion in the list.

3. Inden udloebet af den i stk. 1, litra a), fastsatte frist paa to aar kan medlemsstaten indgive en anmodning til Kommissionen om at faa det stof, der er omfattet af en national tilladelse i

henhold til stk. 1 i denne artikel, optaget paa den i artikel 3, stk. 3, litra a), omhandlede liste. Dem fremlaegger samtidig den dokumentation, i henhold til hvilken denne optagelse forekommer den berettiget, og anfoerer, til hvilke formaal der pagaeldende stot er beregnet.

Article 5

Inden for en first paa 18 maaneder fra anmodningens indgivelse traeffes der paa grundlag af oplysninger om den offentlige sundhed, efter hoering af Den Videnskebelige Komité for Levnedsmidler og efter fremgangsmaaden i artikel 9, afgoerelse om, hvorvidt der paagaeldende stof kan optages paa den i artikel 3, stk. 3, litra a), omhandlede liste, eller om den nationale tilladelse skal inddrages. Saafremt det viser sig noedvendigt at traffe bestemmelser i medfoer af artikel 3, litra b), c) og d), skal dette ske efter samme fremgangsmaade. Uanset stk. 1, litra a), inaervaerende artikel forbliver den nationale tilladelse i kraft, indtil der er truffet en afgoerelse om anmodningen om optagelse paa listen.

1. Where a Member State, as a result of new information or of a reassessment of existing information made since one of the specific directives was adopted, has detailed grounds for establishing that the use of a material or article endangers human health although it complies with the relevant specific directive, that Member State may temporarily suspend or restrict application of the provisions in question within its territory. It shall immediately inform the other Member States and the Commission thereof and give reasons for its decision

Saafremt der i medfoer af andet afsnit traeffes afgoerelse om inddragelsen af den nationale tilladelse, finder denne afgoerelse anvendelse paenhver anden national tilladelse vedroerende det paagaeldende stof. Afgoerelsen kan fastslaa, at forbudet mod at anvende stoffet ogsaa omfatter anden anvendelse end den, der er anfoert i anmodningen om optagelse paa listen.

2. The Commission shall examine as soon as possible within the Standing Committee on Foodstuffs the grounds adduced by the Member State referred to in Paragraph 1 and shall deliver its opinion without delay and take the appropriate measures.

3. If the Commission considers that amendments to the specific directives in question are necessary in order to remedy the difficulties mentioned in paragraph 1 and to ensure the protection of human health, it shall initiate the procedure laid down in Article 9 with a view to adopting those amendments; the Member State which has adopted safeguard measures may in that event retain them until the amendments have been adopted.

Artikel 5

1. Saafremt en medelmssat ud fra en udfoerlig begrundelse, som foelge af nye data eller en nyvurdering af allerede foreliggende data fremkommet efter vedtagelsen af et saerdirektiv, bliver klar over, at anvendelsen af en materiale eller en genstand, selv om det/den er i overensstemmelse med det paagaeldende saerdirektiv, udgoer en fare for menneskers sundhed, kan denne medlemsstat paa sit omraade midlertidigt suspendere eller indskraenke anvendelsen af de paagaeldende bestemmelser. Den underretter straks de oevrige medlemsstater og Kommissionen herom, idet den angiver de grunde, der har foert til dens afgoerelse.

Article 6

2. Kommissionen undersoeger snarest muligt i Den Staaende Levnedsmiddelkomité de grunde, som den i stk. 1 omhandlede medlemsstat har anfoert, hvorefter den omgaaende afgifer sin udtalelse og traeffer passende foranstaltninger.

1. Without prejudice to any exceptions provided for in the specific directives, materials and articles not already in contact with foodstuffs must, when placed on the market, be accompanied by:

3. Saafremt Kommissionen finder, at det er noedvendigt at foretage aendringer i det paagaeldende saerdirektiv for at loese de i stk. 1 anfoerte problemer og for at sikre beskyttelse af menneskers sundhed, indleder den den i artikel 9 fastsatte fremgangsmaade med henblik paa at vedtage saadanne aendringer; i saa fald kan den medlemsstat, som har indfoert beskyttelsesforanstaltninger, opretholde disse, indtil de omhandlede aendringer vedtages.

(a) - the words 'for food use',

- or a specific indication as to their use, such as coffee-machine, wine bottle, soup spoon,

Artikel 6

- or a symbol determined in accordance with the procedure laid down in Article 9;

1. Med forbehold af eventuelle undtagelser fastsat i saerdirektiverne skal materialer oig genstande, der endnu ikke er bragt i beroering med levnedsmidler, vaere ledsaget af foelgende angivelser, naar de bringes i handelen:

(b) where appropriate, any special conditions to be observed when they are being used:

a) - enten angivelsen »til levnedsmidler«

(c) - either the name or trade name and the address or registered office,

- eller en saerlig angivelse af deres anvendelse, saasom kaffemaskine, vinflaske, suppeske

- or the registered trade mark,

- eller et symbol fastsat efter fremgangsmaaden i artikel 9

of the manufacturer or processor, or of a seller established within the Community.

b) i givet fald de saerlige betingelser, som skal overholdes ved anvendelsen af dem

2. The particulars listed in paragraph 1 must be conspicuous, clearly legible and indelible:

c)-enten navn eller firmabetegnelse og adresse eller firmaets hovedsaede

(a) at the retail stage:

- eller registreret varemaerke

- on the materials and articles or on the packaging,

for fabrikanten, forarbejdningsvirksomheden eller for en saelger, der er etableret inden for Faellesskabet.

- or on labels affixed to the materials and articles or to their packaging,

2. De i stk. 1 naevnte angivelser skal fremtraede klart synlige, vaere let laeselige og maa ikke kunne slettes:

- or on a notice in the immediate vicinity of the materials and articles and clearly visible to purchasers; in the case mentioned in paragraph 1 (e), however, the latter option shall only be open if these particulars or a label bearing them cannot, for technical reasons, be affixed to the said materials and articles at either the manufacturing or the marketing stage;

a) ved detailsalg:

(b) at the marketing stages other than the retail stage:

- enten direkte paa materialerne og genstandene eller paa emballagen

- on the accompanying documents,

- eller paa etiketter, der er anbragt paa materialerne og genstandene eller paa deres emballage

- on the labels or packaging,

- eller paa et skilt, der er anbragt i umiddelbar naerhed af materialerne og genstandene, og som er klart synligt for koeberen; sidstnaevnte mulighed kan dog, hvor det drejer sig om en angivelse, som den i stk. 1, litra c), anfoerte, kun benyttes, dersom anbringelsen paa disse materialer og genstande af denne angivelse eller af en hermed forsynet etiket ikke kan foretages hverker paa tekniske aarsager

- or on the materials and articles themselves.

b) paa andre stadier i afsaetningen end detailsalg:

3. However, the particulars provided for in paragraph 1 shall not be compulsory for materials and articles which by their nature are clearly intended to come into contact with foodstuffs.

- enten paa ledsagedokumenterne

4. The particulars provided for in paragraph 1 (a) and (b) shall be confined to materials and articles which comply:

- eller paa etiketzterne eller emballagen

(a) with the criteria laid down in Article 2;

- eller direkte paa materialerne og genstandene.

(b) with the specific directives, in the absence of such directives, with any national provisions.

3. De i stk. 1 naevnte angivelser er dog ikke obligatoriske for materialer og gfenstande, som ved deres beskaffenhed klart er beregnet til at komme i beroering med levnedsmidler.

5. The specific directives shall require that such materials and articles be accompanied by a written declaration attesting that they comply with the rules applicable to them.

4. De i stk. 1, litra a) og b), naevnte angivelser er forbeholdt materialer og genstande, som er i overensstemmelse:

a) med bestemmelserne i artikel 2

In the absence of specific directives, Member States may retain existing provisions or adopt provisions to this effect.

b) med saerdirektiverne eller, saafremt der ikke findes saadanne direktiver, med eventuelle nationale bestemmlser.

6. Member States shall ensure that retail trade in materials and articles is prohibited if the particulars required under paragraph 1 (a) and (b) are not given in a language easily understood by purchasers, unless the purchaser is informed by other means. This provision shall not preclude such particulars appearing in several languages.

5. Isaerdirektiverne skal det fastsaettes, at disse materialer og genstande skal vaere ledsaget af en skriftlig erklaering, hvori det attesteres, at de er i overensstemmelse med de regler, der gaelder for dem.

Hvis der ikke findes saerdirektiver, kan medlemsstaterne bibeholde eller vedtage bestemmelser herom.

Article 7

6. Medlemsstaterne soerger for forbud mod detailhandelen med materialer og genstande, saafremt de i stk. 1, litra a) og b), naenvte angivelser ikke er affattet paa et sprog, der er let forstaaeligt for koeberne, medmindre andre foranstaltninger sikrer, at koeberen informeres. Denne bestemmelse er ikke til hinder for, at de omhandlede angivelser anfoeres paa flere sprog.

1. Member States shall not, for reasons relating to composition, behaviour in the presence of foodstuffs or labelling, prohibit or restrict either trade in or the use of materials and articles complying with this Directive or with the specific directives.

2. Paragraph 1 shall not affect national provisions which are applicable in the absence of the specific directives.

Artikel 7

1. Medlemsstaterne kan ikke paa grund af sammensaetning, indvirkning paa levnedsmidler eller maerkning forbyde eller begraense handelen med eller anvendelsen af materialer eller genstande, som er i overensstemmelse med dette direktiv eller saerdirektiverne.

Article 8

2. Stk. 1 beroerer ikke de nationale bestemmelser, der gaelder, saafremt der ikke er udstedt saerdirektiver.

Amendments made to existing specific directives in order to bring them into line with this Directive shall be adopted in accordance with the procedure laid down in Article 9.

Artikel 8

Article 9

De aendringer, der skal foretages i de allerede gaeldende saerdirektiver for at bringe dem i overensstemmelse med dette direktiv, vedtages efter fremgangsmaaden i artikel 9

1. Where the procedure laid down in this Article is to be followed, the chairman shall refer the matter to the Standing Committee on Foodstuffs either on his own initiative or at the request of the representative of a Member State.

2. The Commission representative shall submit to the committee a draft of measures to be taken. The committee shall deliver its opinion on the draft within a time limit which the chairman may lay down according to the urgency of the matter. The opinion shall be delivered by the qualified majority laid down in Article 148 (2) of the Treaty. The chairman shall not vote.

Artikel 9

3. (a) The Commission shall adopt the intended measures when they are in accordance with the committee's opinion;

1. Naar der henvises til fremgangsmaaden i denne artikel, indbringer formanden sagen for Den Staaende Levnedsmiddelkomité, enten paa eget initiativ eller efter anmodning fra en medlemsstats repraeserttant.

(b) where the intended measures are not in accordance with the opinion of the committee, or in the absence of any opinion, the Commission shall forthwith submit to the Council a proposal relating to the measures to be taken. The Council shall act on a qualified majority.

2. Kommissionens repraesentant forelaegger komitéen et udkast til de foranstaltninger, der skal traeffes. Komitéen afgiver udtalelse om dette udkast inden for en frist, som formanden kan fastsaette under hensyn til, hvor meget spoergsmaalet haster. Udtalelsen vedtages med kvalificeret flertal, som fastsat i Traktatens artikel 148, stk. 2. Formanden deltager ikke i afstemningen.

If, on the expiry of three months from the date on which the matter was referred to it, the Council has not adopted any measures, the Commission shall adopt the proposed measures and apply them immediately.

3. a) Kommissionen vedtager de paataenne foranstaltninger, naar de er i overensstemmelse med komitéens udtalelse.

b) Naar de paataenkte foranstaltninger ikke er i overensstemmelse med komitéens udtalelse, eller naar der ikke er afgivet nogen udtalelse, forelaegger Kommissionen omgaaende Raadet et forslag om de foranstaltninger, der skal traeffes. Raadet traeffer afgoerelse med kvalificeret flertal.

Article 10

Saafremt Raadet ikke har truffet nogen afgoerelse inden udloebet af en frist paa tre maaneder fra den dato, paa hvilken det har faaet sagen forelagt, vedtager Kommissionen de foreslaaede foranstaltninger

1. Directive 76/893/EEC is hereby repealed

2. References to the Directive repealed under paragraph 1 shall be construed as references to this Directive.

Artikel 10

References to the Articles of the repealed Directive should be read in accordance with the correlation table appearing in Annex III.

1. Direktiv 76/893/EOEF ophaeves.

2. Henvisninger til det i stk. I naevnte direktiv skal forstaas som henvisninger til naervaerende direktiv.

Article 11

Henvisninger til artikler i det i stk. 1 naevnte direktiv laeses i overensstemmelse med konkordansskemaet i bilag III.

1. Member States shall take all measures necessary to comply with this Directive. They shall forthwith inform the Commission thereof. He measures taken shall:

- permit, not later than 18 months after notification (1), trade in and use of materials and articles complying with this Directive, without prejudice to the application of national provisions which, in the absence of specific directives, apply to certain groups of materials and articles;

Artikel 11

- prohibit not later than 36 months after notification trade in and use of materials and articles which do not comply with this Directive.

1. Medlemsstaterne traeffer de noedvendige foranstaltninger for at efterkomme dette direktiv. De underretter straks Kommissionen herom. Ved foranstaltningerne skal der:

2. Paragraph 1 shall not affect those national provisions which, in the absence of the specific directives, apply to certain groups of materials and articles intended to come into contact with foodstuffs.

- senest 18 maaneder efter meddelelser (1) gives tilladelse til handel med og brug af materialer og genstande, som er i overensstemmelse med dette direktiv, med forbehold af anvendelsen af nationale bestemmelser, som, i mangel af saerdirektiver, gaelder for visse grupper af materialer og genstande

- senest 36 maaneder efter meddelelser udstedes forbud mod handel med og brug af materialer og genstande, som ikke er i overensstemmelse med dette direktiv

Article 12

2. Stk. 1 beroerer ikke de nationale bestemmelser, som, i mangel af saerdirektiver, gaelder for visse grupper af materialer og genstande, der er bestemt til at komme i beroering af levnedsmidler.

This Directive shall not apply to materials and articles intended for export outside the Community.

Artikel 12

Article 13

Dette direktiv finder ikke anvendelser paa materialer og genstande, der er bestemt til at udfoeres fra Faellesskabet.

This Directive is addressed to the Member States.

Artikel 13

Done at Brussels, 21 December 1988.

Dette direktiv er rettet til medlemsstaterne.

For the Council The President

V. PAPANDREOU

Udfaerdiget i Bruxelles, den 21. december 1988.

Paa Raadets vegne

(1) This Directive was notified to the Member States on 10 January 1989

V. PAPANDREOU

Formand

(1) OJ N° C 99, 13. 4. 1987, p. 65 and OJ N° C 12, 16. 1989.

(1) Dette direktiv er meddelt medlemsstaterne den 10. januar 1989.

(2) OJ N° C 328, 22. 12. 1986, p. 5.

(3) OJ N° L 340, 9. 12. 1976, p. 19.

(5) EFT nr. L 136, af 20. 5. 1974, s. 1.

(4) OJ N° L 302, 15. 11. 1985, p. 216.

(1) EFT nr. L 291 af 19. 11. 1969, s. 9

(5) OJ N° L 136, 20. 5. 1974, p. 1.

(1) OJ N° L. 291, 19. 11. 1969, p. 9

BILAG I

ANNEX I

Liste over de grupper af materialer og genstande, der er undergivet saerditektiver

Plast, herunder lak og beklaedninger

List of groups of materials and articles covered by specific directives

Gelluloseregenerater

Plastics, including varnish and coatings

Elastomerer og naturgummi (kautsjuk)

Regenerated cellulose

Papir og pap

Elastomers and rubber

Keramik

Paperand board

Glas

Ceramics

Metaller og legeringer

Glass

Trae, herunder kork

Metals and alloys

Tekstilvarer

Wood, including cork

Parafinvoks eller mikrokrystallinsk voks.

Textile products

Paraffin waxes and micro-cystalline waxes

BILAG II

ANNEX II

Sundhedsmaessige kriterier, der skal anvendes ved udarbejdelsen af saerdirektiver

1. Der opstilles i givet fald positivlister over stoffer, der kan indgaa i materialer og genstande, som er bestemt til at komme i beroering med levnedsmidler. Naar det bestemmes, om et stof kan optages paa en positivliste, tages der baade hensyn til maengden af det stof, der vil kunne optages i levnedsmidlerne, og til stoffets toksicitet.

Health criteria to be applied in the drafting of specific directives

2. Et stof optages kun paa en positivlistc, naar stoffct ved normal eller paaregnelig anvendelse af et materiale eller en genstand, som det indgaar i, ikke optages i levnedsmidlerne i en saadan maernde, at det kan frembyde en fare for menneskers sundhed.

1. Where appropriate, Positive lists of substances shall be established for materials and articles intended to come into contact with foodstuffs. The acceptability of a substance for inclusion in a positive list shall be determined by considering both the quantity of the substance which is liable to migrate into foodstuffs and the toxicity of the substance

3. For visse materialer kan det vaere uhensigtsmaessigt at udarbejde en positivliste, da en saadan liste ikke vil vaere af nogen vaesentlig betydning for den sundhedsmaessige beskyttelse. I saadanne tilfaelde maa alle de stoffer, for hvilke der skal fastsaettes specifikke migrationsgraenser, identificeres for at hindre, at naevnte stoffer optages i levnedsmidlerne i en saadan maengde, at de kan frembyde sundhedsmaessige farer. De i punkt 1 og 2 omhandlede kriterier gaelder ligeledes for disse stoffer.

2. A substance shall only be included in a positive list where, under normal or foreseeable conditions of use of any material or article of which it forms a part, the substance is not liable to migrate into foodstuffs in a quantity likely to constitute a danger to human health

4. Der foeres loebende tilsyn med samtlige stoffer, og disse undersoeges paa ny, naar nye videnskabelige oplysninger eller en nyvurdering af eksisrerende videnskabelige data goer det berettiget.

3. For certain materials it may be inappropriate to establish a positive list because such a list would offer no tangible benefit in terms of safeguarding human health. In such circumstances, any substances for which specific migration limits need to be established in order to prevent their being transferred to foodstuffs in quantities likely to constitute a danger to health shall be identified. The criteria set out in paragraphs 1 and 2 shall also apply to these substances

5. Hvis der for et bestemt stof fastsaettes en acceptabel dagsdosis eller en tolereret dagsdosis, maa det overvejes, om der skal fastsaettes en specifik migrationsgraense for at sikre, at denne dosis bliver overholdt. Ved fastsaettelsen af en saadan specifik migrationsgraense for et stof boer der tages behoerigt hensyn til, om det paagaeldende stof kan hidroere fra andre eksponeringskilder.

4. All substances shall be kept under review and reassessed whenever this is justified by fresh scientific data or a re-evaluation of existing scientific data

6. I visse tilfaelde vil fastsaettelsen af en specifik migrationsgraense for et stof ikke vaere det mest hensigtsmaessige middel til beskyttelse af den menneskelige sundhed. I saadanne tilfaelde gaar hensynet til den menneskelige sundhed forud for alle andre hensyn, naar det afgoeres, hvad der skal foretages.

5. Where an acceptable daily intake or a tolerable daily intake is established foraparticular substance, the need to establish a specific migration limit in order that this intake is not exceeded shall be considered. Where such a specific migration limit is established for a substance, due regard shall be paid to other possible sources of exposure to the substance

6. In certain circumstances, a specific migration limit on a substance may not be the most valid means of safeguarding human health. In such circumstances, the need to protect human health shall be the primary consideration in determining what action might be appropriate.

BILAG III

ANNEX III

KONKORDANSSKEMA

>TABELPOSITION>

CORRELATION TABLF

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