REGULATION (EC) No 258/97 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 January 1997 concerning novel foods and novel food ingredients

Ir-Regolament (Ke) Nru. 258/97 tal-Parlament Ewropew u tal-Kunsill

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

tas-27 ta’ Jannar 1997

Having regard to the Treaty establishing the European Community, and in particular Article 100a thereof,

dwar l-ikel il-ġdid u l-ingredjenti ta’ l-ikel il-ġdid

Having regard to the proposal from the Commission (1),

IL-PARLAMENT EWROPEW U L-KUNSILL TA’ L-UNJONI EWROPEA,

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

Wara li kkunsidraw it-Trattat li jistabbilixxi l-Komunità Ewropea, u b’mod partikolari l-Artikolu 100a tiegħu,

Acting in accordance with the procedure laid down in Article 189b of the Treaty (3) in the light of the joint text approved by the Conciliation Committee on 9 December 1996,

Wara li kkunsidraw il-proposta mill-Kummissjoni [1],

(1) Whereas differences between national laws relating to novel foods or food ingredients may hinder the free movement of foodstuffs; whereas they may create conditions of unfair competition, thereby directly affecting the functioning of the internal market;

Wara li kkunsidraw l-opinjoni tal-Kumitat Ekonomiku u Soċjali [2],

(2) Whereas, in order to protect public health, it is necessary to ensure that novel foods and novel food ingredients are subject to a single safety assessment through a Community procedure before they are placed on the market within the Community; whereas in the case of novel foods and novel food ingredients which are substantially equivalent to existing foods or food ingredients a simplified procedure should be provided for;

Waqt li jaġixxu skond il-proċedura indikata fl-Artikolu 189b tat-Trattat [3] fid-dawl tat-test konġunt approvat mill-Kumitat tal-Konċiljazzjoni fid-9 ta’ Diċembru 1996,

(3) Whereas food additives, flavourings for use in foodstuffs and extraction solvents are covered by other Community legislation and should therefore be excluded from the scope of this Regulation;

(1) Billi d-differenzi bejn il-liġijiet nazzjonali li għandhom x’jaqsmu ma’ l-ikel il-ġdid jew l-ingredjenti ta’ l-ikel il-ġdid jistgħu jfixklu l-moviment ħieles ta’ l-oġġetti ta’ l-ikel; billi dawn jistgħu joħolqu l-kondizzjonijiet għall-kompetizzjoni inġusta, u b’hekk jaffettwaw direttament il-funzjonament tas-suq intern;

(4) Whereas appropriate arrangements should be made for the placing on the market of novel foods and novel food ingredients derived from plant varieties subject to Council Directive 70/457/EEC of 29 September 1970 on the common catalogue of varieties of agricultural plant species (4) and Council Directive 70/458/EEC of 29 September 1970 on the marketing of vegetable seed (5);

(2) Billi, sabiex tiġi protetta s-saħħa pubblika, huwa meħtieġ li jiġi żgurat illi l-ikel il-ġdid u l-ingredjenti ta’ l-ikel il-ġdid ikunu soġġetti għal valutazzjoni waħda dwar is-sigurtà permezz ta’ proċedura Komunitarja qabel ma jitqiegħdu fis-suq fil-Komunità; billi fil-każ ta’ l-ikel il-ġdid u l-ingredjenti ta’ l-ikel il-ġdid li huma sostanzjalment ekwivalenti għall-ikel jew l-ingredjenti ta’ l-ikel eżistenti għandha tiġi pprovduta proċedura simplifikata;

(5) Whereas risks to the environment may be associated with novel foods or novel food ingredients which contain or consist of genetically modified organisms; whereas Council Directive 90/220/EEC of 23 April 1990 on the deliberate release into the environment of genetically modified organisms (6) stipulates that, for such products, an environmental risk assessment must always be undertaken to ensure environmental safety; whereas, in order to establish a unified Community system for assessment of such products, provision must be made under this Regulation for a specific environmental risk assessment, which in accordance with the procedure provided for in Article 10 of Directive 90/220/EEC must be similar to that laid down in that Directive, but must also include the assessment of the suitability of the product to be used as a food or food ingredient;

(3) Billi l-addittivi ta’ l-ikel, il-ħwawar għall-użu fl-oġġetti ta’ l-ikel u s-solventi ta’ l-estrazzjoni huma koperti b’leġislazzjoni Komunitarja oħra u għalhekk għandhom ikunu esklużi mill-kamp ta’ applikazzjoni ta’ dan ir-Regolament;

(6) Whereas the Scientific Committee for Food set up by Decision 74/234/EEC (7) should be consulted on any question relating to this Regulation which may have an effect on public health;

(4) Billi għandhom isiru arranġamenti xierqa dwar it-tqegħid fis-suq ta’ ikel ġdid u ingredjenti ta’ ikel ġodda derivati minn varjetajiet ta’ pjanti soġġetti għad-Direttiva tal-Kunsill 70/457/KEE tad-29 ta’ Settembru 1970 dwar il-katalgu komuni tal-varjetajiet ta’ l-ispeċi tal-pjanti agrikoli [4] u d-Direttiva tal-Kunsill 70/458/KEE tad-29 ta’ Settembru 1970 dwar il-marketing taż-żerriegħa tal-ħxejjex. [5]

(7) Whereas Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs (8) and Council Directive 93/99/EEC of 29 October 1993 on the subject of additional measures concerning the official control of foodstuffs (9) apply to novel foods or food ingredients;

(5) Billi r-riskji għall-ambjent jistgħu ikunu assoċjati ma’ l-ikel il-ġdid jew l-ingredjenti ta’ l-ikel il-ġdid li jkun fihom jew ikunu jikkonsistu f’organiżmi ġenetikament modifikati; billi d-Direttiva tal-Kunsill 90/220/KEE tat-23 ta’ April 1990 dwar ir-rilaxx deliberat fl-ambjent ta’ organiżmi ġenetikament modifikati [6] tistabbilixxi illi, għal dawn il-prodotti, dejjem għandha issir stima tar-riskju ambjentali sabiex tiżgura s-sigurtà ambjentali; billi sabiex tiġi stabbilita sistema unifikata Komunitarja għal dawn il-prodotti, għandha issir dispożizzjoni skond dan ir-Regolament għal stima speċifika tar-riskju ambjentali, li skond il-proċedura stipulata fl-Artikolu 10 ta’Direttiva 90/220/KEE għandha tkun simili għal dik stabbilita b’din id-Direttiva, imma għandha ukoll tinkludi stima ta’ kemm ikun xieraq il-prodott li jrid ikun użat bħala ikel jew ingredjent ta’ l-ikel;

(8) Whereas, without prejudice to the other requirements in Community legislation relating to the labelling of foodstuffs, additional specific requirements on labelling should be laid down; whereas these requirements must be subject to precise provisions in order to ensure that the necessary information is available to the consumer; whereas defined population groups associated with well established practices regarding food should be informed when the presence in a novel food of material which is not present in the existing equivalent foodstuff gives rise to ethical concerns as regards those groups; whereas foods and food ingredients which contain genetically modified organisms and which are placed on the market must be safe for human health; whereas this assurance is provided for through compliance with the authorization procedure contained in Directive 90/220/EEC and/or by the single assessment procedure laid down in this Regulation; whereas insofar as an organism is defined by Community law, with respect to labelling, information to the consumer on the presence of an organism which has been genetically modified constitutes an additional requirement applicable to the foods and food ingredients referred to in this Regulation;

(6) Billi l-Kumitat Xjentifiku għall-Ikel stabbilit bid-Deċiżjoni 74/234/KEE [7] għandu jkun ikkonsultat dwar kull kwistjoni u li għandha x’taqsam ma’ dan ir-Regolament u li jista’ jkollha effett fuq is-saħħa pubblika;

(9) Whereas, in respect of foods and food ingredients which are intended to be placed on the market to be supplied to the final consumer, and which may contain both genetically modified and conventional produce, and without prejudice to the other labelling requirements of this Regulation, information for the consumer on the possibility that genetically modified organisms may be present in the foods and food ingredients concerned is deemed - by way of exception, in particular as regards bulk consignments - to fulfil the requirements of Article 8;

(7) Billi d-Direttiva tal-Kunsill 89/397/KEE ta’ fl-14 ta’ Ġunju 1989 dwar il-kontroll uffiċjali ta’ l-oġġetti ta’ l-ikel [8] u d-Direttiva tal-Kunsill 92/99/KEE tad-29 ta’ Ottubru 1993 dwar is-suġġett tal-miżuri addizzjonali li jirrigwardaw il-kontroll uffiċjali ta’ l-oġġetti ta’ l-ikel [9] tapplika għall-ikel il-ġdid u l-ingredjenti ta’ l-ikel il-ġdid.

(10) Whereas nothing shall prevent a supplier from informing the consumer on the labelling of a food or food ingredient that the product in question is not a novel food within the meaning of this Regulation or that the techniques used to obtain novel foods indicated in Article 1 (2) were not used in the production of that food or food ingredient;

(8) Billi, mingħajr preġudizzju għal ħtiġiet l-oħra tal-leġislazzjoni Komunitarja li għandhom x’jaqsmu mat-tikkettjar ta’ l-oġġetti ta’ l-ikel, għandhom jiġu stabbiliti l-ħtiġiet addizzjonali speċifiċi dwar it-tikkettjar; billi dawn il-ħtiġiet għandhom ikunu soġġetti għal dispożizzjonijiet preċiżi sabiex jiżguraw illi t-tagħrif meħtieġ ikun disponibbli għall-konsumatur; billi gruppi definiti fost il-popolazzjoni assoċjati ma’ prattiki stabbiliti sewwa dwar l-ikel, għandhom ikunu mgħarrfa meta l-preżenza fl-ikel il-ġdid ta’ materjal li ma jkunx preżenti fl-ikel ekwivalenti eżistenti joħloq tħassib etiku rigward dawk il-gruppi; billi l-ikel u l-ingredjenti ta’ l-ikel li jkun fihom organiżmi ġenetikament modifikati u li jitqiegħdu fis-suq jeħtieġ li ma jkunux ta’ ħsara għas-saħħa tal-bniedem; billi din l-assigurazzjoni hija pprovduta permezz tal-konformità mal-proċedura ta’ l-awtorizzazzjoni li tinsab fid-Direttiva 90/220/KEE u/jew mal-proċedura ta’ stima waħda stabbilita f’dan ir-Regolament; billi safejn organiżmu huwa definit bil-liġi tal-Komunità fejn għandu x’jaqsam it-tikkettjar, it-tagħrif lill-konsumatur dwar il-preżenza ta’ xi organiżmu li jkun ġie ġenetikanent modifikat jikkostitwixxi ħtieġa addizzjonali li japplika għall-ikel u l-ingredjenti ta’ l-ikel riferiti f’dan ir-Regolament;

(11) Whereas, under this Regulation, provision should be made for a procedure instituting close cooperation between Member States and the Commission within the Standing Committee on Foodstuffs set up by Decision 69/414/EEC (10);

(9) Billi, rigward l-ikel u l-ingredjenti ta’ l-ikel li huma maħsuba biex jitqiegħdu fis-suq sabiex ikunu forniti lill-konsumatur finali, u li jista’ jkun fihom prodott kemm ġentikament modifikat u kemm konvenzjonali, u mingħajr preġudizzju għal ħtiġiet oħra tat-tikkettjar skond dan ir-Regolament, it-tagħrif lill-konsumatur dwar il-possibbiltà li organiżmi ġenetikament modifikati jistgħu jkunu preżenti fl-oġġetti ta’ l-ikel u fl-ingredjenti ta’ l-ikel konċernati jitqies - bħala eċċezzjoni, b’mod partikolari rigward il-kunsinji bl-ingrossa - li jissodisfa l-ħtiġiet ta’ l-Artikolu 8;

(12) Whereas a modus vivendi between the European Parliament, the Council and the Commission concerning the implementing measures for acts adopted in accordance with the procedure laid down in Article 189b of the Treaty was concluded on 20 December 1994 (11),

(10) Billi xejn ma għandu jwaqqaf fornitur milli jgħarraf lill-konsumatur fuq it-tikketti ta’ ikel jew ingredjent ta’ l-ikel illi l-prodott fil-kwistjoni mhuwiex ikel ġdid fit-tifsira ta’ dan ir-Regolament jew illi t-teknika użata sabiex jinkiseb l-ikel il-ġdid indikat fl-Artikolu 1(2) ma kenux ġew użati fil-produzzjoni ta’ dan l-ikel jew dan l-ingredjent ta’ l-ikel;

HAVE ADOPTED THIS REGULATION:

(11) Billi, skond dan ir-Regolament, għandha ssir dispożizzjoni għal proċedura li tistitwixxi kooperazzjoni mill-qrib bejn l-Istati Membri u l-Kummissjoni fil-Kumitat Permanenti dwar l-Oġġetti ta’ l-Ikel stabbilit bid-Deċiżjoni 69/414/KEE [10];

(12) Billi, fl-20 ta’ Diċembru 1994 kien konkluż modusvivendi bejn il-Parlament Ewropew, il-Kunsill u l-Kummissjoni li jirrigwarda l-miżuri sabiex jiġu implimentati għall-atti adottati skond il-proċedura stabilita fl-Artikolu 189b tat-Trattat [11],

ADOTTAW DAN IR- REGOLAMENT:

Article 1

L-Artikolu 1

1. This Regulation concerns the placing on the market within the Community of novel foods or novel food ingredients.

1. Dan ir-Regolament jirrigwarda t-tqegħid fis-suq fil-Komunità ta’ ikel ġdid jew l-ingredjenti ta’ ikel ġdid.

2. This Regulation shall apply to the placing on the market within the Community of foods and food ingredients which have not hitherto been used for human consumption to a significant degree within the Community and which fall under the following categories:

2. Dan ir-Regolament għandu japplika għat-tqegħid fis-suq fil-Komunità ta’ ikel jew ingredjenti ta’ l-ikel li s’issa ma ġewx użati għall-konsum mill-bniedem fi grad sinifikanti ġewwa l-Komunità u li jaqgħu taħt il-kategoriji li ġejjin:

(a) foods and food ingredients containing or consisting of genetically modified organisms within the meaning of Directive 90/220/EEC;

(a) l-ikel u l-ingredjenti ta’ l-ikel li jkun fihom jew jikkonsistu f’organiżmi ġenetikament modifikati fit-tifsira tad-Direttiva 90/220/KEE;

(b) foods and food ingredients produced from, but not containing, genetically modified organisms;

(b) l-ikel u l-ingredjenti ta’ l-ikel prodotti minn, imma li ma fihomx, organiżmi ġenetikament modifikati;

(c) foods and food ingredients with a new or intentionally modified primary molecular structure;

(ċ) l-ikel u l-ingredjenti ta’ l-ikel bi struttura primarja molekulari ġdida jew modifikata intenzjonalment;

(d) foods and food ingredients consisting of or isolated from micro-organisms, fungi or algae;

(d) l-ikel u l-ingredjenti ta’ l-ikel li jikkonsistu fi, jew iżolati mill-mikro-organiżmi, il-fungi jew l-alka;

(e) foods and food ingredients consisting of or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices and having a history of safe food use;

(e) l-ikel u l-ingredjenti ta’ l-ikel li jikkonsistu fi, jew iżolati minn pjanti u ingredjenti ta’ l-ikel iżolati mill-bhejjem, għajr l-ikel u l-ingredjenti ta’ l-ikel miksuba mill-propagazzjoni jew il-prattiki tat-tgħammir tradizzjonali u li għandhom storja ta’ użu ta’ ikel fis-sigurtà;

(f) foods and food ingredients to which has been applied a production process not currently used, where that process gives rise to significant changes in the composition or structure of the foods or food ingredients which affect their nutritional value, metabolism or level of undesirable substances.

(f) l-ikel u l-ingredjenti ta’ l-ikel li lilhom ġie applikat proċess tal-produzzjoni mhux użat korrentement fejn dan il-proċess joħloq bidliet sinifikanti fil-kompożizzjoni jew l-istruttura ta’ l-ikel jew l-ingredjenti ta’ l-ikel li jaffettwaw il-valur nutrizzjonali, il-metaboliżmu jew il-livell tas-sustanzi mhux mixtieqa.

3. Where necessary, it may be determined in accordance with the procedure laid down in Article 13 whether a type of food or food ingredient falls within the scope of paragraph 2 of this Article.

3. Fejn ikun meħtieġ, jista’ jiġi stabbilit skond il-proċedura stabbilita fl-Artikolu 13 jekk tip ta’ ikel jew ta’ ingredjent ta’ l-ikel jaqax jew le skond fil-kamp ta’ applikazzjoni tal-paragrafu 2 ta’ dan l-Artikolu.

L-Artikolu 2

Article 2

1. Dan ir-Regolament ma għandux japplika għal:

1. This Regulation shall not apply to:

(a) l-additivi ta’ l-ikel li jidħlu fil-kamp ta’ applikazzjoni tad-Direttiva tal-Kunsill 89/107/KEE tal-21 ta’ Diċembru 1988 dwar l-approssimazzjoni tal-liġijiet ta’ l-Istati Membri li jirrigwardaw l-additivi ta’ l-ikel awtorizzati għall-użu fl-oġġetti ta’ l-ikel maħsuba għall-konsum mill-bniedem [12];

(a) food additives falling within the scope of Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorized for use in foodstuffs intended for human consumption (12);

(b) il-ħwawar sabiex jintużaw fl-oġġetti ta’ l-ikel li jidħlu fil-kamp ta’ applikazzjoni tad-Direttiva tal-Kunsill 88/388/KEE tat-22 ta’ Ġunju 1988 dwar l-approssimazzjoni tal-liġijiet ta’ l-Istati Membri li għandhom x’jaqsmu mal-ħwawar għall-użu fl-oġġetti ta’ l-ikel u fil-materji prima għall-produzzjoni tagħhom [13];

(b) flavourings for use in foodstuffs, falling within the scope of Council Directive 88/388/EEC of 22 June 1988 on the approximation of the laws of the Member States relating to flavourings for use in foodstuffs and to source materials for their production (13);

(ċ) is-solventi ta’ l-estrazzjoni użati fil-produzzjoni ta’ l-oġġetti ta’ l-ikel li jidħlu fil-kamp ta’ applikazzjoni tad-Direttiva tal-Kunsill 88/344/KEE tat-13 ta’ Ġunju 1988 dwar l-approssimazzjoni tal-liġijiet ta’ l-Istati Membri dwar is-solventi ta’ l-estrazzjoni użati fil-produzzjoni ta’ l-oġġetti ta’ l-ikel u ta’ l-ingredjenti ta’ l-ikel [14].

(c) extraction solvents used in the production of foodstuffs, falling within the scope of Council Directive 88/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (14).

2. L-esklużjonijiet mill-kamp ta’ applikazzjoni ta’ dan ir-Regolament riferiti fl-inċiżi (a) sa (ċ) tal-paragrafu 1 għandhom japplikaw biss sakemm il-livelli tas-sigurtà stabbiliti bid-Direttivi 80/107/KEE, 88/388/KEE u 88/344/KEE jikkorrispondu mal-livell ta’ sigurtà ta’ dan ir-Regolament.

2. The exclusions from the scope of this Regulation referred to in paragraph 1, indents (a) to (c) shall only apply for so long as the safety levels laid down in Directives 89/107/EEC, 88/388/EEC and 88/344/EEC correspond to the safety level of this Regulation.

3. Filwaqt li jingħata l-qies dovut lill-Artikolu 11 il-Kummissjoni għandha tiżgura illi l-livelli tas-sigurtà stabbiliti bid-Direttivi ta’ hawn fuq, kif ukoll fil-miżuri ta’ l-implimentazzjoni ta’ dawn id-Direttivi u għal dan ir-Regolament jikkorrispondu mal-livell tas-sigurtà ta’ dan ir-Regolament.

3. With due regard for Article 11 the Commission shall ensure that the safety levels laid down in the above Directives, as well as in the implementing measures for these Directives and this Regulation, correspond to the safety level of this Regulation.

L-Artikolu 3

1. L-ikel u l-ingredjenti ta’ l-ikel li jidħlu fil-kamp ta’ applikazzjoni ta’ dan ir-Regolament ma għandhomx:

Article 3

- ikunu ta’ perikolu għall-konsumatur,

1. Foods and food ingredients falling within the scope of this Regulation must not:

- iqarrqu bil-konsumatur,

- present a danger for the consumer,

- ikunu differenti mill-ikel jew l-ingredjenti ta’ l-ikel li posthom huma maħsuba biex jieħdu safejn u sakemm il-konsum normali tagħhom ikun nutrizzjonalment ta’ żvantaġġ għall-konsumatur.

- mislead the consumer,

2. Bil-għan li l-ikel u l-ingredjenti ta’ l-ikel li jidħlu fil-kamp ta’ applikazzjoni ta’ dan ir-Regolament jitqiegħdu fis-suq ġewwa l-Komunità, il-proċeduri stabbiliti fl-Artikoli 4, 6, 7 u 8 għandhom japplikaw abbażi tal-kriterji definiti fil-paragrafu 1 ta’ dan l-Artikolu u l-fatturi l-oħra rilevanti riferiti f’dawk l-Artikoli.

- differ from foods or food ingredients which they are intended to replace to such an extent that their normal consumption would be nutritionally disadvantageous for the consumer.

Madankollu, fil-każ ta’ ikel jew l-ingredjenti ta’ l-ikel riferiti f’dan ir-Regolament idderivati minn varjetajiet ta’ pjanti soġġetti għad-Direttivi 70/457/KEE u 70/458/KEE, id-deċiżjoni dwar l-awtorizzazzjoni riferita fl-Artikolu 7 ta’ dan ir-Regolament għandha tittieħed skond il-proċeduri pprovduti f’dawk id-Direttivi, sakemm iqisu l-prinċipji ta’ l-istima stabbiliti f’dan ir-Regolament u l-kriterji stabbiliti fil-paragrafu 1 ta’ dan l-Artikolu, bl-eċċezzjoni tad-dispożizzjonijiet li għandhom x’jaqsmu mat-tikkettjar ta’ dan l-ikel jew dawn l-ingredjenti ta’ l-ikel, li għandhom jiġu stabbiliti, skond l-Artikolu 8, skond il-proċedura stabilita fl-Artikolu 13

2. For the purpose of placing the foods and food ingredients falling within the scope of this Regulation on the market within the Community, the procedures laid down in Articles 4, 6, 7 and 8 shall apply on the basis of the criteria defined in paragraph 1 of this Article and the other relevant factors referred to in those Articles.

3. Il-paragrafu 2 ma għandux japplika għall-ikel u l-ingredjenti ta’ l-ikel riferiti fl-Artikolu 1(2)(b) fejn l-organiżmu ġenetikament modifikat użat fil-produzzjoni ta’ l-ikel jew ta’ l-ingredjent ta’ l-ikel ikun imqiegħed fis-suq skond dan ir-Regolament.

However, in the case of foods or food ingredients referred to in this Regulation derived from plant varieties subject to Directives 70/457/EEC and 70/458/EEC, the authorization decision referred to in Article 7 of this Regulation shall be taken in accordance with the procedures provided for in those Directives, provided they take account of the assessment principles laid down in this Regulation and the criteria set out in paragraph 1 of this Article, with the exception of the provisions relating to the labelling of such foods or food ingredients, which shall be established, pursuant to Article 8, in accordance with the procedure laid down in Article 13.

4. Bħala deroga mill-paragrafu 2, il-proċedura stabbilita fl-Artikolu 5 għandha tapplika għall-ikel jew l-ingredjenti ta’ l-ikel riferiti fl-Artikolu 1(2)(b), (d) u (e) li, abbażi tax-xhieda xjentifika disponibbli u ġeneralment rikonoxxuta jew abbażi ta’ l-opinjoni mogħtija minn wieħed mill-korpijiet kompetenti riferiti fl-Artikolu 4(3), huma sostanzjalment ekwivalenti għall-ikel jew l-ingredjenti ta’ l-ikel eżistenti rigward il-kompożizzjoni, il-valur nutrizzjonali, il-metaboliżmu, u l-użu maħsub tagħhom u l-livell tas-sustanzi mhux mixtieqa li jkunu jinsabu fihom;

3. Paragraph 2 shall not apply to the foods and food ingredients referred to in Article 1 (2) (b) where the genetically modified organism used in the production of the food or food ingredient has been placed on the market in accordance with this Regulation.

Fejn meħtieġ, jista’ jiġi stabilit skond il-proċedura stabilita fl-Artikolu 13 jekk tip ta’ ikel jew ingredjent ta’ l-ikel jidħlux jew le f’dan il-paragrafu.

4. By way of derogation from paragraph 2, the procedure laid down in Article 5 shall apply to foods or food ingredients referred to in Article 1 (2) (b), (d) and (e) which, on the basis of the scientific evidence available and generally recognized or on the basis of an opinion delivered by one of the competent bodies referred to in Article 4 (3), are substantially equivalent to existing foods or food ingredients as regards their composition, nutritional value, metabolism, intended use and the level of undesirable substances contained therein.

L-Artikolu 4

Where necessary, it may be determined in accordance with the procedure laid down in Article 13 whether a type of food or food ingredient falls under this paragraph.

1. Il-persuna responsabbli milt-tqegħid fis-suq tal-Komunità (minn issa ’l quddiem imsejjaħ "l-applikant") għandha tissottometti talba lill-Istat Membru li fih il-prodott ikun sejjer jitqiegħed fis-suq għall-ewwel darba. Fl-istess ħin, din il-persuna għandha tibgħat kopja tat-talba lill-Kummissjoni.

2. Għandha tiġi mwettqa stima inizjali kif ipprovdut fl-Artikolu 6.

Article 4

Wara l-proċedura riferita fl-Artikolu 6(4), l-Istat Membru riferit fil-paragrafu 1 għandu jgħarraf lill-applikant mingħajr dewmien:

1. The person responsible for placing on the Community market (hereinafter 'the applicant`) shall submit a request to the Member State in which the product is to be placed on the market for the first time. At the same time, he shall forward a copy of the request to the Commission.

- li jista’ jqiegħed l-ikel jew l-ingredjent ta’ l-ikel fis-suq, fejn l-istima addizzjonali riferita fl-Artikolu 6(3) ma tkunx meħtieġa, u li ma tkun ġiet ippreżentata l-ebda oġġezzjoni raġunata skond l-Artikolu 6(4), jew

2. An initial assessment as provided for in Article 6 shall be carried out.

- li, skond l-Artikolu 7, tinħtieġ deċiżjoni ta’ awtorizzazzjoni.

Following the procedure referred to in Article 6 (4), the Member State referred to in paragraph 1 shall inform the applicant without delay:

3. Kull Stat Membru għandu jinnotifika lill-Kummissjoni bl-isem u l-indirizz ta’ l-korpijiet ta’ l-istima ta’ l-ikel responsabbli fit-territorju tiegħu għat-tħejjija tar-rapporti inizjali riferiti fl-Artikolu 6(2).

- that he may place the food or food ingredient on the market, where the additional assessment referred to in Article 6 (3) is not required, and that no reasoned objection has been presented in accordance with Article 6 (4), or

4. Qabel id-data tad-dħul fis-seħħ ta’ dan ir-Regolament, il-Kummissjoni għandha tippubblika r-rakkomandazzjonijiet li jirrigwardaw l-aspetti xjentifiċi ta’:

- that, in accordance with Article 7, an authorization decision is required.

- it-tagħrif meħtieġ sabiex jappoġġja l-applikazzjoni u l-preżentazzjoni ta’ dan it-tagħrif,

3. Each Member State shall notify to the Commission the name and address of the food assessment bodies responsible in its territory for preparing the initial assessment reports referred to in Article 6 (2).

- it-tħejjija tar-rapporti inizjali ta’ l-istima pprovduti fl-Artikolu 6.

4. Before the date of entry into force of this Regulation, the Commission shall publish recommendations concerning the scientific aspects of:

5. Kull regola ddettaljata sabiex jiġi implimentat dan l-Artikolu għandha tiġi adottata skond il-proċedura stabilita fl-Artikolu 13.

- the information necessary to support an application and the presentation of such information,

L-Artikolu 5

- the preparation of the initial assessment reports provided for in Article 6.

Fil-każ ta’ l-ikel jew l-ingredjenti ta’ l-ikel riferiti fl-Artikolu 3(4), l-applikant għandu jinnotifika lill-Kummissjoni dwar it-tqegħid gid fis-suq meta jagħmel dan. Din in-notifika għandha tkun akkumpanjata bid-dettalji rilevanti stipulati fl-Artikolu 3(4). Il-Kummissjoni għandha tagħddi lill-Istati Membri kopja ta’ dik in-notifika fi żmien 60 jum u, fuq it-talba ta’ Stat Membru, kopja tad-dettalji rilevanti msemmija. Il-Kummissjoni għandha tippublika kull sena sommarju ta’ dawn in-notifiki fis-serje "C' tal-Ġurnal Uffiċjali tal-Komunitajiet Ewropej".

5. Any detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 13.

Rigward it-tikkettjar, għandhom japplikaw id-dispożizzjonijiet ta’ l-Artikolu 8.

L-Artikolu 6

Article 5

1. It-talba riferita fl-Artikolu 4(1) għandu jkun fiha t-tagħrif meħtieġ, inkluża kopja ta’ l-istudji li kienu ġew imwettqa u kull materjal ieħor li huwa disponibbli sabiex juri illi l-ikel jew l-ingredjent ta’ l-ikel jikkonformaw mal-kriterji stabbiliti fl-Artikolu 3(1), kif ukoll proposta xierqa għall-preżentazzjoni u t-tikkettjar, skond il-ħtiġiet ta’ l-Artikolu 8, ta’ l-ikel jew l-ingredjent ta’ l-ikel. Minbarra dan, it-talba għandha tkun akkumpanjata minn sommarju tad-dossier.

In the case of the foods or food ingredients referred to in Article 3 (4), the applicant shall notify the Commission of the placing on the market when he does so. Such notification shall be accompanied by the relevant details provided for in Article 3 (4). The Commission shall forward to Member States a copy of that notification within 60 days and, at the request of a Member State, a copy of the said relevant details. The Commission shall publish each year a summary of those notifications in the 'C` series of the Official Journal of the European Communities.

2. Malli jirċievi t-talba, l-Istat Membru riferit fl-Artikolu 4(1) għandu jiżgura illi titwettaq l-istima inizjali. Għal dak l-iskop, għandu jinnotifika lill-Kummissjoni bl-isem tal-korp kompetenti għall-istima ta’ l-ikel li huwa responsabbli għat-tħejjija tar-rapport ta’ l-istima inizjali, jew isaqsi lill-Kummissjoni sabiex jiftiehem ma’ Stat Membru ieħor sabiex wieħed mill-korpijiet ta’ l-istima ta’ l-ikel riferit fl-Artikolu 4(3) iħejji dan ir-rapport.

With respect to labelling, the provisions of Article 8 shall apply.

Il-Kummissjoni għandha tgħaddi lill-Istati Membri mingħajr dewmien kopja tas-sommarju pprovdut mill-applikant u l-isem tal-korp kompetenti responsabbli mit-twettiq ta’ l-istima inizjali.

3. Ir-rapport ta’ l-istima inizjali għandu jkun imfassal f’perjodu ta’ tliet xhur mill-irċevuta tat-talba li għandha tilħaq il-kondizzjonijiet stabbiliti fil-paragrafu 1, skond ir-rakkomandazzjonijiet riferiti fl-Artikolu 4(4), u għandu jiddeċiedi jekk l-ikel jew l-ingredjent ta’ l-ikel jirrikjedux stima addizzjonali skond l-Artikolu 7 jew le.

Article 6

4. L-Istat Membru konċernat għandu mingħajr dewmien jibgħat ir-rapport tal-korp kompetenti ta’ stima ta’ l-ikel lill-Kummissjoni, li għandha tgħaddih lill-Istati Membri l-oħra. F’perjodu taż-żmien ta’ 60 jum mid-data taċ-ċirkolazzjoni tar-rapport mill-Kummissjoni, Stat Membru jew il-Kummissjoni jistgħu jagħmlu l-kummenti tagħhom jew jippreżentaw oġġezzjoni raġunata għall-marketing ta’ l-ikel jew l-ingredjent ta’ l-ikel konċernat. Il-kummenti jew oġġezzjonijiet jistgħu jikkonċernaw ukoll il-preżentazzjoni jew it-tikkettjar ta’ l-ikel jew l-ingredjent ta’ l-ikel

1. The request referred to in Article 4 (1) shall contain the necessary information, including a copy of the studies which have been carried out and any other material which is available to demonstrate that the food or food ingredient complies with the criteria laid down in Article 3 (1), as well as an appropriate proposal for the presentation and labelling, in accordance with the requirements of Article 8, of the food or food ingredient. In addition, the request shall be accompanied by a summary of the dossier.

Il-kummenti jew l-oġġezzjonijiet għandhom jiġu mgħoddija lill-Kummissjoni, li għandha tiċċirkolahom lill-Istati Membri fil-perjodu taż-żmien ta’ 60 jum rferit fl-ewwel sotto-paragrafu.

2. Upon receipt of the request, the Member State referred to in Article 4 (1) shall ensure that an initial assessment is carried out. To that end, it shall notify the Commission of the name of the competent food assessment body responsible for preparing the initial assessment report, or ask the Commission to arrange with another Member State for one of the competent food assessment bodies referred to in Article 4 (3) to prepare such a report.

L-applikant għandu, fejn Stat Membru hekk jitlob, jipprovdi kopja ta’ kull tagħrif pertinenti li tidher fit-talba.

The Commission shall forward to the Member States without delay a copy of the summary provided by the applicant and the name of the competent body responsible for carrying out the initial assessment.

L-Artikolu 7

3. The initial assessment report shall be drawn up within a period of three months from receipt of a request meeting the conditions laid down in paragraph 1, in accordance with the recommendations referred to in Article 4 (4), and shall decide whether or not the food or food ingredient requires additional assessment in accordance with Article 7.

1. Fejn tinħtieġ stima addizzjonali skond l-Artikolu 6(3) jew titqajjem oġġezzjoni skond l-Artikolu 6(4), għandha tittieħed deċiżjoni ta’ awtorizzazzjoni skond il-proċedura stabbilita fl-Artikolu 13.

4. The Member State concerned shall without delay forward the report of the competent food assessment body to the Commission, which shall forward it to the other Member States. Within a period of 60 days from the date of circulation of the report by the Commission, a Member State or the Commission may make comments or present a reasoned objection to the marketing of the food or food ingredient concerned. The comments or objections may also concern the presentation or labelling of the food or food ingredient.

2. Id-deċiżjoni għandha tiddefinixxi l-kamp ta’ applikazzjoni ta’ l-awtorizzazzjoni u għandha tistabbilixxi, fejn xieraq:

Comments or objections shall be forwarded to the Commission, which shall circulate them to Member States within the period of 60 days referred to in the first subparagraph.

- il-kondizzjonijiet dwar l-użu ta’ l-ikel jew ta’ l-ingredjent ta’ l-ikel,

The applicant shall, where a Member State so requests, provide a copy of any pertinent information appearing in the request.

- l-isem mogħti lill-ikel jew lill-ingredjent ta’ l-ikel u l-ispeċifikazzjoni tagħhom.

- il-ħtiġiet speċifiċi tat-tikkettjar kif riferit fl-Artikolu 8.

Article 7

3. Il-Kummissjoni għandha tgħarraf mingħajr dewmien lill-applikant bid-deċiżjoni meħuda. Id-deċiżjonijiet għandhom jiġu ppublikati fil-Ġurnal Uffiċjali tal-Komunitajiet Ewropej.

1. Where an additional assessment is required in accordance with Article 6 (3) or an objection is raised in accordance with Article 6 (4), an authorization decision shall be taken in accordance with the procedure laid down in Article 13.

L-Artikolu 8

2. The decision shall define the scope of the authorization and shall establish, where appropriate:

1. Mingħajr preġudizzju għall-ħtiġiet l-oħra tal-liġi Komunitarja li tirrigwardja it-tikkettjar ta’ l-oġġetti ta’ l-ikel, il-ħtiġiet addizzjonali speċifiċi tat-tikkettjar li ġejjin għandhom japplikaw għall-oġġetti ta’ l-ikel sabiex jiżguraw illi l-konsumatur ta’ l-aħħar jiġi mgħarraf bi:

- the conditions of use of the food or food ingredient,

(a) kull karatteristika jew proprjeta’ ta’ l-ikel bħal:

- the designation of the food or food ingredient, and its specification,

- il-komposizzjoni,

- specific labelling requirements as referred to in Article 8.

- il-valur nutrizzjonali jew l-effetti nutrizzjonali,

3. The Commission shall without delay inform the applicant of the decision taken. Decisions shall be published in the Official Journal of the European Communities.

- l-użu maħsub ta’ l-ikel,

li jwassal sabiex ikel ġdid jew ingredjent ta’ ikel ġdid ma jibqgħux aktar ekwivalenti għall-ikel jew l-ingredjent ta’ l-ikel eżistenti.

Article 8

Ikel ġdid jew ingredjent ta’ l-ikel ġdid għandhom jitqiesu bħala mhux aktar ekwivalenti għall-iskop ta’ dan l-Artikolu jekk stima xjentifika, ibbażata fuq analiżi xierqa ta’ l-informazzjoni eżistenti, tista’ turi illi l-karatteristiċi stmati huma differenti meta mqabbla ma’ ikel konvenzjonali jew ingredjent konvenzjonali ta’ l-ikel, filwaqt li jitqiesu l-limiti aċċettati tal-varjazzjonijiet naturali dwar dawn il-karatterisitiċi.

1. Without prejudice to the other requirements of Community law concerning the labelling of foodstuffs, the following additional specific labelling requirements shall apply to foodstuffs in order to ensure that the final consumer is informed of:

F’dan il-każ, it-tikkettjar għandu jindika l-karatteristiċi jew il-proprjetajiet modifikati flimkien mal-metodu li bihom ġiet miksuba din il-karatterisitika jew proprjetà;

(a) any characteristic or food property such as:

(b) il-preżenza fl-ikel il-ġdid jew fl-ingredjent ta’ l-ikel il-ġdid ta’ materjal li ma jkunx preżenti f’oġġett ta’ l-ikel ekwivalenti eżistenti u li jista’ jkollha implikazzjonijiet għas-saħħa ta’ ċertu sezzjonijiet tal-popolazzjoni;

- composition,

(ċ) il-preżenza fl-ikel il-ġdid jew fl-ingredjent ta’ l-ikel il-ġdid ta’ materjal li mhux preżenti f’oġġett ta’ ikel ekwivalenti eżistenti u li jqajjem tħassib etiku;

- nutritional value or nutritional effects,

(d) il-preżenza ta’ organiżmu ġenetikament modifikat b’t-teknika tal-modifikazzjoni ġenetika, li l-lista mhux eżawrjenti tiegħu hija stabilita fil-Parti I ta’ l-Anness I A, għad-Direttiva 90/220/KEE.

- intended use of the food,

2. Fin-nuqqas ta’ ikel ekwivalenti eżistenti jew ta’ ingredjent ta’ l-ikel ekwivalenti eżistenti, għandhom jiġu adottati d-dispożizzjonijiet xierqa fejn meħtieġ sabiex jiżguraw illi konsumaturi jiġu mgħarrfa adegwatament dwar in-natura ta’ l-ikel jew ta’ l-ingredjent ta’ l-ikel.

which renders a novel food or food ingredient no longer equivalent to an existing food or food ingredient.

3. Kull regola ddettaljata sabiex jiġi implimentat dan l-Artikolu għandha tiġi adottata skond il-proċedura stabbilita fl-Artikolu 13.

A novel food or food ingredient shall be deemed to be no longer equivalent for the purpose of this Article if scientific assessment, based upon an appropriate analysis of existing data, can demonstrate that the characteristics assessed are different in comparison with a conventional food or food ingredient, having regard to the accepted limits of natural variations for such characteristics.

L-Artikolu 9

In this case, the labelling must indicate the characteristics or properties modified, together with the method by which that characteristic or property was obtained;

1. Fejn ikel jew ingredjent ta’ l-ikel li jidħlu fil-kamp ta’ applikazzjoni ta’ dan ir-Regolament ikun fihom jew huma organiżmu ġenetikament modifikat fit-tifsira ta’ l-Artikolu 2(1) u (2) tad-Direttiva 90/220KEE, it-tagħrif meħtieġ fit-talba għat tqegħid fis-suq riferita fl-Artikolu 6(1) għandu ikun akkumpanjat minn:

(b) the presence in the novel food or food ingredient of material which is not present in an existing equivalent foodstuff and which may have implications for the health of certain sections of the population;

- kopja tal-kunsens bil-miktub, jekk ikun hemm, mill-awtorità kompetenti, għar-rilaxx deliberat ta’ l-organiżmi ġenetikament modifikati għall-iskopijiet tar-riċerka u ta’ l-iżvilupp ipprovduti fl-Artikolu 6(4) tad-Direttiva 90/220/KEE, flimkien mar-riżultati tar-rilaxx(i) fir-rigward ta’ kull riskju għas-saħħa tal-bniedem u ta’ l-ambjent;

(c) the presence in the novel food or food ingredient of material which is not present in an existing equivalent foodstuff and which gives rise to ethical concerns;

- id-dossier tekniku komplet li jforni t-tagħrif rilevanti mitlub fl-Artikolu 11 tad-Direttiva 90/220/KEE u l-istima tar-riskju fuq l-ambjent ibbażata fuq dan it-tagħrif, ir-riżultati ta’ kull studju mwettaq għall-iskopijiet tar-riċerka u ta’ l-iżvilupp jew, fejn xieraq, id-deċiżjoni li tawtoriżża t-tqegħid fis-suq ipprovdut fil-Parti Ċ tad-Direttiva 90/220/KEE.

(d) the presence of an organism genetically modified by techniques of genetic modification, the non-exhaustive list of which is laid down in Annex I A, Part 1 of Directive 90/220/EEC.

L-Artikoli 11 sa 18 tad-Direttiva 90/220/KEE ma għandhomx japplikaw għall-prodotti jew l-ingredjenti ta’ l-ikel li jkun fihom jew jikkonsistu f’organiżmi ġenetikament modifikati.

2. In the absence of an existing equivalent food or food ingredient, appropriate provisions shall be adopted where necessary in order to ensure that consumers are adequately informed of the nature of the food or food ingredient.

2. Fil-każ ta’ l-ikel jew l-ingredjenti ta’ l-ikel li jidħlu fil-kamp ta’ applikazzjoni ta’ dan ir-Regolament li jkun ikun fihom jew li jikkonsistu f’organiżmi ġenetikament modifkati, id-deċiżjoni riferita fl-Artikolu 7 għandha tirrispetta l-ħtiġiet tas-sigurtà ambjentali stabbiliti bid-Direttiva 90/220/KEE sabiex jiġi żgurat illi jittieħdu l-miżuri xierqa kollha sabiex jiġu evitati l-effetti kuntrarji fuq is-saħħa tal-bniedem u ta’ l-ambjent li jistgħu jirriżultaw mir-rilaxx deliberat ta’ organiżmi ġenetikament modifikati. Matul l-evalwazzjoni tat-talbiet għat-tqegħid fis-suq tal-prodotti li jkun fihom jew li jikkonsistu f’organiżmi ġenetikament modifikati, għandhom isiru l-konsultazzjonijiet meħtieġa mill-Kummissjoni jew mill-Istati Membri mal-korpi mwaqqfa mill-Komunità jew mill-Istati Membri skond id-Direttiva 90/220/KEE.

3. Any detailed rules for implementing this Article shall be adopted in accordance with the procedure laid down in Article 13.

L-Artikolu 10

Għandhom jiġu adottati regoli ddettaljati għall-protezzjoni tat-tagħrif ipprovdut mill-applikant skond il-proċedura stabbilita fl-Artikolu 13.

Article 9

L-Artikolu 11

1. Where a food or food ingredient falling within the scope of this Regulation contains or consists of a genetically modified organism within the meaning of Article 2 (1) and (2) of Directive 90/220/EEC, the information required in the request for placing on the market referred to in Article 6 (1) shall be accompanied by:

Il-Kumitat Xjentifiku ta’ l-Ikel għandu jiġi kkonsultat fuq kull materja li tidħol fil-kamp ta’ applikazzjoni ta’ dan ir-Regolament li x’aktarx ikollha effett fuq is-saħħa pubblika.

- a copy of the written consent, if any, from the competent authority, to the deliberate release of the genetically modified organisms for research and development purposes provided for in Article 6 (4) of Directive 90/220/EEC, together with the results of the release(s) with respect to any risk to human health and the environment;

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- the complete technical dossier supplying the relevant information requested in Article 11 of Directive 90/220/EEC and the environmental risk assessment based on this information, the results of any studies carried out for the purposes of research and development or, where appropriate, the decision authorizing the placing on the market provided for in part C of Directive 90/220/EEC.

1. Fejn Stat Membru, bħala riżultat ta’ tagħrif ġdid jew ta’ stima mill-ġdid tat-tagħrif li diġà jeżisti, ikollu raġunijiet iddettaljati sabiex iqis illi l-użu ta’ ikel jew ta’ ingredjent ta’ l-ikel li jikkonformaw ma’ dan ir-Regolament jipperikola s-saħħa tal-bniedem jew l-ambjent, dak l-Istat Membru jista’ jew jirrestrinġi temporanjament jew jissospendi l-kummerċ fl-ikel jew l-ingredjent ta’ l-ikel fil-kwistjoni u l-użu tagħhom fit-territorju tiegħu. Għandu jgħarraf minnufih lill-Istati Membri l-oħra u lill-Kummissjoni u jagħti r-raġunijiet għad-deċiżjoni tiegħu.

Articles 11 to 18 of Directive 90/220/EEC shall not apply to foods or food ingredients which contain or consist of genetically modified organisms.

2. Il-Kummissjoni għandha teżamina r-raġunijiet referiti fil-paragrafu 1 mill-aktar fis possibli fil-Kumitat Permanenti ta’ l-Oġġetti ta’ l-Ikel; għandha tieħu l-miżuri xierqa skond il-proċedura stabbilita fl-Artikolu 13. L-Istat Membru li jkun ħa d-deċiżjoni riferita fil-paragrafu 1 jista’ jmantniha sakemm il-miżuri jkunu daħlu fis-seħħ.

2. In the case of foods or food ingredients falling within the scope of this Regulation containing or consisting of genetically modified organisms, the decision referred to in Article 7 shall respect the environmental safety requirements laid down by Directive 90/220/EEC to ensure that all appropriate measures are taken to prevent the adverse effects on human health and the environment which might arise from the deliberate release of genetically modified organisms. During evaluation of requests for the placing on the market of products containing or consisting of genetically modified organisms, the necessary consultations shall be held by the Commission or the Member States with the bodies set up by the Community or the Member States in accordance with Directive 90/220/EEC.

L-Artikolu 13

1. Fejn il-proċedura definita f’dan l-Artikolu għandha tiġi implimentata, il-Kummissjoni għandha tkun assistita mill-Kumitat Permanenti ta’ l-Oġġetti ta’ l-Ikel, minn issa ’l quddiem imsejjaħ "il-Kumitat".

Article 10

2. Kwistjonijiet għandhom jiġu riferiti lill-Kumitat mill-President jew fuq l-inizjattiva tiegħu jew fuq it-talba tar-rappreżentant ta’ xi Stat Membru.

Detailed rules for the protection of the information provided by the applicant shall be adopted in accordance with the procedure laid down in Article 13.

3. Ir-rappreżentant tal-Kummissjoni għandu jissottometti lill-Kumitat abbozz tal-miżuri li jridu jittieħdu. Il-Kumitat għandu jagħti l-opinjoni tiegħu dwar l-abbozz f’limitu taż-żmien li jista’ jistabilixxi l-President skond l-urġenza tal-kwistjoni. L-opinjoni għandha tiġi mogħtija bil-maġġoranza stabbilita fl-Artikolu 148(2) tat-Trattat fil-każ tad-deċiżjonijiet illi l-Kunsill ikun meħtieġ illi jadotta fuq proposta mill-Kummissjoni. Il-voti tar-rappreżentanti ta’ l-Istati Membri fil-Kumitat għandhom jiġu peżati bil-mod stabbilit f’dak l-Artikolu. Il-President ma għandux jivvota.

4. (a) Il-Kummissjoni għandha tadotta l-miżuri previsti jekk dawn ikunu skond l-opinjoni tal-Kumitat.

Article 11

(b) Jekk il-miżuri previsti ma jkunux skond l-opinjoni tal-Kumitat, jew jekk l-ebda opinjoni ma tiġi mogħtija, il-Kummissjoni għandha mingħajr dewmien, tissottometti lill-Kunsill proposta li għandha x’taqsam mal-miżuri li jridu jittieħdu. Il-Kunsill għandu jaġixxi b’maġġoranza kkwalifikata.

The Scientific Committee for Food shall be consulted on any matter falling within the scope of this Regulation likely to have an effect on public health.

Jekk, mat-temma tal-perjodu taż-żmien ta’ tliet xhur mid-data tar-riferiment lill-Kunsill, il-Kunsill ma jkunx aġixxa, il-miżuri proposti għandhom jiġu adottati mill-Kummissjoni.

L-Artikolu 14

Article 12

1. Mhux aktar tard minn ħames snin mid-dħul fis-seħħ ta’ dan ir-Regolament u fid-dawl ta’ l-esperjenza miksuba, il-Kummissjoni għandha tibgħat lill-Parlament Ewropew u lill-Kunsill rapport dwar l-implimetazzjoni ta’ dan ir-Regolament akkumpanjat, fejn xieraq, b’kull proposta xierqa.

1. Where a Member State, as a result of new information or a reassessment of existing information, has detailed grounds for considering that the use of a food or a food ingredient complying with this Regulation endangers human health or the environment, that Member State may either temporarily restrict or suspend the trade in and use of the food or food ingredient in question in its territory. It shall immediately inform the other Member States and the Commission thereof, giving the grounds for its decision.

2. Minkejja l-eżami mill-ġdid stipulat fil-paragrafu 1, il-Kummissjoni għandha tissorvelja l-applikazzjoni ta’ dan ir-Regolament u l-impatt tiegħu fuq is-saħħa, il-protezzjoni tal-konsumatur, it-tagħrif lill-konsumatur u l-funzjonament tas-suq intern u, jekk meħtieġ, għandha tressaq proposti fl-iktar data kmieni possibbli.

2. The Commission shall examine the grounds referred to in paragraph 1 as soon as possible within the Standing Committee for Foodstuffs; it shall take the appropriate measures in accordance with the procedure laid down in Article 13. The Member State which took the decision referred to in paragraph 1 may maintain it until the measures have entered into force.

L-Artikolu 15

Dan ir-Regolament għandu jidħol fis-seħħ 90 jum wara l-pubblikazzjoni tiegħu fil-Ġurnal Uffiċjali tal-Komunitajiet Ewropej.

Article 13

Dan ir-Regolament għandu jorbot fl-intier tiegħu u japplika direttament fl-Istati Membri kollha.

1. Where the procedure defined in this Article is to be implemented, the Commission shall be assisted by the Standing Committee for Foodstuffs, hereinafter referred to as the 'Committee`.

2. Matters shall be referred to the Committee by the Chairman either on his own initiative or at the request of the representative of a Member State.

Magħmul fi Brussel, fis-27 ta’ Jannar 1997.

3. The representative of the Commission shall submit to the Committee a draft of the 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 majority laid down in Article 148 (2) of the Treaty in the case of decisions which the Council is required to adopt on a proposal from the Commission. The votes of the representatives of the Member States within the Committee shall be weighted in the manner set out in that Article. The Chairman shall not vote.

Għall-Parlament Ewropew

4. (a) The Commission shall adopt the measures envisaged if they are in accordance with the opinion of the Committee.

Il-President

(b) If the measures envisaged are not in accordance with the opinion of the Committee, or if no opinion is delivered, the Commission shall, without delay, submit to the Council a proposal relating to the measures to be taken. The Council shall act by a qualified majority.

J. M. Gil-Robles

If, on the expiry of a period of three months from the date of referral to the Council, the Council has not acted, the proposed measures shall be adopted by the Commission.

Għall-Kunsill

Il-President

Article 14

G. Zalm

1. No later than five years from the date of entry into force of this Regulation and in the light of experience gained, the Commission shall forward to the European Parliament and to the Council a report on the implementation of this Regulation accompanied, where appropriate, by any suitable proposal.

[1] ĠU C 190, tad-29.7.1992, p. 3 u ĠU C 16, tad-19.1.1994, p. 10

2. Notwithstanding the review provided for in paragraph 1, the Commission shall monitor the application of this Regulation and its impact on health, consumer protection, consumer information and the functioning of the internal market and, if necessary, will bring forward proposals at the earliest possible date.

[2] ĠU C 108, tad-19.4.1993, p. 8.

[3] L-Opinjoni tal-Parlament Ewropew tas-27 ta’ Ottubru 1993 (ĠU C 315, tat-22.11.1993, p. 139). Il-Pożizzjoni Komuni tal-Kunsill tat-23 ta’ Ottubru 1995 (ĠU C 320, tat-30.11.1995 p. 1) u d-Deċiżjoni tal-Parlament Ewropew tat-12 ta’ Marzu 1996 (ĠU C 96, ta’ l-1.4.1996, p. 26). Id-Deċiżjoni tal-Kunsill tad-19 ta’ Diċembru 1996 u d-Deċiżjoni tal-Parlament Ewropew tas-16 ta’ Jannar 1997.

Article 15

[4] ĠU L 225, tat-12.10.1970, p. 1. Direttiva kif l-aħħar emendata bid-Direttiva 90/654/KEE (ĠU L 353, tas-17.12.1990, p. 48.

This Regulation shall enter into force 90 days following its publication in the Official Journal of the European Communities.

[5] ĠU L 225, tat-12.10.1970, p. 7. Direttiva kif l-aħħar emendata bid-Direttiva 90/654/KEE (ĠU L 353, tas-17.12.1990, p. 48.

[6] ĠU L 117, tat-8.5.1990, p. 15. Direttiva kif l-aħħar emendata bid-Direttiva 94/15/KE (ĠU L 103, tat-22.4.1994, p. 20).

This Regulation shall be binding in its entirety and directly applicable in all Member States.

[7] ĠU L 136, ta’ l-20.5.1974, p. 1.

Done at Brussels, 27 January 1997.

[8] ĠU L 186, tat-30.6.1989, p. 23. Direttiva kif l-aħħar emendata bid-Direttiva 93/99/KEE (ĠU L 290, ta’ l-24.11.1993, p. 14).

For the European Parliament

[9] ĠU L 290, ta’ l-24.11.1993, p. 14.

The President

[10] ĠU L 291, tad-19.11.1969, p. 9.

J. M. GIL-ROBLES

[11] ĠU C 102, ta’ l-4.4.1996, p. 1.

For the Council

[12] ĠU L 40, tal-11.2.1989, p. 27. Direttiva kif l-aħħar emendata bid-Direttiva 94/34/KE (ĠU L 237, ta’ l-10.9.1994, p. 1.

The President

[13] ĠU L 184, tal-15.7.1988, p. 61. Direttiva kif l-aħħar emendata bid-Direttiva 91/71/KEE (ĠU L 42, tal-15.2.1991, p. 25.

G. ZALM

[14] ĠU L 157, ta’ l-24.6.1988, p. 28. Direttiva kif l-aħħar emendata bid-Direttiva 92/115/KEE (ĠU L 409, tal-31.12.1992, p. 31.

--------------------------------------------------

(1) OJ No C 190, 29. 7. 1992, p. 3

and OJ No C 16, 19. 1. 1994, p. 10.

(2) OJ No C 108, 19. 4. 1993, p. 8.

(3) Opinion of the European Parliament of 27 October 1993 (OJ No C 315, 22. 11. 1993, p. 139). Council Common Position of 23 October 1995 (OJ No C 320, 30. 11. 1995, p. 1) and Decision of the European Parliament of 12 March 1996 (OJ No C 96, 1. 4. 1996, p. 26). Decision of the Council of 19 December 1996 and Decision of the European Parliament of 16 January 1997.

(4) OJ No L 225, 12. 10. 1970, p. 1. Directive as last amended by Directive 90/654/EEC (OJ No L 353, 17. 12. 1990, p. 48).

(5) OJ No L 225, 12. 10. 1970, p. 7. Directive as last amended by Directive 90/654/EEC (OJ No L 353, 17. 12. 1990, p. 48).

(6) OJ No L 117, 8. 5. 1990, p. 15. Directive as last amended by Directive 94/15/EC (OJ No L 103, 22. 4. 1994, p. 20).

(7) OJ No L 136, 20. 5. 1974, p. 1.

(8) OJ No L 186, 30. 6. 1989, p. 23. Directive as last amended by Directive 93/99/EEC (OJ No L 290, 24. 11. 1993, p. 14).

(9) OJ No L 290, 24. 11. 1993, p. 14.

(10) OJ No L 291, 19. 11. 1969, p. 9.

(11) OJ No C 102, 4. 4. 1996, p. 1.

(12) OJ No L 40, 11. 2. 1989, p. 27. Directive as last amended by Directive 94/34/EC (OJ No L 237, 10. 9. 1994, p. 1).

(13) OJ No L 184, 15. 7. 1988, p. 61. Directive as last amended by Directive 91/71/EEC (OJ No L 42, 15. 2. 1991, p. 25).

(14) OJ No L 157, 24. 6. 1988, p. 28. Directive as last amended by Directive 92/115/EEC (OJ No L 409, 31. 12. 1992, p. 31).

COMMISSION STATEMENT - AD ARTICLE 2

The Commission confirms that should it appear, in the light of experience, that there are gaps in the system of protection of public health provided for by the existing legal framework, in particular in respect of processing aids, it will formulate appropriate proposals in order to fill those gaps.