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

Uredba (ES) št. 258/97 Evropskega parlamenta in Sveta

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

z dne 27. januarja 1997

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

v zvezi z novimi živili in novimi živilskimi sestavinami

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

EVROPSKI PARLAMENT IN SVET EVROPSKE UNIJE STA

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

ob upoštevanju pogodbe o ustanovitvi Evropske skupnosti in zlasti člena 100a Pogodbe,

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,

ob upoštevanju predloga Komisije [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;

ob upoštevanju mnenja Ekonomsko-socialnega odbora [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;

v skladu s postopkom, določenim v členu 189b Pogodbe [3], ob upoštevanju skupnega besedila, ki ga je 9. decembra 1996 odobril Spravni odbor,

(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) ker lahko razlike med nacionalnimi predpisi v zvezi z novimi živili in živilskimi sestavinami ovirajo prosto gibanje živil; ker lahko ustvarijo pogoje nelojalne konkurence in s tem neposredno prizadenejo delovanje notranjega trga;

(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) ker je za varovanje javnega zdravja treba zagotoviti, da so nova živila in nove živilske sestavine po postopku Skupnosti podvrženi enotni presoji varnosti, preden se dajo na trg Skupnosti; ker bi bilo treba v primeru novih živil in novih živilskih sestavin, ki so snovno enakovredne obstoječim živilom in živilskim sestavinam, poskrbeti za poenostavljen postopek;

(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) ker so živilski aditivi, arome za živila in ekstrakcijska topila zajeti v drugi zakonodaji Skupnosti ter bi jih bilo treba zaradi tega izključiti s področja uporabe te uredbe;

(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) ker bi bilo treba ustrezno urediti dajanje na trg novih živil in novih živilskih sestavin, ki izhajajo iz rastlinskih sort, za katere veljata Direktiva Sveta 70/457/EGS z dne 29. septembra 1970 o skupnem imeniku sort kmetijskih rastlin [4] in Direktiva Sveta 70/458/EGS z dne 29. septembra 1970 o trženju semen vrtnin [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) ker se tveganje za okolje lahko povezuje z novimi živili in novimi živilskimi sestavinami, ki vsebujejo gensko spremenjene organizme ali jih ti sestavljajo; ker Direktiva Sveta 90/220/EGS z dne 23. aprila 1990 o namernem izpustu gensko spremenjenih organizmov [6] določa, da je treba za zagotovitev varnosti okolja za take izdelke vedno opraviti presojo tveganja za okolje; ker je za vzpostavitev enotnega sistema Skupnosti za presojo teh izdelkov treba v tej uredbi izdelati določbo za posebno presojo tveganja za okolje, ki mora biti v skladu s postopkom, predvidenim v členu 10 Direktive 90/220/EGS, podobna tisti, določeni v navedeni direktivi, vendar mora vključevati tudi presojo, ali je izdelek primeren za uporabo kot živilo ali živilska sestavina;

(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) Ker bi se bilo treba z Znanstvenim odborom za živila, vzpostavljenim s Sklepom 74/234/EGS [7], posvetovati o vseh vprašanjih v zvezi s to uredbo, ki bi lahko vplivala na zdravje ljudi;

(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) ker se Direktiva Sveta 89/397/EGS z dne 14. junija 1989 o uradnem nadzoru živil [8] in Direktiva Sveta 93/99/EGS z dne 29. oktobra 1993 o dodatnih ukrepih v zvezi z uradnim nadzorom živil [9] uporabljata za nova živila ali živilske sestavine;

(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) ker bi bilo treba brez poseganja v druge zahteve v zakonodaji Skupnosti, ki se nanašajo na označevanje živil, določiti dodatne zahteve za označevanje; ker bi te zahteve morale biti urejene z natančnimi določbami, da bi tako zagotovili, da so potrošniku na voljo potrebne informacije; ker bi bilo treba informirati določene skupine prebivalstva, ki imajo dokaj ustaljene navade v zvezi z živili, kadar se pri teh skupinah pojavljajo etična vprašanja zaradi prisotnosti materiala, ki ni prisoten v obstoječih enakovrednih živilih, v novih živilih; ker morajo biti živila in živilske sestavine, ki vsebujejo gensko spremenjene organizme in se dajejo na trg, varni za človekovo zdravje; ker se to varovanje zagotavlja z upoštevanjem postopka za odobritev, vsebovanega v Direktivi 90/220/EGS in/ali s postopkom enotne presoje, določenim v tej uredbi; ker kolikor pravo Skupnosti določa, da se organizem posebno označi in da se potrošnika obvesti o prisotnosti organizma, ki je bil gensko spremenjen, to predstavlja dodatno zahtevo, ki se uporablja za živila in živilske sestavine, navedene v tej uredbi;

(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) ker v zvezi z živili in živilskimi sestavinami, namenjenimi dajanju na trg za oskrbo končnega potrošnika, ki lahko vsebujejo gensko spremenjene in običajne pridelke, brez poseganja v druge zahteve glede označevanja po tej direktivi, velja – kot izjema, zlasti v zvezi s pošiljkami v velikih količinah – da informacija potrošniku o možnosti prisotnosti gensko spremenjenih organizmov v živilih in živilskih sestavinah izpolnjuje zahteve člena 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) ker dobavitelju nič ne preprečuje, da ne bi potrošnika na oznaki živila ali živilske sestavine informiral, da zadevni izdelek ni novo živilo v smislu te uredbe in da metode za pridobitev novih živil, navedenih v členu 1(2), niso bile uporabljene v proizvodnji navedenega živila ali živilskih sestavin;

HAVE ADOPTED THIS REGULATION:

(11) ker bi bilo treba po tej uredbi izdelati določbo za postopek, ki vpeljuje tesno sodelovanje držav članic in Komisije s Stalnim odborom za živila, vzpostavljenim s Sklepom 69/414/EGS [10];

(12) Ker je bil med Evropskim parlamentom, Svetom in Komisijo v zvezi z ukrepi za izvajanje pravnih aktov, sprejetih po postopku, določenim v členu 189b Pogodbe, 20. decembra 1994 sklenjen modus vivendi [11],

SPREJELA NASLEDNJO UREDBO:

Article 1

Člen 1

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

1. Ta uredba zadeva dajanje novih živil ali novih živilskih sestavin na trg znotraj Skupnosti.

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. Ta uredba se uporablja za dajanje na trg znotraj Skupnosti živil in živilskih sestavin, ki se do sedaj še niso v pomembnem obsegu uporabljale za prehrano ljudi v Skupnosti in se razvrščajo v naslednje skupine:

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

(a) živila in živilske sestavine, ki vsebujejo gensko spremenjene organizme v smislu Direktive 90/220/EGS ali jih ti sestavljajo;

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

(b) živila in živilske sestavine, pridobljena iz gensko spremenjenih organizmov, vendar brez njih;

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

(c) živila in živilske sestavine z novo ali namerno spremenjeno primarno molekularno strukturo;

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

(d) živila in živilske sestavine, ki jih sestavljajo ali so pridobljeni iz mikroorganizmov, gliv ali alg;

(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) živila in živilske sestavine, ki jih sestavljajo rastline ali so pridobljeni iz rastlin, ter živilske sestavine, pridobljene iz živali, razen živil in živilskih sestavin, pridobljenih s tradicionalnim razmnoževanjem ali gojenjem, ki že iz preteklosti veljajo za varna živila;

(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) živila in živilske sestavine, za katere se je uporabil proizvodni postopek, ki se do zdaj še ni uporabljal in, kjer je navedeni postopek povzročil pomembne spremembe v sestavi ali strukturi živil ali živilskih sestavin, ki vplivajo na njihovo prehransko vrednost, metabolizem ali raven neželenih snovi.

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. Po potrebi je mogoče po postopku iz člena 13 določiti, ali vrsta živila ali živilske sestavine sodi na področje uporabe odstavka 2 tega člena.

Člen 2

Article 2

1. Ta uredba se ne uporablja za:

1. This Regulation shall not apply to:

(a) živilske aditive, ki sodijo na področje uporabe Direktive Sveta 89/107/EGS z dne 21. decembra 1988 o približevanju zakonodaje držav članic v zvezi z aditivi za živila, ki se smejo uporabljati v živilih, namenjenih za prehrano ljudi [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) arome za uporabo v živilih, ki sodijo na področje uporabe Direktive Sveta 88/388/EGS z dne 22. junija 1988 o približevanju zakonodaje držav članic v zvezi z aromami za uporabo v živilih in surovinah za njihovo proizvodnjo [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);

(c) ekstrakcijska topila, ki se uporabljajo pri proizvodnji živil in sodijo na področje uporabe Direktive Sveta 88/344/EGS z dne 13. junija 1988 o približevanju zakonodaje držav članic o ekstrakcijskih topilih pri proizvodnji živil in živilskih sestavin [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. Izključitve s področja uporabe te uredbe, navedene v odstavku 1, alineah (a) do (c), se uporabljajo samo, dokler varnostne ravni, določene v direktivah 89/107/EGS, 88/388/EGS in 88/344/EGS, ustrezajo varnostni ravni te uredbe.

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. Ob upoštevanju člena 11 Komisija zagotovi, da varnostne ravni, določene v zgornjih direktivah, pa tudi ukrepi za izvajanje teh direktiv in te uredbe, ustrezajo varnostni ravni te uredbe.

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.

Člen 3

1. Živila in živilske sestavine, ki sodijo na področje uporabe te uredbe, ne smejo:

Article 3

- predstavljati nevarnosti za potrošnika,

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

- potrošnika,

- present a danger for the consumer,

- se razlikovati od živil ali živilskih sestavin, ki naj bi jih nadomestile, v takem obsegu, da bi bilo njihovo običajno uživanje za potrošnika prehransko nekoristno.

- mislead the consumer,

2. Za dajanje živil in živilskih sestavin, ki sodijo na področje uporabe te uredbe, na trg Skupnosti, se uporabljajo postopki iz členov 4, 6, 7 in 8 na podlagi meril, opredeljenih v odstavku 1 tega člena in drugih ustreznih dejavnikov, navedenih v teh členih.

- 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.

Vendar se v primeru živil in živilskih sestavin, navedenih v tej uredbi, ki izhajajo iz rastlinskih sort, ki sodijo na področje uporabe direktiv 70/457/EGS in 70/458/EGS, odločba o odobritvi, navedena v členu 7 te uredbe, sprejme po postopkih, predvidenih v teh direktivah, če upoštevajo načela presoje, določena v tej uredbi, in merila, določena v odstavku 1 tega člena, razen določb, ki se nanašajo na označevanje teh živil in živilskih sestavin, ki bodo po členu 8 določene po postopku iz člena 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. Odstavek 2 se ne uporablja za živila in živilske sestavine, navedene v členu 1(2)(b), kadar je bil gensko spremenjeni organizem, uporabljen v proizvodnji živila ali živilske sestavine, dan na trg v skladu s to uredbo.

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. Z odstopanjem od odstavka 2 se postopek iz člena 5 uporablja za živila ali živilske sestavine, navedene v členu 1(2)(b), (d) in (e), ki so na podlagi razpoložljivih in splošno priznanih znanstvenih dokazil ali na podlagi mnenja, ki ga je dal eden od pristojnih organov, navedenih v členu 4(3), snovno enakovredna obstoječim živilom ali živilskim aditivom glede njihove sestave, prehranske vrednosti, metabolizma, nameravane uporabe in ravni neželenih snovi, ki jih vsebujejo.

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.

Po potrebi se lahko po postopku iz člena 13 določi, ali živilo ali živilska sestavina sodi na področje uporabe tega odstavka.

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.

Člen 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. Oseba, odgovorna za dajanje na trg Skupnosti (v nadaljevanju "prosilec"), predloži zahtevek državi članici, na katere trg želi prvič dati izdelek. Istočasno mora kopijo zahtevka izročiti Komisiji.

2. Opravi se začetna presoja, kakor je predvidena v členu 6.

Article 4

Po postopku, navedenem v členu 6(4), država članica, navedena v odstavku 1, brez odlašanja obvesti prosilca:

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.

- da lahko da na trg živilo ali živilsko sestavino, kadar se ne zahteva dodatna presoja, kakor je navedena v členu 6(3), in da ni bil predložen upravičen ugovor v skladu s členom 6(4), ali

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

- da je v skladu s členom 7 potrebna odločba o odobritvi.

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

3. Vsaka država članica uradno sporoči Komisiji imena in naslove organov za presojo živil, ki so na njenem ozemlju odgovorni za pripravo poročil o začetni presoji, navedenih v členu 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. Pred začetkom veljavnosti te uredbe Komisija objavi priporočila v zvezi z znanstvenimi vidiki:

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

- informacij, ki morajo spremljati zahtevke, in predstavitev teh informacij,

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).

- priprave poročil o začetni presoji, predvidenih v členu 6.

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

5. Vsa podrobna pravila za izvajanje tega člena se sprejmejo po postopku iz člena 13.

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

Člen 5

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

V primeru živil ali živilskih sestavin, navedenih v členu 3(4), prosilec uradno obvesti Komisijo o dajanju na trg, ko to stori. Tako uradno obvestilo spremljajo ustrezne podrobnosti, predvidene v členu 3(4). Komisija posreduje državam članicam v 60 dneh kopijo navedenega uradnega obvestila in, na zahtevo države članice, kopijo z navedenimi ustreznimi podrobnostmi. Komisija vsako leto objavi pregled teh uradnih obvestil v seriji "C"Uradnega lista Evropskih skupnosti.

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

V zvezi z označevanjem veljajo določbe člena 8.

Člen 6

Article 5

1. Zahtevek, naveden v členu 4(1), vsebuje vse potrebne informacije, vključno s kopijami opravljenih študij in vsega drugega gradiva, ki je na voljo kot dokazilo, da to živilo ali živilske sestavine izpolnjujejo merila, določena v členu 3(1), pa tudi ustrezen predlog za predstavitev in označevanje živil ali živilskih sestavin v skladu z zahtevami člena 8. Poleg tega mora zahtevek spremljati povzetek spisa.

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. Po prejemu zahtevka država članica, navedena v členu 4(1), zagotovi, da se opravi začetna presoja. V ta namen Komisiji sporoči ime pristojnega organa za presojo živil, odgovornega za pripravo poročila o začetni presoji, ali pa jo zaprosi, da v dogovoru z drugo državo članico uredi vse potrebno, da eden od pristojnih organov za presojo živil, navedenih v členu 4(3), pripravi tako poročilo.

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

Komisija brez odlašanja posreduje državi članici kopijo povzetka, ki ga je pripravil prosilec, in ime pristojnega organa, odgovornega za pripravo začetne presoje.

3. Poročilo o začetni presoji je treba sestaviti v treh mesecih od prejema zahtevka, ki izpolnjuje pogoje iz odstavka 1, v skladu s priporočili, navedenimi v členu 4(4), in mora odločiti, ali živilo ali živilska sestavina zahteva dodatno presojo v skladu s členom 7.

Article 6

4. Zadevna država članica mora brez odlašanja posredovati poročilo pristojnega organa za presojo živil Komisiji, ki ga posreduje drugim državam članicam. V 60. dneh od dneva, ko je Komisija razposlala poročilo, lahko država članica ali Komisija da pripombe ali upravičeno ugovarja trženju zadevnega živila ali živilske sestavine. Pripombe ali ugovori lahko zadevajo tudi predstavitev ali označevanje živila ali živilske sestavine.

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.

Pripombe ali ugovore je treba posredovati Komisiji, ki jih potem razpošlje državam članicam v 60. dneh, navedenih v prvem pododstavku.

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.

Če tako zahteva država članica, prosilec priskrbi kopijo vseh informacij, ki se pojavljajo v zahtevku.

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.

Člen 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. Če se v skladu s členom 6(3) zahteva dodatna presoja ali pride do ugovora v skladu s členom 6(4), se odločba o odobritvi sprejme po postopku iz člena 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. Odločba opredeljuje področje uporabe odobritve in po potrebi določa:

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.

- pogoje za uporabo živila ali živilske sestavine,

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

- označbo živila ali živilske sestavine in njegovo specifikacijo,

- posebne zahteve glede označevanja, navedene v členu 8.

Article 7

3. Komisija brez odlašanja obvesti prosilca o sprejeti odločbi. Odločbe se objavijo v Uradnem listu Evropskih skupnosti.

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.

Člen 8

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

1. Brez poseganja v druge zahteve prava Skupnosti v zvezi z označevanjem živil se za živila uporabljajo naslednje dodatne zahteve po posebnem označevanju, da bi tako zagotovili obveščenost končnega potrošnika v zvezi z:

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

(a) vsemi značilnostmi ali lastnostmi živil, kot so:

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

- sestava,

- specific labelling requirements as referred to in Article 8.

- prehranska vrednost ali prehranski učinki,

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.

- predvidena uporaba živila,

zaradi česar novo živilo ali živilska sestavina ni več enakovredna obstoječemu živilu ali živilski sestavini.

Article 8

Šteje se, da novo živilo ali živilska sestavina ni več enakovredna za namene tega člena, če znanstvena presoja na podlagi ustrezne analize obstoječih podatkov lahko dokaže, da so presojene značilnosti drugačne v primerjavi z običajnim živilom ali živilsko sestavino ob upoštevanju sprejetih omejitev naravnih variacij teh značilnosti.

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:

V tem primeru mora označevanje navesti spremenjene značilnosti ali lastnosti, skupaj z metodo, po kateri so navedeno značilnost ali lastnost pridobili;

(a) any characteristic or food property such as:

(b) prisotnostjo materiala v novem živilu ali živilski sestavini, ki ni prisoten v obstoječem enakovrednem živilu in ki lahko ima posledice za zdravje nekaterih skupin prebivalstva;

- composition,

(c) prisotnostjo materiala v novem živilu ali živilski sestavini, ki ni prisoten v obstoječem enakovrednem živilu in ki povzroča etično zaskrbljenost;

- nutritional value or nutritional effects,

(d) prisotnostjo organizma, gensko spremenjenega s tehnikami genske spremembe, katerih nepopolni seznam je določen v delu 1 Priloge I A k Direktivi 90/220/EGS.

- intended use of the food,

2. Ko ni obstoječega enakovrednega živila ali živilske sestavine, je treba po potrebi sprejeti ustrezne določbe za zagotovitev ustrezne obveščenosti potrošnika o naravi živila ali živilske sestavine.

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

3. Vsa podrobna pravila za izvajanje tega člena se sprejmejo po postopku iz člena 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.

Člen 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. Ko živilo ali živilska sestavina, ki sodi na področje uporabe te uredbe, vsebuje gensko spremenjene organizme v smislu člena 2(1) in (2) Direktive 90/220/EGS ali je iz njih sestavljena, morajo informacije v zahtevku za dajanje na trg, navedenem v členu 6(1), spremljati:

(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;

- kopija pisnega soglasja pristojnega organa, če obstaja, za namerni izpust gensko spremenjenih organizmov za namene raziskav in razvoja, predvidenih v členu 6(4) Direktive 90/220/EGS, skupaj z rezultati izpustov v zvezi s tveganji za človekovo zdravje in okolje;

(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;

- popoln tehnični spis, ki daje ustrezne informacije, zahtevane v členu 11 Direktive 90/220/EGS, in ocena tveganj za okolje na podlagi teh informacij, rezultate vseh morebitnih študij, opravljenih za namene raziskave in razvoja, ali po potrebi odločba, ki dovoljuje dajanje na trg, predvidena v delu C Direktive 90/220/EGS.

(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.

Členi 11 do 18 Direktive 90/220/EGS se ne uporabljajo za živila in živilske sestavine, ki vsebujejo gensko spremenjene organizme ali so iz njih sestavljena.

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. V primeru živil ali živilskih sestavin, ki sodijo na področje uporabe te uredbe in vsebujejo gensko spremenjene organizme ali so iz njih sestavljena, mora odločba, navedena v členu 7, upoštevati zahteve po varnosti za okolje, določene v Direktivi 90/220/EGS, za zagotovitev sprejetja vseh ukrepov za preprečitev škodljivih učinkov na človekovo zdravje in okolje, do katerih bi lahko prišlo zaradi namernega izpusta gensko spremenjenih organizmov. Med ovrednotenjem zahtevkov za dajanje izdelkov, ki vsebujejo gensko spremenjene organizme ali so iz njih sestavljeni, na trg, Komisija ali države članice z organi, ki jih je vzpostavila Skupnost ali države članice, opravi potrebna posvetovanja v skladu z Direktivo 90/220/EGS.

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

Člen 10

Podrobna pravila za zaščito informacij, ki jih zagotovi prosilec, se sprejmejo po postopku iz člena 13.

Article 9

Člen 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:

O vsaki zadevi, ki sodi na področje uporabe te uredbe in bi lahko vplivala na zdravje ljudi, se posvetuje z Znanstvenim odborom za živila.

- 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;

Člen 12

- 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. Kadar ima država članica na podlagi novih informacij ali ponovne presoje obstoječih informacij izčrpne razloge za mnenje, da uporaba živila ali živilske sestavine, ki izpolnjuje to uredbo, ogroža človekov zdravje ali okolje, lahko začasno omeji ali ustavi trgovanje in uporabo tega živila ali živilske sestavine na svojem ozemlju. O tem nemudoma obvesti druge države članice in Komisijo ter navede razloge za svojo odločitev.

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. Komisija v okviru Stalnega odbora za živila, kakor hitro je mogoče, preuči razloge, navedene v odstavku 1; po postopku iz člena 13 sprejme ustrezne ukrepe. Država članica, ki je sprejela odločitev, navedeno v odstavku 1, jo lahko ohrani, dokler ukrepi ne začnejo veljati.

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.

Člen 13

1. Če je treba ravnati po postopku, opredeljenem v tem členu, Komisiji pomaga Stalni odbor za živila, v nadaljnjem besedilu "odbor".

Article 10

2. Zadeve preda odboru predsednik na lastno pobudo ali na zahtevo predstavnika države članice.

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. Predstavnik Komisije predloži odboru osnutek potrebnih ukrepov. Odbor da svoje mnenje o osnutku v roku, ki ga lahko glede na nujnost zadeve določi predsednik. Mnenje se sprejme z večino, ki jo določa člen 148(2) Pogodbe za sprejemanje odločitev Sveta na predlog Komisije. Glasovi predstavnikov držav članic v odboru se ponderirajo na način iz navedenega člena. Predsednik ne glasuje.

4. (a) Komisija sprejme predlagane ukrepe, če so v skladu z mnenjem odbora.

Article 11

(b) Če predlagani ukrepi niso v skladu z mnenjem odbora ali če mnenje ni dano, Komisija brez odlašanja predloži Svetu predlog ukrepov, ki naj se sprejmejo. Svet odloča s kvalificirano večino.

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.

Če Svet ne odloči v treh mesecih po prejemu predloga, predlagane ukrepe sprejme Komisija.

Člen 14

Article 12

1. Najpozneje pet let od začetka veljavnosti te uredbe in ob upoštevanju pridobljenih izkušenj Komisija predloži Evropskemu parlamentu in Svetu poročilo o izvajanju te uredbe, ki ga po potrebi spremlja ustrezni predlog.

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. Ne glede na poročilo, predvideno v odstavku 1, Komisija spremlja uporabo te uredbe in njen vpliv na zdravje, varstvo potrošnika, obveščanje potrošnika in delovanje notranjega trga ter po potrebi čimprej predstavi predloge.

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.

Člen 15

Ta uredba začne veljati 90 dni po objavi v Uradnem listu Evropskih skupnosti.

Article 13

Uredba je v celoti zavezujoča in se neposredno uporablja v vseh državah članicah.

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.

V Bruslju, 27. januarja 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.

Za Evropski parlament

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

Predsednik

(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.

Za Svet

Predsednik

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] UL C 190, 29.7.1992, str. 3in UL C 16, 19.1.1994, str. 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] UL C 108, 19.4.1993, str. 8.

[3] Mnenje Evropskega parlamenta z dne 27. oktobra 1993 (UL C 315, 22.11.1993, str. 139). Skupno stališče Sveta z dne 23. oktobra 1995 (UL C 320, 30.11.1995, str. 1) in Sklep Evropskega parlamenta z dne 12. marca 1996 (UL C 96, 1.4.1996, str. 26). Sklep Sveta z dne 19. decembra 1996 in Sklep Evropskega parlamenta z dne 16. januarja 1997.

Article 15

[4] UL C 225, 12.10.1970, str. 1. Direktiva, kakor je bila nazadnje spremenjena z Direktivo 90/654/EGS (UL L 353, 17.12.1990, str. 48).

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

[5] UL C 225, 12.10.1970, str. 7. Direktiva, kakor je bila nazadnje spremenjena z Direktivo 90/654/EGS (UL L 353, 17.12.1990, str. 48).

[6] UL L 117, 8.5.1990, str. 15. Direktiva, kakor je bila nazadnje spremenjena z Direktivo 94/15/ES (UL L 103, 22.4.1994, str. 20).

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

[7] UL L 136, 20.5.1974, str. 1.

Done at Brussels, 27 January 1997.

[8] UL L 186, 30.6.1989, str. 23. Direktiva, kakor je bila nazadnje spremenjena z Direktivo 93/99/EGS (UL L 290, 24.11.1993, str. 14).

For the European Parliament

[9] UL L 290, 24.11.1993, str. 14.

The President

[10] UL L 291, 19.11.1969, str. 9.

J. M. GIL-ROBLES

[11] UL C 102, 4.4.1996, str. 1.

For the Council

[12] UL L 40, 11.12.1989, str. 27. Direktiva, kakor je bila nazadnje spremenjena z Direktivo 94/34/ES (UL L 237, 10.9.1994, str. 1).

The President

[13] UL L 184, 15.7.1988, str. 61. Direktiva, kakor je bila nazadnje spremenjena z Direktivo 91/71/EGS (UL L 42, 15.2.1991, str. 25).

G. ZALM

[14] UL L 157, 24.6.1988, str. 28. Direktiva, kakor je bila nazadnje spremenjena z Direktivo 92/115/EGS (UL L 409, 31.12.1992, str. 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.