natgillin/translations-raw huggingface dataset:
claims which make reference to recommendations of individual doctors or health professionals and other associations not referred to in Article 11.
trditve, ki se sklicujejo na priporočila posameznih zdravnikov ali zdravstvenih strokovnjakov in drugih združenj, ki niso omenjena v členu 11.
Health claims other than those referring to the reduction of disease risk
Zdravstvene trditve, ki se ne nanašajo na zmanjšanje tveganja za bolezen
Health claims describing or referring to:
Zdravstvene trditve, ki opisujejo ali se sklicujejo na:
the role of a nutrient or other substance in growth, development and the functions of the body, or
vlogo hranila ali druge snovi pri rasti, razvoju in telesnih funkcijah; ali
psychological and behavioural functions; or
psihične in vedenjske funkcije; ali
without prejudice to Directive 96/8/EC, slimming or weight-control or a reduction in the sense of hunger or an increase in the sense of satiety or to the reduction of the available energy from the diet,
brez poseganja v Direktivo 96/8/ES, hujšanje ali nadzorovanje teže ali zmanjšanje občutka lakote ali povečanje občutka sitosti ali zmanjšanje razpoložljive energijske vrednosti iz prehrane;
which are included in the list provided for in paragraph 3 may be made without undergoing the authorisation procedure laid down in Articles 15 to 18, if they are:
ki so vključene v seznam iz odstavka 3, se lahko oblikujejo brez opravljenega postopka odobritve iz členov 15 do 18, če:
based on generally accepted scientific data; and
temeljijo na splošno sprejetih znanstvenih podatkih; in
well understood by the average consumer.
jih povprečni potrošnik dobro razume.
Member States shall provide the Commission with lists of claims as referred to in paragraph 1 by 31 January 2008 at the latest accompanied by the conditions applying to them and by references to the relevant scientific justification.
Države članice Komisiji posredujejo sezname trditev iz odstavka 1 najpozneje do 31. januarja 2008, skupaj s pogoji, ki veljajo zanje in, s sklicevanjem na ustrezno znanstveno utemeljitev.
After consulting the Authority, the Commission shall adopt, in accordance with the procedure referred to in Article 24(2), a Community list of permitted claims as referred to in paragraph 1, and all necessary conditions for the use of these claims by 31 January 2010 at the latest.
Komisija po posvetovanju z Agencijo in v skladu s postopkom iz člena 24(2) sprejme najpozneje do 31. januarja 2010 seznam Skupnosti z dopustnimi trditvami iz odstavka 1 in vse pogoje, potrebne za uporabo teh trditev.
Any changes to the list referred to in paragraph 3, based on generally accepted scientific data, shall be adopted in accordance with the procedure referred to in Article 24(2), after consulting the Authority, on the Commission's own initiative or following a request by a Member State.
Vse spremembe seznama iz odstavka 3 se sprejmejo na podlagi splošno sprejetih znanstvenih podatkov in v skladu s postopkom iz člena 24(2), in sicer po posvetovanju z Agencijo, na lastno pobudo Komisije ali zahtevo države članice.
Any additions of claims to the list referred to in paragraph 3 based on newly developed scientific data and/or which include a request for the protection of proprietary data shall be adopted following the procedure laid down in Articles 15 to 18.
Vse dodane trditve na seznamu iz odstavka 3, ki so utemeljene na novo ugotovljenih znanstvenih podatkih in/ali vključujejo zahtevo za zakonsko zaščito podatkov, sprejmejo po postopku iz členov 15 do 18.
Reduction of disease risk claims
Trditve v zvezi z zmanjšanjem tveganja za bolezen
Notwithstanding Article 2(1)(b) of Directive 2000/13/EC, reduction of disease risk claims may be made where they have been authorised in accordance with the procedure laid down in Articles 15 to 18 of this Regulation for inclusion in a Community list of such permitted claims together with all the necessary conditions for the use of these claims.
Ne glede na člen 2(1)(b) Direktive 2000/13/ES so trditve v zvezi z zmanjšanjem tveganja za bolezni dopustne, če so bile v skladu s postopkom iz členov 15 do 18 te uredbe odobrene za vključitev med takšne dovoljene trditve v seznam Skupnosti, skupaj z vsemi pogoji, potrebnimi za uporabo teh trditev.
In addition to the general requirements laid down in this Regulation and the specific requirements of paragraph 1, for reduction of disease risk claims the labelling or, if no such labelling exists, the presentation or advertising shall also bear a statement indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.
Poleg splošnih zahtev, določenih v tej uredbi, in posebnih zahtev iz odstavka 1, je treba pri označevanju ali, če tako označevanje ne obstaja, pri predstavljanju ali oglaševanju trditev v zvezi z zmanjšanjem tveganja za bolezen, navesti, da za bolezen, na katero se trditev nanaša, obstaja več dejavnikov tveganja in da ima sprememba enega teh dejavnikov tveganja lahko ugoden učinek, kar pa ni njuno.
Application for authorisation
Vloga za odobritev
When reference is made to this Article, an application for authorisation shall be submitted in accordance with the following paragraphs.
Ob sklicevanju na ta člen se predloži vloga za odobritev v skladu z naslednjimi odstavki.
The application shall be sent to the national competent authority of a Member State.
Vloga se pošlje pristojnemu nacionalnemu organu države članice.
The national competent authority shall:
Pristojni nacionalni organ:
acknowledge receipt of an application in writing within 14 days of its receipt.
pisno potrdi prejem vloge v roku 14 dni po prejemu.
The acknowledgement shall state the date of receipt of the application;
V potrdilu je zabeležen datum prejema vloge;
inform without delay the Authority; and
o vlogi nemudoma obvesti Agencijo; in
make the application and any supplementary information supplied by the applicant available to the Authority;
Agenciji da na razpolago vlogo in vse dodatne informacije, ki jih je predložil vlagatelj.
the Authority shall:
Agencija:
inform without delay the other Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them;
nemudoma obvesti druge države članice in Komisijo o vlogi ter jim jo da na razpolago skupaj z vsemi dodatnimi informacijami, ki jih je predložil vlagatelj;
make the summary of the application referred to in paragraph 3(g) available to the public.
da javnosti na voljo povzetek vloge iz odstavka 3(g).
The application shall include the following:
Vloga vsebuje:
the nutrient or other substance, or the food or the category of food, in respect of which the health claim is to be made and its particular characteristics;
hranilo ali drugo snov ali živilo ali kategorijo živila, za katero naj velja zdravstvena trditev, ter njene posebne značilnosti;
a copy of the studies, including, where available, independent, peer-reviewed studies, which have been carried out with regard to the health claim and any other material which is available to demonstrate that the health claim complies with the criteria provided for in this Regulation;
kopije študij, vključno z — kadar so na voljo — neodvisnimi, strokovno pregledanimi študijami, ki so bile opravljene, da potrdijo zdravstveno trditev, in katerim koli drugim razpoložljivim gradivom, s katerim se lahko dokaže, da je zdravstvena trditev v skladu z merili, določenimi v tej uredbi;
where appropriate, an indication of the information which should be regarded as proprietary accompanied by verifiable justification;
kjer je to ustrezno, navedbo, kateri podatek velja za zakonsko zaščitenega, vključno s preverljivo utemeljitvijo;
a copy of other scientific studies which are relevant to that health claim;
kopije drugih znanstvenih študij, ki so pomembne za to zdravstveno trditev;
a proposal for the wording of the health claim for which authorisation is sought including, as the case may be, specific conditions for use;
predlog besedila zdravstvene trditve, za katero se išče odobritev, vključno, odvisno od primera, s posebnimi pogoji uporabe;
a summary of the application.
povzetek vloge.
The Commission, having first consulted the Authority, shall establish in accordance with the procedure referred to in Article 24(2) implementing rules for the application of this Article, including rules concerning the preparation and presentation of the application.
Komisija po posvetovanju z Agencijo in v skladu s postopkom iz člena 24(2) določi pravila za izvajanje tega člena, vključno s pravili za pripravo in vložitev vloge.
The Commission, in close cooperation with the Authority, shall make available appropriate technical guidance and tools to assist food business operators, in particular SMEs, in the preparation and presentation of the application for scientific assessment.
Komisija da, v tesnem sodelovanju z Agencijo, na voljo ustrezna tehnična navodila in orodja za pomoč nosilcem živilske dejavnosti in zlasti MSP pri pripravi in oddaji vloge za znanstveno presojo.
In giving its opinion, the Authority shall endeavour to respect a time limit of six months from the date of receipt of a valid application.
Agencija si prizadeva upoštevati rok šestih mesecev od datuma prejema veljavne vloge za pripravo mnenja.
Such time limit shall be extended whenever the Authority seeks supplementary information from the applicant as provided for in paragraph 2.
Ta rok se podaljša vedno kadar Agencija na podlagi odstavka 2 tega člena od vlagatelja zahteva dodatne informacije.
The Authority or a national competent authority through the Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specified time limit.
Agencija ali pristojni nacionalni organ preko Agencije lahko, kadar je to primerno, od vlagatelja zahteva, da v določenem roku dopolni podatke, ki so priloženi vlogi.
In order to prepare its opinion, the Authority shall:
Za pripravo svojega mnenja Agencija:
verify that the proposed wording of the health claim is substantiated by scientific data;
preveri, ali je predlagano besedilo zdravstvene trditve utemeljeno z znanstvenimi podatki;
consider whether the wording of the health claim complies with the criteria laid down in this Regulation;
preuči, ali je besedilo zdravstvene trditve v skladu z merili, določenimi v tej uredbi;
give advice on whether the proposed wording of the health claim is understandable and meaningful to the average consumer.
svetuje, ali je predlagano besedilo zdravstvene trditve razumljivo in jasno povprečnemu potrošniku.
In the event of an opinion in favour of authorising the health claim, the opinion shall include the following particulars:
V primeru, da mnenje podpira odobritev zdravstvene trditve, mora le- to vsebovati še naslednje podatke:
the nutrient or other substance, or the food or the category of food, in respect of which a claim is to be made and its particular characteristics;
hranilo ali drugo snov ali živilo ali kategorijo živila, za katero naj velja trditev, ter njene posebne lastnosti;
the recommended wording of the proposed health claim, including, as the case may be, the specific conditions of use;
priporočeno besedilo predlagane zdravstvene trditve in, odvisno od primera, posebne pogoje uporabe;
where applicable, conditions or restrictions of use of the food and/or an additional statement or warning that should accompany the health claim on the label and in advertising.
kjer je to ustrezno, pogoje ali omejitve uporabe živila in/ali dodatno pojasnilo ali opozorilo, ki mora spremljati zdravstveno trditev na označbi in pri oglaševanju.
The Authority shall forward its opinion to the Commission, the Member States and the applicant, including a report describing its assessment of the health claim and stating the reasons for its opinion and the information on which its opinion was based.
Agencija posreduje svoje mnenje Komisiji, državam članicam in vlagatelju, vključno s poročilom o oceni zdravstvene trditve in obrazložitvijo svojega mnenja ter podatki, na katerih je bilo mnenje utemeljeno.
The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public.
Agencija objavi svoje mnenje v skladu s členom 38(1) Uredbe (ES) št. 178/2002.
The applicant or members of the public may make comments to the Commission within 30 days from such publication.
Vlagatelj ali javnost lahko v roku 30 dni po taki objavi predložita svoje pripombe Komisiji.
Within three months after receiving the opinion of the Authority, the Commission shall submit to the Committee referred to in Article 22(2) a draft decision on the lists of permitted health claims, taking into account the opinion of the Authority, any relevant provisions of Community law and other legitimate factors relevant to the matter under consideration.
V roku treh mesecev po prejemu mnenja Agencije Komisija odboru iz člena 22(2) predloži osnutek odločbe o seznamih dovoljenih zdravstvenih trditev, pri čemer se upošteva mnenje Agencije, vse zadevne določbe prava Skupnosti in druge zakonite dejavnike, pomembne za obravnavano zadevo.
Where the draft Decision is not in accordance with the opinion of the Authority, the Commission shall provide an explanation for the differences.
Če se osnutek odločbe ne ujema z mnenjem Agencije, Komisija pojasni razloge za odstopanje.
Any draft decision to amend the lists of permitted health claims shall include the particulars referred to in Article 16(4).
Vsak osnutek odločbe za dopolnitev seznamov dovoljenih zdravstvenih trditev vsebuje podatke, ki so opredeljeni v členu 16(4).
A final decision on the application shall be adopted in accordance with the procedure referred to in Article 24(2).
Dokončna odločba o vlogi se sprejme v skladu s postopkom iz člena 24(2).
The Commission shall, without delay, inform the applicant of the decision taken and publish details of the decision in the Official Journal of the European Union.
Komisija o svoji odločitvi nemudoma obvesti vlagatelja, podrobnosti te odločbe pa objavi v Uradnem listu Evropske unije.
Health claims included in the lists provided for in Articles 13 and 14 may be used, in conformity with the conditions applying to them, by any food business operator, if they are not restricted for use in accordance with the provisions of Article 20.
Zdravstvene trditve, vključene v sezname iz členov 13 in 14, lahko v skladu s pogoji, ki zanje veljajo, uporabljajo vsi nosilci živilske dejavnosti, če uporaba teh trditev ni omejena v skladu z določbami iz člena 20.
The granting of authorisation shall not lessen the general civil and criminal liability of any food business operator in respect of the food concerned.
Pridobitev dovoljenja ne zmanjšuje splošne civilne in kazenske odgovornosti nosilca živilske dejavnosti v zvezi z zadevnim živilom.
Modification, suspension and revocation of authorisations
Sprememba, začasna prekinitev uporabe in preklic dovoljenj
The applicant/user of a claim included in one of the lists provided for in Articles 13 and 14 may apply for a modification of the relevant list.
Vlagatelj/uporabnik trditve, vključene v enega od seznamov iz členov 13 in 14, lahko zaprosi za spremembo zadevnega seznama.
The procedure laid down in Articles 15 to 17 shall apply, mutatis mutandis.
Smiselno se uporablja postopek iz členov 15 do 17.
On its own initiative or following a request from a Member State or from the Commission, the Authority shall issue an opinion on whether a health claim included in the lists provided for in Articles 13 and 14 still meets the conditions laid down in this Regulation.
Agencija na lastno pobudo ali na predlog države članice ali Komisije poda mnenje o tem, ali zdravstvena trditev, vključena v seznam iz členov 13 in 14, še izpolnjuje pogoje iz te uredbe.
It shall forthwith transmit its opinion to the Commission, the Member States and, where relevant, to the original applicant of the claim in question.
Agencija svoje mnenje nemudoma posreduje Komisiji, državam članicam in po potrebi prvotnemu vlagatelju vloge za odobritev zadevne zdravstvene trditve.
The Authority, in accordance with Article 38(1) of Regulation (EC) No 178/2002, shall make its opinion public.
Agencija v skladu s členom 38(1) Uredbe (ES) št. 178/2002 objavi svoje mnenje.
The applicant/user or a member of the public may make comments to the Commission within 30 days of such publication.
Vlagatelj/uporabnik ali javnost lahko v roku 30 dni po taki objavi predložijo svoje pripombe Komisiji.
The Commission shall examine the opinion of the Authority and any comments received as soon as possible.
Komisija čim prej preuči mnenje Agencije in vse morebitne prejete pripombe.
If appropriate, the authorisation shall be modified, suspended or revoked in accordance with the procedure laid down in Article 17.
Po potrebi se dovoljenje spremeni, začasno prekine uporaba ali prekliče po postopku iz člena 17.
The Commission shall establish and maintain a Community Register of nutrition and health claims made on food, hereinafter referred to as ‘the Register’.
Komisija vzpostavi in vodi register Skupnosti v zvezi s prehranskimi in zdravstvenimi trditvami, v nadaljevanju „register“.
The Register shall include the following:
Register vsebuje:
the nutrition claims and the conditions applying to them as set out in the Annex;
prehranske trditve in pogoje, ki veljajo zanje, kakor je navedeno v prilogi;
restrictions adopted in accordance with Article 4(5);
omejitve, sprejete v skladu s členom 4(5);
the authorised health claims and the conditions applying to them provided for in Articles 13(3), 14(1), 18(2), 20, 23(2) and 27(6) and the national measures referred to in Article 22(3);
odobrene zdravstvene trditve in pogoje, ki veljajo zanje, kakor je označeno v členih 13(3), 14(1), 18(2), 20, 23(2) in 27(6) in nacionalne ukrepe iz člena 22(3);
a list of rejected health claims and the reasons for their rejection.
seznam zavrnjenih zdravstvenih trditev in utemeljitve njihove zavrnitve.
Health claims authorised on the basis of proprietary data shall be recorded in a separate Annex to the Register together with the following information:
Za zdravstvene trditve, ki so bile odobrene na podlagi pravno zaščitenih podatkov, se v posebno prilogo registra vpišejo skupaj z naslednjimi informacijami:
the date the Commission authorised the health claim and the name of the original applicant that was granted authorisation;
datum odobritve zdravstvene trditve s strani Komisije in ime prvega vlagatelja, ki mu je bilo izdano dovoljenje;
the fact that the Commission authorised the health claim on the basis of proprietary data;
dejstvo, da je Komisija odobrila zdravstveno trditev na podlagi pravno zaščitenih podatkov;
the fact that the health claim is restricted for use unless a subsequent applicant obtains authorisation for the claim without reference to the proprietary data of the original applicant.
dejstvo, da je uporaba zdravstvene trditve omejena, razen če poznejši vlagatelj pridobi dovoljenje za trditev brez sklica na pravno zaščitene podatke prvotnega vlagatelja.
The Register shall be made available to the public.
Register je dostopen javnosti.
The scientific data and other information in the application required under Article 15(2) may not be used for the benefit of a subsequent applicant for a period of seven years from the date of authorisation, unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, where:
Znanstveni podatki in druge informacije, ki jih vsebuje vloga vlagatelja, zahtevana v skladu s členom 15(2), se v roku sedmih let od datuma izdaje dovoljenja ne smejo uporabiti v prid poznejšega vlagatelja, razen če se je poznejši vlagatelj dogovoril s predhodnim vlagateljem, da se lahko takšni podatki in informacije uporabijo, ob predpostavki, da:
the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and
so bili znanstveni podatki in druge informacije s strani prvotnega vlagatelja v času vlaganja prvotne vloge označeni kot pravno zaščiteni; in
the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and
je imel prvotni vlagatelj v času prvotne vloge izključno pravico sklicevanja na pravno zaščitene podatke; in
the health claim could not have been authorised without the submission of the proprietary data by the prior applicant.
zdravstvena trditev ne bi mogla biti odobrena brez predložitve pravno zaščitenih podatkov s strani prvotnega vlagatelja.
Until the end of the seven-year period specified in paragraph 1, no subsequent applicant shall have the right to refer to data designated as proprietary by a prior applicant unless and until the Commission takes a decision on whether a claim could be or could have been included in the list provided for in Article 14 or, where appropriate, Article 13 without the submission of data designated as proprietary by the prior applicant.
Do preteka obdobja sedmih let, določenega v odstavku 1, se noben poznejši vlagatelj nima pravice sklicevati na podatke, ki so bili s strani predhodnega vlagatelja označeni kot pravno zaščiteni, vse dokler Komisija ne sprejme odločbe, po kateri bi se trditev lahko ali bi se lahko bila vključila v seznam iz člena 14 ali, kjer je to ustrezno, člena 13 brez predložitve podatkov, ki so bili s strani predhodnega vlagatelja označeni kot pravno zaščiteni.
Without prejudice to the Treaty, in particular Articles 28 and 30 thereof, Member States may not restrict or forbid trade in or advertising of foods which comply with this Regulation by the application of non-harmonised national provisions governing claims made on certain foods or on foods in general.
Brez poseganja v Pogodbo, zlasti člena 28 in 30 Pogodbe, države članice ne smejo omejiti ali prepovedati trgovine z živili ali oglaševanja živil, ki so v skladu s to uredbo, z izvajanjem neusklajenih nacionalnih predpisov, ki urejajo trditve na nekaterih živilih ali na živilih na splošno.
Notification procedure
Postopek obveščanja
If a Member State considers it necessary to adopt new legislation, it shall notify the Commission and the other Member States of the envisaged measures and give the reasons justifying them.
Če država članica meni, da je nujno sprejeti novo zakonodajo, mora Komisijo in druge države članice obvestiti o predvidenih ukrepih in podati razloge, ki jih opravičujejo.
The Commission shall consult the Standing Committee on the Food Chain and Animal Health instituted by Article 58(1) of Regulation (EC) No 178/2002 (hereinafter referred to as the Committee) if it considers such consultation to be useful or if a Member State so requests, and shall give an opinion on the envisaged measures.
Komisija se posvetuje s Stalnim odborom za prehranjevalno verigo in zdravje živali, ustanovljenim s členom 58(1) Uredbe (ES) št. 178/2002 (v nadaljnjem besedilu „odbor“), če meni, da bi bil tak posvet koristen, ali če tako zahteva država članica, ter poda mnenje o predvidenih ukrepih.
The Member State concerned may take the envisaged measures six months after the notification referred to in paragraph 1, provided that the Commission's opinion is not negative.
Zadevna država članica lahko predvidene ukrepe sprejme šest mesecev po obvestilu iz odstavka 1 pod pogojem, da mnenje Komisije ni negativno.
If the Commission's opinion is negative, it shall determine, in accordance with the procedure referred to in Article 24(2) and before the expiry of the period referred to in the first subparagraph of this paragraph, whether the envisaged measures may be implemented.
Če je mnenje Komisije negativno, je treba v skladu s postopkom iz člena 24(2) in pred iztekom roka iz prvega pododstavka tega odstavka ugotoviti, če je predvidene ukrepe mogoče izvajati.
The Commission may require certain amendments to be made to the envisaged measure.
Komisija lahko za predvidene ukrepe zahteva nekatere spremembe.