natgillin/translations-raw huggingface dataset:
Otroci ne morejo sami presoditi, ali so prehranske navedbe in zdravstvene trditve primerne, zato se jih v poslovnih praksah ne sme izkoriščati.
Children can't judge themselves whether nutrition and health claims are reasonable or not and therefore they shouldn't be exploited in commercial practices.
Člen 5, odstavek1
Article 5, paragraph 1
Uporaba prehranskih navedb in zdravstvenih trditev se dovoli samo, če so izpolnjeni naslednji pogoji:
The use of nutrition and health claims shall only be permitted if the following conditions are fulfilled:
(a) prisotnost, odsotnost ali zmanjšana vsebnost snovi, glede katere so navedene navedbe in trditve, ima dokazano dobrodejen hranilni ali fiziološki učinek, kakor so pokazali splošno sprejeti znanstveni podatki ;
(a) the presence, absence or reduced content of the substance in respect of which the claim is made has been shown to have a beneficial nutritional or physiological effect, as established by generally accepted scientific data ;
(a) prisotnost, odsotnost ali zmanjšana vsebnost hranila ali druge snovi, glede katere so navedene navedbe in trditve, ima dokazano dobrodejen hranilni ali fiziološki učinek, kakor so pokazale splošno sprejeta znanstvena spoznanja ; če so navedene navedbe in trditve o živilu ali kategoriji živila, mora imeti živilo ali kategorija živila dobrodejen hranilni ali fiziološki učinek, kakor so pokazala splošno sprejeta znanstvena spoznanja;
(a) the presence, absence or reduced content of a nutrient or other substance in respect of which the claim is made has been shown to have a beneficial nutritional or physiological effect, as established by generally accepted scientific findings ; if a claim is made about a food or a food category, the food or food category must be shown to have a beneficial nutritional or physiological effect, as established by generally accepted scientific findings;
(b) snov, za katero so navedene navedbe in trditve:
(b) the substance for which the claim is made:
(b) hranilo ali druga snov, za katero so navedene navedbe in trditve:
(b) the nutrient or other substance for which the claim is made:
(i) je v končnem izdelku vsebovana v znatnih količinah, kot je določeno v zakonodaji Skupnosti, ali, če takšni predpisi ne obstajajo, v količini, ki bo ustvarila zahtevani hranilni ali fiziološki učinek, kot so pokazali splošno sprejeti znanstveni podatki; ali
(i) is contained in the final product in a significant quantity as defined in Community legislation or, where such rules do not exist, in a quantity that will produce the nutritional or physiological effect claimed as established by generally accepted scientific data; or
(ii) ni prisotna ali je prisotna v zmanjšani količini, ki bo ustvarila zahtevani hranilni ali fiziološki učinek, kot so pokazali splošno sprejeti znanstveni podatki;
(ii) is not present or is present in a reduced quantity that will produce the nutritional or physiological effect claimed as established by generally accepted scientific data;
(c) kjer je to v uporabi, je snov, za katero so navedene navedbe in trditve, v obliki, ki je na razpolago za uporabo telesa;
(c) where applicable, the substance for which the claim is made is in a form that is available to be used by the body;
(c) kjer je to v uporabi, je hranilo ali druga snov, za katero so navedene navedbe in trditve, v obliki, ki je na razpolago za uporabo telesa;
(c) where applicable, the nutrient or other substance for which the claim is made is in a form that is available to be used by the body;
(e) skladnost s posebnimi pogoji, določenimi v poglavju III ali poglavju IV, kot je primerno.
(e) compliance with the specific conditions set out in Chapter III or Chapter IV as appropriate.
Splošni pogoji za uporabo navedb in trditev, določeni v členu 5, so pretirani.
The general conditions set out in Article 5 for the use of claims go too far.
Navedbe in trditve kot „sadje ali zelenjava so zdravi“ bodo v prihodnje prepovedani, ker sadje in zelenjava v smislu člena 5 niso snov.
Claims such as 'fruit or vegetables are healthy' would be prohibited in future, because fruit and vegetables are not substances within the meaning of Article 5.
Odstavek 1(a) bi tako bilo treba razširiti, da bi pokrili navedbe in trditve v zvezi z živili ali kategorijami živil.
Paragraph 1(a) should therefore be expanded to cover claims relating to foods or food categories.
Prehranske navedbe in zdravstvene trditve temeljijo na in so utemeljene s splošno sprejetimi znanstvenimi spoznanji ali, če je utemeljeno s kategorijo izdelkov, s podatki, dobljenimi iz njihove tradicionalne rabe.
1.Nutrition and health claims shall be based on and substantiated by generally recognised scientific knowledge or, if justified by the category of products, the data derived from their traditional use.
Stopnja utemeljitve je sorazmerna z naravo navedb in trditev.
The level of substantiation shall be commensurate with the nature of the claims made.
Smernice v zvezi z naravo utemeljitve, ki jo zagotovijo proizvajalci, in referenčne vrednosti za oceno organa takšne utemeljitve določi slednji najpozneje do prvega dne v mesecu po dnevu objave te uredbe.
Guidelines concerning the nature of the substantiation to be provided by operators and the reference values for the Authority's assessment of such substantiation shall be established by the latter by the first day of the month following the date of publication of this Regulation at the latest.
Obrazložitev (za odstavek (1))
Justification (for paragraph (1))
Pri utemeljenih navedbah in trditvah je sistem, ki temelji zgolj na znanstvenih podatkih, neprimeren za kmetijske proizvode, kot so zeliščni izdelki.
When it comes to substantiating claims, a system based solely on scientific data is not suitable for agricultural products such as herbal products.
Treba bi bilo upoštevati tudi znanje, dobljeno iz izkušenj in tradicije.
Knowledge derived from experience and tradition should also be taken into account.
To stališče je bilo nedavno sprejeto v primeru tradicionalnih zdravil rastlinskega izvora (Direktiva 2004/24/ES), za katere je bil uveden poseben poenostavljen postopek registracije, ki jih izvzema iz zahteve o dokazovanju svoje klinične učinkovitosti, če je učinkovitost zdravila utemeljena na podlagi dolgotrajne rabe in izkušnjah.
This point was recently accepted in the case of traditional herbal medicinal products (Directive 2004/24/EC), for which a special simplified registration procedure has been established which exempts them from the requirement to prove their clinical efficacy, in so far as the efficacy of the medicinal product is plausible on the basis of long-standing use and experience.
AFSFA (Francoski urad za varno hrano) tudi za tradicionalne zeliščne izdelke predlaga, da se dobrodejne učinke izdelkov utemelji na podlagi „organa za znanje, ustanovljenega na podlagi podatkov, dobljenih iz tradicionalne rabe“*.
Similarly, for traditional herbal extracts, the AFSFA (French food safety agency) proposes that the beneficial effects of products be substantiated on the basis of 'a body of knowledge established on the basis of data derived from traditional use'*.
Poleg tega je pomembno poudariti, da bi moralo tudi načelo sorazmernosti veljati za stopnjo utemeljitve navedb in trditev o izdelkih.
Moreover, it is important to establish that the principle of proportionality should also apply to the level of substantiation to be provided for claims about products.
V nasprotnem primeru bi cena takšne utemeljitve hitro postala previsoka in nedosegljiva za veliko večino malih in srednje velikih podjetij.
Otherwise, the cost of such substantiation would quickly become prohibitive and beyond the possibilities of the great majority of SMEs.
Za izpolnitev bistvenih zahtev pravne varnosti in zaščito pravic potrošnikov je nujno zagotoviti popolno preglednost v zvezi z naravo utemeljitve, ki jo zahteva Evropski urad za varno hrano, in metode, ki jih urad uporablja za oceno takšne utemeljitve.
Finally, to meet the essential requirements of legal certainty and to safeguard consumers' rights, it is essential to ensure total transparency in relation to the nature of the substantiation required by the European Food Safety Authority and the methods that authority uses to assess such substantiation.
* "Démarche d'évaluation de la sécurité, de l'intérêt et de l'allégation des denrées alimentaires, contenant des plantes, destinées à l'alimentation humaine" - februar 2003 – AFSSA http://www.afssa.fr
* "Démarche d'évaluation de la sécurité, de l'intérêt et de l'allégation des denrées alimentaires, contenant des plantes, destinées à l'alimentation humaine" - February 2003 - AFSSA http://www.afssa.fr
Obrazložitev (za odstavek (1a)):
Justification (for paragraph (1a)):
Treba je upoštevati načelo sorazmernosti, ki vključuje preverjanje točnosti ali resničnosti navedb in trditev o izdelku na podlagi dokaza, ki ga zagotovi proizvajalec.
Account must be taken of the principle of proportionality, which consists in 'checking the accuracy or truthfulness of the claims made for the product on the basis of the proof provided by the manufacturer.
Ocena temelji na načelu sorazmernosti med stopnjo zahtevanega dokaza in vplivom domnevnega učinka, z drugimi besedami, pomembnost vpliva izdelka ali sestavine, za katero so navedene navedbe in trditve, na fiziologijo potrošnika in pomembnost zdravstvenih posledic**.
The assessment is based on the principle of proportionality between the extent of the proof required and the impact of the effect claimed, in other words the significance of the impact of the product, or of the constituent for which the claim is made, on the consumer's physiology and the significance of its health consequences'**.
Pristojni organi oblasti države članice lahko zadolžijo proizvajalca živil ali osebo, ki da izdelek na trg, da predloži znanstvena dokazila in podatke, ki so v skladu s predloženo uredbo.
The competent authorities of the Member States may request a food business operator or a person placing a product on the market to produce the scientific work and the data establishing compliance with this Regulation.
Predlagano črtanje postopka odobritve ravno tako razveljavi to določbo.
The proposed abandonment of the authorisation procedure invalidates this provision, too.
Člen 9, odstavek1
Article 9, paragraph 1
Ne glede na Direktivo Sveta št. 84/450/ES je prehranska navedba, ki primerja količino hranljive vrednosti in/ali kalorično vrednost živila z živili iste kategorije , dopustna le, če so med seboj primerjana živila s strani povprečnega potrošnika lahko prepoznavna ali jasno navedena.
Without prejudice to Directive 84/450/EEC, a nutrition claim which compares the quantity of a nutrient and/or the energy value of a food with foods of the same category shall only be made if the foods being compared are easily identified by the average consumer or clearly indicated.
Ne glede na Direktivo Sveta št. 84/450/ES je prehranska navedba o hranilni vrednosti, ki primerja količino hranljive vrednosti in/ali kalorično vrednost živila z drugim živilom , dopustna le, če so med seboj primerjana živila s strani povprečnega potrošnika lahko prepoznavna ali jasno navedena.
Without prejudice to Directive 84/450/EEC, a nutrition claim which compares the quantity of a nutrient and/or the energy value of a food with another food shall only be made if the foods being compared are easily identified by the average consumer or clearly indicated.
Primerjava ne sme biti omejena le na živila iste kategorije.
Comparisons should not be limited just to foods of the same category.
Nasprotno, v interesu boljše možnosti informiranja bi morala biti mogoča tudi primerjava med različnimi živili, kot je na primer primerjava količine kalcija v kozarcu mleka in v kozarcu pomarančnega soka.
Instead, in the interests of improved information it should also be possible to compare different foods, such as a comparison between the calcium content of a glass of milk and that of a glass of orange juice.
Člen 10, odstavek1
Article 10, paragraph 1
Zdravstvene trditve se smejo pripraviti le , če ustrezajo splošnim zahtevam iz poglavja II in posebnim zahtevam v tem poglavju ter so po predloženi uredbi dopustne .
Health claims shall be permitted if they comply with the general requirements in Chapter II and the specific requirements in this Chapter and are authorised in accordance with this Regulation .
Zdravstvene trditve se smejo pripraviti, razen če ne ustrezajo splošnim zahtevam iz poglavja II in posebnim zahtevam v tem poglavju.
Health claims shall be permitted unless they do not comply with the general requirements in Chapter II and the specific requirements in this Chapter.
Odstavek 1 člena 10 predvideva splošno prepoved zdravstvenih trditev s pridržkom odobritve.
Article 10(1) lays down a general ban on health claims, subject to the possibility of authorisation.
Zdravstvene trditve naj bi se torej uporabljaei le, če so bili po določbah uredbe dopustne.
Accordingly, health claims may only be used if they have been authorised pursuant to the provisions of the regulation.
Ta prepoved gre vendarle predaleč, saj se nanaša tudi na priznane in znanstveno dokazane podatke, ki ne zavajajo potrošnika.
However, this ban goes too far, since it also covers recognised and scientifically proven claims which do not mislead consumers.
Postopek odobritve, predviden v osnutku uredbe, je birokratski, nepraktičen in ravno s stališča Lizbonske strategije nesprejemljiv.
Moreover, the authorisation procedure envisaged is bureaucratic, impractical and, especially in the light of the Lisbon strategy, unacceptable.
Zato bi bilo treba vnaprejšnji postopek preverjanja povsem opustiti.
The prior assessment procedure should therefore be totally abandoned.
Člen 10, odstavek2, točka (a)
Article 10, paragraph 2, point (a)
Ker je predviden postopek registracije, ki ocenjuje znanstveno utemeljitev za vse zdravstvene trditve, posebnih prepovedi ni treba izrecno določiti.
Since a registration procedure evaluating the scientific substantiation is foreseen for all health claims, specific prohibitions no longer have to be expressly laid down.
Vse trditve, ki so znanstveno utemeljene, so dovoljene.
All claims that are scientifically substantiated should be allowed.
(a)trditve, ki opozarjajo na splošne, nespecifične prednosti hranljive snovi ali živila glede na javno zdravje in dobro počutje;
(a) claims which make reference to general, non-specific benefits of the nutrient or food for overall good health, well-being;
(b) trditve, ki veljajo za psihične ali vedenjske funkcije;
(b)claims which make reference to psychological and behavioural functions;
(c) trditve, ki ne glede na Direktivo 96/8/ES opozarjajo na lastnosti hujšanja ali nadzorovanja teže ali na podlagi časa ali obsega možno hujšanje ali na zmanjšanje občutka lakote ali povečanje občutka sitosti ali na manjšo absorpcijo energije prek uživanja izdelka;
(c) without prejudice to Directive 96/8/EC claims which make reference to slimming or weight control, or to the rate or amount of weight loss which may result from their use or to 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;
(d) trditve, ki veljajo za nasvet zdravnikov ali drugih strokovnjakov na področju zdravstva ali ustreznih poklicnih združenj ali dobrodelnih ustanov, ali trditve, ki napeljujejo na to, da bi lahko bilo ogroženo zdravje v primeru nezaužitja živila.
(d) claims which make reference to the advice of doctors or other health professionals, or their professional associations, or charities, or suggest that health could be affected by not consuming the food.
Komisija objavi, če je potrebno, po posvetovanju z organom oblasti podrobne smernice za spremembo predloženega člena.
Where appropriate, the Commission having first consulted the Authority shall publish detailed guidelines for the implementation of this article.
Dejansko zaključen seznam implicitnih zdravstvenih trditev je nesorazmeren ukrep.
A virtually exhaustive list of prohibited implicit health claims is a disproportionate measure.
Oglaševalske navedbe na izdelkih ne smejo biti prepovedane.
Publicity indications on products must not be banned.
Tako bi bilo oglaševanje živilskih izdelkov praktično nemogoče.
This would effectively make the advertising of food products impossible.
Zaščito potrošnika pred zavajajočim oglaševanjem ureja druga zakonodaja.
There is other legislation intended to protect the consumer against genuinely misleading publicity.
Ne glede na odstavek 1 člena 10 se smejo pripraviti zdravstvene trditve, ki opisujejo pomen hranljive ali druge snovi za rast, razvoj in normalne fiziološke telesne funkcije na podlagi uveljavljenih in nespornih znanstvenih spoznanj in ki jih povprečen potrošnik pravilno razume, če so na seznamu, predvidenem v odstavku 2.
By way of derogation from Article 10 (1), health claims describing the role of a nutrient or of another substance in growth, development and the normal functions of the body, which are based on generally accepted scientific data and well understood by the average consumer, may be made if they are included in the list provided for in paragraph 2.
Države članice pošljejo Komisiji sezname trditev najkasneje do ... [leto dni po zadnjem dnevu v mesecu, v katerem je bila sprejeta ta uredba] v skladu z odstavkom 1.
Member States shall provide the Commission with lists of claims as referred to in paragraph 1 by … at the latest [last day of the month of adoption of this Regulation + 1 year].
Po posvetovanju organov oblasti bo Komisija v skladu s postopkom iz člena 23 najkasneje do … [tri leta po zadnjem dnevu v mesecu, v katerem je bila sprejeta ta uredba] sprejela skupen seznam dopustnih trditev v skladu z odstavkom 1, ki opisujejo pomen hranljive ali druge snovi za rast, razvoj in normalne fiziološke telesne funkcije.
After consulting the Authority, the Commission shall adopt, in accordance with the procedure referred to in Article 23, a Community list of permitted claims as referred to in paragraph 1, describing the role of a nutrient or other substance in growth, development and normal functions of the body by … at the latest [last day of the month of adoption of this Regulation + 3 years].
Spremembe tega seznama se bodo sprejele na pobudo Komisije same ali na predlog države članice po postopku iz člena 23.
Modifications to the list shall be adopted in accordance with the procedure referred to in Article 23, on the Commission's own initiative or following a request by a Member State.
Ta člen izgubi po predlaganem izbrisu splošne prepovedi zdravstvenih trditev, predvidenih v odstavku 1 člena 10, skupaj s postopkom odobritve, svoj pomen in bi ga tudi bilo treba izbrisati.
The proposed abandonment of the general ban on health claims plus authorisation procedure envisaged in Article 10(1) makes this article meaningless, and it should therefore likewise be deleted.
Člen 13, odstavek1
Article 13, paragraph 1
Ne glede na odstavek 1 člena 2 Direktive 2000/13/ES se lahko pripravijo trditve v zvezi z zmanjšanjem bolezenskega tveganja, če so po tej uredbi dopustne .
By way of derogation from Article 2 (1) of Directive 2000/13/EC, reduction of disease risk claims may be made where they have been authorised in accordance with this Regulation.
Ne glede na odstavek 1 člena 2 Direktive 2000/13/ES se lahko pripravijo zdravstvene trditve v zvezi z zmanjšanjem bolezenskega tveganja, če so po tej uredbi dovoljene .
By way of derogation from Article 2 (1) of Directive 2000/13/EC, reduction of disease risk claims may be made where they are permitted under with this Regulation.
Ta člen je treba po predlaganem izbrisu splošne prepovedi zdravstvenih trditev, predvidenim v odstavku 1 člena 10, skupaj s postopkom odobritve ustrezno popraviti.
The proposed abandonment of the general ban on health claims plus authorisation procedure envisaged in Article 10(1) means that this article should be amended accordingly.
Za pridobitev dovoljenja iz odstavka 1 člena 10 je treba vložiti vlogo pri upravnem organu.
To obtain the authorisation referred to in Article 10 (1), an application shall be submitted to the Authority.
V potrdilu je zabeležen datum prejema vloge;
The acknowledgement shall state the date of receipt of the application;
c) da javnosti na razpolago povzetek dokumentacije, ki je navedena v odstavku 3, točki f.
(c) shall make the summary of the dossier referred to in paragraph 3(f) available to the public.
a) ime in naslov vlagatelja;
(a) the name and address of the applicant;
b) živilo ali kategorijo živila, za katero naj se pripravi zdravstvena trditev, ter njene posebne lastnosti;
(b) the food or the category of food in respect of which the health claim is to be made and its particular characteristics;
c) kopije študij,ki so bile opravljene v zvezi z zdravstvenimi trditvami, vključno – če so na razpolago – z neodvisnimi študijami in študijami, ki so bile opravljene po postopku medsebojnega pregleda in z vsemi drugimi dokazili, iz katerih je razvidno, da trditve izpolnjujejo merila iz te uredbe;
(c) a copy of the studies which have been carried out with regard to the health claim including, where available, independent, peer-reviewed studies, which have been carried out and any other material which is available to demonstrate that it complies with the criteria provided for in this Regulation;
d) kopije drugih znanstvenih raziskav, ki so pomembne za zdravstvene trditve;
(d) a copy of other scientific studies which are relevant to that health claim;
e) predlog za oblikovanje zdravstvene trditve – v vseh jezikih Skupnosti – za katero se zaprosi dovoljenje, po potrebi vključno s posebnimi pogoji za uporabo;
(e) a proposal for the wording, in all Community languages, of the health claim for which authorisation is sought including, as the case may be, specific conditions for use;
f) povzetek dokumentacije.
(f) a summary of the dossier.
Izvedbeni predpisi k obravnavanemu členu, vključno z določbami za pripravo in oddajo vloge, se določijo po razpravi organa oblasti v skladu s postopkom, ki je naveden v odstavku 2 člena 23.
Implementing rules for the application of this Article, including rules concerning the preparation and presentation of the application shall be established in accordance with the procedure referred to in Article 23 (2), after consultation of the Authority.
Zato bi bilo treba vnaprejšnji postopek preverjanja opustiti.
The prior assessment procedure should therefore be abandoned.
Mnenje upravnega organa
Opinion of the Authority
Pri sestavljanju svojega mnenja si upravni organ prizadeva, da se drži roka treh mesecev od datuma prejema vloge.
In giving its opinion, the Authority shall endeavour to respect a time limit of three months from the date of receipt of a valid application.
Ta rok se vedno prekine takrat, ko upravni organ v skladu z odstavkom 2 od vlagatelja zahteva dodatne informacije.
That time limit shall be extended where the Authority seeks supplementary information from the applicant pursuant to paragraph 2.
Upravni organ lahko po potrebi pozove vlagatelja, naj dopolni dokumentacijo k vlogi v določenem roku.
The Authority may, where appropriate, request the applicant to supplement the particulars accompanying the application within a specified time limit.
Ob pripravi svojega mnenja upravni organ preveri,
In order to prepare its opinion, the Authority shall verify:
a) ali je predlagana formulacija zdravstvena trditev podprta z znanstvenimi podatki;
(a) that the proposed wording of the health claim is substantiated by scientific data;
b) ali formulacija zdravstvene trditve ustreza merilom iz te uredbe;
(b) that the wording of the heath claim complies with the criteria laid down in this Regulation;
c) ali je predlagana formulacija zdravstvene trditve razumljiva in bistvena za potrošnika.
(c) that the proposed wording of the health claim is understandable and meaningful to the consumer.
Če mnenje podpira uporabo zdravstvene trditve, mora mnenje poleg tega vsebovati naslednje podatke:
In the event of an opinion in favour of approving the health claim, the opinion shall include the following particulars:
b) oznako živila ali kategorije živil, za katero naj se pripravi zdravstvena trditev, in posebne lastnosti;
(b) the designation of the food or category of food in respect of which a claim is to be used and its particular characteristics;