natgillin/translations-raw huggingface dataset:
Navedbe so pogosto usmerjeni k posebnim skupinam ali podskupinam prebivalstva, ki so lahko bolje seznanjene z nekaterimi živili, hranilnimi snovmi ali snovmi kot povprečni potrošnik.
Claims are often targeted at specific groups or sub-groups of the population who may be more knowledgeable about a specific food, nutrient or substance than the average consumer.
Države članice in zainteresirane stranke (predvsem potrošniške skupine in predstavniki industrije) pošljejo Komisiji sezname razmerij prehrana/zdravje najpozneje do ... [leto dni po zadnjem dnevu v mesecu, v katerem je bila sprejeta ta uredba] v skladu z odstavkom 1.
Member States and interested parties (notably consumer groups and industry representatives) shall provide the Commission with lists of diet/health relationships as referred to in paragraph 1 by … at the latest [last day of the month of adoption of this Regulation + 1 year].
Po posvetovanju z Agencijo bo Komisija v skladu s postopkom iz člena 23 najpozneje 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 hranilne 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].
Po posvetovanju z Agencijo bo Komisija v skladu s postopkom iz člena 23 najpozneje do … [tri leta po zadnjem dnevu v mesecu, v katerem je bila sprejeta ta uredba] sprejela skupen seznam dopustnih razmerij prehrana/zdravje v skladu z odstavkom 1, ki opisujejo pomen hranilne 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 diet/health relationships 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].
Člen 12, odstavek 2, pododstavek 3
Article 12, paragraph 2, subparagraph 3
Spremembe seznama se lahko sprejmejo v skladu s postopkom iz člena 23 na pobudo Komisije ali na ustrezno utemeljeno zahtevo države članice.
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.
Spremembe seznama se lahko sprejmejo v skladu s postopkom iz člena 23(2) na pobudo Komisije ali na ustrezno utemeljeno zahtevo države članice.
Modifications to the list shall be adopted in accordance with the procedure referred to in Article 23(2) , on the Commission's own initiative or following a request by a Member State.
Predlog spremembe 35
Amendment 35
Razen splošnih zahtev, določenih v tej uredbi, in posebnih zahtev iz odstavka 1 morajo oznake zaradi trditev za zmanjšanje tveganj bolezni vključevati tudi izjavo, da imajo bolezni več dejavnikov tveganj in da ima sprememba enega od teh dejavnikov tveganja lahko koristen učinek ali ga nima.
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 label shall also bear a statement indicating that diseases have multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.
Razen zahtev, določenih v tej uredbi, morajo oznake v primeru trditev v zvezi z zmanjšanjem tveganj bolezni vključevati tudi izjavo, da imajo bolezni več dejavnikov tveganj in da ima sprememba enega od teh dejavnikov tveganja lahko koristen učinek ali ga nima.
In addition to the requirements laid down in this Regulation, in the case of claims concerning reduction of disease risk the label shall also bear a statement indicating that diseases have multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.
Za pridobitev dovoljenja iz člena 10(1) je treba vložiti vlogo pri Agenciji.
To obtain the authorisation referred to in Article 10 (1), an application shall be submitted to the Authority.
Za pridobitev dovoljenja iz člena 10(1) in člena 13(1) v primeru zdravstvenih trditev, ki ne sodijo na področje uporabe člena 12 ter zmanjšanja tveganja za obolenja je treba vložiti vlogo pri Agenciji.
To obtain the authorisation referred to in Article 10(1) and Article 13(1) , in the case of health claims not falling within the scope of Article 12 and reduction of disease risk claims, an application shall be submitted to the Authority.
(a) pisno potrdi prejem vloge 14 dni po prejemu.
(a) shall acknowledge receipt of an application in writing within 14 days of its receipt.
V potrdilu je zabeležen datum prejema vloge ;
The acknowledgement shall state the date of receipt of the application .
(b) nemudoma obvesti države članice in Komisijo o vlogi ter jim da na voljo vlogo z vsemi ostalimi informacijami, ki jih je predložil vlagatelj kot dopolnila;
(b) shall inform without delay the Member States and the Commission of the application and shall make the application and any supplementary information supplied by the applicant available to them;
(c) da javnosti na voljo povzetek dokumentacije, navedene v odstavku 3(f).
(c) shall make the summary of the dossier referred to in paragraph 3(f) available to the public.
Vloge za odobritev so oblikovane na podlagi obeh členov.
Applications for authorisation are made on the basis of both Articles.
Predlog spremembe 37
Amendment 37
(b) živilo ali kategorija živila, za katero naj se pripravi zdravstvena trditev, ter njene posebne značilnosti;
(b) the food or the category of food in respect of which the health claim is to be made and its particular characteristics
(b) živilo ali kategorija živila ali ena od njegovih sestavin , za katero naj se pripravi zdravstvena trditev, ter njene posebne značilnosti;
(b) the food or the category of food or the constituent or constituents in respect of which the health claim is to be made and its particular characteristics
Sledi iz opredelitve zdravstvene trditve iz člena 2.
Follows from the definition of a health claim in Article 2.
Predlog spremembe 38
Amendment 38
(e) predlog ubeseditve v vseh jezikih Skupnosti za zdravstveno trditev, za katere se predloži vloga, vključno s posebnimi pogoji uporabe, kjer je to potrebno;
(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;
(e) ilustrativni primer ubeseditve za zdravstveno trditev v jeziku, v katerem je dokumentacija predložena upravnemu organu, in posebnih pogojev uporabe, kjer je to potrebno;
(e) an illustrative example of the wording of the health claim in the language in which the dossier is presented to the Authority and, as the case may be, specific conditions for use;
Od vlagatelja se ne sme zahtevati, da zagotovi podrobni predlog (s končno ubeseditvijo) vloge, niti ni treba, da je natančna ubeseditev vključena v odločba upravnega organa.
One should not demand the applicant to provide the exact proposition (with final wording) of the claim, nor should the exact wording be included in the decision of the Authority.
Proizvajalcem in oglaševalcem je treba dovoliti, da uporabljajo nekaj kreativnosti pri načinu prodaje svojih proizvodov, dokler kateri koli trditve ne presegajo pomena in duha odobrene trditve.
Manufacturers and advertisers should be both free to use some creativity in the way that they sell their products as long as any claims remain within the meaning and spirit of the approved claim.
Da se nevladnim organizacijam dovoli, da prispevajo k seznamu, mora upravni organ sprejeti vloge v katerem koli jeziku Skupnosti, čeprav mora biti odločba organa na voljo v vseh jezikih.
In order to allow non-governmental organisations to contribute to the list, the Authority should accept submissions in any of the Community languages although the Authority decision should be available in all languages.
Člen 14, odstavek 2, točka (f)
Article 14, paragraph 2, point (f)
((f) povzetek dokumentacije.
(f) a summary of the dossier.
(f) znanstveni podatki, sorazmerni z naravo prednosti, ki jih zahtevajo trditve.
(f) scientific data proportional to the nature of the benefits claimed by the assertions.
Ker je razmerje med znanstveno utemeljitvijo in pomenom trditve lahko predmet odobritve, je nujno, da se proizvajalcem določi stopnjo gibljivosti v zvezi s sporočitvijo trditve.
Whilst the relationship between the scientific substantiation and the meaning of the claim can be subject of approval, it is essential to give manufacturers a degree of flexibility regarding the communication of the claim.
Predlog Komisije v osnovi tega ne upošteva.
As it is, the Commission Proposal does not take this into account.
Člen 14, odstavek 2, točka (f a) (novo)
Article 14, paragraph 2, point (f a) (new)
(fa) povzetek dokumentacije.
(fa) a summary of the dossier.
Agencija objavi pred datumom, s katerim začne veljati ta uredba, smernice, da bi vlagateljem olajšala pripravo in oddajo vlog.
Before the date of application of this regulation, the authority shall publish detailed guidance to assist applicants in the preparation and the presentation of applications.
Agencija objavi pred datumom, s katerim začne veljati ta uredba, smernice, da bi vlagateljem olajšala pripravo in oddajo vlog.
Before the date of application of this regulation, the Authority shall publish detailed guidance to assist applicants in the preparation and the presentation of applications.
Vlagatelji imajo pravico, da zastopajo svojo vlogo pred Agencijo in pravico, da med oceno dosjeja s strani Agencije predložijo dodatne podatke.
Applicants shall have the right to defend their applications before the Authority and shall have the right to provide additional data in the course of the Authority's evaluation of the dossier.
Pri sestavljanju svojega mnenja si Agencija prizadeva , da se drži roka treh mesecev od datuma prejema veljavne 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.
Pri sestavljanju svojega mnenja Agencija spoštuje rok treh mesecev od datuma prejema veljavne vloge.
In giving its opinion, the authority shall respect a time limit of three months from the date of receipt of a valid application.
Ta rok se vedno podaljša takrat, ko Agencija 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.
Agencija 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.
Vlagatelj ima neposredni dostop do pristojnega sosveta Agencije, vključno s pravico do zaslišanja in pravico predložitve dodatne dokumentacije k dosjeju.
The applicant shall have direct access to the competent panel of the Authority, the right to be heard and the right to provide additional particulars.
Predlog spremembe 44
Amendment 44
Da bi pripravil svoje mnenje, organ preveri:
In order to prepare its opinion, the Authority shall verify:
Da bi upravni organ pripravil mnenje, preveri, da je ilustrativni primer ubeseditve zdravstvene trditve:
In order to prepare its opinion, the Authority shall verify that the illustrative example of wording of the health claim :
(a) da je predlagana ubeseditev zdravstvene trditve podprta z znanstvenimi podatki ;
(a) that the proposed wording of the health claim is substantiated by scientific data ;
(a) podprt z znanstvenimi spoznanji ;
(a) is substantiated by scientific knowledge ;
(b) da je ubeseditev zdravstvene trditve v skladu s kriteriji, določenimi v tej uredbi;
(b) that the wording of the heath claim complies with the criteria laid down in this Regulation;
(b) v skladu s kriteriji, določenimi v tej uredbi;
(b) complies with the criteria laid down in this Regulation;
(a) da je predlagana ubeseditev zdravstvene trditve razumljiva in smiselna za potrošnika.
(c) that the proposed wording of the health claim is understandable and meaningful to the consumer.
(c) razumljiv in smiseln za potrošnika.
(c) is understandable and meaningful to the consumer.
Sledi iz prejšnjih predlogov sprememb.
Follows on from previous amendments.
Člen 15, odstavek 4, točka (b)
Article 15, paragraph 4, point (b)
(b) oznaka živila ali kategorijo živila, glede na katerega se bo uporabljala trditev, in njegove posebne značilnosti;
(b) the designation of the food or category of food in respect of which a claim is to be used and its particular characteristics;
(b) oznaka živila ali kategorijo živila ali ene od njegovih sestavin , glede na katerega se bo uporabljala trditev, in njegove posebne značilnosti;
(b) the designation of the food or category of food or the constituent or constituents in respect of which the claim is to be used and its particular characteristics;
Sledi iz definicije zdravstvene trditve iz člena 2.
Follows from a definition of the health claim in Art. 2.
(c) priporočena ubeseditev v vseh jezikih Skupnosti za predlagane zdravstvene trditve;
(c) the recommended wording , in all Community languages, of the proposed health claim;
(c) pomen in ilustrativni primer ubeseditev v vseh jezikih Skupnosti za predlagane zdravstvene trditve;
(c) the meaning and an illustrative example of the wording , in all Community languages, of the proposed health claim;
Sledi iz predloga spremembe členov 14(2)(e) in 15(3).
Follows from amendment to Art. 14(2)(e) and 15(3).
Vlagatelji imajo pravico, da se v enem mesecu pritožijo na negativne ali pogojne pozitivne ocene znanstvenih meril trditve s strani Agencije.
The applicant shall have a right of appeal, which must be exercised within one month against any negative or conditional positive assessment of the Authority of the scientific merits of a claim.
Vloga mora zagotoviti pravico do pritožbe na negativne ali pogojne pozitivne odločitve v zvezi z odobritvijo nekaterih trditev.
The application should be provided with a right to appeal against negative or conditional positive decision on the authorisation of a certain claim.
Člen 18, odstavek 2, točka (c)
Article 18, paragraph 2, point (c)
Objava seznama zdravstvenih trditev, ki niso bile odobrene v postopku odobritve, bo zaradi zaščite poštene konkurence in inovativnosti v industriji neugodna.
The publication of a list of claims rejected in the authorisation process will be disadvantageous because of the protection of fair competition and innovativeness in industry.
Predlog spremembe 49
Amendment 49
Člen 19, odstavek 1, uvodni del
Article 19, paragraph 1, introductory part
Znanstveni podatki in druge informacije, ki jih vsebuje dokumentacija vlagatelja, zahtevana v skladu s členom 14(2) se v roku sedmih let od datuma dovoljenja ne smejo uporabiti v prid naslednjega vlagatelja, razen če se je naslednji vlagatelj dogovoril s prejšnjim vlagateljem, da se lahko takšni podatki in informacije uporabijo, če:
The scientific data and other information in the application dossier required under Article 14(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:
V zvezi z zdravstvenimi trditvami, odobrenimi na osnovi zaupnih podatkov , se znanstveni podatki in druge informacije, ki jih vsebuje dokumentacija vlagatelja, zahtevana v skladu s členom 14(2) v roku sedmih let od datuma dovoljenja ne smejo uporabiti v prid naslednjega vlagatelja, razen če se je naslednji vlagatelj dogovoril s prejšnjim vlagateljem, da se lahko takšni podatki in informacije uporabijo, če:
With respect to health claims authorised on the basis of proprietary data, the scientific data and other information in the application dossier required under Article 14(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:
Predlog spremembe 50
Amendment 50
Člen 19, odstavek 2 a (novo)
Article 19, paragraph 2 a (new)
Odstavka 1 in 2 ne izključujeta, da se naslednjim vlagateljem dodeli odobritev v primeru, da so bile zdravstvene trditve, za katere vlagajo vlogo, odobrene na podlagi zaupnih podatkov in drugih znanstvenih podatkov in informacij, ki v vlogi niso označeni za zaupne, če ti podatki ali informacije zadostujejo za odobritev zdravstvene trditve.
Paragraphs 1 and 2 shall not preclude subsequent applicants from being granted an authorisation in the event that a health claim applied for by such applicant would be authorised on the basis of proprietary data or any other scientific data and information not designated as proprietary provided in the application if such data or information are sufficient for authorisation of the health claim.
Predpis, ki dovoljuje sedemletno varstvo podatkov in tržno ekskluzivnost za zdravstvene trditve na osnovi zaupnih podatkov, je dobrodošel.
The provision allowing seven years of data protection and market exclusivity for health claims based on proprietary data is welcomed.
Vendar pa namera Komisije ni popolnoma jasna.
However, the Commission's intention is not fully clear.
Predlog, na primer, ne določa, da bi dva proizvajalca, ki sta predložila dokumentacijo z istim dokazom, imela takšno ekskluzivnost ali da bi se drugim vlagateljem preprečila odobritev.
The proposal does not, for instance, specify whether two manufacturers who submitted a dossier of the same evidence would both have such exclusivity or whether other applicants would be precluded from receiving authorisation.
Zato je namen odstavka 2(a) pojasniti to vprašanje.
Therefore, paragraph 2a aims at clarifying this issue.
Predlog spremembe 51
Amendment 51
Člen 19, odstavek 2 b (novo)
Article 19, paragraph 2 b (new)
Odstavka 1 in 2 veljata za katero koli vlogo, ki temelji na zaupnih podatkih, ne glede na vrstni red, po katerem so bile takšne vloge predložene.
Paragraphs 1 and 2 shall apply to any application based on proprietary data irrespective of the priority order in which the application was submitted.
Zato je namen odstavka 2(a) pojasniti to vprašanje.
Therefore, paragraph 2b aims at clarifying this issue.
Vlagatelj lahko označi, za katere podatke in informacije, oddane v skladu s to uredbo, želi, da jih obravnavajo kot zaupne, če bi njihovo razkritje resno oškodovalo njegov konkurenčni položaj.
An applicant may indicate which data and information submitted under this Regulation he wishes to be treated as confidential on the grounds that its disclosure might significantly harm his competitive position.
Navesti je treba preverljive razloge.
Verifiable reasons must be given.
Komisija, po posvetovanju z vlagateljem, določi, katere podatke in informacije, razen tistih, ki so navedeni v odstavku 3, je treba obravnavati kot zaupne in o odločitvi obvesti vlagatelja.
The Commission shall determine, after consultation with the applicant, which data and information other than that specified in paragraph 3 should be kept confidential and shall inform the applicant of its decision.
Naslednji podatki in informacije se ne štejejo za zaupne:
The following data and information shall not be considered confidential:
(a) ime in ključne značilnosti živila, ki sporočajo lastnosti v zvezi z zdravjem;
(a) the name and essential characteristics of the food that confer its health related properties;
(b) ugotovitve preskusov, izvedenih na vzorcih in vitro, na živalih ali na ljudeh, ki so pomembni za vrednotenje učinkov živila in njegovih sestavin na človeško prehrano in zdravje;
(b) the conclusions of any tests performed on in vitro models, on animals or on humans, relevant to an evaluation of the effects of the food and its constituents on human nutrition and health;
(c) metode odkrivanja ali količinske opredelitve ključnih značilnosti živila ali njegovih sestavin, ki so lahko potrebne za uradni nadzor.
(c) methods for the detection or quantification of key characteristics of the food or its constituents, as may be needed for official control.
Ne glede na odstavek 2 mora Agencija na zahtevo Komisiji in državam članicam predložiti vse podatke, ki jih ima, vključno s kakršnimi koli podatki in informacijami, ki so po odstavku 2 določeni kot zaupni.
Notwithstanding paragraph 2, the Authority shall, on request, supply the Commission and the Member States with all information in its possession, including any data and information identified as confidential pursuant to paragraph 2.
Pri obravnavi vlog za dostop do dokumentov pri Agenciji, Agencija deluje po načelih Uredbe (ES) št. 1049/2001 Evropskega parlamenta in Sveta z dne 30. maja 2001 o dostopu javnosti do dokumentov Evropskega parlamenta, Sveta in Komisije 1 .
The Authority shall apply the principles of Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents¹ when processing applications for access to documents held by the Authority.
Države članice, Komisija in Agencija obravnavajo vse podatke in informacije, ki so po odstavku 2 določeni kot zaupni, kot zaupne, razen če je ustrezno, da se ti podatki objavijo zaradi varovanja zdravja ljudi.
The Member States, the Commission and the Authority shall keep confidential all data and information identified as confidential under paragraph 2 except where it is appropriate for such data and information to be made public in order to protect human health.
Države članice obdelajo vloge za dostop do dokumentov, prejetih na podlagi te uredbe, v skladu s členom 5 Uredbe (ES) št. 1049/2001.
Member States shall process applications for access to documents received under this Regulation in accordance with Article 5 of Regulation (EC) No 1049/2001.
Če vlagatelj umakne vlogo, države članice, Komisija in Agencija upoštevajo zaupnost tržnih in industrijskih podatkov in informacij, vključno s podatki o raziskavah in razvoju, ter podatki, o katerih se država in vlagatelj glede zaupnosti ne strinjata.
Where an applicant withdraws an application, the Member States, the Commission and the Authority shall respect the confidentiality of commercial and industrial data and information, including research and development information, as well as information on which the Commission and the applicant disagree as to its confidentiality.
¹ UL L 145, 31.5.2001, str.
¹ OJ L 145, 31.5.2001, p.
Za spodbudo vlaganja v raziskave, pospešitev novosti in zagotovitev poštene konkurence je ustrezna zaščita podatkov nujno potrebna.
In order to encourage investments in research, promote innovation and ensure fair competition, adequate data protection is indispensable.
V praksi izključna pravica do uporabe zaupnih podatkov ne bo vedno zadostovala, ker se klinični preskusi ponavadi izvajajo s tretjimi strankami, kot so univerze.
In practice, the exclusive right of reference to the proprietary data will not always be sufficient because clinical trials are usually executed with third parties, such as universities.
Največkrat bodo proizvajalci univerzam dodelili pravico do uporabe podatkov za usposabljanje, objavo in nadaljnjo raziskavo.
Most of the time manufacturers will grant universities the right to use the data for training, publication and further research.
Člen 19 b (novo)
Article 19 b (new)