natgillin/translations-raw huggingface dataset:
(i) je v končnem izdelku vsebovana v znatni količini, kakor je določeno v zakonodaji Skupnosti, ali, če takšni predpisi ne obstajajo, v količini, ki bo dosegla zatrjevani hranilni ali fiziološki učinek, na podlagi splošno sprejetih znanstvenih spoznanj ; 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 knowledge ; or
(ii) ni prisotna ali je prisotna v zmanjšani količini, ki bo dosegla zatrjevani hranilni ali fiziološki učinek, na podlagi splošno sprejetih znanstvenih podatkov ;
(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 ;
(ii) ni prisotna ali je prisotna v zmanjšani količini, ki bo dosegla zatrjevani hranilni ali fiziološki učinek, na podlagi splošno sprejetih znanstvenih spoznanj ;
(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 knowledge ;
(c) da je, kjer je primerno, hranilo ali druga snov, za katero je podana trditev, v takšni obliki, da jo lahko telo uporabi;
(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;
(d) da pričakovana količina zaužitega izdelka, vsebuje znatno količino hranila ali druge snovi, na katero se trditev nanaša, kakor je določeno v zakonodaji Skupnosti, ali, če takšni predpisi ne obstajajo, znatno količino, ki bo dosegla zatrjevani hranilni ali fiziološki učinek, na podlagi splošno sprejetih znanstvenih podatkov ;
(d) the quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the nutrient or other substance to which the claim relates, as defined in Community legislation or, where such rules do not exist, a significant quantity that will produce the nutritional or physiological effect claimed as established by generally accepted scientific data ;
(d) da pričakovana količina zaužitega izdelka, vsebuje znatno količino hranila ali druge snovi, na katero se trditev nanaša, kakor je določeno v zakonodaji Skupnosti, ali, če takšni predpisi ne obstajajo, znatno količino, ki bo dosegla zatrjevani hranilni ali fiziološki učinek, na podlagi splošno sprejetih znanstvenih spoznanj ;
(d) the quantity of the product that can reasonably be expected to be consumed provides a significant quantity of the nutrient or other substance to which the claim relates, as defined in Community legislation or, where such rules do not exist, a significant quantity that will produce the nutritional or physiological effect claimed as established by generally accepted scientific knowledge ;
(e) skladnost s posebnimi pogoji, določenimi v poglavju III ali poglavju IV, odvisno od primera.
(e) compliance with the specific conditions set out in Chapter III or Chapter IV as the case may be.
Izraz „splošno sprejeti podatki“ ni bil opredeljen.
The term "generally accepted data" has not been defined.
Predvideti je treba vprašanja v zvezi z znanostjo na podlagi soglasja in nastajajočo znanostjo, tako da se trditve o koristih za zdravje lahko sestavijo ob pričetku postopka odkritja, z uporabo ustreznega jezika in terminologije („smeti“, „moči“, „verjetno“, „mogoče“ itd.).
The issues of consensus science and emerging science need to be provided for so that claims about benefits to health can be made at an earlier stage in the discovery process, using appropriate language and terminology ("may", "can", "probable", "possible", etc).
Prehranske in zdravstvene trditve temeljijo na in so utemeljene s splošno sprejetimi znanstvenimi podatki .
Nutrition and health claims shall be based on and substantiated by generally accepted scientific data .
Prehranske in zdravstvene trditve temeljijo na in so utemeljene s splošno sprejetimi znanstvenimi spoznanji .
Nutrition and health claims shall be based on and substantiated by generally accepted scientific knowledge .
Dovoljene so samo prehranske trditve, ki so navedene v Prilogi in so v skladu s pogoji, določenimi v tej uredbi.
Nutrition claims shall only be permitted if they are listed in the Annex and are in conformity with the conditions set out in this Regulation.
Ob upoštevanju odstavka 1(a) so dovoljene le prehranske trditve, ki so navedene v Prilogi in so v skladu s pogoji, določenimi v tej uredbi.
Subject to paragraph 1a, nutrition claims shall only be permitted if they are in conformity with this Regulation and comply with the conditions set out in the Annex.
Predlogi sprememb Priloge se sprejmejo v skladu s postopkom iz člena 24(2) in po potrebi, po posvetovanju z Agencijo.
Amendments to the Annex shall be adopted in accordance with the procedure referred to in Article 24(2) and, where appropriate, after consulting the Authority.
Predlogi sprememb Priloge se sprejmejo v skladu s postopkom iz člena 24(2) in po potrebi po posvetovanju z Agencijo ter v sodelovanju z združenji potrošnikov, ki bodo presojali o dojemanju in razumevanju zadevnih trditev .
Amendments to the Annex shall be adopted in accordance with the procedure referred to in Article 24(2) and, where appropriate, after consulting the Authority and with the involvement of consumer associations to judge the perception and understanding of the claims in question .
Na splošne, ne posebej opredeljene prednosti, ki jih ima hranilo ali živilo za splošno dobro zdravje ali z zdravjem povezano dobro počutje, se lahko sklicuje le, če se doda posebna zdravstvena trditev, vključena v seznam iz členov 13 ali 14.
Reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being may only be made if accompanied by a specific health claim included in the lists provided for in Article 13 or 14.
Na splošne, ne posebej opredeljene prednosti, ki jih ima hranilo ali živilo za splošno dobro zdravje ali z zdravjem povezano dobro počutje, se lahko sklicuje le, če se doda posebna zdravstvena trditev, vključena v seznam iz členov 13 ali 14 ali Priloge .
Reference to general, non-specific benefits of the nutrient or food for overall good health or health-related well-being may only be made if accompanied by a specific claim included in the list provided for in Articles 13 or 14 or the Annex .
Če ne obstajajo posebni predpisi Skupnosti, ki se nanašajo na priporočila ali odobritve zdravstvenih trditev s strani nacionalnih zdravniških združenj in društev, ki se ukvarjajo z zdravjem, se lahko v skladu z določbami Pogodbe uporabljajo ustrezni nacionalni predpisi.
In the absence of specific Community rules concerning recommendations of or endorsements by national medical associations and health-related charities, relevant national rules may apply in compliance with the provisions of the Treaty.
Če ne obstajajo posebni predpisi Skupnosti, ki se nanašajo na priporočila ali odobritve zdravstvenih trditev s strani nacionalnih zdravstvenih strokovnjakov ter združenj in društev za prehrano/dietetiko , ki se ukvarjajo z zdravjem, se lahko v skladu z določbami Pogodbe uporabljajo ustrezni nacionalni predpisi.
In the absence of specific Community rules concerning recommendations of or endorsements by national health professional and nutrition/dietetic associations and health-related charities, relevant national rules may apply in compliance with the provisions of the Treaty.
Priporočila, ki so potrošnikom koristna v zvezi s prehrano, živili in zdravjem, lahko oblikujejo tudi ustrezno usposobljeni zdravstveni strokovnjaki, kot so medicinske sestre, zobozdravniki in farmacevti, ter ustrezno usposobljeni strokovnjaki za prehrano in dietetiki.
Recommendations helpful to consumers regarding diet, foods and health may also be made by properly qualified health professionals such as nurses, dentists and pharmacists as well as by properly qualified nutritionists and dieticians.
Prvotni predlog Komisije ni predvidel odobritev, urejenih v skladu z nacionalnimi pravili.
The original Commission proposal did not envisage endorsements being governed according to national rules.
Zato je besedilo Skupnega stališča popolnoma novo.
The Common Position text is therefore entirely new.
V prvi obravnavi je Parlament potrdil odobritve s strani zdravstvenih strokovnjakov.
At first reading Parliament acknowledged endorsements by health professionals.
Člen 12, točki (b) in (c)
Article 12, points (b) and (c)
(b) trditve, ki se sklicujejo na stopnjo ali količino izgubljene teže;
(b) claims which make reference to the rate or amount of weight loss;
(b) trditve, ki se sklicujejo na stopnjo ali količino izgubljene teže, razen če so znanstveno utemeljene ;
(b) claims which make reference to the rate or amount of weight loss, unless scientifically substantiated ;
(c) trditve, ki se sklicujejo na priporočila posameznih zdravnikov ali zdravstvenih strokovnjakov in drugih združenj, ki niso omenjena v členu 11.
(c) claims which make reference to recommendations of individual doctors or health professionals and other associations not referred to in Article 11.
(c) trditve, ki se sklicujejo na priporočila posameznih zdravnikov ali zdravstvenih strokovnjakov in drugih združenj, ki niso omenjena v členu 11 , razen če so znanstveno utemeljene .
(c) claims which make reference to recommendations of individual doctors or health professionals and other associations not referred to in Article 11 , unless scientifically substantiated .
(Ta predlog spremembe temelji na predlogu spremembe 42 iz prve obravnave.)
(Reinstates Amendment 42 at first reading)
Omejitve uporabe zdravstvenih trditev morajo biti sprejete na podlagi znanstvenih meril.
Restrictions on the use of health claims should be undertaken on the basis of scientific criteria.
(ca) trditve, namenjene izrecno otrokom, razen če so znanstveno utemeljene.
(ca) claims which are exclusively directed at children, unless scientifically substantiated.
Pomembno je varovati zdravje najbolj ranljivih in s tem tudi najbolj ogroženih.
It is important to protect the health of the most vulnerable and hence most at risk.
Zdravstvene trditve, ki opisujejo ali se sklicujejo na:
Health claims describing or referring to:
(a) vlogo hranila ali druge snovi pri rasti, razvoju in telesnih funkcijah, ali
(a) the role of a nutrient or other substance in growth, development and the functions of the body, or
(b) psihične in vedenjske funkcije, ali
(b) psychological and behavioural functions, or
(c) 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,
(c) 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,
ki so vključene v seznam iz odstavka 3, se lahko oblikujejo brez opravljenega postopka odobritve iz členov 15 do 18, če:
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 temeljijo na seznamu iz odstavka 3, se lahko oblikujejo brez opravljenih postopkov iz členov 15 do 18, če:
which are based on the list provided for in paragraph 3 may be made without undergoing the procedures laid down in Articles 15 to 18, if they are:
(i) temeljijo na splošno sprejetih znanstvenih podatkih , in
(i) based on generally accepted scientific data , and
(i) temeljijo na splošno sprejetih znanstvenih spoznanjih in
(i) based on generally accepted scientific knowledge , and
(ii) jih povprečni potrošnik dobro razume.
(ii) well understood by the average consumer.
Države članice Komisiji posredujejo sezname trditev iz odstavka 1 najpozneje do ...*, skupaj s pogoji, ki veljajo zanje in, s sklicevanjem na ustrezno znanstveno utemeljitev.
Member States shall provide the Commission with lists of claims as referred to in paragraph 1 by …* at the latest accompanied by the conditions applying to them and by references to the relevant scientific justification.
Komisija po posvetovanju z Agencijo in v skladu s postopkom iz člena 24(2) sprejme najpozneje do …* seznam Skupnosti z dopustnimi trditvami iz odstavka 1 in vse pogoje, potrebne za uporabo teh trditev.
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 …* at the latest.
Komisija po posvetovanju z Agencijo in v skladu s postopkom iz člena 24(2) sprejme najpozneje do …* * seznam Skupnosti z dopustnimi trditvami iz odstavka 1 in vse pogoje, potrebne za uporabo teh trditev.
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 …* * at the latest.
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 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 spoznanj in v skladu s postopkom iz člena 24(2), in sicer po posvetovanju z Agencijo, na lastno pobudo Komisije ali zahtevo države članice.
Any changes to the list referred to in paragraph 3, based on generally accepted scientific knowledge , 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 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.
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 spoznanjih in/ali vključujejo zahtevo za zakonsko zaščito spoznanj , se sprejmejo po postopku iz členov 15 do 18.
Any additions of claims to the list referred to in paragraph 3 based on newly developed scientific knowledge 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.
* UL: Zadnji dan meseca od začetka veljavnosti te uredbe, + 1 leto .
* OJ: Last day of the month of entry into force of this Regulation, plus 1 year .
* UL: Zadnji dan meseca od začetka veljavnosti te uredbe, + 6 mesecev .
* OJ: Last day of the month of entry into force of this Regulation plus 6 months.
* UL: Zadnji dan meseca od začetka veljavnosti te uredbe, + 3 leta .
* OJ: Last day of the month of entry into force of this Regulation, plus 3 years .
** UL: Zadnji dan meseca od začetka veljavnosti te uredbe, + 2 leti .
** OJ: Last day of the month of entry into force of this Regulation plus 2 years.
Ta predlog nadomešča „podatke“ s „spoznanji“ v skladu s predlogi sprememb k členoma 5 in 6.
Amendment that replaces “data” by “knowledge” in line with amendments proposed to Articles 5 and 6
Za zagotavljanje hitrejšega dostopa malih in srednje velikih podjetij do seznama odobrenih trditev, ki se lahko uporabljajo brez postopka odobritve, je treba skrajšati časovna obdobja za sestavo seznama.
In order to allow SME's to have a faster access to the list of authorized claims which can be used without undergoing any procedure of authorization, time periods for the compiling of the list have to be shortened.
Cilj teh dveh predlogov sprememb je skrajšati čas uresničitve seznama dovoljenih trditev na 2 leti.
The two proposed ams. are aimed at shortening to 2 years the timing of realization of the list of allowed claims .
Člen 13, odstavek 5 a (novo)
Article 13, paragraph 5 a (new)
Zdravstvene trditve, ki ne zadevajo zmanjšanja tveganja za bolezni ter razvoja in zdravja otrok ter jih odstavek 1 ne zajema, so dovoljene, če so bile registrirane v skladu s postopkom iz člena 17a.
Health claims other than those referring to the reduction of disease risk and those referring to children's development and health, which are not covered by paragraph 1, may be made where they have been registered in accordance with the procedure laid down in Article 17a.
Glavni cilj tega predloga spremembe je uvedba hitrejšega postopka (le 6 mesecev), z zagotavljanjem časa za znanstveno oceno EFSA.
The main aim of this amendment is to have a faster procedure (only 6 months), by preserving all the time for the scientific assessment for the EFSA.
To je edino zagotovilo potrošnikom, da skrajšanje obdobja ne bo ogrozilo kakovosti ocene.
That's the only guarantee for the consumer that the shortening of the period will not damage the quality of the assessment.
Če EFSA meni, da trditev morda ni znanstveno utemeljena, potem se uporablja postopek „odobritve“ s posredovanjem Komisije in postopkom komitologije.
If EFSA thinks that the claim might be not scientific substantiated then the "Authorization" procedure applies with the intervention of the Commission and the Comitology procedure.
Bistveno je, da se vse trditve v zvezi z razvojem in zdravjem otrok ter trditve v zvezi z zmanjšanjem tveganja za bolezni obravnavajo previdno in zelo natančno.
It is of vital importance to consider carefully with the utmost precision all claims referring to children's development and health as well as claims referring to the reduction of disease risk.
Trditve v zvezi z zmanjšanjem tveganja za bolezen
Reduction of disease risk claims
Trditve v zvezi z zmanjšanjem tveganja za bolezen in trditve v zvezi z razvojem in zdravjem otrok
Reduction of disease risk claims and claims related to children's development and health
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.
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 ter trditve v zvezi z razvojem in zdravjem otrok 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.
Notwithstanding Article 2(1)(b) of Directive 2000/13/EC, reduction of disease risk claims and claims related to children's development and health 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.
Bistveno je, da se vse trditve v zvezi z razvojem in zdravjem otrok prav tako obravnavajo previdno in zelo natančno.
It is of vital importance to also consider carefully with the utmost precision all claims referring to children's development and health.
Mala in srednje velika podjetja ne bi smela biti oškodovana zaradi izvajanja novega sistema.
SMEs should not be penalised by the application of the new system.
Agencija si prizadeva upoštevati rok šestih mesecev od datuma prejema veljavne vloge za pripravo mnenja.
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.
Ta rok se podaljša vedno kadar Agencija na podlagi odstavka 2 tega člena od vlagatelja zahteva dodatne informacije.
Such time limit shall be extended whenever the Authority seeks supplementary information from the applicant as provided for in paragraph 2.
Agencija upošteva rok štirih mesecev od datuma prejema veljavne vloge za pripravo mnenja.
In giving its opinion, the Authority shall respect a time limit of four months from the date of receipt of a valid application.
Ta rok se podaljša za dva meseca , vedno kadar Agencija na podlagi odstavka 2 tega člena od vlagatelja zahteva dodatne informacije.
Such time limit shall be extended for two months whenever the Authority seeks supplementary information from the applicant as provided for in paragraph 2.
Ta predlog spremembe predvideva krajše roke za pripravo mnenja s strani EFSA v procesu izdaje dovoljenja, in sicer ob upoštevanju dejstva, da mora omenjeni proces zadostiti zahtevam po sorazmernosti in zaščiti potrošnikov.
This amendment sets tighter timelines for the EFSA opinion in the Authorisation process, in recognition of the fact that the process needs to fit the need for proportionality as well as protection of consumers.
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.
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.
Vlagatelj lahko ima neposredni dostop do pristojnega sosveta Agencije, vključno s pravico do predstavitve in pravico do dopolnitve dokumentacije.
The applicant may have direct access to the competent panel of the Authority including the right to be heard and the right to add further particulars to the dossier.
Za pripravo svojega mnenja Agencija:
In order to prepare its opinion, the Authority shall:
Za pripravo svojega mnenja Agencija preveri :
In order to prepare its opinion, the Authority shall verify:
(a) preveri, ali je predlagano besedilo zdravstvene trditve utemeljeno z znanstvenimi podatki;
(a) verify that the proposed wording of the health claim is substantiated by scientific data;
(a) ali je zdravstvena trditev utemeljena z znanstvenimi podatki;
(a) that the health claim is substantiated by scientific data;
(b) preuči, ali je besedilo zdravstvene trditve v skladu z merili, določenimi v tej uredbi;
(b) consider whether the wording of the health claim complies with the criteria laid down in this Regulation;
(b) ali je besedilo zdravstvene trditve v skladu z merili, določenimi v tej uredbi;
(b) that the wording of the health claim complies with the criteria laid down in this Regulation.
(c) svetuje, ali je predlagano besedilo zdravstvene trditve razumljivo in jasno povprečnemu potrošniku.
(c) give advice on whether the proposed wording of the health claim is understandable and meaningful to the average consumer.
Zahteva, da EFSA oblikuje mnenje o razumevanju trditve s strani potrošnika, je spremenjena, ker to področje ni del njenega strokovnega znanja in izkušenj.
The requirement for EFSA to give an opinion on the consumer understanding of the claim is amended, as this area ise not within EFSA expertise.
V primeru, da mnenje podpira odobritev zdravstvene trditve, mora le-to vsebovati še naslednje podatke:
In the event of an opinion in favour of authorising the health claim, the opinion shall include the following particulars:
Mnenje mora vsebovati še naslednje podatke:
The opinion shall include the following particulars:
(a) ime in naslov vlagatelja;
(a) the name and address of the applicant;