natgillin/translations-raw huggingface dataset:
(b) odobrene zdravstvene trditve in pogoje ki veljajo zanje, kot je navedeno v členih 13(2), 17(2), 19(1) in (2), 21(2) ter 22(2);
(b) the authorised health claims and the conditions applying to them provided for in Articles 13(2), 17(2), 19 (1) and (2), 21(2) and 22(2);
(b) zdravstvene trditve v smislu člena 12 in zdravstvene trditve, glede katerih je bila sprejeta ugodna odločitev v skladu s členi 13(2), 17(2), 19(1) in (2), 21(2), 22(2) , ter vsemi pogoji, ki veljajo zanje ;
(b) the health claims within the meaning of Article 12 and the health claims on which a favourable decision has been reached in accordance with Articles 13(2), 17(2), 19 (1) and (2), 21(2) and 22(2) , and any conditions applying to them ;
(c) seznam neodobrenih zdravstvenih trditev.
(c) a list of rejected health claims.
Zdravstvene trditve, ki so bile odobrene na podlagi zaupnih podatkov, se vpišejo v posebno prilogo registra z naslednjimi informacijami:
Health claims authorised on the basis of proprietary data shall be placed on a separate Annex to the Register with the following information:
Zdravstvene trditve, o katerih je bila sprejeta ugodna odločitev na podlagi zaupnih podatkov, se vpišejo v posebno prilogo registra z naslednjimi informacijami:
Health claims on which a favourable decision has been taken on the basis of proprietary data shall be placed on a separate Annex to the Register with the following information:
(1) datum dovoljenja za zdravstveno trditev s strani Komisije in ime prvotnega vlagatelja, ki mu je bilo izdano dovoljenje ;
(1) the date the Commission authorised the health claim and the name of the original applicant that was granted authorisation ;
(1) datum odločitve o zdravstveni trditvi s strani Komisije in ime prvotnega obvestitelja ;
(1) the date of the decision by the Commission on the health claim and the name of the original notifier ;
(2) opozorilo o tem, da je Komisija odobrila zdravstveno trditev na podlagi zaupnih podatkov;
(2) that the Commission authorised the health claim on the basis of proprietary data;
(2) opozorilo o tem, da je bila sprejeta odločitev na podlagi zaupnih podatkov;
(2) that the decision was reached on the basis of proprietary data;
(3) opozorilo o tem, da je uporaba zdravstvene trditve omejena, razen če kasnejši vlagatelj pridobi dovoljenje za trditev brez sklica na zaupne podatke prvotnega vlagatelja .
(3) 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 .
(3) opozorilo o tem, da je uporaba zdravstvene trditve omejena, razen če kasnejši proizvajalec ali uvoznik pridobi ugodno odločitev brez sklica na zaupne podatke prvotnega proizvajalca ali uvoznika .
(3) that the health claim is restricted for use unless a subsequent manufacturer or importer obtains a favourable decision without reference to the proprietary data of the original manufacturer or importer .
Pravice intelektualne lastnine
Intellectual property rights
Obvestilo, registriranje in objava trditve ne posegajo v pravice intelektualne lastnine, ki bi lahko bile v korist obvestitelja, tako v zvezi s samo trditvijo, kot tudi v zvezi s kakršnimi koli znanstvenimi podatki ali informacijami iz dokumentacije.
Notification, registering and publication of claims shall be without prejudice to any intellectual property rights which the person notifying may enjoy in relation to the claim itself or any scientific data or information contained in the dossier.
Take pravice se varuje v skladu s pravnim redom Skupnosti ali nacionalnimi pravnimi določbami, skladnimi s pravnim redom Skupnosti.
Such rights are to be protected in accordance with Community law or national legal provisions consistent with Community law.
Člen 25
Article 25
Komisija do ... najpozneje [zadnjega dne petega meseca po datumu sprejema + šest let ] Evropskemu parlamentu in Svetu predloži poročilo o izvajanju te uredbe, še zlasti o razvoju trga živil, za katera so narejene prehranske navedbe in zdravstvene trditve, skupaj s predlogi sprememb, če je to potrebno.
By … at the latest [last day of the fifth month following date of adoption + 6 years ], the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation, in particular on the evolution of the market of foods in respect of which nutrition or health claims are made, together with a proposal for amendments if necessary.
Komisija do ... najpozneje [zadnjega dne v mesec u po datumu sprejema + šest let ] Evropskemu parlamentu in Svetu predloži poročilo o izvajanju te uredbe, še zlasti o razvoju trga živil, za katera so narejene prehranske navedbe in zdravstvene trditve, in o vseh problemih, odkritih pri izvajanju člena 1(4 a) o blagovnih znamkah , skupaj s predlogi sprememb, če je to potrebno.
By ... at the latest [last day of the month following date of adoption + 3 years ], the Commission shall submit to the European Parliament and to the Council a report on the application of this Regulation, in particular on the evolution of the market in foods in respect of which nutrition or health claims are made and on any problems encountered in the application of Article 1(4 a) on trade marks , together with a proposal for amendments if necessary.
To poročilo mora vključevati tudi oceno vpliva te uredbe na javno zdravje.
The report should also include an evaluation of the impact of this Regulation on public health.
Zgodnejši datum pregledom bi omogočil priložnost za preučitev vseh neskladij med uredbo in tozadevno zakonodajo o blagovnih znamkah.
An earlier review date would provide the opportunity to explore any conflicts between the Regulation and the relevant Trade Mark legislation.
Člen 26
Article 26
Uporablja se od [prvega dne šestega meseca po objavi].
It shall apply from [first day of the sixth month following publication].
Uporablja se od [prvega dne osemnajstega meseca po objavi].
It shall apply from [first day of the eighteenth month following publication].
Živila, dana na trg ali označena pred tem datumom, ki niso v skladu s to uredbo, se smejo tržiti do [zadnjega dne enajstega meseca po objavi ].
Foods placed on the market or labelled prior to that date which do not comply with this Regulation may be marketed until [last day of the eleventh month following publication ].
Živila, ki so dana na trg ali označena pred datumom veljavnosti te uredbe in niso v skladu s to uredbo, se smejo tržiti do [ zadnjega dne enajstega meseca po vlogi ] ali po poteku roka uporabe, odvisno katero obdobje je pač daljše.
Foods placed on the market or labelled prior to the date of entry into force of this Regulation and which do not comply with this Regulation may be marketed until [ last day of the eleventh month following application ] or the end of their shelf life, which ever is longer.
Razen tistih iz člena 12(1), ki se uporabljajo v skladu z obstoječimi določbami, se lahko zdravstvene trditve za živila, kategorije živil ali sestavine živil v času ko ta uredba stopi v veljavo še naprej uporabljajo pod pogojem, da se napravi obvestilo v skladu s členom 14 v roku 12 mesecev od začetka veljavnosti te uredbe in do šestih mesecev po sprejetju končne odločitve v skladu s členom 16.
Health claims other than those referred to in Article 12(1) that are used in compliance with existing provisions, for foods, categories of foods or food constituents at the time this Regulation enters into force, may continue to be used provided a notification is made pursuant to Article 14 within twelve months of the date of entry into force of this Regulation and until six months after a final decision is taken pursuant to Article 16.
Treba je določiti prehodno obdobje 18 mesecev.
Provision should be made for an 18-month transitional period.
Neomejeno prodajo živil, danih na trg pred veljavnostjo uredbe, je treba dovoliti do poteka njihovega roka trajanja, kot je bilo to storjeno v primeru prejšnje zakonodaje Skupnosti.
The unrestricted sale of foods placed on the market prior to the regulation's entry into force should be permitted up until the end of their shelf lives, as has been the case with previous pieces of Community legislation.
Časovne omejitve za izvajanje morajo upoštevati tako izdelke z omejenim rokom uporabnosti, pri katerih lahko spreminjanje embalaže in ostalega traja nekaj mesecev, kot tudi izdelke z dolgim rokom uporabe, ki bodo v času objave uredbe že proizvedeni.
The time limits for implementation should take account of both products with a limited shelf life, for which packaging and other changes may take several months to make, and those with a long shelf life that have already been manufactured by the time the regulation is published.
Predlog uredbe ureja pogoje, po katerih naj bi bili v prihodnje dopustni označevanje in oglaševanje živil s prehranskimi navedbami in zdravstvenimi trditvami.
The proposal for a regulation lays down the conditions under which the labelling and advertising of foods with nutrition and health claims will be permitted in future.
Medtem ko morajo prehranske navedbe, kot so „nemastno“ ali „brez sladkorja“, ustrezati določilom iz predloga uredbe in si Komisija za določena živila pridrži pripravo tako imenovanih profilov hranilne vrednosti, ki jih je treba upoštevati, da bi lahko z njimi oglaševali prehranske navedbe ali zdravstvene trditve, so v skladu s predlogom Komisije zdravstvene trditve dovoljene samo ob znanstvenem dokazilu in uradnem dovoljenju.
While nutritional claims such as 'low-fat' or 'sugar-free' must comply with the rules laid down in the proposal for a regulation and while the Commission reserves the right, where certain foods are concerned, to establish so-called nutritional profiles which must be complied with if those foods are to be advertised with nutrition or health claims, under the Commission proposal health claims will be permitted only on the basis of scientific proof and following official authorisation.
Strogo prepovedani so trditve o počutju, na primer „živilo ohranja kondicijo, mladostni videz ali razveseljuje“.
Mood- or fitness-related claims about foods, such as that a food keeps people fit or young, or makes them happy, are totally prohibited.
Pripravljavka mnenja ocenjuje predlog Komisije zelo kritično in meni, da je treba številne točke popraviti.
Your draftswoman takes a very critical view of the Commission proposal, and considers that many aspects require changes.
Preučiti je treba že pristop – Prepoved s pridržkom dovoljenja – na katerem temelji osnutek uredbe Komisije.
Even the Commission's basic approach underlying the draft regulation, namely prohibition with the possibility of authorisation, has to be scrutinised.
Za potrošnika so podrobne in bistvene informacije o živilih, ki jih uporablja vsakodnevno, zelo pomembne.
It is essential for consumers to have precise and meaningful information about the foods that they use on a daily basis.
Proizvajalci tudi sami posredujejo velik del teh informacij.
A substantial proportion of such information is supplied by the manufacturers themselves.
Poleg tega da te informacije vplivajo na različne vidike, na primer na ceno izdelka, je od njih lahko odvisna tudi odločitev o nakupu.
In addition to factors such as price, it may influence purchase decisions.
Za evropske proizvajalce živil so že urejena nekatera pravna določila.
However, European food manufacturers do not operate in a legal vacuum.
Že zdaj obstajajo številni nacionalni, pa tudi evropski predpisi v zvezi z etiketiranjem in označevanjem hranilnih vrednosti.
There is already a multiplicity of national and European rules on labelling and nutritional information.
Poleg tega velja tudi splošna prepoved zavajajočega oglaševanja.
In addition, there is a general ban on misleading advertising.
Pomisleki obstajajo predvsem v zvezi s predvideno uvedbo profilov hranilne vrednosti živil iz člena 4 predloga uredbe.
There are reservations, above all, about the introduction of nutritional profiles for foods which is envisaged in Article 4 of the proposal for a regulation.
V skladu s predlogom Komisije bi se morala živila ocenjevati predvsem po količini sladkorja, soli ali maščobe, še preden bi se smela oglaševati s prehranskimi navedbami ali zdravstvenimi trditvami.
The Commission's intention is that the sugar, salt or fat content, in particular, of foods will have to be measured before they may be advertised with nutrition or health claims.
Členitev živil na primeren in manj primeren profil hranilne vrednosti je v nasprotju z zamislijo o uravnoteženi prehrani.
However, the classification of foods into those with a beneficial nutritional profile and those with a less beneficial profile contradicts the idea of a balanced diet.
Načeloma ni dobrih ali slabih živil.
There are, in principle, no good or bad foods.
Nasprotno, bolj pomemben je odnos do zaužitja živil.
The decisive factor, instead, is the proportions in which foods are consumed.
V osnutku uredbe ostaja še naprej odprto vprašanje v zvezi z natančno opredelitvijo pojma profila hranilne vrednosti in njegove določitve.
Moreover, the draft regulation largely leaves open the precise definition, and establishment, of the concept of a nutritional profile.
Uvedbi profilov hranilne vrednosti naj bi se odpovedali, dokler ne bo to vprašanje znanstveno razjasnjeno.
Until this is resolved scientifically, nutritional profiles should not be introduced.
Člen 10 osnutka uredbe predvideva enoten, več mesecev trajajoč postopek za odobritev uporabe zdravstvenih trditev pri oglaševanju živil, ki ga izvaja evropska agencija za živila.
Article 10 of the draft regulation provides for a single authorisation procedure, lasting several months and conducted by a European food agency, for the use of health claims in food advertising.
Ta predlog je birokratski, nepraktičen in ravno s stališča Lizbonske strategije nesprejemljiv.
This proposal is bureaucratic, impractical and, especially in the light of the Lisbon strategy, unacceptable.
Pripravljavka podpira prizadevanje Komisije, da bi utemeljila zahteve o označevanju živil in oglaševanju, odločno pa zavrača predlagan postopek vnaprejšnjega preverjanja.
Your draftswoman supports the Commission's aim of embodying the requirements regarding food labelling and advertising in practical measures, but roundly rejects the proposed grandiose prior assessment procedure.
Poleg tega je treba obravnavati prepoved tako imenovanih implicitnih zdravstvenih trditev iz člena 11 predloga uredbe.
Furthermore, the prohibition of so-called implied health claims in Article 11 of the proposal for a regulation should be the subject of debate.
Zakaj naj bi bilo v prihodnje prepovedano oglaševanje, pri katerem se izpostavlja dobro počutje, na primer „ohranja mladostni videz“ ali „daje zagon“, in ki izraža občutke?
Why is advertising foods with 'feel-good' claims such as 'keeps you young' or 'gives you a boost', which express an individual feeling, to be banned in future?
Potrošnik lahko trditve o občutkih in razpoloženju razpozna kot take in jih oceni.
Consumers are in a position to recognise claims about feelings and moods for what they are, and to make a judgment about them.
Popolna prepoved takih trditev bi bila nesorazmerna, kajti zavajanje potrošnika preprečujejo že Direktiva o zavajajočem oglaševanju in direktive o označevanju živil.
A total ban on such claims would be disproportionate, especially since the Directive on misleading advertising and the labelling directives already prevent consumers being misled.
Na splošno je več kot dvomljivo, da je z obstoječo uredbo znotraj Evropske unije dejansko mogoče uspešno preprečevati napačne navade prehranjevanja.
It is wrong to deprive consumers from the outset of the ability to recognise general mood- and fitness-related claims as advertising and to assess and challenge them.
Naraščajoče število ljudi s prekomerno telesno težo v naši moderni družbi je nedvomno tudi izraz napačnih navad pitja in prehranjevanja.
In general terms it is more than doubtful whether poor dietary habits within the European Union can actually be combated successfully with this regulation.
Toda nanje lahko vplivajo tudi drugi dejavniki, kot so pomanjkanje gibanja, obremenitev okolja in stres.
There is no doubt that the growing number of overweight people in our modern society is partly the outcome of poor drinking and eating habits, but other factors, such as a lack of mobility, environmental pollution or stress, may also have a bearing on these.
Zaradi tega se bodo zdravstveni stroški v prihodnje gotovo zvišali, zato je treba ukrepati.
These developments will certainly cause health costs to rise in future, so that action must be taken to counter them.
Pravna ureditev reklamnih sporočil za živila po mnenju poročevalke ne bo preprečila tega pojava.
Your draftswoman considers, however, that regulating advertising for foods will not prevent this phenomenon.
Teh pojavov ne povzroča neovirano oglaševanje živil, pač pa drugi družbeni dejavniki.
The causes are not be found in unrestricted advertising for foods, but in other social factors.
Delovanje tistega, ki želi trajno spremeniti navade prehranjevanja in nanje pozitivno vplivati, ne sme temeljiti le na prepovedih in omejitvah.
If we wish to change dietary habits in the long term, and have a positive influence on them, we should not rely solely on bans and restrictions.
Dolgoročno izboljšanje razmer se lahko doseže samo s navadami prehranjevanja, ki jih potrošniki priznavajo in sprejmejo.
In the long term, the only remedy can be dietary habits which are recognised and accepted by consumers.
V tej smeri lahko več dosežejo informativne kampanje, ki se že zdaj pogosto izvajajo na nacionalni ravni, kot pa nov sistem državnega nadzora.
In this context more can be achieved by educational campaigns, of which there are already many national examples, than by a new system of State control.
Odbor za industrijo, raziskave in energetiko poziva Odbor za okolje, javno zdravje in varno hrano kot pristojni odbor, da v svoje poročilo vključi naslednje predloge sprememb:
The Committee on Industry, Research and Energy calls on the Committee on the Environment, Public Health and Food Safety, as the committee responsible, to incorporate the following amendments into its report:
(6) Živila, ki se oglašujejo s takimi navedbami in trditvami, lahko potrošnik razume kot izdelke, ki imajo v primerjavi s podobnimi ali drugimi izdelki, ki jim take hranilne snovi niso dodane, hranilne, psihološke in zdravstvene prednosti.
(6) Foods promoted with claims may be perceived by consumers as having a nutritional, physiological or other health advantage over similar or other products without such nutrients added.
Da bi delovali v nasprotju s tem možnim neželenim učinkom, je primerno, da se v zvezi z izdelki, za katere so navedene takšne navedbe in trditve, uvede določene omejitve.
To counter this potential undesirable effect, it is appropriate to impose certain restrictions as regards the products bearing claims.
V tem smislu je vsebnost določenih snovi v izdelku – na primer alkohola – ali profil hranilne vrednosti izdelka primerno merilo pri odločanju, ali smejo biti na izdelku navedene navedbe in trditve.
In this context, factors such as the presence of certain substances such as the alcohol content of the product or the nutrient profile of the product are appropriate criteria for determining whether the product can bear claims.
Zasnova členitve živil na izdelke s primernim in manj primernim profilom hranilne vrednosti je v nasprotju s pojmovanjem uravnotežene prehrane.
The concept of classifying foods as products with a beneficial nutritional profile and products with a less beneficial profile contradicts the idea of a balanced diet.
Nasprotno, bolj pomemben je odnos do zaužitja posameznih živil.
The decisive factor, instead, is the proportions in which individual foods are consumed.
Napačno je tudi sklepanje, da takšne navedbe in trditve v vsakem primeru slabo vplivajo na potrošnike.
It is also incorrect to assume that consumers will be negatively influenced by such claims in every case.
(7 ) Pri določitvi profila hranilne vrednosti se lahko upoštevajo deleži različnih hranilnih snovi in snovi s prehrambenopsihološkim učinkom, zlasti maščob, nasičenih maščobnih kislin, transmaščobnih kislin, soli/natrija in sladkorja, katerih prekomerno uživanje ni priporočljivo, pa tudi polinenasičenih in mononenasičenih maščobnih kislin, dostopnih ogljikovih hidratov razen sladkorja, vitaminov, mineralov, proteinov in balastnih snovi.
(7) The establishment of a nutrient profile may take into account the content of different nutrients and substances with a nutritional or physiological effect, in particular those such as fat, saturated fat, trans-fatty acids, salt/sodium and sugars whose excessive intakes in the overall diet are not recommended and those such as poly- and monounsaturated fats, available carbohydrates other than sugars, vitamins, minerals, protein and fibre.
To bi zahtevalo kompleksen tehnični napor, sprejem ustreznih ukrepov pa bi naj bil zaupan Komisiji.
These would be complex technical exercises and the adoption of the relevant measures should be entrusted to the Commission.
Uporaba prehranskih navedb in zdravstvenih trditev je z različnimi predpisi že urejena na nacionalni, pa tudi na evropski ravni, in naj se je ne bi dodatno povezovalo s profili hranilnih vrednosti, katerih oblika je po določbah osnutka uredbe razmeroma odprta in nedoločena
The use of nutrition and health claims is already regulated by various national and European provisions, and should not additionally be linked to nutritional profiles the formulation of which the provisions of the draft regulation leave largely open and undefined.
(11) Znanstvena utemeljitev mora biti glavni vidik, ki se upošteva pri uporabi prehranskih navedb in zdravstvenih trditev, nosilci živilske dejavnosti pa morajo uporabo takšnih navedb in trditev utemeljiti ob upoštevanju načela sorazmernosti.
(11) Scientific substantiation should be the main aspect to be taken into account for the use of nutrition and health claims and the food business operators using claims should justify them , with due regard for the principle of proportionality .
Znanstvena utemeljitev mora biti sorazmerna z značilnostmi koristi, ki naj bi jih omogočal izdelek.
The scientific substantiation should be commensurate with the nature of the benefits which the product is claimed to confer.
V skladu s splošnimi načeli, zajetimi v uredbi, ki ustanavlja Evropski urad za varno hrano, ta uredba določa zahteve za sorazmernost v zvezi z naravo navedb in trditev o izdelkih: npr. za „trditve za zmanjševanje tveganja bolezni“ se zahteva višja raven znanstvenega utemeljevanja kot za „funkcionalne trditve“.
In accordance with the general principles embodied in the Regulation establishing the European Food Safety Authority, the present regulation should establish a requirement for proportionality in relation to the nature of the claims made for products: for example, a higher level of scientific substantiation should be required for 'reduction of disease risk claims' than for 'functional claims'.
Uvodna izjava 14
Recital 14
(14) zdravstvene trditve bi morale biti za uporabo na trgu Skupnosti dopustne samo po znanstveni oceni na najvišji ravni.
(14) Health claims should only be authorised for use on the Community market after a scientific assessment of the highest possible standard.
Da bi zagotovili usklajeno znanstveno oceno teh trditev, bi moral to ocenjevanje prevzeti evropski organ za varno hrano.
In order to ensure harmonised scientific assessment of these claims, the European Food Safety Authority should carry out such assessments .
(14) Omogočeno bi moralo biti, da se zdravstvene trditve za uporabo na trgu Skupnosti lahko znanstveno preveri.
(14) Health claims should be scientifically verifiable for use on the Community market.
(15) Poleg prehranskih so še številni drugi dejavniki, ki lahko vplivajo na psihično stanje in vedenje.
(15) There are many factors, other than dietary ones, that can influence psychological and behavioural functions.
Zato je primerno, da se prepove trditve, ki se nanašajo na psihične ali vedenjske učinke.
Therefore, it is appropriate to prohibit the use of psychological and behavioural claims.