natgillin/translations-raw huggingface dataset:
Pomembno je, da se to splošno načelo poudari v uvodni izjavi, saj se pri obravnavi novih živil pojavi veliko mejnih primerov.
As many borderline issues arise when dealing with novel foods, it is important to stress this general principle in the recital.
Tako se industriji in potrošnikom pojasni delovanje trga v zvezi z mejnimi proizvodi (zdravila/hrana).
This provides more clarity for industry and consumers about the functioning of the market in relation to borderline products (medicine/food).
(10) Živila, ki niso namenjena za tehnološke uporabe ali so gensko spremenjena, ne smejo soditi na področje uporabe te uredbe.
(10) Foods which are intended for technological uses or which are genetically modified should not fall within the scope of this Regulation.
Treba je pojasniti, da morajo biti v skladu z zakonodajo Skupnosti vsa nova živila in živilske sestavine zajete v eno oceno tveganja.
It is necessary to clarify that all new food and food ingredients should be covered by a single risk assessment according to Community legislation.
Za živila, ki so že zajeta v oceno tveganja in postopek odobritve v skladu z drugo zakonodajo EU, se ne bi smeli zahtevati tudi ocene tveganja in odobritve na podlagi uredbe o novih živilih.
Foods, which are already covered by a risk assessment and approval procedure according to another EU legislation, should not also require a risk assessment and approval under the novel food Regulation.
(13) Z informacijami, ki so na voljo v državah članicah, je treba utemeljiti ali se je živilo uporabljalo v pomembnem obsegu za prehrano ljudi pred 15. majem 1997.
(13) Whether a food was used for human consumption to a significant degree before 15 May 1997, should be based on information available in the Member States.
Če Komisija nima informacij o prehrani ljudi pred 15. majem 1997, je treba uvesti enostaven in pregleden postopek za zbiranje navedenih informacij, ki vključuje države članice in vse zainteresirane strani .
Where the Commission does not have information on human consumption before 15 May 1997 , a simple and transparent procedure for collecting that information should be established involving the Member States and any interested parties .
(13) Komisija bi morala uvesti enostaven in pregleden postopek za primere, kjer nima informacij o prehrani ljudi pred 15. majem 1997.
(13) The Commission sh ould establish a simple and transparent procedure for cases in which it does not have information on human consumption before 15 May 1997.
V tem postopku bi morale sodelovati države članice.
The Member States sh ould be involved in this procedure .
Postopek bi bilo treba sprejeti najpozneje šest mesecev po začetku veljavnosti te uredbe.
The procedure should be adopted no later than six months after the entry into force of this Regulation.
Razjasnitev in poenostavitev predloga Komisije.
Clarification and simplification of the Commission proposal.
Biti mora jasno, katere odgovornosti se dodelijo Komisiji z začetkom veljavnosti te uredbe.
It must be clear what responsibilities are being assigned to the Commission when this Regulation enters into force.
(14) Nova živila se lahko dajo na trg v Skupnosti le, če so varna in ne zavajajo potrošnika.
(14) Novel foods should be placed on the Community market only if they are safe and do not mislead the consumer.
Poleg tega se ne smejo toliko razlikovati od živila, ki ga nadomestijo, da je hranilna vrednost neugodna za potrošnika.
In addition, they should not differ from the food that they are to replace in any way that would be nutritionally disadvantageous for the consumer.
(14) Nova živila se lahko dajo na trg v Skupnosti le, èe so varna in ne zavajajo potrošnika.
(14) Novel foods should be placed on the Community market only if they are safe and do not mislead the consumer.
Njihova ocena varnosti bi morala temeljiti na previdnostnem naèelu, kot je doloèeno v èlenu 7 Uredbe (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o doloèitvi splošnih naèel in zahtevah živilske zakonodaje, ustanovitvi Evropske agencije za varnost hrane in postopkih, ki zadevajo varnost hrane 1 .
Their safety assessment should be based on the precautionary principle as laid down in Article 7 of Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety 1 .
1 UL L 31, 1.2.2002, p.
1 OJ L 31, 1.2.2002, p.
(15) Za oceno varnosti in odobritev je treba uporabiti usklajen, centraliziran postopek, ki je učinkovit, časovno omejen in pregleden.
(15) It is necessary to apply a harmonised centralised procedure for safety assessment and authorisation that is efficient, time-limited and transparent.
Pri odobritvi novih živil bi bilo treba upoštevati tudi druge dejavnike, relevantne za obravnavani primer, vključno z etičnimi dejavniki.
The approval of novel foods should also take into account other factors relevant to the matter under consideration, including ethical factors.
Pri postopku odobritve novih živil (ker ta zajemajo tudi nova živila, proizvedena z nanotehnologijami ali postopki kloniranja) je treba upoštevati vse dejavnike, ki so pomembni za končno odločitev, vključno z etičnimi vprašanji.
It is essential that in the process of approving new foods (since this also covers new foods gained from nanotechnologies or cloning processes) all the relevant factors essential for the final decision are taken into account, including the ethical issues.
(15a) Zaradi preprečevanja poskusov na živalih bi bilo treba poskuse na vretenčarjih za namene te uredbe izvajati samo kot skrajni ukrep.
(15 a ) In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation should be undertaken only as a last resort.
S to uredbo je treba poskuse na vretenčarjih čim bolj omejiti, se izogibati podvajanju poskusov ter spodbujati uporabo poskusnih metod, pri katerih se ne uporabljajo živali, in inteligentnih strategij poskusov.
This Regulation should ensure that testing on vertebrate animals is minimised and that double-testing is avoided, and should promote the use of non-animal test methods and intelligent testing strategies.
Obstoječe rezultate poskusov na vretenčarjih bi si bilo treba v postopku razvijanja novih živil izmenjavati.
Existing results from tests on vertebrate animals should be shared in the process of developing novel foods.
V skladu z Direktivo Sveta 86/609/EGS z dne 24. novembra 1986 o približevanju zakonov in drugih predpisov držav članic o varstvu živali, ki se uporabljajo za preskusne in druge znanstvene namene 1 , je treba poskuse na vretenčarjih nadomestiti, omejiti ali izpopolniti.
In accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes 1 , tests on vertebrate animals must also be replaced, restricted or refined.
Izvajanje te uredbe bi moralo, kolikor je mogoče, temeljiti na uporabi ustreznih alternativnih poskusnih metod.
Implementation of this Regulation should , where possible , be based on the use of appropriate alternative testing methods.
Komisija bi morala najpozneje do ...* ponovno pregledati pravila o varstvu podatkov za rezultate poskusov na vretenčarjih in pravila po potrebi spremeniti.
Not later than ... * , the Commission should review the rules on the data protection of results from tests on vertebrate animals and , where necessary , change those rules.
* Sedem let po začetku veljavnosti te uredbe.
* Seven years after the entry into force of this Regulation.
V skladu z zahtevo iz protokola o zaščiti in dobrem počutju živali, po kateri Skupnost in države članice pri oblikovanju in izvajanju svoje politike v celoti upoštevajo zahteve glede dobrega počutja živali, je treba dodati, da morajo biti poskusi na živalih čim bolj omejeni, da se izvajajo le kot skrajni ukrep in da se spodbuja uporaba alternativ.
In line with the requirement in the Protocol on the Protection and Welfare of Animals that the Community and the Member States pay full regard to the welfare requirements of animals in formulating and implementing policies, it should be included that animal testing is kept to an absolute minimum and carried out only as a last resort, and that the use of alternatives is promoted.
(16) Določiti je treba tudi merila za oceno možnih tveganj, ki jih povzročajo nova živila.
(16) Criteria for the evaluation of the potential risks arising from novel foods should also be laid down.
Da bi zagotovili usklajeno znanstveno oceno novih živil, bi morala tako oceno izdelati Evropska agencija za varnost hrane („agencija“).
In order to ensure a harmonised scientific assessment of novel foods, such assessments should be carried out by the European Food Safety Authority ("the Authority").
Da bi zagotovili usklajeno znanstveno oceno novih živil, bi morala tako oceno izdelati Evropska agencija za varnost hrane („agencija“) v sodelovanju z organi držav članic .
In order to ensure a harmonised scientific assessment of novel foods, such assessments should be carried out by the European Food Safety Authority ("the Authority") in cooperation with the Member States’ authorities .
Pozdravlja se centraliziran postopek za odobritev in oceno novih živil, vendar je treba obdržati sodelovanje med Evropsko agencijo za varnost hrane in pristojnimi nacionalnimi organi držav članic, zlasti pri spremljanju trga, ki jim bo poverjeno v okviru te zakonodaje.
While the centralisation of the authorisation and evaluation procedure for novel foods is to be welcomed, cooperation should also be maintained between EFSA and the Member States’ competent authorities, particularly for any market monitoring missions entrusted to them under this legislation.
To sodelovanje jim bo omogočilo ohranjanje strokovnosti in pristojnosti.
This collaboration will enable them to preserve their expertise and competence.
(16a) V postopku odobritve bi bilo treba kot del ocene tveganja upoštevati etične in okoljske vidike.
(16 a ) Eth ical and environmental aspects m ust be considered as part of the risk assessment during the authorisation procedure .
Te vidike bi morala oceniti evropska skupina za etiko v znanosti in novih tehnologijah oziroma Evropska agencija za okolje.
These aspects should be assessed by the European Group on Ethics in Science and New Technologies and the European Environment Agency respecti vel y .
Ocena tveganja mora poleg vidikov varovanja zdravja, interesov potrošnikov in zdravja živali vključevati tudi obravnavo etičnih in okoljskih vidikov.
Apart from the aspects of protection of health, the interests of consumers and animal health, the risk assessment should also include consideration of ethnical and environmental aspects.
(18) Po potrebi in na podlagi sklepov ocene varnosti je treba uvesti zahteve za spremljanje uporabe novih živil za prehrano ljudi po dajanju na trg.
(18) Where appropriate and based on the conclusions of the safety assessment, post-market monitoring requirements for the use of novel foods for human consumption should be introduced.
(18) Na podlagi sklepov ocene varnosti je treba uvesti morebitne zahteve za spremljanje uporabe novih živil po dajanju na trg.
(18) On the basis of the conclusions of the safety assessment, any post-market monitoring requirements for the use of novel foods should be introduced.
(20) V posebnih okoliščinah se , da bi se spodbujalo raziskave in razvoj v kmetijsko-živilskem sektorju in s tem inovacij , nove znanstvene dokaze in podatke , ki so predmet lastninske pravice, predložene za potrebe vloge za uvrstitev novega živila na seznam Skupnosti, v omejenem časovnem obdobju brez soglasja prvega vložnika ne sme uporabiti v korist drugega vložnika.
(20) Under specific circumstances in order to stimulate research and development within the agri-food industry, and thus innovation, the newly developed scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the Community list should not be used to the benefit of another applicant during a limited period of time, without the agreement of the first applicant.
Varovanje znanstvenih podatkov enega vložnika zahtevka ne sme preprečiti drugim vložnikom zahtevka, da zahtevajo uvrstitev na seznam Skupnosti novih živil na podlagi lastnih znanstvenih podatkov.
The protection of scientific data provided by one applicant should not prevent other applicants from seeking the inclusion in the Community list of novel foods on the basis of their own scientific data.
(20) V posebnih okoliščinah je treba , da bi se spodbujalo raziskave in razvoj v kmetijsko-živilskem sektorju in s tem inovacije , zaščititi naložbe inovatorjev v zbiranje informacij in podatkov, ki se predložijo pri vložitvi zahtevka po tej uredbi .
(20) Under specific circumstances in order to stimulate research and development within the agri-food industry, and thus innovation, it is appropriate to protect the investment made by innovators in gathering the information and data provided in support of an application under this Regulation.
Novi znanstveni dokazi in podatki, ki so predmet lastninske pravice, predloženi za potrebe zahtevka za uvrstitev novega živila na seznam Skupnosti, se v omejenem časovnem obdobju brez soglasja prvega vložnika ne smejo uporabiti v korist drugega vložnika.
The newly developed scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the Community list should not be used to the benefit of another applicant during a limited period of time, without the agreement of the first applicant.
Poleg tega varstvo znanstvenih podatkov ne sme onemogočati preglednosti in dostopnosti informacij pri podatkih, ki se uporabljajo pri oceni varnosti novih živil.
In addition, the protection of scientific data should not prevent transparency and access to information relating to the data used in the safety assessment of novel foods.
Vseeno je treba zagotoviti varstvo pravic intelektualne lastnine.
Intellectual property rights should, however, be respected.
Treba pa je prepovedati ponovne študije, ki vključujejo vretenčarje.
However, the repetition of studies involving vertebrates should be prohibited.
V zvezi s tem je treba sprejeti obveznost, da se omogoči dostop do študij o vretenčarjih in drugih študij, s katerimi se lahko preprečijo poskusi na živalih.
In this context, there should be an obligation to allow access to studies on vertebrates and other studies that may prevent animal testing.
Uvodno izjavo 20 je treba uskladiti z uvodno izjavo 31 Uredbe 1924/2006 o prehranskih in zdravstvenih trditvah na živilih.
The wording of recital 20 should be aligned with the wording of recital 31 of Regulation 1924/2006 on nutrition and health claims.
Predlog spremembe je v skladu s predlogom spremembe 5 v osnutku mnenja, vendar si prizadeva zagotoviti varstvo pravic intelektualne lastnine proizvajalcev.
In line with Amendment 5 of the draft opinion, but aims to guarantee the protection of producers´ intellectual property rights .
(21) Nova živila so predmet splošnih zahtev označevanja iz Direktive 2000/13/ES Evropskega parlamenta in Sveta z dne 20. marca 2000 o približevanju zakonodaje držav članic o označevanju, predstavljanju in oglaševanju živil.
(21) Novel foods are subject to the general labelling requirements laid down in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to labelling, presentation and advertising of foodstuffs.
V nekaterih primerih bi bilo morda treba določiti dodatne podatke na etiketi, zlasti glede opisa živila, njegovega vira ali pogojev uporabe.
In certain cases it might be necessary to provide for additional labelling information, in particular regarding the description of the food, its source, or its conditions of use.
Zato lahko uvrstitev novih živil na seznam Skupnosti naloži posebne pogoje uporabe ali obveznosti označevanja.
Therefore, the inclusion of a novel food in the Community list may impose specific conditions of use or labelling obligations.
V nekaterih primerih bi bilo morda treba določiti dodatne podatke na etiketi zlasti glede opisa živila, njegovega vira ali pogojev uporabe , med katerimi so lahko tudi podatki o etičnih vidikih .
In certain cases it might be necessary to provide for additional labelling information, in particular regarding the description of the food, its source, or its conditions of use , which may include information relating to ethical considerations .
Zato bo uvrstitev novih živil na seznam Skupnosti v teh primerih naložila posebne pogoje uporabe ali obveznosti označevanja.
Therefore, the inclusion of a novel food in the Community list will impose specific conditions of use or labelling obligations in those cases .
Proizvode, ki so proizvedeni z uporabo nanotehnologij in živila, proizvedenimi iz živali, krmljenih z gensko spremenjeno krmo, je treba označiti kot take.
Products produced with the aid of nanotechnologies and food produced from animals fed with genetically modified feeding stuffs must be labelled as such.
Pojasnitev predloga spremembe 12 poročevalke.
Clarification of amendment 12 of the Rapporteur.
To pomeni, da Uredba št. 1829/2003 ne vsebuje določb o označevanju, zato je treba za zapolnitev te vrzeli določiti ustrezna pravila v tej uredbi.
1829/2003 contains no provisions on labelling; therefore corresponding rules must be laid down in this regulation in order to fill that gap.
Merila za dodatno označevanje bi morala vključevati tudi etične vidike, kot je kloniranje.
The criteria for additional labelling should also include ethical considerations like cloning.
Na ta način bi bilo mogoče zahtevati označevanje živil, proizvedenih iz kloniranih živali.
Thus it should be possible to require labelling of foods produced from cloned animals.
(22) Uredba (ES) št. 1924/2006 Evropskega Parlamenta in Sveta z dne 20. decembra 2006 o prehranskih in zdravstvenih trditvah na živilih usklajuje določbe v državah članicah v zvezi s prehranskimi in zdravstvenimi trditvami.
(22) Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods harmonises the provisions in the Member States which relate to nutrition and health claims.
Zato morajo biti trditve glede novih živil zmeraj v skladu z navedeno uredbo.
Therefore, claims regarding novel foods should only be made in accordance with that Regulation.
Če namerava vložnik zahtevka novo živilo opremiti z zdravstveno trditvijo, ki mora biti odobrena v skladu s členoma 17 in 18 Uredbe (ES) št. 1924/2006, in če zahtevka za novo živilo in zdravstveno trditev vključujeta zahtevo za varstvo podatkov, ki so predmet lastninske pravice, se mora na zahtevo vložnika obdobje varstva podatkov zanju začeti in nato teči hkrati.
Where an applicant wishes a novel food to carry a health claim that needs to be authorised in accordance with A rticle 17 or 18 of Regulation (EC) No 1924/2006 and the novel food and health claim applications include requests for the protection of proprietary data, at the request of the applicant, the period of data protection should start together and run concurrently.
(23) Glede ocene varnosti in upravljanja tradicionalnih živil iz tretjih držav je treba upoštevati pretekle izkušnje njihove varne uporabe v tretji državi porekla.
(23) As regards the safety assessment and management of traditional food from third countries, their history of safe use in the third country of origin should be taken into account.
Pretekle izkušnje glede varne uporabe ne smejo vključevati neživilske rabe ali rab, ki niso v zvezi z običajno prehrano.
The history of safe food use should not include non-food uses or uses not related to normal diets.
Če države članice in agencija niso predložili nobenih utemeljenih pripomb glede varnosti na podlagi znanstvenih dokazov, na primer podatkov o škodljivih učinkih na zdravje, je treba dovoliti dajanje živila na trg v Skupnosti po uradnem obvestilu o tej nameri.
If Member States and the Authority have not presented any reasoned safety objections, based on scientific evidence, for example information on adverse health effects, it should be permissible to place the food on the Community market after notification of the intention to do so.
Če države članice in/ali agencija niso predložili nobenih utemeljenih pripomb glede varnosti na podlagi znanstvenih dokazov, na primer podatkov o škodljivih učinkih na zdravje, bo dajanje živila na trg v Skupnosti dovoljeno po uradnem obvestilu o tej nameri , če zoper to namero ni etičnih ugovorov .
If Member States and/or the Authority have not presented any reasoned safety objections, based on scientific evidence, for example information on adverse health effects, it will be permissible to place the food on the Community market after notification of the intention to do so , provided that there are no ethi c al objections .
Jasno mora biti razvidno, da države članice in/ali agencija lahko podajo pripombe.
It must be clear that Member States and/or the Authority can comment.
Četudi je proizvod varen, so možni etični ugovori.
Even if a product is safe, there may be ethical objections.
(24) Po potrebi se lahko opravi posvetovanje z evropsko skupino za etiko v znanosti in novih tehnologijah, ustanovljeno s Sklepom Komisije z dne 16. decembra 1997, z namenom pridobiti nasvet o etičnih vprašanjih dajanja na trg novih živil.
(24) The European Group on Ethics in Science and New Technologies established by Commission Decision of 16 December 1997 may be consulted , where approp ria te, with a view to obtaining advice on ethical issues regarding the placing on the market of novel foods.
(24) V utemeljenih primerih je treba opraviti posvetovanje z evropsko skupino za etiko v znanosti in novih tehnologijah, ustanovljeno s Sklepom Komisije z dne 16. decembra 1997, z namenom pridobiti nasvet o etičnih vprašanjih o uporabi novih tehnologij in dajanju na trg novih živil.
(24) The European Group on Ethics in Science and New Technologies established by Commission Decision of 16 December 1997 should be consulted in substantiated cases with a view to obtaining advice on ethical issues regarding the use of new technologies and the placing on the market of novel foods.
Primerno je, da se o etičnih vprašanjih pri utemeljenih splošnih zadevah (kot je uporaba nanotehnologij ali tehnik kloniranja) posvetuje z evropsko skupino za etiko v znanosti in novih tehnologijah.
On substantiated general matters (such as in the use of nanotechnologies or cloning techniques) it is clearly appropriate that ethical issues should have to be referred to the European Group on Ethics in Science and New Technologies for consultation.
Ta uredba določa usklajena pravila za dajanje na trg novih živil v Skupnosti z namenom zagotavljanja visoke ravni varovanja zdravja ljudi in potrošnikov , ob hkratnem zagotavljanju nemotenega delovanja notranjega trga.
This Regulation lays down harmonised rules for the placing of novel foods on the market in the Community with a view to ensuring a high level of human health and consumers’ protection , whilst ensuring the effective functioning of the internal market.
Ta uredba določa usklajena pravila za dajanje na trg novih živil v Skupnosti z namenom zagotavljanja visoke ravni varovanja življenja in zdravja ljudi, zdravja in dobrega počutja živali, varstva okolja in interesov potrošnikov , ob hkratnem zagotavljanju preglednosti in nemotenega delovanja notranjega trga ter spodbujanju inovacij v kmetijsko-živilskem sektorju .
This Regulation lays down harmonised rules for the placing of novel foods on the market in the Community with a view to ensuring a high level of protection of human life and health, animal health and welfare, the environment and the interests of consumers whilst ensuring transparency and the effective functioning of the internal market and stimulating innovation within the agri-food industry .
Ta uredba se uporablja za dajanje na trg novih živil v Skupnosti.
This Regulation shall apply to the placing of novel foods on the market in the Community.