natgillin/translations-raw huggingface dataset:
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.
Pri označevanju novih živil (ker ta zajemajo tudi nova živila iz nanotehnologij ali postopkov kloniranja) je treba v ustreznih primerih upoštevati etična vprašanja, saj potrebujejo potrošniki pregledne informacije za bolj osveščene odločitve in nakupe.
It is essential that when labelling new foods (since they include new foods gained from nanotechnologies or cloning processes) the ethical issues are taken into account in appropriate cases, as consumers need transparent information to be able to make informed choices and purchases.
Če namerava vložnik zahtevka novo živilo opremiti z zdravstveno trditvijo, dovoljeno v skladu s členoma 17 in 18 navedene uredbe, in če se istočasno vložita zahtevek za novo živilo in za zdravstveno trditev, oba pa vključujeta zahtevo za varstvo podatkov, ki so predmet lastninske pravice, mora na zahtevo vložnika obdobje varstva podatkov zanju začeti in teči istočasno.
Where an applicant intends a novel food to carry a health claim authorised in accordance with Articles 17 or 18 of that Regulation, and where the novel food and health claim applications are introduced at the same time and both include a request for the protection of proprietary data, at the request of the applicant the periods of data protection should start together and run concurrently.
Ni nujno, da reševanje vlog za odobritev novega živila in za zdravstveno trditev, ki sta med seboj povezani, se nanašata na isti proizvod in temeljita na podatkih, ki so predmet lastninske pravice, poteka v istem časovnem okviru.
Related applications for authorisation of a novel food and of a health claim relevant for the same product and both based on proprietary data could proceed according to different schedules.
Zato bi se lahko še pred začetkom obdobja varstva podatkov za povezana dovoljenja iztekel precejšen del obdobja varstva podatkov za eno od dovoljenj.
Consequently, the period of data protection under one authorisation could have elapsed to a significant degree before the data protection period of the related authorisation starts.
Potrebne so določbe za uskladitev obdobij varstva podatkov za povezana dovoljenja, če tako zahteva vložnik.
Provision must be made to align the data protection periods of related authorisations if requested by the applicant.
(24) V utemeljenih primerih se je treba posvetovati 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 should be consulted in substantiated cases with a view to obtaining advice on ethical issues regarding the placing on the market of novel foods.
(25) Nadaljevati je treba dajanje na trg novih živil, ki so se dajala na trg v Skupnosti na podlagi Uredbe (ES) št. 258/97.
(25) Novel foods placed on the Community market under Regulation (EC) No 258/97 should continue to be placed on the market.
Nova živila, odobrena v skladu z Uredbo (ES) št. 258/97, je treba uvrstiti na seznam Skupnosti novih živil, ki ga uvaja ta uredba.
Novel foods authorised in accordance with Regulation (EC) No 258/97 should be included in the Community list of novel foods established by this Regulation.
Poleg tega je treba zahtevke, predložene na podlagi Uredbe (ES) št. 258/97 in za katere končna odločitev ni bila sprejeta pred začetkom uporabe sedanje uredbe , šteti za zahtevke na podlagi te uredbe.
In addition, applications submitted under Regulation (EC) No 258/97 , and for which a final decision has not been take before the date of application of the present Regulation, should be considered as applications under this Regulation.
Poleg tega, kadar se poročilo o začetni presoji, predvideno v členu 6(3) Uredbe (ES) št. 258/97 , še ni posredovalo Komisiji ter v vseh primerih, kjer je pred datumom začetka uporabe te uredbe potrebno dodatno poročilo o presoji v skladu s členom 6(3) in (4) Uredbe (ES) št. 258/97, je treba zahtevke, predložene na podlagi Uredbe (ES) št. 258/97 , šteti za zahtevke na podlagi te uredbe.
In addition, where the initial assessment report provided for by Article 6(3) of Regulation (EC) No 258/97 has not yet been forwarded to the Commission, as well as in all cases where an additional assessment report is required in accordance with Article 6(3) or (4) of that Regulation before the date of application of this Regulation, applications submitted under Regulation (EC) No 258/97 should be considered as applications under this Regulation.
Kadar se od agencije in držav članic zahteva mnenje, morajo upoštevati ugotovitve iz začetne presoje.
When required to give an opinion, the Authority and the Member States should take the outcome of the initial assessment into account.
Drugi zahtevki, predloženi v skladu s členom 4 Uredbe (ES) št. 258/97 pred datumom začetka uporabe te uredbe, se obravnavajo v skladu z določbami Uredbe (ES) št. 258/97.
Other requests submitted under Article 4 of Regulation (EC) No 258/97 before the date of application of this Regulation should be processed under the provisions of Regulation (EC) No 258/97.
Predlagano besedilo Komisije lahko zahtevke, za katere se je poročilo o začetni presoji že posredovalo Komisiji, postavlja v slabši položaj, saj je možno odobriti tovrstne zahtevke, na katere niso bile dane pripombe, ne da bi jih posredovali Evropski agenciji za varnost hrane v oceno.
The Commission’s proposed text potentially disadvantages applications for which an initial assessment has already been forwarded to the Commission, since it may be possible to authorize such an application without redirection of the application to EFSA for evaluation if no objections are raised.
Vse zahtevke, za katere se je poročilo o začetni presoji že posredovalo Komisiji, je treba obravnavati na podlagi postopka iz Uredbe (ES) št. 258/97.
All applications for which an initial assessment report has already been forwarded to the Commission should continue according to the procedure defined in 258/97/EC.
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 zdravja ljudi in potrošnikov ob hkratnem zagotavljanju nemotenega delovanja notranjega trga ter spodbujanju inovacij v zadevnih industrijah .
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 and stimulating innovation within the relevant industries .
Ker je to pomemben cilj Skupnosti in eden izmed namenov, na katere se nanašajo uvodne izjave, bi ga bilo treba neposredno vključiti v predmet te uredbe.
As an important Community objective and one of the purposes referred to in the recitals, this goal should be explicitly included within the subject matter.
Člen 3 – odstavek 2 – točka a – točka i – pododstavek 2
Article 3 – paragraph 2 - point a - point i - subparagraph 2
uporaba živila kot prehransko dopolnilo ali v prehranskem dopolnilu ne zadostuje za dokazilo o tem, ali so se živila uporabljala v pomembnem obsegu za prehrano ljudi v Skupnosti pred 15. majem 1997.
The use of a food exclusively as or in a food supplement shall not be sufficient to show whether it has been used for human consumption to a significant degree within the Community before 15 May 1997.
Vendar, če se je živilo do navedenega dne uporabljalo izključno kot prehransko dopolnilo, se lahko po tem dnevu daje na trg v Skupnosti za isto uporabo in se ne šteje za novo živilo.
However, if a food has been used exclusively as or in a food supplement prior that date, it can be placed on the Community market after that date for the same use without being considered as novel food.
Nadaljnja merila za ocenjevanje, ali so se živila uporabljala v pomembnem obsegu za prehrano ljudi v Skupnosti pred 15. majem 1997, ki so oblikovana za spremembo nebistvenih elementov te uredbe, med drugim z njeno dopolnitvijo, se lahko sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 14(3);
Further criteria for assessing if a food has been used for human consumption to a significant degree within the Community before 15 May 1997, which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).
Pred datumom začetka veljave te uredbe se nadaljnja merila za ocenjevanje, ali so se živila uporabljala v pomembnem obsegu za prehrano ljudi v Skupnosti pred 15. majem 1997, ki so oblikovana za spremembo nebistvenih elementov te uredbe, med drugim z njeno dopolnitvijo, sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 14(3);
Before the date of application of this Regulation, further criteria for assessing if a food has been used for human consumption to a significant degree within the Community before 15 May 1997, designed to amend non-essential elements of this Regulation, inter alia by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).
Komisija bo morala za povečanje pravne varnosti gospodarskih subjektov, dejavnih v tem sektorju, ter usklajevanja na notranjem trgu (zaradi velikih razlik med državami članicami pri uporabi pravil) oblikovati jasna merila, na podlagi katerih bo ocenila, ali se je živilo pomembno uporabljalo za prehrano ljudi v Skupnosti.
To increase legal certainty for business operators active in this sector and harmonisation in the internal market (since there are big differences between Member States in how the rules are applied) the Commission will need to lay down clear criteria on which to assess whether food has been used for human consumption to a significant degree within the Community.
Člen 3 – odstavek 2 – točka b
Article 3 – paragraph 2 - point b
(b) „tradicionalno živilo iz tretjih držav“ pomeni novo živilo s preteklimi izkušnjami glede uporabe živila v tretji državi, kar pomeni, da je zadevno živilo bilo in je še naprej običajna prehrana za vsaj eno generacijo v velikem delu populacije v državi;
(b) “traditional food from a third country” means novel food with a history of food use in a third country, meaning that the food in question has been and continues to be part of the normal diet for at least one generation in a large part of the population of the country;
(b) „tradicionalno živilo iz tretjih držav“ pomeni novo živilo s preteklimi izkušnjami glede uporabe živila v tretji državi, kar pomeni, da je zadevno živilo bilo in je še naprej običajna prehrana vsaj 20 let v velikem delu populacije v državi;
(b) “traditional food from a third country” means novel food with a history of food use in a third country, meaning that the food in question has been part of the normal diet for a period of at least 20 years in a large part of the population of the country;
„Ena generacija“ ni dovolj jasen izraz v pravnem jeziku.
‘One generation’ is not a clear term in legal parlance.
S tem, ko se spremeni v obdobje 20 let, se pravna varnost občutno poveča za vse udeležene stranke.
By changing it to a period of 20 years legal certainty is appreciably increased for all stakeholders.
Hkrati to obdobje ustvarja dovolj prostora za pridobivanje izkušenj z uporabo zlasti znanstvenih podatkov pri odločanju, ali se tradicionalno živilo iz tretje države lahko daje na notranji trg.
At the same time this period provides a margin for gaining experience with using, in particular, scientific data for deciding whether traditional food from a third country can be placed on the internal market.
Komisija zbira informacije od držav članic in/ali nosilcev živilske dejavnosti, da določi v kolikšnem obsegu so je živilo uporabljalo za prehrano ljudi v Skupnosti pred 15. majem 1997.
The Commission shall collect information from the Member States and/or from food business operators to determine to what extent a food has been used for human consumption within the Community before 15 May 1997.
Prepoved mora odvračati goljufije in povečati varstvo potrošnikov.
Prohibition should deter fraudulent operators and enhance consumer protection.
(a) na podlagi razpoložljivih znanstvenih dokazov uporaba pod običajnimi pogoji ne pomeni tveganja za zdravje potrošnika;
(a) it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer under normal consumption conditions ;
(a) na podlagi razpoložljivih znanstvenih dokazov uporaba ne pomeni tveganja za zdravje potrošnika;
(a) it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer;
Dodatna določba za običajno uporabo je nepotrebna ter bi povzročila le težave pri razlagi v praksi in omajala predvidljivost odločanja gospodarskih subjektov v tem sektorju.
Additional provision for normal consumption is superfluous and would only cause interpretation problems in practice and undermine the predictability of practical decision-making for operators in this sector.
Člen 6 – točka c
Article 6 – point c
Če ni znanstvenih dokazov o posledicah novega živila za zdravje, se to živilo ne sme uvrstiti na seznam Skupnosti.
Where there is no scientific evidence as to the health implications of a novel food, the food may not be included in the Community list.
Seznam Skupnosti se posodobi v skladu s postopkom iz Uredbe (ES) št. [enotni postopek] , Komisija pa ga objavi na temu namenjeni spletni strani Komisije .
The Community list shall be updated in accordance with the procedure laid down in Regulation (EC) No [common procedure] and the Commission shall publish it on a dedicated page of its website .
V primerih, navedenih v prvem pododstavku, se pri vnosu novega živila na seznam Skupnosti poleg podatkov iz odstavka 2, navede še:
In the cases referred to in the first subparagraph the entry of a novel food in the Community list shall indicate, in addition to the information referred to in paragraph 2:
(a) datum vnosa novega živila na seznam Skupnosti;
(a) the date of entry of the novel food in the Community list;
(b) dejstvo, da vnos temelji na novih znanstvenih dokazih in /ali podatkih, ki so predmet lastninske pravice, za katere velja varstvo v skladu s členom 12;
(b) the fact that the entry is based on newly developed scientific evidence and/or proprietary data protected in accordance with Article 12;
(c) ime in naslov vložnika.
(c) the name and address of the applicant.
Primerneje je, da se celotni oddelek ureja s členom 12, kamor so se prenesli ti odstavki.
It is more appropriate for this whole section to be governed by Article 12, to which these paragraphs have been transferred.
Pred koncem roka iz člena 12 se seznam Skupnosti posodobi, da se spremenijo nebistveni elementi te uredbe v skladu z regulativnim postopkom s pregledom iz člena 14(3), določenem v Uredbi (ES) št. [enotni postopek], tako da, če odobreno živilo še izpolnjuje pogoje iz te uredbe, niso več navedene posebne navedbe iz drugega pododstavka odstavka 3 tega člena.
Before the expiry of the period referred to in Article 12, the Community list shall be updated to amend non-essential elements of this Regulation in accordance with the regulatory procedure with scrutiny referred to in Article 14(3) laid down in Regulation (EC) No [common procedure] so that, provided that the authorised food still meets the condition laid down in this Regulation, the specific indications referred to in paragraph 3, second subparagraph of this Article, are no longer included.
Primerneje je, da se celotni oddelek ureja s členom 12, kamor so se prenesli ti odstavki.
It is more approp ria te for this whole section to be governed by Article 12, to which these paragraphs have been transferred
Zaradi pomanjkanja statistik je treba upoštevati podatke, ki dokazujejo varno uporabo živila iz katere koli tretje države v preteklosti.
Due to the lack of statistics, it is important to consider data demonstrating the history of safe food use coming from any third country.
V primerjavi z dokazi, potrebnimi za prikaz varne uporabe v preteklosti za uradno obvestilo na podlagi člena 8, bi bile zahteve po dokazih, priloženih zahtevku, bistveno večje.
In comparison to the evidence required to demonstrate history of safe use for a notification under Article 8, the data requirement to support an application would be considerably more extensive.
Zato bi moral vložnik zahtevka imeti možnost umika iz postopka in se uradno obvestilo ne bi samodejno spremenilo v popolni zahtevek.
Consequently it is appropriate that the applicant should have the option to withdraw from the process rather than have the notification automatically convert to a full application.
Komisija ustrezno in nemudoma obvesti zadevnega nosilca živilske dejavnosti, pripombe pa utemelji, največ v petih mesecih od datuma uradnega obvestila v skladu z odstavkom 1.
The Commission shall inform the food business operator concerned accordingly without undue delay and in a demonstrable manner within no more than five months from the date of the notification in accordance with paragraph 1.
Komisija po potrebi v tesnem sodelovanju z agencijo daje na voljo tehnične smernice in orodja za pomoč nosilcem živilske dejavnosti in zlasti malim in srednje velikim podjetjem pri pripravi in predložitvi zahtevkov na podlagi te uredbe .
The Commission shall, where approp ria te, in close cooperation with the Authority, make available technical guidance and tools to assist food business operators and especially small and medium-sized enterprises in preparing and submitting applications under this Regulation.
Komisija v tesnem sodelovanju z agencijo dejavno sodeluje z nosilci živilske dejavnosti in zlasti malimi in srednje velikimi podjetji pri pripravi in predložitvi njihovih zahtevkov ter obvestil na podlagi te uredbe ter jim daje na voljo največ možnih tehničnih smernic in orodij, vključno s predložitvijo enotnega elektronskega zahtevka .
The Commission shall, in close cooperation with the Authority, actively cooperate with food business operators and especially small and medium-sized enterprises in preparing and submitting their applications and notifications under this Regulation , and shall provide them with the maximum possible technical guidance and tools, including the option of submitting a uniform electronic application .
Gospodarskim subjektom je treba zagotoviti tehnične smernice in orodja, kar bi morala biti Komisija vedno pripravljena storiti.
There is a need to provide technical guidance and tools for operators, and this should be an active duty for the Commission.
Praktični primer bi bil lahko enotni elektronski zahtevek ali drugi elementi e-upravljanja, ki se ponavadi uporabljajo v različnih državah članicah.
A practical example might be a uniform electronic application or other elements of e-government normally used in the various Member States.
Člen 10 – uvodno besedilo
Article 10 – introductory part
Agencija pri ocenjevanju novih živil zlasti kadar meni, da je to potrebno :
In assessing the safety of novel foods, the Authority shall in particular, where it considers it appropriate :
Za uradno določitev področja uporabe člena.
Formally specifies the scope of the article’s application.
(a) po potrebi primerja, če je živilo varno kot živilo iz primerljive živilske kategorije, ki že obstaja na trgu v Skupnosti ali kot živilo, ki naj bi ga novo živilo nadomestilo;
(a) compare , where approp ria te, if the food is as safe as food from a comparable food category already existing on the market in the Community or as the food that the novel food is intended to replace;
(a) primerja, če je živilo varno kot živilo iz primerljive živilske kategorije, ki že obstaja na trgu v Skupnosti ali kot živilo, ki naj bi ga novo živilo nadomestilo;
(a) determine whether the food is as safe as food from a comparable food category already existing on the market in the Community or as the food that the novel food is intended to replace;
Zahtevo o pregledu varnosti novih živil glede na primerljive živilske kategorije je treba ubesediti natančneje.
There is a need for more stringent wording of the requirement to check the safety of new foods with regard to comparable food categories.
Komisija lahko zaradi varnosti živil in v skladu z mnenjem agencije zahteva ustrezno, omejeno obdobje spremljanja po dajanju na trg.
The Commission may impose for food safety reasons and following the opinion of the Authority, a requirement for post-market monitoring for an approp ria te limited period .
Ustrezno omejeno obdobje spremljanja hrane na trgu je v utemeljenih primerih mogoče podaljšati le enkrat za naslednje ustrezno in jasno omejeno obdobje spremljanja.
It shall be possible to extend the approp ria te limited period of monitoring of food on the market in justified cases no more than once for a further approp ria te limited period.
Poseganje v delovanje prostega trga s spremljanjem novih živil po dajanju na trg je treba obravnavati kot izjemo, ki velja v ustreznem in strogo omejenem obdobju, zato da gospodarski subjekti niso neomejeno podvrženi pravni negotovosti glede svojih proizvodov.
Interference with the operation of the free market in the form of monitoring new food after its placing on the market must be treated as the exception, and as such subject to an appropriate and strictly limited period so that operators do not face legal uncertainty for their products for an unlimited period.
Člen 11 a (novo) (v poglavju II)
Article 11 a (new) (in Chapter II)
Komisija se lahko o etičnih vprašanjih glede znanosti in novih tehnologij, ki so zelo pomembne z etičnega vidika, na lastno pobudo ali pobudo države članice po potrebi posvetuje z evropsko skupino za etiko in nove tehnologije, da bi pridobila njeno mnenje o teh vprašanjih.
Where appropriate, on ethical questions relating to science and new technologies of major ethical importance, the Commission, on its own initiative or at the request of a Member State, may consult the European Group on Ethics and new Technologies, with a view to obtaining its opinion on ethical issues.
Komisija to mnenje objavi, med drugim na temu namenjeni strani na svojih spletnih straneh.
The Commission shall make this opinion publicly available, including by publishing it on a dedicated page of its website .
V utemeljenih primerih (kot je uporaba nanotehnologij ali tehnik kloniranja) je vsekakor primerno, da se o etičnih vprašanjih posvetuje z evropsko skupino za etiko v znanosti in novih tehnologijah.
In justified cases (such as 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.
Posvetovalni postopek se lahko začne na pobudo Komisije ali države članice.
This consultation process can be launched by the Commission itself or by the Member State.
Zaradi preglednosti in sodelovanja strokovnjakov ter koristi javnosti je treba mnenje objaviti na internetu.
In the interest of transparency and involvement of experts as well as the general public the opinion must be published on the Internet.