natgillin/translations-raw huggingface dataset:
Glede na sklepe evropske skupine za etiko in določbe Direktive Sveta 98/58/ES z dne 20. julija 1998 o zaščiti rejnih živali se živil iz kloniranih živali ali njihovih mladičev 1 ne sme dajati na trg v Skupnosti pred začetkom veljavnosti posebne uredbe za te proizvode.
In the light of the opinion of the European Group on Ethics in Science and New Technologies and the provisions of Council Directive 98/58/EC of 20 July 1998 concerning the protection of animals kept for farming purposes, food produced from cloned animals and their offspring 1 should not be placed on the market before the entry into force of the specific regulation governing these products.
1 UL L 221, 8.8.1998, str.
1 OJ L 221, 8.8.1998, p.
Odločitev o tem, ali se odobrijo živila iz kloniranih živali in njihovih mladičev, je treba dodobra pretehtati z vsemi merili za varnost hrane, etičnimi merili in morebitnim vplivom na dobro počutje živali.
The decision about whether or not to authorise food from cloned animals and their offspring needs in depth consideration of all food safety criteria as well as ethical criteria and potential impacts on animal welfare.
Zato ne bi smela biti prepuščena postopku komitologije, temveč bi morala biti urejena z zakonodajno odločitvijo v postopku soodločanja.
It should therefore not be left to the comitology procedure, but be governed by a legislative decision under application of the co-decision procedure.
Na to hrano bi bilo treba razglasiti moratorij dokler ne bo začela veljati ustrezna zakonodaja.
A moratorium should be put in place for such food, until the specific legislation has entered into force.
(6b) Kloniranje živali ni v skladu z odstavkoma 20 in 21 priloge k Direktivi Sveta 98/58/ES.
(6b) The cloning of animals is incompatible with paragraphs 20 and 21 of the Annex to Directive 98/58/EC.
Odstavek 20 prepoveduje naravno in umetno gojenje ali postopke gojenja, ki povzročajo ali bi utegnili povzročiti trpljenje ali poškodbe gojene živali.
Paragraph 20 prohibits natural or artificial breeding or breeding procedures which cause or are likely to cause suffering or injury to any of the animals concerned.
Odstavek 21 prepoveduje rejo živali, razen če na je podlagi njihovega genotipa ali fenotipa mogoče upravičeno pričakovati, da jih je mogoče rediti brez škodljivih vplivov na njihovo zdravje in dobro počutje.
Paragraph 21 prohibits the keeping of animals for farming purposes unless it can reasonably be expected that, on the basis of their genotype or phenotype, they can be kept without a detrimental effect on their health or welfare.
Težave z zdravjem in dobrim počutjem živali, ki jih povzroča kloniranje, pomenijo, da ta postopek ni v skladu z nekaterimi določbami Direktive Sveta 98/58/ES.
The animal health and welfare problems caused by cloning mean that this process is incompatible with certain provisions of Council Directive 98/58/EC.
(6c) Trenutno vemo malo o vplivih hrane, ki vsebuje nanodelce, pridobljene s postopki nanotehnologije, na zdravje.
(6c) Little is known at present about the health implications of foods containing nanoparticles manufactured by means of nanotechnological procedures.
V skladu s previdnostnim načelom je treba ustaviti uporabo nanodelcev pri proizvodnji hrane dokler ne bodo na voljo znanstvena dognanja o njihovem vplivu.
In keeping with the precautionary principle, the use of nanoparticles in the manufacturing of foods should be suspended until scientific findings concerning the implications of their use are available.
(7) Po potrebi je treba sprejeti izvedbene ukrepe, da se določijo merila za olajšanje ocene, ali so se živila uporabljala v pomembnem obsegu za prehrano ljudi v Skupnosti pred 15. majem 1997.
(7) If necessary, implementing measures should be adopted to provide for criteria in order to facilitate the assessment of whether a food has been used for human consumption to a significant degree within the Community before 15 May 1997.
(7) Treba je sprejeti izvedbene ukrepe, da se določijo nadaljnja merila za olajšanje ocene, ali so se živila uporabljala v pomembnem obsegu za prehrano ljudi v Skupnosti pred 15. majem 1997.
(7) Implementing measures should be adopted to provide for further criteria in order to facilitate the assessment of whether a food has been used for human consumption to a significant degree within the Community before 15 May 1997.
Treba je sprejeti izvedbene ukrepe za nadaljnji opis meril novosti.
It is necessary that implementing measures are adopted in order to further describe the criteria for novelty.
Dodati je treba besedo „nadaljnja“, saj predlogi sprememb uvodne izjave 6 že vsebujejo nekaj pojasnil.
The word further should be added as some explanation is already given with the amendments to recital 6.
(8a) Določbe Direktive 2001/83/ES Evropskega parlamenta in Sveta z dne 6. novembra 2001 o zakoniku Skupnosti o zdravilih za uporabo v humani medicini 1 bi bilo treba uporabljati povsod, kjer bi se proizvod ob upoštevanju vseh njegovih značilnosti lahko opredelil kot „zdravilo“ ali kot proizvod, katerega uporabo ureja druga zakonodaja Skupnosti.
(8a) The provisions of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use 1 should apply where a product, taking into account all its characteristics, may fall within the definition of "medicinal product" and within the definition of a product covered by other Community legislation.
Pomembno je, da se to splošno načelo poudari v uvodni izjavi, saj se ob obravnavi novih živil pojavijo mnogi mejni primeri.
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 podrobneje razloži 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).
Ocena varnosti bi morala temeljiti na previdnostnem načelu, kot je določeno v členu 7 Uredbe (ES) št. 178/2002 Evropskega parlamenta in Sveta z dne 28. januarja 2002 o določitvi splošnih načel 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, str.
1 OJ L 31, 1.2.2002, p.
(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.
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 and which may includeinformation relating to ethical considerations .
Merila za dodatno označevanje bi morala vključevati tudi etične vidike, kot je kloniranje.
The criteria for additional labelling should also include ethical considerations such as cloning.
Na ta način bi bilo mogoče zahtevati označevanje živil, izdelanih iz kloniranih živali.
Thus, it should be possible to require labelling of foods produced from cloned animals.
(21a) Uvedba evropske oznake kakovosti bi potrošnikom omogočila, da prepoznajo proizvode, izdelane v skladu s strogimi standardi Evropske unije glede varstva okolja, dobrega počutja živali in varnosti hrane, in bo skupaj s to uredbo sestavljala bistveni del splošne politike Evropske unije glede obveščanja državljanov o značilnostih proizvodov in razmer, v katerih so bili izdelani.
(21a) The introduction of a European quality label would allow consumers to identify products that are produced in accordance with the European Union´s strict environmental, animal-welfare and food-safety standards and would form another essential part, in addition to this Regulation, of the European Union´s general policy of informing its citizens about the characteristics of products and the circumstances in which they were produced.
(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 appropriate , with a view to obtaining advice on ethical issues regarding the placing on the market of novel foods.
(24) Treba je 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 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, with a view to obtaining advice on ethical issues regarding the use of new technologies and the placing on the market of novel foods.
Člen 2 - odstavek 2 - točka b a (novo)
Article 2 ‑ paragraph 2 ‑ point b a (new)
(ba) živila, proizvedena iz kloniranih živali ali njihovih mladičev.
( ba ) food produced from cloned animals or their offspring .
Komisija pred 31. decembrom 2009 pripravi poseben zakonodajni predlog za ta živila.
The Commission shall present a specific legislative proposal for such food before 31 December 2009.
Odločitev o dajanju na trg živil, proizvedenih iz kloniranih živali ali njihovih mladičev, ne sme biti prepuščena postopku komitologije, ampak jo je treba sprejeti v posebni uredbi Evropskega parlamenta in Sveta na podlagi postopka soodločanja.
The decision about placing on the market of foods produced from cloned animals or their offspring should not be left to a comitology decision, but should be taken in a specific Regulation of the European Parliament and the Council, based on the co-decision procedure.
Ne glede na odstavek 2, ta uredba velja za aditive za živila, živilske encime, minerale in arome ter določene snovi z lastnostmi arom, za katere se je uporabil proizvodni postopek, ki se ni uporabljal pred 15. majem 1997, pri katerem je navedeni postopek povzročil pomembne spremembe v sestavi ali strukturi živila, ki vplivajo na njegovo prehransko vrednost, metabolizem ali raven neželenih snovi.
Notwithstanding paragraph 2, this Regulation shall apply to food additives, food enzymes, minerals and flavourings and certain food ingredients with flavouring properties to which is applied a new production process not used before 15 May 1997 giving rise to significant changes in the composition or structure of the food which affect its nutritional value, metabolism or level of undesirable substances.
Sestavine živil ali dodatke, ki so bili proizvedeni s tehnologijo, ki ni bila predhodno uporabljena, kot sta nanotehnologija in nanoznanost, je treba urediti z uredbo za nova živila.
A food ingredient or additive manufactured using a production technology which has not previously been employed, such as nanotechnology and nanoscience, should be covered by the regulation on novel foods.
Zaradi previdnosti pri varovanju potrošnikov je treba opraviti ločeno oceno, ki ne upošteva predhodne uporabe standardov za snov ali dovoljenj za njeno uporabo.
On precautionary consumer protection grounds, a separate assessment is needed which takes no account of the previous standard use of the substance or of its authorisation.
Po potrebi se lahko po postopku iz člena 14( 2 ) določi, ali vrsta živila sodi na področje uporabe te uredbe.
Where necessary, it may be determined in accordance with the procedure referred to in Article 14(2) whether a type of food falls within the scope of this Regulation.
Po potrebi se lahko po postopku iz člena 14( 3 ) določi, ali vrsta živila sodi na področje uporabe te uredbe.
Where necessary, it may be determined in accordance with the procedure referred to in Article 14(3) whether a type of food falls within the scope of this Regulation.
(a) „novo živilo“ pomeni:
(a)"novel food" means:
(a) „novo živilo“ pomeni živilo, ki se pred 15. majem 1997 ni uporabljalo v pomembnem obsegu za prehrano ljudi v Skupnosti in vključuje :
(a) "novel food" means food that was not used for human consumption to a significant degree within the Community before 15 May 1997, including:
(i) živilo, ki se ni uporabljalo v pomembnem obsegu za prehrano ljudi v Skupnosti pred 15. majem 1997;
(i) food that has not been used for human consumption to a significant degree within the Community before 15 May 1997 ;
(i) živilo rastlinskega in živalskega izvora, če se za rastline in živali uporabljajo netradicionalne tehnike gojenja, ki se niso uporabljale pred 15. majem 1997; in
(i) food of plant or animal origin when a non-traditional breeding technique, other than animal cloning, not commercially used before 15 May 1997 is applied to the plant or animal; and
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).
(ii) živilo, za katerega se je uporabil proizvodni postopek, ki se ni uporabljal pred 15. majem 1997, ki je povzročil pomembne spremembe v sestavi ali strukturi živila, ki vplivajo na njegovo prehransko vrednost, metabolizem ali raven neželenih snovi;
(ii) food to which is applied a new production process not used before 15 May 1997 givings rise to significant changes in the composition or structure of the food which affect its nutritional value, metabolism or level of undesirable substances.
(ii) živilo rastlinskega in živalskega izvora, če se za rastline in živali uporabljajo netradicionalne tehnike gojenja, ki se niso uporabljale pred 15. majem 1997; ter
(ii) food of plant or animal origin when to the plant and animal is applied a non-traditional breeding technique not used before 15 May 1997; and
uporaba živila kot prehransko dopolnilo ali v prehranskem dopolnilu ne zadostuje za dokazilo o tem, da 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 that it was used for human consumption to a significant degree within the Community before 15 May 1997.
Če pa se je živilo do navedenega dne uporabljalo izključno kot prehransko dopolnilo ali v prehranskem dopolnilu, se lahko po tem dnevu daje na trg v Skupnosti za isto uporabo in ne šteje za novo živilo.
However, if a food was used exclusively as, or in, a food supplement prior to that date, it may be placed on the Community market after that date for the same use without being considered novel food.
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 whether a food was 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, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).
(iii) živilo, za katerega se je uporabil proizvodni postopek, ki se ni uporabljal pred 15. majem 1997, pri katerem je navedeni postopek povzročil pomembne spremembe v sestavi ali strukturi živila, ki vplivajo na njegovo prehransko vrednost, metabolizem ali raven neželenih snovi;
(iii) food to which is applied a new production process, not used before 15 May 1997, where that production process gives rise to significant changes in the composition or structure of the food which affect its nutritional value, metabolism or level of undesirable substances.
Novo živilo je splošno opredeljeno v členu 3.2 a(i).
The overall definition of a novel food is given in Article 3.2 a(i).
Naslednji kategoriji (ii) in (iii) sta podskupini te splošne opredelitve.
The following two categories (ii) and (iii) are sub-groups under this overall definition.
Po drugi strani se pododstavek 2 in točka a (i) nanašata na vse kategorije, navedene v členu 3(2)(a).
On the other hand, subparagraph 2 in point a (i) relates to all categories mentioned in Article 3, paragraph 2, point a.
Izvedbene ukrepe bi bilo treba sprejeti pred začetkom uporabe uredbe.
The implementing measures should be adopted before the application of the Regulation.
(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 25 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 and continues to be part of the normal diet for at least 25 years in a large part of the population of the country;
Cilj, da se pripravijo natančnejša pravila za hrano iz tretjih držav, je utemeljen.
The aim of laying down much more precise rules governing traditional food from third countries is a reasonable one.
Vendar je obdobje, ki ga predlaga poročevalec (50 let) predolgo, zlasti ker je pri drugih določbah o živilih generacija običajno opredeljena s 25 leti (glej člen 2(1)(b) Uredbe Sveta (ES) št. 509/2006 z dne 20. marca 2006 o zajamčenih tradicionalnih posebnostih kmetijskih proizvodov in živil) .
However, the period proposed by the rapporteur (50 years) seems too long, particularly as in other food-related provisions a generation is traditionally seen as amounting to 25 years (see Article 2(1)(b) of Council Regulation (EC) No 509/2006 of 20 March 2006 on agricultural products and foodstuffs as traditional specialities guaranteed).
Člen 3 - odstavek 2 - točka c
Article 3 ‑ paragraph 2 ‑ point c
(c) „pretekle izkušnje glede varne uporabe živila“ pomeni, da je varnost zadevnega živila potrjena s podatki o sestavi in najmanj 50-letnimi izkušnjami z uporabo in nadaljnjo uporabo v običajni prehrani velikega dela populacije v državi.
(c) "history of safe food use" means that the safety of the food in question is confirmed with compositional data and from experience of use and continued use in the normal diet of a large part of the population of a country.
(c) „pretekle izkušnje glede varne uporabe živila“ pomeni, da je varnost zadevnega živila potrjena s podatki o sestavi in izkušnjami iz obdobja najmanj 25 let z uporabo in nadaljnjo uporabo v običajni prehrani velikega dela populacije v državi.
(c) "history of safe food use" means that the safety of the food in question is confirmed with compositional data and from experience over a period of at least 25 years of use and continued use in the normal diet of a large part of the population of a country.
Člen 6 - točka a
Article 6 ‑ point a
(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 in ob uporabi previdnostnega načela iz člena 7 Uredbe (ES) št. 178/2002 uporaba pod običajnimi pogoji ne pomeni tveganja za zdravje potrošnika;
(a) it does not, on the basis of the scientific evidence available, and after application of the precautionary principle laid down in Article 7 of Regulation (EC) No 178/2002 , pose a safety concern to the health of the consumer under normal consumption conditions;
Člen 6 – točka c a (novo)
Article 6 – point c a (new)
(ca) šteje, da je bilo proizvedeno v razmerah, ki so sprejemljive z etičnega vidika.
(ca) it is considered to be produced under ethically acceptable conditions.
Omogočeno mora biti, da se ob odobritvi novih živil upoštevajo etični vidiki.
It should be possible to take into account ethical aspects when considering authorisation of a novel food.
Če etični vidiki niso navedeni med merili v členu 6, ni jasno, ali so ti lahko zakonito uporabljeni pri odobritvi novih živil.
Without mentioning ethical aspects as a criterion in Article 6, it is not clear whether ethical aspects can legally be used in relation to authorisation of a novel food.
V primerih iz člena 2(2a) se uporabi enoten postopek ne glede na predhodno uporabo ali odobritev snovi, pri kateri je bil uporabljen standardni postopek.
In the cases referred to in Article 2(2a) the common procedure shall be employed irrespective of the previous use or authorisation of the substance to which a standard production process was applied.
Z odstopanjem od tretjega odstavka člena 7 Uredbe (ES) št. [enotni postopek] se posodabljanje seznama Skupnosti z novim živilom, razen s tradicionalnim živilom iz tretje države, določi v skladu z regulativnim postopkom iz člena 14( 2 ), kadar za nove znanstvene dokaze ali podatke, ki so predmet lastninske pravice, velja varstvo v skladu s členom 12.
By way of derogation from the third paragraph of Article 7 of Regulation (EC) No [common procedure], the updating of the Community list with a novel food, other than traditional food from third countries, shall be decided in accordance with the regulatory procedure referred to in Article 14(2) in cases where newly developed scientific evidence and proprietary data are protected in accordance with Article 12.
Z odstopanjem od tretjega odstavka člena 7 Uredbe (ES) št. [enotni postopek] se posodabljanje seznama Skupnosti z novim živilom, razen s tradicionalnim živilom iz tretje države, določi v skladu z regulativnim postopkom s pregledom iz člena 14( 3 ), kadar za nove znanstvene dokaze ali podatke, ki so predmet lastninske pravice, velja varstvo v skladu s členom 12.
By way of derogation from the third paragraph of Article 7 of Regulation (EC) No [common procedure], the updating of the Community list with a novel food, other than traditional food from third countries, shall be decided in accordance with the regulatory procedure with scrutiny referred to in Article 14(3), in cases where newly developed scientific evidence and proprietary data are protected in accordance with Article 12.
Člen 8 – odstavek 6
Article 8 - paragraph 6