natgillin/translations-raw huggingface dataset:
Ta uredba se ne uporablja za:
This Regulation shall not apply to:
Ta uredba se , razen če ni določeno drugače, ne uporablja za:
This Regulation shall not , unless otherwise provided for, apply to:
(a) živila, ki se uporabljajo in dokler se uporabljajo kot:
(a) foods when and insofar as they are used as:
a) živila, ki se uporabljajo in dokler se uporabljajo kot:
a) foods when and insofar as they are used as:
(i) aditivi za živila, ki spadajo na področje uporabe Uredbe (ES) št. [o aditivih za živila];
(i) food additives falling within the scope of Regulation (EC) No [on food additives];
(1) aditivi za živila, ki sodijo na področje uporabe Uredbe (ES) št. [o aditivih za živila];
(1) food additives falling within the scope of Regulation (EC) No (on food additives);
(ii) arome za živila, ki spadajo na področje uporabe Uredbe (ES) št. [o aromah za živila];
(ii) food flavourings falling within the scope of Regulation (EC) No [on food flavourings];
(2) arome za živila, ki spadajo na področje uporabe Uredbe (ES) št. [o aromah za živila], razen kjer so arome, navedene v členu 8 (1) točke (a), (b) in (c) Uredbe o aromah za živila, proizvedene iz novega živila ;
(2) food flavourings falling within the scope of Regulation (EC) No [on food flavourings], except where the flavourings mentioned in Article 8 ( 1 ), points (a), (b) and (c) of th at Regulation are produced from a novel food ;
(iii) ekstrakcijska topila, ki se uporabljajo pri proizvodnji živil in spadajo na področje uporabe Direktive Sveta 88/344/EGS ;
(iii) extraction solvents used in the production of foodstuffs and falling within the scope of Council Directive 88/344/EEC;
(3) ekstrakcijska topila, ki se uporabljajo pri proizvodnji živil in spadajo na področje uporabe Direktive Sveta 88/344/EGS;
(3) extraction solvents used in the production of foodstuffs and falling within the scope of Council Directive 88/344/EEC;
(iv) živilski encimi, ki spadajo na področje uporabe Uredbe (ES) št. [o živilskih encimih] ;
(iv) food enzymes falling within scope of Regulation (EC) No [on food enzymes];
(4) živilski encimi, ki sodijo na področje uporabe Uredbe (ES) št. [o živilskih encimih];
(4) food enzymes falling within the scope of Regulation (EC) No (on food enzymes);
(v) vitamini in minerali, ki spadajo na področje uporabe Direktive 89/398/EGS, Direktive 2002/46/ES ali Uredbe (ES) št. 1925/2006 .
(v) vitamins and minerals falling within the scope of Directive 89/398/EEC, Directive 2002/46/EC or Regulation (EC) No 1925/2006.
(5) vitamini in minerali, ki spadajo na področje uporabe Direktive 89/398/EGS, Direktive 2002/46/ES ali Uredbe (ES) št. 1925/2006, razen kjer so vitamini ali minerali pridobljeni iz novih virov ali z uporabo proizvodnega postopka, ki ni bil upoštevan pri njihovi odobritvi v skladu z zadevno zakonodajo.
(5) vitamins and minerals falling within the scope of Directive 89/398/EEC, Directive 2002/46/EC or Regulation (EC) No 1925/2006 , except where the vitamins or minerals are obtained from new sources or using a production process which was not taken into account when they were authorised under the respective piece of legislation .
(b) živila, ki spadajo na področje uporabe Uredbe (ES) št. 1829/2003.
(b) foods falling within the scope of Regulation (EC) 1829/2003.
(b) živila, ki spadajo na področje uporabe Uredbe (ES) št. 1829/2003.
(b) foods falling within the scope of Regulation (EC) 1829/2003;
(ba) živila, pridobljena iz kloniranih živali in njihovih potomcev.
( ba ) foods derived from cloned animals and their descendants.
Pred datumom začetka veljavnosti te uredbe iz člena 20 Komisija predloži zakonodajni predlog za prepoved, da se na trg Skupnosti dajo živila, pridobljena iz kloniranih živali in njihovih potomcev.
Before the date of entry in to force of this Regulation referred to in Article 20, the Commission shall present a legislative proposal to prohibit the placing on the market in the Community of foods derived from cloned animals and their descendants.
Predlog se pošlje Evropskemu parlamentu in Svetu.
The proposal shall be forwarded to the European Parliament and the Council.
Ne glede na odstavek 2 velja ta uredba za aditive za živila, živilske encime in arome ter določene snovi z lastnostmi arom, za katere se je uporabil proizvodni postopek, ki se ni uporabljal pred 15. majem 1997, pri katerih je navedeni postopek povzročil pomembne spremembe v sestavi ali strukturi živila (npr. nanotehnologije in nanoznanost).
Notwithstanding paragraph 2, this Regulation shall apply to food additives, food enzymes, 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 (e.g. nanotechnologies and nanoscience).
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.
When 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.
Kadar lahko novo živilo na človeško telo učinkuje podobno kot zdravilo, Komisija zaprosi Evropsko agencijo za zdravila (EMEA) za oceno, če živilo sodi pod Uredbo (ES) št. 726/2004.
Where a novel food can have an effect on the human body comparable to that of a medicinal product, the Commission shall ask the European Medicines Agency (EMEA) to assess whether it falls under Regulation (EC) No 726/2004.
Člen 3 – odstavek 2– točka (a) (i) – uvodni del
Article 3 – paragraph 2 - point (a) (i) – introductory part
(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, ki se ni uporabljalo v pomembnem obsegu za prehrano ljudi v Skupnosti pred 15. majem 1997 , vključno z živili, ki so bila odobrena v skladu s hitrim postopkom iz Uredbe (ES) št. 258/97 v zvezi z novimi živili in novimi živilskimi sestavinami ;
(i) food that has not been used for human consumption to a significant degree within the Community before 15 May 1997, including food which has been approved under the ‘fast track’ procedure of Regulation (EC) No 258/97 concerning novel foods and novel food ingredients.
Omenjeni hitri postopek je uvedel nižjo raven varstva na področju varnosti hrane.
The ‘fast track’ procedure introduced a lower level of protection in the field of food safety.
Člen 3 – odstavek 2 – točka a – točka ii
Article 3 – paragraph 2 – point a – point ii
(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
(ii) živilo rastlinskega in živalskega izvora, če se za rastline in živali uporabljajo netradicionalne tehnike gojenja , razen živil, pridobljenih iz kloniranih živali in njihovih potomcev ;
(ii) food of plant or animal origin when to the plant and animal is applied a non-traditional breeding technique , with the exception of foods derived from cloned animals and their descendants ;
Odločitve, ali se dajo na trg živila, pridobljena iz kloniranih živali in njihovih potomcev, ni dopustno prepustiti postopku komitologije, temveč jo je treba sprejeti s posebno uredbo Evropskega parlamenta in Sveta po postopku soodločanja.
The decision as to whether or not to place foods from cloned animals and their descendants on the market must not be left to the commitology procedure but should be taken by means of a specific regulation of the European Parliament and of the Council under codecision.
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 že vsaj 30 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 30 years in a large part of the population of the country;
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 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 z uporabo in neprekinjeno uporabo že vsaj 30 let 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 for at least 30 years in the customary diet of a large part of the population of a country.
Člen 3 – odstavek 2 – točka (c a) (novo)
Article 3 – paragraph 2 –point (c a) (new)
(ca) „nanomaterial“ pomeni namensko izdelan material z eno ali več zunanjimi dimenzijami ali notranjo strukturo v merilu 100 nm ali manj;
(ca) 'nanomaterial' means an intentionally manufactured material with one or more external dimensions or an internal structure, of the order of 100 nm or less;
Člen 3 – odstavek 2 – točka (c b) (novo)
Article 3 – paragraph 2 –point (c b) (new)
(cb) "proizvedeno z uporabo nanotehnologije" pomeni proizvod, ki vsebuje, ga sestavljajo ali je proizveden z namensko izdelanim materialom z eno ali več zunanjimi razsežnostmi ali notranjo strukturo
(cb) 'produced with the aid of nanotechnology' means a product which contains, consists of or is produced with intentionally manufactured material with one or more external dimensions or an internal structure,
(i) v velikosti od 1 do 100 nm ali
(i) on the scale from from 1 to 100 nm, or,
(ii) je pri velikosti, večji od 100 nm, splošno znanstveno sprejet kot proizvod na osnovi nanotehnologije.
(ii) where larger than 100 nm, is generally scientifically accepted as a product of nanotechnology.
Člen 3 – odstavek 2 – točka (c a) (novo)
Article 3 – paragraph 2 – point c a (new)
(ca) "klonirane živali" pomenijo živali, proizvedene z nespolno, umetno metodo razmnoževanja z namenom proizvodnje genetsko identičnih ali skoraj identičnih kopij posamezne živali;
( c a ) “ cloned animals ” means animals produced by means of an asexual, artificial method of reproducti on with the aim of producing a genetically identical or nearly identi cal copy of an individual animal ;
Razjasnitev definicij.
Clarification of the definitions.
Člen 3 – odstavek 2 – točka c b (novo)
Article 3 – paragraph 2 – point c b (new)
(cb) „potomci kloniranih živali“ pomenijo živali, proizvedene s spolnim razmnoževanjem, pri čemer je vsaj eden od staršev klonirana žival;
( c b ) “ descendants of cloned animals ” means animals produced by means of sexual repro duction , in cases in which at least one of the parents is a cloned animal ;
Člen 4 – odstavek 1 – točka 1 a in 1 b (novo)
Article 4 – paragraph 1, 1 a and 1b (new)
Zbiranje informacij glede uporabe živila za prehrano ljudi
Collection of information regarding the use of a food for human consumption
Zbiranje informacij glede razvrstitve novega živila
Collection of information regarding the classification of a n ovel f ood
Komisija lahko zbira informacije od držav članic in/ali nosilcev živilske dejavnosti, da določi do kolikšnem obsegu so je živilo uporabljalo za prehrano ljudi v Skupnosti pred 15. majem 1997.
The Commission may 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.
Komisija zbira informacije od držav članic in/ali nosilcev živilske dejavnosti ali druge zainteresirane strani , da določi, ali živilo sodi na področje uporabe te uredbe.
The Commission shall collect information from the Member States and/or from food business operators or any other interested party to determine whether a food falls within the scope of this Regulation.
Države članice, nosilci živilske dejavnosti in druge zainteresirane strani Komisiji posredujejo informacije, v kolikšnem obsegu so je živilo uporabljalo za prehrano ljudi v Skupnosti pred 15. majem 1997.
Member States, business operators and other interested parties shall transmit information on the extent a food has been used for human consumption within the Community before 15 May 1997 to the Commission .
Komisija objavi te podatke in zaključke na podlagi zbranih podatkov in podatkov, ki niso zaupni in podpirajo zaključke.
The Commission shall publish these data and the conclusions drawn from the data collection and the non-confidential data supporting it.
Izvedbeni ukrepi za nadaljnje ukrepanje v primerih, kjer Komisija nima informacij o uporabi za prehrano ljudi pred 15. majem 1997, ki so namenjeni spremembi nebistvenih elementov te uredbe, med drugim z njeno dopolnitvijo, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 14(3) najkasneje šest mesecev po začetku veljavnosti te uredbe;
Implementing measures on how to proceed in cases in which the Commission has no information about use for human consumption 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) not later than six months after the entry into force of this Regulation.
Na trg se lahko daje le nova živila, ki so uvrščena na seznam Skupnosti novih živil (v nadaljnjem besedilu „seznam Skupnosti“).
Only novel foods included in the Community list of novel foods (hereinafter "the Community list") may be placed on the market.
Komisija vodi in objavlja seznam Skupnosti na posebej temu namenjeni javno dostopni strani na spletni strani Komisije.
The Commission shall keep and publish the Community list on a publicly accessible page intended for th at purpose on the website of the Commission.
Da se uresniči cilj spodbujanja inovativnosti, mora biti odobritev na voljo vložniku za izrecno uporabo med obdobjem varstva podatkov, kot ga določa člen 12.
In order to meet the goal of stimulating innovation, the authorisation should remain available for the exclusive use of the applicant during the period of data protection as defined by Article 12.
Drugi vložniki morajo zagotoviti zadovoljive podatke, da se utemeljijo nove odobritve brez sklica na podatke prvotnega vložnika, ki so predmet lastninske pravice.
Other applicants must therefore provide data sufficient to substantiate new authorisations without making reference to the proprietary data of the prior applicant.
Mehanizem mora biti isti kot v členu 21(2) Uredbe št. 1924/2006/ES.
The mechanism should be the same as in Article 21(2) of Regulation 1924/2006/EC.
Prepoved novih živil, ki niso v skladu s to uredbo
Prohibition of non-compliant novel foods
Nova živila se ne dajejo na trg, če njihova uporaba ni v skladu z določbami te uredbe.
Novel foods shall not be placed on the market if their use does not comply with the provisions of this Regulation.
Prepoved mora odvračati goljufive nosilce živilske dejavnosti in povečati varstvo potrošnikov.
Prohibition should deter fraudulent operators and enhance consumer protection.
Člen 6 – točka a
Article 6 – point a
Novo živilo se lahko uvrsti na seznam Skupnosti le, če izpolnjuje naslednje pogoje:
A novel food may be included in the Community list only if it meets the following conditions:
(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 ne pomeni tveganja za zdravje potrošnikov in živali, kar pomeni, da se bodo pri oceni tveganja upoštevali kumulativni in sinergijski učinki ter možni negativni učinki na posebne skupine prebivalstva ;
(a) it does not, on the basis of the scientific evidence available, and after application of the precautionary principle , as laid down in Article 7 of Regulation (EC) No 178/2002 , pose a safety concern to the health of the consumer and of animals which implies that cumulative and synergistic effects as well as possible adverse effects on particular groups of the population will be taken into account in the risk assessment;
Nova živila v nobenem primeru ne bi smela ogrožati zdravja potrošnikov.
New food should not pose any health risks for consumers in any circumstances.
Dodatna določba za običajno uporabo je nepotrebna ter bi povzročila le težave pri razlagi v praksi in omajala predvidljivost odločanja nosilcev dejavnosti 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.
Novo besedilo pa hkrati še bolj krepi varstvo potrošnikov.
And the new wording further strengthens consumer protection.
Pomembno je tudi zdravje živali.
Animal health is also relevant here.
Člen 6 – točka b
Article 6 – point b
(b) z načinom svoje predstavitve ali s svojo predvideno uporabo ne zavaja potrošnika;
(b) it does not mislead the consumer , by the way it is presented or by its intended use ;
(b) ne zavaja potrošnika;
(b) it does not mislead the consumer;
Opredelitve v izvirni Uredbi 258/97 so jasnejše in jih je treba ohraniti.
The definitions in original Regulation 258/97 are clearer and should be kept.
Člen 6 – točka (c)
Article 6 – point c
(c) če je predvideno za nadomestitev drugega živila se od navedenega ne razlikuje v takem obsegu , da bi bila njegova običajna poraba glede hranilne vrednosti škodljiva za potrošnika.
(c) in the case where it is intended to replace another food, it does not differ from that food to such an extent that its normal consumption would be nutritionally disadvantageous for the consumer.
(c) če je predvideno za nadomestitev drugega živila, se od navedenega ne razlikuje tako , da bi bila njegova običajna poraba glede hranilne vrednosti škodljiva za potrošnika.
(c) in the case where it is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
Člen 6 – točka (c a) (novo)
Article 6 – point (c a) (new)
(ca) ne sme negativno vplivati na okolje; po njegovi uporabi ali po tem, ko je postal odpadek, ne sme imeti trajnih posledic za okolje ali se v njem kopičiti.
(ca) it has no negative impact on the environment, and has no persistent or accumulative effects on the environment after being consumed or becoming waste.
Člen 6 – točka (c b) (novo)
Article 6 – point (c b) (new)
(c b) pri oceni je treba upoštevati mnenje Evropske agencije za okolje glede škodljivega vpliva proizvodnega postopka in običajne uporabe na okolje;
(c b) t he opinion of the Europe an Environment Agency concerning the extent to which the producti on proces s and normal consumption have a harmful impact on the environment shall be taken into account in the assessment ;
Pomembno je, da se kot del pogojev za uvrstitev na seznam Skupnosti upoštevajo tudi okoljski vidiki.
It is important also to take account of environmental aspects as part of the conditions for inclusion in the Community list.
Člen 6 – (c c) (novo)
Article 6 – (c c) (new)
(c c) pri oceni je treba upoštevati mnenje evropske skupine za etiko v znanosti in novih tehnologijah glede morebitnih etičnih zadržkov .
(c c) t he opinion of the European Gro u p on Ethics in Science and New Technologies , concerning the extent to which there are ethi c al objections , shall be taken into account in the assessment .
Pomembno je, da se kot del pogojev za uvrstitev na seznam Skupnosti upoštevajo tudi etični vidiki.
It is important also to take account of ethical aspects as part of the conditions for inclusion in the Community list.
Člen 6 – točke c d – c f (novo)
Article 6 – points c d - c f (new)
(cd) novo živilo, ki ima lahko kakršne koli negativne učinke na posebne skupine prebivalstva, bo odobreno, če se izvajajo posebni ukrepi za preprečevanje takih negativnih učinkov;
(c d ) a novel food that may have any adverse effects on particular groups of the population will be authorised only where specific measures preventing such adverse effects have been implemented;
(ce) če varna uporaba zahteva, se bo določila najvišja stopnja vnosa novega živila kot takega ali kot del drugega živila ali kategorije živil;
(c e ) maximum intake levels of a novel food as such or as part of another foodstuff or categories of foodstuffs will be laid down , where safe use so requires ;
(cf) ocenjeni so kumulativni učinki novih živil, uporabljenih v različnih živilih ali kategorijah živil;
(c f ) cumulative effects of novel foods that are used in different foodstuffs or categories of foodstuffs have been assessed;
Več pozornosti je treba nameniti možnim tveganjem uporabe novih živil, še posebej v povezavi z ranljivimi skupinami prebivalstva.
More attention should be paid to possible risks of the use of novel foods, in particular in relation to vulnerable groups of the population.
Za uvrstitev novih živil na seznam Skupnosti se zahteva širši sklop pogojev, da se preprečijo nepričakovane pomanjkljivosti, ki se lahko pojavijo z uporabo novega živila.
A broader set of conditions for inclusion of novel foods in the Community list is needed to prevent that unexpected drawbacks appear from the use of a novel food .
Živila, za katera so bili uporabljeni proizvodni postopki, ki zahtevajo posebne metode za ocenjevanje tveganja (npr. živila, proizvedena z uporabo nanotehnologije), se ne uvrstijo na seznam Skupnosti, dokler se te posebne metode ne odobrijo za uporabo in se na podlagi teh metod ne izvedejo ustrezne ocene varnosti, ki pokažejo, da je uporaba zadevnih živil varna.
Foods to which production processes have been applied that require specific risk assessment methods (e.g. foods produced using nanotechnologies) may not be included in the Community list until such specific methods have been approved for use, and an adequate safety assessment on the basis of these methods has shown that the use of the respective foods is safe.
Te metode ne smejo vključevati uporabe vretenčarjev.
These methods must not entail the use of vertebrate animals.
Da se zaščiti zdravje ljudi in preprečijo poskusi na živali, bi bilo treba prepovedati uporabo nanomaterialov v živilih, dokler niso na voljo poskusi, ki so posebej namenjeni nanomaterialom in pri katerih se ne uporabljajo živali.
Until nano-specific non-animal tests are available for an adequate safety assessment of nanomaterials in foods, their use should be prohibited in order to protect human health and to prevent animal testing .
Člen 6 – odstavek 1 b (novo)
Article 6 – paragraph 1 b (new)