natgillin/translations-raw huggingface dataset:
Drugi zahtevki, predloženi pred začetkom uporabe te uredbe v skladu s členom 4 Uredbe (ES) št. 258/97, bi bilo treba obravnavati 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 .
Predlog spremembe 89 iz prve obravnave EP.
EP first reading amendment 89.
(30) Uredba (ES) št. 882/2004 določa splošna pravila o izvajanju uradnega nadzora za preverjanje skladnosti z zakonodajo o živilih.
(30) Regulation (EC) No 882/2004 lays down general rules for the performance of official controls to verify compliance with food law.
Zato bi se od držav članic moralo zahtevati, da izvajajo uradni nadzor v skladu z navedeno uredbo, da se doseže skladnost s to uredbo.
The Member States should be requested to carry out official controls in accordance with that Regulation, in order to enforce compliance with this Regulation.
(30) Uredba (ES) št. 882/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o izvajanju uradnega nadzora, da se zagotovi preverjanje skladnosti z zakonodajo o krmi in živilih ter s pravili o zdravstvenem varstvu živali in zaščiti živali določa splošna pravila o izvajanju uradnega nadzora za preverjanje skladnosti z zakonodajo o živilih.
(30) Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules lays down general rules for the performance of official controls to verify compliance with food law.
Zato morajo države članice izvajati uradni nadzor v skladu z Uredbo (ES) št. 882/2004 , da se doseže skladnost s to uredbo
Therefore, Member States are to carry out official controls in accordance with Regulation (EC) No 882/2004 , in order to enforce compliance with this Regulation.
Uvodna izjava 30 iz dokumenta Komisije.
Recital 30 from the Commission document.
(34) Ukrepe, potrebne za izvajanje te uredbe, bi bilo treba sprejeti v skladu s členoma 5 in 7 Sklepa Sveta 1999/468/ES z dne 28. junija 1999 o določitvi postopkov za uresničevanje Komisiji podeljenih izvedbenih pooblastil.
(34) The measures necessary for the implementation of this Regulation should be adopted in accordance with Articles 5 and 7 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission 1 .
(35) Zlasti bi bilo treba Komisiji podeliti pooblastilo za razjasnitev določenih opredelitev pojmov, da se na podlagi ustreznih meril zagotovi usklajeno izvajanje zadevnih določb v državah članicah, vključno z opredelitvijo "namensko proizvedenega nanomateriala" ob upoštevanju tehničnega in znanstvenega napredka, ter netradicionalne tehnike vzreje živali, tudi tehnik, ki se uporabljajo za nespolno reprodukcijo genetsko identičnih živali, ki se pred 15. majem 1997 niso uporabljale v proizvodnji hrane v Uniji.
(35) In particular, the Commission should be empowered to clarify certain definitions in order to ensure a harmonised implementation of these provisions by the Member States on the basis of relevant criteria, including the definition of "engineered nanomaterial", taking into account the technical and scientific developments, and the non-traditional animal breeding technique that includes techniques used for asexual reproduction of genetically identical animals not used for food production within the Union before 15 May 1997.
Komisiji bi bilo treba podeliti tudi pooblastilo za sprejetje veh primernih prehodnih ukrepov in za posodobitev seznama tradicionalnih živil iz tretjih držav in seznama Unije.
Furthermore, the Commission should be empowered to adopt any appropriate transitional measures and to update the list of traditional foods from third countries and the Union list.
(36) Poleg tega bi bilo Komisiji treba podeliti pooblastilo za sprejemanje delegiranih aktov v skladu s členom 290 Pogodbe o delovanju Evropske unije glede meril, v skladu s katerimi se za živilo lahko šteje, da se je pred 15. majem 1997 v Uniji v pomembnem obsegu uporabljalo za prehrano ljudi.
(36) In addition, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union in respect of the criteria according to which foods may be considered as having been used for human consumption to a significant degree within the Union before 15 May 1997.
Še zlasti je pomembno, da se Komisija pri svojem pripravljalnem delu posvetuje z eksperti, kar je v skladu z njenimi obvezami iz Sporočila Komisije z dne 9. decembra 2009 o izvajanju člena 290 Pogodbe o delovanju Evropske unije .
It is of particular importance that the Commission consult experts in the preparatory phase in accordance with the commitment of the Commission undertaken in the Communication of 9 December 2009 on the implementation of Article 290 of the Treaty on the Functioning of the European Union.
(36) Komisiji bi bilo treba podeliti pooblastilo za sprejemanje delegiranih aktov v skladu s členom 290 Pogodbe o delovanju Evropske unije glede meril, v skladu s katerimi se za živilo lahko šteje, da se je pred 15. majem 1997 v Uniji v pomembnem obsegu uporabljalo za prehrano ljudi, za to da določi, ali vrsta živila sodi na področje uporabe te uredbe, za prilagoditev opredelitve „namensko proizvedenih nanomaterialov“ v skladu s tehničnim in znanstvenim napredkom ter opredelitvami, ki bodo v prihodnje sprejete na mednarodni ravni, za pravila za nadaljnje ukrepanje v primerih, kjer Komisija nima informacij o uporabi živila za prehrano ljudi pred 15. majem 1997, kakor tudi za pravila o uporabi člena 4(1) in posodobitev seznama Unije .
(36) The Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union in respect of the criteria according to which foods may be considered as having been used for human consumption to a significant degree within the Union before 15 May 1997, in respect of the determination of whether a type of food falls within the scope of this Regulation, the adjustment and adaptation of the definition of "engineered nanomaterial" to technical and scientific progress and in line with definitions subsequently agreed at international level, rules on how to proceed in cases in which the Commission has no information about use of a food for human consumption before 15 May 1997, as well as in respect of rules for the application of Article 4(1) and Article 11 and the update of the Union list.
Zlasti je pomembno, da Komisija med svojim pripravljalnim delom izvede ustrezna posvetovanja, tudi s strokovnjaki .
It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.
Ta uredba določa usklajena pravila za dajanje novih živil na trg v Unije , s katerimi se zagotavlja visoka raven varovanja zdravja ljudi in koristi potrošnikov ter hkrati učinkovito delovanje notranjega trga , po potrebi ob upoštevanju varstva okolja in dobrega počutja živali .
This Regulation lays down harmonised rules for the placing of novel foods on the market within the Union with a view to ensuring a high level of protection of human health and consumers' interests , whilst ensuring the effective functioning of the internal market, taking into account, where appropriate, the protection of the environment and animal welfare .
Ta uredba določa usklajena pravila za dajanje novih živil na trg v Uniji , s katerimi se zagotavlja visoka raven varovanja življenja in zdravja ljudi , zdravja in dobrega počutja živali, varstva okolja in koristi potrošnikov ter hkrati preglednost in učinkovito delovanje notranjega trga ter spodbujanje inovacij v kmetijsko-živilskem sektorju .
This Regulation lays down harmonised rules for the placing of novel foods on the market within the Union 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 .
Predlog spremembe 30 iz prve obravnave EP.
EP first reading amendment 30.
Ta uredba se, razen če ni drugače določeno , ne uporablja za:
This Regulation shall, unless otherwise provided for, not apply to:
(a) živila, ki se uporabljajo in dokler se uporabljajo kot:
(a) foods when and in so far as they are used as:
(i) aditivi za živila, ki sodijo na področje uporabe Uredbe (ES) št. 1333/2008;
(i) food additives falling within the scope of Regulation (EC) No 1333/2008;
(ii) arome za živila, ki sodijo na področje uporabe Uredbe (ES) št. 1334/2008;
(ii) food flavourings falling within the scope of Regulation (EC) No 1334/2008;
(iii) ekstrakcijska topila, ki se uporabljajo pri proizvodnji živil in sodijo na področje uporabe Direktive 2009/32/ES;
(iii) extraction solvents used in the production of foodstuffs and falling within the scope of Directive 2009/32/EC;
(iii) ekstrakcijska topila, ki se uporabljajo pri proizvodnji živil in sodijo na področje uporabe Direktive 2009/32/ES;
(iii) extraction solvents used in the production of foodstuffs and falling within the scope of Directive 2009/32/EC ;
(iv) encimi za živila, ki sodijo na področje uporabe Uredbe (ES) št. 1332/2008 ;
(iv) food enzymes falling within scope of Regulation (EC) No 1332/2008;
(v) vitamini in minerali, ki spadajo na področje uporabe Direktive 2002/46/ES, Uredbe (ES) št. 1925/2006 ali Direktive 2009/39/ES, razen že odobreni vitamini ali mineralne snovi, ki so pridobljeni s proizvodnimi metodami ali z uporabo novih virov, ki niso bili upoštevani v času odobritve, v skladu s posebno zakonodajo, kadar te proizvodne metode ali novi viri pomenijo pomembne spremembe , navedene v točki (iii) člena 3(2)(a) te uredbe ;
(v) vitamins and minerals falling within the respective scope of Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Directive 2009/39/EC, except for vitamin and mineral substances already authorised , which are obtained by production methods or using new sources that were not taken into account when they were authorised under specific legislation, where those production methods or new sources give rise to the significant changes referred to in point (iii) of Article 3(2)(a) of this Regulation.
(v) vitamini in minerali, ki spadajo na področje uporabe Direktive 89/398/EGS, Direktive 2002/46/ES ali Uredbe (ES) št. 1925/2006, razen že odobrenih vitaminov in mineralnih snovi, pridobljenih s proizvodnimi metodami ali uporabo novih virov, ki se ob odobritvi na podlagi posebne zakonodaje niso upoštevali, kadar te proizvodne metode ali novi viri povzročijo bistvene spremembe iz člena 3(2) (a)(iii) .
(v) vitamins and minerals falling within the scope of Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Directive 2009/32/EC, except for vitamin and mineral substances already approved which are obtained by production methods or using new sources that were not taken into account when they were authorised under specific legislation, where these production methods or new sources give rise to significant changes referred to in Article 3(2) ( a)(iii).
(b) živila, ki sodijo na področje uporabe Uredbe (ES) št. 1829/2003.
(b) foods falling within the scope of Regulation (EC) No 1829/2003;
(b) živila, ki spadajo na področje uporabe Uredbe (ES) št. 1829/2003.
(b) foods falling within the scope of Regulation (EC) No 1829/2003;
Predlog spremembe 91 iz prve obravnave EP.
EP first reading amendment 91.
Člen 2 – odstavek 2 – točka b a (novo)
Article 2 - paragraph 2 - point b a (new)
(ba) živila, pridobljena iz kloniranih živali in njihovih potomcev.
(ba) foods derived from cloned animals and their descendants.
Komisija do ...* predloži zakonodajni predlog za prepoved, da se na trg Unije dajo živila, pridobljena iz kloniranih živali in njihovih potomcev .
Before ... * , 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 posreduje Evropskemu parlamentu in Svetu.
The proposal shall be forwarded to the European Parliament and the Council.
* Šest mesecev po začetku veljavnosti te uredbe.
* Six months after the date of entry i t fo force of this Regulation.
(2a) Ne glede na odstavek 2 se ta uredba uporablja za aditive za živila, živilske encime, arome in določene živilske sestavine z aromatičnimi lastnostmi, za katere se uporablja nov proizvodni postopek, ki se ni uporabljal pred 15. majem 1997 in ki povzroča bistvene spremembe v sestavi ali strukturi živil, kot so namensko proizvedeni nanomateriali.
(2a) Notwithstanding paragraph 2, this Regulation shall apply to food additives , food enzymes, flavourings and certain food ingredients with flavouring properties to which a new production process not used before 15 May 1997 is applied that gives rise to significant changes in the composition or structure of the food, such as engineered nanomaterials.
(2b) Po potrebi in ob upoštevanju področja uporabe, določenega v tem členu, Komisija lahko sprejme delegirane akte v skladu s členom 21 in pod pogoji iz členov 22 in 23 ter tako določi, ali vrsta živila sodi na področje uporabe te uredbe.
(2b) Where necessary and taking into account the scope defined in this Article, the Commission may determine, by means of delegated acts in accordance with Article 21 and subject to the conditions of Articles 22 and 23, whether a type of food falls within the scope of this Regulation.
Kadar lahko novo živilo na človeško telo učinkuje podobno kot zdravilo, lahko Komisija Evropsko agencijo za zdravila (EMEA) zaprosi za mnenje o tem, ali živilo sodi na področje uporabe Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta z dne 31. marca 2004 o postopkih Skupnosti za pridobitev dovoljenja za promet in nadzor zdravil za humano in veterinarsko uporabo ter o ustanovitvi Evropske agencije za zdravila1 in tako ne na področje uporabe te uredbe.
Where a novel food is capable of having an effect on the human body comparable to that of a medicinal product, the Commission may seek an opinion of the European Medicines Agency (EMEA) on whether it falls under Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency 1 , and therefore not under this Regulation.
Člen 3 – odstavek 2 – točka a – uvodni del in točka i
Article 3 - paragraph 2 - point a - introductory part and point i
(a) "novo živilo" pomeni živilo, ki se ni uporabljalo v pomembnem obsegu za prehrano ljudi v Uniji pred 15. majem 1997, vključno z :
(a) "novel food" means food that was not used for human consumption to a significant degree within the Union before 15 May 1997, including :
(a) "novo živilo" pomeni:
(a) "novel food" means:
(i) živili živalskega izvora, če se za živali uporabljajo netradicionalne tehnike vzreje, ki se pred 15. majem 1997 niso uporabljale za proizvodnjo živil v Uniji, in živili iz mladičev teh živali ;
(i) food of animal origin, when a non ‑traditional breeding technique not used for food production within the Community before 15 May 1997 is applied to the animal and food derived from the offspring of these animals;
(i) živilo, ki se ni uporabljalo v pomembnem obsegu za prehrano ljudi v Uniji pred 15. majem 1997;
(i) food that was not used for human consumption to a significant degree within the Union before 15 May 1997;
Predloga sprememb 92 in 35 iz prve obravnave EP.
EP first reading amendments 92 and 35.
Člen 3 – odstavek 2 – točka a – točka ii
Article 3 - paragraph 2 - point a - point ii
(ii) živili rastlinskega izvora, če se za rastline uporabljajo netradicionalne tehnike gojenja, ki se pred 15. majem 1997 niso uporabljale za proizvodnjo živil v Uniji, če navedena netradicionalna tehnika gojenja pomeni pomembne spremembe v sestavi ali strukturi živila, ki vplivajo na njegovo hranilno vrednost, način njegove presnove ali raven neželenih snovi ;
(ii) food of plant origin, when a non-traditional breeding technique not used for food production within the Union before 15 May 1997 is applied to the plant, if that non-traditional breeding technique applied to a plant gives rise to significant changes in the composition or structure of the food, which affect its nutritional value, how it is metabolised or the level of undesirable substances;
(ii) živili rastlinskega ali živalskega izvora, če se za rastline in živali uporabljajo netradicionalne tehnike gojenja, ki se niso uporabljale pred 15. majem 1997, 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 not used before 15 May 1997 , with the exception of foods derived from cloned animals and their descendants ;
Člen 3 – odstavek 2 – točka a – točka v
Article 3 - paragraph 2 - point a - point v
(v) tradicionalnimi živili iz tretje države; ter
(v) traditional food from a third country; and
Člen 3 – odstavek 2 – točka a – točka vi
Article 3 - paragraph 2 - point a - point vi
(vi) sestavinami živil, ki so se v Uniji pred 15. majem 1997 uporabljale izključno v prehranskih dopolnilih, če se bodo uporabljale v živilih, ki niso prehranska dopolnila.
(vi) food ingredients used exclusively in food supplements within the Union before 15 May 1997, if they are to be used in foods other than food supplements.
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 Uniji 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 may be placed on the market within the Union after that date for the same use without being considered a novel food;
(b) "mladič" pomeni žival, vzrejeno s tradicionalno tehniko vzreje, katere vsaj eden od staršev je žival, vzrejena z netradicionalno tehniko vzreje;
(b) "offspring" means an animal produced by a traditional breeding technique, where at least one of its parents is an animal produced by a non-traditional breeding technique;
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;
(ca) "cloned animals" means animals produced by means of a method of asexual, artificial reproduction with the aim of producing a genetically identical or nearly identical copy of an individual animal;
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;
(cb) " descendants of cloned animals" means animals produced by means of sexual reproduction, in cases in which at least one of the progenitors is a cloned animal;
(d) "tradicionalno živilo iz tretjih držav" pomeni novo živilo, razen novo živilo iz točk (i) do (iv) točke (a), pridobljeno v primarni proizvodnji , s preteklimi izkušnjami o uporabi živila v tretji državi, kar pomeni, da je zadevno živilo bilo vsaj 25 let običajna prehrana za velik del prebivalstva države in bo to še naprej;
(d) "traditional food from a third country" means novel food, other than the novel food under sub-points (i) to (iv) of point (a), derived from primary production , with a history of food use in any third country, such that the food in question has been and continues to be part of the customary diet for at least 25 years in a large part of the population of the country;
(d) "tradicionalno živilo iz tretjih držav" pomeni naravno, nespremenjeno novo živilo s preteklimi izkušnjami o uporabi živila v tretji državi, kar pomeni, da je zadevno živilo bilo vsaj 25 let pred ... * običajna prehrana za velik del prebivalstva države in bo to še naprej;
(d) "traditional food from a third country" means a natural non-engineered novel food with a history of food use in a third country, meaning that the food in question was , for at least 25 years before ... * , and continues to be , part of the normal diet in a large part of the population of the country;
* Šest mesecev po dnevu začetka veljavnosti uredbe.
* Six months after the date of entry in t o force of this Regulation.
Člen 3 – odstavek 2 – točka e
Article 3 - paragraph 2 - point e
(e) "pretekle izkušnje o varni uporabi živila v tretji državi " pomeni, da je varnost zadevnega živila potrjena s podatki o sestavi in izkušnjami z uporabo in neprekinjeno uporabo že vsaj 25 let v običajni prehrani velikega dela prebivalstva države.
(e) "history of safe food use in a third country " 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 25 years in the customary diet of a large part of the population of a country.
(e) "pretekle izkušnje o varni uporabi 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 prebivalstva države.
(e) ''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;
Komisija lahko sprejme nadaljnja merila za pojasnitev opredelitev iz podtočk (i) do(iv) točke (a), ter iz točk (c), (d) in (e) odstavka 2 tega člena v skladu z regulativnim postopkom iz člena 19(2).
The Commission may adopt further criteria to clarify the definitions in sub-points (i) to (iv) of point (a), and in points (c), (d) and (e) of paragraph 2 of this Article in accordance with the regulatory procedure referred to in Article 19(2).
Glede na številne opredelitve nanomaterialov, ki so jih objavili različni organi na mednarodni ravni, ter stalen tehnični in znanstveni razvoj na področju nanotehnologij Komisija s sprejetjem delegiranih aktov v skladu s členom 21 in pod pogoji iz členov 22 in 23 prilagodi točko (c) odstavka 2 tega člena v skladu s tehničnim in znanstvenim napredkom ter opredelitvami, ki bodo v prihodnje sprejete na mednarodni ravni.
In view of the various definitions of nanomaterials published by different bodies at international level and the constant technical and scientific developments in the field of nanotechnologies, the Commission shall adjust and adapt point (c) of paragraph 2 of this Article to technical and scientific progress, and in line with definitions subsequently agreed at international level, by means of delegated acts in accordance with Article 21 and subject to the conditions of Articles 22 and 23.
Predloga spremembe 92 in 35 iz prve obravnave EP.
EP first reading amendment 92 and 35.
Postopek za določitev statusa novega živila
Procedure for determination of novel food status
Zbiranje informacij o razvrstitvi novega živila
Collection of information regarding the classification of a novel food
Predlog spremembe 40 iz prve obravnave EP.
EP first reading amendment 40.
Nosilci živilske dejavnosti preverijo status živila, ki ga nameravajo dati na trg v Uniji, v zvezi s področjem uporabe te uredbe.
Food business operators shall verify the status of the food they intend to place on the market within the Union with respect to the scope of this Regulation.
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.