natgillin/translations-raw huggingface dataset:
Zato ta uredba ne pokriva gensko spremenjenih živil iz Uredbe (ES) št. 1829/2003, živil, ki se uporabljajo izključno kot aditivi v okviru področja uporabe Uredbe (ES) št. 1333/2008 , arom v okviru področja uporabe Uredbe (ES) št. 1334/2008, encimov v okviru področja uporabe Uredbe (ES) št. 1332/2008 in ekstrakcijskih topil v okviru področja uporabe Direktive 2009/32/ES.
Therefore, genetically modified food falling within the scope of Regulation (EC) No 1829/2003 , food used solely as additives falling within the scope of Regulation (EC) No 1333/2008 , flavourings falling within the scope of Regulation (EC) No 1334/2008, enzymes falling within the scope of Regulation (EC) No 1332/2008 and extraction solvents falling within the scope of Directive 2009/32/EC should not be covered by this Regulation.
(13) Živila, ki so namenjena tehnološki uporabi ali so gensko spremenjena, ne bi smela soditi v področje uporabe te uredbe, če so zajeta v oceno varnosti in odobritev v skladu z drugo zakonodajo Unije .
(13) Foods which are intended for technological uses or which are genetically modified should not fall within the scope of this Regulation as long as these foods are co v ered by a safety evaluation and approval according to other Union legisl a tion .
Zato je treba iz področja uporabe te uredbe izvzeti živila , ki se uporabljajo izključno kot aditivi v okviru področja uporabe Uredbe (ES) št. 1333/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aditivih za živila 1 , arome v okviru področja uporabe Uredbe (ES) št. 1334/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aromah in nekaterih sestavinah živil z aromatičnimi lastnostmi za uporabo in na živilih 2 , ekstrakcijska topila v okviru področja uporabe Direktive Sveta 2009/32/EGS z dne 23. aprila 2009 o približevanju zakonodaje držav članic na področju ekstrakcijskih topil, ki se uporabljajo pri proizvodnji živil in njihovih sestavin (prenovitev) 3 , encime v okviru področja uporabe Uredbe (ES) št. 1332/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o encimih za živila 4 in gensko spremenjena živila s področja uporabe Uredbe (ES) št 1829/2003 Evropskega parlamenta in Sveta z dne 22. septembra 2003 o gensko spremenjenih živilih in krmi 5 .
Therefore, food used solely as additives falling within the scope of Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives 1 , flavourings falling within the scope of Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods 2 , extraction solvents falling within the scope of Directive 2009/32/EC of the European Parliament and of the Council of 23 April 2009 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients (recast) 3 , enzymes falling within the scope of Regulation (EC) No 1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes 4 and genetically modified food falling within the scope of Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed 5 should be excluded from the scope of this Regulation.
2 UL L 354, 31.12.2008, str.
2 OJ L 354, 31.12.2008, p.
4 UL L 354, 31.12.2008, str.
4 OJ L 354, 31.12.2008, p.
5 UL L 268, 18.10.2003, str.
5 OJ L 268, 18.10.2003, p.
Predlog spremembe 17 iz prve obravnave EP.
EP first reading amendment 17.
(15) Nova živila, razen vitaminov in mineralov, namenjena za posebne prehranske namene, za obogatitev živil ali uporabljena kot prehranska dopolnila, bi bilo treba oceniti v skladu s to uredbo .
(15) Novel foods, other than vitamins and minerals, intended for particular nutritional uses, for food fortification or as food supplements, should be assessed in conformity with this Regulation .
Hkrati bi se morala zanje še naprej uporabljati pravila, določena v Direktivi 2002/46/ES in Uredbi (ES) št. 1925/2006 in Direktivi 2009/39/ES ter v posebnih direktivah , ki so navedene v Direktivi 2009/39/ES in Prilogi I Direktive 2009/39/ES .
They should also remain subject to the rules provided for in Directive 2002/46/EC, in Regulation (EC) No 1925/2006, in Directive 2009/39/EC , and in the specific Directives referred to in Directive 2009/39/EC and in Annex I thereto .
(15) Nova živila, razen vitaminov in mineralov, namenjena za posebne prehranske namene, za obogatitev živil ali uporabljena kot prehranska dopolnila, bi bilo treba oceniti v skladu z merili varnosti in zahtevami, ki se uporabljajo za vsa nova živila .
(15) Novel foods, other than vitamins and minerals, intended for particular nutritional uses, for food fortification or as food supplements, should be assessed in conformity with the safety criteria and requirements applicable to all novel foods .
Hkrati bi se morala zanje še naprej uporabljati pravila, določena v Direktivi 2009/39/EGS ter v posebnih direktivah iz člena 4(1) in Prilogi I te direktive, v Direktivi 2002/46/ES in Uredbi (ES) št. 1925/2006 .
At the same time they should remain subject to the rules provided for in Directive 2009/39/EC and in the specific Directives referred to in Article 4(1) thereof and Annex I there to , in Directive 2002/46/EC and in Regulation (EC) No 1925/2006 .
Uvodna izjava 12 iz dokumenta Komisije.
Recital 12 from the Commission document..
(16) Na podlagi informacij, ki jih predložijo nosilci živilske dejavnosti in ki jih po potrebi dopolnjujejo druge informacije, ki so na voljo v državah članicah, bi bilo treba utemeljiti, ali se je živilo uporabljalo za prehrano ljudi v Uniji v pomembnem obsegu pred 15. majem 1997.
(16) The determination of whether a food was used for human consumption to a significant degree within the Union before 15 May 1997, should be based on information submitted by food business operators and, where appropriate, supported by other information available in the Member States.
Če ni na voljo dovolj informacij o prehrani ljudi pred 15. majem 1997, bi bilo treba uvesti enostaven in pregleden postopek za pridobitev teh informacij, ki bi vključeval Komisijo, države članice in vse zadevne strani .
When there is no or insufficient information available on human consumption before 15 May 1997 , a simple and transparent procedure, involving the Commission, the Member States and any parties concerned, should be established for collecting that information .
(16) Komisija bi morala uvesti enostaven in pregleden postopek za primere, če ni na voljo dovolj informacij o prehrani ljudi pred 15. majem 1997.
(16) The Commission should establish a simple and transparent procedure for cases in which it does not have information on human consumption before 15 May 1997 .
V tem postopku bi morale sodelovati države članice.
The Member States should be involved in this procedure .
Postopek se sprejme najpozneje do ... *.
The procedure should be adopted no later than ... * .
* Šest mesecev po začetku veljavnosti te uredbe.
*Six months after the entry into force of this Regulation
Predlog spremembe 18 iz prve obravnave EP.
EP first reading amendment 18.
(17) Nova živila bi se smela dajati na trg v Unije le, če so varna in ne zavajajo potrošnika.
(17) Novel foods should be placed on the market within the Union only if they are safe and do not mislead the consumer.
Poleg tega se novo živilo v primerih, ko naj bi nadomestilo drugo živilo , ne bi smelo razlikovati od tega živila na način, ki bi bil hranilno manj ugoden za potrošnika.
In addition, where the novel food is intended to replace another food, it should not differ from that food in a way that would be nutritionally disadvantageous for the consumer.
Ocena njihove varnosti bi morala temeljiti na previdnostnem načelu, kot je določeno v členu 7 Uredbe (ES) št. 178/2002.
The assessment of their safety should be based on the precautionary principle as laid down in Article 7 of Regulation (EC) No 178/2002.
Poleg tega se ne bi smela razlikovati od živil, ki jih nadomestijo, na kakršen koli način, ki bi bil hranilno manj ugoden za potrošnika.
In addition, they should not differ from the food that they are to replace in any way that would be nutritionally disadvantageous for the consumer.
Predlog spremembe 19 iz prve obravnave EP.
EP first reading amendment 19.
(19a) V postopku odobritve je treba kot del obvladovanja tveganja upoštevati etične in okoljske vidike.
(19a) Ethical and environmental aspects must be considered as part of the risk management during the authorisation procedure.
Te vidike bi morala oceniti evropska skupina za etiko v znanosti in novih tehnologijah oziroma Evropska agencija za okolje.
These aspects should be assessed by the European Group on Ethics in Science and New Technologies and the European Environment Agency respectively.
Predlog spremembe deloma znova uvaja predlog spremembe 23 iz prve obravnave EP.
This amendment re-establishes partially the EP first reading amendment 23.
(20) Trenutno informacije o tveganjih, povezanih z namensko proizvedenimi nanomateriali, niso zadostne.
(20) At present, there is inadequate information on the risks associated with engineered nanomaterials .
Da bi lahko bolje ocenila njihovo varnost naj Komisija v sodelovanju z agencijo oblikuje testne metodologije, ki upoštevajo posebne značilnosti namensko proizvedenih nanomaterialov.
In order to better assess their safety the Commission, in cooperation with the Authority, should develop test methodologies which take into account specific characteristics of engineered nanomaterials.
(20) Poskusne metode, ki so zdaj na voljo, ne zadoščajo za oceno tveganj, povezanih z nanomateriali.
(20) Test methods currently available are not adequate for assessing the risks associated with nanomaterials .
Nujno je treba razviti poskusne metode za testiranje nanomaterialov, pri katerih se ne uporabljajo živali.
Non-animal test methods for testing nanomaterials should be developed as a matter of urgency.
(22) Če so tradicionalna živila iz tretjih držav, vključena v seznam tradicionalnih živil iz tretjih držav, bi moralo biti omogočeno, da se dajo na trg v Uniji pod pogoji, ki ustrezajo pogojem, pod katerimi so dokazane pretekle izkušnje o varni uporabi hrane.
(22) If traditional foods from third countries are included in the list of traditional foods from third countries, they should be allowed to be placed on the market within the Union , under conditions that correspond to those for which the history of safe food use has been demonstrated.
Pri oceni varnosti in ravnanju s tradicionalnimi živili iz tretjih držav bi bilo treba upoštevati pretekle izkušnje o varni uporabi v državi njihovega porekla .
As regards the safety assessment and management of traditional food from third countries, their history of safe food use in their country of origin should be taken into account.
Pretekle izkušnje o varni uporabi živila ne bi smele vključevati neživilske rabe ali rabe, ki ni povezana z običajno prehrano.
The history of safe food use should not include non-food uses or uses not related to normal diets.
(22) Pri oceni varnosti in ravnanju s tradicionalnimi živili iz tretjih držav bi bilo treba upoštevati veljavne predpise EU .
(22) As regards the safety assessment and management of traditional food from third countries, the EU rules in force should be taken into account.
Če države članice in/ali agencija niso predložile nobenih utemeljenih pripomb glede varnosti na podlagi znanstvenih dokazov, na primer podatkov o škodljivih učinkih na zdravje, bo dajanje živila na trg v Uniji dovoljeno po uradnem obvestilu o tej nameri pod pogojem, da zoper njo ni etičnih ugovorov.
If Member States and/or the Authority have not presented any reasoned safety objections, based on scientific evidence, for example information on adverse health effects, it will be permissible to place the food on the market within the Union after notification of the intention to do so, provided that there are no ethical objections.
Predlog spremembe 28 iz prve obravnave EP.
EP first reading amendment 28.
(24) Vključitev novih živil na seznam novih živil Unije ali na seznam tradicionalnih živil iz tretjih držav ne bi smela posegati v možnost ocene učinkov skupne porabe snovi, ki je navedenemu živilu dodana ali se uporablja za njegovo proizvodnjo, ali primerljivega proizvoda v skladu z Uredbo (ES) št. 1925/2006.
(24) The inclusion of a novel food in the Union list of novel foods or in the list of traditional foods from third countries should be without prejudice to the possibility of evaluating the effects of the overall consumption of a substance which is added to, or used for the manufacture of that food, or of a comparable product in accordance with Regulation (EC) No 1925/2006.
(24) Vključitev novih živil na seznam novih živil Unije ne bi smela posegati v možnost ocene učinkov skupne porabe snovi, ki je navedenemu živilu dodana ali se uporablja za njegovo proizvodnjo, ali primerljivega proizvoda v skladu s členom 8 Uredbe (ES) št. 1925/2006.
(24) The inclusion of a novel food in the Union list of novel foods should be without prejudice to the possibility of evaluating the effects of the overall consumption of a substance which is added to, or used for the manufacture of that food, or of a comparable product in accordance with Article 8 of Regulation (EC) No 1925/2006.
Uvodna izjava 19 iz dokumenta Komisije.
Recital 19 from the Commission document.
(25) V posebnih okoliščinah in z namenom, da bi se spodbudile raziskave in razvoj v kmetijsko-živilskem sektorju in s tem inovacije, bi se morali novi znanstveni dokazi in pravno zaščiteni podatki, predloženi skupaj z zahtevkom za vključitev novega živila na seznam Unije zaščititi .
(25) 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 Union list should be protected .
Ti podatki in informacije se v omejenem časovnem obdobju ne bi smeli uporabljati v korist drugega predlagatelja brez soglasja prvega predlagatelja.
That data and information should not be used to the benefit of a subsequent applicant, during a limited period of time, without the agreement of the prior applicant.
Zaščita znanstvenih podatkov, ki jih je predložil en predlagatelj, ne bi smela preprečiti drugim predlagateljem, da ne bi mogli zahtevati vključitev novih živil na seznam Unije na podlagi lastnih znanstvenih podatkov.
The protection of scientific data provided by one applicant should not prevent other applicants from seeking the inclusion in the Union list of novel foods on the basis of their own scientific data.
(25) V posebnih okoliščinah in z namenom, da bi se spodbudile raziskave in razvoj v kmetijsko-živilskem sektorju in s tem inovacije, je primerno zaščititi naložbe inovatorjev v zbiranje informacij in podatkov, ki se predložijo pri vložitvi zahtevka po tej uredbi .
(25) Under specific circumstances in order to stimulate research and development within the agri-food industry, and thus innovation, it is appropriate to protect the investment made by innovators in gathering the information and data provided in support of an application under this Regulation.
Novi znanstveni dokazi in pravno zaščiteni podatki, predloženi skupaj z zahtevkom za vključitev novega živila na seznam Unije, se v omejenem časovnem obdobju ne bi smeli uporabljati v korist drugega predlagatelja brez soglasja prvega vlagatelja.
The newly developed scientific evidence and proprietary data provided in support of an application for inclusion of a novel food in the Union list should not be used to the benefit of another applicant during a limited period of time, without the agreement of the first applicant.
Vseeno je treba zagotoviti varstvo pravic intelektualne lastnine.
Intellectual property rights should, nevertheless, be respected.
Predlog spremembe 25 iz prve obravnave EP.
EP first reading amendment 25.
(26) Za nova živila veljajo splošne zahteve glede označevanja, določene v Direktivi 2000/13/ES , in po potrebi zahteve glede označevanja hranilne vrednosti, določene v Direktivi 90/496/EGS .
(26) Novel foods are subject to the general labelling requirements laid down in Directive 2000/13/EC and, where necessary, to the nutritional labelling requirements laid down in Directive 90/496/EEC .
V nekaterih primerih bi bilo morda treba določiti dodatne informacije glede označevanja, zlasti za opis živila, njegov vir ali pogoje uporabe.
In certain cases it might be necessary to provide for additional labelling information, in particular regarding the description of the food, its source or its conditions of use.
Zato bi se lahko , kadar se novo živilo vključi na seznam Unije ali na seznam tradicionalnih živil iz tretjih držav, določili posebni pogoji glede uporabe ali obveznosti označevanja, ki bi se med drugim lahko nanašali na posebne značilnosti ali lastnosti živil, kot je sestava, hranilna vrednost ali prehranski učinki ter namen uporabe živila, ali na etične vidike ali imeli posledice za zdravje nekaterih skupin prebivalstva .
Therefore, when a novel food is included in the Union list or in the list of traditional foods from third countries, specific conditions of use or labelling obligations may be imposed, which might, inter alia, relate to any specific characteristic or food property, such as composition, nutritional value or nutritional effects and intended use of the food, or to ethical considerations or implications for the health of specific groups of the population.
(26) Za nova živila veljajo splošne zahteve glede označevanja, določene v Direktivi 2000/13/ES Evropskega parlamenta in Sveta z dne 20. marca 2000 o približevanju zakonodaje držav članic o označevanju, predstavljanju in oglaševanju živil 1 .
(26) Novel foods are subject to the general labelling requirements laid down in Directive 2000/13/EC of the European Parliament and of the Council of 20 March 2000 on the approximation of the laws of the Member States relating to labelling, presentation and advertising of foodstuffs 1 .
V nekaterih primerih bi bilo morda treba določiti dodatne informacije glede označevanja, zlasti za opis živila, njegov vir ali pogoje uporabe.
In certain cases it might be necessary to provide for additional labelling information, in particular regarding the description of the food, its source, or its conditions of use.
Zato lahko za uvrstitev novih živil na seznam Unije veljajo posebni pogoji uporabe ali obveznosti označevanja .
Therefore, the inclusion of a novel food in the Union list may be subject to specific conditions of use or labelling obligations .
Uvodna izjava 21 iz dokumenta Komisije.
Recital 21 from the Commission document.
(27) Uredba (ES) št. 1924/2006 usklajuje določbe v državah članicah v zvezi s prehranskimi in zdravstvenimi trditvami.
(27) Regulation (EC) No 1924/2006 harmonises the provisions in the Member States which relate to nutrition and health claims.
Zato bi morale biti trditve glede novih živil zmeraj v skladu z navedeno uredbo.
Therefore, claims regarding novel foods should only be made in accordance with that Regulation.
(27) Uredba (ES) št. 1924/2006 Evropskega Parlamenta in Sveta z dne 20. decembra 2006 o prehranskih in zdravstvenih trditvah na živilih usklajuje določbe v državah članicah v zvezi s prehranskimi in zdravstvenimi trditvami.
(27) Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods 2 harmonises the provisions in the Member States which relate to nutrition and health claims.
Če namerava predlagatelj zahtevka novo živilo opremiti z zdravstveno trditvijo, ki mora biti odobrena v skladu s členoma 17 in 18 Uredbe (ES) št. 1924/2006, in če zahtevka za novo živilo in zdravstveno trditev vključujeta zahtevo za varstvo pravno zaščitenih podatkov, obdobja varstva podatkov zanju začnejo in nato tečejo hkrati, če predlagatelj tako zahteva.
Where an applicant wishes a novel food to carry a health claim that needs to be authorised in accordance with Article 17 or 18 of Regulation (EC) No 1924/2006 and the novel food and health claim applications both include requests for the protection of proprietary data, the periods of data protection should start together and run concurrently, where the applicant so requests.
Predlog spremembe 27 iz prve obravnave EP.
EP first reading amendment 27.
(28) Za nasvet glede etičnih vprašanj v zvezi z dajanjem novih živil na trg v Uniji se lahko po potrebi zaprosi Evropsko skupino za etiko v znanosti in novih tehnologijah.
(28) The European Group on Ethics in Science and New Technologies may be consulted, where appropriate , with a view to obtaining advice on ethical issues regarding the placing on the market within the Union of novel foods.
(28) V posebnih primerih je treba za nasvet glede etičnih vprašanj v zvezi z uporabo novih tehnologij in dajanjem novih živil na trg zaprositi Evropsko skupino za etiko v znanosti in novih tehnologijah.
(28) The European Group on Ethics in Science and New Technologies (EGE) should be consulted in specific cases with a view to obtaining advice on ethical issues regarding the use of new technologies and the placing on the market of novel foods.
Predlog spremembe 29 iz prve obravnave EP.
EP first reading amendment 29.
(29) Nova živila, ki so se dajala na trg v Uniji v skladu z Uredbo (ES) št. 258/97, bi bilo treba še naprej dajati na trg.
(29) Novel foods placed on the market within the Union 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, bi bilo treba vključiti na seznam novih živil Unije, ki ga uvaja ta uredba.
Novel foods authorised in accordance with Regulation (EC) No 258/97 should be included in the Union list of novel foods established by this Regulation.
Poleg tega se zahtevki, predloženi v skladu z Uredbo (ES) št. 258/97 pred začetkom uporabe te uredbe, obravnavajo kot zahtevki v skladu s to uredbo, če poročilo o začetni presoji iz Uredbe ( ES) št. 258/97 še ni bilo poslano Komisiji, in v vseh primerih, kadar se v skladu z navedeno uredbo zahteva poročilo o dodatni presoji.
In addition, applications submitted under Regulation (EC) No 258/97 before the date of application of this Regulation should be transformed into an application under this Regulation where the initial assessment report provided for under 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 that Regulation.
Drugi zahtevki v postopku , 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 pending 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.
Poleg tega je treba zahtevke, predložene v skladu z Uredbo (ES) št. 258/97, za katere poročilo o začetni presoji iz člena 6(3) navedene uredbe še ni bilo poslano Komisiji in za katere se zahteva poročilo o dodatni presoji v skladu s členom 6(3) ali 6(4) navedene uredbe pred začetkom uporabe te uredbe, obravnavati kot zahtevek v skladu s to uredbo .
In addition, applications submitted under Regulation (EC) No 258/97, in relation to which the initial assessment report provided for under Article 6(3) of that Regulation has not yet been forwarded to the Commission and in relation to which an additional assessment report is required in accordance with Article 6(3) or 6(4) of that Regulation before the date of application of this Regulation, should be considered as an application 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 into account the outcome of the initial assessment.