natgillin/translations-raw huggingface dataset:
Zato bi bilo treba ustrezno spremeniti Uredbo (ES) št. 1331/2008 .
Regulation (EC) No 1331/2008 should therefore be amended accordingly.
Z začetkom veljave Lizbonske pogodbe 1. decembra 2009 je Evropska unija nadomestila in nasledila Evropsko skupnost in besedo „Skupnost“ bi bilo treba v tej uredbi nadomestiti z besedo „Unija“.
As a consequence of the entry into force of the Treaty of Lisbon on 1 December 2009, the European Union has replaced and succeeded the European Community, and the word ‘Community’ should be replaced by ‘Union’ throughout that Regulation.
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.
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.
Po potrebi in na podlagi ugotovitev ocene varnosti bi bilo treba uvesti zahteve za spremljanje uporabe novih živil za prehrano ljudi po uvedbi na trg.
Where appropriate and based on the conclusions of the safety assessment, post-market monitoring requirements for the use of novel foods for human consumption should be introduced.
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
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
členom 8
Article 8 of
V posebnih okoliščinah in z namenom, da bi se spodbudile raziskave in razvoj v kmetijsko-živilskem sektorju in s tem inovacije,
In specific circumstances, in order to stimulate research and development within the agri-food industry, and thus innovation,
Za nova živila veljajo splošne zahteve glede označevanja, določene v Direktivi 2000/13/ES
Novel foods are subject to the general labelling requirements laid down in Directive 2000/13/EC
Evropskega parlamenta in Sveta z dne 20. marca 2000 o približevanju zakonodaje držav članic o označevanju, predstavljanju in oglaševanju živil
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
▌UL L 109, 6.5.2000, str.
▌OJ L 109, 6.5.2000, p.
za uvrstitev novih živil na seznam Unije veljajo posebni pogoji uporabe ali obveznosti označevanja
the inclusion of a novel food in the Union list may be subject to specific conditions of use or labelling obligations
Evropskega Parlamenta in Sveta z dne 20. decembra 2006 o prehranskih in zdravstvenih trditvah na živilih
of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods
▌UL L 404, 30.12.2006, str.
▌OJ L 404, 30.12.2006, p.
za nasvet glede etičnih vprašanj v zvezi z
with a view to obtaining advice on ethical issues regarding
uporabo novih tehnologij in
the use of new technologies and
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.
Novel foods placed on the market within the Union under Regulation (EC) No 258/97 should continue to be placed on the market.
Poleg tega se zahtevki, predloženi v skladu z Uredbo (ES) št. 258/97
In addition, applications submitted under Regulation (EC) No 258/97
, za katere
, in relation to which
poročilo o začetni presoji iz
the initial assessment report provided for under
in za katere
and in relation to which
se v skladu
an additional assessment report is required in accordance with
Kadar se od znanstvenega odbora 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.
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.
Uredba (ES) št. 882/2004 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 (UL L 165, 30.4.2004, str.
Regulation (EC) 882/2004 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 (OJ L 165, 30.4.2004, p.
Uporabljajo se zahteve glede higiene živil, ki jih določa Uredba (ES) št. 852/2004 Uredba (ES) št. 852/2004 Evropskega parlamenta in Sveta z dne 29. aprila 2004 o higieni živil (UL L 139, 30.4.2004, str.
Requirements in respect of the hygiene of foodstuffs as laid down in Regulation (EC) No 852/2004 Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p.
Ker ciljev te uredbe, in sicer določitev usklajenih pravil za dajanje novih živil na trg v Uniji, države članice ne morejo zadovoljivo doseči in ker te cilje lažje doseže Unija, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 Pogodbe o Evropski uniji.
Since the objective of this Regulation, namely laying down harmonised rules for the placing of novel foods on the market within the Union, cannot be sufficiently achieved by the Member States and can therefore be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union.
V skladu z načelom sorazmernosti, določenim v navedenem členu, ta uredba ne presega tistega, kar je potrebno za dosego navedenega cilja.
In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective.
Države članice bi morale določiti pravila o kaznih, ki se uporabljajo za kršitve določb te uredbe, in bi morale sprejeti vse potrebne ukrepe za njihovo izvajanje.
The Member States should lay down the rules on penalties applicable to infringements of the provisions of this Regulation and should take all measures necessary to ensure that they are implemented.
▌ 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
▌The Commission should be empowered to adopt delegated acts in accordance with Article 290 TFEU 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
. ▌Zlasti je pomembno, da ▌Komisija
It is of particular importance that the Commission
Ta uredba določa usklajena pravila za dajanje novih živil na trg v
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
, zdravja in dobrega počutja živali, varstva okolja
animal health and welfare, the environment and the interests of consumers
in koristi potrošnikov ter hkrati
whilst ensuring
preglednost in
transparency and
učinkovito delovanje notranjega trga
the effective functioning of the internal market
ter spodbujanje inovacij v kmetijsko-živilskem sektorju
and stimulating innovation within the agri-food industry
Ta uredba se uporablja za dajanje novih živil na trg v Uniji.
This Regulation shall apply to the placing of novel foods on the market within the Union.
živila, ki se uporabljajo in dokler se uporabljajo kot:
foods when and in so far as they are used as:
aditivi za živila, ki sodijo na področje uporabe Uredbe (ES) št. 1333/2008;
food additives falling within the scope of Regulation (EC) No 1333/2008;
arome za živila, ki sodijo na področje uporabe Uredbe (ES) št. 1334/2008;
food flavourings falling within the scope of Regulation (EC) No 1334/2008;
ekstrakcijska topila, ki se uporabljajo pri proizvodnji živil in sodijo na področje uporabe Direktive 2009/32/ES;
extraction solvents used in the production of foodstuffs and falling within the scope of Directive 2009/32/EC;
encimi za živila, ki sodijo na področje uporabe Uredbe (ES) št. 1332/2008;
food enzymes falling within the scope of Regulation (EC) No 1332/2008;
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;
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 such production methods or new sources give rise to significant changes referred to in point (iii) of Article 3(2)(a) of this Regulation;
UL: prosimo, vstavite datum: šest mesecev po dnevu začetka veljavnosti te uredbe.
OJ: Please insert date: Six months after the date of entry into force of this Regulation.
predloži zakonodajni predlog za prepoved, da se na trg Unije dajo živila, pridobljena iz kloniranih živali in njihovih potomcev
, the Commission shall present a legislative proposal to prohibit the placing on the market in the Union of foods derived from cloned animals and their descendants.
Komisija lahko po potrebi in ob upoštevanju področja uporabe, določenega v tem členu, sprejme delegirane akte v skladu s členom 20 in pod pogoji iz členov 21 in 22 ter tako določi, ali vrsta živila sodi na področje uporabe te uredbe.
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 20 and subject to the conditions of Articles 21 and 22, whether a type of food falls within the scope of this Regulation.
V tej uredbi se uporabljajo opredelitve pojmov, določene v Uredbi (ES) št. 178/2002.
For the purposes of this Regulation, the definitions laid down in Regulation (EC) No 178/2002 shall apply.
„novo živilo“ pomeni ▌:
‘novel food’ means ▌:
pred 15. majem 1997 ▌;
Union before 15 May 1997 ▌;
ali živalskega
food of plant
in živali
or animal
uporabljajo netradicionalne tehnike gojenja, ki se pred 15. majem 1997
origin when a non-traditional breeding technique not used ▌before 15 May 1997
, razen živil, pridobljenih iz kloniranih živali in njihovih potomcev
is applied to the plant or animal, with the exception of foods derived from cloned animals and their descendants
živili, za katere se uporablja nov proizvodni postopek, ki se pred 15. majem 1997 ni uporabljal za proizvodnjo živil v Uniji, če navedeni proizvodni postopek pomeni pomembne spremembe v sestavi ali strukturi živila, ki vplivajo na njegovo hranilno vrednost, način njegove presnove ali raven neželenih snovi;
food to which a new production process not used for food production within the Union before 15 May 1997 is applied, if that production process 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;
živili, ki vsebujejo namensko proizvedene nanomateriale ali so iz njih sestavljena.
food containing or consisting of engineered nanomaterials;
„namensko proizvedeni nanomaterial“ pomeni namenoma proizveden material, pri katerem je velikost ene ali več dimenzij 100 nm ali manj ali ki je v notranjosti ali na površini sestavljen iz ločenih funkcionalnih delov, številni od njih pa imajo eno ali več dimenzij v velikosti 100 nm ali manj, vključno s strukturami, aglomerati ali agregati, katerih velikost lahko presega 100 nm, vendar pa ohranijo lastnosti, značilne za nanomerilo.
‘engineered nanomaterial’ means any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale.
lastnosti v zvezi z veliko specifično površino zadevnih materialov; in/ali
those properties related to the large specific surface area of the materials considered; and/or
posebne fizikalno-kemijske lastnosti, ki se razlikujejo od lastnosti enakega materiala, ki nima nanooblike;
specific physico-chemical properties that are different from those of the non-nanoform of the same material;
„klonirane živali“ pomenijo živali, proizvedene z nespolno, umetno metodo razmnoževanja z namenom proizvodnje genetsko identičnih ali skoraj identičnih kopij posamezne živali;
‘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;
„potomci kloniranih živali“ pomenijo živali, proizvedene s spolnim razmnoževanjem, pri čemer je vsaj eden od staršev klonirana žival;
‘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;
„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.
‘’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.
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 20 in pod pogoji iz členov 21 in 22 prilagodi točko (b) 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 (b) 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 20 and subject to the conditions of Articles 21 and 22
Komisija zbira informacije od držav članic in/ali nosilcev
The Commission shall collect information from the Member States and/or from
živilske dejavnosti
food business operators
ali druge zainteresirane strani, da določi, ali živilo sodi na področje
or any other interested party to determine whether a food falls within
uporabe te uredbe.
the scope of this Regulation.
Komisija objavi te podatke in zaključke na podlagi zbranih podatkov in podatkov, ki niso zaupne narave in ki podpirajo zaključke
The Commission shall publish those data and the conclusions drawn from the data collection and the non-confidential data supporting it
Komisija za zagotovitev celovitosti informacij o razvrstitvi novega živila najpozneje ...
In order to ensure the completeness of information regarding the classification of novel foods, the Commission shall, not later than ...
UL: prosimo vstavite datum: šest mesecev po datumu začetka veljavnosti te udredbe.
OJ: Please insert date: Six months after the date of entry into force of this Regulation.
z delegiranimi akti v skladu s členom 20 in pod pogoji iz členov 21 in 22 sprejme pravila za nadaljnje ukrepanje v primerih, kjer nima informacij o uporabi živila za prehrano ljudi pred 15. majem 1997
, adopt rules on how to proceed in cases in which the Commission has no information about the use of a food for human consumption before 15 May 1997 by means of delegated acts in accordance with Article 20 and subject to the conditions of Articles 21 and 22
Komisija lahko
The Commission may adopt
Na trg se lahko dajo le nova živila, ki so uvrščena na seznam Unije za nova živila (v nadaljnjem besedilu „seznam Unije“).
Only novel foods included in the Union list of novel foods (‘'the Union list'’) may be placed on the market.
Zahteve za dajanje novih živil na trg v Skupnosti
Requirements for placing novel foods on the market within the Union
na trg, če niso skladna
if they do
z določbami
not comply with
Splošni pogoji za vključitev novih živil na seznama Unije
General conditions for inclusion of novel foods in the Union list
Novo živilo se lahko vključi na ustrezni seznam Unije le, če izpolnjuje naslednje pogoje:
A novel food may be included in the Union list only if it meets the following conditions:
na podlagi razpoložljivih znanstvenih dokazov ne pomeni tveganja za zdravje potrošnika
it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer
in živali, kar pomeni, da se bodo pri oceni tveganja upoštevali kumulativni in sinergijski učinki ter možni negativni učinki na posebne skupine prebivalstva
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
ne zavaja potrošnika;
it does not mislead the consumer;
v primeru, da je namenjeno nadomestitvi drugega živila, se od slednjega ne razlikuje tako, da bi bila njegova običajna poraba za potrošnika hranilno manj ugodna
if 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
pri obvladovanju tveganja se upošteva mnenje znanstvenega odbora o škodljivem vplivu proizvodnega postopka in običajne uporabe na okolje, ki je objavljeno najpozneje na dan objave ocene, ki jo izvede znanstveni odbor;
the opinion of the European Environment Agency, which shall be published no later than the day of the publication of the Authority's assessment, concerning the extent to which the production process and normal consumption have a harmful impact on the environment, is taken into account in the risk assessment;
pri oceni tveganja se upošteva mnenje evropske skupine za etiko v znanosti in novih tehnologijah o morebitnih etičnih zadržkih, ki je objavljeno najpozneje na dan objave ocene, ki jo izvede znanstveni odbor;
the opinion of the European Group on Ethics in Science and New Technologies, which shall be published no later than the day of the publication of the Authority's assessment, concerning the extent to which there are ethical objections, is taken into account in the risk assessment;
v primeru, da ni pridobljeno iz kloniranih živali ali njihovih potomcev;
it is not derived from a cloned animal or its descendants;
če je potrebno zaradi varne uporabe, se določi najvišja stopnja vnosa novega živila kot takega ali kot del drugega živila ali kategorije živil;
maximum intake levels of the novel food as such or as part of another foodstuff or categories of foodstuffs will be laid down, where required in the interests of safe use;
ocenjeni so kumulativni učinki novih živil, uporabljenih v različnih živilih ali kategorijah živil
cumulative effects of novel foods that are used in different foodstuffs or categories of foodstuffs have been assessed
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 Unije, dokler znanstveni odbor teh posebnih metod ne odobri za uporabo in se na njihovi podlagi 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 (for example, foods produced using nanotechnologies) may not be included in the Union list until such specific methods have been approved by the Authority for use, and an adequate safety assessment on the basis of those methods has shown that the use of the respective foods is safe.
Vsebina seznama Unije
Content of the Union list
seznam Unije ▌posodablja v skladu s postopkom iz Uredbe (ES) št. 1331/2008
Union list,
, med drugim tudi v primeru varstva podatkov iz člena 14
inter alia in cases of data protection referred to in Article 14,
Z odstopanjem od odstavkov 4 do 6 člena 7 Uredbe (ES) št. 1331/2008 se uredba o posodobitvi seznama Unije sprejme z delegiranimi akti v skladu s členom 20 in pod pogoji iz členov 21 in 22.
By way of derogation from paragraphs 4 to 6 of Article 7 of Regulation (EC) No 1331/2008, the Regulation updating the Union list shall be adopted by means of delegated acts in accordance with Article 20 and subject to the conditions of Articles 21 and 22.
Komisija seznam Unije objavi na posebni strani svojega spletišča.
The Commission shall publish the Union list on a dedicated page of its website.
Pri vnosu novega živila na seznam Unije se navede
The entry of a novel food in the Union list shall include
specifikacija živila
a specification of the food
predvidena uporaba živila;
the intended use of the food;
pogoji uporabe
the conditions of use
po potrebi dodatne posebne zahteve za označevanje zaradi obveščanja končnega potrošnika;
where appropriate, additional specific labelling requirements to inform the final consumer;
datum vnosa novega živila na seznam Unije in datum prejema zahtevka;
the date of entry of the novel food in the Union list and the date of receipt of the application;
ime in naslov predlagatelja;
the name and address of the applicant;
datum in rezultati zadnjega inšpekcijskega pregleda v skladu z zahtevami za spremljanje iz člena 12;
the date and results of the last inspection according to the monitoring requirements laid down in Article 12;
dejstvo, da vnos temelji na novih znanstvenih dokazih in/ali pravno zaščitenih podatkih, zaščitenih v skladu s členom 14;
the fact that the entry is based on newly developed scientific evidence and/or proprietary data protected in accordance with Article 14;
dejstvo, da lahko novo živilo da na trg samo predlagatelj iz točke (f), razen če poznejši predlagatelj pridobi odobritev za živilo ne glede na pravno zaščitene podatke prvotnega predlagatelja
the fact that the novel food may only be placed on the market by the applicant specified in point (f), unless a subsequent applicant obtains authorisation for the food without prejudice to the proprietary data of the original applicant
Imenu take sestavine sledi beseda „nano“ v oklepaju.
The names of such ingredients shall be followed by the word ‘nano’ in brackets.