natgillin/translations-raw huggingface dataset:
In accordance with Directive 2010/63/EU of the European Parliament and of the Council [17], tests on animals should be replaced, reduced or refined.
V nekaterih primerih bi bilo morda treba navesti dodatne informacije pri označevanju, zlasti glede opisa živila, njegovega vira, sestave ali pogojev predvidene uporabe, da bi zagotovili ustrezno obveščenost potrošnikov o vrsti in varnosti novega živila, zlasti kar zadeva ranljive skupine prebivalstva.
Therefore, within the scope of this Regulation, duplication of animal testing should be avoided, where possible.
Za materiale in izdelke, namenjene za stik z novimi živili, velja Uredba (ES) št. 1935/2004 Evropskega parlamenta in Sveta [18] in posebni ukrepi, sprejeti na njeni podlagi.
Pursuing this goal could reduce possible animal welfare and ethical concerns with regard to novel food applications.
Komisija bi morala v skladu s svojo politiko boljšega pravnega urejanja naknadno oceniti izvajanje te uredbe, zlasti nove postopke za tradicionalna živila iz tretjih držav.
Novel foods are subject to the general labelling requirements laid down in Regulation (EU) No 1169/2011 and other relevant labelling requirements in Union food law.
Za vloge, ki so bile vložene v skladu z Uredbo (ES) št. 258/97 in o katerih pred datumom začetka uporabe te uredbe še ni bila sprejeta dokončna odločitev, bi bilo treba izvesti postopke ocene tveganja in odobritve v skladu s to uredbo.
In certain cases it may be necessary to provide for additional labelling information, in particular regarding the description of the food, its source, its composition or its conditions of intended use to ensure that consumers are sufficiently informed of the nature and safety of the novel food, particularly with regard to vulnerable groups of the population.
Za živilo, ki ne spada na področje uporabe Uredbe (ES) št. 258/97 in je bilo pred datumom začetka uporabe te uredbe že zakonito dano na trg in spada na področje uporabe te uredbe, bi moralo biti načeloma dovoljeno, da še naprej ostane na trgu do zaključka postopkov ocene tveganja in odobritve po tej uredbi.
Materials and articles intended to come into contact with novel foods are subject to Regulation (EC) No 1935/2004 of the European Parliament and of the Council [18] and the specific measures adopted thereunder.
Zato bi bilo treba za zagotovitev nemotenega prehoda na pravila iz te uredbe določiti prehodne določbe.
In line with the Commission's better regulation policy, the Commission should carry out an ex-post evaluation of the implementation of this Regulation, addressing in particular the new procedures on traditional foods from third countries.
Ta uredba spoštuje temeljne pravice in upošteva načela, priznana zlasti z Listino Evropske unije o temeljnih pravicah.
For those applications which have been submitted under Regulation (EC) No 258/97 and for which a final decision has not been taken before the date of application of this Regulation risk assessment and authorisation procedures should be concluded in accordance with this Regulation.
Države članice bi morale določiti pravila za kazni, ki veljajo za kršitve te uredbe, in z ustreznimi ukrepi zagotoviti, da se bodo izvajale.
Furthermore, a food not falling within the scope of Regulation (EC) No 258/97, which was lawfully placed on the market before the date of application of this Regulation and which falls under the scope of this Regulation, should in principle be allowed to continue to be placed on the market until the risk assessment and authorisation procedures under this Regulation have been concluded.
Kazni bi morale biti učinkovite, sorazmerne in odvračilne.
Therefore, transitional provisions should be laid down to ensure a smooth transition to the rules of this Regulation.
Da se dosežejo cilji te uredbe, bi bilo treba na Komisijo prenesti pooblastila, da v skladu s členom 290 Pogodbe o delovanju Evropske unije sprejme akte v zvezi s prilagoditvijo opredelitve namensko proizvedenega nanomateriala tehničnemu in znanstvenemu napredku oziroma mednarodno dogovorjenim opredelitvam.
This Regulation respects the fundamental rights and observes the principles recognised, in particular, by the Charter of Fundamental Rights of the European Union.
Zlasti pomembno je, da se Komisija pri svojem pripravljalnem delu ustrezno posvetuje, tudi na ravni strokovnjakov.
The Member States should lay down rules on penalties applicable to infringements of this Regulation and should take all measures necessary to ensure that they are implemented.
Komisija bi morala pri pripravi in oblikovanju delegiranih aktov zagotoviti, da se zadevni dokumenti posredujejo Evropskemu parlamentu in Svetu sočasno, pravočasno in na ustrezen način.
Those penalties should be effective, proportionate and dissuasive.
Za zagotovitev enotnih pogojev za izvajanje te uredbe v zvezi s posodabljanjem seznama Unije zaradi dodajanja tradicionalnih živil iz tretjih držav, pri katerih ni utemeljenih pripomb glede varnosti, bi bilo treba na Komisijo prenesti izvedbena pooblastila.
In order to achieve the objectives of this Regulation, the power to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the adjustment and adaptation of the definition of engineered nanomaterial to technical and scientific progress or to definitions agreed at international level.
Za sprejetje izvedbenega akta za oblikovanje prvotnega seznama Unije bi bilo treba uporabiti svetovalni postopek, saj bodo na seznamu samo nova živila, ki so že ocenjena kot varna, se zakonito proizvajajo in tržijo v Uniji in so bila doslej zdravstveno neoporečna.
It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level.
V vseh drugih primerih bi bilo treba za sprejetje izvedbenih aktov uporabiti postopek pregleda.
The Commission, when preparing and drawing up delegated acts, should ensure simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.
Ker ciljev te uredbe, to je zlasti določiti pravila za dajanje novih živil na trg v Uniji, države članice ne morejo zadovoljivo doseči, temveč se lažje dosežejo na ravni Unije, lahko Unija sprejme ukrepe v skladu z načelom subsidiarnosti iz člena 5 PEU.
In order to ensure uniform conditions for the implementation of this Regulation with regard to updating the Union list concerning the adding of a traditional food from a third country where no reasoned safety objections have been expressed, implementing powers should be conferred on the Commission.
V skladu z načelom sorazmernosti iz navedenega člena ta uredba ne presega tistega, kar je potrebno za doseganje navedenih ciljev –
The advisory procedure should be used for the adoption of the implementing act establishing the initial Union list given that it will concern only novel foods that have already been assessed for their safety, have been legally produced and marketed in the Union and have not given rise to health concerns in the past.
SPREJELA NASLEDNJO UREDBO:
The examination procedure should be used for the adoption of implementing acts in all other cases.
POGLAVJE I
Since the objectives of this Regulation, in particular the laying down of rules for the placing of novel foods on the market within the Union, cannot be sufficiently achieved by the Member States but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 TEU.
PREDMET UREJANJA, PODROČJE UPORABE IN OPREDELITEV POJMOV
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 those objectives,
Člen 1
HAVE ADOPTED THIS REGULATION:
Predmet urejanja in namen
CHAPTER I
Ta uredba določa pravila za dajanje novih živil na trg v Uniji.
SUBJECT MATTER, SCOPE AND DEFINITIONS
Namen te uredbe je zagotoviti učinkovito delovanje notranjega trga in hkrati visoka raven varovanja zdravja ljudi in interesov potrošnikov.
Subject matter and purpose
Področje uporabe
This Regulation lays down rules for the placing of novel foods on the market within the Union.
Ta uredba se uporablja za dajanje novih živil na trg v Uniji.
The purpose of this Regulation is to ensure the effective functioning of the internal market while providing a high level of protection of human health and consumers' interests.
Ta uredba se ne uporablja za:
Article 2
gensko spremenjena živila, ki spadajo na področje uporabe Uredbe (ES) št. 1829/2003;
Scope
živila, kadar in v kolikor se uporabljajo kot:
This Regulation applies to the placing of novel foods on the market within the Union.
encimi za živila, ki spadajo na področje uporabe Uredbe (ES) št. 1332/2008;
This Regulation does not apply to:
aditivi za živila, ki spadajo na področje uporabe Uredbe (ES) št. 1333/2008;
genetically modified foods falling within the scope of Regulation (EC) No 1829/2003;
arome za živila, ki spadajo na področje uporabe Uredbe (ES) št. 1334/2008;
foods when and in so far as they are used as:
ekstrakcijska topila, ki se uporabljajo pri proizvodnji živil ali sestavin živil ali so namenjena zanjo ter spadajo na področje uporabe Direktive 2009/32/ES;
food enzymes falling within the scope of Regulation (EC) No 1332/2008;
Člen 3
food additives falling within the scope of Regulation (EC) No 1333/2008;
Opredelitev pojmov
food flavourings falling within the scope of Regulation (EC) No 1334/2008;
V tej uredbi se uporabljajo opredelitve iz členov 2 in 3 Uredbe (ES) št. 178/2002.
extraction solvents used or intended to be used in the production of foodstuffs or food ingredients and falling within the scope of Directive 2009/32/EC.
Uporabljajo se tudi naslednje opredelitve:
Article 3
„novo živilo“ pomeni vsako živilo, ki se pred 15. majem 1997 ni v večjem obsegu uporabljalo za prehrano ljudi v Uniji, ne glede na datume pristopa držav članic k Uniji, in spada v vsaj eno od naslednjih kategorij:
Definitions
živilo z novo ali namerno spremenjeno molekularno strukturo, če se ta pred 15. majem 1997 v Uniji ni uporabljala kot živilo ali v živilu;
For the purposes of this Regulation, the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002 apply.
živilo, ki je sestavljeno pridobljeno ali proizvedeno iz mikroorganizmov, gliv ali alg;
The following definitions also apply:
živilo, ki je sestavljeno, pridobljeno ali proizvedeno iz snovi mineralnega izvora;
‘novel food’ means any food that was not used for human consumption to a significant degree within the Union before 15 May 1997, irrespective of the dates of accession of Member States to the Union, and that falls under at least one of the following categories:
živilo, ki je sestavljeno, pridobljeno ali proizvedeno iz rastlin ali njihovih delov, razen če ima to živilo dolgo tradicijo varne uporabe na trgu v Uniji in je sestavljeno, proizvedeno ali pridobljeno iz rastline ali sorte iste rastlinske vrste, pridobljene:
food with a new or intentionally modified molecular structure, where that structure was not used as, or in, a food within the Union before 15 May 1997;
s tradicionalnim razmnoževanjem, ki se je v Uniji za proizvodnjo živil uporabljalo pred 15. majem 1997, ali
food consisting of, isolated from or produced from microorganisms, fungi or algae;
z netradicionalnim razmnoževanjem, ki se v Uniji pred 15. majem 1997 ni uporabljalo za proizvodnjo živil, kadar zaradi tovrstnega razmnoževanja ne pride do večjih sprememb v sestavi ali strukturi živila, ki bi vplivale na njegovo hranilno vrednost, presnovo ali raven neželenih snovi;
food consisting of, isolated from or produced from material of mineral origin;
živilo, ki je sestavljeno, pridobljeno ali proizvedeno iz živali ali njihovih delov, razen če so živali vzrejene na tradicionalen način, ki se je v Uniji uporabljal za proizvodnjo živil pred 15. majem 1997, in ima živilo iz teh živali dolgo tradicijo varne uporabe na trgu v Uniji;
food consisting of, isolated from or produced from plants or their parts, except when the food has a history of safe food use within the Union and is consisting of, isolated from or produced from a plant or a variety of the same species obtained by:
živilo, ki je sestavljeno, pridobljeno ali proizvedeno iz celičnih ali tkivnih kultur iz živali, rastlin, mikroorganizmov, gliv ali alg;
traditional propagating practices which have been used for food production within the Union before 15 May 1997; or
živilo, ki nastane z uporabo postopka proizvodnje, ki se pred 15. majem 1997 ni uporabljal za proizvodnjo živil v Uniji in zaradi katerega se znatno spremeni sestava ali struktura živila, kar vpliva na njegovo hranilno vrednost, presnovo ali raven neželenih snovi;
non-traditional propagating practices which have not been used for food production within the Union before 15 May 1997, where those practices do not give rise to significant changes in the composition or structure of the food affecting its nutritional value, metabolism or level of undesirable substances;
živilo, ki vsebuje namensko proizvedene nanomateriale, kot so opredeljeni v točki (f) tega odstavka;
food consisting of, isolated from or produced from animals or their parts, except for animals obtained by traditional breeding practices which have been used for food production within the Union before 15 May 1997 and the food from those animals has a history of safe food use within the Union;
vitamine, minerale in druge snovi, ki se uporabljajo v skladu z Direktivo 2002/46/ES, Uredbo (ES) št. 1925/2006 ali Uredbo (EU) št. 609/2013, pri čemer:
food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro-organisms, fungi or algae;
je bil uporabljen postopek proizvodnje, ki se v Uniji pred 15. majem 1997 ni uporabljal za proizvodnjo živil, kakor je navedeno v točki (a)(vii) tega odstavka, ali
food resulting from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances;
te snovi vsebujejo namensko proizvedene nanomateriale, kot so opredeljeni točki (f) tega odstavka, ali so iz njih sestavljene;
food consisting of engineered nanomaterials as defined in point (f) of this paragraph;
živilo, ki se je v Uniji pred 15. majem 1997 uporabljalo izključno v prehranskih dopolnilih, kadar je namenjeno uporabi v živilih, ki niso prehranska dopolnila, kot so opredeljena v točki (a) člena 2 Direktive 2002/46/ES;
vitamins, minerals and other substances used in accordance with Directive 2002/46/EC, Regulation (EC) No 1925/2006 or Regulation (EU) No 609/2013, where:
„dolga tradicija varne uporabe živila v tretji državi“ pomeni, da je varnost živila potrjena s podatki o sestavi in z izkušnjami na podlagi neprekinjene uporabe že vsaj 25 let v običajni prehrani znatnega dela prebivalstva vsaj ene tretje države, in sicer pred priglasitvijo iz člena 14;
a production process not used for food production within the Union before 15 May 1997 has been applied as referred to in point (a) (vii) of this paragraph; or
„tradicionalno živilo iz tretje države“ pomeni novo živilo, kakor je opredeljeno v točki (a) tega odstavka, razen novega živila iz točke (a)(i), (iii), (vii), (viii), (ix) in (x) tega odstavka, ki je proizvedeno v primarni pridelavi, kakor je opredeljena v točki 17 člena 3 Uredbe (ES) št. 178/2002, in ima dolgo tradicijo varne uporabe v tretji državi;
they contain or consist of engineered nanomaterials as defined in point (f) of this paragraph;
„vložnik“ pomeni državo članico, tretjo državo ali zainteresirano stran, ki lahko predstavlja več zainteresiranih strani in je Komisiji predložila vlogo v skladu s členom 10 ali 16 ali opravila priglasitev v skladu s členom 14;
food used exclusively in food supplements within the Union before 15 May 1997, where it is intended to be used in foods other than food supplements as defined in point (a) of Article 2 of Directive 2002/46/EC;
„veljavna“ vloga ali priglasitev pomeni vlogo ali priglasitev, ki spada na področje uporabe te uredbe in vsebuje vse informacije, ki so potrebne za oceno tveganja in postopek odobritve;
‘history of safe food use in a third country’ means that the safety of the food in question has been confirmed with compositional data and from experience of continued use for at least 25 years in the customary diet of a significant number of people in at least one third country, prior to a notification referred to in Article 14;
„namensko proizveden nanomaterial“ pomeni vsak namensko proizveden material, ki ima eno ali več dimenzij reda velikosti 100 nm ali manj ali je sestavljen iz ločenih funkcionalnih delov, bodisi znotraj bodisi na površini, od katerih imajo številni eno ali več dimenzij reda velikosti 100 nm ali manj, vključno s strukturami, aglomerati ali agregati, ki so sicer lahko večji od reda velikosti 100 nm, vendar ohranjajo lastnosti, ki so značilne za nanomerilo.
‘traditional food from a third country’ means novel food as defined in point (a) of this paragraph, other than novel food as referred to in points (a) (i), (iii), (vii), (viii), (ix) and (x) thereof which is derived from primary production as defined in point 17 of Article 3 of Regulation (EC) No 178/2002 with a history of safe food use in a third country;
Lastnosti, ki so značilne za nanomerilo, vključujejo:
‘the applicant’ means the Member State, the third country or the interested party, which may represent several interested parties and has submitted to the Commission an application in accordance with Article 10 or 16 or a notification in accordance with Article 14;
lastnosti v zvezi z veliko specifično površino obravnavanih materialov in/ali
‘valid’ in respect to an application or a notification means an application or a notification which falls within the scope of this Regulation and contains the information required for risk assessment and authorisation procedure;
posebne fizično-kemične lastnosti, ki se razlikujejo od lastnosti nenanooblike istega materiala.
‘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.
Člen 4
Properties that are characteristic of the nanoscale include:
Postopek za določitev statusa novega živila
those related to the large specific surface area of the materials considered; and/or
Nosilci živilske dejavnosti preverijo, ali živilo, ki ga nameravajo dati na trg v Uniji, spada na področje uporabe te uredbe.
specific physico-chemical properties that are different from those of the non-nanoform of the same material.
Kadar nosilci živilske dejavnosti niso prepričani, ali živilo, ki ga nameravajo dati na trg v Uniji, spada na področje uporabe te uredbe, se posvetujejo z državo članico, kjer želijo novo živilo najprej dati na trg.
Article 4
Nosilci živilske dejavnosti državi članici zagotovijo potrebne informacije, da ta lahko določi, ali živilo spada na področje uporabe te uredbe.
Procedure for determination of novel food status
Da bi države članice ugotovile, ali živilo spada na področje uporabe te uredbe, se lahko posvetujejo z drugimi državami članicami in Komisijo.
Food business operators shall verify whether or not the food which they intend to place on the market within the Union falls within the scope of this Regulation.
Komisija z izvedbenimi akti določi posamezne stopnje postopka posvetovanja iz odstavkov 2 in 3 tega člena, vključno z roki in načini za zagotovitev javne dostopnosti statusa živila.
Where they are unsure whether or not a food which they intend to place on the market within the Union falls within the scope of this Regulation, food business operators shall consult the Member State where they first intend to place the novel food.
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 30(3).
Food business operators shall provide the necessary information to the Member State to enable it to determine whether or not a food falls within the scope of this Regulation.
Člen 5
In order to determine whether or not a food falls within the scope of this Regulation, Member States may consult the other Member States and the Commission.
Izvedbena pooblastila v zvezi z opredelitvijo novega živila
The Commission shall, by means of implementing acts, specify the procedural steps of the consultation process provided for in paragraphs 2 and 3 of this Article, including deadlines and the means to make the status publicly available.
Komisija lahko na lastno pobudo ali na zahtevo države članice z izvedbenimi akti odloči, ali določeno živilo ustreza opredelitvi novega živila iz točke (a) člena 3(2).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(3).
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 30(3).
Article 5
POGLAVJE II
Implementing power concerning the definition of novel food
ZAHTEVE ZA DAJANJE NOVIH ŽIVIL NA TRG V UNIJI
The Commission may decide, on its own initiative or upon a request by a Member State, by means of implementing acts, whether or not a particular food falls within the definition of novel food, as laid down in point (a) of Article 3(2).
Člen 6
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 30(3).
Seznam Unije z odobrenimi novimi živili
CHAPTER II
Komisija vzpostavi in posodablja seznam Unije z novimi živili, odobrenimi za dajanje na trg v Uniji, v skladu s členi 7, 8 in 9 (v nadaljnjem besedilu: seznam Unije).
REQUIREMENTS FOR PLACING NOVEL FOODS ON THE MARKET WITHIN THE UNION
Le odobrena nova živila, vključena na seznam Unije, se lahko dajo na trg v Uniji kot taka ali se uporabljajo v ali na živilih v skladu s pogoji uporabe in zahtevami za označevanje, navedenimi na seznamu.
Article 6
Člen 7
Union list of authorised novel foods
Splošni pogoji za vključitev novih živil na seznam Unije
The Commission shall establish and update a Union list of novel foods authorised to be placed on the market within the Union in accordance with Articles 7, 8 and 9 (‘the Union list’).
Komisija odobri in vključi na seznam Unije le novo živilo, ki izpolnjuje naslednje pogoje:
Only novel foods authorised and included in the Union list may be placed on the market within the Union as such, or used in or on foods, in accordance with the conditions of use and the labelling requirements specified therein.
živilo na podlagi razpoložljivih znanstvenih dokazov ne ogroža zdravja ljudi;
Article 7
predvidena uporaba živila ne zavaja potrošnika, zlasti kadar naj bi to živilo nadomestilo drugo živilo, njegova hranilna vrednost pa je bistveno spremenjena;
General conditions for inclusion of novel foods in the Union list
kadar naj bi živilo nadomestilo drugo živilo, se od slednjega ne razlikujejo tako, da bi bilo ob običajnem uživanju za potrošnika prehransko manj ugodno.
The Commission shall only authorise and include a novel food in the Union list if it complies with the following conditions:
Člen 8
the food does not, on the basis of the scientific evidence available, pose a safety risk to human health;
Vzpostavitev seznama Unije
the food's intended use does not mislead the consumer, especially when the food is intended to replace another food and there is a significant change in the nutritional value;
Komisija do 1. januarja 2018 z izvedbenim aktom vzpostavi seznam Unije in nanj vključi nova živila, odobrena ali priglašena v skladu s členom 4, 5 ali 7 Uredbe (ES) št. 258/97, po potrebi vključno z morebitnimi pogoji za odobritev.
where the food 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.
Ta izvedbeni akt se sprejme v skladu s svetovalnim postopkom iz člena 30(2).
Initial establishment of the Union list
Vsebina in posodabljanje seznama Unije