natgillin/translations-raw huggingface dataset:
bi bilo treba uporabljati povsod, kjer bi se proizvod ob upoštevanju vseh njegovih značilnosti lahko opredelil kot "zdravilo" ali kot proizvod, katerega uporabo ureja druga zakonodaja Skupnosti.
should apply where, taking into account all its characteristics, a product may fall both within the definition of "medicinal product" and within the definition of a product covered by other Community legislation.
Če država članica v skladu z Direktivo 2001/83/ES ugotovi, da je proizvod zdravilo, lahko skladno z zakonodajo Skupnosti omeji dajanje tovrstnega proizvoda na trg.
In this respect, a Member State may, where it establishes in accordance with Directive 2001/83/EC that a substance is a medicinal product, restrict the placing on the market of such a product in accordance with Community law.
Nova živila, odobrena na podlagi Uredbe (ES) št. 258/97 morajo ohraniti njihov status novih živil, vendar je treba za kakršno koli nove uporabe takih živil zahtevati odobritev.
Novel foods authorised under ║Regulation (EC) No 258/97 should maintain their novel food status but authorisation should be required for any new uses of such foods.
, če so ta živila zajeta v oceno varnosti in odobritev v skladu z drugo zakonodajo Skupnosti
as long as these foods are covered by a safety evaluation and approval according to other Community legislation
Zato, živila, ki se uporabljajo izključno kot aditivi in spadajo na področje uporabe Uredbe (ES) št.
Therefore, food used solely as additives falling within the scope of Regulation (EC) No
1333/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o aditivih za živila
1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives
L 354, 31.12.2008, str.
L 354, 31.12.2008, p.
, ekstrakcijska topila, ki spadajo na področje uporabe Direktive Sveta 88/344/EGS z dne 13. junija 1988 o približevanju zakonodaje držav članic na področju ekstrakcijskih topil, ki se uporabljajo pri proizvodnji živil in njihovih sestavin UL L 157, 24.6.1988, str.
, extraction solvents falling within the scope of Council Directive 88/344/EEC of 13 June 1988 on the approximation of the laws of the Member States on extraction solvents used in the production of foodstuffs and food ingredients OJ L 157, 24.6.1988, p.
, encimi, ki spadajo na področje uporabe Uredbe (ES) št.
, enzymes falling within the scope of Regulation (EC) No
1332/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o encimih za živila
1332/2008 of the European Parliament and of the Council of 16 December 2008 on food enzymes
, in gensko spremenjena živila, ki spadajo na področje uporabe Uredbe (ES) št. 1829/2003 Evropskega Parlamenta in Sveta z dne 22. septembra 2003 o gensko spremenjenih živilih in krmi UL L 268, 18.10.2003, str.
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 OJ L 268, 18.10.2003, p.
, je treba izključiti iz področja uporabe te uredbe.
should be excluded from the scope of this Regulation.
Uporaba vitaminov in mineralov se ureja s posebnimi sektorskimi živilskimi zakonodajami.
The use of vitamins and minerals is governed by specific sectoral food laws.
, Direktive 2002/46/ES in Uredbe (ES) št. 1925/2006 Evropskega Parlamenta in Sveta z dne 20. decembra 2006 o dodajanju vitaminov, mineralov in nekaterih drugih snovi živilom UL L 404, 30.12.2006, str.
, Directive 2002/46/EC║ and Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods OJ L 404, 30.12.2006, p.
, je zato treba izključiti iz področja uporabe te uredbe.
should therefore be excluded from the scope of this Regulation.
Nova živila, razen vitaminov in mineralov, namenjena za posebne prehranske namene, za bogatenje živil ali kot prehranska dopolnila, je treba oceniti v skladu z merili varnosti in zahtevami, ki se uporabljajo za vsa nova živila.
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 se za njih še naprej uporabljajo pravila, določena v Direktivi 89/398/EGS in posebnih direktivah iz člena 4(1) Direktive ter v Prilogi I k Direktivi, v Direktivi 2002/46/ES in v Uredbi (ES) št. 1925/2006.
At the same time they should remain subject to the rules provided for in Directive 89/398/EEC and in the specific Directives referred to in Article 4(1) thereof and in Annex I thereof, in Directive 2002/46/EC and in Regulation (EC) No 1925/2006.
uvesti enostaven in pregleden postopek za
a simple and transparent procedure for
države članice.
The Member States
Nova živila se lahko dajo na trg v Skupnosti le, če so varna in ne zavajajo potrošnika.
Novel foods should be placed on the Community market only if they are safe and do not mislead the consumer.
Za oceno varnosti in odobritev je treba uporabiti usklajen, centraliziran postopek, ki je učinkovit, časovno omejen in pregleden.
It is necessary to apply a harmonised centralised procedure for safety assessment and authorisation that is efficient, time-limited and transparent.
Glede nadaljnjega usklajevanja različnih postopkov odobritve živil, je treba izvesti oceno varnosti novih živil in njihovo uvrstitev na seznam Skupnosti v skladu s postopkom iz Uredbe (ES) št.
With a view to further harmonising different authorisation procedures of food, the safety assessment of novel foods and their inclusion in the Community list should be carried out in accordance with the procedure laid down in Regulation (EC) No
Evropskega parlamenta in Sveta z dne
of the European Parliament and of the Council of
16. decembra 2008
16 December 2008
Zaradi preprečevanja poskusov na živalih bi bilo treba poskuse na vretenčarjih za namene te uredbe izvajati samo kot skrajni ukrep.
In order to avoid animal testing, testing on vertebrate animals for the purposes of this Regulation should be undertaken only as a last resort.
V skladu z Direktivo Sveta 86/609/EGS z dne 24. novembra 1986 o približevanju zakonov in drugih predpisov držav članic o varstvu živali, ki se uporabljajo za preskusne in druge znanstvene namene
Moreover, in accordance with Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes
UL L 358, 18.12.1986, str.
OJ L 358, 18.12.1986, p.
, je treba tudi poskuse na vretenčarjih nadomestiti, omejiti ali izpopolniti.
, tests on vertebrate animals must be replaced, restricted or refined.
Izvajanje te uredbe bi moralo, kolikor je mogoče, temeljiti na uporabi ustreznih alternativnih poskusnih metod.
Implementation of this Regulation should, where possible, be based on the use of appropriate alternative testing methods.
Komisija bi morala najpozneje sedem let po začetku veljavnosti te uredbe ponovno pregledati pravila o varstvu podatkov za rezultate poskusov na vretenčarjih in pravila po potrebi spremeniti.
Not later than seven years after the entry into force of this Regulation., the Commission should review the rules on the data protection of results from tests on vertebrate animals and, where necessary, change those rules.
Določiti je treba tudi merila za oceno možnih tveganj, ki jih povzročajo nova živila.
Criteria for the evaluation of the potential risks arising from novel foods should also be laid down.
V postopku odobritve bi bilo treba kot del ocene tveganja upoštevati etične in okoljske vidike.
Ethical and environmental aspects must be considered as part of the risk assessment during the authorisation procedure.
Da bi se poenostavili postopki, je treba vložnikom zahtevkov dovoliti, da predložijo en sam zahtevek za živila, ki se urejajo z različnimi sektorskimi živilskimi zakonodajami.
In order to simplify procedures, applicants should be allowed to present a single application for foods regulated under different sectoral food laws.
je zato treba ustrezno spremeniti.
should therefore be amended accordingly.
Po potrebi in na podlagi sklepov ocene varnosti je treba uvesti zahteve za spremljanje uporabe novih živil za prehrano ljudi po dajanju 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.
Uvrstitev novih živil na seznam Skupnosti novih živil ne sme posegati v možnost ocenjevanja učinkov na splošno uživanje snovi, ki je dodana navedenemu živilu ali se uporablja za njegovo proizvodnjo, ali v primerljiv proizvod v skladu s členom 8 Uredbe (ES) št. 1925/2006.
The inclusion of a novel food in the Community 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.
Nova živila so predmet splošnih zahtev označevanja iz Direktive 2000/13/ES Evropskega parlamenta in Sveta z dne 20. marca 2000 o približevanju zakonodaje držav članic o označevanju, predstavljanju in oglaševanju živil UL L 109, 6.5.2000, str.
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 OJ L 109, 6.5.2000, p.
Uredba (ES) št. 1924/2006 Evropskega Parlamenta in Sveta z dne 20. decembra 2006 o prehranskih in zdravstvenih trditvah na živilih UL L 404, 30.12.2006, str.
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 OJ L 404, 30.12.2006, p.
usklajuje določbe v državah članicah v zvezi s prehranskimi in zdravstvenimi trditvami.
harmonises the provisions in the Member States which relate to nutrition and health claims.
Če namerava vložnik 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 podatkov, ki so predmet lastninske pravice, obdobja varstva podatkov zanju začnejo in nato tečejo hkrati, če vložnik 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.
Glede ocene varnosti in upravljanja tradicionalnih živil iz tretjih držav je treba upoštevati pretekle izkušnje njihove varne uporabe v tretji državi porekla.
As regards the safety assessment and management of traditional food from third countries, their history of safe use in the third country of origin should be taken into account.
Če države članice
If Member States
agencija niso predložili nobenih utemeljenih pripomb glede varnosti na podlagi znanstvenih dokazov, na primer podatkov o škodljivih učinkih na zdravje,
the Authority have not presented any reasoned safety objections, based on scientific evidence, for example information on adverse health effects, it
posvetovanje z evropsko skupino za etiko v znanosti in novih tehnologijah
The European Group on Ethics in Science and New Technologies
, ustanovljeno s Sklepom Komisije z dne 16. decembra 1997
established by Commission Decision of 16 December 1997
, z namenom pridobiti nasvet o etičnih vprašanjih
with a view to obtaining advice on ethical issues regarding
o uporabi novih tehnologij in dajanju
the use of new technologies and
na trg novih živil.
the placing on the market of novel foods.
Nadaljevati je treba dajanje na trg novih živil, ki so se dajala na trg v Skupnosti na podlagi Uredbe (ES) št. 258/97.
Novel foods placed on the Community market under Regulation (EC) No 258/97 should continue to be placed on the market.
Poleg tega je treba zahtevke, predložene na podlagi Uredbe (ES) št. 258/97
In addition, applications submitted under Regulation (EC) No 258/97,
poročilo o začetni presoji na podlagi člena 6(3) te uredbe ni bilo posredovano Komisiji in za katere je potrebno dodatno poročilo o presoji v skladu s členom 6(3) ali (4) navedene uredbe
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
pred začetkom uporabe
before the date of application of
uredbe, šteti za
Regulation, should be considered as
na podlagi te uredbe.
under this Regulation.
Druge zahteve, predložene v skladu s členom 4 Uredbe (ES) št. 258/97 pred datumom začetka uporabe te uredbe, se obravnavajo 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.
Ker države članice ne morejo doseči ciljev predvidenih ukrepov, ki so zato laže dosegljivi na ravni Skupnosti, lahko Skupnost sprejme ukrepe v skladu z načelom subsidiarnosti, kakor določa člen 5 Pogodbe.
Since the objectives of the action to be taken cannot be achieved by the Member States and can therefore be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty.
V skladu z načelom sorazmernosti, določenim v navedenem členu, ta uredba ne presega tistega, kar je potrebno za dosego navedenih ciljev.
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.
Države članice morajo določiti pravila o kaznih, ki se uporabljajo za kršitve določb te uredbe, in morajo sprejeti vse potrebne ukrepe, da se zagotovi 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.
Zlasti je treba Komisiji podeliti pooblastila za uvedbo meril, na podlagi katerih se živila lahko štejejo, da se uporabljajo v pomembnem obsegu za prehrano ljudi v Skupnosti pred 15. majem 1997.
In particular, power should be conferred on the Commission to establish the criteria under which foods may be considered as having been used for human consumption to a significant degree within the Community before 15 May 1997.
Ker so navedeni ukrepi splošnega obsega in so namenjeni dopolnitvi te uredbe z dodajanjem novih nebistvenih določb, bi jih bilo treba sprejeti v skladu z regulativnim postopkom s pregledom iz člena 5a Sklepa 1999/468/ES.
Since those measures are of general scope and are designed to supplement this Regulation by the addition of new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.
določa splošna pravila o izvajanju uradnega nadzora za preverjanje skladnosti z zakonodajo o živilih.
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
Therefore, ║Member States are to carry out official controls in accordance with Regulation (EC) No 882/2004, in order to enforce compliance with
Uvodne določbe
Introductory provisions
zdravja in dobrega počutja živali, varstva okolja in interesov potrošnikov
animal health and welfare, the environment and the interests of consumers
, ob hkratnem zagotavljanju
whilst ensuring
preglednosti in
transparency and
nemotenega delovanja notranjega trga
the effective functioning of the internal market
ter spodbujanju inovacij v kmetijsko-živilskem sektorju
and stimulating innovation within the agri-food industry
Ta uredba se
This Regulation shall,
, razen če ni določeno drugače,
unless otherwise provided for,
ne uporablja za:
not apply to:
živila, ki se uporabljajo in dokler se uporabljajo kot:
foods when and insofar as they are used as:
aditivi za živila, ki spadajo na področje uporabe Uredbe (ES) št.
food additives falling within the scope of Regulation (EC) No
arome za živila, ki spadajo na področje uporabe Uredbe (ES) št.
food flavourings falling within the scope of Regulation (EC) No
ekstrakcijska topila, ki se uporabljajo pri proizvodnji živil in spadajo na področje uporabe Direktive 88/344/EGS;
extraction solvents used in the production of foodstuffs and falling within the scope of ║ Directive 88/344/EEC;
živilski encimi, ki spadajo na področje uporabe Uredbe (ES) št.
food enzymes falling within scope of Regulation (EC) No
vitamini in minerali, ki spadajo na področje uporabe Direktive 89/398/EGS, Direktive 2002/46/ES ali Uredbe (ES) št. 1925/2006,
vitamins and minerals falling within the scope of Directive 89/398/EEC, Directive 2002/46/EC or Regulation (EC) No 1925/2006,
živila, pridobljena iz kloniranih živali in njihovih potomcev.
foods derived from cloned animals and their descendants.
Komisija predloži zakonodajni predlog za prepoved, da se na trg Skupnosti 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 Community of foods derived from cloned animals and their descendants.
Ne glede na odstavek 2 se ta uredba uporablja za aditive za živila, živalske encime, arome in določene živilske sestavine, za katere se uporablja nov proizvodni postopek, ki se ni uporabljal pred 15. majem 1997, ki povzroča bistvene spremembe v sestavi ali strukturi živil, kot so proizvedeni nano materiali.
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.
postopku iz
referred to in
člena 20(3)
Article 20(3)
določi, ali vrsta živila sodi na področje uporabe te uredbe.
whether a type of food falls within the scope of this Regulation.
Kadar lahko novo živilo na človeško telo učinkuje podobno kot zdravilo, Komisija za mnenje zaprosi Evropsko agencijo za zdravila (EMEA), ali živilo sodi pod Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta
Where a novel food is capable of having an effect on the human body comparable to that of a medicinal product, the Commission shall 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
Za potrebe te uredbe se uporabljajo opredelitve, 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.
živilo rastlinskega in živalskega izvora, če se za rastline in živali uporabljajo netradicionalne tehnike gojenja, ki se niso uporabljale pred 15. majem 1997
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
, razen živil, pridobljenih iz kloniranih živali in njihovih potomcev
, with the exception of foods derived from cloned animals and their descendants
živilo, za katerega se
food to which
živilo, ki vsebuje namensko proizvedene nanomateriale, ki se pred 15. majem 1997 v Skupnosti niso uporabljali za proizvodnjo živil, ali je iz njih sestavljeno.
food containing or consisting of engineered nanomaterials not used for food production within the Community before 15 May 1997.
Uporaba živila izključno kot prehransko dopolnilo ali v prehranskem dopolnilu ne zadostuje za dokazilo o tem, ali se je živilo v pomembnem obsegu uporabljalo za prehrano ljudi v Skupnosti pred 15. majem 1997.
The use of a food exclusively as, or in, a food supplement shall not be sufficient to show whether it was used for human consumption to a significant degree within the Community before 15 May 1997.
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 Skupnosti za isto uporabo in ne šteje za novo živilo.
However, where a food was used exclusively as, or in, a food supplement prior to that date, it may be placed on the Community market after that date for the same use without being considered as a novel food.
Nadaljnja merila za ocenjevanje, ali so se živila uporabljala v pomembnem obsegu za prehrano ljudi v Skupnosti pred 15. majem 1997, ki so oblikovana za spremembo nebistvenih elementov te uredbe, med drugim z njeno dopolnitvijo, se lahko sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 20(3);
Further criteria for assessing if a food was used for human consumption to a significant degree within the Community before 15 May 1997, which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it, may be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20(3);
novo živilo s preteklimi izkušnjami glede uporabe živila v tretji državi, kar pomeni, da je zadevno živilo bilo in je še naprej običajna prehrana
novel food with a history of food use in a third country, meaning that the food in question has been
že vsaj 30 let
for at least 30 years
"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;
"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 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 to the nanoscale.
lastnosti v zvezi s specifično veliko površino zadevnih materialov in/ali
those 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.