natgillin/translations-raw huggingface dataset:
Komisija glede na številne opredelitve nanomaterialov, ki so jih objavili različni organi na mednarodni ravni, ter stalen tehnični in znanstveni razvoj na področju nanotehnologij spremeni točko (f) odstavka 2 v skladu z 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 ( f) of paragraph 2 to technical and scientific progress and with definitions subsequently agreed at international level.
Ta ukrep, namenjen spremembi nebistvenih določb te uredbe se sprejme v skladu z regulativnim postopkom s pregledom iz člena 20(3).
That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20(3).
Zbiranje informacij glede
Collection of information regarding the
razvrstitve novega živila
classification of a novel food
ali druge zainteresirane strani
or any other interested party
, da določi
to determine
ali živilo sodi na področje uporabe te uredbe.
whether a food falls within the scope of this Regulation.
Države članice, nosilci živilske dejavnosti in druge zainteresirane strani Komisiji posredujejo informacije, v
Member States, business operators and other interested parties shall transmit to the Commission information on the
kolikšnem obsegu so je živilo uporabljalo za prehrano ljudi v Skupnosti pred 15. majem 1997.
extent a food has been used for human consumption within the Community before 15 May 1997.
Komisija objavi te podatke in zaključke na podlagi zbranih podatkov in podatkov, ki niso zaupni in podpirajo zaključke.
The Commission shall publish those data and the conclusions drawn from the data collection and the non-confidential data supporting it.
Izvedbeni ukrepi za nadaljnje ukrepanje v primerih, kjer Komisija nima informacij o uporabi za prehrano ljudi pred 15. majem 1997, ki so namenjeni spremembi nebistvenih elementov te uredbe, med drugim z njeno dopolnitvijo, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 20(3) najkasneje
Implementing measures on how to proceed in cases in which the Commission has no information about use for human consumption before 15 May 1997, which are designed to amend non-essential elements of this Regulation, inter alia by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 20 (3) not later than
Zahteve in uvrstitev na Seznam Skupnosti za nova živila
Requirements and inclusion in the Community list of novel foods
Seznami Skupnosti za nova živila
Community list of novel foods
Nova živila se ne dajejo na trg, če njihova uporaba ni v skladu z določbami te uredbe.
Novel foods shall not be placed on the market if they do not comply with the provisions of this Regulation.
Pogoji za uvrstitev na seznam Skupnosti
Conditions for inclusion in the Community list
na podlagi razpoložljivih znanstvenih dokazov uporaba ▌ne pomeni tveganja za zdravje
it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer
▌ ne zavaja potrošnika;
it does not mislead the consumer ▌;
, da bi bila njegova običajna poraba glede hranilne vrednosti škodljiva za potrošnika
that its normal consumption would be nutritionally disadvantageous for the consumer
pri oceni je treba upoštevati mnenje Evropske agencije za okolje glede škodljivega vpliva proizvodnega postopka in običajne uporabe na okolje;
the opinion of the European Environment Agency concerning the extent to which the production process and normal consumption have a harmful impact on the environment shall be taken into account in the assessment;
novo živilo, ki ima lahko kakršne koli negativne učinke na posebne skupine prebivalstva, bo odobreno, če se izvajajo posebni ukrepi za preprečevanje takih negativnih učinkov;
a novel food that may have any adverse effects on particular groups of the population will be authorised only where specific measures preventing such adverse effects have been implemented;
če varna uporaba zahteva, se bo določila najvišja stopnja vnosa novega živila kot takega ali kot del drugega živila ali kategorije živil;
maximum intake levels of a 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 Skupnosti, dokler se te posebne metode ne odobrijo za uporabo in se na podlagi teh metod 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 (e.g. foods produced using nanotechnologies) may not be included in the Community list until such specific methods have been approved for use, and an adequate safety assessment on the basis of those methods has shown that the use of the respective foods is safe.
V primeru dvoma, npr. zaradi nezadostne znanstvene gotovosti ali pomanjkljivih podatkov, se uporabi previdnostno načelo, zadevno živilo pa ne more biti uvrščeno na seznam Skupnosti.
In the event of doubt, due, for example, to insufficient scientific certainty or lack of data, the precautionary principle shall be applied and the food in question shall not be included in the Community list.
Vsebina seznama Skupnosti
Content of the Community list
Seznam Skupnosti se posodobi v skladu s postopkom iz Uredbe (ES) št.
The Community list shall be updated in accordance with the procedure laid down in Regulation (EC) No
specifikacijo živila;
a specification of the food;
predvideno uporabo živila;
the intended use of the food;
datum vnosa novega živila na seznam Skupnosti in datum prejema zahtevka;
the date of entry of the novel food in the Community list and the date of receipt of the application;
ime in naslov vložnika;
the name and address of the applicant;
datum in rezultate zadnjega inšpekcijskega pregleda v skladu z zahtevami za spremljanje iz člena 11;
the date and results of the last inspection according to the monitoring requirements laid down in Article 13;
dejstvo, da vnos temelji na novo razvitih znanstvenih dokazih in/ali lastniških podatkih, zaščitenih v skladu s členom 15;
the fact that the entry is based on newly developed scientific evidence and/or proprietary data protected in accordance with Article 15;
dejstvo, da lahko nova živila da na trg samo vložnik iz točke (e), razen v kolikor kasnejši vložnik pridobi odobritev za živilo, brez sklica na lastninske podatke prvotnega vložnika.
the fact that the novel food may only be placed on the market by the applicant specified in point (e), unless a subsequent applicant obtains authorisation for the food without reference to the proprietary data of the original applicant.
Vsa nova živila, ki so bila odobrena za dajanje na trg, se po petih letih pregledajo in ko je na voljo več znanstvenih dokazov.
All novel foods which have been allowed onto the market shall be reviewed after five years and whenever more scientific evidence becomes available.
V primerih iz člena 2(3) se uporabi enoten postopek ne glede na predhodno uporabo ali odobritev snovi, pri kateri je bil uporabljen standardni postopek.
In the cases referred to in Article 2 (3) the common procedure shall be employed irrespective of the previous use or authorisation of the substance to which a standard production process was applied.
Če novo živilo vsebuje snov, ki lahko ob prekomernem uživanju predstavlja tveganje za zdravje, je treba zanj pridobiti dovoljenje za uporabo v okviru najvišjih vrednosti v določenih živilih ali kategorijah živil.
Where a novel food contains a substance which may pose a risk to human health in the event of excessive consumption, it shall require approval for use within maximum limits in certain foods or food categories.
Imenu take sestavine sledi beseda "nano" v oklepajih.
The names of such ingredients shall be followed by the word 'nano' in brackets.
Proizvodi, proizvedeni iz živali, krmljenih z gensko spremenjeno krmo, morajo biti označeni z besedami "proizvedeno iz živali, krmljenih z gensko spremenjeno krmo".
Products produced from animal fed with genetically modified feeding stuffs must be labelled with the words "produced from animal fed with genetically modified feeding stuffs".
se seznam Skupnosti posodobi, da se spremenijo nebistveni elementi te uredbe v skladu z regulativnim postopkom s pregledom iz
, the Community list shall be updated to amend non-essential elements of this Regulation in accordance with the regulatory procedure with scrutiny referred to in Article
točke (g) odstavka 2
point (g) of paragraph 2
tega člena.
of this Article, are no longer included.
Za namene posodobitve seznama Skupnosti z vnosom novega živila, če novo živilo ni sestavljeno iz živila, za katerega velja varstvo podatkov v skladu s členom 15, ali če ne vsebuje navedenega živila ter:
For the purposes of updating the Community list through entry of a novel food, where the novel food does not consist of or contain food subject to data protection according to Article 15 and:
e novo živilo v sestavi, metabolizmu in ravni neželenih snovi enakovredno obstoječim živilom ali
the novel food is equivalent to existing foods, in composition, metabolism and level of undesirable substances, or
novo živilo vsebuje živilo, predhodno odobreno za uporabo v Skupnosti, ali je iz njega sestavljeno, in kadar se od nove predvidene uporabe lahko pričakuje, da ne bo znatno povečala vnosa pri potrošnikih, vključno s potrošniki iz ranljivih skupin,
the novel food consists of or contains food previously approved for food use in the Community, and the new intended use can be expected not to significantly increase the intake of consumers, including consumers in vulnerable groups,
se postopek uradnega obvestila iz člena 10 te uredbe uporablja smiselno in z odstopanjem od člena 7(3) Uredbe (ES) 1331/2008
the notification procedure referred to in Article 10 of this Regulation shall apply mutatis mutandis, by way of derogation from Article 7 (3) of Regulation (EC) No 1331/2008
Brez poseganja v določbe in zahteve iz Direktive 2000/13/ES je treba za dobro seznanjenost potrošnikov označiti in navesti vse podatke, značilne za nova živila:
Without prejudice to the provisions and requirements of Directive 2000/13/EC, all specific data on novel foods shall be indicated and labelled to ensure proper consumer information:
vsako novo živilo na tržišču mora ob prodaji imeti jasno razpoznavno, natančno in lahko berljivo označbo, na kateri je navedeno, da gre za novo živilo;
all new foods placed on the market shall be sold with clearly distinctive, precise and easily legible labelling indicating that they are novel foods;
vse značilnosti ali lastnosti novega živila, kot so sestava, hranilna vrednost, pravilna uporaba, morajo biti na jasen, natančen, lahko berljiv in razumljiv način navedene na embalaži proizvoda;
all the characteristics or properties of novel foods such as their composition, nutritional value and proper use, shall appear clearly, precisely and in an easily legible and comprehensible manner on their packaging;
prisotnost novega živila ali nove sestavine, ki nadomešča snov ali sestavino v živilu, ne glede na to, ali živilo nadomesti novo živilo, mora biti navedena na oznaki na jasen, natančen, lahko berljiv in razumljiv način.
the presence of a novel food or novel ingredient replacing a material or ingredient in a food, whether or not the food is replaced by a novel food, must be stated clearly, precisely and in an easily legible and comprehensible manner on the labelling.
Tradicionalno živilo iz tretje države
Traditional food from a third country
Nosilec živilske dejavnosti, ki namerava dajati na trg v Skupnosti tradicionalno živilo iz tretje države, o tem uradno obvesti Komisijo z navedbo imena živila, njegove sestave in države porekla.
A food business operator intending to place a traditional food from a third country on the market in the Community shall notify it to the Commission, indicating the name of the food, its composition and country of origin.
Uradno obvestilo spremljajo dokumentirani podatki, ki dokazujejo pretekle izkušnje glede varne uporabe živila v
The notification shall be accompanied by documented data demonstrating the history of safe food use in
tretji državi.
third country.
Komisija državam članicam in agenciji nemudoma posreduje uradno obvestilo, vključno z dokazilom o preteklih izkušnjah glede varne uporabe živila iz odstavka 1
The Commission shall forward the notification including the demonstration of history of safe food use referred to in paragraph 1 without delay to the Member States and the Authority
V štirih mesecih po datumu posredovanja uradnega obvestila iz
Within four months from the date on which the notification provided for in
v skladu z odstavkom 2
according to paragraph 2,
lahko država članica in agencija obvestita Komisijo, da imata
a Member State and the Authority may inform the Commission that they have
pripombe glede varnosti dajanja na trg zadevnega tradicionalnega živila, ki temeljijo na znanstvenih dokazih.
safety objections, based on scientific evidence, to the placing on the market of the traditional food concerned.
Uradno obvestilo iz odstavka 1
The notification as referred to in paragraph 1
se šteje za zahtevo iz člena 3(1) Uredbe
shall be considered as an application referred to in Article 3(1) of ║ Regulation
Komisija ustrezno
The Commission shall inform the food business operator concerned accordingly
obvesti zadevnega nosilca živilske dejavnosti
five months from the date of the notification
v petih mesecih od datuma uradnega obvestila v skladu z odstavkom 1.
paragraph 1.
Če ni bilo predloženih nobenih
If no
pripomb glede varnosti na podlagi znanstvenih dokazov in v skladu z odstavkom 3 zadevnemu nosilcu živilske dejavnosti ni bila sporočena nobena informacija o tem, se lahko tradicionalno živilo daje na trg v Skupnosti po petih mesecih od datuma uradnega obvestila v skladu z odstavkom 1.
safety objections, based on scientific evidence, have been raised and no information thereof has been communicated to the food business operator concerned in accordance with paragraph 3, the traditional food may be placed on the market in the Community after five months from the date of the notification in accordance with paragraph 1.
pravila za izvajanje tega člena, ki so oblikovana za spremembo nebistvenih elementov te uredbe, med drugim z njeno dopolnitvijo, ▌sprejmejo v skladu z regulativnim postopkom s pregledom iz
be adopted in accordance with the regulatory procedure with scrutiny referred to in
člena 20(3)
Article 20(3).
Tehnične smernice
Technical guidance
Ne glede na določbe iz člena 9(1)(a) Uredbe (ES) št. 1331/2008 in
Without prejudice to the provisions of Article 9(1) (a) of Regulation (EC) No 1331/2008 and before
, nosilci živilske dejavnosti ter majhnimi in srednje velikimi podjetji
the food business operators and small and medium-sized enterprises
daje na voljo tehnične smernice in orodja za pomoč nosilcem živilske dejavnosti in zlasti malim in srednje velikim podjetjem pri pripravi in predložitvi zahtevkov na podlagi te uredbe.
make available technical guidance and tools to assist food business operators and especially small and medium-sized enterprises in preparing and submitting applications under this Regulation.
Vložnikom zahtevkov je na voljo Priporočilo Komisije 97/618/ES z dne 29. julija 1997 o znanstvenih vidikih in predstavitvi informacij, potrebnih za podporo vlogo za dajanje na trg novih živil in novih živilskih sestavin, ter o pripravi začetnih ocenjevalnih poročil v skladu z Uredbo (ES) št. 258/97 Evropskega parlamenta in sveta
Commission Recommendation 97/618/EC of 29 July 1997 concerning the scientific aspects and the presentation of information necessary to support applications for the placing on the market of novel foods and novel food ingredients and the preparation of initial assessment reports under Regulation (EC) No 258/97 of the European Parliament and of the Council
UL L 253, 16.9.1997, str.
OJ L 253, 16.9.1997, p.
, dokler se ne nadomesti z revidiranimi tehničnimi smernicami v skladu s tem členom.
shall be available for use by applicants until replaced by revised technical guidance issued in accordance with this Article.
Tehnične smernice in orodja se objavijo najpozneje
The technical guidance and tools shall be published, not later than
na temu namenjeni javno dostopni strani na spletnem mestu Komisije.
, on a publicly accessible page intended for that purpose on the website of the Commission.
Mnenje agencije
Opinion of the Authority
Agencija pri ocenjevanju novih živil
In assessing the safety of novel foods, the Authority shall,
na podlagi zahtev iz člena 6
on the basis of the requirements specified in Article 6
upošteva tradicionalno živilo iz tretje države, pretekle izkušnje glede varne uporabe.
take into account for traditional food from a third country, the history of safe food use.
V primeru etičnih zadržkov se poleg ocene varnosti pridobi mnenje evropske skupine za etiko v znanosti in novih tehnologijah.
In the event of ethical objections, an opinion shall be sought, over and above the safety assessment, from the European Group on Ethics in Science and New Technologies (EGE).
Spremljanje se izvaja pet let po datumu vključitve novih živil na seznam Skupnosti in upošteva vidike varnosti živil, zdravja in dobrega počutja živali ter vplive na okolje.
This monitoring shall take place five years after the date of inclusion of a novel food in the Community list and take into account food safety aspects as well as animal health and welfare aspects and the environmental impact.
Posebno pozornost se nameni skupinam prebivalstva, ki zaužijejo največ hrane.
Special attention shall be paid to the categories of the population with the highest dietary intakes.
Zahteve za spremljanje veljajo tudi za nova živila, ki so že na trgu, vključno z novimi živili, odobrenimi po poenostavljenem postopku (uradno obvestilo) iz člena 5 Uredbe (ES) št. 258/97.
The monitoring requirements shall also apply to novel foods already on the market, including those approved under the simplified procedure ('notification') laid down in Article 5 of Regulation (EC) No 258/97.
in nosilec živilske dejavnosti
and food business operator
kakršnih koli znanstvenih ali tehničnih informacijah, ki bi lahko vplivale na oceno varnosti uporabe novega živila;
any new scientific or technical information which might influence the evaluation of the safety in use of the novel food;
kakršni koli prepovedi ali omejitvi, ki jo naloži pristojni organ ali katera koli tretja država, v kateri se novo živilo daje na trg.
any prohibition or restriction imposed by the competent authority of any third country in which the novel food is placed on the market.
Pristojni organ države članice poroča Komisiji v treh mesecih po opravljenem inšpekcijskem pregledu.
The Member State's competent authority shall report to the Commission within three months of the completion of an inspection.
Spodbujajo se poskusi brez uporabe živali in inteligentne strategije poskusov.
The use of non-animal tests and intelligent testing strategies shall be promoted.
Komisija to mnenje skupine za etiko v znanosti in novih tehnologijah javno objavi.
The Commission shall make that opinion of the European Group on Ethics and new Technologies available to the public.
, razen če se je poznejši vložnik dogovoril s predhodnim vložnikom, da se lahko takšni podatki in informacije uporabijo, ob predpostavki, da:
unless the subsequent applicant has agreed with the prior applicant that such data and information may be used, and where:
so bili znanstveni podatki in druge informacije s strani predhodnega vložnika v času vložitve predhodnega zahtevka označeni kot pravno zaščiteni; in
the scientific data and other information has been designated as proprietary by the prior applicant at the time the prior application was made; and
je imel predhodni vložnik v času prvotnega zahtevka izključno pravico sklicevanja na pravno zaščitene podatke; ter
the prior applicant had exclusive right of reference to the proprietary data at the time the prior application was made; and
novih živil ne bi bilo mogoče odobriti brez predložitve pravno zaščitenih podatkov s strani predhodnega vložnika.
the novel food could not have been authorised without the submission of the proprietary data by the prior applicant.
Podatki raziskovalnih projektov, ki jih deloma ali v celoti financirajo Evropska skupnost in/ali javne institucije, ter študije o tveganju ali s tem povezani podatki, kot so študije o krmi, se objavijo skupaj z zahtevkom in prosto na voljo drugim vložnikom.
Data from research projects partly or completely paid by the EC and/or public institutions and risk studies or data related to risk studies, like feeding studies, shall be published together with the application and shall be freely available for use by other applicants.
Da bi preprečili ponavljanje študij, ki vključujejo vretenčarje, se poznejši vložnik lahko sklicuje na študije na vretenčarjih ali druge študije, s katerimi se lahko preprečijo poskusi na živalih.
In order to avoid the repetition of studies involving vertebrates, reference by a subsequent applicant to studies on vertebrates and other studies that may prevent animal testing shall be allowed.
Lastnik podatkov lahko zahteva ustrezno nadomestilo za uporabo teh podatkov.
The owner of the data may claim adequate compensation for the use of the data.
Ne glede na odobritev novega živila na podlagi členov 7 in 14 Uredbe (ES) št. 1331/2008 ali odobritev zdravstvene trditve na podlagi členov 17, 18 in 25 Uredbe (ES) št. 1924/2006 so podatki v zvezi z odobritvijo in objavo odobritve v Uradnem listu enaki, obdobja varstva podatkov pa tečejo hkrati, če se namerava pridobiti odobritev novega živila in z njim povezane zdravstvene trditve ter če je varstvo podatkov na podlagi določb obeh uredb zagotovljeno in ga zahteva vložnik zahtevka.
Notwithstanding the authorisation of a novel food pursuant to Articles 7 and 14 of Regulation (EC) No 1331/2008 or authorisation of a health claim pursuant to Articles 17, 18 and 25 of Regulation (EC) No 1924/2006, the data concerning the authorisation and the publication of the authorisation in the Official Journal shall be identical and the data protection periods shall run concurrently where authorisation is sought for a novel food and for a health claim relating to that food, and where data protection pursuant to the provisions of both Regulations is warranted and requested by the applicant.
Da se zagotovi skladnost s to uredbo, se mora izvajati uradni nadzor v skladu z Uredbo (ES) št. 882/2004
In order to enforce compliance with this Regulation, official controls are to be carried out in accordance with Regulation (EC) No 882/2004.
Države članice Komisijo uradno obvestijo o navedenih določbah najpozneje
The Member States shall notify those provisions to the Commission
v 12 mesecih
within 12 months
Komisiji pomaga Stalni odbor za prehranjevalno verigo in zdravje živali, ustanovljen s členom 58 Uredbe (ES) št. 178/2002║.
The Commission shall be assisted by the Standing Committee on the Food Chain and Animal Health, set up by Article 58 of Regulation (EC) No 178/2002 ║.
Pri sklicevanju na ta odstavek se uporabljata člena 5 in 7 Sklepa 1999/468/ES ob upoštevanju določb člena 8 Sklepa.
Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply having regard to the provisions of Article 8 thereof.
3 leta in šest mesecev po datumu objave te uredbe.
Three years and six months after the date of publication of this Regulation.