natgillin/translations-raw huggingface dataset:
Novo živilo se lahko uvrsti na seznam Skupnosti le, če je pristojni organ izdal mnenje o neškodljivosti živila za zdravje.
A novel food may be included in the Community list only if the competent authority has submitted an opinion establishing that the food is not harmful to health.
Živila, ki izvirajo iz kloniranih živali ali njihovih potomcev, se ne uvrstijo na seznam Skupnosti.
Foods from cloned animals or their descendants shall not be placed on the Community list.
Člen 6 – odstavek 1 c (novo)
Article 6 – paragraph 1 c (new)
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 should not be included in the Community list.
Seznam Skupnosti se posodobi v skladu s postopkom iz Uredbe (ES) št. [enotni postopek].
The Community list shall be updated in accordance with the procedure laid down in Regulation (EC) No [common procedure].
Seznam Skupnosti se posodobi v skladu s postopkom iz Uredbe (ES) št. [enotni postopek], Komisija pa ga objavi na temu namenjeni spletni strani Komisije .
The Community list shall be updated in accordance with the procedure laid down in Regulation (EC) No [common procedure] and the Commission shall publish it on a dedicated page of its website .
Podobno bi morala biti na internetu na voljo seznam živil iz tretjih držav in seznam novih živil Skupnosti.
Similarly, the list of foods from third countries and the list of new Community foods should be made available on the Internet.
(2) Vnos novega živila v seznam Skupnosti vključuje specifikacijo živila , po potrebi določitev pogojev uporabe, dodatnih posebnih zahtev označevanja za obveščanje končnega potrošnika in/ali zahtevo za spremljanje po dajanju na trg .
(2) The entry of a novel food in the Community list shall include a specification of the food , and, where appropriate, specify the conditions of use, additional specific labelling requirements to inform the final consumer and/or a post-market monitoring requirement.
(2) Vnos novega živila v seznam Skupnosti vsebuje:
(2) The entry of a novel food in the Community list shall include :
(a) specifikacijo živila;
(a) a specification of the food;
(b) predvideno uporabo živila;
(b) the intended use of the food;
(c) pogoje uporabe;
(c) the conditions of use;
(d) datum vnosa novega živila na seznam Skupnosti in datum prejema zahtevka;
(d) the date of entry of the novel food in the Community list and the date of receipt of the application;
(e) ime in naslov vložnika;
(e) the name and address of the applicant;
(f) datum in rezultate zadnjega inšpekcijskega pregleda v skladu z zahtevami za spremljanje iz člena 11.
(f) the date and results of the last inspection according to the monitoring requirements laid down in Article 11.
Pomembno je, da se ti podatki zahtevajo za vsa nova živila (ne samo za tista člena 7(3)(1), kot predlaga Komisija), da se zagotovi preglednost.
It is important to require these information from ALL novel foods (not only the ones referred to in Article 7- paragraph 3- first subparagraph; as proposed by the Commission!) in order to enable transparency.
Za vsa nova živila se zahteva spremljanje po dajanju na trg.
P ost-marketing monitoring shall be required for all novel foods.
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 5 years and when more scientific evidence becomes available.
Pri spremljanju je treba posebno pozornost nameniti skupinam prebivalstva, ki zaužijejo največ hrane.
In the monitoring, special attention should be paid to the categories of the population with the highest dietary intakes.
Da bi bili seznanjeni z negativnimi učinki uporabe novih živil, bi moralo biti spremljanje po dajanju na trg obvezno za vsa nova živila, in sicer vsakih pet let po uvedbi na evropskem trgu.
In order to be informed about adverse effects from the use of a novel food, a post -market monitoring should be required for all novel foods, once 5 years after their introduction onto the European market.
V primerih iz člena 2(2a) 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(2 ), point ( a) the common procedure shall be employed irrespective of the previous use or authorisation of the substance to which a standard production process was applied.
Sestavine živil ali dodatke, proizvedene s tehnologijo, ki ni bila predhodno uporabljena, kot sta nanotehnologija in nanoznanost, je treba urediti z uredbo za nova živila.
A food ingredient or additive manufactured using a production technology which has not previously been employed, such as nanotechnology and nanoscience, should be covered by the regulation on novel foods.
Te snovi imajo lahko povsem nove lastnosti.
These substances may have completely new properties.
Zaradi previdnosti pri varstvu potrošnikov je treba opraviti ločeno oceno, ki ne upošteva predhodne standardne uporabe snovi ali njene odobritve.
On precautionary consumer protection grounds, a separate assessment is needed which takes no account of the previous standard use of the substance or of its authorisation.
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 consum ption , it shall require approval for use with in maximum limits in certain foods or food categories.
Če je novo živilo snov, ki je lahko ob prekomernem uživanju nevarna, je treba zanj pridobiti dovoljenje za uporabo v okviru najvišjih vrednosti v določenih živilih ali kategorijah živil, da se prepreči tveganje zaradi prekomernega uživanja, potrošnike pa je o tem treba obvestiti z jasnimi oznakami.
In case a novel food is a substance with a risk linked with consuming too much of it, it should get approval for use with maximum level in certain foods or food categories in order to prevent the risk of over-dosing and consumers should be informed of this through clear labels.
Člen 7 – odstavek 2 c – pododstavek 1 (novo)
Article 7 – paragraph 2 c – subparagraph 1 (new)
Nova živila so predmet splošnih zahtev označevanja iz Direktive 2000/13/ES.
Novel f oods are subject to the general labelling requirements laid down in Directive 2000/13/EC.
Dodatne posebne zahteve označevanja se lahko določijo za posebna nova živila, zlasti glede opisa živila, njegovega vira ali pogojev uporabe.
Additional specific labelling requirements may be laid down for specific novel foods, in particular regarding the description of the food, its source, or its conditions of use.
V tem primeru se zahteve označevanja navedejo v seznamu Skupnosti.
Where this is the case, the labelling requirement shall be mentioned in the Community list.
Člen 7 – odstavek 2 c – pododstavek 2 (novo)
Article 7 – paragraph 2 c – subparagraph 2 (new)
Proizvodi, proizvedeni z uporabo nanotehnologij, morajo biti označeni z "proizveden z uporabo nanotehnologij";
Products produced with the aid of nanotechnologies must be labelled with the words ‘produced with the aid of nanotechnologies’;
Potrošniki bodo morda želeli vedeti, če je bilo živilo proizvedeno s pomočjo nanotehnologij.
Consumers might like to know whether a food has been produced by the use of nanotechnologies.
Člen 7 – odstavek 2 c – pododstavek 3 (novo)
Article 7 – paragraph 2 c – subparagraph 3 (new)
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 animals fed with genetically modified feeding stuffs must be labelled with the words ‘produced from animals fed with genetically modified feeding stuffs’;
Potrošniki bodo morda želeli vedeti, če je bilo živilo proizvedeno z uporabo gensko spremenjene krme.
Consumers might like to know whether a food has been produced by the use of genetically modified feed.
Z odstopanjem od tretjega odstavka člena 7 Uredbe (ES) št. [enotni postopek] se posodabljanje seznama Skupnosti z novim živilom, razen s tradicionalnim živilom iz tretje države, določi v skladu z regulativnim postopkom iz člena 14(2), kadar za nove znanstvene dokaze ali podatke, ki so predmet lastninske pravice, velja varstvo v skladu s členom 12.
By way of derogation from the third paragraph of Article 7 of Regulation (EC) No [common procedure], the updating of the Community list with a novel food, other than traditional food from third countries, shall be decided in accordance with the regulatory procedure referred to in Article 14(2) in cases where newly developed scientific evidence and proprietary data are protected in accordance with Article 12.
Posodabljanje seznama Skupnosti se določi v skladu z regulativnim postopkom s pregledom iz člena 14(3).
The updating of the Community list shall be decided in accordance with the regulatory procedure with scrutiny referred to in Article 14(3).
Označevanje novih živil in novih sestavin živil
Labelling of novel foods and novel food ingredients
Brez poseganja v določbe in zahteve iz direktive št. 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 No 2000/13/EC, all specific data on novel foods shall be indicated and labelled to ensure proper consumer information:
(a) 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;
( a ) all new foods placed on the market shall be sold with clearly distinctive, precise and easily legible labelling indicating that they are novel foods;
(b) 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;
( b ) all the characteristics or properties of novel foods such as their composition, nutritional value and proper use, should appear clearly, precisely and in an easily legible and comprehensible manner on their packaging;
(c) 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.
( c ) 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.
Če novo živilo vsebuje snov, ki lahko ob prekomernem uživanju predstavlja veliko tveganje za človekovo zdravje, je treba o tem potrošnika seznaniti z jasno, natančno, lahko berljivo in razumljivo oznako na embalaži proizvoda.
Where a novel food contains a substance which may pose a high risk to human health in the event of excessive consumption, the consumer must be informed of this by means of clear, precise and easily legible labelling on the packaging of the food.
Kot vsa nova živila, ki so dana na evropski trg, mora imeti novo živilo oznako v skladu z določbami direktive št. 2000/13/ES, ki je v reviziji, pa tudi v skladu s posebnimi določbami tega člena, pri čemer se upoštevajo posebnosti novega živila ali novih sestavin v živilu.
Like any other foodstuff placed on the European market, a novel food must be labelled in accordance with the provisions of Directive No 2000/13/EC, currently under review, but also in accordance with the specific provisions of this article, taking account of the specific qualities of novel foods and novel food ingredients.
Uradno obvestilo spremljajo dokumentirani podatki, ki dokazujejo pretekle izkušnje glede varne uporabe živila v tretji državi.
The notification shall be accompanied by documented data demonstrating the history of safe food use in the third country.
Uradno obvestilo spremljajo dokumentirani podatki, ki dokazujejo pretekle izkušnje glede varne uporabe živila v kateri koli tretji državi.
The notification shall be accompanied by documented data demonstrating the history of safe food use in any third country.
Zaradi pomanjkanja statistik je treba upoštevati podatke, ki dokazujejo varno uporabo živila v preteklosti v kateri koli tretji državi .
Due to the lack of statistics, it is important to consider data demonstrating the history of safe food use coming from any 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.
Komisija državam članicam in agenciji nemudoma posreduje uradno obvestilo, vključno z dokazilom o preteklih izkušnjah glede varne uporabe živila iz odstavka 1 in jo da na voljo javnosti na svoji spletni strani.
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 and make it publicly available on its website.
Določba, ki zagotavlja visoko stopnjo preglednosti za zainteresirane strani in potrošnike.
Provision in order to provide high transparency for stakeholders and consumers.
Člen 8 – odstavek 3 – pododstavek 2
Article 8 – paragraph 3 – subparagraph 2
V tem primeru se živila ne dajo na trg Skupnosti in se uporabijo členi 5 do 7.
In that case, the food shall not be placed on the market in the Community and Articles 5 to 7 shall apply.
Uradno obvestilo iz odstavka 1 se šteje za zahtevo iz člena 3(1) Uredbe XX/XXX [enotni postopek].
The notification as referred to in paragraph 1 shall be considered as an application referred to in Article 3(1) of the Regulation XX/XXX [common procedure].
Vložnik zahtevka se lahko odloči tudi za umik uradnega obvestila.
Alternatively, the applicant may choose to withdraw the notification.
V primerjavi z dokazi, potrebnimi za prikaz preteklih izkušenj glede varne uporabe za uradno obvestilo na podlagi člena 8, bi bile zahteve za podatke, priložene zahtevku, bistveno večje.
In comparison to the evidence required to demonstrate history of safe use for a notification under Article 8, the data requirement to support an application would be considerably more extensive.
Zato bi moral vložnik zahtevka imeti možnost umika iz postopka, ne pa da se uradno obvestilo samodejno spremenilo v popolni zahtevek.
Consequently it is appropriate that the applicant should have the option to withdraw from the process rather than have the notification automatically convert to a full application.
Člen 8 – odstavek 3 – pododstavek 3
Article 8 – paragraph 3 – subparagraph 3
Komisija ustrezno obvesti zadevnega nosilca živilske dejavnosti v petih mesecih od datuma uradnega obvestila v skladu z odstavkom 1.
The Commission shall inform the food business operator concerned accordingly within five months from the date of the notification in accordance with paragraph 1.
Komisija ustrezno nemudoma na dokazljiv način obvesti zadevnega nosilca živilske dejavnosti najkasneje v petih mesecih od datuma uradnega obvestila v skladu z odstavkom 1.
The Commission shall inform the food business operator concerned accordingly without undue delay and in a demonstrable manner within no more than five months from the date of the notification in accordance with paragraph 1.
Komisija mora za povečanje pravne varnosti vložnike (nosilce živilske dejavnosti) nemudoma in dokazljivo obvestiti o ugovorih v zvezi z uradnim obvestilom.
To increase legal certainty applicants (the food business operators) should be informed by the Commission without undue delay and in a demonstrable manner of objections raised in response to the notification.
Komisija objavi seznam tradicionalnih živil iz tretjih držav, ki se jih lahko daje na trg v Skupnosti v skladu s členom 4, na temu namenjeni spletni strani Komisije.
The Commission shall publish a list of traditional foods from third countries that may be placed on the market in the Community in accordance with paragraph 4 on a dedicated page of the Commission's website.
Ta stran je dostopna prek spletne strani s seznamom Skupnosti o novih živilih iz prvega odstavka člena 5 ter je z njo povezana.
This page shall be accessible from and linked to the page on the Community list on novel foods referred to in Article 5 (1) .
Člen 8 – odstavek 6
Article 8 – paragraph 6
Podrobna pravila za izvajanje tega člena, 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 14(3).
Detailed rules for the implementation of this Article, 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 14(3).
Pred datumom začetka uporabe člena 8 se podrobna 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 člena 14(3).
Before the date of application of Article 8, detailed rules for the implementation of this Article, 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 14(3).
Komisija bo morala za povečanje pravne varnosti gospodarskih subjektov, dejavnih v tem sektorju, oblikovati jasna merila, na podlagi katerih bo ocenila, ali se je živilo v pomembnem obsegu uporabljalo za prehrano ljudi v Skupnosti.
To increase legal certainty for business operators active in this sector the Commission will need to lay down clear criteria on which to assess whether food has been used for human consumption to a significant degree within the Community.
Komisija po potrebi v tesnem sodelovanju z agencijo 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.
The Commission shall, where appropriate, in close cooperation with the Authority, 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.
Ne glede na določbe iz člena 9(1)(a) uredbe [enotni postopek] in pred datumom začetka uporabe te uredbe Komisija po potrebi in v tesnem sodelovanju z Agencijo , nosilci živilske dejavnosti ter majhnimi in srednje velikimi podjetji da na voljo tehnične smernice in orodja za pomoč nosilcem živilske dejavnosti, zlasti malim in srednje velikim podjetjem, pri pripravi in predložitvi zahtevkov in uradnih obvestil v skladu s to uredbo.
Notwithstanding the provisions of Article 9(1) (a) of Regulation (common procedure) and before the date of application of th is Regulation, the Commission shall, where appropriate, in close cooperation with the Authority, the food business operators and small and medium-sized enterprises 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 97/618/ES, dokler se ne nadomesti z revidiranimi tehničnimi smernicami v skladu s tem členom.
Recommendation 97/618/EC 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 šest mesecev po začetku veljavnosti te uredbe na temu namenjeni javno dostopni strani na spletnem mestu Komisije.
The technical guidance and tools shall be published, not more than six months after the date of entry into force of this Regulation, on a publicly accessible page intended for th at purpose on the website of the Commission.
Člen 10 – uvodni del
Article 10 – introductory part
Agencija pri ocenjevanju novih živil:
In assessing the safety of novel foods, the Authority shall:
Agencija pri ocenjevanju novih živil na podlagi zahtev iz člena 6 :
In assessing the safety of novel foods, the Authority shall, on the basis of the requirements specified in Article 6 :
(a) po potrebi primerja, če je živilo varno kot živilo iz primerljive živilske kategorije, ki že obstaja na trgu v Skupnosti ali kot živilo, ki naj bi ga novo živilo nadomestilo .
(a) compare, where appropriate, if the food is as safe as food from a comparable food category already existing on the market in the Community or as the food that the novel food is intended to replace ;
presodi, če novo živilo , ne glede na to, ali je njegov namen nadomestiti živilo, ki je že na tržišču, ne predstavlja tveganja za kakršne koli škodljive posledice za človekovo zdravje ali bi bilo živilo strupeno, pri čemer se upoštevajo tudi posledice morebitnih novih lastnosti;
a) consider if the new food , irrespective of whether or not it is intended to replace a food already existing on the market, does not pose any risk of harmful or toxic effects to human health , while also taking into account the implications of any new characteristics;
Pojasnilo k besedilu, ki ga predlaga Komisija.
Clarification of Commission’s proposed wording.
V povezavi s predlogom spremembe 40 poslanke Liotard.
See also Amendment 40 by Mrs Liotard.
Živila, proizvedena z uporabo nanotehnologije imajo lahko na primer nove lastnosti, ki jih ni mogoče ustrezno oceniti preprosto s primerjavo z obstoječimi proizvodi, ki so že na trgu.
Foods produced using nanotechnologies, for example, may have novel characteristics that cannot be adequately assessed merely by comparing them to existing products already on the market .
Člen 10 – točka a a (novo)
Article 10 – point a a (new)
(aa) v zvezi z znanstvenimi ocenami o nevarnosti novih živil ali novih sestavin v živilih poziva pristojne organe, naj ji posredujejo vse znanstvene ocene, ki so jih izvedli o novem živilu ali novi sestavini v zadevnem živilu.
( a a ) ask the competent authorities, in connection with scientific evaluations of the risks posed by novel foods or novel food ingredients, to supply it with any scientific evaluation they have carried out on the novel food or novel ingredient in question.
Člen 10 - točka b
Article 10 - point b
(b) upošteva tradicionalno živilo iz tretje države, pretekle izkušnje glede varne uporabe.
(b) take into account for traditional food from a third country, the history of safe food use.
(i) pri tradicionalnem živilu iz tretje države, pretekle izkušnje glede varne uporabe;
(i) for traditional food from a third country, the history of safe food use ;
(ii) sestavo novega živila, zlasti na ravni antihranil in naravnih toksinov;
( ii ) the composition of the novel food, particularly the levels of anti-nutrients and naturally occurring toxins ;
(iii) način priprave in specifikacije sestavin novega živila;
( iii ) the method of preparation and specifications of a novel food ingredient ;
(iv) potencial za alergenost novega živila;
( iv ) the potential for allergenicity of the novel food ;
(v) študije presnove/toksikokinetike za sestavino novega živila;
( v ) metabolism/toxicokinetic studies on the novel food ingredient ;
(vi) študije toksičnosti sestavine novega živila za živali;
( vi ) animal toxicity studies on the novel food ingredient ;
(vii) študije prenašanja sestavine novega živila pri ljudeh;
( vii ) human toleration studies on the novel food ingredient .