natgillin/translations-raw huggingface dataset:
Države članice, nosilci živilske dejavnosti in druge zainteresirane strani Komisiji posredujejo informacije, v kolikšnem obsegu se je živilo uporabljalo za prehrano ljudi v Uniji pred 15. majem 1997.
Member States, business operators and other interested parties shall transmit to the Commission information on the extent a food was used for human consumption within the Union before 15 May 1997.
V primeru dvoma se nosilci živilske dejavnosti o statusu tega živila posvetujejo z ustreznim pristojnim organom za nova živila, kakor je opredeljeno v členu 15 Uredbe (ES) št. 1331/2008.
In case of doubt, food business operators shall consult the relevant competent authority for novel foods as defined in Article 15 of Regulation (EC) No 1331/2008 on the status of the food in question.
Nosilec živilske dejavnosti na zahtevo ustreznega pristojnega organa predloži informacije glede obsega, v katerem se je živilo uporabljalo za prehrano ljudi v Uniji pred 15. majem 1997.
On request from the relevant competent authority, food business operators shall submit information concerning the extent to which the food in question was used for human consumption within the Union before 15 May 1997.
Komisija objavi te podatke in zaključke na podlagi zbranih podatkov in nezaupnih podatkov, ki podpirajo zaključke.
The Commission shall publish those data and the conclusions drawn from the data collection and the non-confidential data supporting it.
Pristojni organ se po potrebi lahko posvetuje z drugimi pristojnimi organi in Komisijo o obsegu, v katerem se je živilo uporabljalo za prehrano ljudi v Uniji pred 15. majem 1997.
Where necessary, the competent authority may consult other competent authorities and the Commission concerning the extent to which a food was used for human consumption within the Union before 15 May 1997.
Odgovori na tovrstna posvetovanja se posredujejo tudi Komisiji.
Replies to any such consultation shall also be transmitted to the Commission.
Komisija povzame prejete odgovore in pristojnim organom posreduje ugotovite posvetovanj.
The Commission shall summarise the replies received and communicate the result of the consultation to all competent authorities.
Komisija za zagotovitev celovitosti informacij o razvrstitvi novega živila najpozneje ...* z delegiranimi akti v skladu s členom 21 in pod pogoji iz členov 22 in 23 sprejme pravila za nadaljnje ukrepanje v primerih, kjer nima informacij o uporabi živila za prehrano ljudi pred 15. majem 1997.
In order to ensure the completeness of information regarding the classification of novel foods, the Commission shall, not later than... * , adopt rules on how to proceed in cases in which the Commission has no information about the use of a food for human consumption before 15 May 1997 by means of delegated acts in accordance with Article 21 and subject to the conditions of Articles 22 and 23.
* Šest mesecev po datumu začetka veljavnosti te uredbe.
* Six months after the date of entry into force of this regulation.
Komisija lahko sprejme izvedbena pravila za odstavek 3 tega člena v skladu z regulativnim postopkom iz člena 19(2) .
The Commission may adopt implementing measures for paragraph 3 of this Article in accordance with the regulatory procedure referred to in Article 19(2).
Komisija lahko z delegiranimi akti v skladu s členom 21 in pod pogoji iz členov 22 in 23 sprejme podrobna navodila o uporabi odstavka 1, zlasti glede vrste informacij, ki jih Komisija lahko zbira od držav članic in/ali nosilcev živilske dejavnosti .
The Commission may adopt detailed rules on the application of paragraph 1, in particular as regards the type of information to be collected from Member States and/or from food business operators, by means of delegated acts in accordance with Article 21 and subject to conditions of Articles 22 and 23.
Člen 4(2) iz dokumenta Komisije.
Article 4(2) from the Commission document.
Odločitve o razlagi
Interpretation decisions
Po potrebi lahko Komisija v skladu z regulativnim postopkom iz člena 19(2) odloči ali vrsta živila sodi v področje uporabe te uredbe.
Where necessary, it may be decided in accordance with the regulatory procedure referred to in Article 19(2) whether a type of food falls within the scope of this Regulation.
Seznam Unije za nova živila
Union list of novel foods
Na trg se lahko dajo le nova živila, ki so uvrščena na seznam Unije za nova živila (v nadaljnjem besedilu "seznam Unije").
Only novel foods included in the Union list of novel foods (''the Union list'') may be placed on the market.
Komisija vodi in objavlja seznam Unije na posebej temu namenjeni javno dostopni strani na spletnih straneh Komisije.
The Commission shall keep and publish the Union list on a publicly accessible page intended for that purpose on the website of the Commission.
Predlog spremembe 41 iz prve obravnave EP.
EP first reading amendment 41.
Nihče ne sme na trg v Uniji dajati novih živil , če niso skladna s to uredbo.
No person shall place on the Union market a novel food if it does not comply with this Regulation.
Nova živila se ne dajejo na trg, če niso skladna z določbami te uredbe.
Novel foods shall not be placed on the market if they do not comply with the provisions of this Regulation.
Predlog spremembe 42 iz prve obravnave EP.
EP first reading amendment 42.
Seznama novih živil
Lists of novel foods
Komisija vodi seznam Unije odobrenih novih živil, razen tradicionalnih živil iz tretjih držav (v nadaljnjem besedilu "seznam Unije"), ki se objavi v skladu s členom 2(1) Uredbe (ES) št. 1331/2008.
The Commission shall maintain a Union list of authorised novel foods other than traditional foods from third countries (hereinafter "the Union list"), which will be published in accordance with Article 2(1) of Regulation (EC) No 1331/2008.
Komisija sestavi in vodi seznam tradicionalnih živil iz tretjih držav, odobrenih v skladu s členom 11(5) te uredbe, ki se objavi v seriji C Uradnega lista Evropske unije.
The Commission shall establish and maintain a list of traditional foods from third countries authorised pursuant to Article 11(5) of this Regulation, which shall be published in the C series of the Official Journal of the European Union.
Na trg v Uniji se lahko dajo le nova živila, vključena na seznam Unije ali seznam tradicionalnih živil iz tretjih držav.
Only novel foods included in the Union list or in the list of traditional foods from third countries may be placed on the market within the Union .
Člen 8 – točka a
Article 8 - point a
(a) na podlagi razpoložljivih znanstvenih dokazov ne pomeni tveganja za zdravje potrošnika;
(a) it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer;
(a) na podlagi razpoložljivih znanstvenih dokazov ne pomeni tveganja za zdravje potrošnika in živali, kar pomeni, da se bodo pri oceni tveganja upoštevali kumulativni in sinergijski učinki ter možni negativni učinki na posebne skupine prebivalstva ;
(a) it does not, on the basis of the scientific evidence available, pose a safety concern to the health of the consumer and of animals, which implies that cumulative and synergistic effects as well as possible adverse effects on particular groups of the population will be taken into account in the risk assessment;
Predlog spremembe 43 iz prve obravnave EP.
EP first reading amendment 43.
Člen 8 – točka c
Article 8 - point c
(c) v primeru, da je namenjeno nadomestitvi drugega živila, se od slednjega ne razlikuje tako, da bi bila njegova običajna poraba za potrošnika hranilno manj ugodna.
(c) if it is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
(c) v primeru, ko je namenjeno nadomestitvi drugega živila, se od slednjega ne razlikuje tako, da bi bila njegova običajna poraba za potrošnika hranilno manj ugodna.
(c) in the case where it is intended to replace another food, it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
Predlog spremembe 45 iz prve obravnave EP.
EP first reading amendment 45.
Člen 8 – točka c a (novo)
Article 8 – point c a (new)
(ca) pri obvladovanju tveganja se upošteva mnenje Evropske agencije za okolje o škodljivem vplivu proizvodnega postopka in običajne uporabe na okolje, ki je objavljeno najpozneje na dan objave ocene, ki jo izvede EFSA;
(ca) the opinion of the European Environment Agency, which shall be published no later than the day of the publication of the EFSA assessment, concerning the extent to which the production process and normal consumption have a harmful impact on the environment, is taken into account in the risk management;
Predlog spremembe deloma znova uvaja predlog spremembe 47 iz prve obravnave EP.
This amendment re-establishes partially the EP first reading amendment 47.
Člen 8 – točka c b (novo)
Article 8 – point c b (new)
(cb) pri obvladovanju tveganja se upošteva mnenje evropske skupine za etiko v znanosti in novih tehnologijah o morebitnih etičnih zadržkih, ki je objavljeno najpozneje na dan objave ocene, ki jo izvede EFSA;
(cb) the opinion of the European Group on Ethics in Science and New Technologies, which shall be published no later than the day of the publication of the EFSA assessment, concerning the extent to which there are ethical objections, is taken into account in the risk management;
Predlog spremembe deloma znova uvaja predlog spremembe 48 iz prve obravnave EP.
This amendment re-establishes partially the EP first reading amendment 48.
Člen 8 – točka c c (novo)
Article 8 - point c c (new)
(cc) 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;
(cc) 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;
Predlog spremembe 49 iz prve obravnave EP.
EP first reading amendment 49.
Člen 8 – točka c d (novo)
Article 8 – point c d (new)
(cd) v primeru, da ni pridobljeno iz kloniranih živali ali njihovih potomcev.
(c d ) it is not derived from a cloned animal or its descendants.
Parlament v poročilu za prvo obravnavo izrecno podpira prihodnjo zakonodajo, da se prepove dajanje na trg EU takšnih živil.
Parliament's 1st reading report specifically endorsed future legislation to prohibit these foods being placed on the EU market.
S tem predlogom spremembe bi bilo zagotovljeno, da takšna živila ne bi bila dana na trg pred predložitvijo takšne zakonodaje.
This amendment would ensure that these foods are not placed on the market before such legislation is presented.
Člen 8 – točka c e (novo)
Article 8 - point c e (new)
(ce) če je potrebno zaradi varne uporabe, se določi najvišja stopnja vnosa novega živila kot takega ali kot del drugega živila ali kategorije živil;
(c e ) 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;
Člen 8 – točka c f (novo)
Article 8 - point c f (new)
(cf) ocenjeni so kumulativni učinki novih živil, uporabljenih v različnih živilih ali kategorijah živil.
(c f ) cumulative effects of novel foods that are used in different foodstuffs or categories of foodstuffs have been assessed.
Člen 8 – odstavek 1a (novo)
Article 8 - paragraph 1a (new)
Živila, za katera so bili uporabljeni proizvodni postopki, ki zahtevajo posebne metode za ocenjevanje tveganja (npr. živila, proizvedena z uporabo nanotehnologije), se ne uvrstijo na seznam Unije, dokler se te posebne metode ne odobrijo za uporabo in se na njihovi podlagi ne izvedejo ustrezne ocene varnosti, ki pokažejo, da je uporaba zadevnih živil varna.
Foods to which production processes have been applied that require specific risk assessment methods ( for example, foods produced using nanotechnologies) may not be included in the Union list until such specific methods have been approved for use, and an adequate safety assessment on the basis of those methods has shown that the use of the respective foods is safe.
Predlog spremembe 50 iz prve obravnave EP.
EP first reading amendment 50.
Člen 8 – odstavek 1 b (novo)
Article 8 - paragraph 1 b (new)
Novo živilo se lahko uvrsti na seznam Unije le, če je pristojni organ izdal mnenje o neškodljivosti živila za zdravje.
A novel food may be included in the Union list only if the competent authority has submitted an opinion establishing that the food is not harmful to health.
Predlog spremembe 51 iz prve obravnave EP.
EP first reading amendment 51.
Člen 8 – odstavek 1 c (novo)
Article 8 - paragraph 1 c (new)
V primeru dvoma, npr. zaradi nezadostne znanstvene gotovosti ali pomanjkljivih podatkov, se uporabi previdnostno načelo, zadevno živilo pa se ne uvrsti na seznam Unije.
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 Union list.
Predlog spremembe 52 iz prve obravnave EP.
EP first reading amendment 52.
Seznam Unije se posodablja v skladu s postopkom iz Uredbe (ES) št. 1331/2008 in po potrebi v skladu s členom 16 te uredbe .
The Union list shall be updated in accordance with the procedure laid down in Regulation (EC) No 1331/2008 and, where applicable, in accordance with Article 16 of this Regulation.
Komisija seznam Unije posodablja v skladu s postopkom iz Uredbe (ES) št. 1331/2008, med drugim tudi v primeru varstva podatkov iz člena 16 .
The Commission shall update the Union list, inter alia in cases of data protection referred to in Article 16, in accordance with the procedure laid down in Regulation (EC) No 1331/2008.
Z odstopanjem od odstavkov 4 do 6 člena 7 Uredbe (ES) št. 1331/2008 se uredba o posodobitvi seznama Unije sprejme z delegiranimi akti v skladu s členom 21 in pod pogoji iz členov 22 in 23.
By way of derogation from paragraphs 4 to 6 of Article 7 of Regulation (EC) No 1331/2008, the Regulation updating the Union list shall be adopted by means of delegated acts in accordance with Article 21 and subject to the conditions of Articles 22 and 23.
Komisija seznam Unije objavi na posebni strani svojega spletnega mesta.
The Commission shall publish the Union list on a dedicated page of its website.
Člen 7(4) iz dokumenta Komisije.
Article 7(4) form the Commission document.
Pri vnosu novega živila na seznam Unije se navede specifikacija živila ter po potrebi pogoji uporabe, dodatne posebne zahteve za označevanje zaradi obveščanja končnega potrošnika in/ali zahtevo za spremljanje po dajanju na trg ter po potrebi informacijo iz člena 16(4) .
The entry for a novel food in the Union 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 and, where applicable, the information referred to in Article 16(4).
Pri vnosu novega živila na seznam Unije se navede:
The entry of a novel food in the Union list shall include :
(a) specifikacija živila;
(a) a specification of the food;
(b) predvidena uporaba živila;
(b) the intended use of the food;
(c) pogoji uporabe;
(c) the conditions of use ;
(d) po potrebi dodatne posebne zahteve za označevanje zaradi obveščanja končnega potrošnika;
( d ) where appropriate, additional specific labelling requirements to inform the final consumer;
(e) datum vnosa novega živila na seznam Unije in datum prejema zahtevka;
( e ) the date of entry of the novel food in the Union list and the date of receipt of the application;
(f) ime in naslov predlagatelja;
( f ) the name and address of the applicant;
(g) datum in rezultati zadnjega inšpekcijskega pregleda v skladu z zahtevami za spremljanje iz člena 14;
( g ) the date and results of the last inspection according to the monitoring requirements laid down in Article 1 4 ;
(h) dejstvo, da vnos temelji na novih znanstvenih dokazih in/ali pravno zaščitenih podatkih, zaščitenih v skladu s členom 16;
( h ) the fact that the entry is based on newly developed scientific evidence and/or proprietary data protected in accordance with Article 16 ;
(i) dejstvo, da lahko novo živilo da na trg samo predlagatelj iz točke (e), razen če poznejši predlagatelj pridobi odobritev za živilo ne glede na pravno zaščitene podatke prvotnega predlagatelja.
( i ) 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 prejudice to the proprietary data of the original applicant.
Predlog spremembe 74 iz prve obravnave EP ter člen 7(3)(b) iz dokumenta Komisije.
EP first reading amendment 54 and Article 7(3), point (b) from the Commission document.
Člen 9 – odstavek 2 a (novo)
Article 9 - paragraph 2 a (new)
Za vsa nova živila se zahteva spremljanje po dajanju na trg.
Post-marketing monitoring shall be required for all novel foods.
Vsa nova živila, odobrena za dajanje na trg, se pregledajo po petih letih in kadarkoli 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.
Pri spremljanju je treba posebno pozornost nameniti skupinam prebivalstva, ki zaužijejo največ hrane.
In the context of the monitoring, special attention should be paid to the categories of the population with the highest dietary intakes.
Predlog spremembe 55 iz prve obravnave EP.
EP first reading amendment 55.
Člen 9 – odstavek 2 b (novo)
Article 9 - paragraph 2 b (new)
V primerih iz člena 2(2) (a) se uporabi postopek ne glede na predhodno uporabo ali odobritev snovi, za katero je bil uporabljen standardni postopek.
In the cases referred to in Article 2 ( 2 ) (a) the procedure shall be employed irrespective of the previous use or authorisation of the substance to which a standard production process was applied.
Predlog spremembe 56 iz prve obravnave EP.
EP first reading amendment 56.
Člen 9 – odstavek 2 c (novo)
Article 9 - paragraph 2 c (new)
Če novo živilo vsebuje snov, ki lahko ob prekomernem uživanju predstavlja tveganje za človekovo zdravje, je treba njegovo uporabo odobriti 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.
Predlog spremembe 57 iz prve obravnave EP.
EP first reading amendment 57.
Člen 9 – odstavek 2 d (novo)
Article 9 - paragraph 2 d (new)
Vsaka sestavina, prisotna v obliki nanomateriala, mora biti jasno označena na seznamu sestavin.
All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients.
Imenu take sestavine sledi beseda "nano" v oklepaju.
The names of such ingredients shall be followed by the word 'nano' in brackets.
Predlog spremembe 90 iz prve obravnave EP.
EP first reading amendment 90.
Člen 9 – odstavek 2 e (novo)
Article 9 - paragraph 2 e (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 animal s fed with genetically modified feeding stuffs must be labelled with the words ‘produced from animal fed with genetically modified feeding stuffs’.
Člen 9 – odstavek 2 f (novo)
Article 9 – paragraph 2 f (new)
Pred koncem roka iz člena 16(1) se seznam Unije posodobi v skladu z odstavkom 1 tega člena, če odobreno živilo še vedno izpolnjuje pogoje iz te uredbe, tako da posebne navedbe iz točke (h) odstavka 2 tega člena niso več vključene.
Before the expiry of the period referred to in Article 16(1), the Union list shall be updated in accordance with paragraph 1 of this Article so that, provided that the authorised food still meets the conditions laid down in this Regulation, the specific indications referred to in point ( h ) of paragraph 2 of this Article, are no longer included.
Člen 9 – odstavek 2 g (novo)
Article 9 – paragraph 2 g (new)
Za namene posodobitve seznama Unije z vključitvijo novega živila, če novo živilo ni sestavljeno iz živila, za katerega veljajo določbe o varstvu podatkov iz člena 16, ali če takega živila ne vsebuje, ter:
For the purposes of updating the Union 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 16 and:
(a) je novo živilo po sestavi, presnovi in ravni neželenih snovi enakovredno obstoječim živilom;
(a) the novel food is equivalent to existing foods, in composition, metabolism and level of undesirable substances,
(b) novo živilo vsebuje živilo, predhodno odobreno za uporabo v Uniji, ali je iz njega sestavljeno, in kadar se pri novi predvideni uporabi lahko pričakuje, da se pri potrošnikih, tudi tistih iz ranljivih skupin, ne bo bistveno povečal vnos,
(b) the novel food consists of or contains food previously approved for food use in the Union, and the new intended use can be expected not to significantly increase the intake of consumers, including consumers in vulnerable groups,
se postopek obveščanja iz člena 11 te uredbe uporablja smiselno in ne glede na odstavek 1 tega člena.
then the notification procedure referred to in Article 11 of this Regulation shall apply mutatis mutandis, by way of derogation from paragraph 1 of this Article.
Predlog spremembe 86 iz prve obravnave EP.
EP first reading amendment 86.
Označevanje novih živil in sestavin novih živil
Labelling of novel foods and novel food ingredients
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, kot sledijo:
Without prejudice to the provisions and requirements of Directive 2000/13/EC, all specific data on novel foods shall be indicated and labelled as set out below to ensure proper consumer information:
(a) vsako novo živilo na trgu ima ob prodaji 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 in pravilna uporaba, so na jasen, natančen, lahko berljiv in razumljiv način navedene na embalaži živila;
(b) 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;
(c) prisotnost novega živila ali nove sestavine, ki nadomešča snov ali sestavino v živilu, ne glede na to, ali ga novo živilo nadomesti, je navedena na označbi 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 potrošnika o tem obvestiti z jasno, natančno in lahko berljivo označbo na embalaži živila.
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.
Predlog spremembe 62 iz prve obravnave EP.
EP first reading amendment 62.
Vsebina seznama tradicionalnih živil iz tretjih držav
Content of the list of traditional foods from third countries
Seznam tradicionalnih živil iz tretjih držav se posodablja v skladu s postopkom iz člena 11.
The list of traditional foods from third countries shall be updated in accordance with the procedure laid down in Article 11.