natgillin/translations-raw huggingface dataset:
By 1 January 2018 the Commission shall, by means of an implementing act, establish the Union list by including in it the novel foods authorised or notified under Article 4, 5 or 7 of Regulation (EC) No 258/97, including any existing authorisation conditions.
Komisija odobri novo živilo in posodobi seznam Unije v skladu s pravili, določenimi v:
That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 30(2).
členih 10, 11 in 12 ter po potrebi v členu 27 ali
Article 9
členih 14 do 19.
Content and updating of the Union list
Odobritev novega živila in posodabljanje seznama Unije iz odstavka 1 pomeni:
The Commission shall authorise a novel food and update the Union list in accordance with the rules laid down in:
dodajanje novega živila na seznam Unije;
Articles 10, 11 and 12 and, where applicable, Article 27; or
črtanje novega živila s seznama Unije; ali
Articles 14 to 19.
dodajanje, črtanje ali spreminjanje specifikacij, pogojev uporabe, dodatnih posebnih zahtev za označevanje ali za spremljanje po dajanju na trg, povezanih z vključitvijo novega živila na seznam Unije.
The authorisation of a novel food and updating of the Union list provided for in paragraph 1 shall consist of one of the following:
Vnos novega živila na seznam Unije iz odstavka 2 vključuje specifikacijo novega živila in po potrebi:
adding a novel food to the Union list;
pogoje, pod katerimi se lahko novo živilo uporablja, zlasti zahteve, potrebne za to, da bi preprečili morebitne škodljive učinke pri določenih skupinah prebivalstva, prekoračitve največjega dovoljenega vnosa in tveganja v primeru čezmernega uživanja;
removing a novel food from the Union list;
dodatne posebne zahteve za označevanje zaradi obveščanja končnega potrošnika o vseh posebnih značilnostih ali lastnostih živil, kot so sestava, hranilna vrednost ali hranilni učinki in predvidena uporaba živila, zaradi katerih novo živilo ni več enakovredno obstoječemu živilu, ali o posledicah za zdravje nekaterih skupin prebivalstva;
adding, removing or changing the specifications, conditions of use, additional specific labelling requirements or post-market monitoring requirements associated with the inclusion of a novel food in the Union list.
zahteve za spremljanje po dajanju na trg v skladu s členom 24.
The entry for a novel food in the Union list provided for in paragraph 2 shall include the specification of the novel food and, where appropriate:
POGLAVJE III
the conditions under which the novel food may be used, including in particular any requirements necessary to avoid possible adverse effects on particular groups of the population, the exceeding of maximum intake levels and risks in case of excessive consumption;
POSTOPKI ODOBRITVE NOVEGA ŽIVILA
additional specific labelling requirements to inform the final consumer of any specific characteristic or food property, such as the composition, nutritional value or nutritional effects and intended use of the food, which renders a novel food no longer equivalent to an existing food or of implications for the health of specific groups of the population;
ODDELEK I
post-market monitoring requirements in accordance with Article 24.
Splošna pravila
CHAPTER III
Člen 10
AUTHORISATION PROCEDURES FOR A NOVEL FOOD
Postopek za odobritev dajanja novega živila na trg v Uniji in posodobitev seznama Unije
SECTION I
Postopek za odobritev dajanja novega živila na trg v Uniji ter posodobitev seznama Unije iz člena 9 se začne na pobudo Komisije ali na podlagi vloge, ki jo vložnik predloži Komisiji.
General rules
Komisija brez odlašanja da vlogo na voljo državam članicam.
Article 10
Komisija zagotovi, da je povzetek vloge, ki temelji na informacijah iz točk (a), (b) in (e) odstavka 2 tega člena, javno dostopen.
Procedure for authorising the placing on the market within the Union of a novel food and updating the Union list
Vloga za odobritev vključuje:
The procedure for authorising the placing on the market within the Union of a novel food and updating of the Union list provided for in Article 9 shall start either on the Commission's initiative or following an application to the Commission by an applicant.
ime in naslov vložnika;
The Commission shall make the application available to the Member States without delay.
ime in opis novega živila;
The Commission shall make the summary of the application, based on the information referred to in points (a), (b) and (e) of paragraph 2 of this Article, publicly available.
opis postopka oziroma postopkov proizvodnje;
The application for an authorisation shall include:
podroben opis sestave novega živila;
the name and address of the applicant;
znanstvene dokaze, da novo živilo ne ogroža zdravja ljudi;
the name and description of the novel food;
če je primerno, analitske metode;
the description of the production process(es);
predlog pogojev predvidene uporabe in posebnih zahtev za označevanje, ki ne zavajajo potrošnika, ali preverljivo utemeljitev, zakaj ti elementi niso potrebni.
the detailed composition of the novel food;
3.
scientific evidence demonstrating that the novel food does not pose a safety risk to human health;
Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) na zahtevo Komisije poda mnenje, ali bi lahko posodobitev vplivala na zdravje ljudi.
where appropriate, the analysis method(s);
Če se metode preskušanja uporabljajo za namensko proizvedene nanomateriale iz točk (a)(viii) in (x) člena 3(2), vložniki podajo razlago glede znanstvene ustreznosti teh metod za nanomateriale in po potrebi glede tehničnih prilagoditev, izvedenih zaradi njihovih posebnih značilnosti.
a proposal for the conditions of intended use and for specific labelling requirements which do not mislead the consumer or a verifiable justification why those elements are not necessary.
Postopek za odobritev dajanja novega živila na trg Unije in posodabljanje seznama Unije, kot je določeno v členu 9, se zaključi s sprejetjem izvedbenega akta v skladu s členom 12.
Upon request by the Commission, the European Food Safety Authority (‘the Authority’) shall give its opinion as to whether the update is liable to have an effect on human health.
Z odstopanjem od odstavka 5 lahko Komisija zaključi postopek v kateri koli fazi in ne nadaljuje načrtovane posodobitve, če oceni, da takšna posodobitev ni upravičena.
When test methods are applied to engineered nanomaterials as referred to in points (a) (viii) and (ix) of Article 3(2), an explanation shall be provided by the applicants of their scientific appropriateness for nanomaterials and, where applicable, of the technical adaptations or adjustments that have been made in order to respond to the specific characteristics of those materials.
Komisija v takih primerih, če do njih pride, upošteva stališča držav članic in mnenje Agencije ter vse druge upravičene dejavnike, ki so pomembni za obravnavano posodobitev.
The procedure for authorising the placing on the market within the Union of a novel food and updating the Union list as provided for in Article 9 shall end with the adoption of an implementing act in accordance with Article 12.
Komisija neposredno obvesti vložnika in vse države članice o razlogih, zaradi katerih meni, da posodobitev ni upravičena.
By way of derogation from paragraph 5, the Commission may terminate the procedure at any stage, and decide not to proceed with an update, where it considers that such an update is not justified.
Komisija zagotovi, da je seznam takšnih vlog javno dostopen.
In such cases, where applicable, the Commission shall take account of the views of Member States, the Authority's opinion and any other legitimate factors relevant to the update under consideration.
Vložnik lahko kadar koli umakne vlogo, s čimer se postopek zaključi.
The Commission shall inform the applicant and all Member States directly of the reasons for not considering the update to be justified.
Člen 11
The Commission shall make the list of such applications publicly available.
Mnenje Agencije
The applicant may withdraw its application at any time, thereby terminating the procedure.
Če Komisija zahteva mnenje Agencije, ji veljavno vlogo posreduje brez odlašanja, najkasneje pa en mesec po potrditvi njene veljavnosti.
Article 11
Agencija sprejme mnenje v devetih mesecih od datuma prejema veljavne vloge.
Opinion of the Authority
Pri ocenjevanju varnosti novega živila Agencija, kadar je primerno, upošteva, ali:
Where the Commission requests an opinion from the Authority, it shall forward the valid application to the Authority without delay, and not later than one month after having verified its validity.
je zadevno novo živilo enako varno kot živilo iz primerljive skupine živil, ki je že bilo dano na trg v Uniji;
The Authority shall adopt its opinion within nine months from the date of receipt of a valid application.
sestava novega živila in pogoji njegove uporabe ne ogrožajo zdravja ljudi v Uniji;
In assessing the safety of novel foods, the Authority shall, where appropriate, consider whether:
se novo živilo, ki naj bi nadomestilo drugo živilo, od slednjega ne razlikuje tako, da bi bilo ob običajnem uživanju za potrošnika prehransko manj ugodno.
the novel food concerned is as safe as food from a comparable food category already placed on the market within the Union;
Agencija pošlje mnenje Komisiji, državam članicam in po potrebi vložniku.
the composition of the novel food and the conditions of its use do not pose a safety risk to human health in the Union;
V ustrezno utemeljenih primerih, kadar Agencija od vložnika zahteva dodatne informacije, se lahko devetmesečni rok iz odstavka 1 podaljša.
a novel food, which is intended to replace another food, does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
Agencija po posvetovanju z vložnikom določi rok, v katerem je treba predložiti navedene dodatne informacije, in o tem obvesti Komisijo.
The Authority shall forward its opinion to the Commission, to the Member States and, where applicable, to the applicant.
Če Komisija v osmih delovnih dneh po tem, ko jo Agencija o tem obvesti, ne ugovarja podaljšanju, se devetmesečni rok iz odstavka 1 avtomatično podaljša za obdobje, predvideno z določitvijo dodatnega roka.
In duly justified cases, where the Authority requests additional information from the applicant, the nine-month period provided for in paragraph 1 may be extended.
Komisija o podaljšanju obvesti države članice.
After consulting the applicant, the Authority shall specify a period within which that additional information is to be provided and shall inform the Commission thereof.
Če Agencija ne prejme dodatnih informacij iz odstavka 4 v dodatnem roku iz navedenega odstavka, pripravi mnenje na podlagi razpoložljivih informacij.
Where the Commission does not object to the extension within eight working days of being informed by the Authority, the nine-month period provided for in paragraph 1 shall be automatically extended by that additional period.
Če vložnik predloži dodatne informacije na lastno pobudo, jih pošlje Agenciji.
The Commission shall inform the Member States of that extension.
V teh primerih Agencija mnenje poda v roku devetih mesecev, določenem v odstavku 1.
Where the additional information referred to in paragraph 4 is not provided to the Authority within the additional period referred to in that paragraph, the Authority shall draw up its opinion on the basis of the available information.
Agencija dodatne informacije, posredovane v skladu z odstavkoma 4 in 6, da na voljo Komisiji in državam članicam.
Where an applicant submits additional information on its own initiative, it shall send that information to the Authority.
Člen 12
In such cases, the Authority shall give its opinion within the nine-month period provided for in paragraph 1.
Odobritev novega živila in posodobitve seznama Unije
The Authority shall make the additional information provided in accordance with paragraphs 4 and 6 available to the Commission and to the Member States.
Komisija v sedmih mesecih od datuma objave mnenja Agencije predloži odboru iz člena 30(1) osnutek izvedbenega akta o odobritvi dajanja novega živila na trg v Uniji in posodobitvi seznama Unije, ob upoštevanju naslednjega:
Article 12
pogojev iz točk (a) in (b) člena 7 ter po potrebi točke (c) navedenega člena;
Authorisation of a novel food and updates of the Union list
vseh ustreznih določb prava Unije, vključno s previdnostnim načelom iz člena 7 Uredbe (ES) št. 178/2002;
Within seven months from the date of publication of the Authority's opinion, the Commission shall submit to the committee referred to in Article 30(1) a draft implementing act authorising the placing on the market within the Union of a novel food and updating the Union list, taking into account the following:
mnenja Agencije;
the conditions provided for in points (a) and (b) of Article 7 and, where applicable, in point (c) of that Article;
vseh drugih upravičenih dejavnikov, ki so pomembni za obravnavano vlogo.
any relevant provision of Union law, including the precautionary principle as referred to in Article 7 of Regulation (EC) No 178/2002;
Navedeni izvedbeni akt se sprejme v skladu s postopkom pregleda iz člena 30(3).
the Authority's opinion;
Če Komisija Agencije ne zaprosi za mnenje v skladu s členom 10(3), začne sedemmesečni rok iz odstavka 1 tega člena teči od dne, ko Komisija prejme veljavno vlogo v skladu s členom 10(1).
any other legitimate factors relevant to the application under consideration.
Člen 13
That implementing act shall be adopted in accordance with the examination procedure referred to in Article 30(3).
Izvedbeni akti, s katerimi se določijo upravne in znanstvene zahteve za vloge
Where the Commission has not requested an opinion from the Authority in accordance with Article 10(3), the seven-month period provided for in paragraph 1 of this Article shall start from the date on which a valid application is received by the Commission in accordance with Article 10(1).
Komisija do 1. januarja 2018 sprejme izvedbene akte v zvezi z:
Article 13
vsebino, pripravo in predložitvijo vloge iz člena 10(1);
Implementing acts laying down administrative and scientific requirements for applications
ureditvijo takojšnjega preverjanja veljavnosti navedenih vlog;
By 1 January 2018, the Commission shall adopt implementing acts concerning:
vrsto informacij, ki morajo biti vključene v mnenje Agencije v skladu s členom 11.
the content, drafting and presentation of the application referred to in Article 10(1);
ODDELEK II
the arrangements for verifying the validity, without delay, of those applications;
Posebna pravila za tradicionalna živila iz tretjih držav
the type of information to be included in the opinion of the Authority referred to in Article 11.
Člen 14
SECTION II
Priglasitev tradicionalnega živila iz tretje države
Specific rules for traditional foods from third countries
Namesto postopka iz člena 10 lahko vložnik, ki namerava dati na trg v Uniji tradicionalno živilo iz tretje države, izbere, da bo priglasil to namero Komisiji.
Article 14
Priglasitev vključuje naslednje informacije:
Notification of a traditional food from a third country
ime in opis tradicionalnega živila;
Instead of following the procedure referred to in Article 10, an applicant, who intends to place on the market within the Union a traditional food from a third country, may opt to submit a notification of that intention to the Commission.
podroben opis sestave tradicionalnega živila;
The notification shall include the following information:
državo ali države porekla tradicionalnega živila;
the name and description of the traditional food;
dokumentacijo, ki izkazuje dolgo tradicijo varne uporabe živila v tretji državi;
the detailed composition of the traditional food;
predlog pogojev predvidene uporabe in posebnih zahtev za označevanje, ki ne zavajajo potrošnika, ali preverljivo utemeljitev, zakaj ti elementi niso potrebni.
the country or countries of origin of the traditional food;
Člen 15
documented data demonstrating the history of safe food use in a third country;
Postopek za priglasitev dajanja tradicionalnega živila iz tretje države na trg v Uniji
a proposal for the conditions of intended use and for specific labelling requirements, which do not mislead the consumer, or a verifiable justification why those elements are not necessary.
Komisija državam članicam in Agenciji brez odlašanja, najkasneje pa en mesec po potrditvi veljavnosti, posreduje veljavno priglasitev iz člena 14.
Article 15
V štirih mesecih po tem, ko Komisija v skladu z odstavkom 1 posreduje veljavno priglasitev, lahko država članica ali Agencija Komisiji predloži ustrezno utemeljene pripombe glede varnosti dajanja zadevnega tradicionalnega živila na trg v Uniji.
Procedure for notifying the placing on the market within the Union of a traditional food from a third country
Komisija vložnika obvesti o vsaki ustrezno utemeljeni pripombi glede varnosti, takoj ko je ta predložena.
The Commission shall forward the valid notification provided for in Article 14 without delay, and not later than one month after having verified its validity, to the Member States and to the Authority.
Države članice, Agencija in vložnik se obvestijo o rezultatih postopka iz odstavka 2.
Within four months from the date on which a valid notification is forwarded by the Commission in accordance with paragraph 1, a Member State or the Authority may submit to the Commission duly reasoned safety objections to the placing on the market within the Union of the traditional food concerned.
Kadar v roku, določenem v odstavku 2, ni predloženih ustrezno utemeljenih pripomb glede varnosti v skladu z navedenim odstavkom, Komisija odobri dajanje zadevnega tradicionalnega živila na trg v Uniji in brez odlašanja posodobi seznam Unije.
The Commission shall inform the applicant of any duly reasoned safety objection as soon as it is submitted.
Pri vnosu na seznam Unije se navede, da gre za tradicionalno živilo iz tretje države.
The Member States, the Authority and the applicant shall be informed of the outcome of the procedure referred to in paragraph 2.
Po potrebi se določijo posebni pogoji za uporabo, posebne zahteve v zvezi z označevanjem ali zahteve za spremljanje po dajanju na trg.
Where no duly reasoned safety objections have been submitted in accordance with paragraph 2 within the time-limit laid down in that paragraph, the Commission shall authorise the placing on the market within the Union of the traditional food concerned and update the Union list without delay.
Če so Komisiji predložene ustrezno utemeljene pripombe glede varnosti v skladu z odstavkom 2, Komisija ne odobri dajanja zadevnega tradicionalnega živila na trg v Uniji niti ne posodobi seznama Unije.
The entry in the Union list shall specify that it concerns a traditional food from a third country.
V navedenem primeru lahko vložnik predloži Komisiji vlogo v skladu s členom 16.
Where applicable, certain conditions for use, specific labelling requirements, or post-market monitoring requirements shall be specified.
Člen 16
Where duly reasoned safety objections have been submitted to the Commission in accordance with paragraph 2, the Commission shall not authorise the placing on the market within the Union of the traditional food concerned or update the Union list.
Vloga za odobritev tradicionalnega živila iz tretje države
In that case, the applicant may submit an application to the Commission in accordance with Article 16.
Kadar Komisija v skladu s členom 15(5) ne odobri dajanja zadevnega tradicionalnega živila na trg v Uniji niti ne posodobi seznama Unije, lahko vložnik predloži vlogo, ki poleg že predloženih informacij v skladu s členom 14 vključuje dokumentacijo o ustrezno utemeljenih pripombah glede varnosti, predloženih v skladu s členom 15(2).
Article 16
Komisija veljavno vlogo brez odlašanja posreduje Agenciji in jo da na voljo državam članicam.
Application for the authorisation of a traditional food from a third country
Člen 17
Where the Commission, acting in accordance with Article 15(5), does not authorise the placing on the market within the Union of a traditional food from a third country or update the Union list, the applicant may submit an application including, in addition to the information already provided in accordance with Article 14, documented data relating to the duly reasoned safety objections submitted in accordance with Article 15(2).
Mnenje Agencije o tradicionalnem živilu iz tretje države
The Commission shall, without delay, forward the valid application to the Authority and make it available to Member States.
Agencija sprejme mnenje v šestih mesecih od datuma prejema veljavne vloge.
Article 17
Agencija pri ocenjevanju varnosti tradicionalnega živila iz tretje države upošteva naslednje:
Opinion of the Authority on a traditional food from a third country
ali je dolga tradicija varne uporabe živila v tretji državi podprta z zanesljivimi podatki, ki jih je vložnik predložil v skladu s členoma 14 in 16;
The Authority shall adopt its opinion within six months from the date of receipt of a valid application.
ali sestava živila in pogoji njegove uporabe ne ogrožajo zdravja ljudi v Uniji;
In assessing the safety of a traditional food from a third country, the Authority shall consider the following matters:
če naj bi tradicionalno živilo iz tretje države nadomestilo drugo živilo, ali se od slednjega ne razlikuje tako, da bi bilo ob običajnem uživanju za potrošnika prehransko manj ugodno.
whether the history of safe food use in a third country is substantiated by reliable data submitted by the applicant in accordance with Articles 14 and 16;
Agencija pošlje svoje mnenje Komisiji, državam članicam in vložniku.
whether the composition of the food and the conditions of its use do not pose a safety risk to human health in the Union;
V ustrezno utemeljenih primerih, kadar Agencija od vložnika zahteva dodatne informacije, se lahko šestmesečni rok iz odstavka 1 podaljša.
where the traditional food from the third country is intended to replace another food, whether it does not differ from that food in such a way that its normal consumption would be nutritionally disadvantageous for the consumer.
Če Komisija ne ugovarja podaljšanju v osmih delovnih dneh od dneva, ko jo Agencija o tem obvesti, se šestmesečni rok iz odstavka 1 avtomatično podaljša za obdobje, predvideno z določitvijo dodatnega roka.
The Authority shall forward its opinion to the Commission, the Member States and the applicant.
V takih primerih Agencija poda mnenje v šestmesečnem roku, določenem v odstavku 1.
In duly justified cases, where the Authority requests additional information from the applicant, the six-month period provided for in paragraph 1 may be extended.
Agencija dodatne informacije, pridobljene v skladu s odstavki 4 in 6 da na voljo Komisiji in državam članicam.
Where the Commission does not object to the extension within eight working days of being informed by the Authority, the six-month period provided for in paragraph 1 shall be automatically extended by that additional period.
Člen 18
In such cases, the Authority shall give its opinion within the six-month period provided for in paragraph 1.
Odobritev tradicionalnega živila iz tretje države in posodobitve seznama Unije
The Authority shall make the additional information provided in accordance with paragraphs 4 and 6 available to the Commission and to Member States.
Komisija v treh mesecih od datuma objave mnenja Agencije predloži odboru iz člena 30(1) osnutek izvedbenega akta o odobritvi dajanja tradicionalnega živila iz tretje države na trg v Uniji in posodobitvi seznama Unije, ob upoštevanju naslednjega:
Article 18
pogojev iz točk (a) in (b) člena 7 ter po potrebi točke (c) navedenega člena;
Authorisation of a traditional food from a third country and updates of the Union list
Z odstopanjem od odstavka 1 lahko Komisija zaključi postopek v kateri koli fazi in ne nadaljuje načrtovane posodobitve, če oceni, da takšna posodobitev ni upravičena.