natgillin/translations-raw huggingface dataset:
Applicants should use the format established in Annex III to indicate the information they wish to have treated as confidential and should provide all necessary details to substantiate the request for confidentiality.
Ta priloga se posodobi med postopkom priglasitve ali vloge vsakič, ko vložnik predloži zahtevo, da se informacije obravnavajo kot zaupne.
ANNEX III
Kadar postopek proizvodnje vsebuje zaupne podatke, se predloži nezaupni povzetek postopka proizvodnje.
Justification for confidential information
Informacije, za katere se zahteva, da se obravnavajo kot zaupne
This Annex shall be updated during the notification or application procedure each time an applicant submits a request for information to be treated as confidential.
Utemeljitev
Where the production process contains confidential data, a non-confidential summary of the production process shall be provided.
Oddelek x.y (predložen LLLL/MM/DD)
Information requested to be considered as confidential
Priloga X (predložena LLLL/MM/DD)
Justification
povzetek dokumentacije;
Annex X (submitted on YYYY/MM/DD)
Oddelek x.y.
Section x.y. (submitted on YYYY/MM/DD)
(predložen LLLL/MM/DD)
Commission Implementing Regulation (EU) 2017/2469
Izvedbena uredba Komisije (EU) 2017/2469
laying down administrative and scientific requirements for applications referred to in Article 10 of Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods
o določitvi upravnih in znanstvenih zahtev za vloge iz člena 10 Uredbe (EU) 2015/2283 Evropskega parlamenta in Sveta o novih živilih
Having regard to Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 of the European Parliament and of the Council and repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001 [1], and in particular Article 13 and Article 35(3) thereof,
ob upoštevanju Uredbe (EU) 2015/2283 Evropskega parlamenta in Sveta z dne 25. novembra 2015 o novih živilih, spremembi Uredbe (EU) št. 1169/2011 Evropskega parlamenta in Sveta in razveljaviti Uredbe (ES) št. 258/97 Evropskega parlamenta in Sveta ter Uredbe Komisije (ES) št. 1852/2001 [1] ter zlasti člena 13 in člena 35(3) Uredbe,
Pursuant to Article 13 of Regulation (EU) 2015/2283, the Commission has to adopt implementing acts laying down administrative and scientific data requirements for applications referred to in Article 10(1) of that Regulation.
V skladu s členom 13 Uredbe (EU) 2015/2283 mora Komisija sprejeti izvedbene akte, ki določajo zahteve v zvezi z upravnimi in znanstvenimi podatki za vloge iz člena 10(1) navedene uredbe.
Without prejudice to Articles 5 and 10 of Regulation (EU) 2015/2283, the Commission should verify whether the application falls within the scope of that Regulation and its validity.
Brez poseganja v člena 5 in 10 Uredbe (EU) 2015/2283 bi morala Komisija preveriti, ali vloga spada v področje uporabe navedene uredbe, in njeno veljavnost.
Applications referred to in Article 10(1) of Regulation (EU) 2015/2283 should contain sufficient information and scientific documentation to allow the Commission to verify their validity and enable the European Food Safety Authority (the Authority) to conduct comprehensive risk assessments of the novel foods.
Vloge iz člena 10(1) Uredbe (EU) 2015/2283 bi morale vsebovati zadostne informacije in znanstveno dokumentacijo, da Komisija lahko preveri njihovo veljavnost, Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) pa izvede celovite ocene tveganj novih živil.
The applications should include detailed descriptions of the safety evaluation strategy, the raw data, information on the relevance of the test material used in the toxicological studies, and detection and characterisation test methods for the engineered nanomaterials.
Vloge bi morale vsebovati podrobne opise strategije ocenjevanja varnosti, surove podatke, informacije o ustreznosti testnega materiala, uporabljenega v toksikoloških študijah, ter metode preskušanja za zaznavanje in opredelitev namensko proizvedenih nanomaterialov.
Experience has shown that in certain cases a novel food intended for a particular group of the population may also reasonably be expected to be consumed by other groups of the population and that risk management measures may be necessary to mitigate potential health risks to those other population groups.
Izkušnje so pokazale, da se v nekaterih primerih lahko upravičeno pričakuje, da bodo novo živilo, namenjeno posebni skupini prebivalstva, zaužile tudi druge skupine prebivalstva, in so morda potrebni ukrepi za obvladovanje tveganja, da se zmanjša morebitno tveganje za zdravje za te druge skupine prebivalstva.
Therefore, sufficient information should be provided in the application to enable the risks to those population groups to be assessed.
Zato bi bilo treba v vlogi predložiti dovolj informacij, da se lahko oceni tveganje za te skupine prebivalstva.
Where the applicant submits an application to add, remove or change the conditions of use, the specifications, additional specific labelling requirements or post-market monitoring requirements of an authorised novel food, it may not be necessary for the applicant to provide all the data required for the risk assessment, where the applicant provides verifiable justification.
Kadar vložnik predloži vlogo za dodajanje, črtanje ali spreminjanje pogojev uporabe, specifikacij, dodatnih posebnih zahtev za označevanje ali za spremljanje odobrenega novega živila po dajanju na trg, morda ni treba, da vložnik predloži vse podatke, ki se zahtevajo za oceno tveganja, kadar vložnik predloži preverljivo utemeljitev.
In order to ensure that toxicological tests are performed to a certain standard, they should be carried out in accordance with the rules set out in Directive 2004/10/EC of the European Parliament and of the Council [2].
Da bi bili toksikološki preskusi zagotovo opravljeni v skladu z določenim standardom, bi jih bilo treba izvajati po pravilih iz Direktive 2004/10/ES Evropskega parlamenta in Sveta [2].
Where those tests are carried out outside the territory of the Union, they should follow the OECD Principles of Good Laboratory Practice [3].
Kadar se taki preskusi izvajajo zunaj ozemlja Unije, bi morali slediti načelom dobre laboratorijske prakse OECD [3].
The opinion of the Authority should provide sufficient information to ascertain whether the proposed use of the novel food is safe for consumers.
Mnenje Agencije bi moralo vsebovati zadostne informacije, da se oceni, ali je predlagana uporaba novega živila varna za potrošnike.
In order to benefit from data protection, as laid down in Article 26 of Regulation (EU) 2015/2283, requests for protection of proprietary data should be justified and all data concerned should be kept in a separate part of the application.
Zaradi varstva podatkov, kakor je določeno v členu 26 Uredbe (ES) št. 2015/2283, bi bilo treba zahteve za varstvo pravno zaščitenih podatkov utemeljiti, vse zadevne podatke pa bi bilo treba navesti v ločenem delu vloge.
Pursuant to Article 35 of Regulation (EU) 2015/2283, it is necessary to lay down transitional measures for the entry into force of that Regulation.
V skladu s členom 35 Uredbe (EU) 2015/2283 je treba določiti prehodne ukrepe za začetek veljavnosti navedene uredbe.
This Regulation lays down rules for the implementation of Article 13 of Regulation (EU) 2015/2283 as regards the administrative and scientific requirements for applications referred to in Article 10(1) and the transitional measures referred to in Article 35(3) of that Regulation.
Ta uredba določa pravila za izvajanje člena 13 Uredbe (EU) 2015/2283 glede upravnih in znanstvenih zahtev za vloge iz člena 10(1) in prehodnih ukrepov iz člena 35(3) navedene uredbe.
In addition to the definitions laid down in Articles 2 and 3 of Regulation (EC) No 178/2002 of the European Parliament and of the Council [4] and Regulation (EU) 2015/2283, the following definition shall apply:‘application’ means a stand-alone dossier containing the information and the scientific data submitted for the authorisation of a novel food pursuant to Article 10(1) of Regulation (EU) 2015/2283.
Poleg opredelitev pojmov iz členov 2 in 3 Uredbe (ES) št. 178/2002 Evropskega parlamenta in Sveta [4] in Uredbe (EU) 2015/2283 se uporablja naslednja opredelitev pojmov:„vloga“ pomeni samostojno dokumentacijo, ki vsebuje informacije in znanstvene podatke, predložene za odobritev novega živila v skladu s členom 10(1) Uredbe (EU) 2015/2283.
the scientific data as provided for in Article 5.
znanstvene podatke iz člena 5.
Where the applicant submits an application to modify the conditions of use, the specifications, additional specific labelling requirements or post-market monitoring requirements of an authorised novel food, it may not be necessary for the applicant to provide all the data required under Article 5 of this Regulation where the applicant provides verifiable justification explaining that the proposed changes do not affect the results of the existing risk assessment.
Kadar vložnik predloži vlogo za spreminjanje pogojev uporabe, specifikacij, dodatnih posebnih zahtev za označevanje ali za spremljanje odobrenega novega živila po dajanju na trg, morda ni treba, da vložnik predloži vse podatke, zahtevane v členu 5 te uredbe, kadar vložnik predloži preverljivo utemeljitev, ki pojasnjuje, da predlagane spremembe ne vplivajo na rezultate obstoječe ocene tveganja.
In addition to the information referred to in points (a), (b) and (e) of Article 10(2) of Regulation (EU) 2015/2283, the summary of the dossier referred to in paragraph 1(c) of this Article shall set out the reasons why the use of the novel food complies with the conditions laid down in Article 7 of Regulation (EU) 2015/2283.
Poleg informacij iz točk (a), (b) in (e) člena 10(2) Uredbe (EU) 2015/2283 se v povzetku dokumentacije iz odstavka 1(c) tega člena navedejo razlogi, zaradi katerih je uporaba novega živila v skladu s pogoji iz člena 7 Uredbe (EU) 2015/2283.
Administrative data requirements
Zahteve glede upravnih podatkov
In addition to the information set out in Article 10(2) of Regulation (EU) 2015/2283, the application shall include the following administrative data:
Poleg informacij iz člena 10(2) Uredbe (EU) 2015/2283 vloga vključuje naslednje upravne podatke:
the name(s) of the manufacturer(s) of the novel food, if different than the applicant's, address and contact details;
ime(-na) proizvajalca(-ev) novega živila, če to ni sam vložnik, ter naslov in kontaktne podatke;
the name, address and contact details of the person responsible for the dossier authorised to communicate on behalf of the applicant with the Commission;
ime, naslov in kontaktne podatke osebe, odgovorne za dokumentacijo, pooblaščene za komuniciranje s Komisijo v imenu vložnika;
the date of submission of the dossier;
datum predložitve dokumentacije;
a table of contents of the dossier;
kazalo vsebine dokumentacije;
a detailed list of documents annexed to the dossier, including references to titles, volumes and pages;
podroben seznam dokumentov, priloženih dokumentaciji, vključno s sklicevanji na naslove, zvezke in strani;
a list of the parts of the dossier to be treated as confidential and verifiable justification in accordance with Article 23 of Regulation (EU) 2015/2283 and the rules set out in Annex II to this Regulation.
seznam delov dokumentacije, ki se obravnavajo kot zaupni, in preverljivo utemeljitev v skladu s členom 23 Uredbe (EU) 2015/2283, ter pravila, določena v Prilogi II k tej uredbi.
Where the production process contains confidential data, a non-confidential summary of the production process shall be provided;
Kadar postopek proizvodnje vsebuje zaupne podatke, se predloži nezaupni povzetek postopka proizvodnje;
information and explanations substantiating the existence of the applicant's right of reference to the proprietary scientific evidence or scientific data in accordance with Article 26 of Regulation (EU) 2015/2283.
informacije in razlage, ki utemeljujejo obstoj vložnikove pravice sklicevanja na pravno zaščitene znanstvene dokaze ali znanstvene podatke v skladu s členom 26 Uredbe (EU) 2015/2283.
That information shall be included in a separate folder.
Te informacije se vključijo v ločeno mapo.
Scientific data requirements
Zahteve glede znanstvenih podatkov
The dossier submitted in support of an application for the authorisation of a novel food shall enable a comprehensive risk assessment of the novel food.
Dokumentacija, predložena v podporo vlogi za odobritev novega živila, omogoča celovito oceno tveganja novega živila.
Where the application for the authorisation of a novel food involves the use of engineered nanomaterials as referred to in points (a) (viii) and (ix) of Article 3(2) of Regulation (EU) 2015/2283, the applicant shall provide detection and characterisation test methods in compliance with the requirements of Article 10(4) of that Regulation.
Kadar vloga za odobritev novega živila vključuje uporabo namensko proizvedenih nanomaterialov iz točk (a) (viii) in (ix) člena 3(2) Uredbe (EU) 2015/2283, vložnik predloži metode preskušanja za zaznavanje in opredelitev v skladu s členom 10(4) navedene uredbe.
The applicant shall provide a copy of the documentation on the procedure and strategy followed when gathering the data.
Vložnik predloži kopijo dokumentacije o postopku in strategiji, uporabljenih pri zbiranju podatkov.
The applicant shall provide a description of the safety evaluation strategy and the corresponding toxicological testing strategy and shall justify the inclusion or exclusion of specific studies or information.
Vložnik predloži opis strategije ocenjevanja varnosti in ustrezne strategije toksikološkega preskušanja ter utemelji vključitev ali izključitev posebnih študij ali informacij.
The applicant shall provide on request the raw data for the individual studies, published and unpublished, undertaken by the applicant, or on their behalf, to support their application.
Vložnik v podporo svoji vlogi na zahtevo predloži surove podatke za posamezne študije, objavljene ali neobjavljene, ki jih je izvedel vložnik ali so bile izvedene v njegovem imenu.
This information includes data used to generate the conclusions of the individual studies and results of examinations.
Te informacije vključujejo podatke, uporabljene za pripravo ugotovitev posameznih študij in rezultatov pregledov.
Where it cannot be excluded that a novel food intended for a particular group of the population would be also consumed by other groups of the population the safety data provided shall also cover those groups.
Kadar ni mogoče izključiti možnosti, da bodo novo živilo, namenjeno posebni skupini prebivalstva, zaužile tudi druge skupine prebivalstva, morajo predloženi podatki o varnosti zajemati tudi te skupine.
For each biological or toxicological study, the applicant shall clarify whether the test material conforms to the proposed or existing specification.
Za vsako biološko ali toksikološko študijo vložnik pojasni, ali je preskusna snov skladna s predlagano ali obstoječo specifikacijo.
Where the test material differs from that specification, the applicant shall demonstrate the relevance of those data to the novel food under consideration.
Kadar se preskusna snov razlikuje od specifikacije, vložnik dokaže pomembnost zadevnih podatkov za novo živilo, ki se obravnava.
Toxicological studies shall be conducted in facilities which comply with the requirements of Directive 2004/10/EC or, if they are carried out outside the territory of the Union, they shall follow the OECD Principles of Good Laboratory Practice.
Toksikološke študije se izvedejo v prostorih, ki izpolnjujejo zahteve Direktive 2004/10/ES, če pa se izvajajo zunaj ozemlja Unije, izpolnjujejo načela dobre laboratorijske prakse OECD.
The applicant shall provide evidence of compliance with those requirements and shall justify any deviation from the standard protocols.
Vložnik predloži dokaze o skladnosti z navedenimi zahtevami in upraviči kakršno koli odstopanje od standardnih protokolov.
The applicant shall propose an overall conclusion on the safety of the proposed uses of the novel food.
Vložnik predlaga splošen sklep glede varnosti predlaganih uporab novega živila.
Verification of the validity of an application
Preverjanje veljavnosti vloge
On receipt of an application the Commission shall without delay verify whether the application falls within the scope of Regulation (EU) 2015/2283 and whether the application fulfils the requirements set out in Article 10(2) of that Regulation.
Ob prejemu vloge Komisija nemudoma preveri, ali vloga spada v področje uporabe Uredbe (EU) 2015/2283 in ali vloga izpolnjuje zahteve iz člena 10(2) navedene uredbe.
The Authority shall provide the Commission with its views on whether the application fulfils the relevant requirements set out in Article 10(2) of Regulation (EU) 2015/2283 within a period of 30 working days.
Agencija Komisiji v roku 30 delovnih dni predloži svoje mnenje o tem, ali vloga izpolnjuje ustrezne zahteve iz člena 10(2) Uredbe (EU) 2015/2283.
The Commission may request additional information from the applicant as regards the validity of the application and agree with the applicant of the period within which that information shall be provided.
Komisija lahko od vložnika zahteva dodatne informacije glede veljavnosti vloge in se z njim dogovori o roku, v katerem je informacije treba predložiti.
By way of derogation from paragraph 1 of this Article, and without prejudice to Article 10(2) of Regulation (EU) 2015/2283, an application may be considered as valid even if it does not contain all the elements required under Articles 3 to 5 of this Regulation, provided that the applicant has submitted appropriate justification for each missing element.
Z odstopanjem od odstavka 1 tega člena in brez poseganja v člen 10(2) Uredbe (EU) 2015/2283 se vloga lahko šteje za veljavno, tudi če ne vsebuje vseh elementov, zahtevanih v členih 3 do 5 te uredbe, če je vložnik za vsak manjkajoči element predložil ustrezno utemeljitev.
The Commission shall inform the applicant, the Member States and the Authority whether the application is considered valid or not.
Komisija obvesti vložnika, države članice in Agencijo o tem, ali se vloga šteje za veljavno ali ne.
If the application is not considered valid, the Commission shall indicate the reasons why it is not valid.
Če se vloga ne šteje za veljavno, Komisija navede razloge, zakaj ni veljavna.
the identity of the novel food;
ime novega živila;
the assessment of the production process;
oceno postopka proizvodnje;
compositional data;
podatke o sestavi;
the history of use of the novel food and/or its source;
zgodovino uporabe novega živila in/ali njegov vir;
the proposed uses and use levels and anticipated intake;
predlagane uporabe in ravni uporabe ter pričakovani vnos;
absorption, distribution, metabolism and excretion (ADME);
absorpcijo, porazdelitev, presnovo in izločanje (ADME);
nutritional information;
podatke o hranilni vrednosti;
an overall risk assessment for the novel food under the proposed uses and use levels and highlighting uncertainties and limitations where relevant;
celovito oceno tveganja za novo živilo ob predlaganih uporabah in ravneh uporabe, ki izpostavlja negotovosti in omejitve, kadar je to pomembno;
when the dietary exposure exceeds the health-based guidance value identified in the overall risk assessment, the dietary exposure assessment of the novel food shall be detailed, providing the contribution to the total exposure of each food category or foodstuff for which the use is authorised or has been requested;
če prehranska izpostavljenost presega v celoviti oceni tveganja določeno orientacijsko vrednost, ki upošteva vpliv na zdravje, se ocena prehranske izpostavljenosti pri novem živilu podrobno opiše, z navedbo prispevka k skupni izpostavljenosti vsake kategorije živil ali živila, za katerega je bila uporaba odobrena ali je bil vložen zahtevek za odobritev;
conclusions.
ugotovitve.
The Commission may ask for additional information in its request for an opinion of the Authority.
Komisija lahko v zahtevi za mnenje Agencije zahteva dodatne informacije.
By 1 January 2018 the Member States shall notify to the Commission the lists of requests referred to in Article 35(1) of Regulation (EU) 2015/2283.
Države članice do 1. januarja 2018 obvestijo Komisijo o seznamih zahtev iz člena 35(1) Uredbe (EU) 2015/2283.
The Members States shall make available all the information they have received on each request referred to in paragraph 1 to the Commission.
Države članice Komisiji dajo na voljo vse informacije, ki so jih prejele glede posameznih zahtev iz odstavka 1.
Any request referred to in paragraph 1 of this Article shall be updated by the applicant in order to comply with the requirements set out in Article 10(2) of Regulation (EU) 2015/2283 and in this Regulation.
Vložnik kakršno koli zahtevo iz odstavka 1 tega člena posodobi, da je v skladu z zahtevami iz člena 10(2) Uredbe (EU) 2015/2283 in te uredbe.
By way of derogation, paragraphs 1 and 2 shall not apply to requests referred to in paragraph 1 of this Article for which an initial assessment report has been forwarded to the Commission pursuant to Article 6(4) of Regulation (EC) No 258/97 of the European Parliament and of the Council [5] by 1 January 2018, and for which no reasoned objections have been made to the marketing of the novel food concerned within the period established in Article 6(4) of that Regulation.
Velja odstopanje, da se odstavka 1 in 2 ne uporabljata za zahteve iz odstavka 1 tega člena, za katere je bilo Komisiji do 1. januarja 2018 predloženo poročilo o začetni presoji v skladu s členom 6(4) Uredbe (ES) št. 258/97 Evropskega parlamenta in Sveta [5] in za katere v roku, določenem v členu 6(4) navedene uredbe, ni bilo podanih upravičenih ugovorov glede trženja zadevnega novega živila.
The deadline for the submission of the applications referred to in Article 35(2) of Regulation (EU) 2015/2283 shall be 1 January 2019.
Rok za predložitev vlog iz člena 35(2) Uredbe (EU) 2015/2283 je 1. januar 2019.
OJ L 327, 11.12.2015, p.
UL L 327, 11.12.2015, str. 1.
1.
Direktiva 2004/10/ES Evropskega parlamenta in Sveta z dne 11. februarja 2004 o usklajevanju zakonov in drugih predpisov o uporabi načel dobre laboratorijske prakse ter preverjanju njihove uporabe pri preskusih kemičnih snovi (UL L 50, 20.2.2004, str. 44).
Directive 2004/10/EC of the European Parliament and of the Council of 11 February 2004 on the harmonisation of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their applications for tests on chemical substances (OJ L 50, 20.2.2004, p.
Zbirka OECD o načelih dobre laboratorijske prakse in nadzoru skladnosti.
Number 1.
1).
OECD Principles on Good Laboratory Practice (as revised in 1997) ENV/MC/CHEM(98)17.
PRILOGA I
Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p.
Predloga spremnega dopisa k vlogi za novo živilo
Regulation (EC) No 258/97 of the European Parliament and of the Council of 27 January 1997 concerning novel foods and novel food ingredients (OJ L 43, 14.2.1997, p.
Generalni direktorat
1).
Direktorat
ANNEX I
Enota
Template cover letter accompanying an application for novel food
Datum: …
EUROPEAN COMMISSION
Zadeva: Vloga za odobritev novega živila v skladu z Uredbo (EU) št. 2015/2283
Directorate General
(Jasno označite tako, da odkljukate eno od polj)
Directorate
☐ Vloga za odobritev novega živila.
Unit
☐ Vloga za dodajanje, črtanje ali spreminjanje pogojev uporabe že odobrenega novega živila.
Date: …
Prosimo, navedite sklic na navedeno vlogo.
Subject: Application for authorisation of a novel food in accordance with Regulation (EU) 2015/2283.
☐ Vloga za dodajanje, črtanje ali spreminjanje specifikacij že odobrenega novega živila.
(Please indicate clearly by ticking one of the boxes)
☐ Vloga za dodajanje, črtanje ali spreminjanje dodatnih posebnih zahtev za označevanje že odobrenega novega živila.