natgillin/translations-raw huggingface dataset:
The applicant shall take into account the latest guidance documents adopted or endorsed by the Authority available at the time of the submission of the application (The EFSA Journal).
Predlagatelj upošteva najnovejše dokumente z navodili, ki jih je sprejela ali odobrila Agencija in so na voljo ob vložitvi zahtevka (EFSA Journal).
The documentation on the procedure followed when gathering the data shall be provided, including the literature search strategies (assumptions made, key words used, databases used, time period covered, limitation criteria, etc.) and a comprehensive outcome of such search.
Predloži se dokumentacija o postopku, ki je bil uporabljen za zbiranje podatkov, vključno s strategijami pri iskanju literature (domneve, uporabljene ključne besede, uporabljene zbirke podatkov, zajeto obdobje, omejitvena merila itd.) ter celovit izid takega iskanja.
The safety evaluation strategy and the corresponding testing strategy shall be described and justified with rationales for inclusion and exclusion of specific studies and/or information.
Strategija ocene varnosti in ustrezna strategija preskušanja se opišeta in utemeljita z razlogi za vključitev in izključitev posebnih študij in/ali informacij.
The individual raw data of the unpublished studies and, where possible, of the published studies as well as the individual results of examinations shall be made available on request from the Authority.
Posamezni neobdelani podatki neobjavljenih in po možnosti objavljenih študij ter posamezni rezultati preverjanj se na zahtevo Agencije dajo na voljo.
For each biological or toxicological study, it shall be clarified whether the test material conforms to the proposed or existing specification.
Za vsako biološko ali toksikološko študijo se 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 substance under consideration.
Kadar se preskusna snov razlikuje od specifikacije, predlagatelj dokaže pomembnost zadevnih podatkov za snov, ki se obravnava.
Toxicological studies shall be conducted in facilities which comply with the requirements of Directive 2004/10/EC of the European Parliament and of the Council or, if they are carried out outside the territory of the Union, they shall follow ‘the OECD Principles of Good Laboratory Practice’ (GLP).
Toksikološke študije se izvedejo v prostorih, ki izpolnjujejo zahteve Direktive 2004/10/ES. Če se izvajajo zunaj Unije, izpolnjujejo „Načela dobre laboratorijske prakse (DLP) OECD“.
The applicant shall provide evidence to demonstrate that those requirements are complied with.
Predlagatelj predloži dokaze za skladnost z navedenimi zahtevami.
For studies not conducted according to standard protocols, data interpretation, as well as a justification on their appropriateness for the risk assessment, shall be provided.
Pri študijah, ki niso izvedene v skladu s standardnimi protokoli, se predložita razlaga podatkov in utemeljitev njihove primernosti za oceno tveganja.
The applicant shall propose an overall conclusion on the safety of the proposed uses of the substance.
Predlagatelj predlaga splošen sklep glede varnosti predlaganih uporab snovi.
The overall evaluation of potential risk to human health shall be made in the context of known or likely human exposure.
Splošna ocena možnega tveganja za zdravje ljudi se izvede za znano ali verjetno izpostavljenost ljudi.
Specific data required for risk assessment of food additives
Posebni podatki, potrebni za oceno tveganja pri aditivih za živila
In addition to data to be provided pursuant to Article 5, information shall be provided on:
Poleg podatkov iz člena 5 se sporočijo tudi informacije o:
the identity and characterisation of the additive, including the proposed specifications and analytical data;
identiteti in opredelitvi aditiva, vključno s predlaganimi specifikacijami in analitičnimi podatki;
where applicable, the particle size, particle size distribution and other physicochemical characteristics;
po potrebi velikosti delcev, porazdelitvi velikosti delcev in drugih fizikalno-kemijskih lastnostih;
the manufacturing process;
proizvodnem postopku;
presence of impurities;
prisotnosti nečistot;
the stability, reaction and fate in foods to which the additive is added;
obstojnosti, reakciji in dogajanju v živilih, ki se jim doda aditiv;
where applicable, the existing authorisations and risk assessments;
po potrebi obstoječih odobritvah in ocenah tveganja;
proposed normal and maximum use levels in the food categories mentioned in the Union list, or in a newly proposed food category, or in a more specific foodstuff belonging to one of these categories;
predlaganih običajnih in najvišjih ravneh uporabe v kategorijah živil, navedenih na seznamu Unije, ali novi predlagani kategoriji živil ali bolj specifičnem živilu, ki spada v eno od teh kategorij;
a dietary exposure assessment;
oceni prehranske izpostavljenosti;
the biological and toxicological data.
bioloških in toksikoloških podatkih.
As regards to the biological and toxicological data, referred to in point (i) of paragraph 1, the following core areas shall be covered:
Pri bioloških in toksikoloških podatkih iz točke (i) odstavka 1 so zajeta naslednja glavna področja:
toxicokinetics;
toksikokinetika;
subchronic toxicity;
subkronična toksičnost;
genotoxicity;
genotoksičnost;
chronic toxicity/carcinogenicity;
kronična toksičnost/kancerogenost;
reproductive and developmental toxicity.
toksičnost za razmnoževanje in razvoj.
Data required for risk management of food additives
Podatki, potrebni za obvladovanje tveganja pri aditivih za živila
The dossier submitted in support of an application shall include the information necessary to verify whether there is a reasonable technological need that cannot be achieved by other economically and technologically practicable means and whether the proposed use does not mislead the consumer within the meaning of points (b) and (c) of Article 6(1) of Regulation (EC) No 1333/2008.
Dokumentacija, priložena zahtevku, vključuje informacije, ki so potrebne za preverjanje, ali obstaja razumna tehnološka potreba, ki je ni mogoče doseči z drugimi ekonomsko in tehnološko izvedljivimi sredstvi, ter ali predlagana uporaba ne zavaja potrošnika v smislu točk (b) in (c) člena 6(1) Uredbe (ES) št. 1333/2008.
In order to ensure the verification referred to in paragraph 1, appropriate and sufficient information shall be provided on:
Za zagotovitev preverjanja iz odstavka 1 se sporočijo ustrezne in zadostne informacije o:
the identity of the food additive, including reference to the existing specifications;
identiteti aditiva za živila, vključno s sklicem na obstoječe specifikacije;
the function and technological need for the level proposed in each of the food categories or products for which authorisation is requested and an explanation that this can not be reasonably achieved by other economically and technologically practical means;
funkciji in tehnološki potrebi po ravni, predlagani v vsaki od kategorij živil ali izdelkov, za katere je vložen zahtevek za odobritev, ob pojasnilu, da tega ni mogoče razumno doseči z drugimi ekonomsko in tehnološko izvedljivimi sredstvi;
the investigations on the efficacy of the food additive for the intended effect at the use level proposed;
preiskavah učinkovitosti aditiva za živila pri nameravanem učinku na predlagani ravni uporabe;
advantages and benefit for the consumer.
prednostih in koristih za potrošnika.
The applicant shall take into account the requirements laid down in Article 6(2) of Regulation (EC) No 1333/2008;
Predlagatelj upošteva zahteve iz člena 6(2) Uredbe (ES) št. 1333/2008;
why the use would not mislead the consumer;
razlogih, zakaj uporaba ne bo zavajala potrošnika;
the exposure assessment, based on normal and maximum intended use for each of the categories or products concerned;
oceni izpostavljenosti na podlagi običajne in najvišje ravni nameravane uporabe za vsako od zadevnih kategorij ali izdelkov;
the amount of the food additive present in the final food as consumed by the consumer;
vsebnosti aditiva za živila v končnem živilu, ki ga zaužije potrošnik;
analytical methods allowing the identification and quantification of the additive or its residues in food;
analitičnih metodah, ki omogočajo identifikacijo in količinsko opredelitev aditiva ali njegovih ostankov v živilu;
where applicable, the compliance with the specific conditions for sweeteners and for colours as laid down in Articles 7 and 8 of Regulation (EC) No 1333/2008.
po potrebi skladnosti s posebnimi pogoji za sladila in barvila iz členov 7 in 8 Uredbe (ES) št. 1333/2008.
Specific data required for risk assessment of food enzymes
Posebni podatki, potrebni za oceno tveganja pri encimih za živila
name(s), synonyms, abbreviations and classification(s);
imenih, sopomenkah, kraticah in klasifikacijah;
Enzyme Commission Number;
številki Komisije za encime;
the proposed specifications, including the origin;
predlaganih specifikacijah, vključno s poreklom;
the properties;
lastnostih;
the reference to any similar food enzyme;
sklicu na kakršen koli podoben encim za živila;
the source material;
izvorni snovi;
the stability, reaction and fate in foods in which the food enzyme is used;
obstojnosti, reakciji in dogajanju v živilih, v katerih se uporabi encim za živila;
where applicable the existing authorisations and evaluations;
po potrebi obstoječih odobritvah in ocenah;
the proposed uses in food and, where applicable, the proposed normal and maximum use levels;
predlaganih uporabah v živilih ter po potrebi predlaganih običajnih in najvišjih ravneh uporabe;
the dietary exposure assessment;
oceni prehranske izpostavljenosti;
As regards to the biological and toxicological data, referred to in point (1) of paragraph 1, the following core areas shall be covered:
Pri bioloških in toksikoloških podatkih iz točke (l) v odstavku 1 sta zajeti naslednji glavni področji:
genotoxicity.
genotoksičnost.
Data required for risk management of food enzymes
Podatki, potrebni za obvladovanje tveganja pri encimih za živila
The dossier submitted in support of an application shall include the information necessary to verify whether there is a reasonable technological need and whether the proposed use does not mislead the consumer within the meaning of points (b) and (c) of Article 6 of Regulation (EC) No 1332/2008.
Dokumentacija, priložena zahtevku, vključuje informacije, ki so potrebne za preverjanje, ali obstaja razumna tehnološka potreba in ali predlagana uporaba ne zavaja potrošnika v smislu točk (b) in (c) člena 6 Uredbe (ES) št. 1332/2008.
the identity of the food enzyme, including reference to the specifications;
identiteti encima za živila, vključno s sklicem na specifikacije;
the function and technological need, including a description of the typical process(es) in which the food enzyme may be applied;
funkciji in tehnološki potrebi, vključno z opisom tipičnih postopkov, v katerih je mogoče uporabiti encim;
the effect of the food enzyme on the final food;
vplivu encima za živila na končno živilo;
the proposed normal and maximum use levels where applicable;
po potrebi predlaganih običajnih in najvišjih ravneh uporabe;
the dietary exposure assessment, as described in the Authority’s guidance document on food enzymes [13].
oceni prehranske izpostavljenosti, kot je opisano v smernicah Agencije za encime za živila [13].
Specific data required for risk assessment of flavourings
Posebni podatki, potrebni za oceno tveganja pri aromah
specifications;
specifikacijah;
where applicable, information on particle size, particle size distribution and other physicochemical characteristics;
po potrebi velikosti delcev, porazdelitvi velikosti delcev in drugih fizikalno-kemijskih lastnostih;
the proposed uses in food and proposed normal and maximum use levels in the categories according to the Union list or in a more specified type of product within the categories;
predlaganih uporabah v živilu ter predlaganih običajnih in najvišjih ravneh uporabe v kategorijah v skladu s seznamom Unije ali v bolj specifičnem živilu znotraj kategorij;
the data on dietary sources;
podatkih o prehranskih virih;
As regards to the biological and toxicological data, referred to in point (h) of paragraph 1, the following core areas shall be covered:
Pri bioloških in toksikoloških podatkih iz točke (h) v odstavku 1 so zajeta naslednja glavna področja:
examination for structural/metabolic similarity to flavouring substances in an existing flavouring group evaluation (FGE);
preverjanje strukturne/presnovne podobnosti z aromatičnimi snovmi v obstoječi oceni skupine arom;
subchronic toxicity, where applicable;
po potrebi subkronična toksičnost;
developmental toxicity, where applicable;
po potrebi toksičnost za razvoj;
chronic toxicity and carcinogenicity data, where applicable.
po potrebi podatki o kronični toksičnosti in kancerogenosti.
Data required for risk management of flavourings
Podatki, potrebni za obvladovanje tveganja arom
The dossier submitted in support of an application shall include the following information:
Dokumentacija, priložena zahtevku, vključuje naslednje informacije:
the identity of the flavouring, including reference to the existing specifications;
identiteto arome, vključno s sklicem na obstoječe specifikacije;
organoleptic properties of the substance;
organoleptične lastnosti snovi;
the proposed normal and maximum use levels in the food categories or in a more specific food belonging to one of these categories;
predlagane običajne in najvišje ravni uporabe v kategorijah živil ali v bolj specifičnem živilu, ki spada v eno od teh kategorij;
the exposure assessment, based on normal and maximum intended use for each of the categories or products concerned.
oceno izpostavljenosti na podlagi običajne in najvišje ravni nameravane uporabe za vsako od zadevnih kategorij ali izdelkov.
ARRANGEMENTS FOR CHECKING THE VALIDITY OF AN APPLICATION
UREDITEV PREVERJANJA VELJAVNOSTI ZAHTEVKA
On receipt of an application the Commission shall without delay verify whether the food additive, food enzyme or flavouring falls within the scope of the appropriate sectoral food law and whether the application contains all the elements required under Chapter II.
Komisija po prejemu zahtevka takoj preveri, ali aditiv, encim ali aroma za živila spada v področje uporabe zadevne področne živilske zakonodaje in ali zahtevek vsebuje vse elemente, ki jih določa poglavje II.
Where the application contains all the elements required under Chapter II, the Commission shall, where necessary, request the Authority to verify the suitability of the data for risk assessment in accordance with the scientific opinions on data requirements for the evaluation of substance applications and to prepare, if appropriate, an opinion.
Če zahtevek vsebuje vse elemente, ki jih določa poglavje II, Komisija po potrebi od Agencije zahteva, da preveri primernost podatkov za oceno tveganja v skladu z znanstvenimi mnenji o podatkih, potrebnih za oceno zahtevkov za snov, in da po potrebi pripravi mnenje.
Within 30 working days following the receipt of the Commission’s request, the Authority shall inform the Commission by letter about the suitability of the data for risk assessment.
V 30 delovnih dneh po prejemu zahteve Komisije Agencija pisno obvesti Komisijo o primernosti podatkov za oceno tveganja.
If the data is considered suitable for risk assessment, the evaluation period referred to in Article 5(1) of Regulation (EC) No 1331/2008 shall begin from the date when the Authority’s letter is received by the Commission.
Če so podatki primerni za oceno tveganja, začne teči obdobje ocenjevanja iz člena 5(1) Uredbe (ES) št. 1331/2008, in sicer na datum, ko je Komisija prejela dopis Agencije.
However, in accordance with point (a) of the second subparagraph of Article 17(4) of Regulation (EC) No 1332/2008, in the case of establishment of the Union list of food enzymes, Article 5(1) of Regulation (EC) No 1331/2008 shall not apply.
Vendar se v skladu s točko (a) drugega pododstavka člena 17(4) Uredbe (ES) št. 1332/2008 za sestavljanje seznama Unije encimov za živila ne uporablja člen 5(1) Uredbe (ES) št. 1331/2008.
In case of an application to update the Union list of food additives, food enzymes or flavourings, the Commission may request additional information from the applicant on matters regarding the validity of the application and inform the applicant of the period within which that information shall be provided.
Pri zahtevku za posodobitev seznama Unije aditivov za živila, encimov za živila ali arom lahko Komisija od predlagatelja zahteva dodatne informacije o zadevah v zvezi z veljavnostjo zahtevka in obvesti predlagatelja o roku za predložitev navedenih informacij.
In the case of applications submitted in compliance with Article 17(2) of Regulation (EC) No 1332/2008, the Commission shall determine that period together with the applicant.
Za zahtevke, predložene v skladu s členom 17(2) Uredbe (ES) št. 1332/2008, Komisija določi zadevni rok skupaj s predlagateljem.
When the application does not fall within the appropriate sectoral food law or when it does not contain all the elements required under Chapter II or when the Authority considers that the data for risk assessment are not suitable, the application shall be considered as not valid.
Če zahtevek ne spada v področje uporabe zadevne področne živilske zakonodaje ali ne vsebuje vseh elementov, ki jih določa poglavje II, ali Agencija meni, da podatki za oceno tveganja niso primerni, se zahtevek šteje za neveljavnega.
In such a case the Commission shall inform the applicant, the Member States and the Authority indicating the reasons why the application is considered not valid.
V tem primeru Komisija obvesti predlagatelja, države članice in Agencijo ter navede razloge, zakaj se zahtevek šteje za neveljavnega.
By way of derogation from paragraph 5, an application may be considered as valid even if it does not contain all the elements required under Chapter II, provided that the applicant has submitted verifiable justification for each missing element.
Z odstopanjem od odstavka 5 se zahtevek lahko šteje za veljavnega, čeprav ne vsebuje vseh elementov, ki jih določa poglavje II, če predlagatelj predloži preverljivo utemeljitev za vsak manjkajoči element.
OPINION OF THE AUTHORITY
MNENJE AGENCIJE
Information to be included in the opinion of the Authority
Informacije, ki se vključijo v mnenje Agencije
The opinion of the Authority shall include the following information:
Mnenje Agencije vsebuje naslednje informacije:
the identity and characterisation of the food additive, food enzyme or flavouring;
identiteto in opredelitev aditivov, encimov ali arom za živila;
the assessment of the biological and toxicological data;
oceno bioloških in toksikoloških podatkov;
a dietary exposure assessment for the European population taking into account other possible sources of dietary exposure;
oceno prehranske izpostavljenosti za evropsko prebivalstvo ob upoštevanju drugih možnih virov prehranske izpostavljenosti;
an overall risk assessment establishing if possible and relevant a health-based guidance value, and highlighting uncertainties and limitations where relevant;
celovito oceno tveganja, v kateri so, če je to mogoče in pomembno, določene orientacijske vrednosti, ki upoštevajo vplive na zdravje, ter poudarjene 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 substance shall be detailed, providing where possible 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 snovi podrobno opiše, po možnosti 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.
sklepe.
The Commission may ask for more specific additional information in its request for an opinion of the Authority.
Komisija lahko v zahtevi za mnenje Agencije zahteva podrobnejše dodatne informacije.
It shall apply from 11 September 2011.
Uporabljati se začne 11. septembra 2011.
OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring.
Zbirka OECD o načelih dobre laboratorijske prakse in nadzoru skladnosti.
Guidance of EFSA prepared by the Scientific Panel of Food Contact Material, Enzymes, Flavourings and Processing Aids on the Submission of a Dossier on Food Enzymes.
Smernice Efse, ki jih je pripravil Znanstveni odbor za materiale za stik z živili, encime, arome in pomožna sredstva, za predložitev dokumentacije o encimih za živila.
The EFSA Journal (2009) 1305, p. 1.
EFSA Journal (2009) 1305, str. 1.
MODEL LETTER ACCOMPANYING AN APPLICATION FOR FOOD ADDITIVES
VZOREC DOPISA, PRILOŽENEGA ZAHTEVKU ZA ADITIVE ZA ŽIVILA
Directorate General
Generalni direktorat
Subject: Application for authorisation of food additive in accordance with Regulation (EC) No 1331/2008.
Zadeva: Zahtevek za odobritev aditiva za živila v skladu z Uredbo (ES) št. 1331/2008
 Application for an authorisation of a new food additive
 Zahtevek za odobritev novega aditiva za živila
 Application for a modification of the conditions of use of an already authorised food additive
 Zahtevek za spremembo pogojev uporabe že odobrenega aditiva za živila
 Application for a modification of the specifications of an already authorised food additive
 Zahtevek za spremembo specifikacij že odobrenega aditiva za živila
(Please indicate clearly by ticking one of the boxes).
(Jasno označite tako, da odkljukate eno od polj.)
The Applicant(s) and/or his/their Representative(s) in the European Union.
Predlagatelj(-i) in/ali njegov (njihovi) zastopnik(-i) v Evropski uniji
(name, address, …)
(ime, naslov itd.)
submit(s) the present application in order to update the EU list on food additives.
vlaga(-jo) ta zahtevek za posodobitev seznama aditivov za živila v EU.
Food additive name:
Ime aditiva za živila:
ELINCS or EINECS number (if attributed)
Številka ELINCS ali EINECS (če je dodeljena)
CAS No (if applicable)
Št. CAS (če se uporablja)
Functional class(es) of food additives [1]:
Funkcijski razred(-i) aditivov za živila [1]:
(list)
(seznam)
Food categories and required levels:
Kategorije živil in zahtevane ravni:
Normal use level
Običajna raven uporabe
Maximum proposed use level
Najvišja predlagana raven uporabe
 Complete dossier
 popolna dokumentacija
 Public summary of the dossier
 javni povzetek dokumentacije
 Detailed summary of the dossier
 podroben povzetek dokumentacije
 List of the parts of the dossier requested to be treated as confidential
 seznam delov dokumentacije, ki se morajo obravnavati kot zaupni
 Copy of administrative data of applicant(s)
 kopija upravnih podatkov predlagatelja(-ev)
MODEL LETTER ACCOMPANYING AN APPLICATION FOR FOOD ENZYMES
VZOREC DOPISA, PRILOŽENEGA ZAHTEVKU ZA ENCIME ZA ŽIVILA
Subject: Application for authorisation of food enzyme in accordance with Regulation (EC) No 1331/2008.
Zadeva: Zahtevek za odobritev encima za živila v skladu z Uredbo (ES) št. 1331/2008
 Application for an authorisation of a new food enzyme
 Zahtevek za odobritev novega encima za živila
 Application for a modification of the conditions of use of an already authorised food enzyme
 Zahtevek za spremembo pogojev uporabe že odobrenega encima za živila
 Application for a modification of the specifications of an already authorised food enzyme
 Zahtevek za spremembo specifikacij že odobrenega encima za živila
The Applicant(s) and/or his/their Representative(s) in the European Union
Predlagatelj(-i) in/ali njegov (njihovi) zastopnik(-i) v Evropski uniji
submit(s) the present application in order to update the EU list on food enzymes.
vlaga(-jo) ta zahtevek za posodobitev seznama encimov za živila v EU.
Food enzyme name:
Ime encima za živila:
Enzyme Classification Number of Enzyme Commission of the IUBMB
Klasifikacijska številka encima Komisije za encime pri IUBMB.