natgillin/translations-raw huggingface dataset:
This part shall only relates to additives, which according to point (g) of Article 7(3) of Regulation (EC) No 1831/2003, do not belong to categories shown as (a) or (b) in Article 6(1) of the same Regulation and to additives falling within the scope of Community legislation relating to the marketing of products consisting of, containing or produced from GMOs.
Ta del zadeva le dodatke, ki v skladu s točko (g) člena 7(3) Uredbe (ES) št. 1831/2003 ne spadajo v kategorijo (a) ali (b) iz člena 6(1) iste uredbe, in dodatke, ki jih zajema zakonodaja Skupnosti o dajanju na trg proizvodov, ki vsebujejo GSO, so iz njih sestavljeni ali proizvedeni.
Scientific summary of the dossier
Znanstveni povzetek dokumentacije
A scientific summary including details of each part of the documents submitted to support the application, according to this Annex and Annex III shall be submitted.
Predloži se znanstveni povzetek, ki vključuje podatke iz vsakega dela dokumentov, predloženih v podporo vlogi, v skladu s to prilogo in Prilogo III.
This summary shall include the conclusions made by the applicant(s).
Ta povzetek vključuje ugotovitve vložnikov.
The summary must follow the order of this Annex and address all the different parts with reference to the relevant pages of the dossier.
Povzetek mora upoštevati vrstni red iz te priloge ter obravnavati vse različne dele s sklicevanjem na ustrezne strani dokumentacije.
List of documents and other particulars
Seznam dokumentov in drugi podatki
The applicant must identify the number and titles of volumes of documentation submitted in support of the application.
Vložnik mora navesti številko in naslove sklopov dokumentov, predloženih v podporo vlogi.
A detailed index with reference to volumes and pages shall be added.
Doda se podrobno kazalo, v katerem so navedeni sklopi in strani.
List of parts of the dossier requested to be treated as confidential, where necessary
Seznam delov dokumentacije, za katere se zahteva, da se obravnavajo kot zaupni, kadar je potrebno
The list shall make reference to the relevant volumes and pages of the dossier.
Na seznamu so navedeni ustrezni sklopi in strani dokumentacije.
SECTION II: IDENTITY, CHARACTERISATION AND CONDITIONS OF USE OF THE ADDITIVE; METHODS OF ANALYSIS
ODDELEK II: IDENTITETA, OPIS LASTNOSTI IN POGOJI UPORABE DODATKA; ANALITSKE METODE
The additive has to be fully identified and characterised.
Dodatek je treba v celoti identificirati in opisati njegove lastnosti.
Identity of the additive
Identiteta dodatka
Name of the additive
Ime dodatka
If appropriate, a proposal for the trade name shall be made for additives linked to a holder of authorisation.
Če je primerno, se predlaga trgovsko ime za dodatke, povezane z imetnikom dovoljenja.
Proposal for classification
Predlog za razvrstitev
A proposal for the classification of an additive for one or more categories and functional groups according to its main functions under Article 6 and Annex I of Regulation (EC) No 1831/2003 shall be made.
Pripravi se predlog za razvrstitev dodatka v eno ali več kategorij in funkcionalnih skupin v skladu z njegovimi glavnimi funkcijami na podlagi člena 6 in Priloge I k Uredbi (ES) št. 1831/2003.
Any data from other known uses of the identical active substances or agents (e.g. use in food, human or veterinary medicine, agriculture and industry) must be provided.
Predložiti je treba kakršne koli podatke o drugi znani uporabi enakih aktivnih snovi ali sredstev (npr. uporaba v živilih, medicini ali veterinarstvu, kmetijstvu in industriji).
Any other authorisation as feed or food additive, veterinary drugs or other kind of authorisations of the active substance has to be specified.
Opredeliti je treba tudi kakršno koli drugo dovoljenje za snov kot krmni ali živilski dodatek ali veterinarska zdravila ali drugo vrsto dovoljenj za aktivno snov.
Qualitative and quantitative composition (active substance/agent, other components, impurities, batch to batch variation)
Kakovostna in količinska sestava (aktivna snov/sredstvo, druge sestavine, nečistoče, odstopanje med posameznimi serijami)
The active substance(s)/agent(s) and all other components of the additive shall be listed, giving the proportion by weight in the final product.
Navedejo se aktivne snovi/sredstva in vse druge sestavine dodatka, skupaj z masnim deležem v končnem proizvodu.
The qualitative and quantitative batch to batch variation of the active substance(s)/agent(s) shall be determined.
Določi se kakovostno in količinsko odstopanje med posameznimi serijami aktivnih snovi/sredstev.
For micro-organisms: the number of viable cells or spores expressed as CFU per gram shall be determined.
Za mikroorganizme: določi se število živih celic ali spor, izraženo kot CFU na gram.
For enzymes: each declared (main) activity shall be described and the number of units of each activity in the final product given.
Za encime: opiše se vsaka deklarirana (glavna) aktivnost in navede se število enot vsake aktivnosti v končnem proizvodu.
Relevant side activities shall be also mentioned.
Navedejo se tudi ustrezne stranske aktivnosti.
The units of activity shall be defined and preferably as μmoles of product released per minute from the substrate, also indicating the pH and the temperature.
Opredelijo se enote aktivnosti, po možnosti v μmolih proizvoda, ki nastane iz substrata na minuto, in navedeta se tudi pH in temperatura.
If the active component of the additive is a mixture of active substances or agents, each of which is clearly definable (qualitatively and quantitatively), the active substance(s)/agent(s) components must be described separately and the proportions in the mixture given.
Če je aktivna sestavina dodatka mešanica aktivnih sestavin ali sredstev, od katerih je mogoče vsako jasno opredeliti (kakovostno in količinsko), je treba sestavine aktivnih snovi/sredstev opisati ločeno in navesti njihove deleže v mešanici.
Other mixtures in which the constituents cannot be described by a single chemical formula and/or where not all can be identified shall be characterised by constituent(s) contributing to its activity and/or typical major constituent(s).
Druge mešanice, katerih sestavin ni mogoče opisati z eno kemijsko formulo in/ali jih vseh identificirati, se opredelijo glede na sestavine, ki prispevajo k njihovi aktivnosti, in/ali tipične glavne sestavine.
Without prejudice to any request of supplementary information made by the Authority according to Article 8(2) of Regulation (EC) No 1831/2003, the applicant may omit the description of other components with no safety concerns other than active substances or agents for additives not within the categories of zootechnical additives, coccidiostats and histomonostats, and not in the scope of Regulation (EC) No 1829/2003.
Brez poseganja v kakršno koli zahtevo Agencije za dopolnilne informacije v skladu s členom 8(2) Uredbe (ES) št. 1831/2003 lahko vložnik izpusti opis drugih sestavin, ki ne povzročajo zaskrbljenosti zaradi varnosti, razen aktivnih snovi ali sestavin za dodatke, ki ne spadajo v kategorije zootehničnih dodatkov, kokcidiostatikov in sredstev proti histomonijazi ter jih ne zajema Uredba (ES) št. 1829/2003.
In any case, all studies reported in the dossier must be based on the actual additive requested for the authorisation and may provide information on the other possible different preparations that could be made.
V vsakem primeru morajo vse študije, o katerih se poroča v dokumentaciji, temeljiti na dejanskem dodatku, za katerega se zahteva dovoljenje, in lahko vsebujejo informacije o drugih možnih drugačnih pripravkih, ki se lahko proizvedejo.
An in-house identifier may be allowed, embedded in third-party documents, and a statement is required to list the identifiers and to confirm that the identifier(s) refers to the formulation(s) for which the request is made.
Dovoli se lahko interni identifikator, vključen v dokumente tretjih oseb, potrebna pa je izjava, v kateri se navedejo identifikatorji in potrdi, da identifikatorji zadevajo formulacije, za katere je zahteva predložena.
The applicant shall identify and quantify chemical and microbial impurities, substances with toxic or other undesirable properties that are not intentionally added and do not contribute to the activity of additive.
Vložnik identificira in količinsko opredeli kemične in mikrobne nečistoče, snovi s strupenimi ali drugimi neželenimi lastnostmi, ki niso namerno dodane in ne prispevajo k aktivnosti dodatka.
In addition, for fermentation products, the applicant shall confirm the absence of production organisms in the additive.
Poleg tega za proizvode fermentacije vložnik potrdi odsotnost proizvodnih organizmov v dodatku.
The protocol used for the routine screening of production batches for contaminants and impurities shall be described.
Opiše se postopek, ki se uporablja za rutinsko pregledovanje proizvodnih serij glede onesnaževal in nečistoč.
All the data provided have to support the proposal for a specification of the additive.
Vsi predloženi podatki morajo podpirati predlog za specifikacijo dodatka.
Specific requirements depending on the production process, complying with existing Community legislation, are listed below.
Posebne zahteve, odvisne od postopka proizvodnje, ki je v skladu z veljavno zakonodajo Skupnosti, so navedene spodaj.
Additives whose authorisation is linked to a holder of authorisation
Dodatki, katerih dovoljenje je povezano z imetnikom dovoljenja
For additives whose authorisation is linked to a holder of authorisation, the relevant information related to the specific process used by the manufacturer, based on existing standards used for other related purposes, shall be provided.
Za dodatke, katerih dovoljenje je povezano z imetnikom dovoljenja, se zagotovijo ustrezne informacije v zvezi s posebnim postopkom, ki ga uporablja izdelovalec, na podlagi obstoječih standardov, ki se uporabljajo za druge povezane namene.
Joint FAO/WHO Expert Committee on Food Additives (JECFA) specifications or specifications from European Community food additive authorisations can be used.
Uporabljajo se lahko specifikacije Skupnega strokovnega odbora FAO/SZO za živilske dodatke (JECFA) ali specifikacije iz dovoljenj Evropske skupnosti za živilske dodatke.
Additives whose authorisation is not linked to a holder of authorisation
Dodatki, katerih dovoljenje ni povezano z imetnikom dovoljenja
For feed additives whose authorisation is not linked to a holder of authorisation, existing standards used for other related purposes, or that have specifications for food additives as authorised in the European Community or from JECFA can be used.
Za krmne dodatke, katerih dovoljenje ni povezano z imetnikom dovoljenja, se lahko uporabljajo obstoječi standardi, ki se uporabljajo za druge povezane namene ali ki imajo specifikacije za živilske dodatke, kot so dovoljeni v Evropski skupnosti, ali ki jih je pripravil JECFA.
When such standards are not available, or where relevant to the manufacturing process, at least the following particulars shall be described and their concentrations determined:
Kadar takšni standardi niso na voljo ali kadar je pomembno za postopek izdelave, se opišejo vsaj naslednji podatki in določijo koncentracije:
for micro-organisms: microbiological contamination, mycotoxins, heavy metals;
za mikroorganizme: mikrobiološka onesnaženost, mikotoksini, težke kovine,
for fermentation products (not containing micro-organisms as active agents): they shall follow the same requirements as for micro-organism products (see above).
za proizvode fermentacije (brez mikroorganizmov kot aktivnih sredstev): izpolnjujejo enake zahteve, kot veljajo za proizvode z mikroorganizmi (glej zgoraj).
The extent to which spent growth medium is incorporated into the final product shall also be indicated.
Navede se tudi obseg, v katerem je izrabljeno rastno gojišče vključeno v končni proizvod,
for plant derived substances: microbiological and botanical contamination (e.g. castor oil plant, weed seeds, rye ergot in particular), mycotoxins, pesticide contamination, maximum values for solvents and, where appropriate, substances of toxicological concern known to occur in the original plant;
za snovi, pridobljene iz rastlin: mikrobiološka in rastlinska onesnaženost (npr. zlasti kloščevec, seme plevelov, rženi rožiček), mikotoksini, onesnaženje s pesticidi, največje vrednosti za topila in po potrebi snovi, ki povzročajo zaskrbljenost zaradi toksikoloških lastnosti in za katere je znano, da so v izvorni rastlini,
for animal derived substances: microbiological contamination, heavy metals and maximum values for solvents, where appropriate;
za snovi, pridobljene iz živali: mikrobiološka onesnaženost, težke kovine in po potrebi največje vrednosti za topila,
for mineral substances: heavy metals, dioxins and PCBs;
za minerale: težke kovine, dioksini in poliklorirani bifenili,
for products produced by chemical synthesis and processes: all chemicals used in the synthetic processes and any intermediate products remaining in the final product shall be identified and their concentrations given.
za proizvode, izdelane s kemično sintezo in postopki: identificirajo se vse kemikalije, ki se uporabljajo v postopkih sinteze, in kakršni koli vmesni proizvodi, ki ostanejo v končnem proizvodu, in navedejo se njihove koncentracije.
The selection of mycotoxins for analysis shall be made according to the different matrices, where appropriate.
Izbira mikotoksinov za analizo je v skladu z različnimi matriksi, kadar je primerno.
Physical state of each form of the product
Fizikalno stanje posamezne oblike proizvoda
For solid preparations data on particle size distribution, particle shape, density, bulk density, dusting potential and the use of processes which affect physical properties shall be provided.
Za trdne pripravke se zagotovijo podatki o porazdelitvi velikosti delcev, obliki delcev, gostoti, specifični masi, prašnosti in uporabi postopkov, ki vplivajo na fizikalne lastnosti.
For liquid preparations, data for viscosity and surface tension shall be given.
Za tekoče pripravke se zagotovijo podatki o viskoznosti in površinski napetosti.
Where additive is intended to be used in water, the solubility or extent of dispersion shall be demonstrated.
Kadar je dodatek namenjen za uporabo v vodi, se določi topnost ali stopnja razpršenosti.
Characterisation of the active substance(s)/agent(s)
Opis lastnosti aktivnih snovi/sredstev
A qualitative description of the active substance or agent shall be given.
Predloži se kakovostni opis aktivne snovi ali sredstva.
This shall include purity and origin of the substance or agent, plus any other relevant characteristics.
To vključuje čistost in izvor snovi ali sredstva, skupaj s kakršnimi koli drugimi ustreznimi lastnostmi.
Chemical substances
Kemične snovi
Chemically well-defined substances shall be described by generic name, chemical name according to IUPAC (International Union of Pure and Applied Chemistry) nomenclature, other generic international names and abbreviations and/or Chemical Abstract Service Number (CAS).
Kemijsko natančno opredeljene snovi se opišejo z generičnim imenom, kemijskim imenom po nomenklaturi Mednarodne zveze za čisto in uporabno kemijo (International Union of Pure and Applied Chemistry, IUPAC), drugimi generičnimi mednarodnimi imeni in okrajšavami in/ali številko Službe za izmenjavo kemijskih izvlečkov (Chemical Abstract Service, CAS).
The structural and molecular formula and molecular weight must be included.
Vključiti je treba strukturno in molekulsko formulo ter molekulsko maso.
For chemically defined compound used as flavourings, the FLAVIS number in connection with relevant chemical group shall be included.
Za kemijsko opredeljeno spojino, ki se uporablja kot aromatična snov, se vključi številka FLAVIS v povezavi z ustrezno kemijsko skupino.
For plant extracts the phytochemical markers must be included.
Za rastlinske ekstrakte je treba vključiti fitokemične označevalce.
Mixtures in which the constituents cannot be described by a single chemical formula and/or not all of them can be identified shall be characterised by constituent(s) contributing to its activity and/or typical major constituent(s).
Mešanice, katerih sestavin ni mogoče opisati z eno kemijsko formulo in/ali jih vseh identificirati, se opredelijo glede na sestavine, ki prispevajo k njihovi aktivnosti, in/ali tipične glavne sestavine.
Marker compound shall be identified to allow stability to be assessed and to provide a means of traceability.
Identificira se spojina, ki se uporablja kot označevalec, da se omogoči ocena stabilnosti in zagotovi sredstvo za sledljivost.
For enzyme and enzyme preparations, the number and systematic name proposed by the International Union of Biochemistry (IUB) in the most recent edition of ‘Enzyme Nomenclature’ shall be given for each declared activity.
Za encime in encimske pripravke se za vsako deklarirano aktivnost zagotovita številka in sistematsko ime, ki ju predlaga Mednarodna zveza za biokemijo (International Union of Biochemistry, IUB) v zadnji izdaji „Encimske nomenklature“.
For activities not yet included, a systematic name consistent with the IUB rules of nomenclature shall be used.
Za aktivnosti, ki še niso vključene, se uporabi sistematsko ime v skladu s pravili nomenklature IUB.
Trivial names are acceptable provided that they are unambiguous and used consistently throughout the dossier, and they can be clearly related to the systematic name and IUB number at their first mention.
Navadna imena so dopustna, če so nedvoumna in se uporabljajo dosledno v celotni dokumentaciji in če jih je ob prvi navedbi možno jasno povezati s sistematskim imenom in številko IUB.
The biological origin of each enzyme activity must be given.
Navesti je treba biološki izvor vsake encimske aktivnosti.
The microbial origin of chemical substances produced by fermentation shall also be described (see 2.2.1.2 Micro-organisms).
Opiše se tudi mikrobni izvor kemičnih snovi, ki nastanejo pri fermentaciji (glej 2.2.1.2 Mikroorganizmi).
For all micro-organisms, whether used as product or as production strain, the origin shall be provided.
Za vse organizme, ne glede na to, ali se uporabljajo kot proizvod ali proizvodni sev, se navede izvor.
For micro-organisms used as a product or as production strain, any history of modification shall be indicated.
Za mikroorganizme, ki se uporabljajo kot proizvod ali proizvodni sev, se navedejo kakršne koli pretekle spremembe.
The name and taxonomic classification of each micro-organism shall be provided, according to the latest published information in the International Codes of Nomenclature (ICN).
Navedeta se ime in sistematska uvrstitev vsakega mikroorganizma v skladu z najnovejšimi objavljenimi informacijami v mednarodnih kodeksih nomenklature (International Codes of Nomenclature, ICN).
Microbial strains shall be deposited in an internationally recognised culture collection (preferably in the European Union) and maintained by the culture collection for the authorised life of the additive.
Mikrobni sevi se deponirajo v mednarodno priznani zbirki kultur (po možnosti v Evropski uniji), ki jih hrani za odobreno obdobje za dodatek.
A certificate of deposition from the collection, which shall specify the accession number under which the strain is held, must be provided.
Zagotoviti je treba potrdilo zbirke o deponiranju, na katerem je natančno navedena pristopna številka, pod katero se sev hrani.
In addition, all relevant morphological, physiological and molecular characteristics necessary to provide the unique identification of the strain and the means to confirm its genetic stability shall be described.
Opišejo se tudi vse pomembne morfološke, fiziološke in molekulske lastnosti, ki so potrebne za posebno identifikacijo seva ter omogočajo potrditev njegove genske stabilnosti.
For GMOs the description of the genetic modifications shall be given.
Za GSO se predloži opis genskega spreminjanja.
The unique identifier for each GMO, as referred in Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms, shall be included.
Vključi se posebni identifikator za vsak GSO, kot je naveden v Uredbi Komisije (ES) št. 65/2004 z dne 14. januarja 2004 o vzpostavitvi sistema za razvijanje in dodeljevanje posebnih identifikatorjev za gensko spremenjene organizme.
Relevant properties
Pomembne lastnosti
Description of physical and chemical properties shall be given.
Predloži se opis fizikalnih in kemijskih lastnosti.
Dissociation constant, pKa, electrostatic properties, melting point, boiling point, density, vapour pressure, solubility in water and in organic solvents, Kow and Kd/Koc, mass spectrometry and absorption spectra, NMR data, possible isomers and any other appropriate physical properties shall be provided, where appropriate.
Zagotovijo se disociacijska konstanta, pKa, elektrostatične lastnosti, tališče, vrelišče, gostota, parni tlak, topnost v vodi in organskih topilih, Kow in Kd/Koc, masna spektrometrija in absorpcijski spekter, podatki o NMR, možni izomeri in kakršne koli druge ustrezne fizikalne lastnosti, kadar je primerno.
Substance produced via fermentation shall be free of antimicrobial activities relevant to the use of antibiotics in humans or animals.
Snov, ki nastane pri fermentaciji, nima protimikrobnih aktivnosti, pomembnih za uporabo antibiotikov pri ljudeh ali živalih.
Toxins and virulence factors
Toksini in dejavniki virulence
Toxins or virulence factors shall be demonstrated to be absent or of no concern.
Dokaže se, da toksinov ali dejavnikov virulence ni ali da ne povzročajo zaskrbljenosti.
Strains of bacteria belonging to a taxonomic group that includes members known to be capable of producing toxins or other virulence factors shall be subject to appropriate tests to demonstrate at a molecular and, if necessary, cellular level the absence of any cause for concern.
Za seve bakterij iz taksonomske skupine, v katero spadajo organizmi, ki lahko proizvajajo toksine ali druge dejavnike virulence, se izvedejo ustrezni preskusi, s katerimi se na molekulski in po potrebi celični ravni dokaže, da ni razloga za zaskrbljenost.
For strains of micro-organisms for which there is no history of an apparent safe use and whose biology remains poorly understood, a full package of toxicological studies shall be necessary.
Za seve mikroorganizmov, za katere ni znana pretekla očitna varna uporaba in katerih biologija je še vedno slabo razumljiva, je potreben celoten paket toksikoloških študij.
Antibiotic production and antibiotic resistance
Proizvodnja antibiotikov in odpornost proti antibiotikom
Micro-organisms used as additives or as production strain, shall be free of antibiotic activity or shall not be capable of producing antibiotic substances that are relevant as antibiotics in humans and animals.
Mikroorganizmi, ki se uporabljajo kot dodatki ali proizvodni sev, ne delujejo antibiotično ali ne morejo proizvajati antibiotičnih snovi, ki so pomembne kot antibiotiki pri ljudeh in živalih.
Strains of micro-organisms intended for use as additives shall not contribute further to the reservoir of antibiotic resistance genes already present in the gut flora of animals and the environment.
Sevi mikroorganizmov, ki so namenjeni za uporabo kot dodatki, ne povečujejo dodatno rezervoarja genov za odpornost proti antibiotikom, ki je že prisoten v črevesni flori živali in okolju.
Consequently, all strains of bacteria shall be tested for resistance to antibiotics in use in human and veterinary medicine.
Zato se za vse seve bakterij opravi preskus odpornosti proti antibiotikom, ki se uporabljajo v medicini in veterinarstvu.
Where resistance is detected, the genetic basis of the resistance and the likelihood of transfer of resistance to other gut-inhabiting organisms shall be established.
Kadar se odkrije odpornost, se določita genska osnova te odpornosti in verjetnost prenosa odpornosti na druge organizme v črevesni flori.