natgillin/translations-raw huggingface dataset:
The safety of these products may be assessed on the basis of its major and characteristic components and also considering known substances of toxicological concern.
Varnost teh proizvodov se lahko oceni na podlagi njihovih glavnih in značilnih sestavin in tudi ob upoštevanju znanih snovi, ki povzročajo zaskrbljenost zaradi toksikoloških lastnosti.
If the major or characteristic components are not already authorised as chemically defined flavourings or as feed additives, then it has to be verified whether they are substances of toxicological concern for humans or animals, and its toxicological properties have to be provided in accordance with subsection 3.1 of Annex II.
Če glavne ali značilne sestavine še niso dovoljene kot kemijsko opredeljene aromatične snovi ali kot krmni dodatki, je treba preveriti, ali so snovi, ki povzročajo zaskrbljenost zaradi toksikoloških lastnosti za ljudi ali živali, in določiti njihove toksikološke lastnosti v skladu s pododdelkom 3.1 Priloge II.
If these substances are authorised flavourings for humans, the safety for target species may be assessed taking into account the comparison between the level of intake by the target species from feed proposed by the applicant with that by humans from food.
Če so te snovi dovoljene aromatične snovi za ljudi, se lahko varnost za ciljne vrste oceni tako, da se upošteva primerjava med ravnjo vnosa s krmo s strani ciljne vrste, ki jo predlaga vložnik, in ravnjo vnosa z živili s strani ljudi.
Metabolism and toxicological data on which the assessment for human used was made shall be submitted.
Predložijo se podatki o presnovi in toksičnosti, na podlagi katerih je bila izvedena ocena uporabe za ljudi.
In all other cases different from the case where both levels of intake are similar, such as where the level of intake by the target animal proposed be the applicant is substantially higher than that by human from food or where the substance is not authorised in food, the safety for the target animals may be assessed by taking into account the following data: the principle of threshold of toxicological concern, available toxicological and metabolism data for related compounds, and chemical structural alert consideration (following by analogy of the Commission Regulation (EC) No 1565/2000 of 18 July 2000 laying down the measures necessary for the adoption of an evaluation program in application of Regulation (EC) No 2232/96 of the European Parliament and of the Council).Tolerance studies are needed only where threshold values are exceeded or cannot be determined.
V vseh drugih primerih, v katerih obe ravni vnosa nista podobni, na primer kadar je raven vnosa s strani ciljne živali, ki jo predlaga vložnik, bistveno večja od vnosa z živili s strani ljudi ali kadar snov ni dovoljena v živilih, se lahko varnost za ciljne živali oceni tako, da se upoštevajo naslednji podatki: načelo praga za zaskrbljenost zaradi toksikoloških lastnosti, dostopni podatki o toksičnosti in presnovi za sorodne snovi in vidik opozorila glede kemične strukture (smiselno na podlagi Uredbe Komisije (ES) št. 1565/2000 z dne 18. julija 2000 o določitvi ukrepov, potrebnih za sprejetje programa ocenjevanja, skladno z Uredbo Evropskega parlamenta in Sveta (ES) št. 2232/96).Študije o toleranci so potrebne le, kadar so mejne vrednosti presežene ali jih ni mogoče določiti.
Evidence that the metabolites of the flavouring do not result in an accumulation in the animal of products of toxicological concern for humans shall be provided.
Predložijo se dokazi, da metaboliti aromatične snovi ne povzročajo kopičenja proizvodov, ki povzročajo zaskrbljenost zaradi toksikoloških lastnosti za ljudi, v živalih.
In the case that the use of the requested flavouring product as a consequence of its addition to feedingstuffs results in residues in food of animal origin, detailed calculation of consumer exposure shall be provided.
Če uporaba zahtevanega aromatičnega proizvoda zaradi dodajanja tega proizvoda v krmo povzroči ostanke v živilih živalskega izvora, se zagotovi natančen izračun izpostavljenosti potrošnikov.
The safety of these products for humans when used as flavourings in feed, as regards its metabolism, may be based on the metabolism (in the target animal) and residues studies of their major and characteristic components and the absence of substances of toxicological concern in the extract.
Varnost teh proizvodov za ljudi glede njihove presnove, kadar se ti proizvodi uporabljajo kot aromatične snovi v krmi, lahko temelji na študijah o presnovi (v ciljni živali) in o ostankih njihovih glavnih in značilnih sestavin ter odsotnosti snovi, ki povzročajo zaskrbljenost zaradi toksikoloških lastnosti, v ekstraktu.
If the major or characteristic components are not already authorised as chemically defined flavourings or if the level of intake by the target animals from feed is substantially higher than that by humans from food, the whole of subsection 3.2.1 of Annex II is required.
Če glavne ali značilne sestavine še niso dovoljene kot kemijsko opredeljene aromatične snovi ali če je raven vnosa s krmo s strani ciljnih živali znatno večja od ravni vnosa z živili s strani ljudi, je treba upoštevati celoten pododdelek 3.2.1 Priloge II.
If these products are not authorised as flavourings for humans or if the level of intake by the target animal from feed as proposed be the applicant is substantially higher than that by human from food, available data on metabolic fate shall be provided and used to assess the potential accumulation in edible tissues and products according to subsection 3.2.1 of Annex II.
Če ti proizvodi niso dovoljeni kot aromatične snovi za ljudi ali če je raven vnosa s krmo s strani ciljne živali, kot jo predlaga vložnik, znatno večja od ravni vnosa z živili s strani ljudi, se zagotovijo dostopni podatki o presnovi in se uporabijo za oceno možnega kopičenja v užitnih tkivih in proizvodih v skladu s pododdelkom 3.2.1 Priloge II.
The safety of these products for humans when used as flavouring in feed may be based on the toxicological data of their major or characteristic components and the absence of substances of toxicological concern in the extract.
Varnost teh proizvodov za ljudi, kadar se ti proizvodi uporabljajo kot aromatične snovi v krmi, lahko temelji na toksikoloških podatkih o njihovih glavnih ali značilnih sestavinah in odsotnosti snovi, ki povzročajo zaskrbljenost zaradi toksikoloških lastnosti, v ekstraktu.
A toxicological package is required when the metabolic studies of the major or characteristic compounds show that there is accumulation in animal tissues or products and the threshold of toxicological concern for the target animal is exceeded.
Toksikološki paket je potreben, kadar študije o presnovi za glavne ali značilne snovi kažejo na kopičenje v živalskih tkivih ali proizvodih in na to, da je prag za zaskrbljenost zaradi toksikoloških lastnosti za ciljno žival presežen.
This toxicological package shall comprise genotoxicity studies, including mutagenicity and a subchronic oral toxicity study, according to subsection 3.2.2 of Annex II.
Ta toksikološki paket vključuje študije o genotoksičnosti, vključno z mutagenostjo, in študijo o subkronični oralni toksičnosti v skladu s pododdelkom 3.2.2 Priloge II.
A toxicological package comprising genotoxicity studies, including mutagenicity and a subchronic oral toxicity study, according to subsection 3.2.2 of Annex II, is required when the metabolic studies of these products show that there is accumulation in animal tissues or products and the threshold of toxicological concern for the target animal is exceeded.
Toksikološki paket, ki vključuje študije o genotoksičnosti, vključno z mutagenostjo, in študijo o subkronični oralni toksičnosti v skladu s pododdelkom 3.2.2 Priloge II, je potreben, kadar študije o presnovi za te proizvode kažejo na kopičenje v živalskih tkivih ali proizvodih in na to, da je prag za zaskrbljenost zaradi toksikoloških lastnosti za ciljno žival presežen.
Evidence of the flavouring properties, usually on the basis of the published literature, shall be provided.
Predložijo se dokazi o aromatičnih lastnostih, običajno na podlagi objavljene literature.
This may also be demonstrated by experience of practical use, where available, otherwise animal studies may be required.
To se lahko dokaže tudi z izkušnjami s praktično uporabo, kadar so na voljo, drugače so morda potrebne študije na živalih.
It has to be fully investigated and reported if the product object of the application exerts other functions in the feed, animal or food of animal origin besides the one in the definition of flavouring compounds in Annex I of Regulation (EC) No 1831/2003.
Če ima proizvod, ki je predmet vloge, druge funkcije v krmi, živali ali živilih živalskega izvora poleg funkcije, navedene v opredelitvi aromatičnih snovi v Prilogi I k Uredbi (ES) št. 1831/2003, je treba to v celoti proučiti in vključiti v poročilo.
NUTRITIONAL ADDITIVES
NUTRITIVNI DODATKI
Section III: studies concerning the safety of the additives
Oddelek III: študije o varnosti dodatkov
Studies concerning the safety of use of the additive for the target species
Študije o varnosti uporabe dodatka za ciljne vrste
Tolerance of the target species
Toleranca pri ciljnih vrstah
No studies are required for urea, and amino acids, their salts and analogues authorised by Directive 82/471/EEC and compounds of trace elements and vitamins, pro-vitamins and chemically well-defined substances having similar effect which do not have a potential to accumulate already authorised as feed additives under Directive 70/524/EEC.
Študije niso potrebne za sečnino in aminokisline, njihove soli in analoge, ki so dovoljeni z Direktivo 82/471/EGS, ter spojine elementov v sledeh ter vitamine, provitamine in kemijsko natančno opredeljene snovi s podobnim učinkom, ki nimajo potenciala kopičenja in ki so že dovoljene kot krmni dodatki v skladu z Direktivo 70/524/EGS.
For those additives that fall within the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’ and having a potential to accumulate, tolerance will only be required to be demonstrated for compounds for which potency is expected or has been demonstrated to be different from that of the well established vitamin(s).
Za dodatke, ki spadajo v funkcionalno skupino „vitamini, provitamini in kemijsko natančno opredeljene snovi s podobnim učinkom“ ter imajo potencial kopičenja, bo dokazovanje tolerance potrebno le za snovi, pri katerih se pričakuje učinkovitost ali je bilo dokazano, da se razlikuje od učinkovitosti dobro uveljavljenih vitaminov.
In certain cases elements of the tolerance test (design or criteria) could be combined with one of the efficacy trials.
V nekaterih primerih bi se lahko elementi tolerančnega preskusa (načrtovanje ali merila) združili z enim od preskusov učinkovitosti.
Tolerance will be demonstrated for urea derivatives amino acid analogues and compounds of trace elements not previously authorised.
Toleranca se dokaže za derivate sečnine, analoge aminokislin in spojine elementov v sledeh, ki še niso dovoljeni.
The fermentation products will be requested by tolerance demonstration, unless the active substance is separated from the crude fermentation product and highly purified, or the production organism has a history of apparent safe use and well known about its biology to exclude a potential for the production of toxic metabolites.
Pri dokazovanju tolerance je treba določiti proizvode fermentacije, razen če je aktivna snov ločena od surovega proizvoda fermentacije in je visoko prečiščena ali če je znana pretekla očitna varna uporaba proizvodnega organizma in je dobro znana njegova biologija, da se izključi potencial za proizvodnjo toksičnih metabolitov.
Where the application is for all animal species/categories, one tolerance study on the most sensitive species (or even an appropriate laboratory animal) under the most recent knowledge is sufficient.
Kadar vloga zadeva vse živalske vrste/kategorije, je dovolj ena študija o toleranci na najbolj občutljivi vrsti (ali celo ustrezni laboratorijski živali) v skladu z najnovejšim znanjem.
Metabolic studies normally are not required.
Študije o presnovi običajno niso potrebne.
For urea derivatives, ruminal metabolism shall be studied in the efficacy trials.
Za derivate sečnine se presnova v vampu prouči pri preskusih učinkovitosti.
Residue or deposition studies are only required for those additives that fall within the functional group ‘vitamins, pro-vitamins and chemically well-defined substances, having similar effect’ that have a potential for accumulation in the body and for the functional group of compounds of trace elements where bioavailability has been enhanced.
Študije o ostankih ali kopičenju so potrebne le za dodatke, ki spadajo v funkcionalno skupino „vitamini, provitamini in kemijsko natančno opredeljene snovi s podobnim učinkom“, ki imajo potencial kopičenja v telesu, in funkcionalno skupino spojin elementov v sledeh, kadar je biorazpoložljivost izboljšana.
In that case, the procedure described in subsection 3.2.1 of Annex II does not apply.
V tem primeru se ne uporablja postopek, opisan v pododdelku 3.2.1 Priloge II.
The requirement is limited to the comparison of the levels in the tissues or products between the group supplemented with the highest dose of the substance claimed and a positive control (reference compound).
Zahteva je omejena na primerjavo ravni v tkivih ali proizvodih med skupino, ki je prejela največji zahtevani odmerek snovi, in pozitivno kontrolo (referenčna snov).
These are required for fermentation products and additives not already authorised.
Toksikološke študije so potrebne za proizvode fermentacije in dodatke, ki še niso dovoljeni.
For fermentation products, genotoxicity and subchronic toxicity studies must be provided unless:
Za proizvode fermentacije je treba predložiti študije genotoksičnosti in subkronične oralne toksičnosti, razen če:
the active substance is separated from the crude fermentation product and is highly purified; or
je aktivna snov ločena od surovega proizvoda fermentacije in je visoko prečiščena; ali
the production organism has a history of apparent safe use and there is sufficient knowledge of its biology to exclude a potential for the production of toxic metabolites.
je znana pretekla očitna varna uporaba proizvodnega organizma in je dovolj dobro znana njegova biologija, da se izključi potencial za proizvodnjo toksičnih metabolitov.
Where the production organism belongs to a group in which some strains are known to produce toxins, their presence shall be specifically excluded.
Kadar proizvodni organizem spada v skupino, za katero se ve, da nekateri sevi v njej proizvajajo toksine, se njihova prisotnost jasno izključi.
The whole of subsection 3.2.3 of Annex II applies.
Uporablja se celoten pododdelek 3.2.3 Priloge II.
The whole of subsection 3.3 of Annex II applies
Uporablja se celoten pododdelek 3.3 Priloge II.
The whole of subsection 3.4 of Annex II applies for new active substances belong to the compound of trace elements.
Celoten pododdelek 3.4 Priloge II se uporablja za nove aktivne snovi, ki spadajo med spojine elementov v sledeh.
Efficacy studies are not required for urea, amino acids, amino acid salts and analogues already authorised as feed additives, compounds of trace elements already authorised as feed additives and vitamins, pro-vitamins and chemically well-defined substances having similar effect already authorised as feed additives.
Študije o učinkovitosti niso potrebne za sečnino, aminokisline, soli in analoge aminokislin, ki so že dovoljeni kot krmni dodatki, spojine elementov v sledeh, ki so že dovoljene kot krmni dodatki, ter vitamine, provitamine in kemijsko natančno opredeljene snovi s podobnim učinkom, ki so že dovoljeni kot krmni dodatki.
A short term study is required to support efficacy for urea derivatives, amino acid salts and analogues not already authorised as feed additives, compounds of trace elements not already authorised as feed additives and for vitamins, pro-vitamins and chemically well-defined substances having similar effect not already authorised as feed additives.
Kratkoročna študija je potrebna, da se utemelji učinkovitost za derivate sečnine, soli in analoge aminokislin, ki še niso dovoljeni kot krmni dodatki, spojine elementov v sledeh, ki še niso dovoljene kot krmni dodatki, ter vitamine, provitamine in kemijsko natančno opredeljene snovi s podobnim učinkom, ki še niso dovoljeni kot krmni dodatki.
For other substances for which a nutritional effect is requested at least one long term efficacy study under provisions of Section 4 of Annex II is requested.
Za druge snovi, za katere se zahteva hranilni učinek, je potrebna vsaj ena dolgoročna študija o učinkovitosti v skladu z določbami oddelka 4 Priloge II.
Where required, studies shall demonstrate that the additive can provide the animals' nutritional requirements.
Študije po potrebi dokazujejo, da dodatek lahko izpolnjuje prehranske zahteve za živali.
Tests shall include a test group with a diet that contains the nutrient at concentrations below the animals' requirements.
Preskusi vključujejo preskusno skupino s prehrano, ki vsebuje hranilo v koncentracijah, ki so manjše od zahtev za živali.
However, trials using a severely deficient control group shall be avoided.
Vendar se je treba izogniti preskusom, pri katerih se uporablja zelo pomanjkljiva kontrolna skupina.
Generally, it will be sufficient to demonstrate efficacy in a single animal species or category including laboratory animals.
Običajno je dovolj, da se učinkovitost dokaže pri eni živalski vrsti ali kategoriji, vključno z laboratorijskimi živalmi.
ZOOTECHNICAL ADDITIVES
ZOOTEHNIČNI DODATKI
Zootechnical additives other than enzymes and micro-organisms
Zootehnični dodatki, razen encimov in mikroorganizmov
Section I: summary of the dossier.
Oddelek I: povzetek dokumentacije
The whole of Section II of Annex II applies.
Uporablja se celoten oddelek II Priloge II.
The whole of subsection 3.1 of Annex II applies.
Uporablja se celoten pododdelek 3.1 Priloge II.
Studies concerning the safety of use of the additive for consumer
Študije o varnosti uporabe dodatka za potrošnika
These studies are not required if:
Te študije niso potrebne, če:
the substance or its metabolites can be demonstrated to be excreted unchanged and essentially to be not absorbed; or
se dokaže, da se snov ali njeni metaboliti izločijo nespremenjeni ali se v glavnem niso absorbirali, ali
the substance is absorbed in physiological form and physiological level of compound(s).
se snov absorbira v fiziološki obliki in na fiziološki ravni snovi.
No metabolic studies are needed if the substance is naturally present in significant amounts in food or feedingstuffs or if the substance is a normal constituent of body fluids or tissues.
Študije o presnovi niso potrebne, če je snov v znatnih količinah naravno prisotna v živilih ali krmi ali če je snov običajna sestavina telesnih tekočin ali tkiv.
However, in these cases, there is a requirement for residue studies which can be limited to a comparison of the levels in the tissues or products in an untreated group to the levels found in the group supplemented with the highest recommended dose.
Vendar je treba v teh primerih izvesti študije o ostankih, ki so lahko omejene na primerjavo ravni v tkivih ali proizvodih pri skupini brez dodatka z ravnmi pri skupini, ki je prejela največji priporočeni odmerek.
In all other cases the whole of subsection 3.2.1 of Annex II applies.
V vseh drugih primerih se uporablja celoten pododdelek 3.2.1 Priloge II.
Toxicological studies are not required if the substance is absorbed in the form of physiological compound(s).
Toksikološke študije niso potrebne, če se snov absorbira v obliki fizioloških snovi.
For xenobiotic substances the whole of subsection 3.2.2 of Annex II applies.
Za ksenobiotične snovi se uporablja celoten pododdelek 3.2.2 Priloge II.
For other substances, a case by case approach shall be used, taking into account the level and means of exposure, and any omission of data prescribed in this section must be fully justified.
Druge snovi se obravnavajo posamezno ob upoštevanju ravni in načina izpostavljenosti, poleg tega je treba v celoti utemeljiti kakršno koli izpustitev podatkov iz tega oddelka.
The whole of subsection 3.2.3 of Annex II applies for food producing animals.
Celoten pododdelek 3.2.3 Priloge II se uporablja za živali za proizvodnjo hrane.
Studies concerning the safety of the additive for users/workers
Študije o varnosti dodatka za uporabnike/delavce
Studies concerning the safety of the additive for the environment
Študije o varnosti dodatka za okolje
The whole of subsection 3.4 of Annex II applies
Uporablja se celoten pododdelek 3.4 Priloge II.
Additives favourably affecting animal production, performance or welfare and for the functional group ‘other zootechnical additives’.
Dodatki, ki ugodno vplivajo na živalsko proizvodnjo, učinkovitost ali dobro počutje živali, in za funkcionalno skupino „drugi zootehnični dodatki“
The effects can only be demonstrated in relation to each target animal species or category.
Učinki se lahko dokažejo le za posamezno ciljno živalsko vrsto ali kategorijo.
Depending on the properties of the additive, outcome measures may be based either on performance characteristics (e.g. feed efficiency, average daily gain, increasing of animal products), carcass composition, herd performance, reproduction parameters or animal welfare.
Glede na lastnosti dodatka lahko merjenje učinka temelji na značilnostih učinkovitosti (npr. učinkovitost krme, povprečni dnevni prirast, povečanje živalskih proizvodov), sestavi trupa, uspešnosti črede, reprodukcijskih parametrih ali dobrem počutju živali.
Evidence of the mode of action can be provided by short term efficacy studies or laboratory studies measuring relevant end-point.
Dokazi o načinu delovanja se lahko zagotovijo s kratkoročnimi študijami o učinkovitosti ali laboratorijskimi študijami, pri katerih se meri ustrezna končna točka.
Additives favourably affecting the environmental consequences of animal production
Dodatki, ki ugodno vplivajo na okoljske posledice živalske proizvodnje
For these additives which favourably affect the environment (e.g. reduced nitrogen or phosphorus excretion or reduced methane production, off-flavours), evidence of efficacy for the target species can be given by three short term efficacy studies with animals showing significant beneficial effects.
Za dodatke, ki ugodno vplivajo na okolje (npr. manjše izločanje dušika ali fosforja ali manjša proizvodnja metana, dodatki, ki izboljšajo okus), se lahko učinkovitost za ciljne vrste dokaže s tremi kratkoročnimi študijami o učinkovitosti z živalmi, ki kažejo znatne pozitivne učinke.
The studies shall take into consideration the possibility of an adaptive response to the additive.
Pri študijah se upošteva možnost prilagoditvenega odziva na dodatek.
Zootechnical additives: enzymes and micro-organisms
Zootehnični dodatki: encimi in mikroorganizmi
The whole of subsection 3.1.1 of Annex II applies.
Uporablja se celoten pododdelek 3.1.1 Priloge II.
Applicants are encouraged to use, wherever possible, at least a 100-fold overdose in the experimental group and consequently reduce the number of end-points required.
Vložnike se spodbuja k uporabi najmanj stokratnega predoziranja pri poskusni skupini, kadar je to možno, in k posledičnemu zmanjšanju števila potrebnih končnih točk.
A concentrated form of the additive can be used for this purpose.
Za to se lahko uporabi koncentrirana oblika dodatka.
Concentration shall be adjusted by reducing the amount of carrier present but the ratio of active agent(s)/substance(s) to the other fermentation products must remain the same as in the final product.
Koncentracija se prilagodi tako, da se zmanjša količina prisotne nosilne snovi, razmerje med aktivnimi sredstvi/snovmi in drugimi proizvodi fermentacije pa mora ostati enako kot v končnem proizvodu.
For enzymes, the diet shall provide the appropriate substrate(s).
Za encime se s prehrano zagotovijo ustrezni substrati.