natgillin/translations-raw huggingface dataset:
Using the information from the toxicology and exposure assessment, a conclusion shall be drawn about the risks to health of the users/workers (inhalation, irritancy, sensitisation and systemic toxicity).
Z uporabo informacij iz ocenjevanja toksičnosti in izpostavljenosti se oblikuje zaključek o tveganjih za zdravje uporabnikov/delavcev (vdihavanje, draženje, preobčutljivost in sistemska toksičnost).
Precautionary measures may be proposed to reduce or eliminate exposure.
Predlagajo se lahko previdnostni ukrepi za zmanjšanje ali odpravo izpostavljenosti.
However, use of personal protective devices shall only be regarded as a measure of last resort to protect against any residual risk once control measures are in place.
Vendar se po vzpostavitvi kontrolnih ukrepov uporaba osebnih zaščitnih sredstev obravnava le kot zadnji ukrep za zaščito pred kakršnimi koli drugimi tveganji.
It is preferable, for example, to consider reformulation of the product.
Bolj priporočljiva je na primer nova opredelitev proizvoda.
Studies concerning the safety of use of the additive for the environment
Študije o varnosti uporabe dodatka za okolje
Consideration of the environmental impact of additives is important since administration of additives typically occurs over long periods, often involves large groups of animals and the active substance(s) may be excreted to a considerable extent either as the parent compound or its metabolites.
Pomembno je upoštevati vpliv dodatkov na okolje, ker je dajanje dodatkov običajno dolgotrajno, pogosto vključuje večje skupine živali in aktivne snovi se lahko pogosto izločajo kot primarna snov ali njeni metaboliti.
To determine the environmental impact of additives, a stepwise approach shall be followed.
Vpliv dodatkov na okolje se določi postopno.
All additives have to be assessed through Phase I to identify those additives which do not need further testing.
Vse dodatke je treba oceniti v fazi I, da se določijo dodatki, za katere ni potrebno nadaljnje preskušanje.
For the other additives a second phase (Phase II) assessment is needed to provide additional information, based upon which further studies may be considered necessary.
Za druge dodatke je potrebna ocena v drugi fazi (faza II), da se zagotovijo dodatne informacije, na podlagi katerih so lahko potrebne nadaljnje študije.
These studies shall be conducted according to Directive 67/548/EEC.
Te študije se izvedejo v skladu z Direktivo 67/548/EGS.
Phase I assessment
Faza ocenjevanja I
The purpose of Phase I assessment is to determine if a significant environmental effect of the additive or its metabolites is likely and whether a Phase II assessment is necessary (see decision tree).
Namen faze ocenjevanja I je določiti, ali dodatek ali njegovi metaboliti znatno vplivajo na okolje ali ne in ali je potrebna faza ocenjevanja II (glej drevo odločanja).
Exemption from Phase II assessment may be made on one of two criteria, unless there is scientifically-based evidence for concern:
Izvzetje iz faze ocenjevanja II je možno na podlagi enega od dveh meril, razen če obstaja znanstveni dokaz za zaskrbljenost:
the chemical nature and the biological effect of the additive and its conditions of use indicate that impact will be negligible, i.e. where the additive is:
kemijska narava in biološki učinek dodatka ter pogoji njegove uporabe kažejo, da bo vpliv zanemarljiv, tj. kadar je dodatek:
a physiological or natural substance that will not result in a substantial increase of the concentration in the environment; or
fiziološka ali naravna snov, katere koncentracija v okolju se ne bo znatno povečala, ali
intended for non-food producing animals;
namenjen za živali, ki niso namenjene za proizvodnjo živil;
the worst case Predicted Environmental Concentration (PEC) is too low to be of concern.
največja predvidena koncentracija v okolju (PKO) je prenizka, da bi povzročala zaskrbljenost.
The PEC shall be evaluated for each compartment of concern (see below), assuming that 100 % of the dose ingested is excreted as the parent compound.
PKO se oceni za vsako obravnavano okolje (glej spodaj) ob domnevi, da se 100 % zaužitega odmerka izloči kot primarna snov.
If the applicant cannot demonstrate that the additive falls into one of these exemption categories, a Phase II assessment will be required.
Če vložnik ne more dokazati, da spada dodatek v eno od teh kategorij izvzetja, je potrebna faza ocenjevanja II.
Additives for terrestrial animals
Dodatki za kopenske živali
When excreta from livestock are applied on land, the use of feed additives can lead to contamination of soil, ground water, and surface water (via drainage and run-off).
Kadar se izločki rejnih živali uporabijo na zemlji, lahko uporaba krmnih dodatkov povzroči onesnaženje tal, podzemne vode in površinske vode (prek drenaže in odtekanja).
The worst case PEC for soil (PECsoil) would arise considering all excreted compounds being spread on land.
Največji PKO za tla (PKOtla) se dobi ob upoštevanju vseh izločenih snovi, ki se raztresejo po zemlji.
If the PECsoil (default: 5 cm depth) is less than 10 μg/kg, no further assessment is required.
Če je PKOtla (običajno 5 cm globine) manj kot 10 μg/kg, dodatno ocenjevanje ni potrebno.
If the PEC for contamination of groundwater (PECgw) is less than 0,1 μg/l, no Phase II assessment of the environmental impact of the additive on groundwater is necessary.
Če je PKO za onesnaženje podzemne vode (PKOpod) manj kot 0,1 μg/l, ni potrebna faza II za ocenjevanje okoljskega vpliva dodatka na podzemno vodo.
Additives for aquatic animals
Dodatki za vodne živali
Feed additives used in aquaculture can result in contamination of sediment and water.
Posledica uporabe krmnih dodatkov v ribogojstvu je lahko onesnaženje sedimenta in vode.
The compartment of concern for the environmental risk assessment for fish farmed in cages is assumed to be the sediment.
Kot obravnavano okolje pri oceni tveganja za okolje za ribe, gojene v kletkah, se predvideva sediment.
For fish farmed in land-based systems the effluent flowing to surface water is considered to pose the major environmental risk.
V primeru rib, gojenih v kopenskih sistemih, je pomembno tveganje za okolje odpadna voda, ki se izteka v površinsko vodo.
The worst case PEC for sediment (PECsediment) would arise considering all excreted compounds being deposited in the sediment.
Največji PKO za sediment (PKOsediment) se dobi ob upoštevanju vseh izločenih snovi, ki se odlagajo v sediment.
If the PECsediment (default: 20 cm depth) is less than 10 μg/kg wet weight, then no further assessment is required.
Če je PKOsediment (običajno 20 cm globine) manj kot 10 μg/kg mokre teže, dodatno ocenjevanje ni potrebno.
If the PEC in the surface water (PECsw) is less than 0,1 μg/l, no further assessment is required.
Če je PKO v površinski vodi (PKOpov) manj kot 0,1 μg/l, dodatno ocenjevanje ni potrebno.
Phase I — Decision tree
Faza I – Drevo odločanja
Is the additive a physiological/natural substance of established safety?
Ali je dodatek fiziološka/naravna snov z ugotovljeno varnostjo?
Is the additive intended for non-food producing animals only?
Ali je dodatek namenjen le za živali, ki niso namenjene za proizvodnjo živil?
FOR ADDITIVES USED IN TERRESTRIAL SPECIES
ZA DODATKE, KI SE UPO RABLJAJO ZA KOPENSKE VRSTE
Has the additive a PEC in ground water ≥ 0,1 µg/l or PEC soil ≥ 10 µg/kg-?
Ali je za dodatek PKO v podzemni vodi ≥ 0,1 µg/l ali PKO za tla ≥ 10 µg/kg?
FOR ADDITIVES USED IN AQUATIC SPECIES
ZA DODATKE, KI SE UPO RABLJAJO ZA VODNE VRSTE
Has the additive a PEC in surface water ≥ 0,1 µg/l or PEC sediment ≥ 10 µg/ kg?
Ali je za dodatek PKO v površinski vodi ≥ 0,1 µg/l ali PKO za sediment ≥ 10 µg/kg?
PHASE II
FAZA II
Phase II assessment
Faza ocenjevanja II
The aim of Phase II is to assess the potential for additives to affect non-target species in the environment, including both aquatic and terrestrial species or to reach groundwater at unacceptable levels.
Namen faze ocenjevanja II je oceniti potencial dodatkov, da na nesprejemljivih ravneh vplivajo na neciljne vrste v okolju, vključno z vodnimi in kopenskimi vrstami, ali dosežejo podzemno vodo.
It is not practical to evaluate the effects of additives on every species in the environment that may be exposed to the additive following its administration to the target species.
Ocenjevanje učinkov dodatkov na vsako vrsto v okolju, ki je lahko izpostavljena dodatku po dajanju tega dodatka ciljni vrsti, ni smiselno.
The taxonomic levels tested are intended to serve as surrogates or indicators for the range of species present in the environment.
Preskušene taksonomske stopnje so predvidene kot nadomestki ali kazalniki za obseg vrst v okolju.
The Phase II assessment is based on a risk quotient approach, where the calculated PEC and Predicted No Effect Concentration (PNEC) values for each compartment shall be compared.
Faza ocenjevanja II temelji na pristopu količnika tveganja, pri katerem se primerjata vrednosti izračunanega PKO in predvidene koncentracije brez učinka (PKBU) za vsako okolje.
The PNEC is determined from experimentally determined endpoints divided by an appropriate assessment factor.
PKBU se določi na podlagi eksperimentalno določenih končnih točk, ki se delijo z ustreznim faktorjem ocenjevanja.
The PNEC value shall be calculated for each compartment.
Vrednost PKBU se izračuna za vsako okolje.
The Phase II assessment starts with a refinement of the PEC if possible, and uses a two-tiered approach to the environmental risk assessment.
Faza ocenjevanja II se začne z natančnejšim izračunom PKO, če je možen, uporablja pa se dvostopenjski pristop k ocenjevanju tveganja za okolje.
The first tier, Phase IIA, makes use of a limited number of fate and effect studies to produce a conservative assessment of risk based on exposure and effects in the environmental compartment of concern.
Na prvi stopnji, tj. faza IIA, se uporablja omejeno število študij o obnašanju in učinku, da se pripravi konservativna ocena tveganja na podlagi izpostavljenosti in učinkov v obravnavanem okolju.
If the ratio of the PEC to the PNEC is lower than one (1), no further assessment is required, unless bioaccumulation is expected.
Če je razmerje med PKO in PKBU manj kot ena (1), ni potrebno dodatno ocenjevanje, razen če se pričakuje kopičenje v organizmih.
If the PEC/PNEC ratio predicts an unacceptable risk (ratio > 1), the applicant shall progress to Phase IIB to refine the environmental risk assessment.
Če se na podlagi razmerja PKO/PKBU pričakuje nesprejemljivo tveganje (razmerje > 1), vložnik nadaljuje s fazo IIB, da se natančneje oceni tveganje za okolje.
Phase II A
Faza IIA
In addition to the compartments considered in Phase I, the PEC for surface water has to be calculated considering runoff and drainage.
Poleg okolij, ki se obravnavajo v fazi I, je treba izračunati PKO za površinsko vodo, pri čemer se upoštevata odtekanje in drenaža.
Based on data not considered in Phase I, a more refined PEC can be calculated for each environmental compartment of concern.
Na podlagi podatkov, ki se ne upoštevajo v fazi I, se lahko izračuna natančnejši PKO za vsako obravnavano okolje.
In ascertaining the refined PEC, account shall be taken of:
Pri natančnejši oceni PKO se upoštevajo:
the concentration of active substance(s)/metabolites of concern in manure/fish faeces following administration of the additive to animals at the proposed dose level.
koncentracija zadevnih aktivnih snovi/metabolitov v gnoju/fekalijah rib po dajanju dodatka živalim na predlagani ravni odmerka.
This calculation shall include consideration of dosage rates and amount of excreta produced;
Pri tem izračunu se upoštevajo ravni odmerkov in količina izločkov;
the potential degradation of the excreted active substance(s)/metabolites of concern during normal manure processing practice and storage prior to its application to land;
možno razgrajevanje zadevnih izločenih aktivnih snovi/metabolitov med običajnim postopkom predelave gnoja in skladiščenjem pred uporabo za gnojenje;
the adsorption/desorption of the active substance(s)/metabolites of concern onto soil or sediment for aquaculture, preferentially determined by studies in soil/sediment (OECD 106);
adsorpcija/desorpcija zadevnih aktivnih snovi/metabolitov v tleh ali sedimentu pri ribogojstvu, ki se po možnosti določi s študijami tal/sedimenta (OECD 106);
degradation in soil and water/sediment systems (OECD 307 and 308, respectively); and
razgrajevanje v tleh in vodno-sedimentnih sistemih (OECD 307 in 308); in
other factors such as hydrolysis, photolysis, evaporation, dilution through ploughing.
drugi dejavniki, kot so hidroliza, fotoliza, izhlapevanje, razredčitev z oranjem.
The highest value for the PEC obtained from these calculations for each environmental compartment of concern shall be adopted for Phase II risk assessment purposes.
Največja vrednost PKO, dobljena na podlagi teh izračunov za vsako obravnavano okolje, se sprejme za fazo ocenjevanja tveganja II.
If a high persistence in soil/sediment is anticipated (time to degradation of 90 % of original concentration of the compound: DT90 > 1 year), the potential for accumulation shall be considered.
Če se pričakuje visoka obstojnost v tleh/sedimentu (čas razgradnje 90 % prvotne koncentracije snovi: DT90 > 1 leto), se upošteva potencial kopičenja.
The concentrations of additives (or metabolites) producing serious adverse effects for various trophic levels in the environmental compartments of concern shall be determined.
Določijo se koncentracije dodatkov (ali metabolitov), ki povzročajo resne škodljive učinke za različne prehranjevalne ravni v obravnavanih okoljih.
These tests are mostly acute tests and should follow OECD or similar well-established guidelines.
Ti preskusi so večinoma akutni in jih je treba izvesti v skladu s smernicami OECD ali podobnimi uveljavljenimi smernicami.
Studies for the terrestrial environment shall include: toxicity to earthworms; three terrestrial plants; and soil micro-organisms (e.g. effects on nitrogen fixation).
Študije za kopensko okolje vključujejo: toksičnost za deževnike, tri kopenske rastline in mikroorganizme v tleh (npr. učinki na vezavo dušika).
Studies for the fresh water environment shall include: toxicity to fish; Daphnia magna; algae; and a sediment dwelling organism.
Študije za sladkovodno okolje vključujejo: toksičnost za ribe, vodne bolhe rodu Daphnia magna, alge in organizme v sedimentih.
In case of sea cages, three species of different taxa of sediment dwelling organisms shall be studied.
V primeru kletk za gojenje na morju se preučijo tri vrste različnih taksonomskih skupin organizmov v sedimentih.
Calculation of the PNEC value shall be carried out for each compartment of concern.
Vrednost PKBU se izračuna za vsako obravnavano okolje.
The PNEC is normally derived from the lowest toxicity value observed in the above tests and dividing by a safety factor of at least 100 depending on the endpoint and number of test species used.
PKBU se običajno izračuna tako, da se vzame najmanjša vrednost toksičnosti iz zgoraj navedenih preskusov in se deli z varnostnim faktorjem, ki znaša najmanj 100, odvisno od končne točke in števila uporabljenih preskusnih vrst.
The potential for bioaccumulation can be estimated from the value of the n-octanol/water partition coefficient, Log Kow.
Potencial kopičenja v organizmih se lahko oceni na podlagi vrednosti porazdelitvenega koeficienta n-oktanol/voda, Log Kow.
Values ≥ 3 indicate that the substance may bioaccumulated.
Vrednosti ≥ 3 kažejo, da se lahko snov kopiči v organizmih.
In order to assess the risk for secondary poisoning it shall be considered whether to carry out a bioconcentration factor (BCF) study at Phase IIB.
Za oceno tveganja za sekundarno zastrupitev se preuči, ali se v fazi IIB izvede študija faktorja biokoncentracije (BCF).
Phase IIB (more detailed ecotoxicological studies)
Faza IIB (podrobnejše ekotoksikološke študije)
For those additives where, following Phase IIA assessment, an environmental risk cannot be excluded, more information is required on the effects on biological species in the environmental compartment(s) in which Phase IIA studies indicate possible concern.
Za dodatke, pri katerih po fazi ocenjevanja IIA ni mogoče izključiti tveganja za okolje, je potrebnih več informacij o učinkih na biološke vrste v okoljih, za katere študije v fazi IIA kažejo, da lahko povzročajo zaskrbljenost.
In this situation, further tests are needed to determine the chronic and more specific effects on appropriate microbial, plant, and animal species.
V takšnih okoliščinah so potrebni dodatni preskusi, da se določijo kronični in bolj specifični učinki na primerne mikrobne, rastlinske in živalske vrste.
This additional information will allow the application a lower safety factor.
Na podlagi teh dodatnih informacij se bo lahko uporabil manjši varnostni faktor.
Suitable additional ecotoxicity tests are described in a number of publications, e.g. in OECD Guidelines.
Ustrezni dodatni ekotoksikološki preskusi so opisani v številnih publikacijah, npr. smernicah OECD.
Careful choice of such tests is necessary to ensure that they are appropriate to the situation in which the additive and/or its metabolites may be released and dispersed in the environment.
Takšne preskuse je treba skrbno izbrati, da se zagotovi njihova ustreznost glede na okoliščine, v katerih so lahko dodatek in/ali njegovi metaboliti izpuščeni v okolje in raztreseni po njem.
The refinement of the effect assessment for soil (PNECsoil) could be based on studies on the chronic effects on earthworms, additional studies on soil microflora and a number of relevant plant species, studies on grassland invertebrates (including insects) and feral birds.
Natančnejša ocena učinka za tla (PKBUtla) lahko temelji na študijah o kroničnih učinkih na deževnike, dodatnih študijah o mikroflori v tleh in več ustreznih rastlinskih vrstah ter študijah o pašniških nevretenčarjih (vključno z insekti) in divjih pticah.
The refinement of the effect assessment for water/sediment could be based on chronic toxicity tests on the most sensitive aquatic/benthic organisms identified in Phase IIA assessment.
Natančnejša ocena učinka za vodo/sediment lahko temelji na preskusih kronične toksičnosti pri najobčutljivejših vodnih/bentoških organizmih, določenih v fazi ocenjevanja IIA.
Bioaccumulation studies, if necessary, should be performed according to OECD Guideline 305.
Študije o kopičenju v organizmih je treba po potrebi izvajati v skladu s smernico OECD 305.
SECTION IV: STUDIES CONCERNING THE EFFICACY OF THE ADDITIVE
ODDELEK IV: ŠTUDIJE O UČINKOVITOSTI DODATKA
Studies shall demonstrate the efficacy for each proposed use and satisfy at least one of the characteristics set out in Article 5(3) of Regulation (EC) No 1831/2003, according to the categories and functional groups of feed additives as provided by Article 6 and Annex I of the said Regulation.
Študije dokazujejo učinkovitost za vsako predlagano uporabo in izpolnjujejo vsaj eno od lastnosti iz člena 5(3) Uredbe (ES) št. 1831/2003 po kategorijah in funkcionalnih skupinah krmnih dodatkov iz člena 6 in Priloge I k navedeni uredbi. Takšne študije morajo omogočati tudi oceno učinkovitosti dodatka glede na običajne načine kmetovanja v EU.
Moreover such studies must permit the evaluation of the efficacy of the additive according to common farming practices in the EU.
Uporabljeni načrt poskusa mora biti utemeljen glede na uporabo dodatka, živalsko vrsto in kategorijo.
The experimental design used must be justified according to the additive use, animal species and category.
Kadar se uporabljajo živali, se preskusi izvedejo tako, da njihovo zdravstveno stanje in razmere reje ne vplivajo negativno na razlago rezultatov.
When using animals, the trials shall be conducted such that their health and husbandry conditions do not adversely affect the interpretation of the results.
Za vsak poskus se opišejo pozitivni in negativni učinki, tehnološki in tudi biološki. Dokaže se tudi neobstoj učinkov, ki vplivajo na posebnosti proizvodov živalskega izvora.
The positive and negative effects, both technological and biological, shall be described for each experiment.
V najboljšem primeru preskusi izpolnjujejo merila, določena s priznanim, zunanje revidiranim sistemom zagotavljanja kakovosti.
Absence of effects that impair the distinctive features of animal products shall also be demonstrated. Trials shall ideally be compliant with the criteria established by a recognised, externally-audited, quality assurance scheme.
Če takšen sistem ne obstaja, se zagotovijo dokazi, ki potrjujejo, da je delo opravilo usposobljeno osebje, ki je uporabljalo ustrezne prostore in opremo ter odgovarja določenemu vodji študije.
In the absence of such a scheme, evidence shall be provided to show that the work was done by qualified personnel using appropriate facilities and equipment and responsible to a named study director.
Zapisnik preskusa skrbno sestavi vodja študije ob upoštevanju splošnih opisnih podatkov, na primer uporabljenih metod, opreme in materialov, podrobnosti o živalski vrsti, pasmi ali rodu živali, števila živali ter pogojev, pod katerimi so bivale in bile vzrejene.
The trial protocol shall be carefully drawn up by the study director with regard to general descriptive data, for example methods, apparatus and materials used, details of the species, breed or strain of the animals, their number and the conditions under which they were housed and fed. For all studies involving animals, the experimental conditions shall be described according to 3.1.1.3.
Za vse študije, ki vključujejo živali, se pogoji za poskuse opišejo v skladu s točko 3.1.1.3. Končna poročila, neobdelani podatki, načrti študije ter dobro opisane in identificirane preskusne snovi se arhivirajo za morebitno prihodnjo uporabo.
Final reports, raw data, study plans and well characterised and identified test substances shall be archived for future reference. Studies shall be designed to demonstrate the efficacy of the lowest recommended dose of additive by targeting sensitive parameters in comparison to a negative and, optionally, a positive control group.
Študije so načrtovane tako, da dokazujejo učinkovitost najmanjšega priporočenega odmerka dodatka z obravnavo občutljivih parametrov v primerjavi z negativno in, neobvezno, pozitivno kontrolno skupino.
Such studies shall also include the maximum recommended dose, where this is proposed.
Takšne študije vključujejo tudi največji priporočeni odmerek, kadar se to predlaga.
No single design is recommended, flexibility being provided to allow for scientific discretion in the design and conduct of the studies.
Enotni načrt ni priporočen, da se zagotovi prožnost, ki omogoča znanstveno presojo glede načrtovanja in izvajanja študij.
Attention shall also be paid to known or potential biological or chemical interactions between the additive, other additives and/or veterinary medicines and/or components of the diet, where this is relevant to the efficacy of the additive concerned (e.g. compatibility of microbial additive with coccidiostats and histomonostats or organic acid).
Pozorno se obravnavajo tudi znani ali možni biološki ali kemični medsebojni vplivi med dodatkom, drugimi dodatki in/ali zdravili za uporabo v veterinarski medicini in/ali sestavnimi deli obroka, kadar so pomembni za učinkovitost zadevnega dodatka (npr. združljivost mikrobnega dodatka s kokcidiostatiki in sredstvi proti histomonijazi ali organsko kislino).
In vitro studies
Študije in vitro
For all technological and some sensory additives affecting the characteristics of feed, efficacy shall be demonstrated using a laboratory-based study.
Za vse tehnološke in nekatere senzorične dodatke, ki vplivajo na lastnosti krme, se učinkovitost dokaže s študijo, ki temelji na laboratorijskih preskusih.
The study shall be designed to cover a representative range of materials to which the additive will be applied.
Študija je načrtovana tako, da zajema reprezentativen obseg snovi, h katerim se da dodatek.
Results shall be evaluated preferably by parameter-free tests, and shall demonstrate expected changes with a probability of P ≤ 0,05.
Rezultati se po možnosti ocenijo s preskusi brez parametrov in kažejo pričakovane spremembe z verjetnostjo P ≤ 0,05.