natgillin/translations-raw huggingface dataset:
Outliers identified through an appropriate method (e.g. Dixons or Grubbs test), may be discarded.
Največja odstopanja v katero koli smer, ki se jih ugotovi z ustrezno metodo (na primer Dixonov ali Grubbsov test), se lahko zavržejo.
Where outliers have been discarded, that fact must be clearly indicated.
Kadar se največja odstopanja zavržejo, je treba to jasno navesti.
An explanation as to the reason for the occurrence of individual outliers must be attempted.
Razložiti je treba razlog za pojav posameznih velikih odstopanj v katero koli smer.
Methods for the determination of residues
Metode za določitev ostankov
The methods must be capable of determining the active substance and/or relevant metabolites.
Metode morajo omogočati določitev aktivne snovi in/ali relevantnih metabolitov.
For each method and for each relevant representative matrix, the specificity, precision, recovery, and limit of determination must be experimentally determined and reported.
Za vsako metodo in za vsako relevantno reprezentativno matriko je treba eksperimentalno določiti in navesti specifičnost, natančnost, obnovljivost in mejo določitve.
In principle, residue methods proposed shall be multi-residue methods; a standard multi-residue method must be assessed and reported as to its suitability for residue determination.
Načeloma so predlagane metode za določitev ostankov multirezidualne metode; glede ustreznosti za določitev ostankov je treba oceniti in opisati eno od standardnih multirezidualnih metod.
Where residue methods proposed are not multi-residue methods, or are not compatible with such methods, an alternative method must be proposed.
Kadar predlagane metode za določitev ostankov niso multirezidualne metode ali niso združljive s takimi metodami, je treba predlagati drugo metodo.
Where this requirement results in an excessive number of methods for individual compounds, a ‘common moiety method’ may be acceptable.
Kadar bi to pomenilo veliko število različnih metod za posamezne spojine, se lahko sprejme uporaba „splošne srednje metode“.
For this Section the following definitions apply:
V tem oddelku se uporabljajo naslednje opredelitve pojmov:
Repeatability Precision under repeatability conditions, i.e. conditions where independent test results are obtained with the same method on identical test material in the same laboratory by the same operator using the same equipment within short intervals of time.
Ponovljivost Natančnost pri pogojih ponovljivosti, tj. pogojih, ko isti izvajalec tretiranja v kratkih časovnih razmakih z isto metodo na enaki testni snovi, isti opremi in v istem laboratoriju dobi neodvisne testne rezultate.
Reproducibility As the definition of reproducibility in relevant publications (for example, in ISO 5725) is in general not practicable for residue analytical methods, reproducibility in the context of this Regulation is defined as a validation of repeatability of recovery, from representative matrices and at representative levels, by at least one laboratory which is independent from that which initially validated the study (this independent laboratory may be within the same company) (independent laboratory validation).
Reproduktibilnost Ker opredelitev pojma reproduktibilnosti v ustreznih publikacijah (na primer v ISO 5725) običajno ni uporabna za analitske metode za določitev ostankov, je reproduktibilnost v okviru te uredbe opredeljena kot potrditev ponovljivosti obnovljivosti metode na podlagi reprezentativnih matrik in po reprezentativnih stopnjah v najmanj enem laboratoriju, ki je neodvisen od laboratorija, ki je prvotno potrdil dobljene rezultate (ta neodvisni laboratorij je lahko v istem podjetju) (potrditev neodvisnega laboratorija).
Recovery
Obnovljivost
The percentage of the amount of active substance or relevant metabolite originally added to a sample of the appropriate matrix which contains no detectable level of the analyte.
Odstotek količine aktivne snovi ali relevantnega metabolita, ki je bil prvotno dodan vzorcu ustrezne matrike, ki ne vsebuje zaznavne vrednosti merjene snovi.
Limit of determination
Meja določitve
The limit of determination (often referred to as limit of quantification) is defined as the lowest concentration tested, at which an acceptable mean recovery is obtained (normally 70 to 110 % with a relative standard deviation of preferably ≤ 20 %; in certain justified cases lower or higher mean recovery rates as well as higher relative standard deviations may be acceptable).
Meja določitve (pogosto navedena kot meja kvantifikacije) je opredeljena kot najnižja testirana koncentracija, pri kateri se dobi sprejemljiva srednja obnovljivost (običajno 70 % do 110 %, po možnosti z relativnim standardnim odstopanjem ≤ 20 %; v nekaterih upravičenih primerih se lahko sprejme nižja ali višja srednja obnovljivost ter višja relativna standardna odstopanja).
Residues in and/or on plants, plant products, foodstuffs (of plant and animal origin), feedingstuffs
Ostanki v rastlinah, rastlinskih proizvodih, živilih (rastlinskega ali živalskega izvora), krmi in/ali na njih
Methods submitted must be suitable for the determination of all components included in the residue definition as submitted in accordance with points 6.1 and 6.2 in order to enable Member States to determine compliance with established MRL’s or to determine dislodgeable residues.
Predložene metode morajo biti ustrezne za določitev vseh sestavin iz opredelitve ostankov v skladu s točkama 6.1 in 6.2, da lahko države članice ugotovijo skladnost z uveljavljenimi mejnimi vrednostmi ostankov ali določijo odstranljive ostanke.
The specificity of the methods must enable all components included in the residue definition to be determined, using an additional confirmatory method if appropriate.
Specifičnost metod mora omogočati določitev vseh sestavin iz opredelitve ostankov, po potrebi z uporabo dodatne potrditvene metode.
The repeatability must be determined and reported.
Določiti in navesti je treba ponovljivost.
The replicate analytical portions for test can be prepared from a common field treated sample, containing incurred residues.
Iz skupnega vzorca tretiranega terena, ki vsebuje ostanke, se lahko pripravi več vzorcev za analizo (identični vzorci).
Alternatively the replicate analytical portions for test can be prepared from a common untreated sample with aliquots fortified at the required level(s).
Prav tako je mogoče pripraviti več vzorcev za analizo iz posameznega vzorca netretiranega materiala z ostanki, dodanimi v zahtevani količini.
The results from an independent laboratory validation must be reported.
Navesti je treba rezultate meritev neodvisnega laboratorija.
The limit of determination including the individual and mean recovery must be determined and reported.
Določiti in navesti je treba mejo določitve, vključno s posamezno in srednjo obnovljivostjo.
The overall relative standard deviation, as well as the relative standard deviation for each fortification level must be experimentally determined and reported.
Eksperimentalno je treba določiti in navesti skupno relativno standardno odstopanje in relativno standardno odstopanje za vsako količino dodanega ostanka.
Residues in soil
Ostanki v tleh
Methods for analysis of soil for parent compound and/or relevant metabolites must be submitted.
Navesti je treba metode za analizo tal za osnovno spojino in/ali relevantne metabolite.
The specificity of the methods must enable the parent compound and/or relevant metabolites to be determined, using an additional confirmatory method if appropriate.
Specifičnost metod mora omogočati določitev osnovne spojine in/ali relevantnih metabolitov, po potrebi z uporabo dodatne potrditvene metode.
The repeatability, recovery and the limit of determination including the individual and mean recovery must be determined and reported.
Določiti in navesti je treba ponovljivost, obnovljivost in mejo določitve, vključno s posamezno in srednjo obnovljivostjo.
The proposed limit of determination must not exceed a concentration which is of concern with regard to exposure of non-target organisms or because of phytotoxic effects.
Predlagana meja določitve ne sme preseči koncentracije, katere učinek je pomemben zaradi izpostavljenosti neciljnih organizmov ali zaradi fitotoksičnosti.
Normally the proposed limit of determination shall not exceed 0,05 mg/kg.
Predlagana meja določitve ne presega 0,05 mg/kg.
Residues in water (including drinking water, ground water and surface water)
Ostanki v vodi (vključno s pitno vodo, podtalnico in površinskimi vodami)
Methods for analysis in water for parent compound and/or relevant metabolites must be submitted.
Navesti je treba metode za analizo osnovne spojine in/ali relevantnih metabolitov v vodi.
For drinking water the proposed limit of determination must not exceed 0,1 μg/l.
Predlagana meja določitve za pitno vodo ne sme presegati 0,1 μg/l.
For surface water the proposed limit of determination must not exceed a concentration which has an impact on non-target organisms deemed to be unacceptable in accordance with the requirements of the Annex to Commission Regulation (EU) No 546/2011 [8].
Predlagana meja določitve za površinsko vodo ne sme presegati koncentracije, ki vpliva na neciljne organizme na način, ki je nesprejemljiv v skladu z zahtevami Priloge k Uredbi Komisije (EU) št. 546/2011 [8].
Residues in air
Ostanki v zraku
Methods for the analysis in air of the active substance and/or relevant metabolites formed during or shortly after application must be submitted unless it can be justified that exposure of operators, workers or bystanders is not likely to occur.
Navesti je treba metode za analizo aktivne snovi in/ali relevantnih metabolitov v zraku, ki nastanejo med nanašanjem ali kmalu po njem, razen če je mogoče utemeljiti, da je majhna verjetnost izpostavitve izvajalcev tretiranja, delavcev in drugih navzočih.
The proposed limit of determination must take into account relevant health based limit values or relevant exposure levels.
Predlagana meja določitve mora upoštevati ustrezne na osnovi zdravja določene mejne vrednosti ali ustrezne stopnje izpostavljenosti.
Residues in body fluids and tissues
Ostanki v telesnih tekočinah in tkivih
Where an active substance is classified as toxic or highly toxic appropriate analytical methods must be submitted.
Kadar je aktivna snov razvrščena kot toksična ali zelo toksična, je treba navesti ustrezne analitske metode.
Toxicological and metabolism studies
Toksikološke študije in študije o presnovi
The information provided, taken together with that provided for one or more preparations containing the active substance, must be sufficient to permit an evaluation to be made as to the risks for man, associated with the handling and use of plant protection products containing the active substance, and the risk for man arising from residual traces remaining in food and water.
Predložene informacije, skupaj s podatki za enega ali več pripravkov, ki vsebujejo aktivno snov, morajo zadoščati za oceno možnega tveganja za ljudi, povezanega z ravnanjem in uporabo fitofarmacevtskih sredstev, ki vsebujejo aktivno snov, ter tveganja za ljudi, ki ga povzročajo ostanki fitofarmacevtskih sredstev v živilih in vodi.
In addition, the information provided must be sufficient to:
Poleg tega morajo predložene informacije zadoščati za:
permit a decision to be made as to whether, or not, the active substance can be approved,
odločitev o odobritvi aktivne snovi,
specify appropriate conditions or restrictions to be associated with any approval,
natančno opredelitev ustreznih pogojev ali omejitev v zvezi z vsako odobritvijo,
classify the active substance as to hazard,
razvrstitev aktivne snovi glede na možno nevarnost,
establish a relevant acceptable daily intake (ADI) level for man,
določitev relevantnega sprejemljivega dnevnega vnosa za ljudi,
establish acceptable operator exposure level(s) (AOEL),
določitev stopenj sprejemljive izpostavljenosti izvajalca tretiranja,
specify the pictograms, signal words, and relevant hazard and precautionary statements for the protection of man, animals and the environment to be included in packaging (containers),
določitev piktogramov, opozorilnih besed ter relevantnih stavkov o nevarnosti in previdnostnih stavkov za zaščito ljudi, živali in okolja, ki morajo biti na embalaži (posodah),
identify relevant first aid measures as well as appropriate diagnostic and therapeutic measures to be followed in the event of poisoning in man, and
opredelitev ustreznih ukrepov prve pomoči ter ustreznih diagnostičnih in terapevtskih ukrepov v primeru zastrupitve ljudi ter
permit an evaluation to be made as to the nature and extent of the risks for man, animals (species normally fed and kept or consumed by man) and of the risks for other non-target vertebrate species.
oceno glede vrste in obsega možnega tveganja za ljudi, živali (predvsem domače živali in rejne živali) ter tveganja za druge neciljne vrste vretenčarjev.
There is a need to investigate and report all potentially adverse effects found during routine toxicological investigations (including effects on organs and special systems such as immunotoxicity and neurotoxicity) and to undertake and report such additional studies which may be necessary to investigate the probable mechanism involved, to establish Noaels (no observed adverse effect levels), and to assess the significance of these effects.
Raziskati in navesti je treba vse morebitne škodljive učinke, ugotovljene med običajnimi toksikološkimi študijami (vključno z učinki na organe in posebne sisteme, kot sta imunotoksičnost in nevrotoksičnost), ter pripraviti in navesti dodatne študije, potrebne za raziskavo morebitnih vpletenih mehanizmov, za določitev vrednosti količin, pri katerih škodljivi vplivi niso bili ugotovljeni, ter za oceno pomena teh vplivov.
All available biological data and information which are relevant to the assessment of the toxicological profile of the substance tested, must be reported.
Navesti je treba vse razpoložljive biološke podatke in informacije, pomembne za oceno toksikološkega profila testirane snovi.
Where studies are conducted using an active substance produced in the laboratory or in a pilot plant production system, the studies must be repeated using the active substance as manufactured, unless it can be justified that the test material used is essentially the same, for the purposes of toxicological testing and assessment.
Študije, v katerih se uporablja aktivna snov, proizvedena v laboratoriju ali v poskusni proizvodnji, je treba ponoviti s tehnično aktivno snovjo, razen kadar je mogoče utemeljiti, da je uporabljena testna snov s stališča toksikološkega testa in ocene enaka.
In cases of uncertainty, appropriate bridging studies must be submitted to serve as a basis for a decision as to the possible need for repetition of the studies.
Če gre za negotovost, je treba predložiti primerne povezovalne študije, ki služijo kot podlaga za odločitev o možnosti ponovitve študij.
In the case of studies in which dosing extends over a period, dosing shall preferably be done using a single batch of active substance if stability permits.
Za študije o določanju odmerkov, ki potekajo daljše obdobje, se po možnosti uporabi aktivna snov iz ene same serije, če njena stabilnost to omogoča.
For all studies actual achieved dose in mg/kg body weight, as well as in other convenient units, must be reported.
Za vse študije se navedejo podatki o dejansko pridobljenih odmerkih v mg/kg telesne teže ali v drugih primernih enotah.
Where dosing via the diet is utilised the test compound must be distributed uniformly in the diet.
Kadar se za odmerjanje uporablja hrana ali krma, je treba testno spojino enakomerno porazdeliti v obroke.
The way of administration of the test substance depends on the main exposure routes.
Odločanje o vrsti testiranja testne snovi je odvisno od glavnih oblik izpostavljenosti.
In cases where exposure is mainly by the gas phase, it can be more appropriate to perform inhalation studies instead of oral studies.
Kadar gre za izpostavljenost plinski fazi, je namesto oralnih študij morda primerneje izvesti inhalacijske študije.
Studies on absorption, distribution, excretion and metabolism in mammals
Študije o absorpciji, porazdelitvi, izločanju in presnovi pri sesalcih
Quite limited data, as described below and restricted to one test species (normally the rat) may be all that is required in this area.
Na tem področju se lahko zahtevajo dokaj omejeni podatki, kot so opisani spodaj in omejeni na eno testno vrsto (običajno podgano).
These data can provide information useful in the design and interpretation of subsequent toxicity tests.
Ti podatki lahko zagotavljajo informacije, uporabne pri načrtovanju in razlagi poznejših testov toksičnosti.
However, it must be remembered that information on interspecies differences may be crucial in extrapolation of animal data to man and information on percutaneous penetration, absorption, distribution, excretion and metabolism may be useful in operator risk assessments.
Informacije o razlikah med vrstami so lahko ključne pri ekstrapolaciji podatkov z živali na človeka, podatki o prehajanju aktivne snovi skozi kožo, absorpciji, porazdelitvi, izločanju in presnovi pa se lahko uporabijo pri oceni tveganja za izvajalca tretiranja.
It is not possible to specify detailed data requirements in all areas, since the exact requirements will be dependent upon the results obtained for each particular test substance.
Vseh zahtevanih podrobnih podatkov na vseh področjih ni mogoče opredeliti, ker je natančnejša opredelitev potrebnih podatkov odvisna od rezultatov, pridobljenih za posamezno testno snov.
Aim of the test:
Namen testiranja:
The tests shall provide sufficient data to permit:
Testi zagotovijo dovolj podatkov za:
an evaluation of the rate and extent of absorption,
oceno stopnje in obsega absorpcije,
an evaluation of the tissue distribution and the rate and extent of excretion of the test substance and the relevant metabolites,
oceno porazdelitve v tkivu ter stopnje in obsega izločanja testirane snovi in relevantnih metabolitov,
the identification of metabolites and the metabolic pathway.
določitev metabolitov in metabolnih poti.
The effect of dose level on these parameters and whether the results are different after single versus repeated doses, shall also be investigated.
Preuči se tudi vpliv količine odmerka na te parametre in ali so rezultati po enem samem odmerku enaki rezultatom ponavljajočih se odmerkov.
Circumstances in which required
Okoliščine, v katerih se zahteva
A single dose toxicokinetic study in rats (oral route of administration) in at least two dose levels as well as a repeated dose toxicokinetic study in rats (oral route of administration) at a single dose level, must be conducted and reported.
Izvesti je treba toksikokinetično študijo na podganah z enkratnim oralnim vnosom dvojnega odmerka in s ponavljajočim oralnim vnosom enojnih odmerkov ter o njej poročati.
It may be necessary in some cases to perform additional studies on another species (such as goat or chicken).
V nekaterih primerih je treba izvesti dodatne študije na drugih vrstah (kot so koze ali piščanci).
Test guideline
Smernice za testiranje
The studies, data and information to be provided and evaluated must be sufficient to permit the identification of effects following a single exposure to the active substance, and in particular to establish, or indicate:
Študije, podatki in informacije, ki jih je treba navesti in oceniti, morajo zadoščati za določitev učinkov enkratne izpostavljenosti aktivni snovi, in zlasti za določitev ali navedbo:
the toxicity of the active substance,
toksičnosti aktivne snovi,
the time course and characteristics of the effects with full details of behavioural changes and possible gross pathological findings at post-mortem,
časovnega poteka in značilnosti učinkov z izčrpnimi podrobnostmi o spremembah v obnašanju in morebitnimi makroskopskimi patološkimi ugotovitvami pri obdukciji,
where possible mode of toxic action, and
načina toksičnega delovanja, kadar je to mogoče, ter
the relative hazard associated with the different routes of exposure.
relativne nevarnosti, povezane z različnimi načini izpostavljenosti.
While the emphasis must be on estimating the toxicity ranges involved, the information generated must also permit the active substance to be classified in accordance with Regulation (EC) No 1272/2008.
Poudarek mora biti na oceni stopenj toksičnosti, pridobljene informacije pa morajo omogočati tudi razvrstitev aktivne snovi v skladu z Uredbo (ES) št. 1272/2008.
The information generated through acute toxicity testing is of particular value in assessing hazards likely to arise in accident situations.
Informacije, pridobljene z izvajanjem testov akutne toksičnosti, so zlasti koristne pri ocenjevanju nevarnosti, ki se lahko pojavijo v primerih nesreč.
Oral
Oralna toksičnost
The acute oral toxicity of the active substance must always be reported.
Vedno je treba navesti akutno oralno toksičnost aktivne snovi.
The test must be carried out in accordance with the Annex to Regulation (EC) No 440/2008, Method B 1 bis or B 1 ter.
Test je treba izvesti v skladu z metodo B1 bis ali B1 ter iz Priloge k Uredbi (ES) št. 440/2008.
Percutaneous
Perkutana toksičnost
The acute percutaneous toxicity of the active substance must always be reported.
Vedno je treba navesti akutno perkutano toksičnost aktivne snovi.
Both local and systemic effects must be investigated.
Preučiti je treba lokalne in sistemične učinke.
The test must be carried out in accordance with the Annex to Regulation (EC) No 440/2008, method B 3.
Test je treba izvesti v skladu z metodo B3 iz Priloge k Uredbi (ES) št. 440/2008.
Inhalation
Inhalacijska toksičnost
The inhalation toxicity of the active substance must be reported where the active substance is:
Inhalacijsko toksičnost aktivne snovi je treba navesti, kadar je aktivna snov:
a gas or liquified gas,
plin ali utekočinjeni plin,
is to be used as a fumigant,
snov, ki se uporablja kot fumigant (zaplinjevalno sredstvo),
is to be included in a smoke generating, aerosol or vapour releasing preparation,
snov, ki je vključena v pripravke za dimljenje, aerosole ali pripravke za sproščanje pare,
is to be used with fogging equipment,
snov, ki se nanaša z opremo za zamegljevanje,
has a vapour pressure > 1 × 10–2 Pa and is to be included in preparations to be used in enclosed spaces such as warehouses or glasshouses,
snov s parnim tlakom večjim od 1 × 10–2 Pa, ki je vključena v pripravke za uporabo v zavarovanih prostorih, kot so skladišča ali rastlinjaki,
is to be included in preparations which are powders containing a significant proportion of particles of diameter < 50 μm (> 1 % on a weight basis), or
snov, ki je vključena v pripravke v obliki praška, ki vsebujejo znaten delež delcev premera, manjšega od 50 μm (več kot 1 mas. %), ali
is to be included in preparations to be applied in a manner which generates a significant proportion of particles or droplets of diameter < 50 μm (> 1 % on a weight basis).
snov, ki je vključena v pripravke, ki se uporabljajo na način, ki povzroči nastanek znatnega deleža delcev ali kapljic s premerom, manjšim od 50 μm (več kot 1 mas. %).
The test must be carried out in accordance with the Annex to Regulation (EC) No 440/2008, Method B 2.
Test je treba izvesti v skladu z metodo B2 iz Priloge k Uredbi (ES) št. 440/2008.
Aim of the test
Namen testiranja
The test will provide the potential of skin irritancy of the active substance including the potential reversibility of the effects observed.
S testom se prikaže možnost draženja kože zaradi aktivne snovi ter morebitna reverzibilnost opaženih učinkov.
The skin irritancy of the active substance must be determined except where it is likely, as indicated in the test guideline, that severe skin effects may be produced or that effects can be excluded.
Draženje kože, ki jo povzroča aktivna snov, je treba določiti, razen kadar obstaja možnost hudih kožnih reakcij, kot je navedeno v smernicah za testiranje, ali se učinki draženja kože lahko izključijo.
The acute skin irritation must be carried out in accordance with the Annex to Regulation (EC) No 440/2008, Method B 4.
Test akutnega draženja kože je treba izvesti v skladu z metodo B4 iz Priloge k Uredbi (ES) št. 440/2008.
Aim of test
Namen testiranja