natgillin/translations-raw huggingface dataset:
The identity of breakdown products formed which at any time during the study are present in quantities ≥ 10 % of the active substance added, a mass balance to account for at least 90 % of the applied radioactivity, as well as photochemical halflife must be reported.
Navesti je treba nastale razgradne produkte, katerih količina kadar koli med študijo je ≥ 10 % dodane aktivne snovi, masno ravnotežje, s katero se lahko utemelji najmanj 90 % uporabljene radioaktivnosti, in fotokemično razpolovno dobo.
Where necessary to investigate direct phototrans-formation, the quantum yield of direct photodegradation in water must be determined and reported, together with calculations to estimate theoretical lifetime of the active substance in the top layer of aqueous systems and the real lifetime of the substance.
Po potrebi je pri preučevanju direktne fototransformacije treba določiti in navesti količino razgradnih produktov neposredne fotorazgradnje v vodi in izračune za oceno teoretične življenjske dobe aktivne snovi v zgornji plasti vodnih sistemov ter dejanske življenjske dobe snovi.
The identity of the dissociated species formed, based on theoretical considerations, must be reported.
Na podlagi teoretičnih predpostavk je treba navesti nastale razgradne produkte.
If the active substance is a salt, the pKa value of the active principle must be given.
Če je aktivna snov sol, je treba navesti vrednost pKa aktivne sestavine.
Stability in air, photochemical degradation, identity of breakdown product(s)
Stabilnost na zraku, fotokemična razgradnja, identiteta razgradnih produktov
An estimation of the photochemical oxidative degradation (indirect phototransformation) of the active substance, must be submitted.
Predložiti je treba oceno fotokemične oksidativne razgradnje (indirektna fototransformacija) aktivne snovi.
Flammability including auto-flammability
Vnetljivost in samovžig
The flammability of active substances as manufactured, which are solids, gases, or are substances which evolve highly flammable gases, must be determined and reported in accordance with method A 10, A 11 or A 12 of Regulation (EC) No 440/2008 as appropriate.
Vnetljivost tehničnih aktivnih snovi, ki so trdne snovi, plini ali snovi, ki razvijajo močno vnetljive pline, je treba določiti in navesti v skladu z metodo A10, A11 ali A12 Uredbe (ES) št. 440/2008, kakor je primerno.
The auto-flammability of active substances as manufactured must be determined and reported in accordance with method A 15 or A 16 of Regulation (EC) No 440/2008 as appropriate, and/or, where necessary in accordance with the UN-Bowes-Cameron-Cage-Test (UN-Recommendations on the Transport of Dangerous Goods, Chapter 14, No 14.3.4).
Temperaturo samovžiga tehničnih aktivnih snovi je treba določiti in navesti v skladu z metodo A15 ali A16 Uredbe (ES) št. 440/2008, kakor je primerno, in/ali kadar je to potrebno, v skladu s testom UN-Bowes-Cameron-Cage (Priporočila ZN o prevozu nevarnega blaga, poglavje 14, št. 14.3.4).
The flash point of active substances as manufactured with a melting point below 40 °C, must be determined and reported in accordance with method A 9 of Regulation (EC) No 440/2008; only closed cup methods shall be used.
Plamenišče tehničnih aktivnih snovi s tališčem pod 40 °C je treba določiti in navesti v skladu z metodo A9 Uredbe (ES) št. 440/2008; uporabijo se samo metode v zaprti posodi.
The explosive properties of active substances as manufactured, must be determined and reported in accordance with method A 14 of Regulation (EC) No 440/2008 where necessary.
Eksplozivne lastnosti tehničnih aktivnih snovi je treba določiti in navesti v skladu z metodo A14 Uredbe (ES) št. 440/2008, kadar je to potrebno.
The surface tension has to be determined and reported in accordance with method A 5 of Regulation (EC) No 440/2008.
Površinsko napetost je treba določiti in navesti v skladu z metodo A5 Uredbe (ES) št. 440/2008.
Oxidising properties
Oksidacijske lastnosti
The oxidising properties of active substances as manufactured, must be determined and reported in accordance with method A 17 of Regulation (EC) No 440/2008, except where examination of its structural formula, establishes beyond reasonable doubt that the active substance is incapable of reacting exothermically with a combustible material.
Oksidacijske lastnosti tehničnih aktivnih snovi je treba določiti in navesti v skladu z metodo A17 Uredbe (ES) št. 440/2008, razen kadar se na podlagi njene strukturne formule nedvoumno ugotovi, da aktivna snov z vnetljivo snovjo ne more eksotermno reagirati.
In such cases, it is sufficient to provide that information as justification for not determining the oxidising properties of the active substance.
V takih primerih je dovolj, če se navede ta informacija kot utemeljitev, zakaj oksidacijske lastnosti aktivne snovi niso navedene.
Further information on the active substance
Dodatne informacije o aktivni snovi
The information provided must describe the intended purposes for which preparations containing the active substance are used, or are to be used and the dose and manner of their use or proposed use.
V predloženih informacijah je treba opisati, za kakšen namen se pripravki, ki vsebujejo aktivno snov, uporabljajo ali se bodo uporabljali ter odmerek in način njihove uporabe ali predlagane uporabe.
The information provided must specify the normal methods and precautions to be followed, in the handling, storage and transport of the active substance.
V predloženih informacijah je treba navesti običajne metode in varnostne ukrepe pri ravnanju z aktivno snovjo, njenem shranjevanju in prevozu.
The studies, data and information submitted, together with other relevant studies, data and information, must both specify and justify the methods and precautions to be followed in the event of fire.
V predloženih študijah, podatkih in informacijah, skupaj z drugimi relevantnimi študijami, podatki in informacijami, je treba podrobno določiti in utemeljiti postopke in varnostne ukrepe v primeru požara.
The possible products of combustion in the event of fire shall be estimated, based on the chemical structure and the chemical and physical properties of the active substance.
Na podlagi kemijske strukture ter kemijskih in fizikalnih lastnosti aktivne snovi se ocenijo možni produkti gorenja v primeru požara.
The studies, data and information submitted, together with other relevant studies, data and information, must demonstrate the suitability of measures proposed for use in emergency situations.
V predloženih študijah, podatkih in informacijah, skupaj z drugimi relevantnimi študijami, podatki in informacijami, je treba prikazati primernost predlaganih ukrepov v izrednih razmerah.
Function, e.g. fungicide, herbicide, insecticide, repellent, growth regulator
Funkcija, npr. fungicid, herbicid, insekticid, repelent, regulator rasti
The function must be specified from among the following:
Delovanje je treba določiti po naslednjem seznamu:
acaricide
akaricid,
bactericide
baktericid,
fungicide
fungicid,
herbicide
herbicid,
insecticide
insekticid,
molluscicide
moluskicid,
nematicide
nematicid,
plant growth regulator
regulator rasti in razvoja rastlin,
repellent
repelent,
rodenticide
rodenticid,
semio-chemicals
semio-kemikalije,
talpicide
talpicid,
viricide
viricid,
other (must be specified).
drugo (treba je natančno določiti).
Effects on harmful organisms, e.g. contact poison, inhalation poison, stomach poison, fungitoxic, etc. systematic or not in plants
Vplivi na škodljive organizme, npr. kontaktni, inhalacijski ali želodčni strup, fungitoksik itd., sistemičen ali nesistemičen v rastlinah
The nature of the effects on harmful organisms must be stated:
Navesti je treba način delovanja na škodljive organizme:
contact action
kontaktno delovanje,
stomach action
želodčno delovanje,
inhalation action
inhalacijsko delovanje,
fungitoxic action
fungitoksično delovanje,
fungistatic action
fungistatično delovanje,
reproduction inhibitor
zaviralec procesov razmnoževanja,
It must be stated whether or not the active substance is translocated in plants and where relevant whether such translocation is apoplastic, symplastic or both.
Navesti je treba, ali se aktivna snov v rastlinah premešča (translocira) in, kadar je to relevantno, ali je translokacija apoplastna, simplastna ali oboje.
Field of use envisaged, e.g. field, protected crops, storage of plant products, home gardening
Predvideno področje uporabe, npr. na prostem, v zavarovanem prostoru, skladiščenje rastlinskih proizvodov, hišno vrtnarjenje
The field(s) of use, existing and proposed, for preparations containing the active substance must be specified from among the following:
Za pripravke, ki vsebujejo aktivno snov, je treba natančno navesti obstoječa ali predlagana področja uporabe, tj.:
Field use, such as agriculture, horticulture, forestry and viticulture
na prostem, kot na primer v poljedelstvu, hortikulturi, gozdarstvu in vinogradništvu,
Protected crops
zavarovani prostori,
Amenity
okrasne in rekreacijske površine,
Weed control on non-cultivated areas
uničevanje plevela na nekmetijskih površinah,
Home gardening
urejanje hišnih vrtov,
House plants
sobne rastline,
Plant products storage practice
skladiščenje rastlinskih proizvodov,
Other (specify).
drugo (navesti).
Harmful organisms controlled and crops or products protected or treated
Ciljne vrste škodljivih organizmov in vrste kultur ali proizvodov, ki se varujejo ali tretirajo
Details of existing and the intended use in terms of crops, groups of crops, plants, or plant products treated and where relevant protected, must be provided.
Navesti je treba podrobne informacije o obstoječi in načrtovani uporabi v obliki podatkov o tretiranih in, kadar je relevantno, varovanih kulturah, skupinah kultur, rastlinah ali rastlinskih proizvodih.
Where relevant, details of harmful organisms against which protection is afforded, must be provided.
Kadar je relevantno, je treba navesti podrobne informacije o škodljivih organizmih, pred katerimi je varstvo mogoče.
Where relevant, effects achieved e.g. sprout suppression, retardation of ripening, reduction in stem length, enhanced fertilisation, etc. must be reported.
Kadar je relevantno, je treba navesti podatke o doseženih učinkih, npr. zaviranje kaljenja, zakasnitev zorenja, skrajšanje stebla, boljši učinki pognojevanja itd.
To the extent that is has elucidated, a statement must be provided as to the mode of action of the active substance in terms, where relevant, of the biochemical and physiological mechanism(s) and biochemical pathway(s) involved.
Predložiti je treba izjavo o načinu delovanja aktivne snovi glede, kadar je to relevantno, biokemijskih in fizioloških mehanizmov delovanja ter vpletenih biokemijskih poti.
Where available, the results of relevant experimental studies must be reported.
Kadar so na voljo, je treba navesti rezultate relevantnih eksperimentalnih študij.
Where it is known that to exert its intended effect, the active substance must be converted to a metabolite or degradation product following application or use of preparations containing it, the following information, cross referenced to and drawing on information provided in the context of paragraphs 5.6, 5.11, 6.1, 6.2, 6.7, 7.1, 7.2 and 9, where relevant, must be provided for active metabolite or degradation product:
Kadar je znano, da se mora aktivna snov za doseganje predvidenih učinkov po nanosu ali uporabi pripravkov pretvoriti v metabolit ali razgradni produkt, je treba za aktivni metabolit ali razgradni produkt predložiti podatke, pridobljene po navzkrižnem preverjanju in preučevanju informacij iz odstavkov 5.6, 5.11, 6.1, 6.2, 6.7, 7.1, 7.2 in 9, kakor je relevantno:
ISO common name or proposed common name,
splošno ali predlagano splošno ime po ISO,
CAS EC-number EC (Einecs or ELINCS) number, and CIPAC number if available,
številke CAS, ES (EINECS ali ELINCS) in CIPAC, če so na voljo,
empirical and structural formula, and
empirično in strukturno formulo ter
molecular mass.
molekulsko maso.
Available information relating to the formation of active metabolites and degradation products must be provided, to include:
Navesti je treba razpoložljive podatke o tvorbi aktivnih metabolitov in razgradnih produktov, ki vključujejo:
the processes, mechanisms and reactions involved,
zadevne postopke, mehanizme in reakcije,
kinetic and other data concerning the rate of conversion and if known the rate limiting step,
kinetične in druge podatke o hitrosti pretvorbe in načinu za zmanjšanje hitrosti, če je znan,
environmental and other factors effecting the rate and extent of conversion.
dejavnike okolja in druge dejavnike, ki vplivajo na hitrost in obseg pretvorbe.
Information on the occurrence or possible occurrence of the development of resistance and appropriate management strategies
Podatki o pojavu ali možnem pojavu razvoja odpornosti in ustrezni ukrepi obvladovanja
Where available, information on possible occurrence of the development of resistance or cross-resistance must be provided.
Kadar so na voljo, je treba navesti podatke o možnem pojavu razvoja odpornosti ali navzkrižne odpornosti.
Recommended methods and precautions concerning handling, storage, transport or fire
Priporočene metode in varnostni ukrepi v zvezi z ravnanjem, shranjevanjem, prevozom ali požarom
A safety data sheet pursuant to Article 31 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council [7] must be provided for all active substances.3.8. Procedures for destruction or decontamination
Za vse aktivne snovi je treba predložiti varnostni list v skladu s členom 31 Uredbe (ES) št. 1907/2006 Evropskega parlamenta in Sveta [7].3.8 Postopki uničenja ali dekontaminacije
In many cases the preferred or sole means to safely dispose of active substances, contaminated materials, or contaminated packaging, is through controlled incineration in a licensed incinerator.
V številnih primerih je najprimernejši ali edini način varnega uničenja aktivnih snovi in kontaminiranih snovi ali embalaže nadzorovani sežig v sežigalni napravi, ki ima za to uradno dovoljenje.
Where the content of halogens of the active substance is greater than 60 %, the pyrolytic behaviour of the active substance under controlled conditions (including where relevant supply of oxygen and defined residence time), at 800 °C and the content of polyhalogenated dibenzo-p-dioxins and dibenzo-furans in the products of pyrolysis must be reported.
Kadar je vsebnost halogenov v aktivni snovi višja od 60 %, je treba navesti podatke o pirolitskih lastnostih aktivne snovi v nadzorovanih pogojih (vključno s preskrbo s kisikom in opredeljenim časom, kadar je to relevantno) pri temperaturi 800 °C in o vsebnosti polihalogeniranih dibenzo-p-dioksinov in dibenzo-furanov v produktih pirolize.
The application must provide detailed instructions for safe disposal.
V vlogi je treba opisati podrobna navodila za varno uničenje.
Other methods to dispose of the active substance, contaminated packaging and contaminated materials, where proposed, must be fully described.
Natančno je treba opisati druge postopke uničenja aktivne snovi ter kontaminirane embalaže in kontaminiranih snovi, kadar se to predlaga.
Data must be provided for such methods, to establish their effectiveness and safety.
Za takšne postopke je treba navesti podatke za določitev njihove učinkovitosti in varnosti.
Emergency measures in case of an accident
Nujni ukrepi ob nesrečah
Procedures for the decontamination of water in case of an accident must be provided.
Navesti je treba postopke za dekontaminacijo vode v primeru nesreče.
Analytical methods
Analitske metode
The provisions of this Section only cover analytical methods required for post-registration control and monitoring purposes.
Določbe tega oddelka veljajo le za analitske metode, potrebne za namene nadzora in spremljanja po registraciji.
For analytical methods used for generation of data as required in this Regulation or for other purposes the applicant has to provide a justification for the method used; where necessary separate guidance will be developed for such methods on the basis of the same requirements as defined for methods for post-registration control and monitoring purposes.
Za analitske metode, potrebne za pridobivanje podatkov, kakor jih zahteva ta uredba, ali za druge namene, mora vlagatelj navesti utemeljitev za uporabljeno metodo; kadar je to potrebno, se za takšne metode pripravijo ločene smernice na podlagi enakih zahtev, kakor so določene za metode za namene nadzora in spremljanja po registraciji.
Descriptions of methods must be provided and include details of equipment, materials and conditions used.
Navesti je treba opise metod, ki vključujejo podrobnosti o uporabljeni opremi, materialih in pogojih.
As far as practicable these methods must employ the simplest approach, involve the minimum cost, and require commonly available equipment.
Kolikor je to praktično mogoče, je treba za izvajanje teh metod uporabljati najenostavnejši pristop, ki zahteva najnižje stroške in splošno dostopno opremo.
For this Section the following applies:
V tem oddelku se uporabljajo naslednje opredelitve:
Impurities, metabolites, relevant metabolites
Nečistoče, metaboliti, relevantni metaboliti
as defined in Regulation (EC) No 1107/2009
Kakor so opredeljeni v Uredbi (ES) št. 1107/2009
Relevant impurities
Relevantne nečistoče
Impurities of toxicological and/or ecotoxicological or environmental concern
Nečistoče, ki so pomembne s toksikološkega in/ali ekotoksikološkega vidika ali zaradi vpliva na okolje
Significant impurities
Pomembne nečistoče
Impurities with a content of ≥ 1 g/kg in the active substance as manufactured
Nečistoče z vsebnostjo ≥ 1 g/kg tehnične aktivne snovi
On request the following samples must be provided:
Na zahtevo je treba predložiti naslednje vzorce:
analytical standards of the pure active substance;
analitskih standardov čiste aktivne snovi;
samples of the active substance as manufactured;
tehnične aktivne snovi;
analytical standards of relevant metabolites and all other components included in the residue definition;
analitskih standardov relevantnih metabolitov in vseh drugih sestavin, ki so opredeljene kot ostanki;
if available, samples of reference substances for the relevant impurities.
referenčnih snovi relevantnih nečistoč, če so na voljo.
Methods for the analysis of the active substance as manufactured
Metode za analizo tehnične aktivne snovi
For this point the following definitions apply:
V tej točki se uporabljajo naslednje opredelitve pojmov:
Specificity is the ability of a method to distinguish between the analyte being measured and other substances.
Specifičnost je sposobnost metode za razlikovanje med merjeno snovjo in drugimi snovmi.
Linearity is defined as the ability of the method, within a given range, to obtain an acceptable linear correlation between the results and the concentration of analyte in samples.
Linearnost je opredeljena kot sposobnost metode, da v danem območju dobi sprejemljivo linearno korelacijo med rezultati in koncentracijo merjene snovi v vzorcih.
The accuracy of a method is defined as the degree to which the determined value of analyte in a sample corresponds to the accepted reference value (for example ISO 5725).
Točnost metode je opredeljena kot stopnja, do katere je določena vrednost merjene snovi v vzorcu skladna s sprejemljivo referenčno vrednostjo (na primer ISO 5725).
Precision is defined as the closeness of agreement between independent test results obtained under prescribed conditions.
Natančnost je opredeljena kot stopnja skladnosti med dobljenimi rezultati iz neodvisnih testov pri predpisanih pogojih.
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, z isto opremo in v istem laboratoriju dobi neodvisne testne rezultate.
The reproducibility is not required for the active substance as manufactured (for definition of reproducibility see ISO 5725).
Reproduktibilnost se ne zahteva za tehnične aktivne snovi (za opredelitev pojma reproduktibilnosti glej ISO 5725).
Methods, which must be described in full, must be provided for the determination of pure active substance in the active substance as manufactured as specified in the dossier submitted in support of approval.
Navesti je treba natančen opis metod za določitev čiste aktivne snovi v tehnični aktivni snovi, ki so navedene v dokumentaciji za odobritev.
The applicability of existing Cipac methods must be reported.
Navedena mora biti možnost uporabe obstoječih metod Cipac.
Methods must also be provided for the determination of significant and/or relevant impurities and additives (e.g. stabilisers) in the active substance as manufactured.
Navesti je treba tudi metode za določanje pomembnih in/ali relevantnih nečistoč in dodatkov (na primer stabilizatorjev) v tehnični aktivni snovi.
Specificity, linearity, accuracy and repeatability
Specifičnost, linearnost, točnost in ponovljivost
Specificity of methods submitted must be demonstrated and reported.
Prikazati in navesti je treba specifičnost predloženih metod.
In addition, the extent of interference by other substances present in the active substance as manufactured (e.g. isomers, impurities or additives), must be determined.
Poleg tega je treba določiti obseg motenj drugih snovi v tehnični aktivni snovi (na primer izomerov, nečistoč ali dodatkov).
While interferences due to other components may be identified as systematic errors in the assessment of the accuracy of methods proposed for the determination of pure active substance in the active substance as manufactured, an explanation must be provided for any interference occurring which contributes more than ± 3 % to the total quantity determined.
Čeprav se motnje drugih sestavin v oceni točnosti predlaganih metod za določitev čiste aktivne snovi v tehnični aktivni snovi lahko opredelijo kot sistematične napake, je treba predložiti obrazložitev za vse motnje, ki povzročajo več kot ± 3 % odstopanja od celotne določene količine.
The degree of interference for methods for the determination of impurities must also be demonstrated.
Prikazati je treba tudi stopnjo motenj za metode za določitev nečistoč.
The linearity of proposed methods over an appropriate range must be determined and reported.
Določiti in navesti je treba linearnost predlaganih metod v ustreznem območju.
For the determination of pure active substance, the calibration range must extend (by at least 20 %) the highest and lowest nominal content of the analyte in relevant analytical solutions.
Za določitev čiste aktivne snovi mora kalibracijsko območje presegati (za najmanj 20 %) najvišjo in najnižjo nominalno vsebnost merjene snovi v ustreznih analitičnih raztopinah.
Duplicate calibration determinations must be made at three or more concentrations.
Za tri ali več koncentracij je potrebna dvojna kalibracija.
Alternatively, five concentrations, each as single measurements, are acceptable.
Sprejemljivih pa je tudi pet koncentracij, vsaka kot posebna meritev.
Reports submitted must include the equation of the calibration line and the correlation coefficient and representative and properly labelled documentation from the analysis, e.g. chromatograms.
Predložena poročila morajo vključevati izenačitev kalibracijske krivulje in korelacijskega koeficienta ter reprezentativno in ustrezno označeno dokumentacijo analize, na primer kromatograme.
Accuracy is required for methods for the determination of pure active substance and significant and/or relevant impurities in the active substance as manufactured.
Navesti je treba točnost metod za določanje čiste aktivne snovi ter pomembnih in/ali relevantnih nečistoč v tehnični aktivni snovi.
For the repeatability in the determination of the pure active substance in principle a minimum of five determinations must be made.
Za ponovljivost pri določanju čiste aktivne snovi je načeloma potrebnih najmanj pet določitev.
The relative standard deviation (% RSD) must be reported.
Navesti je treba relativno standardno odstopanje (% RSD).