natgillin/translations-raw huggingface dataset:
The solubility of the active substances as manufactured or purified active substance in the following organic solvents at 15 to 25 °C shall be determined and reported if less than 250 g/L;
Če je topnost tehnične aktivne snovi ali čiste aktivne snovi manjša od 250 g/l, se določi in navede pri 15 °C do 25 °C v naslednjih organskih topilih;
the temperature applied shall be specified.
navede se tudi temperatura, pri kateri se je topnost določala.
Results shall be reported as g/L.
Rezultati se navedejo v g/l.
Aliphatic hydrocarbon:
alifatski ogljikovodik:
preferably heptane
po možnosti heptan;
Aromatic hydrocarbon:
aromatski ogljikovodik:
preferably toluene
po možnosti toluen;
Halogenated hydrocarbon:
halogenirani ogljikovodik:
preferably dichloromethane
po možnosti diklorometan;
preferably methanol or isopropyl alcohol
po možnosti metanol ali izopropil alkohol;
preferably acetone
po možnosti aceton;
preferably ethyl acetate.
po možnosti etil acetat.
If for a particular active substance, one or more of those solvents is unsuitable (for example reacts with test material), alternative solvents may be used instead.
Kadar je za posamezno aktivno snov eno ali več navedenih topil neprimernih (npr. reagirajo s preskusno snovjo), se namesto njih lahko uporabijo druga topila.
In such cases, choices of solvents shall be justified in terms of their structure and polarity.
V takem primeru se izbira topil utemelji glede na njihovo strukturo in polarnost.
The n-octanol/water partition coefficient (Kow or log Pow) of purified active substance and of all components of the residue definition for risk assessment shall be determined and reported for 20 °C or 25 °C.
Porazdelitveni koeficient n-oktanol/voda (v nadaljnjem besedilu: Kow ali log Pow) za čisto aktivno snov in vse sestavine iz opredelitve ostankov za oceno tveganja se določijo in navedejo pri 20 °C ali 25 °C.
The effect of pH (4 to 10) shall be investigated when the active substance has a pKa value between 2 and 12.
Vpliv vrednosti pH (4 do 10) se preuči, kadar je vrednost pKa snovi med 2 in 12.
Where dissociation in water occurs, the dissociation constants (pKa values) of the purified active substance shall be determined and reported for 20 °C.
Kadar čista aktivna snov v vodi disociira, se določijo in navedejo konstante disociacije (vrednosti pKa) čiste aktivne snovi pri 20 °C.
The identity of the dissociated species formed, based on theoretical considerations, shall be reported.
Na podlagi teoretičnih predpostavk se opredelijo in navedejo nastali razgradni produkti.
If the active substance is a salt the pKa value of the non-dissociated form of the active substance shall be given.
Če je aktivna snov sol, se navede vrednost pKa nedisociirane oblike aktivne sestavine.
The flammability and self-heating of active substances as manufactured shall be determined and reported.
Določita in navedeta se vnetljivost in samosegrevanje tehničnih aktivnih snovi.
A theoretical estimation based on structure shall be accepted if it meets the criteria set out in Appendix 6 of the United Nations’ Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria [6].
Sprejemljiva je teoretična ocena na podlagi strukture, če izpolnjuje merila iz Dodatka 6 k Priporočilom Združenih narodov o prevozu nevarnega blaga: Priročnik preskusov in meril [6].
In justified cases, data for purified active substance may be used.
V utemeljenih primerih se lahko uporabijo podatki za čisto aktivno snov.
The flash point of active substances as manufactured with a melting point below 40 °C shall be determined and reported.
Določi in navede se plamenišče tehničnih aktivnih snovi, ki imajo tališče pod 40 °C.
The explosive properties of active substances as manufactured shall be determined and reported.
Določijo in navedejo se eksplozivne lastnosti tehničnih aktivnih snovi.
A theoretical estimation based on structure shall be accepted if it meets the criteria set out in Appendix 6 of the United Nations ‘Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria’.
Sprejemljiva je teoretična ocena na podlagi strukture, če izpolnjuje merila iz Dodatka 6 k Priporočilom Združenih narodov o prevozu nevarnega blaga: Priročnik preskusov in meril.
The surface tension of purified active substance shall be determined and reported.
Določi in navede se površinska napetost čiste aktivne snovi.
The oxidising properties of active substances as manufactured, shall be determined and reported.
Določijo in navedejo se oksidacijske lastnosti tehničnih aktivnih snovi.
A theoretical estimation based on structure shall be accepted if it meets the criteria set out in Appendix 6 of the United Nations ‘Recommendations on the Transport of Dangerous Goods Manual of Tests and Criteria’.
Sprejemljiva je teoretična ocena na podlagi strukture, če izpolnjuje merila iz Dodatka 6 k Priporočilom Združenih narodov o prevozu nevarnega blaga: Priročniku preskusov in meril.
In justified cases data for purified active substance may be used.
V utemeljenih primerih se lahko uporabijo podatki za čisto aktivno snov.
Supplementary studies necessary for the classification of the active substance by hazard shall be carried out in accordance with Regulation (EC) No 1272/2008.
Dodatne študije, ki so potrebne za razvrstitev aktivne snovi glede na nevarnost, se izvedejo v skladu z Uredbo (ES) 1272/2008.
The information provided shall describe the intended purposes for which plant protection products 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 se opiše, za kakšne namene se fitofarmacevtska sredstva, ki vsebujejo aktivno snov, uporabljajo ali se bodo uporabljala, ter odmerek in način njihove uporabe ali predlagane uporabe.
The function shall be specified from among the following:
Delovanje se določi glede na naslednje:
acaricide;
akaricid;
bactericide;
baktericid;
insecticide;
insekticid;
molluscicide;
moluskicid;
nematicide;
nematicid;
plant growth regulator;
regulator rasti rastlin;
semio-chemical;
semio-kemikalija;
viricide;
viricid;
other (shall be specified by the applicant).
drugo (določi vlagatelj).
The nature of the effects on harmful organisms shall be stated:
Navede se 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 shall be stated whether or not the active substance is translocated in plants and where relevant whether such translocation is apoplastic, symplastic or both.
Navede se, ali se aktivna snov v rastlinah premešča (translocira) in, kadar je ustrezno, ali je translokacija apoplastna, simplastna ali oboje.
The fields of use, existing and proposed, for plant protection products containing the active substance shall be specified from among the following:
Za fitofarmacevtska sredstva, ki vsebujejo aktivno snov, se obstoječa ali predlagana področja uporabe določijo glede na naslednje:
field use, such as agriculture, horticulture, forestry and viticulture;
na prostem, npr. v poljedelstvu, hortikulturi, gozdarstvu in vinogradništvu;
protected crops;
zavarovani prostori;
amenity;
okrasne in rekreacijske površine;
weed control on non-cultivated areas;
zatiranje plevela na nekmetijskih površinah;
home gardening;
urejanje hišnih vrtov;
house plants;
sobne rastline;
plant products storage practice;
skladiščenje rastlinskih proizvodov;
other (shall be specified by applicant).
drugo (določi vlagatelj).
Details of existing use and the intended use in terms of crops, groups of crops, plants, or plant products treated and where relevant protected shall be provided.
Navedejo se podrobne informacije o obstoječi in predvideni uporabi v obliki podatkov o tretiranih in, kadar je ustrezno, varovanih kulturah, skupinah kultur, rastlinah ali rastlinskih proizvodih.
Where relevant, details of harmful organisms against which protection is afforded shall be provided.
Kadar je ustrezno, se navedejo podrobne informacije o škodljivih organizmih, pred katerimi je zagotovljena zaščita.
Where relevant, effects achieved, such as sprout suppression, retardation of ripening, reduction in stem length, enhanced fertilisation shall be reported.
Kadar je ustrezno, se navedejo podatki o doseženih učinkih, kot so zaviranje kaljenja, zakasnitev zorenja, skrajšanje stebla, boljši učinki pognojevanja.
To the extent that it has been elucidated, a statement shall be provided as to the mode of action of the active substance in terms, where relevant, of the biochemical and physiological mechanisms and biochemical pathways involved.
Predloži se izjava o načinu delovanja aktivne snovi glede, kadar je ustrezno, biokemijskih in fizioloških mehanizmov delovanja ter vpletenih biokemijskih poti, če je način delovanja aktivne snovi pojasnjen.
Where available, the results of relevant experimental studies shall be reported.
Kadar so na voljo, se navedejo rezultati ustreznih eksperimentalnih študij.
Where it is known that to exert its intended effect, the active substance has to be converted to a metabolite or breakdown product following application or use of plant protection products containing it, the following information shall be provided for active metabolite or breakdown products:
Kadar je znano, da se mora aktivna snov za doseganje predvidenih učinkov po nanosu ali uporabi fitofarmacevtskih sredstev, ki jo vsebujejo, pretvoriti v metabolit ali razgradni produkt, se za aktivni metabolit ali razgradne produkte navedejo naslednje informacije:
ISO common name or proposed common name;
splošno ali predlagano splošno ime po ISO;
CAS-number EC number;
številka CAS, številka ES;
molecular and structural formula; and
molekulska in strukturna formula ter
molar mass.
molska masa.
The information referred to in points (a) to (e) shall be cross referenced to and drawing on information provided under Sections 5 to 8, where relevant.
Informacije iz točk (a) do (e) se pridobijo po navzkrižnem preverjanju in preučevanju informacij iz oddelkov 5 do 8, kadar je ustrezno.
Available information relating to the formation of active metabolites and breakdown products shall be provided.
Navedejo se razpoložljive informacije o tvorbi aktivnih metabolitov in razgradnih produktov.
Such information shall include:
Te informacije vključujejo:
environmental and other factors effecting the rate and extent of conversion.
okoljske in druge dejavnike, ki vplivajo na hitrost in obseg pretvorbe.
Where available, information on the occurrence or possible occurrence of the development of resistance or cross-resistance shall be provided.
Kadar so na voljo, se navedejo informacije o pojavu ali možnem pojavu razvoja odpornosti ali navzkrižne odpornosti.
Appropriate risk management strategies shall be addressed for national/regional areas.
Pripravijo se ustrezne strategije za obvladovanje tveganja na nacionalnih/regionalnih območjih.
A safety data sheet pursuant to Article 31 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council [7] shall be provided for all active substances.The studies, data and information submitted, together with other relevant studies, data and information, shall both specify and justify the methods and precautions to be followed in the event of fire.
Za vse aktivne snovi se predloži varnostni list v skladu s členom 31 Uredbe (ES) št. 1907/2006 Evropskega parlamenta in Sveta [7].V predloženih študijah, podatkih in informacijah, skupaj z drugimi ustreznimi študijami, podatki in informacijami, se podrobno določijo in utemeljijo metode in varnostni ukrepi v primeru požara.
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.
Najprimernejši ali edini način varnega uničenja aktivnih snovi in kontaminiranih snovi ali embalaže je pogosto nadzorovani sežig v sežigalni napravi, ki ima za to uradno dovoljenje.
Such incineration shall be carried out in accordance with the criteria set out in Council Directive 94/67/EC [8].Other methods to dispose of the active substance, contaminated packaging and contaminated materials, where proposed, shall be fully described.
Navedeni sežig se izvede v skladu z merili iz Direktive Sveta 94/67/ES [8].Natančno se opišejo drugi postopki uničenja aktivne snovi, kontaminirane embalaže in kontaminiranih snovi, kadar se to predlaga.
Data shall be provided for such methods, to establish their effectiveness and safety.
Za takšne postopke se navedejo podatki za določitev njihove učinkovitosti in varnosti.
Procedures for the decontamination of water and soil in case of an accident shall be provided.
Navedejo se postopki za dekontaminacijo vode in tal v primeru nesreče.
The studies, data and information submitted, together with other relevant studies, data and information, shall demonstrate the suitability of measures proposed for use in emergency situations.
V predloženih študijah, podatkih in informacijah, skupaj z drugimi ustreznimi študijami, podatki in informacijami, se dokaže primernost predlaganih ukrepov za uporabo v izrednih razmerah.
The provisions of this Section cover analytical methods used for the generation of pre-approval data and required for post-approval control and monitoring purposes.
V določbah tega oddelka so obravnavane analitske metode, ki se uporabljajo za pridobivanje podatkov pred odobritvijo in so potrebne za namene nadzora in spremljanja po odobritvi.
Descriptions of methods shall be provided and include details of equipment, materials and conditions used.
Navedejo se opisi metod, ki vključujejo podrobnosti o uporabljeni opremi, materialih in pogojih.
On request, the following shall be provided:
Na zahtevo se predložijo:
analytical standards of the purified active substance;
analitski standardi čiste aktivne snovi;
samples of the active substance as manufactured;
vzorci tehnične aktivne snovi;
analytical standards of relevant metabolites and all other components included in all monitoring residue definitions;
analitski standardi relevantnih metabolitov in vseh drugih sestavin, ki so navedene v vseh opredelitvah ostankov za spremljanje;
samples of reference substances for the relevant impurities.
vzorci referenčnih snovi relevantnih nečistoč.
Where possible, the standards referred to in points (a) and (c) shall be made commercially available and, on request, the distributing company shall be named.
Kadar je to mogoče, se zagotovi razpoložljivost standardov iz točk (a) in (c) na trgu, pri čemer se na zahtevo imenuje distribucijsko podjetje.
Methods shall be provided, with a full description, for the determination of:
V celoti se opišejo metode za določitev:
pure active substance in the active substance as manufactured and specified in the dossier submitted in support of approval under Regulation (EC) No 1107/2009;
čiste aktivne snovi v tehnični aktivni snovi, ki je navedena v dokumentaciji za odobritev v skladu z Uredbo (ES) št. 1107/2009;
significant and relevant impurities and additives (such as stabilisers) in the active substance as manufactured.
pomembnih in relevantnih nečistoč ter aditivov (na primer stabilizatorjev) v tehnični aktivni snovi.
The applicability of existing CIPAC methods shall be assessed and reported.
Oceni in navede se uporabnost obstoječih metod CIPAC.
In case of use of a CIPAC method, further validation data shall not be required, but example chromatograms shall be submitted, where available.
Če se uporabi metoda CIPAC, niso potrebni dodatni podatki o potrditvi, predložijo pa se primeri kromatogramov, kadar so na voljo.
The specificity of the methods shall be determined and reported.
Določi in navede se specifičnost metod.
In addition, the extent of interference by other substances present in the active substance as manufactured (such as impurities or additives), shall be determined.
Poleg tega se določi obseg motenj drugih snovi v tehnični aktivni snovi (na primer nečistoč ali aditivov).
The linearity of methods shall be determined and reported.
Določi in navede se linearnost metod.
The calibration range shall extend (by at least 20 %) beyond the highest and lowest nominal content of the analyte in relevant analytical solutions.
Kalibracijsko območje presega (za najmanj 20 %) najvišjo in najnižjo nominalno vsebnost analita v ustreznih analitskih raztopinah.
Either duplicate determinations at three or more concentrations or single determinations at five or more concentrations shall be made.
Izvedeta se dve določitvi pri treh ali več koncentracijah ali ena sama določitev pri petih ali več koncentracijah.
The equation of the calibration line and the correlation coefficient shall be reported and a typical calibration plot shall be submitted.
Navedejo se izenačitev kalibracijske krivulje, korelacijski koeficient in običajen umeritveni graf.
In cases where a non-linear response is used, this shall be justified by the applicant.
Vlagatelj utemelji primere, v katerih se uporabi nelinearen odziv.
The precision (repeatability) of the methods shall be determined and reported.
Določi in navede se natančnost (ponovljivost) metod.
A minimum of five replicate sample determinations shall be made and the mean, the relative standard deviation and the number of determinations shall be reported.
Izvede se najmanj pet ponovitvenih določitev vzorca, pri čemer se navedejo povprečje, relativni standardni odmik in število določitev.
For the determination of the active substance content, an assessment of accuracy of the method shall be made by an assessment of the interference and precision.
Točnost metode za določitev vsebnosti aktivne snovi se ovrednoti z oceno motenj in natančnosti.
As regards additives and significant and relevant impurities:
V zvezi z aditivi ter pomembnimi in relevantnimi nečistočami:
the accuracy of the methods shall be determined on at least two representative samples at levels appropriate to the batch data and material specification.
se točnost metod določi na najmanj dveh reprezentativnih vzorcih pri vrednostih, ki ustrezajo podatkom o seriji in specifikaciji snovi.
The mean and the relative standard deviation of the recoveries shall be reported,
Navedeta se povprečje in relativni standardni odmik izkoristkov,
the experimental determination of the limit of quantification (LOQ) shall not be required.
eksperimentalna določitev meje določanja (LOQ) ni potrebna.
However, it shall be demonstrated that the methods are sufficiently precise to analyse significant impurities at levels appropriate to the material specification and relevant impurities at a concentration equivalent to at least 20 % less than the specification limit.
Vendar se dokaže, da so metode dovolj natančne za analizo pomembnih nečistoč pri vrednostih, ki ustrezajo specifikaciji snovi, in relevantnih nečistoč v koncentraciji, ki je najmanj 20 % manjša od meje specifikacije.
Methods shall be submitted, with a full description, for the determination of non-isotope-labelled residues in all areas of the dossier, as set out in detail in the following points:
V celoti se v vseh delih dokumentacije opišejo naslednje metode za določanje ostankov, ki niso izotopno označeni:
in soil, water, sediment, air and any additional matrices used in support of environmental fate studies;
v tleh, vodi, usedlini, zraku in vseh dodatnih matriksih, ki se uporabljajo za utemeljitev študij končnega stanja v okolju;
in soil, water and any additional matrices used in support of efficacy studies;
v tleh, vodi in vseh dodatnih matriksih, ki se uporabljajo za utemeljitev študij učinkovitosti;
in feed, body fluids and tissues, air and any additional matrices used in support of toxicology studies;
v krmi, telesnih tekočinah in tkivih, zraku in vseh dodatnih matriksih, ki se uporabljajo za utemeljitev toksikoloških študij;
in body fluids, air and any additional matrices used in support of operator, worker, resident and bystander exposure studies;
v telesnih tekočinah, zraku in vseh dodatnih matriksih, ki se uporabljajo za utemeljitev študij izpostavljenosti izvajalcev tretiranja, delavcev, prebivalcev in drugih navzočih oseb;
in or on plants, plant products, processed food commodities, food of plant and animal origin, feed and any additional matrices used in support of residues studies;
v ali na rastlinah, rastlinskih proizvodih, predelanih živilskih proizvodih, živilih rastlinskega in živalskega izvora, krmi in vseh dodatnih matriksih, ki se uporabljajo za utemeljitev študij o ostankih;
in soil, water, sediment, feed and any additional matrices used in support of ecotoxicology studies;
v tleh, vodi, usedlini, krmi in vseh dodatnih matriksih za utemeljitev ekotoksikoloških študij;
in water, buffer solutions, organic solvents and any additional matrices used in the physical and chemical properties tests.
v vodi, pufrskih raztopinah, organskih topilih in vseh dodatnih matriksih, ki se uporabljajo v preskusih fizikalnih in kemijskih lastnosti.
Validated confirmatory methods shall be submitted if appropriate.
Po potrebi se navedejo potrjene potrditvene metode.
The linearity, recovery and precision (repeatability) of methods shall be determined and reported.
Določijo in navedejo se linearnost, izkoristek in natančnost (ponovljivost) metod.
Data shall be generated at the LOQ and either the likely residue levels or ten times the LOQ.
Podatki se pridobijo pri LOQ in verjetnih vrednostih ostankov ali 10-kratni vrednosti LOQ.
Where relevant, the LOQ shall be determined and reported for each analyte.
Kadar je ustrezno, se določi in navede LOQ za vsak analit.
Methods, with a full description, shall be submitted for:
V celoti se opišejo metode za:
the determination of all components included in the monitoring residue definition as submitted in accordance with the provisions of point 6.7.1 in order to enable Member States to determine compliance with established maximum residue levels (MRLs);
določitev vseh sestavin iz opredelitve ostankov za spremljanje, predložene v skladu z določbami točke 6.7.1, da lahko države članice ugotovijo skladnost z uveljavljenimi mejnimi vrednostmi ostankov;
they shall cover residues in or on food and feed of plant and animal origin;
to vključuje ostanke v ali na živilih ter krmi rastlinskega in živalskega izvora;
the determination of all components included for monitoring purposes in the residue definitions for soil and water as submitted in accordance with the provisions of point 7.4.2;
določitev vseh sestavin, ki so za namene spremljanja zajete v opredelitve ostankov za tla in vodo, predložene v skladu z določbami točke 7.4.2;
the analysis in air of the active substance and relevant breakdown products formed during or after application, unless the applicant shows that exposure of operators, workers, residents or bystanders is negligible;
analizo aktivne snovi in ustreznih razgradnih produktov v zraku, ki nastanejo med nanašanjem ali po njem, razen če vlagatelj dokaže, da je izpostavljenost izvajalcev tretiranja, delavcev, prebivalcev in drugih navzočih oseb zanemarljiva;
the analysis in body fluids and tissues for active substances and relevant metabolites.
analizo telesnih tekočin in tkiv za določitev aktivnih snovi in relevantnih metabolitov.
As far as practicable these methods shall employ the simplest approach, involve the minimum cost, and require commonly available equipment.
Kolikor je to mogoče, se za izvajanje teh metod uporabi najenostavnejši pristop, s katerim so povezani najnižji stroški in pri katerem se uporabi splošno dostopna oprema.
It shall enable all components included in the monitoring residue definition to be determined.
Metode omogočajo določitev vseh sestavin iz opredelitve ostankov za spremljanje.
The LOQ shall be determined and reported for each component included in the monitoring residue definition.
Določi in navede se LOQ vsake sestavine iz opredelitve ostankov za spremljanje.