natgillin/translations-raw huggingface dataset:
Effects on any other specific, non-target organisms (flora and fauna) believed to be at risk
Učinki na druge specifične neciljne organizme (floro in favno), za katere se predvideva, da so ogroženi
Studies on sediment- dwelling organisms
Študije na organizmih, živečih v usedlinah
Effects on aquatic macrophytes
Učinki na vodne makrofite
Terrestrial toxicity, initial tests
Toksičnost za organizme v zemlji, začetni preskusi
Effects on earthworms or other soil- dwelling non-target invertebrates
Učinki na deževnike ali druge neciljne nevretenčarje, ki živijo v zemlji
Acute toxicity to plants
Akutna toksičnost za rastline
Terrestrial tests, long term
Preskusi v zemlji, dolgoročni
Reproduction study with earthworms or other soil-dwelling non-target invertebrates
Študija razmnoževanja deževnikov ali drugih neciljnih nevretenčarjev, ki živijo v zemlji
Effects on birds
Učinki na ptice
For endpoint 9.4.3 the study does not need to be conducted if:
Za končno točko 9.4.3 študije ni treba izvesti, če:
the dietary toxicity study shows that the LC50 is above 2000 mg/kg
krmna študija toksičnosti pokaže, da je LC50 nad 2000 mg/kg.
Short-term toxicity — eight-day dietary study in at least one species (other than chickens, ducks and geese)
Kratkotrajna toksičnost – osemdnevna krmna študija na vsaj eni vrsti (razen piščancev, rac in gosi)
Effects on reproduction
Učinki na razmnoževanje
Effects on arthropods
Učinki na členonožce
Effects on honeybees
Učinki na čebele
Other non-target terrestrial arthropods, e.g. predators
Drugi neciljni kopenski členonožci, npr. plenilci
Bioconcentration, terrestrial
Biokoncentracija, na kopnem
Bioaccumulation, terrestrial
Bioakumulacija, na kopnem
Effects on other non-target, non-aquatic organisms
Učinki na druge neciljne nevodne organizme
Effects on mammals
Učinki na sesalce
Data are derived from the mammalian toxicological assessment.
Podatki so pridobljeni iz toksikološke ocene za sesalce.
The most sensitive relevant mammalian long-term toxicological endpoint (NOAEL) expressed as mg test compound/kg bw/day shall be reported
Najbolj občutljiva pomembna dolgoročna toksikološka končna točka (NOAEL) za sesalce, izražena kot mg preskusna spojina/kg bw/dnevno se sporoči.
Short term toxicity
Kratkotrajna toksičnost
Long term toxicity
Dolgoročna toksičnost
Identification of endocrine activity
Določitev endokrine dejavnosti
ENVIRONMENTAL FATE AND BEHAVIOUR
USODA IN OBNAŠANJE V OKOLJU
Fate and behaviour in water and sediment
Usoda in obnašanje v vodi in usedlinah
Degradation, initial studies
Razgradnja, začetne študije
If the assessment performed indicates the need to investigate further the degradation of the substance and its degradation products or the active substance has an overall low or absent abiotic degradation, then the tests described in 10.1.3 and 10.3.2 and where appropriate — in 10.4 shall be required.
Če opravljena ocena kaže, da je treba nadalje raziskati razgradnjo snovi in njene produkte razgradnje ali da ima aktivna snov v splošnem majhno ali nično abiotično razgradnjo, so potrebni preskusi, opisani v oddelkih 10.1.3 in 10.3.2 in, kadar je ustrezno, v 10.4.
The choice of the appropriate test(s) depends on the results of the initial assessment performed
Izbira ustreznega preskusa oziroma preskusov je odvisna od rezultatov začetne opravljene ocene.
Hydrolysis as a function of pH and identification of breakdown products
Hidroliza v odvisnosti od pH vrednosti in določitev produktov razgradnje
The identification of breakdown products is required when the breakdown products at any sampling time are present at ≥ 10 %
Določitev produktov razgradnje je potrebna, kadar je prisotnost produktov razgradnje ob katerem koli vzorčenju ≥ 10 %.
Phototransformation in water, including identification of transformation products
Fototransformacija v vodi, vključno z določitvijo produktov transformacije
Ready biodegradability
Hitra biorazgradljivost
Inherent biodegradability (where appropriate)
Inherentna biorazgradljivost (če je primerno)
Adsorption/desorption
Adsorpcija/desorpcija
Rate and route of degradation including identification of metabolites and degradation products
Hitrost in pot razgradnje, vključno z določitvijo metabolitov in produktov razgradnje
Biological sewage treatment
Biološko čiščenje odplak
Aerobic biodegradation
Aerobna biorazgradljivost
Anaerobic biodegradation
Anaerobna biorazgradljivost
STP simulation test
Simulacijski preskus za aerobno čiščenje odplak
Biodegradation in freshwater
Biorazgradnja v sladki vodi
Aerobic aquatic degradation study
Študija aerobne razgradnje v vodi
Water/sediment degradation test
Preskus razgradnje v vodi/usedlinah
Biodegradation in sea water
Biorazgradnja v morski vodi
Biodegradation during manure storage
Biorazgradnja pri shranjevanju gnojila
Adsorption and desorption in water/aquatic sediment systems and, where relevant, adsorption and desorption of metabolites and degradation products
Adsorpcija in desorpcija v vodi/sistemi vodnih usedlin ter po potrebi adsorpcija in desorpcija metabolitov in razgradnih produktov
Field study on accumulation in sediment
Terenska študija o kopičenju v usedlinah
Inorganic substances: information on fate and behaviour in water
Anorganske snovi: informacije o usodi in obnašanju v vodi
Fate and behaviour in soil
Usoda in obnašanje v tleh
Laboratory study on rate and route of degradation including identification of the processes involved and identification of any metabolites and degradation products in one soil type (unless pH dependent route) under appropriate conditions
Laboratorijska študija o hitrosti in poti razgradnje, vključno z določitvijo procesov, ki pri tem sodelujejo, in določitev vseh metabolitov in razgradnih produktov v eni vrsti tal (razen če je pot odvisna od vrednosti pH) v ustreznih razmerah.
Laboratory studies on rate of degradation in three additional soil types
Laboratorijske študije o hitrosti razgradnje v treh dodatnih vrstah tal.
Field studies, two soil types
Terenske študije, dve vrsti tal
Soil accumulation studies
Študije kopičenja v tleh
Adsorption and desorption in at least three soil types and, where relevant, adsorption and desorption of metabolites and degradation products
Adsorpcija in desorpcija v vsaj treh vrstah tal ter po potrebi adsorpcija in desorpcija metabolitov in razgradnih produktov
Further studies on sorption
Nadaljnje študije o sorpciji
Mobility in at least three soil types and where relevant mobility of metabolites and degradation products
Mobilnost v vsaj treh vrstah tal in po potrebi mobilnost metabolitov in razgradnih produktov
Column leaching studies
Študija izpiranja v koloni
Lysimeter studies
Lizimetrične študije
Field leaching studies
Terenske študije izpiranja
Extent and nature of bound residues
Količina in vrsta vezanih ostankov
The determination and characteristics of bound residues is recommended to be combined with a soil simulation study
Priporočljivo je, da se določitev vezanih ostankov in njihovih značilnosti poveže s študijo simulacije v tleh.
Other soil degradation studies
Druge študije razgradnje v tleh
Inorganic substances: information on fate and behaviour in soil
Anorganske snovi: informacije o usodi in obnašanju v tleh
Fate and behaviour in air
Usoda in obnašanje v zraku
Phototransformation in air (estimation method)
Fototransformacija v zraku (metoda ocenjevanja)
Identification of transformation products
Določitev produktov transformacije.
Fate and behaviour in air, further studies
Usoda in obnašanje v zraku, nadaljnje študije
Additional studies on fate and behaviour in the environment
Dodatne študije o usodi in obnašanju v okolju
Definition of the residue
Opredelitev ostankov
Definition of the residue for risk assessment
Opredelitev ostankov za oceno tveganja
Definition of the residue for monitoring
Opredelitev ostankov za spremljanje
Identification of all degradation products (> 10 %) must be included in the studies on degradation in soil, water and sediments
V študije razgradnje v tleh, vodi in usedlinah mora biti vključena določitev vseh produktov razgradnje (> 10 %)
MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT
UKREPI, POTREBNI ZA ZAŠČITO LJUDI, ŽIVALI IN OKOLJA
Recommended methods and precautions concerning handling, use, storage, transport or fire
Priporočene metode in previdnostni ukrepi v zvezi z ravnanjem, uporabo, shranjevanjem, prevozom ali ob požaru
In case of fire, nature of reaction products, combustion gases etc.
Ob požaru: vrsta reakcijskih produktov, plinov, ki nastanejo pri zgorevanju itd.
Emergency measures in case of accident
Nujni ukrepi ob nesrečah
Possibility of destruction or decontamination following release in or on the following:
Možnost uničenja ali dekontaminacije po izpustu v:
air
zrak;
water, including drinking water
vodo, vključno s pitno vodo;
soil
tla.
Procedures for waste management of the active substance for industry or professional users
Postopki za industrijo ali poklicne uporabnike pri ravnanju z odpadki pri aktivni snovi
Possibility of reuse or recycling
Možnost ponovne uporabe ali recikliranja
Possibility of neutralisation of effects
Možnost nevtralizacije učinkov
Conditions for controlled discharge including leachate qualities on disposal
Pogoji za nadzorovan izpust, vključno z lastnostmi izlužnin pri odstranjevanju
Conditions for controlled incineration
Pogoji za nadzorovan sežig
Identification of any substances falling within the scope of List I or List II of the Annex to Council Directive 80/68/EEC of 17 December 1979 on the protection of groundwater against pollution caused by certain dangerous substances [6], of Annexes I and II to Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration [7], of Annex I to Directive 2008/105/EC of the European Parliament and of the Council of 16 December 2008 on environmental quality standards in the field of water policy [8], of Part B of Annex I to Directive 98/83/EC or Annexes VIII and X to Directive 2000/60/EC
Določitev vseh snovi, ki spadajo na seznam I ali seznam II v Prilogi k Direktivi Sveta 80/68/EGS z dne 17. decembra 1979 o varstvu podzemne vode pred onesnaževanjem z določenimi nevarnimi snovmi [6], v prilogah I in II k Direktivi 2006/118/ES Evropskega parlamenta in Sveta z dne 12. decembra 2006 o varstvu podzemne vode pred onesnaževanjem in poslabšanjem [7], v Prilogi I k Direktivi 2008/105/ES Evropskega parlamenta in Sveta z dne 16. decembra 2008 o okoljskih standardih kakovosti na področju vodne politike [8], v delu B Priloge I k Direktivi 98/83/ES ali v prilogah VIII in X k Direktivi 2000/60/ES.
CLASSIFICATION, LABELLING AND PACKAGING
RAZVRŠČANJE, OZNAČEVANJE IN PAKIRANJE
State any existing classification and labelling
Navesti razvrstitev in označevanje, če že obstajata.
The hazard classification of the substance resulting from the application of Regulation (EC) No 1272/2008
Razvrščanje glede na nevarne lastnosti snovi, ki izhaja iz uporabe Uredbe (ES) št. 1272/2008
In addition, for each entry, the reasons why no classification is given for an endpoint should be provided
Poleg tega naj bodo za vsak vnos navedeni razlogi, zaradi katerih končna točka ni bila razvrščena.
Hazard classification
Razvrščanje glede na nevarnosti
Hazard pictogram
Piktogram nevarnosti
Hazard statements
Stavki o nevarnosti
Precautionary statements including prevention, response, storage and disposal
Previdnostni stavki, vključno s preprečevanjem, odzivom, shranjevanjem in odstranjevanjem
Specific concentration limits, where applicable, resulting from the application of Regulation (EC) No 1272/2008
Po potrebi posebne mejne koncentracije, ki izhajajo iz uporabe Uredbe (ES) št. 1272/2008
SUMMARY AND EVALUATION
POVZETEK IN OCENA
The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed
Povzeti in oceniti ključne informacije, pridobljene iz končnih točk v vsakem od pododdelkov (2–12), ter pripraviti osnutek ocene tveganja.
MICRO-ORGANISMS
MIKROORGANIZMI
Conditions for not requiring a specific test that are set out in the appropriate test methods in Regulation (EC) No 440/2008 that are not repeated in column 3, also apply.
Prav tako se uporabljajo pogoji, pod katerimi se določen preskus ne zahteva in so določeni v ustreznih preskusnih metodah v Uredbi (ES) št. 440/2008 in se v stolpcu 3 ponovno ne navajajo.
Manufacturer (name, address and location of manufacturing plant)
Proizvajalec (ime, naslov in kraj proizvodnega obrata)
IDENTITY OF THE MICRO-ORGANISM
OPIS MIKROORGANIZMA
Common name of the micro-organism (including alternative and superseded names)
Splošno ime mikroorganizma (vključno z drugimi in prej veljavnimi imeni)
Taxonomic name and strain
Taksonomska oznaka in sev
Methods, procedures and criteria used to establish the presence and identity of the micro-organism
Metode, postopki in merila za ugotavljanje prisotnosti in opis mikroorganizma
Specification of the technical grade active ingredient
Opis aktivne sestavine na tehnični stopnji
Identity and content of impurities, additives, contaminating micro-organisms
Identiteta in vsebnost nečistot, dodatkov, kontaminantnih mikroorganizmov
General information on the micro-organism
Splošne informacije o mikroorganizmu
Historical uses
Uporabe v preteklosti
Origin, natural occurrence and geographical distribution
Izvor, naravna prisotnost in geografska razširjenost
Development stages/life cycle of the micro-organism
Razvojne faze / življenjski ciklus mikroorganizma
Production and resistance to antibiotics and other anti-microbial agents
Proizvodnja ter odpornost na antibiotike in druga antimikrobiološka sredstva
Further information on the micro-organism
Nadaljnje informacije o mikroorganizmu
Analytical methods for the analysis of the micro-organism as manufactured
Analitične metode za analizo mikroorganizma, kakor se proizvaja
Methods used for monitoring purposes to determine and quantify residues (viable or non-viable)
Metode, namenjene spremljanju, za določitev in količinsko opredeljevanje ostankov (živih ali neživih)
EFFECTIVENESS AGAINST TARGET ORGANISM
UČINKOVITOST PROTI CILJNEMU ORGANIZMU
Function and mode of control e.g. attracting, killing, inhibiting
Uporaba in način nadzora, na primer privabljanje, uničenje, zaviranje
Representative organism(s) controlled and products, organisms or objects to be protected
Reprezentativni organizem oziroma organizmi, ki jih je treba nadzirati, in proizvodi, organizmi ali predmeti, ki jih je treba zaščititi
Effects on materials, substances and products
Učinki na materiale, snovi in proizvode
Likely concentration at which the micro-organism will be used
Koncentracija, pri kateri bo mikroorganizem verjetno uporabljen
Information on the occurrence or possible occurrence of the development of resistance of the target organism(s) and appropriate management strategies
Informacije o pojavu ali možnem pojavu razvoja odpornosti ciljnega organizma oziroma organizmov in ustrezni protiukrepi
Observations on undesirable or unintended side effects
Opažanja o nezaželenih ali nenačrtovanih stranskih učinkih
Host specificity, range and effects on species other than the target organism
Razpon specifičnih gostiteljev in učinki na vrste, ki niso ciljni organizmi
Field of use(s) envisaged
Predvideno področje uporabe oziroma uporab
Detailed description of the use pattern(s)
Podrobni opis vzorca oziroma vzorcev uporabe
Category of users for which the micro-organism should be approved
Skupina uporabnikov, za katere bi mikroorganizmi morali biti odobreni
Exposure data applying, as appropriate, the methodologies described in Section 5 of Annex I to Regulation (EC) No 1907/2006
Podatki o izpostavljenosti, ki ustrezno uporabljajo metodologije, opisane v oddelku 5 Priloge I k Uredbi (ES) št. 1907/2006
Information on exposure of food-producing animals and food and feeding stuffs associated with the intended uses of the active substance
Informacije o izpostavljenosti živali za proizvodnjo živil ter živil in krme, povezani s predvideno uporabo aktivne snovi
EFFECT ON HUMAN AND ANIMAL HEALTH
UČINEK NA ZDRAVJE ČLOVEKA IN ŽIVALI
Information requirements in this Section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex.
Zahteve glede informacij v tem oddelku se lahko po potrebi prilagodijo v skladu s specifikacijami iz naslova 1 te priloge.
Direct observation, e.g. clinical cases
Neposredna opažanja, npr. klinični primeri
Acute inhalatory toxicity, pathogenicity and infectiveness
Akutna toksičnost pri vdihavanju, patogenost in kužnost
Health effects after repeated inhalatory exposure
Učinki na zdravje po ponovljeni izpostavljenosti vdihavanju
Genotoxicity — in vivo studies in somatic cells
Genotoksičnost – študije in vivo na somatskih celicah
Genotoxicity — in vivo studies in germ cells
Genotoksičnost – študije in vivo na zarodnih celicah
Residues in or on treated articles, food and feedingstuffs
Ostanki v ali na tretiranih izdelkih, hrani in krmi
Persistence and likelihood of multiplication in or on treated articles, feedingstuffs or foodstuffs
Obstojnost in verjetnost razmnoževanja v ali na tretiranih izdelkih, krmi ali živilih
Further information required
Nadaljnje zahtevane informacije
Summary and evaluation of residues in or on treated articles, food and feedingstuffs
Povzetek in ocena ostankov v ali na tretiranih izdelkih, hrani in krmi
EFFECTS ON NON-TARGET ORGANISMS
UČINKI NA NECILJNE ORGANIZME
Effects on aquatic organisms
Učinki na vodne organizme
Effects on fish
Učinki na ribe
Effects on freshwater invertebrates
Učinki na sladkovodne nevretenčarje
Effects on algae growth
Učinki na rast alg
Effects on plants other than algae
Učinki na rastline, razen alg
Effects on earthworms
Učinki na deževnike
Effects on bees
Učinki na čebele
Further studies
Nadaljnje študije
Summary and evaluation of effects on non-target organisms
Povzetek in ocena učinkov na neciljne organizme
Summary and evaluation of fate and behaviour in the environment
Povzetek in ocena usode in obnašanja v okolju
Recommended methods and precautions concerning handling, storage, transport or fire
Priporočene metode in previdnostni ukrepi v zvezi z ravnanjem, shranjevanjem, prevozom ali ob požaru
Monitoring plan to be used for the active micro-organism including handling, storage, transport and use
Načrt spremljanja, ki se uporabi za aktivne mikroorganizme, vključno z ravnanjem, shranjevanjem, prevozom in uporabo
CLASSIFICATION, LABELLING AND PACKAGING OF THE MICRO-ORGANISM
RAZVRŠČANJE, OZNAČEVANJE IN PAKIRANJE MIKROORGANIZMA
Relevant risk group specified in Article 2 of Directive 2000/54/EC
Ustrezna rizična skupina iz člena 2 Direktive 2000/54/ES
The information provided should be for the purified active substance of stated specification or for the active substance as manufactured, if different.
Zagotoviti bi bilo treba informacije za prečiščeno aktivno snov, za katero veljajo navedene specifikacije, ali za aktivno snov, kot je bila proizvedena, če so te različne.
The information provided should be for the purified active substance of stated specification.
Informacije se predložijo za prečiščeno aktivno snov, za katero veljajo navedene specifikacije.
INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS
ZAHTEVE GLEDE INFORMACIJ O BIOCIDNIH PROIZVODIH
This Annex sets out the information requirements that shall be included in the dossier for the biocidal product accompanying an application for the approval of an active substance in accordance with point (b) of Article 6(1) and the dossier accompanying an application for the authorisation of a biocidal product in accordance with point (a) of Article 20(1).
V tej prilogi so določene zahteve po informacijah, ki se vključijo v dokumentacijo za biocidni proizvod, priloženo vlogi za odobritev aktivne snovi v skladu s točko (b) člena 6(1), in v dokumentacijo, ki se priloži vlogi za izdajo dovoljenja za biocidni proizvod v skladu s točko (a) člena 20(1).
The data elements belonging to the CDS are considered as the basic data which should, in principle, be provided for all biocidal products.
Podatki, ki spadajo v ZOP, štejejo za osnovne podatke, ki bi morali biti načeloma na voljo za vse biocidne proizvode.
With regard to the ADS, the data elements to be provided for a specific biocidal product shall be determined by considering each of the ADS data elements indicated in this Annex taking into account, inter alia, the physical and chemical properties of the product, existing data, information which is part of the CDS and the types of products and the exposure patterns related to these uses.
Kar zadeva ZDP, se podatki, ki se navedejo za določen biocidni proizvod, določijo z obravnavo vsakega od podatkov iz ZDP, navedenih v tej prilogi, med drugim, ob upoštevanju fizikalnih in kemijskih lastnosti proizvoda, obstoječih podatkov, informacij, ki so del ZOP, in vrst proizvodov, ter vzorcev izpostavljenosti, povezanih s to uporabo.
Specific indications for the inclusion of some data elements are provided in column 1 of the Annex III table.
Posebne določbe za vključitev nekaterih podatkov so v stolpcu 1 tabele v Prilogi III.
The general considerations regarding adaptation of information requirements as set out in Annex IV to this Regulation shall also apply.
Uporabljajo se tudi splošni preudarki za prilagoditev zahtev glede informacij, kot so navedeni v Prilogi IV k tej uredbi.
In light of the importance of reducing testing on vertebrates, column 3 of the table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrates.
Zaradi pomembnosti zmanjšanja števila preskusov na vretenčarjih so v stolpcu 3 tabele navedene posebne določbe o prilagoditvi zahtev glede nekaterih podatkov, za katere bi lahko bili potrebni takšni preskusi na vretenčarjih.
For some of the information requirements set out in this Annex, it may be possible to satisfy these requirements based on available information of the properties of the active substance(s) contained in the product and the properties of non-active substance(s) included in the product.
Nekatere zahteve glede informacij, določene v tej prilogi, je mogoče izpolniti na podlagi dostopnih informacij o lastnostih aktivne oziroma aktivnih snovi v proizvodu in lastnostih neaktivne oziroma neaktivnih snovi v proizvodu.
For non-active substances, applicants shall use the information provided to them in the context of Title IV of Regulation (EC) No 1907/2006, where relevant, and the information made available by the Agency in accordance with point (e) of Article 77(2) of that Regulation.
Vlagatelji za neaktivne snovi po potrebi uporabijo informacije, pridobljene v okviru naslova IV Uredbe (ES) št. 1907/2006, in informacije, ki jih da na razpolago Agencija v skladu s točko (e) člena 77(2) navedene uredbe.
The relevant calculation methods used for the classification of mixtures as laid down in Regulation (EC) No 1272/2008 shall, where appropriate, be applied in the hazard assessment of the biocidal product.
Ustrezne metode izračunavanja, ki se uporabljajo za razvrstitev zmesi, kot so določene v Uredbi (ES) št. 1272/2008, se po potrebi uporabijo pri oceni nevarnosti biocidnega proizvoda.
Such calculation methods shall not be used if, in relation to a particular hazard, synergistic and antagonistic effects between the different substances contained in the product are considered likely.
Take metode izračunavanja se ne uporabijo, če so v zvezi z določeno nevarnostjo pričakovani sinergijski in nasprotni učinki med različnimi snovmi v proizvodu.
Detailed technical guidance regarding the application of this Annex and the preparation of the dossier is available on the website of the Agency.
Podrobne tehnične smernice o uporabi te priloge in pripravi dokumentacije so na voljo na spletišču Agencije.