natgillin/translations-raw huggingface dataset:
In particular, the information provided for the micro-organism, together with other relevant information, and that provided for one or more preparations containing it, shall be sufficient to:
Zlasti informacije v zvezi z mikroorganizmom, predložene skupaj z drugimi relevantnimi informacijami in informacijami za enega ali več pripravkov, ki ga vsebujejo, zadoščajo za:
classify the micro-organism as to biological hazard,
razvrstitev mikroorganizma glede na biološko nevarnost,
specify the pictograms (once introduced), signal words, and relevant hazard and precautionary statements for the protection of the environment, to be mentioned on packaging (containers).
določitev piktogramov (ko bodo uvedeni), opozorilnih besed ter relevantnih stavkov o nevarnosti in previdnostnih stavkov za zaščito okolja, ki morajo biti navedeni na embalaži (posodah).
There is a need to report all potentially adverse effects found during routine investigations on environmental effects, to undertake and report, where required by the competent authorities, such additional studies which may be necessary to investigate the probable mechanisms involved and to assess the significance of these effects.
Navesti je treba vse morebitne škodljive učinke, ugotovljene med rutinskimi preučevanji učinkov na okolje, da se takšne dodatne študije, ki so morda potrebne za preučitev morebitnih mehanizmov v teh procesih in oceno pomena takšnih učinkov, na zahtevo pristojnih organov izvedejo in navedejo.
All available biological data and information which are relevant to the assessment of the ecology profile of the micro-organism must be reported.
Poročati je treba o vseh razpoložljivih bioloških podatkih in informacijah, relevantnih za oceno ekološkega profila mikroorganizma.
For all studies, average achieved dose in cfu/kg body weight as well as in other appropriate units must be reported.
Pri vseh študijah je treba navesti povprečni odmerek v cfu/kg telesne teže ter tudi v drugih primernih enotah.
It may be necessary to conduct separate studies for relevant metabolites (especially toxins), where these products can constitute a relevant risk to non-target organisms and where their effects cannot be evaluated by the available results relating to the micro-organism.
Morda je treba izvesti ločene študije za relevantne metabolite (zlasti toksine), če ti produkti predstavljajo resno tveganje za neciljne organizme in kadar se njihovi učinki ne morejo oceniti na podlagi razpoložljivih rezultatov, ki se nanašajo na mikroorganizem.
Before such studies are performed, the applicant shall seek agreement of the competent authorities on whether such studies need to be performed and, if so, the type of study to be conducted.
Pred začetkom izvajanja takšnih študij vlagatelj pridobi soglasje pristojnih organov o potrebi po izvajanju takšnih študij in, če je tako, vrsti študije, ki se bo izvajala.
The information from Sections 5, 6 and 7 has to be taken into account.
Upoštevati je treba informacije iz oddelkov 5, 6 in 7.
In order to facilitate the assessment of the significance of test results obtained, the same strain (or recorded origin) of each relevant species shall, where possible, be used in the various tests specified.
Da se olajša ocena statistične značilnosti pridobljenih rezultatov testa, se v različnih testih, kadar je to mogoče, uporabi isti sev (ali organizem dokazano enakega izvora) vsake relevantne vrste.
Tests must be performed unless it can be justified that the non-target organism will not be exposed to the micro-organism.
Testi so obvezni, razen če se lahko utemelji, da neciljni organizem ne bo izpostavljen mikroorganizmu.
If it is justified that the micro-organism does not cause toxic effects or is not pathogenic or infective to vertebrates or plants, only reaction to appropriate non-target organisms must be investigated.
Če se utemelji, da mikroorganizem ne povzroča toksičnih učinkov ali ni patogen ali kužen za vretenčarje in rastline, je treba preučiti le reakcijo na primerne neciljne organizme.
Information on toxicity, infectiveness and pathogenicity to birds must be reported.
Navesti je treba informacije o toksičnosti, kužnosti in patogenosti za ptice.
Information on toxicity, infectiveness and pathogenicity to aquatic organisms must be reported.
Navesti je treba informacije o toksičnosti, kužnosti in patogenosti za vodne organizme.
Information on toxicity, infectiveness and pathogenicity to fish must be reported.
Navesti je treba informacije o toksičnosti, kužnosti in patogenosti za ribe.
Information on toxicity, infectiveness and pathogenicity to freshwater invertebrates must be reported.
Navesti je treba informacije o toksičnosti, kužnosti in patogenosti za sladkovodne nevretenčarje.
Information on effects on algal growth, growth rate and capacity to recover must be reported.
Navesti je treba informacije o vplivih na rast alg, stopnjo rasti in sposobnost obnovitve.
Information on effects on plants other than algae must be reported.
Navesti je treba informacije o vplivih na rastline, razen alg.
Information on toxicity, infectiveness and pathogenicity to bees must be reported.
Navesti je treba informacije o toksičnosti, kužnosti in patogenosti za čebele.
Effects on arthropods other than bees
Učinki na členonožce, razen čebel
Information on toxicity, infectiveness and pathogenicity to arthropods other than bees must be reported.
Navesti je treba informacije o toksičnosti, kužnosti in patogenosti za členonožce, razen čebel.
The selection of the test species should be related to the potential use of the plant protection products (e.g. foliar or soil application).
Izbira testnih vrst mora biti povezana s predvideno uporabo fitofarmacevtskih sredstev (npr. foliarni ali talni nanos).
Special attention should be given to organisms used for biological control and organisms playing an important role in integrated pest management.
Posebno pozornost je treba nameniti organizmom, ki se uporabljajo za biološko varstvo, in organizmom, ki so pomembni pri integriranem zatiranju škodljivcev.
Information on toxicity, infectiveness and pathogenicity to earthworms must be reported.
Navesti je treba informacije o toksičnosti, kužnosti in patogenosti za deževnike.
Effects on non-target soil micro-organisms
Učinki na neciljne talne mikroorganizme
Impact on relevant non-target micro-organisms and on their predators (e.g. protozoa for bacterial inoculants) shall be reported.
Navede se vpliv na relevantne neciljne mikroorganizme in njihove plenilce (npr. praživali za bakterijska cepiva).
Expert judgement is required to decide whether additional studies are necessary.
Za odločitev o potrebi po izvajanju dodatnih študij je potrebna strokovna ocena.
Such decision will take into consideration the available information in this Section and other Sections, in particular data on the specificity of the micro-organism, and the expected exposure.
Pri takšni odločitvi se upoštevajo razpoložljive informacije v tem oddelku in drugih oddelkih, zlasti podatki o specifičnosti mikroorganizma, in pričakovana izpostavljenost.
Useful information may also be available from the observations carried out in efficacy testing.
Koristne informacije so lahko tudi tiste, pridobljene na podlagi ugotovitev pri testiranjih učinkovitosti.
Special attention shall be given to organisms used in integrated crop management (ICM).
Posebna pozornost se nameni organizmom, ki se uporabljajo pri integrirani pridelavi (Integrated Crop Management – ICM).
Additional studies
Dodatne študije
The additional studies might include further acute studies on additional species or processes (such as sewage systems) or higher tier studies such as chronic, sub-lethal or reproductive studies on selected non-target organisms.
Dodatne študije lahko vključujejo nadaljnje študije o akutni toksičnosti na dodatnih vrstah ali procesih (npr. kanalizacijskih sistemih) ali študije na višji stopnji, kot so študije o kronični toksičnosti, subletalnosti ali razmnoževanju na izbranih neciljnih organizmih.
Summary and evaluation of environmental impact
Povzetek in ocena vpliva na okolje
A summary and evaluation of all data relevant to the environmental impact, shall be carried out in accordance with the guidance given by the competent authorities of the Member States concerning the format of such summaries and evaluations.
Povzetek in ocena vseh relevantnih podatkov o vplivu na okolje se pripravita v skladu s smernicami, ki jih predpišejo pristojni organi držav članic v zvezi z obliko takšnih povzetkov in ocen.
It shall include a detailed and critical assessment of those data in the context of relevant evaluative and decision making criteria and guidelines, with particular reference to the risks for the environment and non-target species that may or do arise, and the extent, quality and reliability of the data base.
Vključujeta podrobno in kritično oceno navedenih podatkov, skladno z ustreznimi merili in smernicami za ocenjevanje in odločanje, s posebnim poudarkom na možnem ali dejanskem tveganju za okolje in neciljne vrste ter obsegu, kakovosti in zanesljivosti podatkovne zbirke.
In particular the following issues shall be addressed:
Obravnavajo se zlasti naslednja vprašanja:
distribution and fate in the environment, and the time courses involved,
porazdelitev in končno stanje v okolju ter časovni potek v teh procesih,
identification of non-target species and populations at risk, and the extent of their potential exposure,
opredelitev neciljnih vrst in populacij, za katere obstaja tveganje, ter obseg njihove morebitne izpostavljenosti,
identification of precautions necessary to avoid or minimise contamination of the environment, and for the protection of non-target species.
opredelitev varnostnih ukrepov, potrebnih za preprečevanje ali zmanjševanje kontaminacije okolja ter zaščito neciljnih vrst.
Food and Agriculture Organisation of the United Nations Rome — December 1989. http://www.fao.org/ag/AGP/AGPP/Pesticid/Code/Download/ENVICRI.pdf
Food and Agriculture Organisation of the United Nations Rome – december 1989. http://www.fao.org/ag/AGP/AGPP/Pesticid/Code/Download/ENVICRI.pdf
Standardised System of Nomenclature and Diagnostic Criteria — Guides for Toxicologic Pathology.
Standardiziran sistem nomenklature in diagnostičnih meril – Smernice za toksikološko patologijo.
Guidelines for Good Epidemiology Practices for Occupational and Environmental Research, developed by the Chemical Manufacturers Association’s Epidemiology Task Group, as part of the Epidemiology Resource and Information Centre (ERIC), Pilot Project, 1991.
Smernice za dobre epidemiološke prakse pri raziskavah o delu in okolju, ki jih je pripravila Delovna skupina za epidemiologijo Združenja proizvajalcev kemikalij v okviru Centra za epidemiološke raziskave in informacije, pilotni projekt, 1991.
Society of Environmental Toxicology and Chemistry (SETAC), 1995.
Društvo za okoljsko toksikologijo in kemijo (Society of Environmental Toxicology and Chemistry, SETAC), 1995.
Procedures for assessing the environmental fate and ecotoxicity of pesticides, ISBN 90-5607-002-9.
Postopki za ocenjevanje končnega stanja pesticidov v okolju in njihove ekotoksičnosti (Procedures for assessing the environmental fate and ecotoxicity of pesticides), ISBN 90-5607-002-9.
FOrum for the Co-ordination of pesticide fate models and their USe.
FOrum for the Co-ordination of pesticide fate models and their USe (Forum za usklajevanje modelov končnega stanja pesticidov in njihove uporabe).
From the Workshop European Standard Characteristics of beneficials Regulatory Testing (Escort), 28 to 30 March 1994, ISBN 0-95-22535-2-6.
Z delavnice „European Standard Characteristics of beneficials Regulatory Testing (Escort)“, 28.–30. marca 1994, ISBN 0-95-22535-2-6.
As a consequence of the absence of proper test methods all micro-organisms will be labelled as potential sensitisers, unless the applicant wants to demonstrate the non-sensitising potential by submitting data.
Zaradi odsotnosti primernih testnih metod se vsi mikroorganizmi označujejo kot možni dražitelji, razen če želi vlagatelj s predložitvijo podatkov prikazati, da mikroorganizem ni nujno dražljiv.
Therefore, this data requirement should be regarded as not obligatory but optional, on a provisional base.
To zahtevo po podatkih je do nadaljnjega zato treba upoštevati kot izbirno in ne obvezno.
An inhalation study may be replaced by an intratracheal study.
Študija inhalacije se lahko nadomesti z intratrahealno študijo.
As the present test methods are designed to be performed on soluble chemicals, it is necessary that the methods are developed so as to become relevant for micro-organisms.
Ker so obstoječe testne metode zasnovane za izvajanje na topnih kemijskih snoveh, se morajo metode razvijati v takšni smeri, da postanejo primerne za mikroorganizme.
The method is described in the FAO Revised Guidelines on Environmental Criteria for the Registration of Pesticides [6].
Metoda je opisana v Revidiranih smernicah o okoljskih merilih za registracijo pesticidov FAO [6].
Where dissociation in water occurs, the dissociation constant(s) (pKa values) of the purified active substance must be determined and reported in accordance with OECD Test Guideline 112.
Kadar čista aktivna snov v vodi disociira, je treba določiti in navesti konstante disociacije (vrednosti pKa) čiste aktivne snovi v skladu s Smernicami za testiranje 112 OECD.
Where, as a result of metabolism or other processes in or on treated plants, or as a result of processing of treated products, the terminal residue (to which consumers or workers as defined in the Annex to Regulation (EU) No 545/2011 point 7.2.3 of Part A will be exposed) contains a substance which is not the active substance itself and is not identified as a metabolite in mammals, it will be necessary to carry out toxicity studies on these components of the terminal residue unless it can be demonstrated that consumer or worker exposure to these substances does not constitute a relevant risk to health.
Kadar končni ostanek (kateremu bodo izpostavljeni potrošniki ali delavci, kot je opredeljeno v točki 7.2.3 dela A Priloge k Uredbi (EU) št. 545/2011), ki kot posledica presnove ali drugih procesov v tretiranih rastlinah ali na njih ali kot posledica predelave tretiranih proizvodov vsebuje snov, ki ni aktivna snov sama in ni opredeljena kot metabolit pri sesalcih, je treba izvesti študije o toksičnosti teh sestavin končnega ostanka, razen če je mogoče prikazati, da izpostavljenost potrošnika ali delavca tem snovem ne predstavlja pomembnega tveganja za zdravje.
Toxicokinetic and metabolism studies relating to metabolites and degradation products shall only be conducted if toxicity findings of the metabolite cannot be evaluated by the available results relating to the active substance.
Toksikokinetične študije in študije o presnovi v zvezi z metaboliti in razgradnimi produkti se izvedejo samo, če ugotovitev o toksičnosti metabolita ni mogoče oceniti na podlagi razpoložljivih rezultatov o aktivni snovi.
Regulation (EC) No 440/2008, Method B 36, Toxicokinetics.
Uredba (ES) št. 440/2008, metoda B36, tokiskokinetika.
Where available, and supported with data on levels and duration of exposure, and conducted in accordance with recognised standards [11], epidemiological studies are of particular value and must be submitted.5.9.4.
Kadar so epidemiološke študije na voljo in so podprte s podatki o stopnji in trajanju izpostavljenosti ter izvedene v skladu s priznanimi standardi [11], so še zlasti pomembne in jih je treba predložiti.
Diagnosis of poisoning (determination of active substance, metabolites), specific signs of poisoning, clinical tests
Diagnoza zastrupitve (določitev aktivne snovi, metabolitov), posebni znaki zastrupitve, klinični testi
Short-term dietary toxicity
Kratkotrajna toksičnost pri vnosu s hrano
The test shall provide the short-term dietary toxicity (LC50 values, lowest lethal concentration (LLC), where possible no observed effect concentrations (NOEC), time courses of response and recovery) and include relevant gross pathological findings.
Test zagotovi podatke o kratkotrajni toksičnosti pri vnosu s hrano (vrednosti LC50, najnižjo letalno koncentracijo (LLC), kadar je to mogoče, koncentracije, pri katerih ni opaženih učinkov (NOEC), časovni potek odziva in okrevanja) in vse relevantne makroskopske patološke ugotovitve.
protected crops (e.g. in greenhouses),
zavarovani prostori (npr. rastlinjaki),
amenity,
okrasne in rekreacijske površine,
the active micro-organism(s),
aktivnih mikroorganizmov,
Acute inhalation toxicity, pathogenicity and infectiveness
Akutna toksičnost, patogenost in kužnost pri vdihavanju
The intraperitoneal/subcutaneous test is considered a highly sensitive assay to elicit in particular infectiveness.
Intraperitonealni/subkutani test se obravnava kot visoko občutljiv poskus, zlasti za ugotavljanje kužnosti.
The available methods for testing dermal sensitisation are not suitable for testing micro-organisms.
Razpoložljive metode za testiranje preobčutljivosti kože niso ustrezne za testiranje mikroorganizmov.
Sensitisation by inhalation is most probably a greater problem compared with dermal exposure to micro-organisms but so far, there are no validated test methods.
V primerjavi z dermalno izpostavljenostjo mikroorganizmom je inhalacijska preobčutljivost verjetno večja težava, toda zaenkrat še ni potrjenih testnih metod.
Development of these kinds of methods is therefore of great importance.
Razvoj takšnih metod je zato izjemnega pomena.
Until then, all micro-organisms should be regarded as potential sensitisers.
Do takrat je treba vse mikroorganizme obravnavati kot morebitne dražitelje.
This approach also takes into consideration immuno-compromised or other sensitive individuals in the population (e.g. pregnant women, new-born children or elderly).
Takšen pristop upošteva tudi posameznike s pomanjkljivo imunostjo ali drugače občutljive ljudi v populaciji (npr. nosečnice, novorojenčki ali starejši občani).
In the context of the influence that impurities can have on toxicological behaviour, it is essential that for each study submitted, a detailed description (specification) of the material used, as mentioned under point 1.11 of Part A be provided. Tests shall be conducted using active substance of that specification to be used in the manufacture of preparations to be authorised, except where radiolabelled material is required or permitted.
Glede na vpliv, ki ga nečistoče lahko imajo na toksikološko obnašanje, je bistveno, da se za vsako izvedeno študijo predloži natančen opis (specifikacija) uporabljene snovi, kot je navedeno v točki 1.11 dela A. Testi se izvedejo z aktivno snovjo, kakršno se glede na specifikacijo uporablja pri proizvodnji pripravkov, ki so v postopku registracije, razen kadar se zahteva ali dovoljuje snov, označena z radioaktivnimi markerji.
The provisions on choice of soil and its collection and handling, as referred to in the introduction to point 7.1 of Part A, have to be followed. If the test organism is to be used in association with other media, e.g. rockwool, this must be included in the test range.
Upoštevati je treba določbe o izbiri tal ter zbiranju vzorcev in ravnanju z njimi, kakor je določeno v uvodu točke 7.1 dela A. Če se testni organizem uporablja v povezavi z drugimi sredstvi, npr. kameno volno, je to treba vključiti v serijo testov.
In such cases the principles of the method(s) of purification must be reported. The purity of such test material, which must be as high as can be achieved using the best available technology, must be reported.
V takih primerih je treba navesti postopke čiščenja in čistost testne snovi, ki mora biti najvišja možna, ki jo je mogoče doseči z najboljšo razpoložljivo tehnologijo.
the relationship between dose and adverse effects, toxicity of the active substance including where possible the Noael,
toksičnosti aktivne snovi vključno s količinami, pri katerih škodljivi učinki niso bili opaženi, kadar je to mogoče,
Commission Regulation (EU) No 545/2011
Uredba Komisije (EU) št. 545/2011
implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the data requirements for plant protection products
o izvajanju Uredbe (ES) št. 1107/2009 Evropskega parlamenta in Sveta glede zahtevanih podatkov o fitofarmacevtskih sredstvih
In accordance with Regulation (EC) No 1107/2009 the dossier to be submitted for the approval of an active substance or for the authorisation of a plant protection product is to fulfil the same requirements in respect of the data requirements for the plant protection product as under the previously applicable rules which are set out in Annexes II and III to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market [2].
V skladu z Uredbo (ES) št. 1107/2009 mora dokumentacija, ki se predloži za odobritev aktivne snovi ali registracijo fitofarmacevtskega sredstva, izpolnjevati iste zahteve glede zahtevanih podatkov za fitofarmacevtsko sredstvo kot iz prej veljavnih pravil, ki so določena v prilogah II in III k Direktivi Sveta 91/414/EGS z dne 15. julija 1991 o dajanju fitofarmacevtskih sredstev v promet [2].
It is therefore necessary for the implementation of Regulation (EC) No 1107/2009 to adopt a regulation containing those data requirements for the plant protection product.
Zato je treba za izvajanje Uredbe (ES) št. 1107/2009 sprejeti uredbo, ki vključuje navedene zahtevane podatke za fitofarmacevtska sredstva.
The data requirements for the plant protection product provided for in Article 8(1)(c) of Regulation (EC) No 1107/2009 shall be as set out in the Annex to this Regulation.
V Prilogi k tej uredbi se določijo zahtevani podatki za fitofarmacevtsko sredstvo, kakor so določeni v členu 8(1)(c) Uredbe (ES) št. 1107/2009.
Done at Brussels, 10 June 2011.
V Bruslju, 10. junija 2011.
DATA REQUIREMENTS FOR PLANT PROTECTION PRODUCTS, AS PROVIDED FOR IN ARTICLE 8(1)(c) OF REGULATION (EC) No 1107/2009
ZAHTEVANI PODATKI ZA FITOFARMACEVTSKA SREDSTVA, KAKOR SO DOLOČENI V ČLENU 8(1)(c) UREDBE (ES) št. 1107/2009
include a technical dossier supplying the information necessary for evaluating efficacy and the foreseeable risks, whether immediate or delayed, which the plant protection product may entail for humans, animals and the environment and containing at least the information and results of the studies referred to below;
vključujejo tehnično dokumentacijo s potrebnimi informacijami za oceno učinkovitosti in predvidenih tveganj, takojšnjih ali poznejših, ki jih fitofarmacevtsko sredstvo lahko pomeni za ljudi, živali in okolje, ter ki vsebuje vsaj informacije in rezultate študij iz točk v nadaljevanju;
in the event of a test guideline being inappropriate or not described, or where another one than those referred to in this Annex has been used, include a justification, which is acceptable to the competent authority for the guidelines used.
vključujejo utemeljitev uporabljene smernice za testiranje, ki je sprejemljiva za pristojni organ, kadar smernice za testiranje niso ustrezne ali opisane ali kadar so uporabljene smernice, ki niso navedene v tej prilogi.
In particular, when reference is made in this Annex to a method laid down in Commission Regulation (EC) No 440/2008 [1] which consists in the transposal of a method developed by an international organisation (e.g. OECD), Member States may accept that the required information is generated in accordance with the latest version of that method if at the initiation of the studies the method under Regulation (EC) No 440/2008 has not yet been updated;
Kadar je v tej prilogi navedena metoda iz Uredbe Komisije (ES) št. 440/2008 [1], ki vključuje prenos metode, ki jo je razvila mednarodna organizacija (npr. OECD), lahko država članica sprejme, da so zahtevane informacije pridobljene v skladu z zadnjo različico navedene metode, če metoda iz Uredbe (ES) št. 440/2008 ob začetku študij še ni bila posodobljena;