natgillin/translations-raw huggingface dataset:
Če je aktivna snov namenjena uporabi v mešanicah za dimljenje (fumigant), v razpršilih, če je hlapna, ali če druge informacije kažejo, da je to pomembno, je treba določiti hitrost in pot razgradnje v zraku, če to ni zajeto v točki 7.4.3
If the active substance is to be used in mixtures for fumigants, if it is to be applied by a spray method, if it is volatile, or if any other information indicates that this is relevant, then the rate and route of degradation in air shall be determined as far as is not covered by section 7.4.3
Dodatne ekotoksikološke študije
Additional ecotoxicological studies
Če rezultati ekotoksikoloških raziskav in predvidene uporabe aktivne snovi kažejo na nevarnost za okolje, so obvezni preskusi, opisani v tem oddelku
If the results of the ecotoxicological studies and the intended use(s) of the active substance indicate a danger for the environment then the tests described in this Section shall be conducted.
Vplivi na ptice
Effects on birds
Kratkotrajna toksičnost - osemdnevna krmna raziskava na ▌eni vrsti ▌
Short-term toxicity - eight-day dietary study in ▌one species ▌
Vplivi na razmnoževanje
Effects on reproduction
Ta preskus ni zahtevan, če študija strupenosti krme (oddelek 11.1.1) pokaže, da je LC50 (srednja smrtna koncentracija) višja od 2 000 mg/kg.
This test is not required if the dietary toxicity study (section 11.1.1) shows that the LC50 is above 2 000 mg/kg.
Vplivi na druge neciljne organizme
Effects on other non-target organisms
Akutna toksičnost za čebele in druge koristne členonožce, na primer za plenilce.
Acute toxicity to honeybees and other beneficial arthropods, e.g. predators. ▌
Toksičnost za deževnike in druge neciljne makroorganizme v tleh
Toxicity to earthworms and to other soil non-target macro-organisms
Vplivi na neciljne mikroorganizme v tleh
Effects on soil non-target micro-organisms
Vplivi na druge specifične neciljne organizme (floro in favno), ki so ogroženi
Effects on any other specific, non-target organisms (flora and fauna) believed to be at risk
Povzetek in ocena oddelkov od 1 do 12
Summary and evaluation of Sections 1 to 12
NASLOV 2 – Mikroorganizmi
TITLE 2 - Micro-organisms
Dokumentacija se pripravi za seve mikroorganizmov, razen če se ne predložijo informacije, ki kažejo, da so vrste dovolj homogene, kar zadeva vse lastnosti, ali da predlagatelj predloži druge argumente.
Dossiers shall be prepared on strain level of the micro-organism unless information is submitted that shows that the species is known to be sufficiently homogeneous regarding all characteristics, or the applicant provides other arguments.
Kadar je bil mikroorganizem gensko spremenjen v smislu člena 2(2) Direktive 2001/18/ES Evropskega parlamenta in Sveta o namernem sproščanju gensko spremenjenih organizmov v okolje in razveljavitvi Direktive Sveta 90/220/EGS UL L 106, 17.4.2001, str.
Where the micro-organism has been genetically modified within the meaning of Article 2(2) of Directive 2001/18/EC of the European Parliament and of the Council on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC OJ L 106, 17.4.2001, p.
, se predloži tudi kopija vrednotenja podatkov v zvezi z oceno tveganj za okolje, kot določa člen 4(2) navedene direktive.
, a copy of the evaluation of the data concerning the assessment of the risks to the environment as established in Article 4(2) of that Directive, shall also be submitted.
Če je znano, da je učinek biocidnega pripravka delno ali v celoti posledica delovanja toksina/metabolita, ali se pričakujejo znatni ostanki toksinov/metabolitov, ki niso povezani z učinkovanjem aktivnega mikroorganizma, je treba za toksin/metabolit predložiti dokumentacijo v skladu z zahtevami iz naslova 1.
If the biocidal product action is known to be partly or entirely due to the effect of a toxin/metabolite, or if significant residues of toxins/metabolites are to be expected not related to the effect of the active micro-organism, a dossier for the toxin/metabolite shall be submitted in accordance with the requirements of Title 1.
Dokumentaciji je treba priložiti naslednje podatke.
The following data will be required to support submissions.
Opis mikroorganizma
Identity of the micro-organism
Ime in opis vrste, karakterizacija seva
Name and species description, strain characterisation
Splošno ime mikroorganizma (tudi druga in prej veljavna imena)
Common name of the micro-organism (including alternative and superseded names)
Taksonomska oznaka in sev, ki pove, ali gre za izhodiščni sev, mutantni sev ali gensko spremenjeni organizem (GSO); pri virusih: taksonomska oznaka organizma, serotip, sev ali mutant
Taxonomic name and strain indicating whether it is a stock variant, a mutant strain or a genetically modified organism (GMO); for viruses, taxonomic designation of the agent, serotype, strain or mutant
Zbirka in referenčna številka kulture, če je ta shranjena
Collection and culture reference number where the culture is deposited
Metode, postopki in merila za ugotavljanje prisotnosti in opis mikroorganizma (na primer morfologija, biokemija, serologija, itd.)
Methods, procedures and criteria used to establish the presence and identity of the micro-organism (e.g. morphology, biochemistry, serology, etc.)
Specifikacija snovi, uporabljene za proizvodnjo formuliranih proizvodov
Specification of the material used for manufacturing of formulated products
Vsebina mikroorganizma
Content of the micro-organism
Identiteta in vsebnost nečistot, dodatkov, kontaminantnih mikroorganizmov
Identity and content of impurities, additives, contaminating micro-organisms
Analitske lastnosti partij
Analytical profile of batches
Biološke lastnosti mikroorganizma
Biological properties of the micro-organism
Zgodovina mikroorganizma in njegovih uporab.
History of the micro-organism and its uses.
Naravna navzočnost in geografska razširjenost
Natural occurrence and geographical distribution
Izvor in naravna navzočnost
Origin and natural occurrence
Informacije o ciljnem(-ih) organizmu(-ih)
Information on target organism(s)
Opis ciljnega(-ih) organizma(-ov)
Description of the target organism(s)
Način delovanja
Mode of action
Razpon specifičnih gostiteljev in vplivi na vrste, ki niso ciljni organizmi
Host specificity range and effects on species other than the target organism
Razvojne faze/življenjski ciklus mikroorganizma
Development stages/life cycle of the micro-organism
Kužnost, širjenje in sposobnost koloniziranja
Infectiveness, dispersal and colonisation ability
Razmerja z znanimi rastlinskimi, živalskimi ali človeškimi patogeni
Relationships to known plant or animal or human pathogens
Genska stabilnost in dejavniki, ki vplivajo nanjo
Genetic stability and factors affecting it
Informacije o tvorjenju metabolitov (zlasti toksinov)
Information on the production of metabolites (especially toxins)
Antibiotiki in druga antimikrobiološka sredstva
Antibiotics and other anti-microbial agents
Stabilnost pri okoljskih dejavnikih
Robustness to environmental factors
Vplivi na materiale, snovi in proizvode
Effects on materials, substances and products
Dodatne informacije o mikroorganizmu
Additional information on the micro-organism
Tipi pripravka in kategorije uporabnikov, za katere je mikroorganizme treba uvrstiti v Prilogo I
Product type(s) and category of users for which the micro-organism should be listed in Annex I
Proizvodni postopek in obvladovanje kakovosti
Method of production and quality control
Informacije o pojavu ali možnem pojavu razvoja odpornosti ciljnih organizmov
Information on the occurrence or possible occurrence of the development of resistance of the target organism(s)
Postopki preprečevanja izgube virulence izvorne kulture mikroorganizma
Methods to prevent loss of virulence of seed stock of the micro-organism
Priporočene metode in varnostni ukrepi v zvezi z rokovanjem, skladiščenjem, prevozom ali požarom
Recommended methods and precautions concerning handling, storage, transport or fire
Postopki uničenja ali dekontaminacije
Procedures for destruction or decontamination
Ukrepi v primeru nesreče
Measures in case of an accident
Postopki za ravnanje z odpadki
Procedures for waste management
Načrt spremljanja, ki se uporabi za aktivne mikroorganizme, vključno z rokovanjem, shranjevanjem, prevozom in uporabo
Monitoring plan to be used for the active micro-organism including handling, storage, transport and use
Razvrstitev mikroorganizmov v zadevne skupine tveganja, določene v členu 2 Direktive 2000/54/ES
Classification of the micro-organism in the relevant risk group specified in Article 2 of Directive 2000/54/EC
Analitske metode
Analytical methods
Metode analiz mikroorganizma, kakor se proizvaja
Methods for the analysis of the micro-organism as manufactured
Metode za določitev in količinsko opredeljevanje ostankov (živih ali neživih)
Methods to determine and quantify residues (viable or non-viable)
Vplivi na zdravje ljudi
Effects on human health
RAVEN I
TIER I
Osnovne informacije
Basic information
Zdravstveni podatki
Medical data
Zdravstveni nadzor delavcev v proizvodnih obratih
Medical surveillance on manufacturing plant personnel
Ugotovitve o občutljivosti/alergenosti
Sensitisation/allergenicity observations
Neposredna opazovanja, npr. klinični primeri
Direct observation, e.g. clinical cases
Osnovne raziskave
Basic studies
preskušanje in vivo.
in-vivo testing.
Akutna toksičnost, patogenost in kužnost
Acute toxicity, pathogenicity, and infectiveness
Akutna oralna toksičnost, patogenost in kužnost
Acute oral toxicity, pathogenicity and infectiveness
Akutna toksičnost pri vdihavanju, patogenost in kužnost
Acute inhalation toxicity, pathogenicity and infectiveness
Preskušanje genotoksičnosti in vitro
In vitro genotoxicity testing
Raziskava o celičnih kulturah
Cell culture study
Informacije o kratkoročni toksičnosti in patogenosti
Information on short-term toxicity and pathogenicity
Vplivi na zdravje po ponovljeni izpostavljenosti vdihavanju
Health effects after repeated inhalatory exposure
Predlagano ravnanje: ukrepi prve pomoči, zdravljenje
Proposed treatment: first aid measures, medical treatment
Patogenost in infektivnost za ljudi in druge sesalce pri imunosupresiji
Any pathogenicity and infectiveness to humans and other mammals under conditions of immunosuppression
KONEC RAVNI I
END OF TIER I
RAVEN II
TIER II
Posebne raziskave o toksičnosti, patogenosti in kužnosti
Specific toxicity, pathogenicity and infectiveness studies
KONEC RAVNI II
END OF TIER II
Povzetek toksičnosti, patogenosti in kužnosti pri sesalcih in splošna ocena
Summary of mammalian toxicity, pathogenicity and infectiveness and overall evaluation
Ostanki v ali na tretiranih snoveh, hrani in krmi
Residues in or on treated materials, food and feedingstuffs
Obstojnost in verjetnost razmnoževanja v ali na tretiranih materialih, krmi ali živilih
Persistence and likelihood of multiplication in or on treated materials, feedingstuffs or foodstuffs
Dodatne zahtevane informacije
Further information required
Neživi ostanki
Non-viable residues
Živi ostanki
Viable residues
Povzetek in ocena ostankov v ali na tretiranih snoveh, hrani in krmi
Summary and evaluation of residues in or on treated materials, food and feedingstuffs
Obstojnost in razmnoževanje
Persistence and multiplication
Povzetek in ocena končnega stanja in obnašanja v okolju
Summary and evaluation of fate and behaviour in the environment
Vplivi na neciljne organizme
Effects on non-target organisms
Študija reproduktivnosti ptic navadno ni zahtevana in ni ustrezna, če študija strupenosti krme pokaže, da je LC50 (srednja smrtna koncentracija) višja od 5 000 mg/kg.
An avian reproduction study is not generally required, and is not appropriate if the dietary toxicity study shows that the LC50 is above 5 000 mg/kg.
Vplivi na vodne organizme
Effects on aquatic organisms
Vplivi na ribe
Effects on fish
Vplivi na sladkovodne nevretenčarje
Effects on freshwater invertebrates
Vplivi na rast alg
Effects on algae growth
Vplivi na rastline, razen alg
Effects on plants other than algae
Vplivi na čebele
Effects on bees
Vplivi na členonožce, razen čebel
Effects on arthropods other than bees
Vplivi na deževnike
Effects on earthworms
Zemeljske rastline
Terrestrial plants
Druge zadevne vrste in procesi
Other relevant species and processes
Povzetek in ocena vplivov na neciljne organizme
Summary and evaluation of effects on non-target organisms
Povzetek in ocena oddelkov 1 do 8 vključno z zaključki ocene tveganja in priporočili
Summary and evaluation of sections 1 to 8 including conclusions of the risk assessment and recommendations
Zahteve glede podatkov za biocidne pripravke
Data requirements for biocidal products
Dokumentacija o
Dossiers on
biocidnih pripravkih
biocidal products
vsebuje informacije, ki so potrebne za določitev
shall contain the information needed to establish
Podatke bi bilo treba po možnosti pridobiti iz že obstoječih podatkov, da se zmanjša število poskusov na živalih.
Whenever possible, the information should be derived from existing data in order to reduce the number of tests on animals.
Uporabljajo se zlasti določbe Direktive 1999/45/ES in Uredbe (ES) št. 1272/2008.
In particular, the provisions of Directive 1999/45/EC and Regulation (EC) No 1272/2008 shall apply.
Informacij, ki niso potrebne zaradi vrste biocidnega pripravka ali njegove nenačrtovane uporabe, ni treba navajati.
Information which is however not necessary owing to the nature of the biocidal product or of its proposed uses need not be supplied.
Vključi se podroben in popoln opis opravljenih študij ter uporabljenih postopkov ali bibliografsko navedbo teh postopkov.
A detailed and full description of the studies conducted and of the methods used or a bibliographical reference to those methods shall be included.
Dokumentacija morajo biti predložena v obliki, ki jo predpisuje Komisija.
The formats made available by the Commission must be used for submission of the dossiers.
Poleg tega je treba uporabiti posebno programsko opremo (IUCLID), ki jo predpisuje Komisija, za tiste dele dokumentacije, za katere se lahko uporablja IUCLID.
In addition, the special software package (IUCLID) made available by the Commission must be used for those parts of the dossiers to which IUCLID applies.
Oblike in nadaljnje smernice glede zahtevanih podatkov in priprave dokumentacije so na voljo na spletni strani Agencije.
Formats and further guidance on data requirements and dossier preparation are available on the Agency homepage.
Vendar se, če je metoda neustrezna ali ni opisana, uporabijo druge metode, ki so,
However, if a method is inappropriate or not described, other methods shall be used which are
zadostne z znanstvenega vidika, njihova veljavnost pa mora
scientifically satisfactory
Opravljeni preskusi bi morali biti v skladu z ustreznimi zahtevami za varstvo laboratorijskih živali iz Direktive 86/609/EGS ter, v primeru ekotoksikoloških in toksikoloških preskusov, dobro laboratorijsko prakso iz Direktive 2004/10/ES ali iz drugih mednarodnih standardov, ki sta jih Komisija ali Agencija priznali kot ustrezne.
Tests performed should comply with the relevant requirements of protection of laboratory animals, set out in Directive 86/609/EEC, and, in the case of ecotoxicological and toxicological tests, good laboratory practice, set out in Directive 2004/10/EC or other international standards recognised as being equivalent by the Commission or the Agency.
Kadar se preskus opravi, je treba predložiti natančen opis (specifikacijo) uporabljenega materiala in nečistot, ki jih vsebuje. ▌
Where testing is done, a detailed description (specification) of the material used and its impurities must be provided. ▌
z metodami, ki niso določene v Uredbi (ES) št. 440/2008, mora pristojni organ države članice
by methods other than those laid down in Regulation (EC) No 440/2008, the adequacy of such data for the purposes of this Regulation and the need to conduct new tests according to the Regulation (EC) No 440/2008 must be decided by the competent authority of the Member State
, ki jo zadeva dogovor z Agencijo ,
concerned in agreement with the Agency
odločiti o primernosti takšnih podatkov za namene te uredbe ter o potrebi po izvedbi novih preskusov v skladu z Uredbo (ES) št. 440/2008, in sicer za vsak posamezen primer posebej, pri čemer mora med drugimi dejavniki upoštevati tudi potrebo po zmanjšanju števila poskusov na vretenčarjih.
, on a case-by-case basis, taking into account, among other factors, the need to minimise testing on vertebrate animals.
Zagotoviti je treba vse ustrezno znanje in informacije, ki so na voljo.
All available relevant knowledge and information in literature should be provided.
NASLOV 1 – Kemijski pripravki
TITLE 1 – Chemical products
Zahteve glede dokumentacije
Dossier requirements
Ime in naslov, itd.
Name and address, etc.
Proizvajalec (formulator) biocidnega pripravka in aktivnih snovi (imena, naslovi, vključno s krajem proizvodnega obrata(-ov))
Formulator of the biocidal product and the active substance(s) (names, addresses, including location of plant(s))
Blagovna znamka ali predlagana blagovna znamka in proizvajalčeva razvojna šifra pripravka, če je primerno
Trade name or proposed trade name, and manufacturer's development code number of the preparation, if appropriate
, ob upoštevanju koncentracij iz člena 16(4)
, taking account of the concentrations referred to in Article 16(4)
Agregatno stanje in vrsta biocidnega pripravka, na primer koncentrat za emulzijo, močljiv prašek, raztopina
Physical state and nature of the biocidal product, e.g. emulsifiable concentrate, wettable powder, solution
Fizikalne, kemijske in tehnične lastnosti
Physical, chemical and technical properties
Videz (agregatno stanje, barva)
Appearance (physical state, colour)
Plamenišče in druge oznake vnetljivosti ali samovžiga
Flash-point and other indications of flammability or spontaneous ignition
Kislost/bazičnost in, po potrebi, pH vrednost (1 % v vodi)
Acidity/alkalinity and if necessary pH value (1 % in water)
Tehnične lastnosti biocidnega pripravka, na primer stopnja higroskopičnosti, penjenje, pretočnost, sipkost, sposobnost upraševanja
Technical characteristics of the biocidal product, e.g. wettability, persistent foaming, flowability, pourability and dustability
Fizikalna in kemijska združljivost z drugimi pripravki, vključno z drugimi biocidnimi pripravki, za kombinacijo katerih bo izdano dovoljenje za uporabo
Physical and chemical compatibility with other products including other biocidal products with which its use is to be authorised
Postopki za določanje in analizo
Methods of identification and analysis
Analitska metoda za določanje koncentracije aktivnih snovi v biocidnem pripravku
Analytical method for determining the concentration of the active substance(s) in the biocidal product
Če niso zajete v določbah razdelka 4.2 Priloge II, analitske metode, vključno z odstotki izkoristka in območjem določanja toksikološko in ekotoksikološko pomembnih sestavin biocidnega pripravka in/ali za njegove ostanke (kjer je primerno) v/na:
In so far as not covered by Annex II, Section 4.2, analytical methods including recovery rates and the limits of determination for toxicologically and ecotoxicologically relevant components of the biocidal product and/or residues thereof, where relevant in or on the following:
vodi (vključno s pitno vodo)
Water (including drinking water)
telesnih tekočinah in tkivih živali in človeka
Animal and human body fluids and tissues
tretirani hrani ali krmi
Treated food or feedingstuffs
Predvidene uporabe in učinkovitost
Intended uses and efficacy
Vrsta pripravka in predvideno področje uporabe
Product type and field of use envisaged
Način uporabe, vključno z opisom uporabljenega sistema
Method of application including description of system used
Odmerek, in če je primerno, končna koncentracija biocidnega pripravka in aktivne snovi v sistemu, v katerem bo pripravek uporabljen, na primer v vodi za hlajenje, površinski vodi, vodi za ogrevanje
Application rate and if appropriate, the final concentration of the biocidal product and active substance in the system in which the preparation is to be used, e.g. cooling water, surface water, water used for heating purposes
Število in pogostnost uporabe, in kadar je to ustrezno, posebni podatki o različnih zemljepisnih legah, klimatskih razlikah in/ali potrebni karenci za zaščito človeka in živali
Number and timing of applications, and where relevant, any particular information relating to geographical variations, climatic variations, or necessary waiting periods to protect man and animals
Škodljivi organizmi, ki jih je treba zatirati ter proizvodi, organizmi ali predmeti, ki jih je treba zaščititi
Pest organism(s) to be controlled and products, organisms or objects to be protected
Vplivi na ciljne organizme
Effects on target organisms
Način delovanja (vključno z zapoznelim delovanjem), če to ni zajeto v razdelku 5.4 Priloge II
Mode of action (including time delay) in so far as not covered by Annex II, Section 5.4
Predlagano besedilo na oznaki pripravka
The proposed label claims for the product
Podatke o učinkovitosti, ki utemeljujejo besedilo, vključno z vsemi uporabljenimi standardnimi protokoli, laboratorijskimi preskusi ali preskusi na prostem, kjer je primerno
Efficacy data to support these claims, including any available standard protocols used, laboratory tests, or field trials, where appropriate
Druge znane omejitve glede učinkovitosti, vključno z odpornostjo
Any other known limitations on efficacy including resistance
Toksikološke študije
Toxicological studies
Pri raziskavah razdelkov od 6.1.1 do 6.1.2
For studies of Sections 6.1.1 to 6.1.2,
je lahko razvrščanje na podlagi izračuna, brez poseganja v člena 6 in 9 Uredbe (ES) št. 1272/2008, privzeti pristop.
without prejudice to Articles 6 and 9 of regulation (EC) No 1272/2008, classification by calculation may
Pline in hlapne tekočine je treba preskušati z vdihavanjem
Gases and volatile liquids should be administered by the inhalation route
Preskušanje pri vdihavanju je ustrezno le, če
Testing by the inhalation route is appropriate only if:
razvrščanje na podlagi izračuna ni izvedljivo; in
classification by calculation is not feasible; and
to pomeni glavni način izpostavljenost ljudi, pri tem pa je treba upoštevati parni tlak snovi in možnost izpostavljenosti aerosolom, delcem ali kapljicam, ki jih je mogoče vdihniti.
this constitutes the primary route of human exposure, taking into account the vapour pressure of the substance and the possibility of exposure to aerosols, particles or droplets of an inhalable size.
Zagotovi se utemeljitev uporabe drugega preskusa
Justification for the use of another test shall be provided.
Draženje kože in oči Preskus draženja oči ni potreben, kadar je dokazano, da ima biocidni pripravek možne jedke lastnosti.
Skin and eye irritation Eye-irritation test shall not be necessary where the biocidal product has been shown to have potential corrosive properties.
Razvrščanje na podlagi izračuna je lahko privzeti pristop
Classification by calculation may be the default approach.
Podatki o
Information on
dermalni absorpciji
dermal absorption
Razpoložljivi toksikološki podatki o toksikološko pomembnih neaktivnih snoveh (tj. pogojno nevarnih snoveh)
Available toxicological data relating to toxicologically relevant non-active substances (i.e. substances of concern)
Podatki o izpostavljenosti človeka in delavca/uporabnika biocidnemu pripravku
Information related to the exposure of the biocidal product to man and the operator
Kjer je potrebno, se preskus(-i), opisan(-i) v Prilogi II, zahteva(-jo) za toksikološko pomembne neaktivne snovi v pripravku
Where necessary, the test(s) described in Annex II, shall be required for the toxicologically relevant non-active substances of the preparation
Ekotoksikološke študije
Ecotoxicological studies
Predvidene poti vstopa v okolje na podlagi predvidene uporabe
Foreseeable routes of entry into the environment on the basis of the use envisaged
Podatki o ekotoksičnosti aktivne snovi v pripravku, kadar o tem ni mogoče sklepati iz podatkov o sami aktivni snovi
Information on the ecotoxicology of the active substance in the product, where this cannot be extrapolated from the information on the active substance itself