natgillin/translations-raw huggingface dataset:
Podatki o izpostavljenosti, ki ustrezno uporabljajo metodologije, opisane v oddelku 5 Priloge I k Uredbi (ES) št. 1907/2006
Exposure data applying, as appropriate, the methodologies described in section 5 of Annex I to Regulation (EC) No 1907/2006
Informacije o izpostavljenosti živali za proizvodnjo živil ter živil in krme, povezani s predvideno uporabo aktivne snovi
Information on exposure of food producing animals and food and feeding stuffs associated with the intended uses of the active substance
UČINEK NA ZDRAVJE ČLOVEKA IN ŽIVALI
EFFECT ON HUMAN AND ANIMAL HEALTH
Neposredna opažanja, npr. klinični primeri
Direct observation, e.g. clinical cases
Osnovne študije
Basic studies
Akutna toksičnost pri vdihavanju, patogenost in kužnost
Acute inhalatory toxicity, pathogenicity and infectiveness
Enkratni intraperitonealni/ subkutani odmerek
Intraperitoneal/subcutaneous single dose
Študija o celičnih kulturah
Cell culture study
Učinki na zdravje po ponovljeni izpostavljenosti vdihavanju
Health effects after repeated inhalatory exposure
Posebne študije o toksičnosti, patogenosti in kužnosti
Specific toxicity, pathogenicity and infectiveness studies
na somatskih celicah
studies in somatic cells
na zarodnih celicah
studies in germ cells
Ostanki v ali na tretiranih izdelkih, hrani in krmi
Residues in or on treated articles, food and feedingstuffs
Obstojnost in verjetnost razmnoževanja v ali na tretiranih izdelkih, krmi ali živilih
Persistence and likelihood of multiplication in or on treated articles, feedingstuffs or foodstuffs
Nadaljnje zahtevane informacije
Further information required
Povzetek in ocena ostankov v ali na tretiranih izdelkih, hrani in krmi
Summary and evaluation of residues in or on treated articles, food and feedingstuffs
UČINKI NA NECILJNE ORGANIZME
EFFECTS ON NON-TARGET ORGANISMS
Zahteve za informacije v tem oddelku se lahko po potrebi prilagodijo v skladu s specifikacijami iz naslova 1 te priloge.
Information requirements in this section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex.
Učinki na ribe
Effects on fish
Učinki na sladkovodne nevretenčarje
Effects on freshwater invertebrates
Učinki na rast alg
Effects on algae growth
Učinki na rastline, razen alg
Effects on plants other than algae
Nadaljnje študije
Further studies
Povzetek in ocena usode in obnašanja v okolju
Summary and evaluation of fate and behaviour in the environment
UKREPI, POTREBNI ZA ZAŠČITO LJUDI, ŽIVALI IN OKOLJA
MEASURES NECESSARY TO PROTECT HUMANS, ANIMALS AND THE ENVIRONMENT
Priporočene metode in previdnostni ukrepi v zvezi z ravnanjem, shranjevanjem, prevozom ali ob požaru
Recommended methods and precautions concerning handling, storage, transport or fire
Nujni ukrepi ob nesrečah
Emergency measures in case of an accident
Načrt spremljanja, ki se uporabi za aktivne mikroorganizme, vključno z ravnanjem, shranjevanjem, prevozom in uporabo
Monitoring plan to be used for the active micro-organism including handling, storage, transport and use
RAZVRŠČANJE, OZNAČEVANJE IN PAKIRANJE MIKROORGANIZMA
CLASSIFICATION, LABELLING AND PACKAGING OF THE MICRO-ORGANISM
Ustrezna rizična skupina iz člena 2 Direktive 2000/54/ES
Relevant risk group specified in Article 2 of Directive 2000/54/EC
Povzeti in oceniti ključne informacije, pridobljene iz končnih točk v vsakem od pododdelkov (2–12) ter pripraviti osnutek ocene tveganja.
The key information identified from the endpoints in each subsection (2-12) is summarised, evaluated and a draft risk assessment is performed.
ZAHTEVE GLEDE INFORMACIJ O BIOCIDNIH PROIZVODIH
INFORMATION REQUIREMENTS FOR BIOCIDAL PRODUCTS
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).
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).
Podatki, ki spadajo v ZOP, štejejo za osnovne podatke, ki bi morali biti načeloma na voljo za vse biocidne proizvode.
The data elements belonging to the CDS are considered as the basic data which should, in principle, be provided for all biocidal products.
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.
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.
Posebne določbe za vključitev nekaterih podatkov so v stolpcu 1 tabele v Prilogi III.
Specific indications for the inclusion of some data elements are provided in column 1 of the Annex III table.
Uporabljajo se tudi splošni preudarki za prilagoditev zahtev glede informacij, kot so navedeni v Prilogi IV k tej uredbi.
The general considerations regarding adaptation of information requirements as set out in Annex IV to this Regulation shall also apply.
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.
In light of the importance of reducing testing on vertebrate animals, 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 vertebrate animals.
Nekatere zahteve glede informacij, določene v tej prilogi, je mogoče izpolniti na podlagi dostopnih informacij o lastnostih aktivnih snovi v proizvodu in lastnostih neaktivnih snovi v proizvodu.
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.
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 ECHA v skladu s točko (e) člena 77(2) navedene uredbe.
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 ECHA in accordance with point (e) of Article 77(2) of that Regulation.
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.
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.
Take metode izračunavanja se ne uporabijo, če so v zvezi z določeno nevarnostjo pričakovani sinergijski in nasprotni učinki med različnimi snovmi v proizvodu.
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.
Podrobne tehnične smernice o uporabi te priloge in pripravi dokumentacije so na voljo na spletišču Agencije.
Detailed technical guidance regarding the application of this Annex and the preparation of the dossier is available on the web-site of the Agency.
Poleg obveznosti iz člena 62(2) se lahko vlagatelji prav tako posvetujejo s pristojnim organom, ki bo ocenil dokumentacijo glede predlaganih zahtev glede informacij in zlasti glede preskusov na vretenčarjih, za katere vlagatelj predlaga, da jih bo izvedel.
In addition to the obligation set out in Article 62(2), applicants may also consult with the competent authority that will evaluate the dossier with regard to the proposed information requirements and in particular the testing on vertebrate animals that the applicant proposes to carry out.
Če je treba opraviti oceno iz člena 29(3) ali 44(2), utegnejo biti potrebne dodatne informacije.
Additional information may need to be submitted if necessary to carry out the evaluation as indicated in Article 29(3) or 44(2).
Predloženi podatki morajo biti v vsakem primeru zadostni, da se opravi ocena tveganja, ki naj bi pokazala, da so merila iz člena 19(1)(b) izpolnjena.
The information submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria in Article 19(1)(b) are met.
Vključi se podroben in popoln opis opravljenih študij ter uporabljenih postopkov.
A detailed and full description of studies conducted and of the methods used shall be included.
Dokumentacija se predloži v formatih, ki jih predpiše Agencija.
The formats made available by the Agency shall be used for submission of the dossiers.
Poleg tega se uporabi IUCLID za tiste dele dokumentacije, za katere se lahko uporablja IUCLID.
In addition, IUCLID shall be used for those parts of the dossiers to which IUCLID applies.
Formati in nadaljnja navodila glede zahtevanih podatkov in priprave dokumentacije so na voljo na domači 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
znanstveno ustrezne
scientifically appropriate
, kjer je to mogoče, mednarodno priznane, njihova
, whenever possible internationally recognised and
pa mora biti utemeljena v vlogi.
must be justified in the application.
Če se preskusne metode uporabljajo za nanometariale, se zagotovi obrazložitev znanstvene ustreznosti za nanomateriale in, kjer je primerno, pojasnilo o tehničnih prikrojitvah/prilagoditvah, ki so bile potrebne zaradi posebnih lastnosti teh materialov.
When test methods are applied to nanomaterials, an explanation shall be provided of their scientific appropriateness for nanomaterials, and, where applicable, of the technical adaptations/adjustments that have been made in order to respond to the specific characteristics of these materials.
Opravljeni preskusi bi morali biti v skladu z ustreznimi zahtevami za varstvo laboratorijskih živali iz Direktive 2010/63/EU ter v primeru ekotoksikoloških in toksikoloških preskusov v skladu z dobro laboratorijsko prakso iz Direktive 2004/10/ES ali z drugimi mednarodnimi standardi, ki sta jih Komisija ali Agencija priznali kot enakovredne.
Tests performed should comply with the relevant requirements of protection of laboratory animals, set out in Directive 2010/63/EC 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.
Preskusi v zvezi s fizikalno-kemijskimi lastnostmi in podatki o snovi v zvezi z varnostjo bi morali biti opravljeni vsaj v skladu z mednarodnimi standardi.
Tests on physico-chemical properties and safety-relevant substance data should be performed at least according to international standards.
Kadar se preskus opravi, je treba predložiti podroben kvantitativen in kvalitativen opis (specifikacijo) proizvoda, uporabljenega v vsakem od preskusov, in nečistot, ki jih vsebuje.
Where testing is done, a detailed quantitative and qualitative description (specification) of the product used for each test and its impurities must be provided.
Kadar obstajajo podatki o preskusih, pridobljeni pred … * UL: vstaviti datum začetka veljavnosti te uredbe.
Where test data exist that have been generated before … * OJ: insert the date of the entry into force of this Regulation.
z metodami, ki niso določene v Uredbi (ES) št. 440/2008, mora pristojni organ države članice 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 drugim upoštevati tudi potrebo po izogibanju nepotrebnim preskusom.
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, on a case-by-case basis, taking into account, among other factors, the need to avoid unnecessary testing.
z jedkimi snovmi pri ravneh koncentracije/odmerka, ki povzročajo korozijo, se je treba izogibati.
testing with corrosive substances at concentration/dose levels causing corrosivity shall also be avoided.
NASLOV 1 KEMIČNI PROIZVODI ZBIRKA OSNOVNIH PODATKOV IN ZBIRKA DODATNIH PODATKOV ZA KEMIČNE PROIZVODE
TITLE 1 CHEMICAL PRODUCTS CORE DATA SET AND ADDITIONAL DATA SET FOR CHEMICAL PRODUCTS
Informacije, ki so potrebne za dovoljenje za biocidni proizvod, so naštete v spodnji tabeli.
Information required to support the authorisation of a biocidal product is listed in the table below.
Za vsako zahtevano informacijo v tej prilogi se uporabljajo tudi določbe iz stolpcev 1 in 3 Priloge II za isto zahtevano informacijo.
For each information requirement set down in this Annex the indications given in columns 1 and 3 of Annex II for the same information requirement shall also apply.
Ime in naslov itd.
Name and address, etc
Proizvajalec in formulator biocidnega proizvoda in aktivnih snovi (imena, naslovi, vključno s krajem proizvodnega obrata(-ov))
Manufacturer and formulator of the biocidal product and the active substance(s) (names, addresses, including location of plant(s))
OPIS BIOCIDNEGA PROIZVODA
IDENTITY OF THE BIOCIDAL PRODUCT
Trgovsko ime ali predlagano trgovsko ime
Trade name or proposed trade name
Po potrebi proizvajalčeva razvojna koda in številka proizvoda
Manufacturer's development code and number of the product, if appropriate
Celotna kvantitativna (v g/kg, g/l ali % – m/m (v/v)) sestava biocidnega proizvoda, tj. navedba vseh aktivnih snovi in pomožnih snovi v formulaciji (snov ali zmes v skladu s členom 3 Uredbe (ES) št. 1907/2006), ki so namerno dodani biocidnemu proizvodu (formulaciji), ter podrobne kvantitativne in kvalitativne informacije o sestavi vsebovanih aktivnih snovi.
Complete quantitative (g/kg, g/l or % w/w (v/v)) composition of the biocidal product, i.e. declaration of all active substances and co-formulants (substance or mixture according to Article 3 of Regulation (EC) No 1907/2006), which are intentionally added to the biocidal product (formulation) as well as detailed quantitative and qualitative information on the composition of the active substance(s) contained.
Za pomožne snovi v formulaciji je treba predložiti varnostne liste v skladu s členom 31 Uredbe (ES) št. 1907(2006).
For co-formulants, a safety data sheet in compliance with Article 31 of Regulation (EC) No 1907/2006 has to be provided.
Poleg tega se navedejo vse pomembne informacije o posameznih sestavinah in njihovi funkciji, pri reakcijskih zmeseh pa tudi končna sestava biocidnega proizvoda.
In addition, all relevant information on individual ingredients, their function and, in case of a reaction mixture, the final composition of the biocidal product shall be given.
Vrsta formulacije in narava biocidnega proizvoda, na primer koncentrat za emulzijo, močljiv prašek, raztopina
Formulation type and nature of the biocidal product, e.g. emulsifiable concentrate, wettable powder, solution
FIZIKALNE, KEMIJSKE IN TEHNIČNE LASTNOSTI
PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES
Videz (pri 20 °C in 101,3 kPa)
Appearance (at 20°C and 101.3 kPa)
Fizikalno stanje (pri 20 °C in 101,3 kPa)
Physical state (at 20°C and 101.3 kPa)
Preskus se uporabi, kadar je vrednost pH biocidnega proizvoda ali njegove disperzije v vodi (1 %) zunaj območja pH: 4–10
The test is applicable when the pH of the biocidal product or its dispersion in water (1%) is outside the pH range 4-10
Relativna gostota (tekočine) in nasipna gostota (trdne snovi)
Relative density (liquids) and bulk, tap density (solids)
Obstojnost pri shranjevanju, obstojnost in rok uporabnosti
Storage stability, stability and shelf-life
Preskusi obstojnosti pri shranjevanju
Storage stability tests
Hitri preskus obstojnosti pri shranjevanju
Accelerated storage test
Preskus dolgoročne obstojnosti pri shranjevanju pri temperaturi prostora
Long term storage test at ambient temperature
Preskus obstojnosti pri nizki temperaturi (tekočine)
Low temperature stability test (liquids)
Učinki na vsebnost aktivne snovi in tehnične značilnosti biocidnega proizvoda
Effects on content of the active substance and technical characteristics of the biocidal product
Tehnične značilnosti biocidnega proizvoda
Technical characteristics of the biocidal product
Sposobnost tvorjenja suspenzije, spontanost in obstojnost disperzije
Suspensibility, spontaneity and dispersion stability
Mokra sejalna analiza in suhi sejalni preskus
Wet sieve analysis and dry sieve test
Sposobnost emulgiranja, ponovnega emulgiranja, obstojnost emulzije
Emulsifiability, re-emulsifiability and emulsion stability
Čas razpadanja
Disintegration time
Razporeditev delcev po velikosti, vsebnost prahu/drobnih delcev, drobljivost in krušljivost
Particle size distribution, content of dust/fines, attrition, friability
Hitrost gorenja – generatorji dima
Burning rate- smoke generators
Popolnost zgorevanja – generatorji dima
Burning completeness- smoke generators
Sestava dima – generatorji dima
Composition of smoke -smoke generators
Vzorec razprševanja – aerosoli
Spraying pattern -aerosols
Druge tehnične značilnosti
Other technical characteristics
Fizikalna in kemijska združljivost z drugimi proizvodi, vključno z drugimi biocidnimi proizvodi, 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
Stopnja raztopljenosti in stabilnost raztopine
Degree of dissolution and dilution stability
FIZIKALNE NEVARNOSTI IN ZADEVNE ZNAČILNOSTI
PHYSICAL HAZARDS AND RESPECTIVE CHARACTERIESTICS
Samosegrevajoče se snovi in zmesi
Self heating substances and mixtures
Dodatni fizikalni znaki nevarnosti
Additional physical indications of hazard
Temperatura samovžiga proizvodov (tekočine in plini)
Auto-ignition temperatures of products (liquids and gases)
Analitska metoda, vključno z validacijskimi parametri, za določanje koncentracije aktivnih snovi, ostankov, pomembnih nečistot in pogojno nevarnih snovi v biocidnem proizvodu
Analytical method including validation parameters for determining the concentration of the active substance(s), residues, relevant impurities and substances of concern in the biocidal product
Če niso zajete v oddelkih 5.2 in 5.3 Priloge II, analitske metode za namene spremljanja, vključno z odstotki izkoristka in mejo določitve pomembnih sestavin biocidnega proizvoda in/ali njegovih ostankov v (kakor je ustrezno):
In so far as not covered by Annex II 5.2 and 5.3, analytical methods for monitoring purposes including recovery rates and the limits of determination of relevant components of the biocidal product and/or residues thereof, where relevant in or on the following:
Vodi (vključno s pitno vodo) in usedlinah
Water (including drinking water) and sediment
Telesnih tekočinah ter tkivih živali in človeka
Animal and human body fluids and tissues
Analitske metode za namene spremljanja, vključno z odstotki izkoristka ter mejo količinske opredelitve in določitve aktivne snovi in njenih ostankov v/na živilih rastlinskega in živalskega izvora ali krme in po potrebi drugih proizvodih (ni potrebno, če niti aktivna snov niti material, tretiran z njimi, ne pridejo v stik z živalmi za proizvodnjo živil, živili rastlinskega in živalskega izvora ali krmo)
Analytical methods for monitoring purposes including recovery rates and the limit of quantification and detection for the active substance, and for residues thereof, in/on food of plant and animal origin or feeding stuffs and other products where relevant (not necessary if neither the active substance or the material treated with it does not come into contact with food producing animals, food of plant and animal origin or feeding stuffs)
Način nadziranja, na primer privabljanje, uničenje, zaviranje
Mode of control e.g. attracting, killing, inhibiting
Učinki na reprezentativne ciljne organizme
Effects on representative target organisms
Verjetna koncentracija, v kateri bo aktivna snov uporabljena
Likely concentration at which the active substance will be used
Predlagano besedilo oznake proizvoda in, kadar so navedbe na oznaki, tretiranih izdelkov
The proposed label claims for the product and, where label claims are made, for treated articles
Podatki o učinkovitosti, ki utemeljujejo te navedbe, vključno z vsemi razpoložljivimi uporabljenimi standardnimi protokoli, laboratorijskimi preskusi ali preskusi na prostem, vključno s standardi učinkovitosti, kadar je primerno.
Efficacy data to support these claims, including any available standard protocols, laboratory tests or field trials used including performance standards where appropriate and relevant
Opažanja o neželenih ali nepredvidenih stranskih učinkih, na primer na koristne in druge neciljne organizme
Observations on undesirable or unintended side effects e.g. on beneficial and other non-target organisms
Povzetek in ocena
Summary and evaluation
Predvideno področje ali področja uporabe za biocidne proizvode in, kadar je primerno, tretirane izdelke
Field(s) of use envisaged for biocidal products and, where appropriate, treated articles
Vrsta proizvoda
Product type
Podroben opis vzorca ali vzorcev predvidene uporabe biocidnih proizvodov in, kadar je primerno, tretiranih izdelkov
Detailed description of intended use pattern(s) for biocidal products and, where appropriate, treated articles
Uporabnik, na primer industrijski, usposobljeni poklicni, poklicni ali širša javnost (nepoklicni)
User e.g. industrial, trained professional, professional or general public (non-professional)
, in po potrebi za različne kategorije uporabe
and where relevant, for different use categories
Metoda uporabe in opis te metode
Method of application and a description of this method
Odmerek in po potrebi končna koncentracija biocidnega proizvoda in aktivne snovi v tretiranem izdelku ali sistemu, v katerem bo proizvod 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 a treated article or in the system in which the product is to be used, e.g. cooling water, surface water, water used for heating purposes.
Število in pogostnost uporabe, po potrebi pa tudi podrobne informacije o zemljepisni legi ali podnebnih nihanjih, vključno s potrebno karenco, časom, potrebnim za izločanje iz organizma, delovno karenco ali drugimi previdnostnimi ukrepi za zaščito zdravja človeka in živali ter okolja
Number and timing of applications, and where relevant, any particular information relating to geographical location or climatic variations including necessary waiting periods, clearance times, withdrawal periods or other precautions to protect human and animal health and the environment
Informacije o izpostavljenosti ljudi, povezani s proizvodnjo in formulacijo, predlagano/pričakovano uporabo in odstranjevanjem
Information on human exposure associated with production and formulation, proposed/expected uses and disposal