natgillin/translations-raw huggingface dataset:
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 vertebrates that the applicant proposes to carry out.
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.
Additional information may need to be submitted if necessary to carry out the evaluation as indicated in Article 29(3) or Article 44(2).
Če je treba opraviti oceno iz člena 29(3) ali člena 44(2), utegnejo biti potrebne dodatne informacije.
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.
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.
A detailed and full description of studies conducted and of the methods used shall be included.
Vključi se podroben in popoln opis izvedenih študij ter uporabljenih postopkov.
The formats made available by the Agency shall be used for submission of the dossiers.
Dokumentacija se predloži v formatih, ki jih predpiše Agencija.
In addition, IUCLID shall be used for those parts of the dossiers to which IUCLID applies.
Poleg tega se uporabi IUCLID za tiste dele dokumentacije, za katere se lahko uporablja IUCLID.
Formats and further guidance on data requirements and dossier preparation are available on the Agency homepage.
Formati in nadaljnja navodila glede zahtevanih podatkov in priprave dokumentacije so na voljo na domači spletni strani Agencije.
Tests submitted for the purpose of authorisation shall be conducted according to the methods described in Regulation (EC) No 440/2008.
Preskusi, predloženi za izdajo dovoljenja, se izvedejo po metodah iz Uredbe (ES) št. 440/2008.
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.
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.
Tests performed should comply with the relevant requirements of protection of laboratory animals, set out in Directive 2010/63/EU 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.
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.
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 se preskus opravi, je treba predložiti podroben kvantitativen in kvalitativen opis (specifikacijo) proizvoda, uporabljenega v vsakem od preskusov, in nečistot, ki jih vsebuje.
Where test data exist that have been generated before 17 July 2012 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.
Kadar obstajajo podatki o preskusih, pridobljeni pred 17. julijem 2012 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.
In vivo testing with corrosive substances at concentration/dose levels causing corrosivity shall also be avoided.
Preskušanju in vivo z jedkimi snovmi pri ravneh koncentracije/odmerka, ki povzročajo korozijo, se je treba izogibati.
CHEMICAL PRODUCTS
KEMIČNI PROIZVODI
Core data set and additional data set for chemical products
Zbirka osnovnih podatkov in zbirka dodatnih podatkov za kemične proizvode
Information required to support the authorisation of a biocidal product is listed in the table below.
Informacije, ki so potrebne za dovoljenje za biocidni proizvod, so naštete v spodnji tabeli.
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.
Za vsako zahtevano informacijo v tej prilogi se uporabljajo tudi navedbe iz stolpcev 1 in 3 Priloge II za isto zahtevano informacijo.
Information required:
Zahtevane informacije:
Name and address, etc.
Ime in naslov itd.
Manufacturer and formulator of the biocidal product and the active substance(s) (names, addresses, including location of plant(s))
Proizvajalec in formulator biocidnega proizvoda in aktivne oziroma aktivnih snovi (imena, naslovi, vključno s krajem proizvodnega obrata(-ov))
IDENTITY OF THE BIOCIDAL PRODUCT
OPIS BIOCIDNEGA PROIZVODA
Trade name or proposed trade name
Trgovsko ime ali predlagano trgovsko ime
Manufacturer’s development code and number of the product, if appropriate
Po potrebi proizvajalčeva razvojna koda in številka proizvoda
In addition, all relevant information on individual ingredients, their function and, in the case of a reaction mixture, the final composition of the biocidal product shall be given
Poleg tega se navedejo vse pomembne informacije o posameznih sestavinah in njihovi funkciji, pri reakcijskih zmeseh pa tudi končna sestava biocidnega proizvoda.
Formulation type and nature of the biocidal product, e.g. emulsifiable concentrate, wettable powder, solution
Vrsta formulacije in narava biocidnega proizvoda, na primer koncentrat za emulzijo, močljiv prašek, raztopina
PHYSICAL, CHEMICAL AND TECHNICAL PROPERTIES
FIZIKALNE, KEMIJSKE IN TEHNIČNE LASTNOSTI
Appearance (at 20 °C and 101,3 kPa)
Videz (pri 20 °C in 101,3 kPa)
Physical state (at 20 °C and 101,3 kPa)
Fizikalno stanje (pri 20 °C in 101,3 kPa)
Acidity/alkalinity
Kislost/bazičnost
The test is applicable when the pH of the biocidal product or its dispersion in water (1 %) is outside the pH range 4-10
Preskus se uporabi, kadar je vrednost pH biocidnega proizvoda ali njegove disperzije v vodi (1 %) zunaj območja pH 4–10
Relative density (liquids) and bulk, tap density (solids)
Relativna gostota (tekočine) in nasipna gostota (trdne snovi)
Storage stability, stability and shelf-life
Obstojnost pri shranjevanju, obstojnost in rok uporabnosti
Storage stability tests
Preskusi obstojnosti pri shranjevanju
Accelerated storage test
Hitri preskus obstojnosti pri shranjevanju
Long term storage test at ambient temperature
Preskus dolgoročne obstojnosti pri shranjevanju pri temperaturi prostora
Low temperature stability test (liquids)
Preskus obstojnosti pri nizki temperaturi (tekočine)
Effects on content of the active substance and technical characteristics of the biocidal product
Učinki na vsebnost aktivne snovi in tehnične značilnosti biocidnega proizvoda
Temperature and humidity
Temperatura in vlažnost
Technical characteristics of the biocidal product
Tehnične značilnosti biocidnega proizvoda
Suspensibility, spontaneity and dispersion stability
Sposobnost tvorjenja suspenzije, spontanost in obstojnost disperzije
Wet sieve analysis and dry sieve test
Mokra sejalna analiza in suhi sejalni preskus
Emulsifiability, re-emulsifiability and emulsion stability
Sposobnost emulgiranja, ponovnega emulgiranja, obstojnost emulzije
Disintegration time
Čas razpadanja
Particle size distribution, content of dust/fines, attrition, friability
Razporeditev delcev po velikosti, vsebnost prahu/drobnih delcev, drobljivost in krušljivost
Flowability/Pourability/Dustability
Sipkost, pretočnost, prašljivost
Burning rate — smoke generators
Hitrost gorenja – generatorji dima
Burning completeness — smoke generators
Popolnost zgorevanja – generatorji dima
Composition of smoke — smoke generators
Sestava dima – generatorji dima
Spraying pattern — aerosols
Vzorec razprševanja – aerosoli
Other technical characteristics
Druge tehnične značilnosti
Physical and chemical compatibility with other products including other biocidal products with which its use is to be authorised
Fizikalna in kemijska združljivost z drugimi proizvodi, vključno z drugimi biocidnimi proizvodi, za kombinacijo katerih bo izdano dovoljenje za uporabo
Degree of dissolution and dilution stability
Stopnja raztopljenosti in stabilnost raztopine
Additional physical indications of hazard
Dodatni fizikalni znaki nevarnosti
Auto-ignition temperatures of products (liquids and gases)
Temperatura samovžiga proizvodov (tekočine in plini)
Relative self-ignition temperature for solids
Relativna temperatura samovžiga za trdne snovi
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
Analitska metoda, vključno z validacijskimi parametri, za določanje koncentracije aktivne oziroma aktivnih snovi, ostankov, pomembnih nečistot in pogojno nevarnih snovi v biocidnem proizvodu
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:
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):
Water (including drinking water) and sediment
Vodi (vključno s pitno vodo) in usedlinah
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 nor the material treated with it come into contact with food- producing animals, food of plant and animal origin or feeding stuffs)
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)
Function, e.g. fungicide, rodenticide, insecticide, bactericide
Uporaba, na primer fungicid, rodenticid, insekticid, baktericid
Mode of control e.g. attracting, killing, inhibiting
Način nadziranja, na primer privabljanje, uničenje, zaviranje
Effects on representative target organisms
Učinki na reprezentativne ciljne organizme
Likely concentration at which the active substance will be used
Verjetna koncentracija, v kateri bo aktivna snov uporabljena
The proposed label claims for the product and, where label claims are made, for treated articles
Predlagano besedilo oznake proizvoda in, kadar so navedbe na oznaki, tretiranih izdelkov
Efficacy data to support these claims, including any available standard protocols, laboratory tests or field trials used including performance standards where appropriate and relevant
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
Observations on undesirable or unintended side effects e.g. on beneficial and other non-target organisms
Opažanja o neželenih ali nepredvidenih stranskih učinkih, na primer na koristne in druge neciljne organizme
Summary and evaluation
Povzetek in ocena
Field(s) of use envisaged for biocidal products and, where appropriate, treated articles
Predvideno področje oziroma področja uporabe za biocidne proizvode in, kadar je primerno, tretirane izdelke
Detailed description of intended use pattern(s) for biocidal products and, where appropriate, treated articles
Podroben opis vzorca oziroma vzorcev predvidene uporabe biocidnih proizvodov in, kadar je primerno, tretiranih izdelkov
User e.g. industrial, trained professional, professional or general public (non-professional)
Uporabnik, na primer industrijski, usposobljeni poklicni, poklicni ali širša javnost (nepoklicni)
Likely tonnage to be placed on the market per year and, where relevant, for different use categories
Predvidena teža v tonah, ki se bo letno dajala na trg, in po potrebi za različne kategorije uporabe
Method of application and a description of this method
Metoda uporabe in opis te metode
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
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
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 health, animal health and the environment
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, zdravja živali in okolja
Information on human exposure associated with production and formulation, proposed/expected uses and disposal
Informacije o izpostavljenosti ljudi, povezani s proizvodnjo in formulacijo, predlagano/pričakovano uporabo in odstranjevanjem
Information on environmental exposure associated with production and formulation, proposed/expected uses and disposal
Informacije o izpostavljenosti okolja, povezani s proizvodnjo in formulacijo, predlagano/pričakovano uporabo in odstranjevanjem
Information regarding other products that the product is likely to be used together with, in particular the identity of the active substances in these products, if relevant, and the likelihood of any interactions
Informacije o drugih proizvodih, skupaj s katerimi se bo proizvod verjetno uporabljal, zlasti navedba aktivnih snovi v teh proizvodih, če je to pomembno, in verjetnost morebitnega medsebojnega delovanja
TOXICOLOGICAL PROFILE FOR HUMANS AND ANIMALS
TOKSIKOLOŠKI PROFIL PRI ČLOVEKU IN ŽIVALIH
Skin corrosion or skin irritation
Jedkost za kožo ali draženje kože
Testing on the product/mixture does not need to be conducted if:
Preskusa proizvoda/zmesi ni treba izvesti, če:
there are valid data available on each of the components in the mixture sufficient to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected
so na voljo veljavni podatki o vsaki od sestavin v zmesi, ki so zadostni, da je možna razvrstitev zmesi v skladu s pravili iz Direktive 1999/45/ES in Uredbo (ES) št. 1272/2008 (CLP), sinergijski učinki med katero koli od sestavin pa niso pričakovani.
Eye irritation [1]
Draženje oči [1] Ocena te končne točke se izvede v skladu s strategijo zaporednega preskušanja za draženje oči in jedkost, določeno v dodatku k smernici za preskušanje B.5.
there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/ECand Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected
so na voljo veljavni podatki o vsaki od sestavin zmesi, ki omogočajo razvrstitev zmesi v skladu s pravili iz Direktive 1999/45/ES in Uredbo (ES) št. 1272/2008 (CLP), sinergijski učinki med katero koli od sestavin pa niso pričakovani.
Skin sensitisationThe assessment of this endpoint shall comprise the following consecutive steps:
Preobčutljivost kožeOceno te končne točke sestavljajo naslednji zaporedni koraki:
there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP), and synergistic effects between any of the components are not expected
so na voljo veljavni podatki o vsaki od sestavin zmesi, ki omogočajo razvrstitev zmesi v skladu s pravili iz Direktive 1999/45/ES in Uredbo (ES) št. 1272/2008 (CLP), sinergijski učinki med katero koli od sestavin pa niso pričakovani.
the available information indicates that the product should be classified for skin sensitisation or corrosivity; or
razpoložljive informacije kažejo, da bi moral biti proizvod razvrščen glede preobčutljivosti kože ali jedkosti za kožo, ali
Classification using the tiered approach to classification of mixtures for acute toxicity in Regulation (EC) No 1272/2008 is the default approach
Privzeti pristop je razvrstitev na podlagi stopenjskega pristopa za razvrstitev zmesi za akutno strupenost iz Uredbe (ES) št. 1272/2008.
For biocidal products that are intended to be authorised for use with other biocidal products, the risks to human health, animal health and the environment arising from the use of these product combinations shall be assessed.
Pri biocidnih proizvodih, za katere je predvidena izdaja dovoljenja za uporabo z drugimi biocidnimi proizvodi, se ocenijo tveganja za zdravje človeka, zdravje živali ter okolje, ki izvirajo iz uporabe teh kombinacij proizvodov.
As an alternative to acute toxicity studies, calculations can be used.
Kot alternativa študijam akutne toksičnosti se lahko uporabijo izračuni.
In some cases, for example where there are no valid data available of the kind set out in column 3, this may require a limited number of acute toxicity studies to be carried out using combinations of the products
V nekaterih primerih, na primer kadar ni na voljo veljavnih podatkov takšne vrste, kot je določeno v stolpcu 3, bo morda treba z uporabo kombinacij teh proizvodov izvesti omejeno število študij akutne toksičnosti.
Testing on the mixture of products does not need to be conducted if:
Preskusa zmesi proizvodov ni treba izvesti, če:
The assessment of this endpoint shall proceed using a tiered approach
Ta končna točka se oceni s stopenjskim pristopom.
Available toxicological data relating to:
Razpoložljivi toksikološki podatki v zvezi z naslednjim:
non-active substance(s) (i.e. substance(s) of concern), or
neaktivna oziroma neaktivne snovi v formulaciji (tj. pogojno nevarna oziroma nevarne snovi) ali
a mixture that a substance(s) of concern is a component of
zmes, katere del je oziroma so pogojno nevarne snovi.
If insufficient data are available for a non-active substance(s) and cannot be inferred through read-across or other accepted non-testing approaches, targeted test(s) described in Annex II shall be carried out for the substance(s) of concern or a mixture that a substance(s) of concern is a component of
Če podatki za neaktivno oziroma neaktivne snovi ne zadostujejo in jih ni mogoče povzeti z navzkrižnim branjem ali drugimi sprejetimi pristopi, ki ne temeljijo na preskušanju, se izvede ciljni preskus oziroma preskusi toksičnosti iz Priloge II za snov oziroma snovi v pogojno nevarni snovi oziroma snoveh ali za zmes, katere del je pogojno nevarna snov.
there are valid data available on each of the components in the mixture to allow classification of the mixture according to the rules laid down in Directive 1999/45/EC and Regulation (EC) No 1272/2008 (CLP)
so na voljo veljavni podatki o vsaki od sestavin zmesi, ki omogočajo razvrstitev zmesi v skladu s pravili iz Direktive 1999/45/ES in Uredbo (ES) št. 1272/2008 (CLP).
Food and feedingstuffs studies
Študije hrane in krme
If residues of the biocidal product remain in or on feedingstuffs for a significant period of time, then feeding and metabolism studies in livestock shall be required to permit evaluation of residues in food of animal origin
Če ostanejo ostanki biocidnega proizvoda v ali na krmi dalj časa, so potrebne študije krme in študije metabolizma pri živini, da bi lahko ocenili ostanke v hrani živalskega izvora.
Effects of industrial processing and/or domestic preparation on the nature and magnitude of residues of the biocidal product
Učinki industrijske predelave in/ali domačega pripravka na vrsto in količino ostankov biocidnega proizvoda
Other test(s) related to the exposure to humans
Drugi preskus oziroma preskusi v zvezi z izpostavljenostjo človeka
Suitable test(s) and a reasoned case will be required for the biocidal product
Za biocidni proizvod se zahteva ustrezni preskus oziroma preskusi in primer z utemeljitvijo.
In addition, for certain biocides which are applied directly or around livestock (including horses) residue studies might be needed
Poleg tega bi lahko bile potrebne študije ostankov za nekatere biocide, ki se uporabljajo neposredno na živini (vključno s konji) ali v njihovi okolici.
Information relating to the ecotoxicity of the biocidal product which is sufficient to enable a decision to be made concerning the classification of the product is required
Na voljo mora biti dovolj informacij glede ekotoksičnosti biocidnega proizvoda, da omogočajo odločitev o razvrstitvi proizvoda.
Where there are valid data available on each of the components in the mixture and synergistic effects between any of the components are not expected, classification of the mixture can be made according to the rules laid down in Directive 1999/45/EC, Regulation (EC) No 1907/2006 (REACH) and Regulation (EC) No 1272/2008 (CLP)
Kadar so na voljo veljavni podatki o vsaki od sestavin zmesi, sinergijski učinki med katero koli od sestavin pa niso pričakovani, je mogoče zmes razvrstiti v skladu s pravili iz Direktive 1999/45/ES, Uredbo (ES) št. 1907/2006 (REACH) in Uredbo (ES) št. 1272/2008 (CLP).
Where valid data on the components are not available or where synergistic effects may be expected then testing of components and/or the biocidal product itself may be necessary
Kadar veljavnih podatkov o sestavinah ni na voljo ali kadar je mogoče pričakovati sinergijske učinke, je morda treba opraviti preskuse sestavin in/ali samega biocidnega proizvoda.
Further Ecotoxicological studies
Nadaljnje ekotoksikološke študije
Further studies chosen from among the endpoints referred to in Section 9 of Annex II for relevant components of the biocidal product or the biocidal product itself may be required if the data on the active substance cannot give sufficient information and if there are indications of risk due to specific properties of the biocidal product
Kadar podatki o aktivni snovi ne morejo dati zadostnih informacij in kadar obstajajo znaki tveganja zaradi posebnih lastnosti biocidnega proizvoda, so lahko potrebne nadaljnje študije, izbrane med končnimi točkami iz oddelka 9 Priloge II, za pomembne sestavine biocidnega proizvoda ali sam biocidni proizvod.
Data for the assessment of hazards to wild mammals are derived from the mammalian toxicological assessment
Podatki za oceno tveganj v zvezi z divjimi sesalci se pridobijo iz ocene toksičnosti za sesalce.