natgillin/translations-raw huggingface dataset:
There may be sufficient weight of evidence from the use of positive results of newly developed test methods, not yet included in the relevant test methods or from an international test method recognised by the Commission as being equivalent, leading to the conclusion that a substance has a particular dangerous property.
Na podlagi dokazov iz uporabe pozitivnih rezultatov novih preskusnih metod, ki še niso vključene med zadevne preskusne metode, ali mednarodne poskusne metode, ki jo kot enakovredno priznava Komisija, je mogoče dovolj zanesljivo sklepati, da ima snov določeno nevarno lastnost.
However, if the newly developed test method has been approved by the Commission, but has not yet been published, its results may be taken into account even where this leads to the conclusion that a substance does not have a particular dangerous property.
Vendar če je novo preskusno metodo Komisija odobrila, a ta še ni bila objavljena, se lahko njeni rezultati upoštevajo, tudi če je na njihovi podlagi mogoče sklepati, da snov nima določene nevarne lastnosti.
Where consideration of all the available data provides sufficient weight of evidence for the presence or absence of a particular dangerous property:
Kadar upoštevanje vseh razpoložljivih podatkov pomeni dovolj zanesljiv dokaz za prisotnost ali odsotnost določene nevarne lastnosti:
further testing on vertebrates for that property shall not be undertaken,
se za to lastnost ne izvedejo nadaljnji preskusi na vretenčarjih,
further testing not involving vertebrates may be omitted.
se lahko opustijo nadaljnji preskusi, ki ne vključujejo vretenčarjev.
Qualitative or Quantitative structure-activity relationship ((Q)SAR)
Kvalitativno in kvantitativno razmerje med strukturo in aktivnostjo ((Q)SAR)
Results obtained from valid qualitative or quantitative structure-activity relationship models ((Q)SARs) may indicate the presence, but not the absence of a given dangerous property.
Rezultati, pridobljeni iz veljavnih kvalitativnih ali kvantitativnih modelov razmerja med strukturo in aktivnostjo ((Q)SAR), lahko kažejo na prisotnost določene nevarne lastnosti, a ne na njeno odsotnost.
Results of (Q)SARs may be used instead of testing when the following conditions are met:
Rezultati iz (Q)SAR se lahko uporabijo namesto preskusov, če so izpolnjeni naslednji pogoji:
the results are derived from a (Q)SAR model whose scientific validity has been established,
rezultati so izpeljani iz modela (Q)SAR, katerega znanstvena veljavnost je bila ugotovljena,
the results are adequate for the purpose of classification and labelling and risk assessment, and
rezultati so primerni za razvrščanje in označevanje ter oceno tveganja in
The Agency shall, in collaboration with the Commission, Member States and interested parties, develop and provide guidance on the use of (Q)SARs.
Agencija v sodelovanju s Komisijo, državami članicami in interesnimi skupinami oblikuje in zagotavlja navodila za uporabo (Q)SAR.
Results obtained from suitable in vitro methods may indicate the presence of a given dangerous property or may be important in relation to a mechanistic understanding, which may be important for the assessment.
Rezultati, pridobljeni iz ustreznih metod in vitro, lahko kažejo na prisotnost določene nevarne lastnosti ali so lahko pomembni za razumevanje mehanizmov, ki so lahko pomembni za oceno.
In this context, ‘suitable’ means sufficiently well-developed according to internationally agreed test development criteria.
Pri tem „ustrezen“ pomeni dovolj dobro razvit v skladu z mednarodno dogovorjenimi merili za razvoj preskusov.
Where such in vitro tests are positive, it is necessary to confirm the dangerous property by adequate in vivo tests.
Če so taki preskusi in vitro pozitivni, je treba nevarno lastnost potrditi s primernimi preskusi in vivo.
However, such confirmation may be waived if the following conditions are met:
Vendar ta potrditev ni potrebna, če so izpolnjeni naslednji pogoji:
results are adequate for the purpose of classification and labelling and risk assessment; and
rezultati so primerni za razvrščanje in označevanje ter oceno tveganja in
In the case of negative results, these exemptions do not apply.
Te izjeme ne veljajo v primeru negativnih rezultatov.
A confirmation test may be requested on a case-by-case basis.
Lahko se zahteva potrditveni preskus za vsak primer posebej.
Substances whose physico-chemical, toxicological and ecotoxicological properties are similar or follow a regular pattern as a result of structural similarity may be considered as a group or ‘category’ of substances.
Snovi, katerih fizikalno-kemijske, toksikološke ali ekotoksikološke lastnosti so podobne ali sledijo urejenemu vzorcu kot rezultat strukturne podobnosti, se lahko upoštevajo kot skupina ali „kategorija“ snovi.
Application of the group concept requires that physico-chemical properties, human and animal health effects, and environmental effects or environmental fate may be predicted from data for reference substance(s) within the group by interpolation to other substances in the group (read-across approach).
Uporaba koncepta skupine zahteva, da je mogoče fizikalno-kemijske lastnosti, učinke na zdravje človeka in živali ter vplive na okolje ali usodo v okolju napovedati iz podatkov za referenčno snov oziroma snovi znotraj skupine z interpolacijo na druge snovi v skupini (pristop navzkrižnega branja).
This avoids the need to test every substance for every endpoint.
Tako se je mogoče izogniti preskušanju vsake snovi za vsako končno točko.
a common functional group indicating the presence of dangerous properties;
skupni funkcionalni skupini, ki kaže na prisotnost nevarnih lastnosti;
common precursors and/or the likelihood of common breakdown products via physical and biological processes, which result in structurally similar chemicals and indicates the presence of dangerous properties; or
skupnih predhodnih sestavinah in/ali verjetnosti skupnih produktov razgradnje preko fizikalnih in bioloških procesov, ki so rezultat strukturno podobnih kemikalij in kažejo na prisotnost nevarnih lastnosti, ali
In all cases results shall:
Rezultati morajo vedno:
be adequate for the purpose of classification and labelling and risk assessment,
biti primerni za namen razvrščanja in označevanja ter ocene tveganja,
have adequate and reliable coverage of the key parameters addressed in the corresponding test method, and
primerno in zanesljivo zajemati ključne parametre, obravnavane z ustrezno preskusno metodo, in
cover an exposure duration comparable to or longer than the corresponding test method if exposure duration is a relevant parameter.
zajemati trajanje izpostavljenosti, ki je primerljivo z ustrezno preskusno metodo ali je od nje daljše, če je trajanje izpostavljenosti primeren parameter.
In all cases, adequate and reliable documentation of the applied method shall be provided.
V vseh primerih je treba predložiti primerno in zanesljivo dokumentacijo uporabljene metode.
The Agency shall, in collaboration with the Commission, Member States and interested parties, develop and provide guidance on technically and scientifically justified methodology for the grouping of substances.
Agencija v sodelovanju s Komisijo, državami članicami in zainteresiranimi stranmi oblikuje in zagotavlja smernice glede tehnično in znanstveno utemeljene metodologije za združevanje snovi v skupine.
TESTING IS TECHNICALLY NOT POSSIBLE
PRESKUSI TEHNIČNO NISO IZVEDLJIVI
Testing for a specific endpoint may be omitted if it is technically not possible to conduct the study as a consequence of the properties of the substance: e.g. very volatile, highly reactive or unstable substances cannot be used, mixing of the substance with water may cause danger of fire or explosion, or the radio-labelling of the substance required in certain studies may not be possible.
Preskusi za določeno končno točko se lahko opustijo, če študije zaradi lastnosti snovi tehnično ni mogoče izvesti: kadar npr. ni mogoče uporabiti zelo hlapljivih, visoko reaktivnih ali nestabilnih snovi, kadar lahko mešanje snovi z vodo povzroči požar ali eksplozijo ali kadar označevanje radioaktivnosti snovi, ki se zahtevajo v določenih študijah, ni mogoče.
The guidance given in the relevant test methods, more specifically on the technical limitations of a specific method, shall always be respected.
Vedno se upoštevajo smernice, ki so navedene v zadevnih preskusnih metodah, zlasti o tehničnih omejitvah določene metode.
PRODUCT-TAILORED EXPOSURE-DRIVEN TESTING
PRESKUŠANJE NA PODLAGI IZPOSTAVLJENOSTI, PRILAGOJENO PROIZVODU
Testing in accordance with some endpoints in Sections 8 and 9 of Annexes II and III, notwithstanding Article 6(2), may be omitted based on exposure considerations, where exposure data in accordance with Annex II or III are available.
Preskusi v skladu z nekaterimi končnimi točkami v oddelkih 8 in 9 prilog II in III se ne glede na člen 6(2) lahko opustijo na podlagi podatkov o izpostavljenosti, kadar so na voljo podatki o izpostavljenosti v skladu s prilogama II ali III.
In that case, the following conditions shall be met:
V tem primeru se izpolnijo naslednji pogoji:
An exposure assessment shall be performed, covering primary and secondary exposure under realistic worst case for all intended uses of the biocidal product that contains the active substance for which approval is applied, or of the biocidal product for which the authorisation is sought.
Izdela se ocena izpostavljenosti, ki zajema predvsem primarno in sekundarno izpostavljenost v realno najslabšem možnem primeru za vse predvidene uporabe biocidnega proizvoda, ki vsebuje aktivno snov, za katero velja odobritev, ali biocidnega proizvoda, za katerega se skuša pridobiti dovoljenje.
If a new exposure scenario is introduced at a later stage, during the product authorisation process, additional data shall be submitted to assess whether the justification for data adaptation still applies.
Če se na poznejši stopnji postopka izdaje dovoljenja za proizvod uvede nov scenarij izpostavljenosti, se predložijo dodatni podatki za oceno, ali je odstop od zahtev glede podatkov še vedno upravičen.
The reasons why the outcome of the exposure assessment justifies waiving of data requirements shall be clearly and transparently explained.
Jasno in pregledno se razloži, zakaj rezultat ocene izpostavljenosti upravičuje odstop od zahtev glede podatkov.
However, testing cannot be omitted for non-threshold effects.
Vendar ni mogoče opustiti preskusov glede učinkov, ki nimajo mejnih vrednosti.
As a consequence, certain core data shall always be obligatory, e.g. genotoxicity testing.
Zato so določeni osnovni podatki vedno obvezni, npr. preskušanje genotoksičnosti.
If relevant, the Agency shall, in collaboration with the Commission, Member States and interested parties, develop and provide further guidance on the criteria established in accordance with Article 6(4) and Article 21(3).
Agencija v sodelovanju s Komisijo, državami članicami in interesnimi skupinami po potrebi oblikuje in zagotavlja nadaljnje smernice o merilih, opredeljenih v skladu s členom 6(4) in členom 21(3).
The justification shall be based on an exposure assessment, in accordance with the relevant Technical Notes for Guidance where available.
Za utemeljitev se uporablja ocena izpostavljenosti v skladu z ustreznimi tehničnimi navodili, kadar so na voljo.
BIOCIDAL PRODUCT-TYPES AND THEIR DESCRIPTIONS AS REFERRED TO IN ARTICLE 2(1)
VRSTE BIOCIDNIH PROIZVODOV IN NJIHOVI OPISI, KOT JE NAVEDENO V ČLENU 2(1)
MAIN GROUP 1:
GLAVNA SKUPINA 1:
Disinfectants
razkužila
These product-types exclude cleaning products that are not intended to have a biocidal effect, including washing liquids, powders and similar products.
Te vrste proizvodov ne obsegajo čistilnih sredstev, ki nimajo biocidnega učinka, kar velja tudi za tekočino za pomivanje, pralni prašek in podobne proizvode.
Product-type 1: Human hygiene
Vrsta proizvodov 1: človekova osebna higiena
Products in this group are biocidal products used for human hygiene purposes, applied on or in contact with human skin or scalps for the primary purpose of disinfecting the skin or scalp.
Proizvodi v tej skupini so biocidni proizvodi, ki se uporabljajo za človekovo osebno higieno bodisi z nanosom na kožo ali lasišče bodisi s stikom z njima, in sicer predvsem zaradi razkuževanja kože ali lasišča.
Product-type 2: Disinfectants and algaecides not intended for direct application to humans or animals
Vrsta proizvodov 2: razkužila in algicidi, ki niso namenjeni neposredni uporabi na ljudeh ali živalih
Products used for the disinfection of surfaces, materials, equipment and furniture which are not used for direct contact with food or feeding stuffs.
Proizvodi, ki se uporabljajo za razkuževanje površin, materialov, opreme in pohištva ter se ne uporabljajo v neposrednem stiku s hrano ali krmo.
Usage areas include, inter alia, swimming pools, aquariums, bathing and other waters; air conditioning systems; and walls and floors in private, public, and industrial areas and in other areas for professional activities.
Uporabljajo se med drugim v plavalnih bazenih, akvarijih, kopalni in drugih vodah, klimatskih napravah ter na stenah in tleh zasebnih, javnih in industrijskih površin, pa tudi na drugih območjih za poklicne dejavnosti.
Products used for disinfection of air, water not used for human or animal consumption, chemical toilets, waste water, hospital waste and soil.
Proizvodi, ki se uporabljajo za razkuževanje zraka, vode, ki ni namenjena uživanju za ljudi in živali, kemičnih stranišč, odpadnih voda, bolnišničnih odpadkov in prsti.
Products used as algaecides for treatment of swimming pools, aquariums and other waters and for remedial treatment of construction materials.
Proizvodi, ki se uporabljajo kot algicidi v plavalnih bazenih, akvarijih in drugih vodah ter za sanacijo gradbenega materiala.
Products used to be incorporated in textiles, tissues, masks, paints and other articles or materials with the purpose of producing treated articles with disinfecting properties.
Proizvodi, ki se uporabljajo tako, da se z njimi prepojijo tekstil, higienski papir, maske, barvila in drugi izdelki ali materiali, da bi proizvedeni tretirani izdelki delovali razkužilno.
Product-type 3: Veterinary hygiene
Vrsta proizvodov 3: veterinarska higiena
Products used for veterinary hygiene purposes such as disinfectants, disinfecting soaps, oral or corporal hygiene products or with anti-microbial function.
Proizvodi, ki se uporabljajo za veterinarsko higienske namene, kot so razkužila, razkužilna mila, proizvodi za higieno ust ali telesa ali z antimikrobiološkim učinkom.
Products used to disinfect the materials and surfaces associated with the housing or transportation of animals.
Proizvodi, ki se uporabljajo za razkuževanje materialov in površin, povezanih z nastanitvijo ali prevozom živali.
Product-type 4: Food and feed area
Vrsta proizvodov 4: za območja s hrano in krmo
Products used for the disinfection of equipment, containers, consumption utensils, surfaces or pipework associated with the production, transport, storage or consumption of food or feed (including drinking water) for humans and animals.
Proizvodi, ki se uporabljajo za razkuževanje opreme, posod, posod za hrano, orodja, površin ali cevovodov, ki so povezani s proizvodnjo, prevozom, skladiščenjem ali uživanjem hrane ali krme (vključno s pitno vodo) za ljudi in živali.
Products used to impregnate materials which may enter into contact with food.
Proizvodi, ki se uporabljajo za impregnacijo materialov, ki lahko pridejo v stik s hrano.
Product-type 5: Drinking water
Vrsta proizvodov 5: pitna voda
Products used for the disinfection of drinking water for both humans and animals.
Proizvodi, ki se uporabljajo za razkuževanje pitne vode za ljudi in živali.
MAIN GROUP 2:
GLAVNA SKUPINA 2:
Preservatives
sredstva za konzerviranje
Unless otherwise stated these product-types include only products to prevent microbial and algal development.
Če ni drugače navedeno, vključujejo te vrste proizvodov samo proizvode, ki preprečujejo razvoj mikrobov in alg.
Product-type 6: Preservatives for products during storage
Vrsta proizvodov 6: sredstva za konzerviranje proizvodov med shranjevanjem
Products used for the preservation of manufactured products, other than foodstuffs, feedingstuffs, cosmetics or medicinal products or medical devices by the control of microbial deterioration to ensure their shelf life.
Proizvodi, ki se uporabljajo za konzerviranje izdelkov razen hrane, krme, kozmetičnih proizvodov, zdravil ali medicinskih pripomočkov in delujejo tako, da preprečujejo kvarjenje izdelka zaradi delovanja mikrobov in s tem zagotavljajo njegov veljavni rok uporabnosti.
Products used as preservatives for the storage or use of rodenticide, insecticide or other baits.
Proizvodi, ki se uporabljajo kot konzervansi za shranjevanje ali uporabo rodenticidnih, insekticidnih ali drugih vab.
Product-type 7: Film preservatives
Vrsta proizvodov 7: sredstva za zaščito (ohranitev) prevlek
Products used for the preservation of films or coatings by the control of microbial deterioration or algal growth in order to protect the initial properties of the surface of materials or objects such as paints, plastics, sealants, wall adhesives, binders, papers, art works.
Proizvodi, ki se uporabljajo za ohranjanje zaščitnih prevlek ali premazov in delujejo tako, da preprečujejo kvarjenje izdelka zaradi delovanja mikrobov ali rasti alg, da bi zaščitili prvotne lastnosti površine materiala ali predmetov, kot so barve, plastika, tesnilna sredstva, stenska veziva, veziva, papirni izdelki in umetniška dela.
Product-type 8: Wood preservatives
Vrsta proizvodov 8: sredstva za zaščito lesa
Products used for the preservation of wood, from and including the saw-mill stage, or wood products by the control of wood-destroying or wood-disfiguring organisms, including insects.
Proizvodi, ki se uporabljajo za zaščito lesa ne glede na stopnjo predelave, vključno z lesom na žagi, ali preprečujejo razvoj organizmov, ki uničujejo ali kvarijo les, vključno z žuželkami.
This product-type includes both preventive and curative products.
Med te izdelke spadajo preventivna sredstva in sredstva za sanacijo.
Product-type 9: Fibre, leather, rubber and polymerised materials preservatives
Vrsta proizvodov 9: proizvodi za zaščito vlaken, usnja, gume in polimeriziranih materialov
Products used for the preservation of fibrous or polymerised materials, such as leather, rubber or paper or textile products by the control of microbiological deterioration.
Proizvodi, ki se uporabljajo za zaščito vlaknastih ali polimeriziranih materialov, na primer izdelkov iz usnja, gume ali papirja ali tekstilnih izdelkov s preprečevanjem kvarjenja zaradi mikrobov.
This product-type includes biocidal products which antagonise the settlement of micro-organisms on the surface of materials and therefore hamper or prevent the development of odour and/or offer other kinds of benefits.
Ta vrsta proizvodov vključuje biocidne proizvode, ki preprečujejo naselitev mikroorganizmov na površini materialov in zato ovirajo ali preprečujejo nastanek neprijetnega vonja in/ali prinašajo druge vrste koristi.
Product-type 10: Construction material preservatives
Vrsta proizvodov 10: sredstva za zaščito gradbenega materiala
Products used for the preservation of masonry, composite materials, or other construction materials other than wood by the control of microbiological, and algal attack.
Proizvodi, ki se uporabljajo za zaščito zidarskih proizvodov, sestavljenih materialov ali drugega gradbenega materiala razen lesa in preprečujejo mikrobno delovanje in naseljevanje alg.
Product-type 11: Preservatives for liquid-cooling and processing systems
Vrsta proizvodov 11: proizvodi za zaščito sistemov hladilnih tekočin in predelovalnih sistemov
Products used for the preservation of water or other liquids used in cooling and processing systems by the control of harmful organisms such as microbes, algae and mussels.
Proizvodi, ki se uporabljajo za konzerviranje vode ali drugih tekočin za rabo v hladilnih in predelovalnih sistemih, in sicer s preprečevanjem razvoja škodljivih organizmov, kot so mikrobi, alge in školjke.
Products used for the disinfection of drinking water or of water for swimming pools are not included in this product-type.
Proizvodi, ki se uporabljajo za razkuževanje pitne vode ali vode v plavalnih bazenih, niso vključeni v to vrsto proizvodov.
Product-type 12: Slimicides
Vrsta proizvodov 12: slimicidi
Products used for the prevention or control of slime growth on materials, equipment and structures, used in industrial processes, e.g. on wood and paper pulp, porous sand strata in oil extraction.
Proizvodi, ki se uporabljajo za preprečevanje ali nadzor nastajanja sluzi na materialih, opremi ali konstrukcijah, ki se uporabljajo v industrijskih postopkih, na primer pri lesni ali papirni kaši, pri poroznih peščenih slojih pri pridobivanju naftnih derivatov.
Product-type 13: Working or cutting fluid preservatives
Vrsta proizvodov 13: sredstva za zaščito tekočin, ki se uporabljajo pri rezanju ali obdelavi materialov
Products to control microbial deterioration in fluids used for working or cutting metal, glass or other materials.
Proizvodi, ki preprečujejo kvarjenje tekočin, ki se uporabljajo pri rezanju ali obdelavi kovin, stekla ali drugih materialov, zaradi delovanja mikrobov.
MAIN GROUP 3:
GLAVNA SKUPINA 3:
Pest control
nadzor škodljivcev
Product-type 14: Rodenticides
Vrsta proizvodov 14: rodenticidi
Products used for the control of mice, rats or other rodents, by means other than repulsion or attraction.
Proizvodi, ki se uporabljajo za nadzor miši, podgan ali drugih glodavcev, vendar ne z njihovim odganjanjem ali privabljanjem.
Product-type 15: Avicides
Vrsta proizvodov 15: avicidi
Products used for the control of birds, by means other than repulsion or attraction.
Proizvodi, ki se uporabljajo za nadzor ptic, vendar ne z njihovim odganjanjem ali privabljanjem.
Product-type 16: Molluscicides, vermicides and products to control other invertebrates
Vrsta proizvodov 16: moluskicidi, vermicidi in proizvodi za nadzor drugih nevretenčarjev
Products used for the control of molluscs, worms and invertebrates not covered by other product-types, by means other than repulsion or attraction.
Proizvodi, ki se uporabljajo za nadzor mehkužcev, črvov in nevretenčarjev ter niso vključeni v druge vrste proizvodov, vendar ne z njihovim odganjanjem ali privabljanjem.
Product-type 17: Piscicides
Vrsta proizvodov 17: piskicidi
Products used for the control of fish, by means other than repulsion or attraction.
Proizvodi, ki se uporabljajo za nadzor rib, vendar ne z njihovim odganjanjem ali privabljanjem.
Product-type 18: Insecticides, acaricides and products to control other arthropods
Vrsta proizvodov 18: insekticidi, akaricidi in proizvodi za nadzor drugih členonožcev
Products used for the control of arthropods (e.g. insects, arachnids and crustaceans), by means other than repulsion or attraction.
Proizvodi, ki se uporabljajo za nadzor členonožcev (npr. žuželk, pajkov in rakov), vendar ne z njihovim odganjanjem ali privabljanjem.
Product-type 19: Repellents and attractants
Vrsta proizvodov 19: repelenti in atraktanti
Products used to control harmful organisms (invertebrates such as fleas, vertebrates such as birds, fish, rodents), by repelling or attracting, including those that are used for human or veterinary hygiene either directly on the skin or indirectly in the environment of humans or animals.
Proizvodi, ki se neposredno ali posredno uporabljajo za nadzor škodljivih organizmov (nevretenčarjev, kot so bolhe, in vretenčarjev, kot so ptice, ribe, glodavci) z odganjanjem ali privabljanjem, vključno s sredstvi za higieno ljudi ali živali, ki se uporabljajo bodisi neposredno na koži bodisi posredno v človeškem ali živalskem okolju.
Product-type 20: Control of other vertebrates
Vrsta proizvodov 20: nadzor drugih vretenčarjev
Products used for the control of vertebrates other than those already covered by the other product-types of this main group, by means other than repulsion or attraction.
Proizvodi, ki se uporabljajo za nadzor vretenčarjev in niso vključeni v druge vrste proizvodov te glavne skupine, vendar ne z njihovim odganjanjem ali privabljanjem.
MAIN GROUP 4:
GLAVNA SKUPINA 4:
Other biocidal products
drugi biocidni proizvodi