natgillin/translations-raw huggingface dataset:
Proizvodi, ki se uporabljajo za zaščito vlaknastih ali polimeriziranih materialov, na primer izdelkov iz usnja, gume ali papirja ali tekstilnih izdelkov s preprečevanjem kvara zaradi mikrobov.
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.
Ta vrsta proizvodov vključuje sredstva, ki preprečujejo naselitev mikroorganizmov na površini materialov in zato ovirajo ali preprečujejo nastanek neprijetnega vonja in/ali prinašajo druge prednosti.
This product-type includes agents which antagonise the settlement of micro organisms on the surface of materials and therefore hamper or avoid the development of odour and /or offer other kinds of benefits.
Vrsta proizvodov 10: sredstva za zaščito gradbenega materiala
Product-type 10: Construction material preservatives
Proizvodi, ki se uporabljajo za zaščito zidarskih proizvodov, sestavljenih materialov ali drugega gradbenega materiala razen lesa in preprečujejo mikrobno delovanje in naseljevanje alg.
Products used for the preservation of masonry, composite materials, or other construction materials other than wood by the control of microbiological, and algal attack.
Vrsta proizvodov 11: proizvodi za zaščito sistemov hladilnih tekočin in predelovalnih sistemov
Product-type 11: Preservatives for liquid-cooling and processing systems
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 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 razkuževanje pitne vode ali vode v plavalnih bazenih, niso vključeni v to vrsto proizvodov.
Products used for the disinfection of drinking water or of water for swimming pools are not included in this product type.
Vrsta proizvodov 12: Sredstva za preprečevanje nastajanja sluzi (slimicidi)
Product-type 12: Slimicides
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.
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.
Vrsta proizvodov 13: sredstva za zaščito tekočin, ki se uporabljajo pri rezanju ali obdelavi materialov
Product-type 13: Working or cutting fluid preservatives
Proizvodi, ki preprečujejo kvarjenje tekočin, ki se uporabljajo pri rezanju ali obdelavi kovin, stekla ali drugih materialov, zaradi delovanja mikrobov.
Products to control microbial deterioration in fluids used for working or cutting metal, glass or other materials.
GLAVNA SKUPINA 3: nadzor škodljivcev
MAIN GROUP 3: Pest control
Vrsta proizvodov 14: rodenticidi
Product-type 14: Rodenticides
Proizvodi, ki se uporabljajo za nadzor miši, podgan ali drugih glodavcev, vendar ne z njihovim odganjanjem ali privabljanjem.
Products used for the control of mice, rats or other rodents, by means other than repulsion or attraction.
Vrsta proizvodov 15: avicidi
Product-type 15: Avicides
Proizvodi, ki se uporabljajo za nadzor ptic, vendar ne z njihovim odganjanjem ali privabljanjem.
Products used for the control of birds,by means other than repulsion or attraction.
Vrsta proizvodov 16: moluskicidi, vermicidi in proizvodi za nadzor drugih nevretenčarjev
Product-type 16: Molluscicides, vermicides and products to control other invertebrates
Proizvodi, ki se uporabljajo za nadzor mehkužcev, črvov in nevretenčarjev ter niso vključeni v druge vrste proizvodov, vendar ne z njihovim odganjanjem ali privabljanjem.
Products used for the control of molluscs, worms and invertebrates not covered by other product types, by means other than repulsion or attraction.
Vrsta proizvodov 17: piskicidi
Product-type 17: Piscicides
Proizvodi, ki se uporabljajo za nadzor rib, vendar ne z njihovim odganjanjem ali privabljanjem.
Products used for the control of fish,by means other than repulsion or attraction.
Vrsta proizvodov 18: insekticidi, akaricidi in proizvodi za nadzor drugih členonožcev
Product-type 18: Insecticides, acaricides and products to control other arthropods
Vrsta proizvodov 19: repelenti in sredstva za privabljanje (atraktanti)
Product-type 19: Repellents and attractants
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 človekovem ali živalskem okolju.
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 man or animals.
Vrsta proizvodov 20: nadzor drugih vretenčarjev
Product-type 20: Control of other vertebrates
Proizvodi, ki se uporabljajo za nadzor vretenčarjev in niso vključeni v druge vrste proizvodov te glavne skupine, vendar ne z njihovim odganjanjem ali privabljanjem.
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..
GLAVNA SKUPINA 4: Drugi biocidni proizvodi
MAIN GROUP 4: Other biocidal products
Vrsta proizvodov 21: proizvodi za preprečevanje naselitve organizmov na površini, ki je v stiku z vodo (antivegetacijska sredstva)
Product-type 21: Antifouling products
Proizvodi za preprečevanje rasti in naselitve neželenih organizmov (mikrobov in rastlinskih ali živalskih vrst) na plovilih, opremi za vodno kulturo in drugih objektih in konstrukcijah, ki se uporabljajo v vodi.
Products used to control the growth and settlement of fouling organisms (microbes and higher forms of plant or animal species) on vessels, aquaculture equipment or other structures used in water.
Vrsta proizvodov 22: Tekočine za balzamiranje in prepariranje
Product-type 22: Embalming and taxidermist fluids
Proizvodi, ki se uporabljajo za razkuževanje in ohranjanje človeških ali živalskih trupel ali njihovih delov.
Products used for the disinfection and preservation of human or animal corpses, or parts thereof.
SPLOŠNA NAČELA ZA OCENJEVANJE DOKUMENTACIJE ZA BIOCIDNE PROIZVODE
COMMON PRINCIPLES FOR THE EVALUATION OF DOSSIERS FOR BIOCIDAL PRODUCTS
Izrazi in opredelitve pojmov
Terms and Definitions
Učinki na zdravje človeka in živali
Effects on human and animal health
Učinki na ciljne organizme
Effects on target organisms
Povezovanje ugotovitev v celoto
Overall integration of conclusions
IZRAZI IN OPREDELITVE POJMOV
TERMS AND DEFINITIONS
Skladnost z merili iz člena 19(1)(b)
Correspondence with the criteria set out in Article 19(1)(b)
Podnaslovi „Učinki na zdravje človeka in živali“, „Vplivi na okolje“, „Učinki na ciljne organizme“ in „Učinkovitost“ iz oddelkov „Ocena“ in „Ugotovitve“ ustrezajo naslednjim štirim merilom iz člena 19(1)(b):
The subheadings ‘Effects on human and animal health’, ‘Effects on the Environment’, ‘Effects on Target Organisms’ and ‘Efficacy’ used in the sections ‘Assessment’ and ‘Conclusions’ correspond to the four criteria set out in Article 19(1)(b) as follows:
„Učinkovitost“ ustreza merilu (i): „je dovolj učinkovit“.
‘Efficacy’ corresponds to criterion (i): ‘is sufficiently effective’.
„Učinki na ciljne organizme“ ustreza merilu (ii): „nima nesprejemljivih učinkov na ciljne organizme, predvsem nesprejemljive odpornosti ali navzkrižne odpornosti ali nepotrebnega trpljenja in bolečine pri vretenčarjih“.
‘Effects on Target Organisms’ corresponds to criterion (ii): ‘has no unacceptable effects on target organisms, in particular unacceptable resistance or cross resistance or unnecessary suffering and pain for vertebrates’.
„Učinki na zdravje človeka in živali“ ustreza merilu (iii): „sam po sebi ali njegovi ostanki nimajo takojšnjih ali zapoznelih nesprejemljivih učinkov na zdravje človeka in živali, vključno z ranljivimi skupinami Glej opredelitev ranljivih skupin v členu 3.
‘Effects on human and animal health’ corresponds to criterion (iii): ‘has no immediate or delayed unacceptable effects itself or as a result of its residues on human and animal health, including that of vulnerable groups See definition of vulnerable groups in Article 3.
, bodisi neposredno ali prek pitne vode, hrane, krme, zraka ali prek drugih posrednih učinkov“.
either directly or through drinking water, food, feed, air or through other indirect effects’.
njegovo usodo in porazdelitev v okolju,
its fate and distribution in the environment;
onesnaženje površinskih voda (vključno s somornico in morsko vodo), podtalnice in pitne vode, zraka ter tal ob upoštevanju lokacij, oddaljenih od kraja uporabe snovi zaradi prenosa v okolju na velike razdalje,
contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil taking into account locations distant from its use following long-range environmental transportation;
njegov vpliv na neciljne organizme,
its impact on non-target organisms;
njegov vpliv na biotsko raznovrstnost in ekosistem“.
its impact on biodiversity and the ecosystem’.
Tehnične opredelitve
Technical Definitions
Je ugotavljanje neželenih učinkov, ki jih biocidni proizvod lahko povzroči zaradi svojih lastnosti.
This is the identification of the adverse effects which a biocidal product has an inherent capacity to cause.
Je ocena razmerja med odmerkom ali stopnjo izpostavljenosti aktivne snovi ali pogojno nevarne snovi v biocidnem proizvodu ter resnostjo učinka.
This is the estimate of the relationship between the dose, or level of exposure, of an active substance or substance of concern in a biocidal product and the incidence and severity of an effect.
Je opis emisij, poti in hitrosti prehajanja aktivne snovi ali pogojno nevarne snovi v biocidnem proizvodu ter njene preobrazbe ali razgradnje, da se oceni razmerje med koncentracijo in odmerki, ki so jim ali so jim lahko izpostavljene populacije ljudi, živali ali ekosistemi.
This is the determination of the emissions, pathways and rates of movement of an active substance or a substance of concern in a biocidal product and its transformation or degradation in order to estimate the concentration/doses to which human populations, animals or environmental compartments are or may be exposed.
Je ocena pojava in resnosti neželenih učinkov, za katere obstaja verjetnost, da bi se pojavili pri populaciji ljudi, živali ali v ekosistemih zaradi dejanske ali predvidene izpostavljenosti aktivni snovi ali pogojno nevarni snovi v biocidnem proizvodu.
This is the estimation of the incidence and severity of the adverse effects likely to occur in a human population, animals or environmental compartments due to actual or predicted exposure to any active substance or substance of concern in a biocidal product.
Ta ocena lahko zajema „oceno tveganja“, torej količinsko oceno verjetnosti.
This may include ‘risk estimation’ i.e. the quantification of that likelihood.
Voda, vključno z usedlinami, zrak, zemlja, prosto živeče vrste živali in rastline ter vsa medsebojna razmerja med njimi kot tudi vsa razmerja z živimi organizmi.
Water, including sediment, air, soil, wild species of fauna and flora, and any interrelationship between them, as well as any relationship with living organisms.
V tej prilogi so določena splošna načela za ocenjevanje dokumentacije za biocidne proizvode iz člena 19(1)(b).
This Annex sets out the common principles for the evaluation of dossiers for biocidal products referred to in Article 19(1)(b).
Država članica ali Komisija sprejme sklep o izdaji dovoljenja za biocidni proizvod na podlagi pogojev, določenih v členu 19, ob upoštevanju ocene, opravljene v skladu s to prilogo.
A decision by a Member State or the Commission to authorise a biocidal product shall be taken on the basis of the conditions set down in Article 19 taking account of the evaluation carried out according to this Annex.
Podrobne tehnične smernice o uporabi te priloge so na voljo na spletnem mestu Agencije.
Detailed technical guidance regarding the application of this Annex is available on the web-site of the Agency.
Načela iz te priloge se lahko v celoti uporabljajo za ocenjevanje biocidnih proizvodov, ki jih sestavljajo kemične snovi.
The principles set out in this Annex can be applied in their entirety to the evaluation of biocidal products comprised of chemical substances.
Za biocidne proizvode, ki vsebujejo mikroorganizme, bi morali ta načela bolj podrobno opisati v tehničnih smernicah, pri čemer bi bilo treba upoštevati pridobljene praktične izkušnje, ter jih uporabljati ob upoštevanju narave proizvoda in najnovejših znanstvenih dognanj.
For biocidal products containing micro-organisms, these principles should be further developed in technical guidance taking into account practical experience gained, and be applied taking into account the nature of the product and the latest scientific information.
Tudi za biocidne proizvode, ki vsebujejo nanomateriale, bo treba načela iz te priloge prilagoditi in podrobneje opredeliti v tehničnih smernicah, da bi upoštevali najnovejša znanstvena dognanja.
In the case of biocidal products containing nanomaterials the principles set out in this Annex will also need to be adapted and elaborated in technical guidance to take account of the latest scientific information.
Ocena tveganja je vedno obvezna za aktivno snov ali snovi, ki je oz. so prisotne v biocidnem proizvodu.
A risk assessment on the active substance(s) present in the biocidal product is always required.
Po takšni oceni tveganja se opredeli nevarnost in opravi, če je primerno, ocena razmerja med odmerkom (koncentracijo) in odzivom (učinkom) ter ocena izpostavljenosti in pripravi opis tveganja.
This risk assessment shall entail hazard identification, and, as appropriate, dose (concentration) - response (effect) assessment, exposure assessment and risk characterisation.
Če kvantitativna ocena tveganja ni mogoča, se pripravi kvalitativna ocena.
Where a quantitative risk assessment cannot be made a qualitative assessment shall be produced.
Na enak način, kot je opisano zgoraj, se izvedejo dodatne ocene tveganja za vse pogojno nevarne snovi, ki so prisotne v biocidnem proizvodu.
Additional risk assessments shall be carried out, in the same manner as described above, on any substance of concern present in the biocidal product.
Po potrebi se upoštevajo podatki, predloženi v okviru Uredbe (ES) št. 1907/2006.
Information submitted in the framework of Regulation (EC) No 1907/2006 shall be taken into account where appropriate.
Za oceno tveganja so potrebni podatki, ki so podrobno opisani v prilogah II in III in pri katerih se upošteva dejstvo, da obstajajo različne vrste uporabe in proizvodov, kar vpliva na tveganja, povezana z njimi.
These data are detailed in Annexes II and III and take account of the fact that there are a wide variety of applications as well as different product types and that this has an impact on the associated risks.
Organ za ocenjevanje upošteva zahteve iz členov 6, 21 in 62, da bi se izognil podvajanju predloženih podatkov.
The evaluating body shall take due consideration of the requirements of Article 6, Article 21 and Article 62 in order to avoid duplication of data submissions.
Zahtevajo se lahko tudi podatki za pogojno nevarne snovi v biocidnem proizvodu.
Data may also be required on a substance of concern present in a biocidal product.
Pri aktivnih snoveh, nastalih na kraju samem, ocena tveganja vključuje tudi morebitna tveganja predhodne(-ih) sestavine (prekurzorja(-ev)).
In case of in-situ generated active substances the risk assessment includes also the possible risks from the precursor(s).
Rezultate ocen tveganja, ki se opravijo za aktivno snov in pogojno nevarne snovi v biocidnem proizvodu, je treba združiti v skupno oceno za biocidni proizvod.
The results of the risk assessments carried out on an active substance and on substances of concern present in the biocidal product shall be integrated to produce an overall assessment for the biocidal product itself.
Organ za ocenjevanje pri ocenjevanju biocidnega proizvoda:
When making evaluations of a biocidal product the evaluating body shall:
upošteva druge primerne tehnične informacije ali znanstvena dognanja, ki so na voljo v zvezi z lastnostmi biocidnega proizvoda, njegovimi sestavinami, metaboliti ali ostanki,
take into consideration other relevant technical or scientific information which is reasonably available to them with regard to the properties of the biocidal product, its components, metabolites, or residues;
po potrebi oceni utemeljitve, ki jih je vlagatelj predložil, kadar ni priskrbel določenih podatkov.
evaluate, where relevant, justifications submitted by the applicant for not supplying certain data.
Uporaba teh splošnih načel, kadar so povezani z drugimi pogoji iz člena 19, naj pristojne organe ali Komisijo vodi pri odločanju, ali naj izda dovoljenje za biocidni proizvod ali ne; v dovoljenju so lahko tudi omejitve glede uporabe ali drugi pogoji.
The application of these common principles shall when taken together with the other conditions set out in Article 19 lead to the competent authorities or the Commission deciding whether or not a biocidal product can be authorised, such authorisation may include restrictions on use or other conditions.
V določenih primerih država članica lahko sklene, da potrebuje več podatkov, preden lahko sprejme odločitev o izdaji dovoljenja.
In certain cases the competent authorities may conclude that more data are required before an authorisation decision can be made.
V primeru biocidnih proizvodov z aktivnimi snovmi, ki so zajete v merilih za izključitev v členu 5(1), pristojni organi ali Komisija prav tako ocenijo, ali je mogoče izpolniti pogoje iz člena 5(2).
In the case of biocidal products containing active substances covered by the exclusion criteria in Article 5(1), the competent authorities or the Commission shall also evaluate whether the conditions of Article 5(2) can be satisfied.
Vlagatelji in organi za ocenjevanje v postopku ocenjevanja sodelujejo, da hitreje razrešijo kakršna koli vprašanja v zvezi z zahtevami glede podatkov ali da v zgodnji fazi določijo kakršne koli potrebne dodatne raziskave ali dopolnijo vse predlagane pogoje za uporabo biocidnega proizvoda ali spremenijo njegovo vrsto ali sestavo, da bi zagotovili popolno upoštevanje zahtev iz člena 19 in te priloge.
During the process of evaluation, applicants and the evaluating bodies shall cooperate in order to resolve any questions on the data requirements quickly or to identify at an early stage any additional studies required, or to amend any proposed conditions for the use of the biocidal product or to modify its nature or its composition in order to ensure full compliance with the requirements of Article 19 and of this Annex.
Upravno breme, zlasti za MSP, naj bi bilo čim manjše, pri tem pa se ne sme posegati v stopnjo zaščite, namenjene ljudem, živalim in okolju.
The administrative burden, especially for SMEs, shall be kept to the minimum necessary without prejudicing the level of protection afforded to humans, animals and the environment.
Presoje, ki jih sprejmejo organi za ocenjevanje v postopku ocenjevanja, morajo temeljiti na znanstvenih načelih, po možnosti priznanih na mednarodni ravni, in upoštevati nasvete strokovnjakov.
The judgments made by the evaluating body during the evaluation must be based on scientific principles, preferably recognised at international level, and be made with the benefit of expert advice.
Podatke, ki jih vlagatelj predloži v vlogi za izdajo dovoljenja za biocidni proizvod, organi, pristojni za ocenjevanje ali prejem vlog, potrdijo v skladu z ustreznimi členi Uredbe.
The data submitted in support of an application for authorisation of a biocidal product shall be validated by the evaluating or receiving competent authority in accordance with the relevant Articles of the Regulation.
Po potrditvi podatkov jih pristojni organi uporabijo za oceno tveganja, ki temelji na predlagani uporabi.
After validation of these data the competent authorities shall utilise them by carrying out a risk assessment based on the proposed use.
Za aktivno snov v biocidnem proizvodu se vedno pripravi ocena tveganja.
A risk assessment on the active substance present in the biocidal product shall always be carried out.
Če so poleg tega v biocidnem proizvodu tudi druge pogojno nevarne snovi, se ocena tveganja pripravi tudi za vsako od njih.
If there are, in addition, any substances of concern present in the biocidal product then a risk assessment shall be carried out for each of these.
Ocena tveganja zajema predlagano običajno uporabo biocidnega proizvoda, skupaj z realno najslabšim možnim primerom, v katerem so zajeti vsi pomembni problemi proizvodnje in odstranjevanja.
The risk assessment shall cover the proposed normal use of the biocidal product together with a realistic worst-case scenario including any relevant production and disposal issue.
V oceni je prav tako upoštevano, kako se uporabljajo vsi „tretirani izdelki“, ki so tretirani s takšnim proizvodom ali ga vsebujejo, ter kako se jih odstranjuje.
The assessment shall also take account of how any ‘treated articles’ treated with or containing the product may be used and disposed of.
V poštev pridejo tudi aktivne snovi, nastale na kraju samem, in z njimi povezane predhodne sestavine.
Active substances that are generated in-situ and the associated precursors shall also be considered.
Agencija v sodelovanju s Komisijo, državami članicami in zainteresiranimi stranmi oblikuje in zagotavlja dodatne smernice glede znanstvenih opredelitev in metodologije za oceno kumulativnih in sinergijskih učinkov.
The Agency shall, in collaboration with the Commission, Member States and interested parties, develop and provide further guidance on the scientific definitions and methodologies for the assessment of cumulative and synergistic effects.
Za vsako aktivno in vsako pogojno nevarno snov, ki je v biocidnem proizvodu, oceni tveganja, kadar je to mogoče, sledi določitev nevarnosti in ustreznih referenčnih vrednosti za odmerek ali učinek koncentracij, kot je NOAEL, oziroma predvidenih koncentracij brez učinka (PNEC).
For each active substance and each substance of concern present in the biocidal product, the risk assessment shall entail hazard identification and the establishment of appropriate reference values for dose or effect concentrations such as NOAEL or Predicted No Effect Concentrations (PNEC), where possible.
Ocena prav tako vsebuje, kot je primerno, oceno razmerja med odmerkom (koncentracijo) in odzivom (učinkom), skupaj z oceno izpostavljenosti in opisom tveganja.
It shall also include, as appropriate, a dose (concentration) - response (effect) assessment, together with an exposure assessment and a risk characterisation.
Rezultati, pridobljeni s primerjavo izpostavljenosti ustreznim referenčnim vrednostim za vsako aktivno ali pogojno nevarno snov, se združijo v skupno oceno tveganja biocidnega proizvoda.
The results arrived at from a comparison of the exposure to the appropriate reference values for each of the active substances and any substances of concern shall be integrated to produce an overall risk assessment for the biocidal product.
Če kvantitativni rezultati niso na voljo, je treba združiti rezultate kvalitativnih ocen.
Where quantitative results are not available the results of the qualitative assessments shall be integrated in a similar manner.
nevarnosti zaradi fizikalno-kemijskih lastnosti,
the hazards due to the physico-chemical properties,