natgillin/translations-raw huggingface dataset:
Za vsak ekosistem se v opis tveganja, če je le mogoče, vključi primerjava PEC s PNEC, tako da je mogoče izračunati razmerje PEC/PNEC.
For any given environmental compartment, the risk characterisation shall, as far as possible, entail comparison of the PEC with the PNEC so that a PEC/PNEC ratio may be derived.
Če razmerja PEC/PNEC ni mogoče izračunati, sledi opisu tveganja kvalitativna ocena verjetnosti, da obstaja učinek v sedanjih pogojih izpostavljenosti ali da se bo tak učinek v pričakovanih pogojih izpostavljenosti pojavil.
If it has not been possible to derive a PEC/PNEC ratio, the risk characterisation shall entail a qualitative evaluation of the likelihood that an effect is occurring under the current conditions of exposure or will occur under the expected conditions of exposure.
Nesprejemljivi vplivi
Unacceptable effects
Pristojnim organom se predloži podatke, ki jih ta ovrednoti, da oceni, ali biocidni pripravek pri svojem učinkovanju ne povzroča nepotrebnega trpljenja
Data shall be submitted to and evaluated by the competent authorities to assess whether the biocidal product does not cause unnecessary suffering
in bolečine
and pain
pri ciljnih vretenčarjih.
in its effect on target vertebrates.
V to je zajeta ocena mehanizma, s katerim se učinek doseže, ter opaženi vplivi na obnašanje in zdravje ciljnih vretenčarjev; če je načrtovani učinek ubiti ciljnega vretenčarja, se oceni čas, ki je potreben, da nastopi smrt, in pogoje, v katerih nastopi smrt.
This shall include an evaluation of the mechanism by which the effect is obtained and the observed effects on the behaviour and health of the target vertebrates; where the intended effect is to kill the target vertebrate the time necessary to obtain the death of the target vertebrate and the conditions under which death occurs shall be evaluated.
Pristojni organi, kadar je to primerno, ocenijo možnost, da se pri ciljnem organizmu razvije odpornost na aktivno snov v biocidnem pripravku.
The competent authorities shall, where relevant, evaluate the possibility of the development of resistance to an active substance in the biocidal product by the target organism.
Če obstajajo znaki, da lahko nastanejo drugi nesprejemljivi učinki, pristojni organi preučijo in ocenijo verjetnost pojava takih učinkov.
If there are indications that any other unacceptable effects may occur the competent authorities shall evaluate the possibility of such effects occurring.
Primer takega neželenega učinka je neželena reakcija na kovinsko opremo , ki se uporablja v lesu po nanosu sredstva za zaščito lesa.
An example of such an unacceptable effect would be an adverse reaction to fastenings and fittings used in wood following the application of a wood preservative.
Predloži in oceni se podatke, da bi ugotovili, ali je mogoče trditve o učinkovitosti biocidnega pripravka utemeljiti.
Data shall be submitted and evaluated to ascertain if the efficacy claims of the biocidal product can be substantiated.
Podatki, ki jih predloži predlagatelj ali ki jih imajo pristojni organi ali Agencija, morajo prikazati učinkovitost biocidnega pripravka na ciljne organizme pri normalni uporabi v skladu s pogoji za izdajo dovoljenja.
Data submitted by the applicant or held by the competent authorities or the Agency must be able to demonstrate the efficacy of the biocidal product against the target organism when used normally in accordance with the conditions of authorisation.
Preskuse je treba opraviti v skladu s smernicami Unije, če so te na voljo in se uporabljajo.
Testing should be carried out according to Union guidelines if these are available and applicable.
Kjer je to primerno, se lahko uporabljajo druge metode, kot je prikazano na seznamu spodaj.
Where appropriate, other methods can be used as shown in the list below.
Če obstajajo ustrezni sprejemljivi podatki raziskav na prostem, jih je mogoče uporabiti in sicer:
If relevant acceptable field data exist, these can be used.
ISO, CEN ali druge mednarodne standardne metode
ISO, CEN or other international standard method
nacionalno standardno metodo
national standard method
standardno metodo v industriji (ki so jo sprejeli pristojni organi ali Agencija)
industry standard method (accepted by competent authorities or the Agency)
standardno metodo posameznega proizvajalca (ki so jo sprejeli pristojni organi ali Agencija)
individual producer standard method (accepted by competent authorities or the Agency)
podatke iz dejanskega razvoja biocidnega pripravka (ki so jih sprejeli pristojni organi ali Agencija).
data from the actual development of the biocidal product (accepted by competent authorities or the Agency).
Na vsakem področju, kjer so bile opravljene ocene tveganja, to so vplivi na človeka, živali in okolje, pristojni organi združijo rezultate za aktivno snov z rezultati za vsako pogojno nevarno snov, in tako pripravijo skupno oceno za biocidni pripravek.
In each of the areas where risk assessments have been carried out, i.e. effects on man, animals, and the environment, the competent authorities shall combine the results for the active substance together with the results for any substance of concern to produce an overall assessment for the biocidal product itself.
Pri tem je treba upoštevati vse možne sinergične učinke aktivne snovi (aktivnih snovi) in pogojno nevarnih snovi, ki so v biocidnem pripravku.
This should take account of any likely synergistic effects of the active substance(s) and substances of concern in the biocidal product.
Pri biocidnih pripravkih, ki vsebujejo več kot eno aktivno snov, je treba upoštevati tudi kombinacijo neželenih učinkov, da bi dobili skupni učinek biocidnega pripravka.
For biocidal products containing more than one active substance any adverse effects shall also be combined to produce an overall effect for the biocidal product itself.
Ob upoštevanju točke 90 pristojni organi ali Komisija sprejmejo odločitev o izdaji dovoljenja za biocidni pripravek na podlagi povezovanja tveganja, ki ga povzročajo posamezne aktivne snovi, s tveganji zaradi pogojno nevarnih snovi v biocidnem pripravku.
Subject to point 90, the competent authorities or the Commission shall come to a decision regarding the authorisation for use of a biocidal product as a result of the integration of the risks arising from each active substance together with the risks from each substance of concern present in the biocidal product.
Ocene tveganja vključujejo normalno uporabo biocidnega pripravka skupaj z resnično najslabšim možnim primerom, v katerega so vključeni vsi pomembni problemi v zvezi z odstranjevanjem samega biocidnega pripravka ali materiala, ki je bil obdelan s tem pripravkom.
The risk assessments shall cover normal use of the biocidal product together with a realistic worst-case scenario including any relevant disposal issue either of the biocidal product itself or any material treated with it.
Pri odločitvi o izdaji dovoljenja pristojni organi ali Komisija sprejmejo enega od naslednjih sklepov za vsako vrsto pripravka in za vsako področje uporabe biocidnega pripravka, za katerega je bila vložena vloga za izdajo dovoljenja:
In making a decision concerning authorisation, the competent authorities or the Commission shall arrive at one of the following conclusions for each product type and for each area of use of the biocidal product for which application has been made:
za biocidni pripravek ni mogoče izdati dovoljenja;
the biocidal product cannot be authorised;
za biocidni pripravek je dovoljenje mogoče izdati pod določenimi pogoji/omejitvami;
the biocidal product can be authorised subject to specific conditions/restrictions;
pred sprejemom odločitve o izdaji dovoljenja je potrebno več podatkov.
more data is required before a decision on authorisation can be made.
Če pristojni organi ali Komisija sprejmejo sklep, da se, preden je mogoče sprejeti odločitev o izdaji dovoljenja, zahtevajo dodatni podatki ali informacije, se potreba po dodatnih podatkih ali informacijah utemelji.
If the conclusion arrived at by the competent authorities or the Commission is that additional information or data are required before an authorisation decision can be made, then the need for any such information or data shall be justified.
Take dodatne informacije ali podatki so minimalni potrebni podatki za izvedbo nadaljnje ustrezne ocene tveganja.
This additional information or data shall be the minimum necessary to carry out a further appropriate risk assessment.
Pristojni organi ali Komisija dovolijo uporabo le tistih biocidnih pripravkov, ki, kadar se uporabljajo v skladu s pogoji v izdanem dovoljenju, ne pomenijo nesprejemljivega tveganja za ljudi, živali ali okolje, ki so učinkoviti in vsebujejo aktivne snovi, ki jih je na ravni Unije dovoljeno uporabljati v takih biocidnih pripravkih.
The competent authorities or the Commission shall only grant authorisation to those biocidal products which, when used according to their conditions of authorisation, do not present an unacceptable risk to humans, animals or the environment, are efficacious and which contain active substances permitted at Union level to be used in such biocidal products.
Pristojni organi ali Komisija pri izdaji dovoljenja določijo, kadar je to primerno, pogoje ali omejitve.
The competent authorities or the Commission shall impose, where appropriate, conditions or restrictions when giving authorisations.
Vrsta in zahtevnost pogojev ali omejitev se določi na osnovi pričakovanih koristi in tveganj in mora ustrezati vrsti in obsegu pričakovanih koristi in tveganj za katere je verjetno, da se bodo pojavili zaradi uporabe biocidnega pripravka.
The nature and severity of these shall be selected on the basis of, and be appropriate to, the nature and extent of the expected advantages and the risks likely to arise from the use of the biocidal product.
V postopku odločanja pristojni organi ali Komisija upoštevajo zlasti naslednje:
In the decision-making process the competent authorities or the Commission shall take into consideration the following:
rezultate ocene tveganja, zlasti razmerje med izpostavljenostjo in učinkom,
the results of the risk assessment, in particular the relationship between exposure and effect,
vrsto in resnost učinka
the nature and severity of the effect,
obvladovanje stopnje tveganja,
the risk management which can be applied,
področje uporabe biocidnega pripravka,
the field of use of the biocidal product,
učinkovitost biocidnega pripravka,
the efficacy of the biocidal product,
fizikalne lastnosti biocidnega pripravka,
the physical properties of the biocidal product,
koristi, ki izhajajo iz uporabe biocidnega pripravka.
the benefits of using the biocidal product.
Pristojni organi ali Komisija pri odločanju o izdaji dovoljenja za biocidni pripravek upoštevajo stopnjo zaupanja zaradi variabilnosti podatkov, uporabljenih v postopku ocenjevanja in odločanja.
The competent authorities or the Commission shall, when taking a decision concerning the authorisation of a biocidal product, take into account the uncertainty arising from the variability in the data used in the evaluation and decision-making process.
Pristojni organi ali Komisija predpišejo, da se biocidni pripravki pravilno uporabljajo.
The competent authorities or the Commission shall prescribe that biocidal products shall be used properly.
Med pravilno uporabo spada uporaba učinkovitega odmerka in čim bolj racionalna uporaba biocidnega pripravka, kadar je to mogoče.
Proper use shall include application at an efficacious dose and minimisation of use of biocidal products where possible.
Pristojni organi ali Komisija ne izdajo dovoljenja za biocidni pripravek, če se pri oceni tveganja potrdi, da pri predvideni uporabi, vključno z resnično najslabšim možnim primerom, pripravek pomeni nesprejemljivo tveganje za ljudi.
The competent authorities or the Commission shall not authorise a biocidal product if the risk assessment confirms that, in foreseeable application including a realistic worst possible scenario, the product presents an unacceptable risk to humans.
Pristojni organi ali Komisija pri odločanju o izdaji dovoljenja za biocidni pripravek preučijo možne vplive na vse populacije ljudi, t.j. na poklicne uporabnike, nepoklicne uporabnike in ljudi, ki so neposredno ali posredno izpostavljeni preko okolja.
The competent authorities or the Commission shall consider possible effects on all human populations, namely professional users, non-professional users and humans exposed directly or indirectly through the environment when making a decision on the authorisation of a biocidal product.
Pristojni organi ali Komisija preučijo razmerje med izpostavljenostjo in učinkom in to uporabi v postopku odločanja.
The competent authorities or the Commission shall examine the relationship between the exposure and the effect, and use this in the decision-making process.
Pri preučevanju tega razmerja je treba upoštevati več dejavnikov, eden najpomembnejših pa je vrsta neželenega učinka snovi.
A number of factors need to be considered when examining this relationship and one of the most important is the nature of the adverse effect of the substance.
Med take učinke sodijo akutna toksičnost, draženje, jedkost, preobčutljivost, toksičnost pri ponovljenih odmerkih, mutagenost, rakotvornost, nevrotoksičnost, toksičnost za razmnoževanje, skupaj s fizikalno-kemijskimi lastnostmi in vsemi drugimi neželenimi lastnostmi aktivne snovi ali pogojno nevarne snovi.
These effects include acute toxicity, irritancy, corrosivity, sensitisation, repeated dose toxicity, mutagenicity, carcinogenicity, neurotoxicity, reproduction toxicity together with physico-chemical properties, and any other adverse properties of the active substance or substance of concern.
Pristojni organi ali Komisija pri odločanju o izdaji dovoljenja za biocidni pripravek primerjajo, kadar je to mogoče, dobljene rezultate z rezultati iz prejšnjih ocen tveganja za enake ali podobne neželene učinke in se odločijo glede ustrezne meje varnosti (v nadaljnjem besedilu: UMV).
The competent authorities or the Commission shall, where possible, compare the results obtained with those obtained from previous risk assessments for an identical or similar adverse effect and decide on an appropriate margin of safety (MOS) when making an authorisation decision.
UMV je običajno 100, vendar je lahko ustrezna tudi UMV, višja ali nižja od 100, kar je med drugim odvisno od vrste nevarnega toksičnega učinka.
An appropriate MOS is typically 100 but an MOS higher or lower than this may be appropriate depending on, among other things, the nature of the critical toxicological effect.
Če je primerno, morajo pristojni organi ali Komisija kot pogoj za izdajo dovoljenja za pripravek predpisati uporabo osebne zaščitne opreme, kot so plinske maske, dihalne maske, delovna obleka, rokavice in zaščitna očala, da bi se zmanjšala izpostavljenost poklicnih uporabnikov.
The competent authorities or the Commission shall, if appropriate, impose, as a condition of authorisation, the wearing of personal protective equipment such as respirators, breathing-masks, overalls, gloves and goggles in order to reduce exposure for professional operators.
Taka oprema jim mora biti vedno na voljo.
Such equipment must be readily available to them.
Če bi bila uporaba zaščitne opreme edini možni način za zmanjšanje izpostavljenosti pri nepoklicnih uporabnikih, se za pripravek navadno ne izda dovoljenje za uporabo.
If for non-professional users the wearing of personal protective equipment would be the only possible method for reducing exposure, the product shall not normally be authorised.
Če razmerja med izpostavljenostjo in učinkom ni mogoče zmanjšati na sprejemljivo raven, pristojni organi ali Komisija ne smejo izdati dovoljenja za biocidni pripravek.
If the relationship between the exposure and the effect cannot be reduced to an acceptable level then no authorisation can be given by the competent authorities or the Commission for the biocidal product.
Pristojni organi ali Komisija ne izdajo dovoljenja za biocidni pripravek, če se pri oceni tveganja potrdi, da pri običajni uporabi izdelek pomeni nesprejemljivo tveganje za neciljne živali.
The competent authorities or the Commission shall not authorise a biocidal product if the risk assessment confirms that, in normal use, the biocidal product presents an unacceptable risk to non-target animals.
Pristojni organi ali Komisija pri odločanju o izdaji dovoljenja za biocidni pripravek preučijo tveganja, ki jih pripravek pomeni za živali ob upoštevanju enakih ustreznih meril, kakor so opisana v poglavju, ki obravnava vplive na ljudi.
Using the same relevant criteria as described in the section dealing with effects on humans, the competent authorities or the Commission shall consider the risks posed to animals from the biocidal product when making an authorisation decision.
Pristojni organi ali Komisija ne izdajo dovoljenja za biocidni pripravek, če ocena tveganja potrdi, da aktivna snov ali katera koli pogojno nevarna snov, razgradni ali reakcijski produkt predstavlja nesprejemljivo tveganje v katerem koli ekosistemu, vodi (vključno s sedimenti), tleh in zraku.
The competent authorities or the Commission shall not authorise a biocidal product if the risk assessment confirms that the active substance, or any substance of concern, or any degradation, or reaction product presents an unacceptable risk in any of the environmental compartments, water (including sediment), soil and air.
Sem spada tudi ocena tveganja za neciljne organizme v omenjenih ekosistemih.
This shall include the assessment of risks to non-target organisms in these compartments.
Pristojni organi ali Komisija pri odločanju o obstoju nesprejemljivega tveganja pred sprejetjem končne odločitve v skladu s točko 90, upoštevajo merila iz točk od 75 do 85.
In considering whether there is an unacceptable risk competent authorities or the Commission shall, when coming to a final decision in accordance with point 90, take into account the criteria in points 75 to 85.
Osnovno orodje, ki se uporablja v postopku odločanja, je razmerje PEC/PNEC, ali če ta ni na voljo, kvalitativna ocena tega razmerja.
The basic tool used in the decision making is the PEC/PNEC ratio or, if this is not available, a qualitative estimation.
Ustrezno se upošteva natančnost razmerja zaradi spremenljivosti podatkov, ki se uporabljajo pri meritvah koncentracije in oceni.
Due consideration shall be given to the accuracy of this ratio due to variability in the data used both in measurements of concentration and of estimation.
Pri določanju PEC je treba uporabiti najprimernejši model, ob upoštevanju obnašanja končnega stanja biocidnega pripravka v okolju.
In the determination of the PEC the most appropriate model should be used taking into account the environmental fate and behaviour of the biocidal product.
Če je razmerje PEC/PNEC za katerikoli dani ekosistem enako ali manjše od ena, se v opisu tveganja navede, da niso potrebni nadaljnji podatki in/ali preskusi.
For any given environmental compartment if the PEC/PNEC ratio is equal to or less than 1 the risk characterisation shall be that no further information and/or testing are necessary.
Če je razmerje PEC/PNEC večje od ena, pristojni organi ali Komisija na osnovi velikosti tega razmerja in na osnovi drugih ustreznih dejavnikov presodijo, ali so potrebni nadaljnji podatki in/ali preskusi, da bi pojasnili, ali je zaskrbljenost upravičena in ugotovili, ali so potrebni ukrepi za zmanjšanje tveganja in ali za pripravek sploh ni mogoče izdati dovoljenja.
If the PEC/PNEC ratio is greater than 1 the competent authorities or the Commission shall judge, on the basis of the size of that ratio and on other relevant factors, if further information and/or testing are required to clarify the concern or if risk reduction measures are necessary or if the product cannot be given an authorisation at all.
Pri tem je treba upoštevati ustrezne dejavnike, navedene v točki 37.
Relevant factors to be considered are those previously mentioned in point 37.
Pristojni organi ali Komisija ne izdajo dovoljenja za biocidni pripravek, če ima pod predlaganimi pogoji uporabe predvidena koncentracija aktivne snovi ali katere koli druge pogojno nevarne snovi, ali ustreznih presnovkov ali razgradnih ali reakcijskih produktov v vodi (ali v sedimentih) nesprejemljiv učinek na neciljne vrste v vodnem ali morskem okolju ali v rečnih ustjih, razen če ni znanstveno dokazano, da v ustreznih pogojih na prostem ni nesprejemljivih učinkov.
The competent authorities or the Commission shall not authorise a biocidal product, if under the proposed conditions of use, the foreseeable concentration of the active substance or of any other substance of concern or of relevant metabolites or breakdown or reaction products in water (or its sediments) has an unacceptable impact on non-target species in the aquatic, marine or estuarine environment unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect.
Pristojni organi ali Komisija ne izdajo dovoljenja za biocidni pripravek, če v predlaganih pogojih uporabe predvidena koncentracija aktivne snovi ali katere koli druge pogojno nevarne snovi, ali ustreznih presnovkov ali razgradnih ali reakcijskih produktov v podtalnici presega manjšo od naslednjih dveh koncentracij:
The competent authorities or the Commission shall not authorise a biocidal product if, under the proposed conditions of use, the foreseeable concentration of the active substance or of any other substance of concern or of relevant metabolites or breakdown or reaction products in groundwater exceeds the lower of the following concentrations:
največjo dovoljeno koncentracijo, določeno z Direktivo Sveta 80/778/EGS z dne 15. julija 1980 o kakovosti vode za prehranske namene UL L 229, 30.8.1980, str.
the maximum permissible concentration laid down by Council Directive 80/778/EEC of 15 July 1980 relating to the quality of water intended for human consumption OJ L 229, 30.8.1980, p.
največjo koncentracijo, določeno po postopku za vključitev aktivne snovi v Prilogo I k tej uredbi, na osnovi ustreznih podatkov, zlasti toksikoloških,
the maximum concentration as laid down following the procedure for including the active substance in Annex I to this Regulation, on the basis of appropriate data, in particular toxicological data
razen če je znanstveno dokazano, da v ustreznih razmerah na prostem nižja koncentracija ni presežena.
unless it is scientifically demonstrated that under relevant field conditions the lower concentration is not exceeded.
Pristojni organi ali Komisija ne izdajo dovoljenja za biocidni pripravek, če predvidena koncentracija aktivne snovi ali katere druge pogojno nevarne snovi, ali ustreznih presnovkov ali razgradnih ali reakcijskih produktov, ki se pričakujejo v
The competent authorities or the Commission shall not authorise a biocidal product if the foreseeable concentration of the active substance or a substance of concern or of relevant metabolites, breakdown or reaction products to be expected in
podtalnici ali
groundwater or
površinski vodi ali njenih sedimentih po uporabi biocidnega pripravka v predlaganih pogojih uporabe:
surface water or its sediments after use of the biocidal product under the proposed conditions of use:
če je površinska voda na področju ali s področja predvidene uporabe namenjena za zajetje in obdelavo/čiščenje pitne vode, presega vrednosti, določene v
exceeds, where the surface water in or from the area of envisaged use is intended for the abstraction of drinking water, the values fixed by
Direktivi Sveta 75/440/EGS z dne 16. junija 1975 o zahtevah glede kakovosti površinske vode za odvzem pitne vode v državah članicah UL L 194, 25.7.1975, str.
Council Directive 75/440/EEC of 16 June 1975 concerning the quality required of surface water intended for the abstraction of drinking water in the Member States OJ L 194, 25.7.1975, p.
Direktivi 80/778/EGS ali
Directive 80/778/EEC or
če ima nesprejemljiv učinek na neciljne vrste,
has an impact deemed unacceptable on non-target species
tvega neizpolnitev ciljev ali standardov, določenih v:
risks a non-achievement of the objectives or standards fixed by:
Direktivi 98/83/ES, ali
Directive 98/83/EC, or
Direktivi 2000/60/ES, ali
Directive 2000/60/EC or
Direktivi 2006/118/ES, ali
Directive 2006/118/EC or