natgillin/translations-raw huggingface dataset:
Ker se podatki za glodavce in druge sesalce običajno uporabljajo tudi pri ocenah za zdravje ljudi v okoljskih toksikoloških ocenah za zaščito divjih sesalcev, bi bilo treba to izrecno navesti, da bi preprečili dodatne nepotrebne preskuse na živalih.
Because it is standard to use rodent and other mammalian data developed for human health assessments in environmental toxicology assessments aimed at protecting wild mammals, this should be stated explicitly to avoid unnecessary additional animal testing.
Besedilo predlagane spremembe izhaja iz predlaganih novih zahtev EU po podatkih za fitofarmacevtska sredstva.
The language of the proposed amendment is derived from proposed new EU data requirements for plant protection products.
Priloga II – naslov 2 – 7.
Annex II – Title 2 – 7.
Učinki na zdravje človeka in živali – stolpec 3 (novo)
Effects on human and animal health – Column 3 (new)
Zahteve glede informacij v tem oddelku se lahko po potrebi prilagodijo v skladu s specifikacijami iz naslova 1 te priloge.
Information requirements in this section may be adapted as appropriate in accordance with the specifications of Title 1 of this Annex.
Prilagoditev nekaterih standardnih zahtev glede informacij za biocidne proizvode iz mikroorganizmov z dodanim pojasnilom k uvodnemu besedilu.
Adaptation of certain standard information requirements for microbial biocides through the addition of qualifying sentence to the introductory text.
Priloga II – naslov 2 – 7.2.2.2.
Annex II – Title 2 – 7.2.2.2.
Akutna toksičnost pri vdihavanju – stolpec 2 (novo)
Acute inhalatory toxicity– Column 2 (new)
Zahteva po takšnih študijah z več kot enim načinom izpostavljenosti (zaužitje+vdihavanje+intraperitonealna/subkutana izpostavljenost) bi morala biti izjema in ne pravilo.
Requiring such studies by more than one exposure route (i.e. oral + inhalatory + intraperitoneal/subcutaneous) should be the exception rather than the rule.
Prav tako bi moral biti podatek o akutni pljučni toksičnosti kvečjemu postranska zahteva.
Accordingly, acute pulmonary toxicity should at most be a second-tier data requirement.
Priloga II – naslov 2 – 7.2.2.3.
Annex II – Title 2– 7.2.2.3.
Enkratni intraperitonealni/subkutani odmerek – stolpec 2 (novo)
Intraperitoneal/subcutaneous single dose – Column 2 (new)
Pri študijah akutne toksičnosti je zastrupitev živali smrtna, zato so to ene od najhujših in etično spornih preskusov toksičnosti.
Acute toxicity studies involve literally poisoning animals to death, making them among the most severe and ethically objectionable type of toxicity test.
Zahteva po takšnih študijah z več kot enim načinom izpostavljenosti (zaužitje+vdihavanje+intraperitonealna/subkutana izpostavljenost) bi morala biti izjema in ne pravilo.
Requiring such studies by more than one exposure route (i.e. oral + pulmonary + intraperitoneal/subcutaneous) should be the exception rather than the rule.
To velja tudi za študije akutnega injiciranja.
Accordingly, an acute injection study should at most be a second-tier data requirement.
Priloga II – naslov 2 – 8.
Annex II – Title 2 – 8.
Učinki na neciljne organizme– stolpec 3 (novo)
Effects on non-target organisms – Column 3 (new)
Komisija je načeloma podprla prilagoditev nekaterih standardnih zahtev glede informacij za biocidne proizvode iz mikroorganizmov z dodanim pojasnilom k uvodnemu besedilu.
The Commission has expressed support in principle for the adaptation of certain standard information requirements for microbial biocides through the addition of qualifying sentence to the introductory text.
Priloga III– točka 5
Annex III – point 5
Če je metoda neustrezna ali ni opisana, pa se uporabijo druge metode, ki so, kadar je to mogoče, mednarodno priznane in znanstveno ustrezne, poleg tega pa morajo biti utemeljene v vlogi.
However, if a method is inappropriate or not described, other methods shall be used which are , whenever possible, internationally recognised and scientifically appropriate and must be justified in the application .
Če je metoda neustrezna ali ni opisana, pa se uporabijo druge metode, ki so z znanstvenega vidika zadostne , njihova veljavnost pa mora biti utemeljena v vlogi.
However, if a method is inappropriate or not described, other methods shall be used which are scientifically satisfactory and the validity of which must be justified in the application
(Ponovna vložitev predloga spremembe 293 iz prve obravnave.)
(Reinstatement of amendment 293 from first reading.)
Priloga III – točka 1 – 7,5. – stolpec 1
Annex III – Title 1 – 7.5. – Column 1
7.5 Predvidena teža v tonah, ki bo se bo letno dajala na trg
7.5 Likely tonnage to be placed on the market per year
7.5 Predvidena teža v tonah, ki se bo letno dajala na trg , in po potrebi za različne kategorije uporabe.
7.5 Likely tonnage to be placed on the market per year and where relevant, for different use categories.
Priloga III – naslov 1 – 8.5.4. – stolpec 1
Annex III – Title 1 – 8.5.4. – Column 1
Pri biocidnih proizvodih, za katere je predvidena izdaja dovoljenja za uporabo z drugimi biocidnimi proizvodi, je potrebna pozornost glede preskusne kombinacije proizvodov za akutno dermalno toksičnost ter draženje kože in oči .
For biocidal products that are intended to be authorised for use with other biocidal products, consideration should be given totesting combinations of the products for acute dermal toxicity and skin and eye irritation.
Pri biocidnih proizvodih, za katere je predvidena izdaja dovoljenja za uporabo z drugimi biocidnimi proizvodi, se ocenijo tveganja za človekovo zdravje in okolje, ki izvirajo iz uporabe teh kombinacij proizvodov.
For biocidal products that are intended to be authorised for use with other biocidal products, the risks to human health and the environment arising from the use of these product combinations shall be assessed.
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 .
In some cases, for example where there is 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.
Priloga III – naslov 1 – 8.7 – stolpec 1
Annex III – Title 1 – 8.7 – Column 1
Razpoložljivi toksikološki podatki v zvezi z naslednjim:
Available toxicological data relating to:
– pomožne snovi v formulaciji (tj. pogojno nevarne snovi) ali
– co-formulants (i.e. substance(s) of concern), or
– zmes, katere del je pogojno nevarna snov ,
– a mixture that a substance(s) of concern is a component of
– zmes, katere del je pogojno nevarna snov .
– a mixture that a substance(s) of concern is a component of.
– če niso na voljo nikakršni podatki , se opravijo preskusi iz Priloge II za pomožne snovi v formulaciji (tj. pogojno nevarne snovi) ali zmes, katere del je pogojno nevarna snov.
– If no data is available, then the appropriate test(s) described in Annex II, shall be carried out for the co-formulants (i.e . substance(s) of concern ) or a mixture that a substance(s) of concern is a component of.
Če podatki za pomožne snovi ne zadostujejo in jih ni mogoče povzeti z navzkrižnim branjem ali drugimi sprejetimi pristopi , ki ne temeljijo na preskušanju, se izvedejo ciljni preskusi akutne toksičnosti iz Priloge II za pomožne snovi v formulaciji (tj. pogojno nevarne snovi) ali zmes, katere del je pogojno nevarna snov.
If insufficient data are available for a co-formulant(s) and cannot be inferred through read-across or other accepted non-testing approaches, targeted acute 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.
Priloga III – točka 1 – 9,3.
Annex III – Title 1 – 9.3.
Učinki na druge specifične neciljne organizme (floro in favno), za katere se predvideva, da so ogroženi – stolpec 3
Effects on any other specific, non-target organisms (flora and fauna) believed to be at risk – Column 3
Podatki za oceno tveganj v zvezi z divjimi sesalci se pridobijo iz ocene toksičnosti za sesalce.
Data for the assessment of hazards to wild mammals are derived from the mammalian toxicological assessment.
Priloga III – točka 2 – 8,7. – stolpec 1
Annex III – Title 2 – 8.7. – Column 1
– pomožne snovi v formulaciji (tj. pogojno nevarne snovi) ali
- co-formulants (i.e. substance(s) of concern), or
– zmes, katere del je pogojno nevarna snov ,
- a mixture that a substance(s) of concern is a component of
– zmes, katere del je pogojno nevarna snov .
– a mixture that a substance(s) of concern is a component of .
če niso na voljo nikakršni podatki , se opravijo preskusi iz Priloge II za pomožne snovi v formulaciji (tj. pogojno nevarne snovi ) ali zmes, katere del je pogojno nevarna snov.
If no data is available, then the appropriate test(s) described in Annex II, shall be carried out for the co-formulants (i.e. substance(s) of concern ) or a mixture that a substance(s) of concern is a component of
Če podatki za pomožne snovi ne zadostujejo in jih ni mogoče povzeti z navzkrižnim branjem ali drugimi sprejetimi pristopi , ki ne temeljijo na preskušanju, se opravijo ciljni preskusi akutne toksičnosti iz Priloge II za pogojno nevarne snovi ali zmes, katere del je pogojno nevarna snov.
If insufficient data are available for a coformulant(s) and cannot be inferred through read-across or other accepted non-testing approaches , targeted acute 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 .
V Prilogi III so določene zahteve za biocidne proizvode, med drugim za kemijske snovi (naslov 1) in mikroorganizme (naslov 2).
Annex III sets out the requirements for biocidal products, including chemical products (Title 1) and micro-organisms (Title 2).
Zahteva za podatke 8.7 se pojavi pod obema naslovoma.
The data requirement 8.7 appears in both titles.
Če se spremeni ta zahteva pod naslovom 1 (predlog spremembe 96), je zaradi povezanosti besedila nujno, da se to naredi tudi pod naslovom 2.
If the data requirement 8.7 in Title 1 is amended (Amendment 96), the same amendment needs to be made to the corresponding data requirement 8.7 in Title 2 to ensure consistency.
Priloga III – točka 2 – 8,8. – stolpec 1
Annex III – Title 2 – 8.8. – Column 1
Dopolnilne študije za kombinacije biocidnih proizvodov
Supplementary studies for combinations of biocidal products
Pri biocidnih proizvodih, za katere se predvideva izdaja dovoljenja za uporabo z drugimi biocidnimi proizvodi, se, kadar je to mogoče, zmes proizvodov preskusi v zvezi z akutno dermalno toksičnostjo in draženjem kože in oči, kakor je ustrezno .
For biocidal products that are intended to be authorised for use with other biocidal products, the mixture of products, where possible, shall be tested for acute dermal toxicity and skin and eye irritation, as appropriate.
Pri biocidnih proizvodih, za katere je predvidena izdaja dovoljenja za uporabo z drugimi biocidnimi proizvodi, se ocenijo tveganja za človekovo zdravje in okolje , ki izvirajo iz uporabe teh kombinacij proizvodov.
For biocidal products that are intended to be authorised for use with other biocidal products, the risks to humans and the environment arising from the use of these product combinations shall be assessed.
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.
In some cases, for example where there is 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 using combinations of the products.
Priloga III – točka 2 – 9,3.
Annex III – Title 2 – 9.3.
Učinki na druge specifične neciljne organizme (floro in favno), za katere se predvideva, da so ogroženi – stolpec 3
Effects on any other specific non-target organisms (flora and fauna) believed to be at risk – Column 3
Priloga V – Glavna skupina 1: razkužila – vrsta proizvodov 2 – odstavek 5 a (novo)
Annex V – Main Group 1: Disinfectants – Product-type 2 – paragraph 5 a (new)
Te vrste proizvodov ne obsegajo čistilnih sredstev, ki nimajo biocidnega učinka, kar velja tudi za tekočino za pomivanje, pralni prašek in podobne proizvode.
These product types exclude cleaning products that are not intended to have a biocidal effect, including washing liquids, powders and similar products.
Pojasnitev, da za pralna in čistilna sredstva, ki na primer vsebujejo kisline (za raztopitev kamenca), alkalije (za raztopitev maščob), oksidacijska sredstva (za beljenje madežev) ali alkohol (kot topilno sredstvo), ni potrebno dovoljenje v smislu biocidnih proizvodov.
Clarification, to ensure that washing and cleaning products which contain for example acids (to remove lime), alkalis (to remove greasy dirt), oxidising agents (to bleach stains) or alcohol (as a solvent) do not require authorisation as biocidal products.
Imenovane snovi imajo lahko biocidne stranske učinke.
These substances may have a biocidal side-effect.
Priloga V – Glavna skupina 1: razkužila – vrsta proizvodov 6 – odstavek 2
Annex V – Main group 1: Disinfectants – product-type 6 – paragraph 2
Proizvodi, ki se uporabljajo kot konzervansi za shranjevanje ali uporabo rodenticidnih ali insekticidnih vab.
Products used as preservatives for the storage or use of rodenticide or insecticide baits.
Proizvodi, ki se uporabljajo kot konzervansi za shranjevanje ali uporabo rodenticidnih , insekticidnih ali drugih vab.
Products used as preservatives for the storage or use of rodenticide , insecticide or other baits.
Priloga V– Glavna skupina 2: sredstva za konzerviranje – vrsta proizvodov 9 – odstavek 1 a (novo)
Annex V– Main Group 2: Preservatives – Product-type 9 – paragraph 1 a (new)
Ta vrsta proizvodov vključuje agente, ki nasprotujejo naselitvi mikroorganizmov (na primer patogenih klic ali klic, ki povzročajo neprijeten vonj) 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 (e.g. pathogenic germs and those developing odour) on the surface of materials and therefore hamper or avoid the development of odour and /or offer other kinds of benefits.
Če se tekstil obdeluje z biocidnimi proizvodi, v ospredju ponavadi ni zaščita vlaken, ampak gre večkrat za preprečevanje naselitve mikroorganizmov na površini tekstila.
If textiles are treated with biocidal products, the prime concern is generally not to protect the fibres but rather to control the settlement of micro-organisms on the surface of the textile.
Priloga VI – Uvod – točka 3
Annex VI– Introduction – point 3
Da se zagotovi visoka in usklajena raven varovanja zdravja človeka in živali ter okolja, se opredelijo vsa tveganja, ki izhajajo iz uporabe biocidnega proizvoda.
In order to ensure a high and harmonised level of protection of human and animal health and of the environment, any risks arising from the use of a biocidal product shall be identified.
Da se to doseže, se opravi ocena tveganja, s katero se ugotovi sprejemljivost ali nesprejemljivost vseh ugotovljenih tveganj.
To achieve this, a risk assessment shall be carried out to determine the acceptability or otherwise of any risks that are identified.
To se opravi z oceno tveganj, povezanih z ustreznimi posameznimi sestavinami biocidnega proizvoda, ob upoštevanju kakršnih koli kumulativnih in sinergijskih učinkov.
This is done by carrying out an assessment of the risks associated with the relevant individual components of the biocidal product taking into account any cumulative and synergistic effects.
Znanstvene opredelitve in metodologije za ocenjevanje kumulativnih ali sinergijskih učinkov bodo temeljile na tehničnih smernicah, ki jih bo določila Komisija, kot je določeno v členu 23.
Scientific definitions and methodologies for the assessment of cumulative or synergistic effects will be based on the technical guidance notes provided by the Commission as foreseen in Article 23.
Trenutno ne obstaja enotna dogovorjena znanstvena opredelitev za zamisli o kumulativnih učinkih in učinkih sinergije, pa tudi ne skupna, dogovorjena metoda analize.
At present, there is no single agreed scientific definition for the concepts of cumulative and synergistic effects, neither is there a common, agreed method of analysis.
Komisija bi morala sprejeti te opredelitve in metodologije na podlagi tehničnih smernic pred začetkom veljavnosti uredbe.
The Commission should adopt these definitions and methodologies by way of technical guidance notes, before the regulation's entry into force.
Priloga VI – Ocena – točka 15
Annex VI – Assessment – point 15
Pri ocenjevanju se upoštevajo tudi možni kumulativni ali sinergijski učinki.
In carrying out the assessment, the possibility of cumulative or synergistic effects shall also be taken into account.
Priloga VI– Ocena – točka 47 a (novo)
Annex VI – Assessment – point 47 a (new)
Organ za ocenjevanje sklene, da biocidni proizvod ne izpolnjuje merila (iv) v točki (b) člena 18(1), če vsebuje pogojno nevarno snov ali pomembne metabolite ali razgradne ali reakcijske produkte, ki izpolnjujejo merila za strupene snovi ali snovi, ki se zelo lahko kopičijo v organizmu, v skladu s prilogo XIII Uredbe (ES) št. 1907/2006, ali imajo lastnosti endokrinih motilcev, razen če je znanstveno dokazano, da v ustreznih razmerah na prostem ni nesprejemljivih vplivov.
The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 18(1) if it contains any substance of concern or of relevant metabolites or breakdown or reaction products fulfilling the criteria for being PBT or vPvB in accordance with Annex XIII of Regulation (EC) No 1907/2006, or have endocrine-disrupting properties unless it is scientifically demonstrated that under relevant field conditions there is no unacceptable effect.
Namen je zagotoviti ustrezno obravnavo potencialno strupenih snovi ali snovi, ki se zelo kopičijo v organizmu.
In order to ensure proper consideration of potentially PBT and vPvB substances.
Merilo za izključitev v členu 5 zagotavlja nekakšno varnost, da aktivne snovi nimajo takšnih lastnosti; vendar to velja tudi za pomožne snovi v formulaciji v biocidnih proizvodih, zlasti ker koncentracija teh snovi običajno obstaja v precej višjih koncentracijah v primerjavi z aktivnimi snovmi.
The exclusion criteria in Article 5 give some security that the active substances do not have such properties; however this also applies for coformulants in biocidal products especially because the concentration of these substances normally exist in much higher concentrations compared to the active substances.
Priloga VI – Ocena – točka 52
Annex VI – Assessment – point 52
Na vsakem področju, na katerem so bile opravljene ocene tveganja, organ za ocenjevanje združi rezultate za aktivno snov z rezultati za posamezne pogojno nevarne snovi, in tako pripravi skupno oceno za biocidni proizvod.
In each of the areas where risk assessments have been carried out, the evaluating body 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 se upoštevajo tudi vsi možni kumulativni ali sinergijski učinki.
This shall also take account of any cumulative or synergistic effects.
Priloga VI – Ugotovitve – točka 68 – uvodni del
Annex VI – Conclusion – point 68 – introductory part
Organ za ocenjevanje sklene, da biocidni proizvod ne izpolnjuje merila (iv) iz točke (b) člena 18(1), če predvidena koncentracija aktivne snovi ali katere druge pogojno nevarne snovi ali ustreznih metabolitov ali razgradnih ali reakcijskih produktov, ki se pričakujejo v površinski vodi ali njenih usedlinah po uporabi biocidnega proizvoda v predlaganih pogojih uporabe:
The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 18(1) 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 surface water or its sediments after use of the biocidal product under the proposed conditions of use:
Organ za ocenjevanje sklene, da biocidni proizvod ne izpolnjuje merila (iv) iz točke (b) člena 18(1), če predvidena koncentracija aktivne snovi ali katere druge pogojno nevarne snovi ali ustreznih metabolitov ali razgradnih ali reakcijskih produktov, ki se pričakujejo v podtalnici ali površinski vodi ali njenih usedlinah po uporabi biocidnega proizvoda v predlaganih pogojih uporabe:
The evaluating body shall conclude that the biocidal product does not comply with criterion (iv) under point (b) of Article 18(1) 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 groundwater or surface water or its sediments after use of the biocidal product under the proposed conditions of use:
(Ponovna vložitev predloga spremembe 328 iz prve obravnave.)
(Reinstatement of amendment 328 from first reading)
Priloga VI – Ugotovitve – točka 68 – alinea 1 a (novo)
Annex VI – Conclusion – point 68 – indent 1 a (new)
– tvega neizpolnitev ciljev ali standardov, določenih v:
– risks 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
Direktivah 2008/56/ES ali
– Directives 2008/56/EC, or
– Direktivi 2008/105/ES ali
– Directive 2008/105/EC, or
– mednarodnih sporazumih, ki vsebujejo pomembne obveznosti za varstvo morskih voda pred onesnaževanjem ali
– international agreements containing important obligations on the protection of marine waters from pollution, or
( Ponovno se vloži predlog spremembe 329 iz prve obravnave. )
( Reinstatement of amendment 329 from first reading. )
Poročevalka pozdravlja, da je Svet v svojem skupnem stališču k osnutku uredbe o dostopnosti na trgu in uporabi biocidnih proizvodov sprejel skoraj polovico predlogov sprememb Parlamenta.
The rapporteur welcomes the fact that, in its common position on the proposal for a regulation concerning the making available on the market and use of biocidal products, the Council has incorporated just under half of Parliament’s amendments.
Vendar meni, da je treba za dosego zastavljenih ciljev, kot je odprava slabosti veljavne direktive o odobritvi 98/8/ES, izboljšanje postopka odobritve in bolj ekonomičnega postopka odločanja, ob hkratnem zagotavljanju visoke ravni zaščite, še veliko storiti.
She nonetheless considers the proposal to be in considerable need of improvement in order to achieve the stated purposes, such as eliminating the shortcomings in the existing authorisation directive, 98/8/EC, improving the authorisation procedure and streamlining decision-making while further developing the high level of protection.
V ta okvir spada na primer poenostavljena odobritev družine proizvodov in blagovnih znamk.
This applies, for example, to the simplified authorisation of product families and brands.
Poročevalka obžaluje, da skupno stališče vsebuje veliko pomanjkljivosti in protislovij, ki jih mora Evropski parlament sedaj odpraviti, in kritizira samovoljno prestrukturiranje člena.
The rapporteur regrets that the common position contains many inconsistencies and contradictions, which the European Parliament must now correct, and she is critical of the arbitrary restructuring of the articles.
Številne spremembe so zato tehnične narave in ne prinašajo vsebinskih sprememb besedila.
Many of the amendments are therefore of a technical nature and do not contain any substantive modifications of the text.
Namesto tega je njihov cilj izboljšati skladnost (v besedilu ter med uredbo in drugimi zakoni EU), odpraviti podvajanje zakonskih obveznosti in poenostaviti besedilo.
Instead, their aim is to improve consistency (within the text and between this regulation and other EU legislation), eliminate duplications of legal obligations and simplify the text.