natgillin/translations-raw huggingface dataset:
Upoštevanje kumulativnih učinkov, kombinacij učinkov ter sinergijskih učinkov je treba izrecno vključiti v skupna načela za oceno dokumentacije.
The consideration of cumulative, combination and synergistic effects needs to be included explicitly in the common principles for the evaluation of dossiers.
Predlog spremembe
Amendment 32
Priloga VI – uvod – točka 3
Annex VI - introduction - point 3
Ocena tveganja je vedno obvezna za aktivno snov ali za snovi, ki so prisotne v biocidnem pripravku.
A risk assessment on the active substance or substances present in the biocidal product is always required.
Če količinska ocena tveganja ni mogoča, se pripravi kakovostna ocena.
Where a quantitative risk assessment cannot be made a qualitative assessment shall be produced.
Priloga VI – uvod – točka 4
Annex VI – introduction – point 4
Na enak način, kot je opisano zgoraj, se izvedejo dodatne ocene tveganja za vse druge pogojno nevarne snovi, prisotne v biocidnem pripravku, če je to pomembno za njegovo uporabo.
Additional risk assessments shall be carried out, in the same manner as described above, on any other substance of concern present in the biocidal product where relevant for the use of the biocidal product.
Ni sprejemljivo zahtevati ocene tveganja za druge snovi razen aktivnih snovi v biocidnem pripravku.
It is not acceptable to require risk assessments for other substances than the active substances in a biocidal product.
To bi privedlo do podvajanja postopkov preskušanja, tudi poskusov na živalih, saj je treba tudi vse kemijske sestavine oceniti v okviru področja uporabe uredbe REACH.
This would lead to a duplication of testing procedures, including animal experimentation, as all chemical ingredients also have to be assessed within the scope of the REACH regulation.
Vse razpoložljive podatke za sestavine, ki so neaktivne snovi, je treba vključiti v dokumentacijo.
All available data for non-active substance ingredients rather has to be included in dossiers.
Priloga VI – ocena – točka 14
Annex VI – evaluation – point 14
Za aktivno snov v biocidnem pripravku 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 pripravku 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 pripravka, skupaj z realno najslabšim možnim primerom, v katerem so zajeti vsi pomembni problemi proizvodnje in odstranjevanje samega biocidnega pripravka ali katerega koli s pripravkom obdelanega materiala.
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 either of the biocidal product itself or any material treated with it.
Če so poleg tega v biocidnem pripravku tudi druge pogojno nevarne snovi, se vsi razpoložljivi podatki vključijo v dokumentacijo za odobritev biocidnega pripravka za vsako od njih.
If there are, in addition, any substances of concern present in the biocidal product then all available data shall be included in the dossier for authorisation of a biocidal product for each of these.
Podatki zajemajo predlagano običajno uporabo biocidnega pripravka, skupaj z realno najslabšim možnim primerom, v katerem so zajeti vsi pomembni problemi proizvodnje in odstranjevanje samega biocidnega pripravka ali katerega koli s pripravkom obdelanega materiala.
The data shall cover the proposed normal use of the biocidal product together with a realistic worst-case scenario including any relevant production and disposal issue either of the biocidal product itself or any material treated with it.
Priloga VI – ocena – točka 15
Annex VI - evaluation - point 15
Za vsako aktivno in vsako pogojno nevarno snov, ki je v biocidnem pripravku, oceni tveganja sledi, kadar je to mogoče, opis nevarnosti in vzpostavitev ustreznih koncentracij, pri katerih ni opaziti neželenih učinkov (NOAEL).
For each active substance and each substance of concern present in the biocidal product, the risk assessment shall entail a hazard identification and the establishment of appropriate no-observed-adverse-effect levels (NOAEL), where possible.
Ocena tudi vsebuje, kakor 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.
Ocena tudi vsebuje, kakor je primerno, oceno razmerja med odmerkom (koncentracijo) in odzivom (učinkom), skupaj z oceno izpostavljenosti in opisom tveganja ob ustreznem upoštevanju kumulativnih učinkov, kombinacij učinkov ter sinergijskih učinkov .
It shall also include, as appropriate, a dose (concentration) - response (effect) assessment, together with an exposure assessment and a risk characterisation, taking due account of cumulative, combination and synergistic effects .
Priloga VI – ocena – točka 20 – alinea 9 a (novo)
Annex VI – evaluation – point 20 – indent 9 a (new)
Priloga VI – odstavek 22 a (novo)
Annex VI - point 22 a (new)
(22a) Da bi zmanjšali število poskusov na živalih, bi moralo ugotavljanje neželenih učinkov po možnosti temeljiti na podatkih o aktivni snovi in obstoječih podatkih o problematični snovi, ki jo vsebuje biocidni pripravek.
(22a) In order to reduce the number of tests on animals, adverse effects should , whenever possible , be studied on the basis of the information on the active substance and existing information on the substances that give cause for concern which the biocidal product contains.
Za ugotavljanje neželenih učinkov biocidnega pripravka bi bilo treba uporabljati zlasti določbe Direktive 1999/45/ES ali Uredbe ES št. 1272/2008.
In particular, the provisions of Directive 1999/45/EC or Regulation (EC) No 1272/2008 shall be applied for the purpose of ascertaining adverse effects of the biocidal product.
Priloga VI – ocena – točka 47
Annex VI – evaluation – point 47
Pristojnim organom se predloži podatke, ki jih ta ovrednoti, da oceni, ali biocidni pripravek pri svojem učinkovanju ne povzroča nepotrebnega trpljenja pri ciljnih vretenčarjih.
Data shall be submitted to and evaluated by the competent authorities to assess whether the biocidal product does not cause unnecessary suffering 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.
Pristojnim organom se predloži podatke, ki jih ta ovrednoti, da oceni, ali biocidni pripravek pri svojem učinkovanju ne povzroča nepotrebnega trpljenja in bolečine pri ciljnih vretenčarjih.
Data shall be submitted to and evaluated by the competent authorities to assess whether the biocidal product does not cause unnecessary suffering and pain in its effect on target vertebrates.
Te ugotovitve se za vsak odobren biocidni pripravek dajo na voljo javnosti na spletni strani Agencije.
These findings shall for each authorised biocidal product be made publicly available on the Agency website.
Priloga VI – odločanje – točka 59 – alinea 2
Annex VI- decision making - point 59 - indent 2
– vrsto in resnost učinka,
- the nature and severity of the effect,
– vrsto in resnost učinka ob ustreznem upoštevanju kumulativnih učinkov, kombinacij učinkov ter sinergijskih učinkov
- the nature and severity of the effect, taking due account of cumulative, combination and synergistic effects
Upoštevanje kumulativnih učinkov, kombinacij učinkov ter sinergijskih učinkov je treba obravnavati v postopku odločanja.
The consideration of cumulative, combination and synergistic effects needs to be considered in the decision-making process.
Priloga VI – odločanje – točka 77 – uvodni del
Annex VI – decision making – point 77 – introductory part
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 površinski vodi ali njenih sedimentih po uporabi biocidnega pripravka v predlaganih pogojih uporabe:
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 surface water or its sediments after use of the biocidal product under the proposed conditions of use:
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 podtalnici ali površinski vodi ali njenih sedimentih po uporabi biocidnega pripravka v predlaganih pogojih uporabe:
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 groundwater or surface water or its sediments after use of the biocidal product under the proposed conditions of use:
Zagotavlja skladnost s standardi določb Skupnosti in mednarodnih sporazumov za zaščito voda.
Ensures to comply with the standards of Community provisions and international agreements for the protection of waters.
Priloga VI – odločanje – točka 77 – alinea 2 a (novo)
Annex VI – decision making – point 77 – indent 2 a (new)
– tvega neizpolnitev ciljev ali standardov, določenih v:
– – risk 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
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
Predlog spremembe
Amendment 33
Priloga VI – odločanje – točka 77 – zadnji del
Annex VI – decision making – point 77 – last part
razen če je znanstveno dokazano, da v ustreznih razmerah na prostem ta koncentracija ni presežena.
unless it is scientifically demonstrated that under relevant field conditions this concentration is not exceeded.
Biocidi so del naše civilizacije in našega življenjskega standarda.
Biocidal products are part of our civilisation, and our standard of living depends on them.
So nepogrešljivi pri ohranjanju naše pravice do zdravja in higiene.
They are essential in order to maintain the high standards of health and hygiene on which we insist.
Zaradi visoke gostote prebivalstva in mednarodne mobilnosti potrebuje naša družba posebne oblike higiene, da se klice in bolezni ne bi mogle prenašati.
Because of high population density and international mobility, our society requires particular forms of hygiene to prevent germs and diseases from being transmitted.
Biocidi morajo biti učinkoviti, so pa zaradi tega pogosto tudi nevarni.
Biocidal products must be effective, which often also makes them dangerous.
Zato je pri obravnavanju teh snovi potrebna posebna občutljivost.
Special sensitivity is therefore called for in dealing with these substances.
Hkrati je treba zagotoviti sprejetje nove uredbe o biocidih, da bi proizvajalci, med katerimi je največ srednje velikih, lahko te zahteve upoštevali pri proizvodnji, ne da bi bili zaradi tega v slabšem konkurenčnem položaju, kar bi lahko sicer pripeljalo celo do izpada izhodnih surovin ali pripravkov.
At the same time the new regulation on biocidal products must ensure that manufacturers, the majority of whom are medium-sized companies, can apply the regulations in their production without being placed at a competitive disadvantage, as that might in some circumstances even result in raw materials or products ceasing to be available.
Namen direktive je poenotenje obstoječih zakonskih predpisov na evropski ravni in njihova prilagoditev tekočemu tehnološkemu razvoju.
The aim of this regulation is to unify the existing European legislation and update it according to the state of the art.
Pri tem je pomembno, da lahko oba, uporabnik in proizvajalec biocidov oziroma pripravkov, ki vsebujejo biocide, izhajata iz minimalnih standardov, ki veljajo po vsej EU.
Both consumers and manufacturers of biocidal products or of products containing them must be able to rely on minimum standards applicable throughout the EU.
Poročevalka meni, da je osnutek uredbe, ki ga je predlagala Komisija, potreben obsežnih izboljšav, da bi zagotovili uresničenje ciljev, kot so odstranitev pomanjkljivosti sedanje direktive, izboljšanje postopka odobritve in lažje odločanje, obenem pa naprej razvijali visoko raven zaščite zdravja.
The rapporteur considers that the Commission's proposal for a regulation is in considerable need of improvement in order to achieve the stated purposes, such as eliminating the shortcomings in the existing directive, improving the authorisation procedure and streamlining decision-making while further developing the high level of protection.
Nova uredba mora zlasti upoštevati tri bistvena področja: varstvo okolja, varstvo potrošnikov ter omogočanje varnega in v prakso usmerjenega izvajanja proizvajalcem.
The new regulation must take account of three essential fields: environmental protection, consumer protection and safe and practical implementation by manufacturers.
Za okolje
Regarding the environment:
Pri izdajanju dovoljenj za biocide, njihovem trženju in uporabi je treba zagotoviti uresničevanje previdnostnega načela in jasna merila za izključitev.
The authorisation procedure, marketing and use of biocidal products must accord with the precautionary principle and clear exclusion criteria.
Le tako lahko hkrati dosežemo največjo možno raven varovanja zdravja ljudi in živali in ohranimo ustvarjalnost.
Only then can the highest possible standard of protection of human and animal health alike be attained and Creation as a whole preserved.
Pri izdaji dovoljenj bi morala uredba upoštevati tudi prihodnji tehnološki razvoj aktivnih snovi, na primer vse pogosteje uporabljanih nanomaterialov.
The authorisation rules laid down in the regulation should also make allowance for the further technical development of active substances, for example nanomaterials, the use of which is increasingly widespread.
Poročevalka meni, da bi bilo treba za zagotovitev visoke ravni varstva v prihodnosti in pravne varnosti proizvajalcev oblikovati enotno opredelitev nanomaterialov in besedilo uredbe redno prilagajati tehnološkemu razvoju.
In order to guarantee a high standard of protection for the future as well as legal certainty for producers, therefore, the rapporteur considers that a uniform definition of nanomaterials should be formulated and that the text of the regulation should be regularly updated in the light of technical developments.
Za varstvo potrošnikov
Regarding consumer protection:
Potrošnikom je treba omogočiti, da lahko računajo na to, da kupljeni pripravki izpolnjujejo enotne minimalne standarde notranjega trga EU, ne glede na to, v kateri državi članici so jih kupili.
Consumers must be able to rely on the assumption that the products they acquire comply with uniform minimum standards in the EU internal market, irrespective of which Member State they have purchased a product in.
Standardom EU morajo ustrezati tudi proizvodi neevropskih proizvajalcev in snovi ter aktivne snovi, ki jih uporabljajo, s čemer bi zagotovili, da teh standardov ne bi bilo mogoče obiti.
So that these standards cannot be evaded, it is also necessary for the products of non-European manufacturers and the materials and active substances which they use to comply with EU standards.
Prav tako je treba zagotoviti jasno označevanje tretiranih snovi in izdelkov, pa tudi ustrezno izdajo dovoljenj za biocidne pripravke, ne glede na to, ali nastajajo v Evropski uniji ali zunaj nje.
Clear labelling of materials processed and of products is therefore just as necessary as appropriate authorisation of biocidal products, whether produced inside or outside the European Union.
Nadalje je treba uporabnike in potrošnike biocidnih pripravkov seznaniti z varnim načinom njihove uporabe, pa tudi s sprejemljivimi alternativami in z neoporečnostjo biocidnih pripravkov.
Professional users and consumers of biocidal products must also be informed about how to use them safely, about compatible alternatives and that biocidal products are safe.
Pri tem bi bilo treba vsekakor vključiti usposabljanje pomembnejših ciljnih skupin, zlasti poklicnih uporabnikov.
This should without fail entail training of relevant target groups, at least among professional users.
Za praktično uporabo in izvajanje uredbe
Regarding the practical application and enforcement of the regulation:
Da bi zadostili vse večjemu povpraševanju po biocidnih pripravkih, je treba poleg same proizvodnje posebno pozornost nameniti raziskavam in razvoju.
In catering for the increasingly stringent requirements applicable to biocidal products, not only production itself is important but so, in particular, are research and development.
Industrija pa mora zlasti v sektorju biocidov vzpostaviti ravnotežje med majhnim obsegom proizvodnje in dragimi postopki proizvodnje in izdaje dovoljenj.
However, the biocidal products industry is one which is particularly required to combine small quantities of product with complex manufacturing processes and authorisation procedures.
To zahteva primerna sredstva, enake pogoje in sprejemljive stroške za registracijo in izdajo dovoljenj za biocidne pripravke, ne da bi pri tem podjetjem odvzeli zagon za nadaljnji razvoj obstoječih in raziskovanje novih proizvodov.
It follows that the registration and authorisation of biocidal products must involve a proportionate amount of administration, fair conditions and acceptable costs without removing the incentive for undertakings to continue to develop existing products and research new ones.
Uvedba dovoljenja Skupnosti v tem smislu predstavlja pomemben korak v smeri uravnoteženega evropskega trga za biocidne pripravke.
In this connection the introduction of a Community authorisation system represents a significant step towards a harmonised European market for biocidal products.
To je najboljši in najučinkovitejši način, kako izboljšati razpoložljivosti teh proizvodov, dajati spodbude za inovacije in prispevati k zdravju človeka in varovanju okolja.
It is the best and most efficient system for improving the availability of these products, providing incentives for innovation and creating added value for human health and nature conservation.
Centralni sistem izdaje dovoljenj ima gotovo pozitiven učinek na notranji trg, saj omogoča usklajeno ocenjevanje in enotno izvajanje zahtev v vseh državah članicah EU.
A central authorisation system will also have an unequivocally positive effect on the internal market as it will facilitate consistent assessments and uniform enforcement of the requirements in all EU Member States.
To vodi nenazadnje tudi k boljši zaščiti potrošnikov.
This will, in particular, also improve consumer protection.
Postopek izdaje dovoljenj Skupnosti bi bilo zato treba razširiti na vse kategorije proizvodov.
The Community authorisation procedure should therefore be extended to all categories of products.
V okviru postopka izdaje dovoljenj so koristoljubni nameni in neželeni stranski učinki, na primer pri informacijah o proizvodu ali poslovnih skrivnostih, izključeni.
It is important that the authorisation procedure should be designed to prevent free-rider and cashing-in effects, for example with regard to product information or business secrets.
Bodoča uredba predvideva poenostavljen postopek za izdajo dovoljenja za pripravek pod določenimi pogoji, da bi se izognili nepotrebnim stroškom in pretirano visokim pristojbinam.
The future regulation provides for a simplified procedure for product authorisation subject to certain conditions in order to avoid unnecessary costs and excessive fees.
Treba je tudi pojasniti, da se različni postopki uporabljajo glede na stopnjo in obseg predvidenih sprememb biocidnega pripravka v primerjavi z izvirnim dovoljenjem.
It should also be made clear that different procedures are to be applied, depending on the extent of proposed changes to a biocidal product in comparison with that which was originally authorised.
Poenostavljeni postopek brez zapletenega in dolgotrajnega upravnega postopka bi bil zato nujen za manjše spremembe biocidnih pripravkov, ki nimajo negativnega vpliva na oceno tveganja in na delovanje.
Minor changes in biocidal products would therefore require only a simplified procedure rather than a cumbersome and time-consuming procedure, provided that this was not detrimental either to the risk assessment or to its effectiveness.
z dopisom z dne 21. aprila 2010 ste v skladu s členom 37(2) poslovnika Odbor za pravne zadeve prosili za mnenje o predlagani spremembi pravne podlage z ene pravne podlage (člen 114 PDEU) na trojno podlago (členi 114, 192 in 169 PDEU).
By letter of 21 April 2010 you asked the Committee on Legal Affairs pursuant to Rule 37(2) of the Rules of Procedure, to give its opinion on a proposed change to the legal basis of the proposal from a single basis of Article 114 TFEU to a triple basis of Articles 114, 192 and 168 TFEU.
Odbor je omenjeno vprašanje obravnaval na seji dne 17. maja 2010.
The committee considered the above question at its meeting of 17 May 2010.
Direktiva 98/8/ES Evropskega parlamenta in Sveta o dajanju biocidnih pripravkov v promet je bila sprejeta 16. februarja 1998.
Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market was adopted on 16 February 1998.
Določa skladen regulativni okvir za odobritev biocidnih pripravkov in njihovo dajanje v promet, vzajemno priznavanje teh odobritev v EU in vzpostavitev na ravni EU pozitivnega seznama aktivnih snovi, ki se lahko uporabljajo za biocidne pripravke.
It establishes a harmonised regulatory framework for the authorisation and the placing on the market of biocidal products, the mutual recognition of these authorisations within the EU and the establishment at EU level of a positive list of active substances that may be used in biocidal products.
Regulativni okvir za biocidne pripravke sestavljajo tudi številne izvedbene uredbe Komisijie, zlasti Uredba Komisije (ES) št. 1451/2007
The regulatory framework for biocidal products also consists of a number of implementing Commission Regulations, in particular Commission Regulation (EC) No 1451/2007
Poročilo, ki ga je predložila Komisija o izvajanju direktive (KOM(208)620), v nadaljevanju „revizija“), je temelj predloga.
The report submitted by the Commission on the implementation of the Directive (COM(2008)620, hereinafter "the review") forms the basis for the proposal.