natgillin/translations-raw huggingface dataset:
Če so bili takšni preskusi ali študije že predloženi Agenciji ali pristojnemu organu v povezavi s prejšnjo vlogo v skladu s to uredbo ali Direktivo 98/8/ES, Agencija morebitnemu vlagatelju nemudoma sporoči ime in kontaktne podatke predlagatelja podatkov.
Where such tests or studies have already been submitted to the Agency, or to a competent authority in connection with a previous application, under this Regulation or Directive 98/8/EC, the Agency shall, without delay, communicate the name and contact details of the data submitter(s) to the prospective applicant.
Predlagatelj podatkov po potrebi olajša kontakte med morebitnim vlagateljem in lastnikom podatkov.
The data submitter(s) shall where relevant, facilitate contacts between the prospective applicant and the data owner(s) .
Kadar so podatki, pridobljeni s temi preskusi ali študijami, še vedno varovani v skladu s členom 59, morebitni vlagatelj:
Where the data acquired under those tests or studies are still protected under Article 59, the prospective applicant:
(a) v primeru podatkov, ki vključujejo preskuse na vretenčarjih, zaprosi lastnika podatkov za dovoljenje za sklicevanje na te preskuse ali študije, in
(a) shall, in the case of data involving tests on vertebrate animals, request from the data owner the right to refer to those tests or studies ; and
(a) v primeru podatkov, ki vključujejo preskuse na vretenčarjih, in
(a) shall, in the case of data involving tests on vertebrate animals; and
(b) v primeru podatkov, ki ne vključujejo preskusov na vretenčarjih, lahko zaprosi lastnika podatkov za dovoljenje za sklicevanje na te preskuse ali študije.
(b) may, in the case of data not involving tests on vertebrate animals, request from the data owner the right to refer to those tests or studies.
(b) v primeru podatkov, ki ne vključujejo preskusov na vretenčarjih, lahko
(b) may, in the case of data not involving tests on vertebrate animals,
zaprosi lastnika podatkov za vse znanstvene in tehnične podatke, povezane z zadevnimi preskusi in študijami, ter za pravico do sklicevanja na te podatke pri predložitvi vlog v skladu s to uredbo.
request from the data owner(s) all the scientific and technical data related to the tests and studies concerned as well as the right to refer to these data when submitting applications within the framework of this Regulation .
Glede na najnovejše izkušnje z uredbo REACH bi bilo treba nekatere dele besedila Sveta spremeniti ter zagotoviti skladen pristop med dvema regulatornima okviroma.
On the basis of the most recent experience with REACH, some changes should made to the Council text to benefit from that experience and to ensure a consistent approach between the two regulatory frameworks.
Besedilo bi moralo biti kot prvo bolj specifično z vidika podatkov, ki jih je treba zagotoviti, in z vidika namena uporabe besedila.
Firstly, the text should be more specific in terms of the data to be made available and the purposes for which it can be used.
Kot drugo pa bo Agencija v nekaterih primerih poznala identiteto predlagatelja podatkov, ne pa tudi lastnika podatkov.
Secondly, in some cases the Agency will know the identity of the data submitter but not the data owner.
Zahteva v skladu s tem členom bi morala biti povezana s plačilom pristojbine, da se prepreči zloraba ali uporaba določbe za zbiranje tržnih podatkov.
Lastly, a request under this Article should be associated with the payment of a fee to prevent the provision being (ab)used in order to collect market intelligence.
Člen 62 – odstavki 1-3
Article 62 – paragraphs 1-3
Kadar je bil zahtevek vložen v skladu s členom 61(2), si morata morebitni vlagatelj in lastnik podatkov prizadevati za dosego dogovora o izmenjavi rezultatov preskusov ali študij, za katere je zaprosil morebitni vlagatelj.
Where a request has been made in accordance with Article 61(2), the prospective applicant and the data owner shall make every effort to reach an agreement on the sharing of the results of the tests or studies requested by the prospective applicant.
Namesto takšnega dogovora se lahko zadeva predloži razsodišču z zavezo, da se sprejme njegova odločitev.
Such an agreement may be replaced by submission of the matter to an arbitration body and a commitment to accept the arbitration order.
Kadar je bil zahtevek vložen v skladu s šestim pododstavkom člena 61(2), si morata morebitni vlagatelj in lastnik podatkov prizadevati za dosego dogovora o izmenjavi rezultatov preskusov ali študij, za katere je zaprosil morebitni vlagatelj.
Where a request has been made in accordance with the sixth subparagraph of Article 61(2), the prospective applicant and the data owner shall make every effort to reach an agreement on the sharing of the results of the tests or studies requested by the prospective applicant.
Če se doseže tak dogovor, lastnik podatkov morebitnemu vlagatelju da na voljo podatke in mu dovoli, da se sklicuje na preskuse ali študije.
Where such agreement is reached, the data owner shall make the data available to the prospective applicant and shall give the prospective applicant permission to refer to the data owner's tests or studies.
Če se doseže tak dogovor, lastnik podatkov morebitnemu vlagatelju da na voljo vse znanstvene in tehnične podatke , povezane z zadevnimi preskusi in študijami, ali mu dovoli, da se sklicuje na preskuse ali študije pri predložitvi vlog v skladu s to uredbo .
Where such agreement is reached, the data owner shall make all the scientific and technical data related to the tests and studies concerned available to the prospective applicant or shall give the prospective applicant permission to refer to the data owner's tests or studies where submitting applications under this Regulation.
Če se dogovor v zvezi s podatki , ki vključujejo preskuse na vretenčarjih , ne doseže v 60 dneh po vložitvi zahtevka v skladu s členom 61(2) , morebitni vlagatelj o tem nemudoma ustrezno obvesti Agencijo , pristojni organ in lastnika podatkov .
Where no such agreement is reached within 60 days of a request made according to Article 61(2) with respect to data involving tests on vertebrate animals, the prospective applicant shall , without delay, inform the Agency , competent authority and the data owner accordingly.
Agencija v 60 dneh od prejema obvestila o nedosegi dogovora morebitnemu vlagatelju dovoli, da se sklicuje na te preskuse ali študije.
Within 60 days of being informed about the failure to reach an agreement , the Agency shall give the prospective applicant the right to refer to those tests or studies.
Če se morebitni vlagatelj in lastnik podatkov ne moreta dogovoriti, nacionalna sodišča odločijo o sorazmernem deležu stroškov , ki jih morebitni vlagatelj plača lastniku podatkov .
Where the prospective applicant and data owner cannot agree, national courts shall decide on the proportionate share of the cost that the prospective applicant shall pay to the data owner .
Če se dogovor v zvezi s preskusi in študijami, ki vključujejo vretenčarje, ne doseže, morebitni vlagatelj o tem obvesti Agencijo in lastnika podatkov najbolj zgodaj v enem mesecu po tem, ko Agencija prejme potrdilo o imenu in naslovu predlagatelja podatkov .
Where no agreement is reached with respect to tests and studies involving vertebrate animals, the prospective applicant shall inform the Agency and the data owner(s) thereof at the earliest one month after receipt, from the Agency, of the name and address of the data submitter(s).
Agencija v 60 dneh od prejema obvestila morebitnemu vlagatelju dovoli, da se sklicuje na zahtevane preskuse in študije, ki vključujejo vretenčarje, če morebitni vlagatelj dokaže, da je lastniku podatkov za preskuse in študije plačal delež nastalih stroškov in storil vse, kar je bilo v njegovi moči za dosego dogovora o skupni uporabi teh testov in študij.
Within 60 days of being informed, the Agency shall give the prospective applicant permission to refer to the requested tests and studies involving vertebrate animals provided that the prospective applicant demonstrates that it has paid the data owner(s) for these tests and studies a share of cost incurred, and that every effort has been made to reach an agreement on the sharing of these tests and studies.
Lastnik podatkov zahteva od morebitnega vlagatelja sorazmeren delež nastalih stroškov .
The data owner(s) shall have a claim on the prospective applicant for a proportionate share of the cost incurred by it .
Glede na najnovejše izkušnje z uredbo REACH bi bilo treba nekatere dele besedila Sveta spremeniti ter zagotoviti skladen pristop med dvema regulatornima okviroma. .
On the basis of the most recent experience with REACH, some changes should made to the Council text to benefit from that experience and to ensure a consistent approach between the two regulatory frameworks.
Nekatere od predlaganih sprememb bodo zagotovile skladnost s spremembami, predlaganimi v povezavi s členom 61.
Some of the proposed changes are to ensure consistency with those proposed in relation to Article 61.
Poleg tega bi bilo treba besedilo uskladiti z določbami, ki veljajo za izmenjavo podatkov v okviru uredbe REACH.
In addition, the text should be aligned with the provisions applicable to data sharing under REACH.
Namen je izboljšati skladnost (tako znotraj besedila kot tudi z drugimi deli zakonodaje).
It aims to improve consistency (both within the text and with other pieces of legislation).
Člen 62 – odstavek 4 a (novo)
Article 62 – paragraph 4 a (new)
Stroški iz odstavka 4 lahko vključujejo stroške preiskav, poskusov ali poročil, vključno z oceno izpostavljenosti in oceno tveganja, katerih namen je določiti lastnosti in obnašanje aktivnih snovi ali biocidnih proizvodov, napovedati izpostavljenost aktivnim snovem in/ali njihovim pomembnim metabolitom, določiti varne ravni izpostavljenosti in zagotoviti pogoje za varno uporabo biocidnih proizvodov.
The costs referred to in paragraph 4 may include costs from investigations, experiments or reports, including exposure and risk assessments, whose purpose is to determine the properties and behaviour of an active substance or of biocidal products, predict exposure to active substances and/or their relevant metabolites, determine safe levels of exposure and establish conditions for the safe use of biocidal products.
Člen 64 – odstavek 2 – pododstavek 2
Article 64 – paragraph 2 – subparagraph 2
Zaradi lažjega tozadevnega zagotavljanja proizvajalci biocidnih proizvodov, ki so dani na trg Unije, vzdržujejo ustrezen sistem nadzora kakovosti proizvodnega postopka , ne da bi bili gospodarski subjekti in države članice zaradi tega nesorazmerno upravno obremenjeni.
In order to facilitate such enforcement, manufacturers of biocidal products placed on the Union market shall maintain a suitable system of quality control of the manufacturing process without causing disproportionate administrative burden to economic operators and Member States .
Zaradi lažjega tozadevnega zagotavljanja proizvajalci biocidnih proizvodov, ki so dani na trg Unije, vzdržujejo ustrezen sistem nadzora kakovosti proizvodnega postopka .
In order to facilitate such enforcement, manufacturers of biocidal products placed on the Union market shall maintain a suitable system of quality control of the manufacturing process .
V ta namen uvedejo in hranijo najmanj ustrezno dokumentacijo v papirni ali elektronski obliki glede:
To that end they shall establish and maintain, as a minimum, appropriate documentation in paper or electronic format with respect to :
(a) vnosa sestavin, ki se dodajo biocidnemu proizvodu, da se vključijo specifikacije, proizvodne formule in varnostni list, ki so pomembni za skladnost in varnost biocidnega proizvoda, ki se daje na trg;
(a) the input of the ingredients to be added to the biocidal product to include specifications, manufacturing formulae and safety data sheets which are relevant to compliance and the safety of the biocidal product to be placed on the market;
(b) različnih izvedenih proizvodnih operacij, ki so pomembne za skladnost in varnost biocidnih proizvodov, ki se dajo na trg, in omogočajo njihovo sledljivost; in
(b) the various manufacturing operations performed which are relevant to compliance and safety of the biocidal product to be placed on the market and allow its traceability; and
c) podatkov, ki se nanašajo na rezultate nadzora kakovosti in serijsko identifikacijo kodo.
c) data concerning the results of the quality control and batch identification.
Državi članici ni treba uvesti sistema uradnih kontrol, če ima podjetje mednarodno priznan certifikat zagotovitve kakovosti (npr.
A Member State does not need to undertake a system of official controls where a company holds an internationally recognised quality assurance certificate (e . g.
ISO9001), kar vključuje revizijo, s katero se preveri vsaj, ali so bili ohranjeni vsi zgoraj navedeni elementi.
ISO9001) that includes an audit to verify, as a minimum, that all of the above elements have been maintained.
Če je to potrebno za zagotavljanje enotnega izvajanja tega odstavka, lahko Komisija sprejme izvedbene akte v skladu s postopkom iz člena 81(3).
Where necessary in order to ensure uniform application of this paragraph, the Commission may adopt implementing acts in accordance with the procedure referred to in Article 81(3)".
Na trgu je preveč nekvalitetnih proizvodov.
There are too many products on the market which are of poor quality.
Namen tega predloga spremembe besedila Sveta je povečati možnost, da se zagotovi učinkovit nadzor kakovosti proizvodov, kot je predvideno v drugi zakonodaji.
This amendment to the Council’s text reinforces the possibility to secure an efficient control of the quality of products, as it is foreseen in other legislations.
Poleg tega bo ta določba pomagala spodbuditi inovacije, da bi na tržišče prišli varnejši izdelki.
Furthermore, this provision will help to stimulate innovation with a view to have safer products on the market.
Člen 64 – odstavek 3 – pododstavek 1 – uvodni del
Article 64 – paragraph 3 – subparagraph 1 – introductory part
Od … države članice vsaka tri leta Komisiji predložijo poročilo o izvajanju te uredbe na njihovih ozemljih.
Every three years, from … , Member States shall submit to the Commission a report on the implementation of this Regulation in their respective territories.
Od … države članice vsaka tri leta Komisiji predložijo poročilo o izvajanju te uredbe na njihovih ozemljih.
Every three years, from …, Member States shall submit to the Commission a report on the implementation of this Regulation in their respective territories.
Poročila o izvajanju se objavljajo na ustreznem spletnem mestu Komisije.
The implementation reports shall be published on the relevant website of the Commission.
(Ponovna vložitev predloga spremembe 199 iz prve obravnave.)
(Reinstatement of amendment 199 from first reading.)
Člen 64 – odstavek 3 – pododstavek 1 – točka b
Article 64 – paragraph 3 – subparagraph 1 – point b
(b) informacije o vseh zastrupitvah in poklicnih boleznih, če so te na voljo, v zvezi z biocidnimi proizvodi.
(b) information on any poisonings and, where available, occupational diseases involving biocidal products.
(b) informacije o vseh zastrupitvah in poklicnih boleznih, če so te na voljo, v zvezi z biocidnimi proizvodi , zlasti v zvezi z ranljivimi skupinami, ter ukrepi, ki jih je treba sprejeti za zmanjšanje tveganja prihodnjih primerov .
(b) information on any poisonings and, where available, occupational diseases involving biocidal products , especially regarding vulnerable groups, and the actions undertaken to lower the risk of future cases .
(Ponovna vložitev predloga spremembe 200 iz prve obravnave.)
(Reinstatement of amendment 200 from first reading.)
Člen 64 – odstavek 3 – pododstavek 1 – točka b a (novo)
Article 64 – paragraph 3 – subparagraph 1 – point b a (new)
(Ponovna vložitev predloga spremembe 201 iz prve obravnave.)
(Reinstatement of amendment 201 from first reading.)
Komisija do 1. januarja 2020 pripravi poročilo o izvajanju te uredbe, zlasti člena 57.
The Commission shall draw up a report on the implementation of this Regulation, in particular Article 57, by 1 January 2020.
Komisija to poročilo predloži Evropskemu parlamentu in Svetu.
The Commission shall submit the report to the European Parliament and to the Council.
Komisija do 1. januarja 2020 , nato pa vsaka tri leta, pripravi poročilo o izvajanju te uredbe, zlasti člena 57.
The Commission shall draw up a report on the implementation of this Regulation, in particular Article 57, by 1 January 2020 and every three years thereafter .
(Delna ponovna vložitev predloga spremembe 350 iz prve obravnave.)
(Partial reinstatement of amendment 350 from first reading.)
Člen 64 – odstavek 4 a (novo)
Article 64 – paragraph 4 a (new)
Komisija najkasneje v petih letih po začetku veljavnosti te uredbe pripravi poročilo o vplivu sproščanja biocidnih proizvodov v okolje.
Not later than five years after the entry into force of this Regulation, the Commission shall draw up a report on the impact of the spread of biocidal products in the environment.
(Ponovna vložitev predloga spremembe 204 iz prve obravnave.)
(Reinstatement of amendment 204 from first reading.)
Člen 64 – odstavek 4 b (novo)
Article 64 – paragraph 4 b (new)
Komisija najkasneje dve leti po začetku veljavnosti te uredbe Evropskemu parlamentu in Svetu predloži poročilo o oceni tveganja glede uporabe nanomaterialov v biocidnih proizvodih za zdravje ljudi in okolje ter o posebnih ukrepih, ki bi jih bilo treba sprejeti v zvezi z njimi.
At the latest two years after the entry into force of this Regulation, the Commission shall submit to the European Parliament and Council a report on the assessment of the risks to human health and the environment presented by the use of nanomaterials in biocidal products and on specific measures to be taken with regard to them.
(Ponovna vložitev predloga spremembe 203 iz prve obravnave.)
(Reinstatement of amendment 203 from first reading.)
Nanomateriali spadajo na področje uporabe te uredbe.
Nanomaterials fall within the scope of the Regulation.
Zlahka pa se primeri, da ustrezna ocena nima potrebnih metod.
However, a proper assessment may well lack the necessary methods.
Obravnava nanomaterialov v tej uredbi bi morala biti popolnoma pregledna.
There should be full transparency about how this Regulation deals with nanomaterials.
Zatorej bi bilo potrebno namensko poročilo Komisije o tem.
As such, there should be a dedicated Commission report on the matter.
Člen 65 – odstavek 4 – pododstavek 1 a (novo)
Article 65 – paragraph 4 – subparagraph 1 a (new)
Informacije, ki jih pristojni organ ali Agencija potrdita kot zaupne, drugi pristojni organi, Agencija in Komisija obravnavajo kot zaupne.
Information accepted as confidential by a competent authority or the Agency shall be treated as confidential by other competent authorities, the Agency and the Commission.
Člen 66 – odstavek 1 – pododstavek 1 – uvodni del
Article 66 – paragraph 1 – subparagraph 1 – introductory part
Javnosti se omogoči lahko dosegljiv in brezplačen dostop do naslednjih informacij o aktivnih snoveh, ki jih ima Agencija ali Komisija:
The following information held by the Agency or the Commission on active substances shall be made publicly and easily available free of charge :
Javnosti se v eni sami podatkovni bazi, v strukturirani obliki vsaj na ustreznem spletnem mestu Komisije omogoči brezplačen dostop do naslednjih informacij o aktivnih snoveh, ki jih ima Agencija ali Komisija , kjer je to ustrezno :
The following information held by the Agency or , as appropriate, the Commission on active substances shall be made , free of charge, publicly available in a single database, in a structured format on at least the relevant website of the Commission :
Člen 66 – odstavek 1 – pododstavek 1 – točka d
Article 66 – paragraph 1 – subparagraph 1 – point d
(d) fizikalno-kemijski podatkov ter podatkov o porazdelitvi in vplivu v okolju ter obnašanju;
(d) physicochemical data and data on pathways and environmental fate and behaviour;
(d) fizikalno-kemijskih končnih točk ter podatkov o porazdelitvi in vplivu v okolju ter obnašanju;
(d) physicochemical endpoints and data on pathways and environmental fate and behaviour;
Izraz „podatki“ je presplošen; pomeni, da se študije ne nanašajo neposredno na končne točke.
The word "data" is too generic and means studies doesn't refers directly to endpoints.
Treba je razlikovati med specifičnimi rezultati študij (končne točke) in splošno besedo „podatki“.
It is necessary to clarify between the specific results of studies (endpoints) from the generic word data.
Namen predloga spremembe je poudariti razliko med izrazoma.
The aim of the amendment is to underline the difference between "end results" and "studies".
Člen 66 – odstavek 2 a (novo)
Article 66 – paragraph 2 a (new)
Brezplačno se zagotovi dostop javnosti do seznama, na katerem so navedeni biocidni proizvodi, ki so odobreni v skladu s členom 25, ter ustrezni proizvajalci.
Public access shall be granted free of charge to an inventory containing details of biocidal products authorised pursuant to Article 25 and of the corresponding manufacturers.
(Ponovna vložitev predloga spremembe 211 iz prve obravnave.)
(Reinstatement of amendment 211 from first reading.)
Nujno je, da se sestavi seznam proizvodov, da se tako potrošnike obvesti o biocidnih proizvodih, ki so dovoljeni v skladu z novim poenostavljenim dovoljenjem (ki nadomešča postopek z nizkim tveganjem).
It is essential to establish a product list to inform consumers about biocidal products authorised according to the new simplified authorization (which replaces the low risk procedure).
Člen 66 – odstavek 2 b (novo)
Article 66 – paragraph 2 b (new)
Osebe, odgovorne za dajanje biocidnih proizvodov na trg, na internetu objavijo seznam teh proizvodov.
The persons responsible for the placing on the market of biocidal products shall make available on the internet a list of such products.
To spletno mesto je treba uporabiti za izboljšanje preglednosti za potrošnike ter omogočiti lahko in hitro zbiranje podatkov o lastnostih in pogojih uporabe teh proizvodov.
This website shall serve to increase transparency for consumers and to facilitate an easy and fast collection of data on the properties and conditions of use of these products.
(Delna ponovna vložitev predloga spremembe 219 iz prve obravnave.)
(Partial reinstatement of amendment 219 from first reading.)
Člen 68 – odstavek 2 – pododstavek 1 – točka a a (novo)
Article 68 – paragraph 2 – subparagraph 1 – point a a (new)
(aa) ali izdelek vsebuje nanomateriale ter vsa s tem povezana posebna tveganja, ob vsaki navedbi nanomateriala pa v oklepaju tudi besedo „nano“;
(aa) whether the product contains nanomaterials and any specific related risks, and, following each reference to nanomaterials, the word "nano" in brackets;
(Ponovna vložitev predloga spremembe 213 iz prve obravnave.)
(Reinstatement of amendment 213 from first reading.)
Vpliv nanomaterialov na zdravje in okolje je še zelo slabo raziskan, lahko pa so vir specifičnih težav.
The impact of nanomaterials on health and the environment is largely unknown at present, yet they may pose specific problems.
Uporabnike biocidnih proizvodov bi bilo zato treba obvestiti prek ustreznega označevanja.
Any user of a biocidal product should therefore be informed via adequate labelling.
Člen 70 – odstavka 3 in 4
Article 70 – paragraphs 3 and 4
Vlagatelji uporabljajo register biocidnih proizvodov za pripravo in oddajo obrazca vloge za vse postopke v zvezi z odobritvijo aktivnih snovi in dovoljenjem za biocidne proizvode, medsebojnim priznanjem, izdajo dovoljenj za vzporedno trgovanje ter podaljšanjem, preklicem in spremembo dovoljenj.
Applicants shall use the Register for Biocidal Products to generate and submit the application form for all procedures relating to the approval of active substances and the authorisation of biocidal products, mutual recognition, the granting of parallel trade permits and the renewal, the cancellation and amendment of authorisations.