natgillin/translations-raw huggingface dataset:
Proizvajalec ali uvoznik snovi iz Priloge XIII ali pripravka ali izdelka, ki vsebuje tako snov, bo na zahtevo uporabnika na nižji stopnji, v kolikor je to razumno mogoče zahtevati, priskrbel nujne podatke za oceno učinkov snovi na zdravje ljudi in okolje, ob upoštevanju delovanja in uporabe, ki je navedeno v zahtevi.
Any manufacturer or importer of a substance listed in Annex XIII, or a preparation or article containing such a substance, shall at the request of the downstream user, in so far as this may reasonably be required, furnish the information necessary to assess the effects of the substance on human health or the environment with respect to the operations and uses indicated in that request.
Zahteve za podatke iz odstavka 1 veljajo smiselno na višji stopnji v dobavni verigi.
The information requirements specified in paragraph 1 shall apply mutatis mutandis up the supply chain.
Potrošniki imajo pravico od proizvajalca ali uvoznika zahtevati informacije o snoveh, prisotnih v izdelku, ki ga proizvaja ali uvaža.
Consumers shall have the right to ask the producer or importer for information on the substances present in an article produced or imported by him.
Izdelovalci ali uvozniki omogočijo, na zahtevo in v 15 delovnih dneh, kateremu koli posameznemu potrošniku brezplačen dostop do vseh podrobnosti o varnosti in uporabo informacij v zvezi s prisotnostjo snovi v katerem koli izdelku, ki so ga proizvedli ali uvozili.
Producers or importers shall, on request and within 15 working days, enable any individual consumer to obtain, free of charge, full details of safety and use information concerning the substances present in any article they have produced or imported.
Dostopnost informacij iz varnostnega lista delavcem
Access to the safety data sheet information for workers
ali proizvajalci
or the producer
, o snoveh, ki jih uporabljajo ali so jim lahko izpostavljeni med svojim delom.
in relation to substances they use or may be exposed to in the course of their work.
Prodajalec nevarne snovi, pripravka ali izdelka, ki vsebuje nevarne snovi, uporabniku, potrošniškim organizacijam ali drugim zainteresiranim organom omogoča dostopnost do informacij o snoveh, pripravkih in izdelkih iz členov 33 in 34.
The seller of a dangerous substance or preparation or a product containing dangerous substances shall grant the client, consumer bodies, or other interested bodies access to the information on those substances, preparations and products provided under Articles 33 and 34.
Obvezno shranjevanje informacij
Obligation to keep information
UPORABNIKI NA NIŽJI STOPNJI
DOWNSTREAM USERS
Ocene kemijske varnosti uporabnikov na nižji stopnji ter obvezna uporaba in priporočilo ukrepov za zmanjšanje tveganja
Downstream user chemical safety assessments and duty to apply and recommend risk reduction measures
Uporabnik na nižji stopnji lahko zagotovi informacije, ki pomagajo pri pripravi registracije.
A downstream user may provide information to assist in the preparation of a registration.
Te informacije se lahko pošljejo neposredno Agenciji.
The information may be submitted directly to the Agency.
Določbe poglavja III v zvezi z izmenjavo podatkov smiselno veljajo tudi za uporabnike na nižji stopnji.
The provisions of Title III relating to data sharing shall apply to the downstream user, mutatis mutandis.
Uporabnik na nižji stopnji ima pravico, da o uporabi pisno obvesti proizvajalca, uvoznika ali uporabnika na nižji stopnji, ki mu dobavlja snov, zato da bi ta postala navedena uporaba.
Any downstream user shall have the right to make a use known in writing to the manufacturer, importer or downstream user who supplies him with a substance with the aim of making this an identified use.
Pri tem zagotovi dovolj informacij, ki njegovemu dobavitelju omogočijo, da v svoji oceni kemijske varnosti za uporabo pripravi predviden potek izpostavljenosti.
In so doing, he shall provide sufficient information to allow his supplier to prepare an exposure scenario for his use in the supplier's chemical safety assessment.
Pri registriranih snoveh mora proizvajalec ali uvoznik izpolniti obveznost iz
For registered substances, the manufacturer or importer shall comply with the obligation laid down in
, preden naslednjič dobavi snov uporabniku na nižji stopnji, ki ga je obvestil o uporabi, če je bilo obvestilo poslano vsaj en mesec pred dobavo, ali pa v enem mesecu po obvestilu, kar nastopi pozneje.
before he next supplies the substance to the downstream user making the request, provided that the request was made at least one month before the supply, or within 1 month after the request, whichever is the later.
Pri snoveh v postopnem uvajanju mora proizvajalec ali uvoznik izpolniti to zahtevo in obveznosti iz
For phase-in substances, the manufacturer or importer shall comply with this request and with the obligations laid down in
pred potekom zadevnega roka iz
before the relevant deadline in
, če uporabnik na nižji stopnji pošlje obvestilo vsaj 12 mesecev pred potekom zadevnega roka.
, provided that the downstream user makes his request at least 12 months before the deadline in question.
Uporabnik snovi kot take ali v pripravku na nižji stopnji pripravi poročilo o kemijski varnosti v skladu s Prilogo XI za vse uporabe, ki ne spadajo pod pogoje iz predvidenega poteka izpostavljenosti, ki mu je bil sporočen v varnostnem listu.
A downstream user of a substance on its own or in a preparation shall prepare a chemical safety report in accordance with Annex XI for any use outside the conditions described in an exposure scenario communicated to him in a safety data sheet.
Če uporabnik na nižji stopnji izvaja ali priporoča predvideni potek izpostavljenosti, ki vključuje najmanj pogoje iz predvidenega poteka izpostavljenosti, ki mu je bil sporočen, mu ni treba sestaviti poročila o kemijski varnosti.
If the downstream user implements or recommends an exposure scenario which includes as a minimum the conditions described in the exposure scenario communicated to him, he need not prepare a chemical safety report.
Uporabniku na nižji stopnji ni treba pripraviti poročila o kemijski varnosti v naslednjih dveh primerih:
The downstream user need not prepare a chemical safety report in either of the following cases:
za snov ni treba dostaviti varnostnega lista;
a safety data sheet is not required to be communicated with the substance;
dobavitelju ni treba sestaviti poročila o kemijski varnosti.
a chemical safety report is not required to be completed by his supplier.
v njegovi oceni kemijske varnosti.
his own chemical safety assessment.
Uporabniki na nižji stopnji dajo svoja poročila o kemijski varnosti na razpolago drugim in jih sproti dopolnjujejo.
Downstream users shall keep their chemical safety report available and up to date.
Obvezno sporočanje informacij pri uporabnikih na nižji stopnji
Obligation for downstream users to report information
Pred začetkom določene uporabe snovi, ki jo je v skladu s
Before commencing a particular use of a substance that has been registered by an actor up the supply chain in accordance with
5 ali
5 or
registriral udeleženec, ki je v dobavni verigi na višji stopnji, mora uporabnik na nižji stopnji Agenciji sporočiti informacije iz odstavka 2 tega člena, če je dobil varnostni list, ki vključuje predvideni potek izpostavljenosti, in če uporabnik na nižji stopnji snov uporablja pod pogoji, ki niso opisani v tem predvidenem poteku izpostavljenosti.
, any downstream user shall report to the Agency the information specified in paragraph 2 of this Article, if a safety data sheet is communicated to him that includes an exposure scenario and the downstream user is using the substance outside the conditions described in that exposure scenario.
podatke o njem in podatke za stike;
his identity and contact details;
podatke o proizvajalcu(ih) ali uvozniku(ih), če je (so) znan(i);
if known, the identity of the manufacturer(s) or the importer(s);
kratek splošen opis uporabe (uporab);
a brief general description of the use(s);
predlog dodatnih preskusov na vretenčarjih, če uporabnik na nižji stopnji meni, da so nujno potrebni za dokončanje njegove ocene kemijske varnosti.
a proposal for additional testing on vertebrate animals, where this is considered necessary by the downstream user to complete his chemical safety assessment.
Če ti podatki niso na voljo, velja postopek iz člena 28.
Where such data are not available, the procedure under Article 28 shall apply.
Uporabnik na nižji stopnji te informacije takoj dopolni, če se spremenijo informacije, sporočene v skladu z odstavkom 1.
The downstream user shall update this information without delay in the event of a change in the information reported in accordance with paragraph 1.
Uporabnik na nižji stopnji obvesti Agencijo v obliki, ki jo določi Agencija v skladu s
A downstream user shall report to the Agency in the format specified by the Agency in accordance with
, če se njegova razvrstitev snovi razlikuje od razvrstitve njegovega dobavitelja.
if his classification of a substance is different to that of his supplier.
Poročanje v skladu z odstavki 1 do 4 se ne zahteva za snov kot tako ali v pripravku, ki jo uporabnik na nižji stopnji uporablja v količini, ki ne doseže ene tone na leto.
Reporting in accordance with paragraphs 1 to 4 shall not be required in respect of a substance, on its own or in a preparation, used by the downstream user in quantities of less than 1 tonne per year.
Postopek obveznega sporočanja informacij za mala in srednje velika podjetja
Procedure for compulsory notification of information by SMEs
Kjer je uporabnik na nižji stopnji malo ali srednje veliko podjetje v smislu člena 3(32) te uredbe, se uporablja postopek sporočanja iz člena 40, razen odstavka 2(f) in odstavkov 3, 4 in 5.
Where the downstream user is an SME within the meaning of Article 3(32), the notification procedure provided for in Article 40 shall apply, with the exception of paragraphs 2(f), 3, 4 and 5 thereof.
Nadaljnje podrobnejše preskuse na vretenčarjih in nevretenčarjih, ki se izkažejo za potrebne zaradi ocene Agencije, določi Agencija med obstoječimi preskusi.
Further more detailed tests on vertebrate and non-vertebrate animals which prove necessary as a result of the Agency's assessment shall be identified by the Agency from among existing tests.
Če preskusi iz odstavka 2 še ne obstajajo, Agencija naroči državi članici, v kateri ima malo ali srednje veliko podjetje sedež, da opravi preskuse.
If the tests referred to in paragraph 2 do not already exist, the Agency shall instruct the Member State in which the SME has its head office to carry out the tests.
Rezultati, ki so koristni za oceno varnosti, se sporočijo malemu ali srednje velikemu podjetju po zaključku preskusov.
Results which are useful to the safety assessments shall be notified to the SME following conclusion of the tests.
Če so rezultati preskusa negativni, Agencija čim prej obvesti vlagatelja (malo ali srednje veliko podjetje) in državo članico, v kateri ima vlagatelj sedež, da se zaustavi uporaba snovi, ki je bila preskušena.
The Agency shall as soon as possible notify the applicant (SME) and the Member State in which it has its head office if the results of the tests are negative with a view to blocking the use of the substance which has been tested.
Uporabnik na nižji stopnji mora posodobiti informacije, ki se sporočajo v skladu s členom 1, takoj ko se pojavijo spremembe teh informacij.
The downstream user SME shall be required to update the information reported under paragraph 1 as soon as any change occurs in this information.
Uporabnik na nižji stopnji obvesti Agencijo v obliki, ki jo določi Agencija v skladu s členom 119, če se njegova razvrstitev snovi razlikuje od razvrstitve njegovega dobavitelja.
A downstream user SME shall report to the Agency in the format specified by the Agency in accordance with Article 119 if his classification of a substance is different from that of his supplier.
Poročanje v skladu z odstavki 1 do 6 se ne zahteva za snov kot tako ali v pripravku, ki jo uporabnik na nižji stopnji uporablja v količini, ki ne doseže ene tone na leto.
Reporting in accordance with paragraphs 1 to 6 shall not be required in respect of a substance, on its own or in a preparation, used by the downstream user SME in quantities of less than one tonne per year.
Izpolnitev obveznosti uporabnikov na nižji stopnji
Application of downstream user obligations
Uporabniki na nižji stopnji morajo izpolniti zahteve iz
Downstream users shall be required to comply with the requirements of
najpozneje v 12 mesecih po prejemu številke registracije, ki jo sporočijo njihovi dobavitelji v varnostnem listu.
at the latest 12 months after receiving a registration number communicated to them by their suppliers in a safety data sheet.
najpozneje v 6 mesecih po prejemu številke registracije, ki jo sporočijo njihovi dobavitelji v varnostnem listu.
at the latest 6 months after receiving a registration number communicated to them by their suppliers in a safety data sheet.
NASLOV VI VREDNOTENJE SNOVI
TITLE VI EVALUATION OF SUBSTANCES
Polimeri so izvzeti iz vrednotenja v skladu s tem naslovom.
Polymers are exempted from evaluation under this Title.
OCENA DOKUMENTACIJE
DOSSIER EVALUATION
Odgovornost Agencije pri ocenjevanju dokumentacije
Responsibility of the Agency for dossier evaluation
Agencija je odgovorna za vrednotenje predlogov za preskuse in registracijske dokumentacije.
The Agency shall be responsible for the evaluation of the testing proposals and registration dossiers.
Agencija se za ta vrednotenja zanaša na organe, ki so jih za to določile posamezne države članice.
The Agency shall rely, for these evaluations, on the bodies designated for that purpose by each Member State.
Preučitev predlogov za preskuse
Examination of testing proposals
, ki vključuje preskuse na vretenčarjih
which involves vertebrate animal testing
Da se prepreči podvajanje preskusov na živalih, je kakršen koli predlog za preskus, ki vključujejo preskuse na vretenčarjih, odprt za pripombe zainteresiranih strank 90 dni.
In order to prevent duplication of animal testing, any testing proposal involving tests on vertebrate animals shall be open for comment by interested parties for a period of 90 days.
Vse prejete pripombe bo upošteval registracijski zavezanec ali uporabnik na nižji stopnji, ki Agencijo obvesti, ali kljub prejetim pripombam še vedno verjame, da je nujno izvesti predlagani preskus, in o svojih razlogih za to.
All comments received shall be taken into account by the registrant or the downstream user, who shall notify the Agency whether, in the light of the comments received, he nonetheless believes that it is necessary to carry out the proposed test and of his reasons therefor.
Pred pripravo osnutka odločitve se je treba posvetovati z ECVAM, kakor je navedeno v odstavku 4 o predlogu preskusa, ki vključuje preskuse na vretenčarjih.
ECVAM shall be consulted before a decision as referred to in paragraph 4 on a testing proposal that includes vertebrate animal tests is drafted.
Na podlagi preučitve v skladu z
On the basis of the examination under
členov 56 in 57
Articles 56 and 57
odločitev, ki od zadevnega(ih) registracijskega(ih) zavezanca(ev) ali uporabnika(ov) na nižji stopnji zahteva, da izvede(jo) predlagani preskus, in vsebuje rok za predložitev povzetka rezultatov preskusa ali zanesljivega študijskega povzetka, če to zahteva Priloga I;
a decision requiring the registrant(s) or downstream user(s) concerned to carry out the proposed test and setting a deadline for submission of the summary of the test result, or the robust study summary if required by Annex I;
odločitev v skladu s točko (a), vendar ob spremenjenih pogojih, pod katerimi naj bi se izvedel preskus;
a decision in accordance with point (a), but modifying the conditions under which the test is to be carried out;
odločitev o zavrnitvi predloga za preskus.
a decision rejecting the testing proposal.
Registracijski zavezanec zahtevane informacije predloži Agenciji.
The registrant shall submit the information required to the Agency.
lahko preuči vsako registracijo, da preveri eno ali oboje od naslednjega:
may examine any registration in order to verify either or both of the following:
ali informacije iz tehnične dokumentacije, predložene v skladu s
that the information in the technical dossier(s) submitted pursuant to
členom 11
Article 11
, izpolnjujejo zahteve iz
complies with the requirements of
členov 11, 13 in 14
Articles 11, 13 and 14
ter prilog IV do VIII;
and with Annexes IV to VIII;
ali prilagoditve zahtev za standardne informacije in utemeljitve zanje iz tehnične dokumentacije upoštevajo pravila, ki urejajo takšne prilagoditve iz prilog V do VIII, in splošna pravila iz Priloge IX.
that the adaptations of the standard information requirements and the related justifications submitted in the technical dossier(s) comply with the rules governing such adaptations set out in Annexes V to VIII and with the general rules set out in Annex IX.
Agencija v dvanajstih mesecih od objave letnega načrta ocenjevanja iz spodnjega odstavka 4
within 12 months of the publication of the annual evaluation plan referred to in paragraph 4
pripravi osnutek odločitve, ki od registracijskega(ih) zavezanca(ev) zahteva predložitev vseh informacij, potrebnih za uskladitev registracije (registracij) z ustreznimi zahtevami za informacije, ta odločitev pa se sprejme
requiring the registrant(s) to submit any information needed to bring the registration(s) into compliance with the relevant information requirements and that decision shall be taken in accordance
v skladu
with Articles
Registracijski zavezanec zahtevane informacije predloži Agenciji
The registrant shall submit the information required to the Agency
v razumnem roku, ki ga določi Agencija.
within a reasonable deadline to be set by the Agency.
Ta rok ne sme presegati šest mesecev.
This deadline shall not exceed six months.
Agencija prekliče številko registracije, če registracijski zavezanec v določenem roku ne predloži ustreznih informacij
The agency shall withdraw the registration number if the registrant fails to submit the relevant information within the deadline set
Agencija sestavi letni načrt za ocenjevanje registracijske dokumentacije, zlasti da oceni splošno kakovost.
The Agency shall establish an annual evaluation plan for registration dossiers, in particular to evaluate their overall quality.
Načrt zlasti določa, da se v tem obdobju oceni najmanjši odstotek registracijske dokumentacije.
The plan shall specify, in particular, the minimum percentage of registration dossiers to be evaluated during that period.
Ta odstotek ni nižji od 5 % povprečnega števila registracijskih dokumentacij v zadnjih treh letih.
This percentage shall not be lower than 5% of the average number of registration dossiers of the last three years.
Načrt se objavi na spletni strani Agencije.
The plan shall be published on the Agency's website.
Agencija pripravi letno poročilo o rezultatih ocenjevanja registracijske dokumentacije.
The Agency shall prepare an annual report on the results of the evaluation of the registration dossiers.
To poročilo še zlasti vključuje priporočila registracijskim zavezancem, da se izboljša kakovost prihodnjih registracij.
This report shall include, in particular, recommendations to registrants in order to improve the quality of future registrations.
Poročilo se objavi na spletni strani Agencije.
The report shall be published on the Agency's website.
Preverjanje predloženih informacij in nadaljnje ocenjevanje dokumentacije
Check of information submitted and follow-up to dossier evaluation
členom 45 ali 46
Article 45 or 46
, ter po potrebi pripravi ustrezne osnutke odločitev v skladu s
, and draft any appropriate decisions in accordance with
Ko je ocenjevanje dokumentacije končano,
Once the dossier evaluation is completed, the
uporabi informacije, pridobljene s tem
shall use the information obtained from this evaluation for the purposes of
členov 51(1), 65(4) in 75(2),
1), 65(4) and 75(2
ter pridobljene informacije pošlje
), and shall transmit the information obtained to the
Komisiji in državam članicam
Commission and the Member
Postopek in roki za preučitev predlogov za
Procedure and time periods for examination of testing
členom 45(4)
Article 45(4)
v 120 dneh
within 120 days of receiving a registration or downstream user report containing a testing
Pri snoveh v postopnem uvajanju pripravi
In the case of phase-in substances, the
osnutek odločitev v skladu s
shall prepare the draft decisions in accordance with
najpozneje do...
not later than ...
Pet let po začetku veljavnosti te uredbe.
Five years after the date of entry into force of this Regulation.
za vse registracije, prejete v roku iz
for all registrations received within the deadline referred to in Article
, ki vsebujejo predloge za preskuse za izpolnitev zahtev za informacije iz
containing proposals for testing in order to fulfil the information requirements in
prilog V do VIII
Annexes V to VIII
najpozneje do ..
not later than ...
Devet let po začetku veljavnosti te uredbe.
Nine years after the date of entry into force of this Regulation.
*. za vse registracije, prejete v roku iz
* for all registrations received within the deadline referred to in Article
prilog V do VII
Annexes V to VII
po rokih iz točk (a) in (b) za vse registracije s predlogi za preskuse, prejete v roku iz
after the deadlines set in points (a) and (b) for any registrations containing testing proposals received within the deadline referred to in Article
Seznam registracijskih dokumentacij, ki se ocenjujejo v skladu s členoma 45 in 46, je na voljo državam članicam.
The list of registration dossiers which are evaluated in accordance with Articles 45 and 46 shall be made available to the Member States.
Zahteve za informacije bodo izpolnjene v dveh letih po koncu vrednotenja predlogov za preskušanje.
The information requirements shall be fulfilled within two years after the finalisation of the evaluation of the testing proposals.
Postopek in roki za preverjanje
Procedure and time periods for compliance
organ pripravi osnutek odločitve v skladu s
shall prepare a draft decision in accordance with Article
v 12 mesecih po začetku vrednotenja snovi.
within 12 months of the start of the evaluation of the substance.
VREDNOTENJE SNOVI
SUBSTANCE EVALUATION
Merila za vrednotenje snovi
Criteria for substance evaluation
Za zagotovitev usklajenega pristopa Agencija pripravi merila za določitev prednostnega seznama snovi za nadaljnje vrednotenje.
In order to provide a harmonised approach, the Agency shall develop criteria for prioritising substances with a view to further evaluation.
Prednostni seznam se določi na podlagi pristopa, utemeljenega na
Prioritisation shall be on a risk-based approach
Agencija objavi seznam prednostnih snovi za oceno na svoji spletni strani.
The Agency shall publish the list of priority substances for evaluation on its website.
Tekoči načrt Skupnosti
Community rolling plan
Agencija sestavi osnutek
The Agency
za namene
plan for
enega od naslednjih vzrokov:
on the basis of either of the following:
strukturne podobnosti snovi z znanimi snovmi, ki vzbujajo skrb, ali snovmi, ki so obstojne in se lahko kopičijo v organizmih, kar kaže na to, da ima snov ali eden ali več njenih proizvodov preobrazbe lastnosti, ki vzbujajo skrb, ali da so obstojni in se lahko kopičijo v organizmih;
structural similarity of the substance with known substances of concern or with substances which are persistent and liable to bio-accumulate, suggesting that the substance or one or more of its transformation products has properties of concern or is persistent and liable to bio-accumulate;
skupne količine iz registracij, ki jih predloži več registracijskih zavezancev.
aggregated tonnage from the registrations submitted by several registrants.
Agencija predloži državam članicam osnutek tekočega načrta Skupnosti do 31. decembra vsako leto.
The Agency shall submit the draft Community rolling plan to Member States by 31 December of each year.