natgillin/translations-raw huggingface dataset:
in, kjer je ustrezno, ime in naslov tretje strani, ki je sporazumno imenovana, da deluje kot oseba za stike za potencialnega registracijskega zavezanca za namene tega člena in členov 30 in 31;
and, where appropriate, the name and address of any third party appointed by mutual agreement to act as contact person for the potential registrant for the purposes of this Article and Articles 30 and 31;
izjavo o tem, ali proizvajalec ali uvoznik ali tretja stran iz točke (b) soglaša z objavo svojega imena in naslova v skladu s členom 30;
a statement indicating whether consent is given for the publication, pursuant to Article 30, of the name and address of the manufacturer or importer or a third party as referred to in point (b);
predvideni rok za registracijo/količinski
the envisaged deadline for the registration/tonnage
kratek splošen opis navedenih uporab; kot najmanjše osnovne informacije o skupinah uporabe in izpostavljenosti, kot je določeno v oddelku 6 Priloge IV;
a brief general description of identified uses; as a minimum initial information on use and exposure categories as specified in section 6 of Annex IV;
seznam uporab, ki jih namerava podpirati z registracijo.
a list of the uses which he intends to support through registration.
Potencialni registracijski zavezanec lahko omeji informacije, ki se predložijo v skladu s prvim pododstavkom, na tiste končne točke/lastnosti, za katere so se zahtevali preskusi.
The potential registrant may limit the information to be submitted under the first subparagraph to those endpoints/properties for which tests were required.
Informacije iz odstavka 1 se predložijo
The information referred to in paragraph 1 shall be submitted
Po poteku obdobja iz odstavka 3 Agencija na zahtevo nižjestopenjskega uporabnika snovi, ki ni bila predhodno registrirana, kateri koli osebi, ki ni prvotni dobavitelj te snovi uporabniku na nižji stopnji, dovoli poznejšo prijavo na seznam snovi, in sicer še dodatnih šest mesecev po objavi seznama.
If the deadline laid down in paragraph 3 has elapsed, the Agency shall, upon request by a downstream user of a substance that has not been pre-registered, permit late notification to the register of substances by any person other than the original supplier of that substance to the downstream user for a further six months after the publication of the register.
Takšna prijava potencialnim registracijskim zavezancem omogoča, da so upravičeni do prehodnega režima.
Such notification shall enable the potential registrant to benefit from the transitional regime.
V skladu z odstavkom 4
Subject to paragraph 4,
registracijski zavezanci, ki ne predložijo zahtevanih informacij iz odstavka 1, ne morejo uveljavljati
registrants who do not submit the information required under paragraph 1 shall not be able to rely on
v enem mesecu od izteka roka iz odstavkov 3 sestavi seznam snovi, predhodno registriranih v skladu s tem odstavkom, javno dostopen prek spleta.
within one month of the expiry of the deadline laid down in paragraph 3, make a list of the substances pre-registered in accordance with that paragraph publicly available over the Internet.
Seznam vsebuje le imena snovi, vključno s številkama EINECS in CAS, če sta na voljo;
The list shall comprise only the names of the substances, including their EINECS and CAS number if available;
če je bila enaka snov registrirana pred manj kot desetimi leti, potencialnemu(im) registracijskemu(im) zavezancu(em) takoj sporoči ime(na) in naslov(e) predhodnega(ih) registracijskega(ih) zavezanca(ev) ter ustrezne povzetke ali zanesljive študijske povzetke študij, odvisno od primera, ki so jih ti predložili.
if the same substance has been previously registered less than 10 years earlier, inform the potential registrant(s) without delay of the name(s) and address(es) of the previous registrant(s) and of the relevant summaries or robust study summaries of the studies, as the case may be, already submitted by them.
Dostopne raziskave je treba deliti s potencialnim(i) registracijskim(i) zavezancem(i).
The available studies must be shared with the potential registrant(s).
Proizvajalci in uvozniki predložijo Agenciji kakršne koli podatke, ki jih imajo o preskusih na vretenčarjih, in druge podatke, s katerimi bi se lahko izognili preskusom na živalih, tudi v zvezi s snovmi, ki so jih prenehali izdelovati ali uvažati.
Manufacturers and importers shall forward to the Agency any information in their possession deriving from experiments on vertebrate animals and other information that could prevent animal experimentation, in relation also to substances they have ceased to manufacture or import.
Registracijski zavezanci, ki takšne podatke kasneje uporabljajo, delijo stroške nastajanja takšnih podatkov v skladu s sorazmernim obsegom proizvodnje vsake strani.
Registrants who later make use of such information shall share the costs of creating such information in a manner that is proportional to each party's production volume.
Vsakdo, ki ima rezultate raziskav ali druge podatke o snovi, ki izhaja iz preskusov na vretenčarjih, po preteku roka iz odstavka 2, mora takšne podatke predložiti Agenciji.
Anyone coming into possession of the results of studies or other information on a substance derived from experiments on vertebrate animals after the expiry of the deadline referred to in paragraph 2 shall forward such information to the Agency.
Proizvajalci in uvozniki snovi v postopnem uvajanju v količini, ki znaša manj kot eno tono na leto, ter uporabniki na nižji stopnji lahko predložijo Agenciji informacije iz odstavka 1 v obliki, ki jo določi Agencija v skladu s
Manufacturers and importers of phase-in substances in quantities of less than 1 tonne per year, as well as downstream users, may submit the information referred to in paragraph 1 to the Agency in the format specified by the Agency in accordance with
Agencija vnese informacije, predložene v skladu z
The Agency shall record the information submitted in accordance with
odstavki 1 do 8
paragraphs 1 to 8
, v zbirko podatkov.
in a database.
Proizvajalcem in uvoznikom, ki so predložili informacije o teh snoveh v skladu z
It shall grant access to these data held on each substance to the manufacturers and importers who have submitted information on that substance in accordance with
Seznam snovi
Register of substances
Agencija vodi seznam snovi, ki vključuje informacije iz člena 29.
The Agency shall operate a register of substances containing the information specified in Article 29.
Agencija objavi vse predregistrirane snovi s seznama snovi v enem mesecu po preteku roka iz člena 29(3) in navede:
The Agency shall publish all pre-registered substances in the register of substances within one month after the expiry of the deadline laid down in Article 29(3), indicating:
ime snovi in, kjer je ustrezno, skupino snovi, vključno s številkama EINECS in CAS, če sta na voljo;
the name of the substance and, where applicable, the group of substances, including EINECS and CAS numbers, if available;
kjer je ustrezno, ime in naslov proizvajalca ali uvoznika ali predstavnika tretje strani, če je bilo dano soglasje v skladu s členom 29(1)(c);
where applicable, the name and address of the manufacturer or importer or the third party representative, provided that consent pursuant to Article 29(1)(c) has been given;
splošen opis navedenih uporab; kot najmanjše osnovne informacije o uporabi in izpostavljenosti v skladu s členom 29(1)(e);
a general description of identified uses; as a minimum, initial information on use and exposure in accordance with Article 29(1)(e);
prvi rok za registracijo vsake snovi v skladu s členom 23.
the first deadline for the registration of each substance in accordance with Article 23.
Agencija objavi ime snovi in, kjer je ustrezno, skupino snovi, vključno s številkama EINECS in CAS, če sta na voljo, za katere je bila zahtevana poznejša prijava, takoj po prejemu takšnih zahtev.
The Agency shall publish the name of the substance and, where applicable, the group of substances, including EINECS and CAS numbers, if available, in respect of which late notification has been requested, immediately following the receipt of such requests.
V enem mesecu po poteku roka za poznejšo prijavo v skladu s členom 29(4) Agencija prilagodi seznam snovi zadnjemu stanju, da vključi tiste snovi, za katere so bile prejete poznejše predregistracije.
Within one month of the expiry of the late notification period pursuant to Article 29(4), the Agency shall update the register of substances to include those substances for which late pre-registrations have been received.
Agencija skupaj z objavo seznama snovi v skladu z odstavkoma 1 in 4 objavi zahtevo za vse, ki imajo študije o vretenčarjih, ki niso dostopne javnosti, da predložijo podatke o razpoložljivosti takšnih študij.
The Agency shall publish together with the publication of the register of substances, pursuant to paragraphs 1 and 4, a request to anyone who owns studies on vertebrate animals which are not publicly available to submit indications on the availability of such studies.
Vsak, ki ima takšne študije, lahko Agenciji pošlje podatke o njihovi razpoložljivosti v šestih mesecih od objave seznama snovi v skladu z odstavkom 4 in Agencija te informacije vključi v zbirko podatkov v skladu s členom 29(9).
Anyone who owns such studies may send indications on the availability of such studies to the Agency, within six months of the publication of the register of substances, pursuant to paragraph 4, and the Agency shall include this information in the database in accordance with Article 29(9).
Takšne študije se uporabljajo v skladu s členom 32.
Such studies shall be used in accordance with Article 32.
Pristojna mesta za izmenjavo informacij o snoveh
Substance Information Exchange Fora
Vsi proizvajalci in uvozniki, ki so Agenciji predložili informacije v skladu s
All manufacturers and importers who have submitted information to the Agency in accordance with
členom 29
Article 29
Udeleženci SIEF si morajo prizadevati za dogovor o razlagi informacij, ki si jih izmenjujejo.
Sief participants shall make every effort to agree on the interpretation of the information that they exchange.
Izmenjava podatkov o preskusih
Sharing of data involving tests
med registracijskimi zavezanci
between registrants
preskus za
testing is
člena 29(9)
Article 29(9)
zanjo v dveh mesecih po poteku roka iz člena
request that study within two months of the deadline set in
V dveh tednih po oddaji zahtevka lastnik študije zagotovi udeležencu(em), ki je (so) to zahteval(i) dokazilo o svojih stroških.
Within two weeks of the request, the owner of the study shall provide proof of its cost to the participant(s) requesting it.
Udeleženec(ci) in lastnik sprejmejo vse razumne ukrepe, da dosežejo sporazum o razdelitvi stroškov.
The participant(s) and the owner shall take all reasonable steps to reach an agreement on how to share the cost.
Če takšnega sporazuma ne morejo doseči, se stroški razdelijo
If they cannot reach such an agreement, the cost shall be shared
sorazmerno z obsegom proizvodnje vsake stranke
in a way which is proportional to each party's production volume
Lastnik študijo zagotovi v dveh tednih po prejemu plačila.
The owner shall provide the study within two weeks of receipt of payment.
Če morebitni registracijski zavezanci ne dajo informacij o preskusih na vretenčarjih ali drugih informacij, ki bi lahko preprečile preskušanje na živalih, na razpolago Agenciji, izgubijo pravico do registracije zadevne snovi.
Failure to make available to the Agency vertebrate animal data or other information that could prevent animal testing will result in potential registrants forfeiting their right to register the substance concerned.
Če drug(i) udeleženec(ci) ne plača(jo) svojega deleža stroškov, ne bo(do) mogel(li) registrirati svoje snovi.
If the other participant(s) fail to pay their share of the cost, they shall not be able to register their substance.
Če lastnik študije ne da študije na razpolago Agenciji, ne bo mogel registrirati svoje snovi.
If the owner of the study fails to make the study available to the Agency, he shall not be able to register his substance.
Če zadevna študija, ki vključuje
If a relevant study involving
Sprejmejo vse razumne ukrepe, da se sporazumejo o tem, kdo jo bo opravil v imenu drugih udeležencev.
They shall take all reasonable steps to reach an agreement as to who is to carry it out on behalf of the other participants.
Če lastnik študije iz
If the owner of a study as referred to in
odstavka 5
paragraph 5
V takšnih primerih se Agencija odloči, da da drugemu(im) udeležencu(em) na razpolago ta povzetek ali zanesljivi študijski povzetek, odvisno od primera.
In such cases, the Agency shall take the decision to make available to the other participant(s) that summary or robust study summary, as the case may be.
Drugi registracijski zavezanec ima do udeležencev terjatev v višini
The other registrant shall have a claim on the participants for
sorazmernega z obsegom njegove proizvodnje,
which is proportional to his production volume,
ki je izterljiv na nacionalnih sodiščih.
which shall be enforceable in the national courts.
tega člena se lahko vloži pritožba v skladu s
An appeal may be brought, in accordance with
členi 98, 99
Articles 98, 99
Lastnik študije, ki zavrne zagotovitev dokazila o stroških ali same študije, kot je navedeno v
The owner of the study who has refused to provide either the costs or the study itself, as referred to in
odstavku 6
paragraph 6
, je kaznovan v skladu s
, shall be penalised in accordance with
členom 134
Article 134
OBVEŠČANJE V DOBAVNI VERIGI
INFORMATION IN THE SUPPLY CHAIN
Zahteve za varnostne liste
Requirements for Safety Data Sheets
oseba, odgovorna za dajanje snovi ali pripravka v promet, pa naj si bo to proizvajalec, uvoznik, uporabnik na nižji stopnji ali distributer, dostavi prejemniku, ki je uporabnik snovi ali pripravka na nižji stopnji ali njun distributer,
, the person responsible for placing that substance or preparation on the market, whether the manufacturer, importer, downstream user or distributor, shall supply the recipient, who is a downstream user or distributor of the substance or preparation,
varnostni list
with a safety data sheet
v zvezi s snovjo ali pripravkom
relating to the substance or the preparation and
oceniti kemijsko varnost, zagotovi, da so informacije v varnostnem listu skladne z informacijami iz te ocene.
, to carry out a chemical safety assessment as part of his registration for a substance shall ensure that the information in the safety data sheet is consistent with the information in this assessment.
Če se varnostni list sestavi za pripravek, lahko udeleženec dobavne verige pripravi oceno kemijske varnosti za pripravek v skladu s Prilogo Ib.
If the safety data sheet is developed for a preparation, the actor in the supply chain may prepare a chemical safety assessment for the preparation in accordance with Annex Ib.
V tem primeru zadostuje, da so informacije iz varnostnega lista skladne s poročilom o kemijski varnosti za pripravek, in ni treba, da so skladne s poročilom o kemijski varnosti za vsako snov iz pripravka.
In that case, it is sufficient if the information in the safety data sheet is consistent with the chemical safety report for the preparation instead of with the chemical safety report for each substance in the preparation.
Če pripravek ne izpolnjuje meril za razvrstitev kot nevaren v skladu s členi 5, 6 in 7 Direktive 1999/45/
Where a preparation does not meet the criteria for classification as dangerous in accordance with Articles 5, 6 and 7 of Directive 1999/45/EC, but contains in an individual concentration of ≥ 1 % by weight for non-gaseous preparations and ≥
, vsebuje pa v posamezni koncentraciji ≥ 1 mas. % za neplinaste pripravke in ≥ 0,2 vol. % za plinaste pripravke vsaj eno snov, ki je nevarna za zdravje ali okolje, ali eno snov, za katero veljajo v Skupnosti omejitve glede izpostavljenosti na delovnem mestu, oseba, ki je odgovorna za dajanje tega pripravka v promet, pa naj si bo to proizvajalec, uvoznik, uporabnik na nižji stopnji ali distributer,
% by volume for gaseous preparations at least one substance posing health or environmental hazards, or one substance for which there are Community workplace exposure limits, the person who is responsible for placing that preparation on the market, whether the manufacturer, importer, downstream user or distributor, shall supply
na nižji stopnji varnostni list v skladu s Prilogo Ia.
a safety data sheet compiled in accordance with Annex Ia.
Varnostnih listov ni treba dostaviti, če so nevarne snovi ali pripravki, ki so v ponudbi ali prodaji za splošno javnost, opremljeni z zadostnimi informacijami, ki uporabnikom omogočajo sprejetje vseh potrebnih ukrepov glede varovanja zdravja, varnosti in okolja, razen če jih ne zahteva uporabnik na nižji stopnji.
The safety data sheet need not be supplied where dangerous substances or preparations offered or sold to the general public are provided with sufficient information to enable users to take the necessary measures as regards the protection of health, safety and the environment, unless requested by a downstream user.
Varnostni list se
The safety data sheet shall be
dostavi v
supplied in
uradnih jezikih držav članic, v katerih se snov ali pripravek daje v promet.
the official languages of the Member States in which the substance or preparation is placed on the market.
Varnostni list se opremi z datumom in vsebuje naslednje postavke:
The safety data sheet shall be dated and shall contain the following headings:
podatke o snovi/pripravku in podjetju;
identification of the substance/preparation and of the company/undertaking;
opredelitev nevarnosti;
hazards identification;
sestavo/informacije o sestavinah;
composition/information on ingredients;
ukrepe prve pomoči;
first-aid measures;
ukrepe za gašenje požara;
fire-fighting measures;
ukrepe ob nenamernem izpustu;
accidental release measures;
ravnanje in skladiščenje;
handling and storage;
nadzor izpostavljenosti/osebno varovanje;
exposure controls/personal protection;
obstojnost in reaktivnost;
stability and reactivity;
toksikološke informacije;
toxicological information;
ekološke informacije;
ecological information;
premisleke o odstranjevanju;
disposal considerations;
informacije o prevozu;
transport information;
regulativne informacije;
regulatory information;
druge informacije.
other information.
Če se oceni kemijska varnost, se ustrezni predvideni potek izpostavljenosti
Where a chemical safety assessment is performed the relevant exposure scenarios
, ustrezni opisi tveganja in z njim povezane skupine uporab in izpostavljenosti dodajo
and the corresponding description of the risk, and the related use and exposure categories,
kot priloga k varnostnemu listu.
shall be placed in an annex to the safety data sheet.
Za navedene uporabe uporabnik na nižji stopnji uporabi ustrezne informacije iz varnostnega lista, ki je bil dostavljen.
For identified uses, a downstream user shall use appropriate information from the safety data sheet supplied to him.
Varnostni list se dostavi
A safety data sheet shall be supplied on paper or electronically
na papirju ali v elektronski obliki najpozneje do prve dostave snovi, ki sledi začetku veljavnosti te uredbe
at the latest at the time of the first delivery of a substance following the entry into force of this Regulation
, razen če je bil varnostni list v skladu s temi določbami dostavljen pred začetkom veljavnosti te uredbe
, unless a safety data sheet has been supplied, in accordance with these provisions, prior to the entry into force of this Regulation
Dobavitelji ga takoj prilagodijo zadnjemu stanju v naslednjih primerih:
Suppliers shall update it without delay on the following occasions:
ki lahko vplivajo na ukrepe
risk management measures
za obvladovanje
becomes available
izdaji dovoljenja ali njegovi zavrnitvi;
an authorisation has been granted or refused;
Komisija organizira razvoj tehničnih smernic, ki določajo najmanjše zahteve za varnostne liste, da bi se zagotovilo jasno in primerno zagotavljanje podatkov za najboljšo uporabo s strani vseh udeležencev v dobavni verigi navzgor in navzdol.
The Commission shall organise the development of technical guidelines setting minimum requirements for safety data sheets, to ensure the provision of clear and adequate information of optimal use to all actors up and down the supply chain.
Obvezno sporočanje informacij po dobavni verigi navzdol za snovi in pripravke, za katere se ne zahteva varnostnega lista
Duty to communicate information down the supply chain for substances and preparations for which a safety data sheet is not required
Vsi udeleženci dobavne verige
All actors in the supply chain
ali distributerji
or distributors
snovi kot take ali v pripravku, ki jim ni treba dostaviti varnostnega lista v skladu s
of a substance on its own or in a preparation who do not have to supply a safety data sheet in accordance with
sporočijo neposrednemu uporabniku ali distributerju na nižji stopnji v dobavni verigi naslednje informacije:
the following information down the supply chain to the immediate downstream user or distributor:
, če je (so) na voljo
, if available
, za vse snovi, za katere se sporočajo podatki iz te točke ali točke (b) ali (c) tega odstavka
, for any substances for which information is communicated under this point or points (b) or (c) of this paragraph
ali je treba za snov pridobiti dovoljenje ter vse podrobnosti o dovoljenjih, ki so bila v tej dobavni verigi izdana ali zavrnjena v skladu z naslovom VII;
whether the substance is subject to authorisation and details of any authorisation granted or denied under Title VII in this supply chain;
podrobne podatke o vseh omejitvah, uvedenih v skladu z naslovom VIII;
details of any restriction imposed under Title VIII;
vse druge razpoložljive in pomembne informacije o snovi,
any other available and relevant information about the substance
ki lahko vplivajo na ukrepe
which may affect the
za obvladovanje tveganja,
risk management measures
takoj ko bodo na voljo.
becomes available.
Informacije se sporočijo pisno
Information shall be communicated in writing
ali v elektronski obliki
or electronically
najpozneje do prve dostave snovi, ki sledi začetku veljavnosti te uredbe.
at the latest at the time of the first delivery of a substance following the entry into force of this Regulation.
Dobavitelji te informacije takoj prilagodijo zadnjemu stanju in sporočijo navzdol po dobavni verigi v naslednjih primerih:
Suppliers shall update this information and communicate it down the supply chain without delay on the following occasions:
takoj ko so na voljo novi podatki, ki so lahko potrebni, da omogočijo določitev in uporabo ustreznih ukrepov za obvladovanje tveganja;
as soon as new data which may be necessary to enable appropriate risk management measures to be identified and applied become available;
po registraciji snovi;
once the substance has been registered;
po izdaji dovoljenja ali njegovi zavrnitvi;
once an authorisation has been granted or refused;
po uvedbi omejitve.
once a restriction has been imposed.
Obvezno sporočanje informacij o snoveh in pripravkih po dobavni verigi navzgor
Duty to communicate information on substances and preparations up the supply chain
Vsak udeleženec dobavne verige snovi ali pripravka sporoči naslednjemu udeležencu ali distributerju, ki je v dobavni verigi na višji stopnji, naslednje informacije:
Any actor in the supply chain of a substance or a preparation shall communicate the following information to the next actor or distributor up the supply chain:
nove informacije o nevarnih lastnostih, ne glede na zadevne uporabe;
new information on hazardous properties, regardless of the uses concerned;
vse druge informacije, ki bi lahko povzročile dvom o ustreznosti ukrepov za obvladovanje tveganja iz dostavljenega varnostnega lista, ki bodo sporočene samo za navedene uporabe.
any other information that might call into question the appropriateness of the risk management measures identified in a safety data sheet supplied to him, which shall be communicated only for identified uses.
Distributerji te informacije sporočijo naslednjemu udeležencu ali distributerju iz dobavne verige, ki je na višji stopnji.
Distributors shall pass on that information to the next actor or distributor up the supply chain.