natgillin/translations-raw huggingface dataset:
Skupina uporabe in izpostavljenosti pomeni glavne skupine uporab (npr. industrijsko uporabo, poklicno uporabo, potrošniško uporabo) in pomembne načine izpostavljenosti (npr. oralno, dermalno, z vdihavanjem, iz okolja) ter vzorce izpostavljenosti (npr. pogosto, slučajno, občasno, trajno).
Use and exposure category means the main use categories (e.g. industrial use, professional use, consumer use) and the significant routes of exposure (e.g. oral, dermal, inhalation, environmental) and patterns of exposure (e.g. frequent, accidental, occasional, continuous);
Mineral pomeni kombinacijo anorganskih sestavin, kot se nahajajo v zemeljski skorji, z značilnim sklopom kemijskih sestav, kristaliničnih oblik in fizikalno-kemijskih lastnosti.
Mineral means a combination of inorganic constituents as found in the earth's crust, with a characteristic set of chemical compositions, crystalline forms and physicochemical properties.
NASLOV II REGISTRACIJA SNOVI
TITLE II REGISTRATION OF SUBSTANCES
PODROČJE UPORABE Člen 4 Področje
SCOPE Article 4
tega naslova se izvzamejo naslednje snovi:
following shall be exempted from this Title:
snovi iz Priloge II;
substances included in Annex II;
snovi iz Priloge III;
substances covered by Annex III;
snovi kot take ali v pripravkih, registrirane v skladu s tem naslovom, ki jih udeleženec dobavne verige izvozi iz Skupnosti, nazaj v Skupnost pa ponovno uvozi drug udeleženec iste dobavne verige, ki dokaže:
substances on their own or in preparations, registered in accordance with this Title, exported from the Community by an actor in the supply chain and re-imported into the Community by another actor in the same supply chain who shows that:
da je snov, ki naj bi se ponovno uvozila, ista kot izvožena snov;
the substance being re-imported is the same as the exported substance;
da je za izvoženo snov dobil informacije v skladu
he has been provided with the information in accordance with
s členoma 34
Articles 34
snovi v pripravkih, ki izpolnjujejo merila za registracijo, ki jih je za to uporabo že registriral udeleženec dobavne verige;
substances in preparations meeting the criteria for registration, that have already been registered for that use by an actor in the supply chain;
snovi kot take ali v pripravkih, ki jih proizvajalec ali uvoznik registrira v skladu s tem naslovom in ki jih v Skupnosti reciklira drugi proizvajalec ali uvoznik, ki dokaže, da:
substances on their own or in preparations, which have been registered in accordance with this Title by a manufacturer or importer and which are recycled in the Community by another manufacturer or importer who shows that:
je snov, ki izvira iz postopka recikliranja, enaka snovi, ki je že registrirana; in
the substance resulting from the recycling process is the same as the already registered substance; and
je dobil informacije v skladu s členoma 33 in 34 v zvezi z registriranimi snovmi.
he has been provided with the information in accordance with Articles 33 and 34 relating to the registered substance.
SPLOŠNA OBVEZNOST REGISTRIRANJA IN ZAHTEVE GLEDE OBVEŠČANJA Člen 5 Splošna obveznost registriranja snovi kot takih ali v pripravkih
GENERAL OBLIGATION TO REGISTER AND INFORMATION REQUIREMENTS Article 5 General obligation to register substances on their own or in preparations
Razen tam, kjer ta uredba določa drugače, mora vsak proizvajalec snovi v količini, ki znaša letno eno tono ali več, pri Agenciji vložiti zahtevek za registracijo.
Save where this Regulation provides otherwise, any manufacturer of a substance in quantities of 1 tonne or more per year shall submit a registration to the Agency.
Razen tam, kjer ta uredba določa drugače, mora vsak uvoznik snovi kot take ali v pripravku v količini, ki znaša eno tono ali več na leto, pri Agenciji vložiti zahtevek za registracijo.
Save where this Regulation provides otherwise, any importer of a substance, either on its own or in a preparation, in quantities of 1 tonne or more per year shall submit a registration to the Agency.
člena 17
Articles 17
ne uporabljata.
shall not apply.
Vsak proizvajalec ali uvoznik polimera vloži pri Agenciji zahtevek za registracijo neregistrirane(ih) monomerne(ih) snovi
Any manufacturer or importer of a polymer shall submit a registration to the Agency for the non-registered monomer substance(s)
, ki je(jih) ni registriral udeleženec dobavne verige na višji stopnji,
not registered by an upstream actor in the supply chain
ali druge(ih) neregistrirane(ih) snovi,
or other non-registered substance(s)
razen če te monomerne snovi nastanejo pri sintezi in se jih ne da izolirati,
, except where such monomer substances are formed during synthesis and cannot be isolated,
če sta izpolnjena oba naslednja pogoja:
if both the following conditions are met:
polimer vsebuje 2 odstotka mase na maso (m/m) ali več takšne(ih) monomerne(ih) ali druge(ih) snovi;
the polymer consists of 2% weight by weight (w/w) or more of such monomer substance(s) or other substance(s);
skupna količina takšne(ih) monomerne(ih) ali druge(ih) snovi znaša eno tono ali več na leto.
the total quantity of such monomer substance(s) or other substance(s) makes up 1 tonne or more per year.
Prijava takšnega monomera/snovi vključuje naslednje informacije v obliki, ki jo določi Agencija v skladu s členom 119:
A notification for such monomer/substance shall include the following information in the format specified by the Agency in accordance with Article 119:
podatke o proizvajalcu ali uvozniku ter podatke za vzpostavitev stika z njim;
the identity and contact details of the producer or importer;
podatke o monomeru/snovi v skladu z oddelkom 2 Priloge IV;
the identity of the monomer/substance as specified in section 2 of Annex IV;
razvrstitev snovi;
the classification of the substance;
kratek opis uporabe polimera.
a brief description of the use of the polymer.
Registracija v skladu s tem naslovom se opravi za neregistrirano monomerno snov ali drugo neregistrirano snov, ki se proizvede ali uvozi v količini, ki presega 1000 ton na leto.
A registration under this Title shall be made for the non-registered monomer substance manufactured or imported in quantities of more than 1000 tonnes per year.
Ta registracija poleg zgoraj zahtevanih informacij vključuje še informacije iz Priloge V.
This registration shall include the information specified in Annex V in addition to the information required above.
Neregistrirane monomerne snovi ali druge neregistrirane snovi so snovi, ki jih proizvajalec, ki takšne snovi dobavlja proizvajalcu polimerov, ni registriral.
Non-registered monomer substances or other non-registered substances are substances that have not been registered by the manufacturer who supplies such substances to the polymer manufacturer.
Vseeno pa, če je prvotni proizvajalec ali njegov imenovani zastopnik registriral neregistrirane monomerne snovi ali druge snovi, lahko proizvajalec polimera uporabi to registracijo pod pogojem, da je registracijski zavezanec navedel, da se uporablja pri proizvodnji polimerov.
However, where non-registered monomer substances or other substances were registered by the original manufacturer or by a designated representative thereof, the polymer manufacturer may make use of this registration provided that the registrant has indicated that it is used in the manufacture of polymers.
Ob predložitvi vloge za registracijo se plača pristojbina, kot jo določi Agencija.
A submission for registration shall be accompanied by the fee as set by the Agency.
Člen 6 Splošna obveznost registriranja snovi v izdelkih
Article 6 General obligation to register substances in articles
Proizvajalec ali uvoznik izdelkov predloži Agenciji vlogo za registracijo vseh snovi, ki jih vsebujejo ti izdelki, če so izpolnjeni vsi naslednji pogoji:
Any producer or importer of articles shall submit a registration to the Agency for any substance contained in those articles, if all the following conditions are met:
snov izpolnjuje merila za razvrstitev kot nevarna v skladu z Direktivo 67/548/EGS;
the substance meets the criteria for classification as dangerous in accordance with Directive 67/548/EEC;
snov naj bi se sprostila pod običajnimi in razumno predvidljivimi pogoji uporabe.
the substance is intended to be released under normal and reasonably foreseeable conditions of use.
Odstavek 1(a) ne velja za snovi, ki so sestavine, dodane tobačnim izdelkom v smislu člena 2(1) in (5) Direktive 2001/37/ES.
Paragraph 1(a) shall not apply to substances which are ingredients added to tobacco products within the meaning of Article 2(1) and (5) of Directive 2001/37/EC.
Kateri koli
listed in Annex XIII(a)
proizvajalec ali uvoznik izdelkov prijavi pri Agenciji v skladu z
contained in those articles in accordance with
odstavkom 4
paragraph 4
presegajo mejne vrednosti, določene v Direktivi 1999/45/ES, zaradi česar so pripravki razvrščeni kot nevarni, za vse druge snovi;
it is present above the concentration limits specified in Directive 1999/45/EC for classification as dangerous, for all other substances;
proizvajalec ali uvoznik
the producer or importer
ne more izključiti izpostavljenosti ljudi in okolja tej snovi v celotnem življenjskem ciklu izdelka.
cannot exclude any exposure of the public or the environment to the substance during the full life-cycle of the article.
, morajo informacije, ki se sporočijo v obliki, ki jo določi Agencija v skladu s
are met, the information to be notified shall include the following, in the format specified by the Agency in accordance with
členom 119
Article 119
, če je (so) na voljo;
, if available;
podatke o snovi v skladu z oddelkom 2 Priloge IV;
the identity of the substance(s) as specified in section 2 of Annex IV;
kratek opis uporabe (uporab) izdelka;
a brief description of the use(s) of the article;
količinski razpon snovi, kot na primer od 1 do 10 ton, od 10 do 100 ton itd.
the tonnage range of the substance, such as 1-10 tonnes, 10-100 tonnes and so on.
Agencija se lahko odloči, da od proizvajalcev ali uvoznikov izdelkov zahteva, da v skladu s tem naslovom registrirajo vse snovi, ki jih vsebujejo ti izdelki in ki so bile prijavljene v skladu z
The Agency may take decisions requiring producers or importers of articles to register, in accordance with this Title, any substance contained in those articles and notified in accordance with
, če utemeljeno sumi, da:
where the Agency has grounds for suspecting that:
snov ogroža zdravje ljudi ali okolje;
the substance presents a risk to human health or the environment;
se ne uporabljajo za snovi, ki jih je za to uporabo že registriral udeleženec dobavne verige na višji stopnji.
shall not apply to substances that have already been registered for that use by an actor up the supply chain.
Odstavka 1
Paragraphs 1
po roku, navedenem v členu 23(3)
Article 23(3)
Odstavka 3 in 4 se uporabljata za snovi, vsebovane v izdelkih, ki izpolnjujejo merila iz člena 63, 3 mesece po datumu, ko so te snovi navedene v Prilogi XIII(a).
Paragraphs 3 and 4 shall apply to substances, contained in articles, that fulfill the criteria of Article 63 three months after the date these substances are listed in Annex XIII(a).
Ko se snov vključi v Prilogo XIII(b), Agencija obvesti vse proizvajalce in uvoznike izdelkov, ki vsebujejo to snov, o tem, da je bila vključena v omenjeno prilogo.
When a substance is included in Annex XIII(b), the Agency shall notify all producers and importers of articles containing that substance about its inclusion in that Annex.
Naslov VII se smiselno uporablja za proizvajalca in uvoznika izdelkov, ki vsebujejo to snov, od datuma obvestila.
Title VII shall apply mutatis mutandis to the producer and the importer of articles containing that substance as from the date of the notification.
Vsi ukrepi za izvajanje
Any measures for the implementation of
odstavkov 1 do 8
paragraphs 1 to 8
se sprejmejo v skladu s postopkom iz
shall be adopted in accordance with the procedure referred to in
člena 141(3)
Article 141(3)
Agencija bo zagotovila smernice za pomoč proizvajalcem in uvoznikom izdelkov ter pristojnim organom.
The Agency shall provide guidelines to help the producers and importers of articles as well as the competent authorities.
Edini zastopnik proizvajalca, ki nima sedeža v Skupnosti
Only representative of a non-Community manufacturer
Fizična ali pravna oseba s stalnim bivališčem oziroma sedežem zunaj Skupnosti, ki proizvaja snov,
A natural or legal person established outside the Community who manufactures a substance
pripravek ali izdelek,
, preparation or article
njen zastopnik
his representative
izpolnjuje obveznosti uvoznikov iz tega naslova.
, the obligations on importers under this Title.
Zastopnik izpolnjuje tudi vse druge obveznosti uvoznikov iz te uredbe.
The representative shall also comply with all other obligations of importers under this Regulation.
Zato mora imeti zadostne izkušnje s področja praktičnega ravnanja s snovmi in informacije o njih, brez vpliva na
To this end, he shall have a sufficient background in the practical handling of substances and the information related to them and, without prejudice to
člen 38
Article 38
pa mora dati na razpolago in sproti dopolnjevati informacije o uvoženih količinah in kupcih, katerim so bile te prodane, ter podatke o dobavi iz varnostnega lista, prilagojenega zadnjemu stanju.
, he shall keep available and up-to-date information on quantities imported and customers sold to, as well as information on the supply of the latest update of the safety data sheet.
Če se imenuje zastopnik v skladu z odstavkoma 1 in 2, mora izvoznik, ki nima sedeža v Skupnosti, o imenovanju obvestiti uvoznika(e) iz iste dobavne verige.
If a representative is appointed in accordance with paragraphs 1 and 2, the non-Community exporter shall inform the importer(s) within the same supply chain of the appointment.
Ti uvozniki se za to uredbo štejejo za uporabnike na nižji stopnji.
These importers shall be regarded as downstream users for the purposes of this Regulation.
Komisija do ....
Not later than ….
Dve leti po začetku veljavnosti te uredbe.
Two years after the date of entry into force of this Regulation.
Prenos in delitev registracij ter "skupinska registracija"
Transfer and splitting of registrations and 'collective registrations'
Zakonita pravica, pridobljena z registracijo, je prenosljiva in deljiva.
The legal entitlement acquired through registration shall be both transferable and divisible.
Pridobitelj te pravice prevzame pravice in obveznosti prvotnega registracijskega zavezanca.
The party acquiring such an entitlement shall take over the rights and obligations of the original registrant.
V primeru delitve registracije dodeli Agencija novemu lastniku novo registracijsko številko.
Where a registration is split, the Agency shall assign a new registration number to the new holder.
Če je proizvajalec hčerinska družba druge pravne osebe (tako imenovane "matične družbe"), lahko matična družba zaprosi za registracijo in jo obdrži v imenu hčerinske družbe.
Where a manufacturer is a subsidiary of another legal person (termed the 'parent company'), the parent company may undertake and maintain a registration on behalf of the subsidiary.
Nasprotno pa lahko hčerinska družba zaprosi za registracijo in jo obdrži za svojo matično družbo ali druge hčerinske družbe.
Conversely, a subsidiary may also undertake and maintain a registration for its parent company or for other subsidiaries.
V takšnih primerih se zahteva le ena registracija.
In such cases registration shall be required once only.
Pravna oseba, imenovana za skupinsko registracijo, je odgovorna za izpolnjevanje obveznosti v skladu s to uredbo.
The legal person designated for collective registration purposes shall be responsible for performance of duties under this Regulation.
Odstavek 2 velja tudi, če registrirani sedež matične ali hčerinske družbe ni v Evropski uniji.
Paragraph 2 shall also apply where the registered office of the parent company or the subsidiary is not located in the European Union.
Pravna oseba, ki je imenovana za skupinsko registracijo, mora imeti registrirani sedež v Uniji.
The legal person designated for collective registration purposes must have his registered office in the Union.
Izvzetje iz splošne obveznosti registriranja za v proizvode in postopke usmerjene raziskave in razvoj (PPORD)
Exemption from the general obligation to register for product and process orientated research and development (PPORD)
se izvzame iz obveznosti registriranja, določene v členih 5, 6, 17, 18, in 21 za obdobje petih let, če
shall be exempt from the obligation to register set out in Articles 5, 6, 17, 18 and 21 for a period of five years, provided that
podatke o proizvajalcu ali uvozniku;
the identity of the manufacturer or importer;
podatke o snovi;
the identity of the substance;
razvrstitev snovi, če obstaja;
the classification of the substance, if any;
ocenjeno količino;
the estimated quantity;
seznam kupcev
the list of
, ki se jim snov dobavi, če je to potrebno
customers to which the substance is being supplied
dovolj informacij o raziskovalnem in razvojnem programu, na podlagi katerih lahko Agencija sprejme odločitve v skladu
sufficient information on the research and development programme to enable the Agency to take informed decisions under
s tem členom
this Article
Obdobje iz
The period set out in
tega odstavka
this paragraph
začne teči, ko Agencija prejme obvestilo z informacijami.
shall begin at receipt of the notification at the Agency.
Agencija dodeli obvestilu številko in datum obvestila, ki je datum, na katerega je prejela obvestilo, ter ju takoj sporoči zadevnemu proizvajalcu ali uvozniku,
The Agency shall assign a number to the notification and a notification date, which shall be the date of receipt of the notification at the Agency, and shall forthwith communicate that number and date to the manufacturer or importer concerned
za zagotovitev
decide to impose conditions
se snov uporablja tako, da so tveganja za zdravje ljudi in/ali okolje nadzorovana.
is used in such a way that risks to human health and/or the environment are controlled.
Proizvajalec ali uvoznik upošteva vse pogoje, ki jih naloži Agencija
The manufacturer or importer shall comply with any conditions imposed by the Agency
Če ni navedeno drugače, proizvajalec ali uvoznik snovi ne sme proizvesti ali uvoziti prej kot v štirih tednih po
In the absence of any indication to the contrary, the manufacturer or importer of the substance may manufacture or import the substance not earlier than four weeks after the
petletno obdobje izvzetja podaljša za največ
the five-year exemption period by a further maximum
dodatnih deset
upon request
Agencija vse osnutke odločitev sporoči pristojnim organom posameznih držav članic, v katerih potekajo proizvodnja, uvoz ali v proizvode in postopke usmerjene
The Agency shall forthwith communicate any draft decisions to the competent authorities of each Member State in which the manufacture, import or product and process orientated research takes
in pristojni organi
Agency and the competent authorities of the respective Member
odstavkom 1
paragraph 1
Agencija teh informacij ne razkrije nobenemu drugemu pristojnemu organu.
The Agency shall not release this information to any other competent authority.
odločitvam iz
Articles 98, 99
Informacije, ki se predložijo za splošno registracijo
Information to be submitted for general registration purposes
tehnično dokumentacijo, ki zajema:
a technical dossier including:
podatke o proizvajalcu(ih) ali uvozniku(ih) v skladu z oddelkom 1 Priloge IV;
the identity of the manufacturer(s) or importer(s) as specified in section 1 of Annex IV;
informacije o proizvodnji in uporabi(ah) snovi v skladu z oddelkom 3 Priloge IV; te informacije vključujejo vse navedene uporabe registracijskega zavezanca;
information on the manufacture and use(s) of the substance as specified in section 3 of Annex IV; this information shall represent all the registrant's identified use(s);
informacije o skupinah uporabe in izpostavljenosti, kot so določene v oddelku 6 Priloge IV;
(iv) information on use and exposure categories as specified in section 6 of Annex IV;
, vključno s tem, kateri preskusi na vretenčarjih so bili opravljeni in število uporabljenih živali
, including which tests on vertebrate animals have been carried out and the number of animals used
potrdilo, da je registracijski zavezanec lastnik vseh prvotnih študij, iz katerih izhajajo predloženi povzetki študij ali grobi povzetki študij, ali pisno soglasje lastnika (lastnikov) prvotnih študij za sklicevanje nanje;
(x) confirmation that the registrant is the owner of all original studies from which study summaries or robust study summaries are derived and submitted, or has the written consent of the owner(s) of the original studies to refer to them;
Registracijski zavezanec lahko ob predložitvi informacij, ki so potrebne za registracijo, v skladu z določili točk (a) in (b) zahteva za zaupno obravnavo posebno oblikovanih dokumentov ali delov dokumentov.
The registrant, at the time of submitting the information needed for registration under the terms of points (a) and (b), may ask for specifically designated documents or parts of documents to be treated confidentially.
Registracijski zavezanec navede razloge za takšno prošnjo.
The registrant shall provide reasons for such a request.
Organ, ki prejme informacije, odloči, ob upoštevanju člena 127, katere informacije ostanejo zaupne.
The authority which receives the information shall, with due reference to Article 127, decide which information is to remain confidential.
Informacije, potrebne po odstavku 1 in ustvarjene v skladu z drugo zakonodajo EU, OECD ali drugo mednarodno zakonodajo in/ali programi v zvezi s kemikalijami, se lahko predložijo v izvirni obliki; te informacije predvidoma izpolnjujejo zahteve iz tega člena.
Information required under the first paragraph and generated under other European Union, OECD or international legislation and/or chemicals programmes may be submitted in its original format and shall be presumed to meet the requirements of this Article.
Skupna predložitev podatkov, ki jo opravijo
Joint submission of data by
večkratni registracijski zavezanci
multiple registrants
Če naj bi snov v Skupnosti
When a substance is intended to be manufactured in the Community by
ali več proizvajalcev in/ali
or more manufacturers and/or imported by
ali več uvoznikov,
or more importers,
velja naslednje:
the following shall apply:
informacije iz
shall submit separately the information specified in
se lahko sami odločijo, ali bodo informacije iz
may decide themselves whether to submit the information specified in
v celoti ali delno
whether one or more manufacturers
ali več proizvajalcev
to submit this information
V zvezi z informacijami, določenimi v členu 11(a)(v), (vii), (viii) in (x), te predloži en proizvajalec ali uvoznik, ki ukrepa s soglasjem drugega proizvajalca (drugih proizvajalcev) ali drugega uvoznika (drugih uvoznikov).
As regards the information specified in Article 11(a)(v), (vii), (viii) and (x), this shall be submitted by one manufacturer or importer acting with the agreement of the other manufacturer(s) or importer(s).
Če se registracijski zavezanec ne strinja z izborom informacij, določenim v členu 11(a)(v), (vii), (viii) ali (x), ali če iz drugih razlogov ne more sodelovati pri skupni predložitvi enega ali več podatkov, Agenciji skupaj z registracijo predloži svoje razloge.
If a registrant does not agree with the selection of the information specified in Article 11(a)(v), (vii), (viii) or (x) or if he is not able to participate in the joint submission of single data or multiple data points for other reasons, then he shall submit to the Agency an indication of his reasons along with his registration.
Takšni razlogi so:
Such reasons are:
informacije niso uporabne (npr. zaradi razlik v sestavi snovi) ali
the information is not applicable (e.g. due to differences in the substance composition); or
nesorazmernost stroškov za dosego soglasja ali stroškov skupne registracije (npr. podjetje je MSP ali obstajajo stroški v zvezi z jezikom) ali
the disproportionality of the costs of reaching an agreement or the costs of a joint registration (e.g. the company is an SME or costs due to language problems exist); or
težave v zvezi z vprašanji zaupnosti ali konkurence ali
problems with regard to confidentiality or competition issues; or