natgillin/translations-raw huggingface dataset:
Agencija opravi dodatni pregled popolnosti in pri tem upošteva predložene dodatne informacije.
The Agency shall perform a further completeness check, considering the further information submitted.
Agencija registracijo zavrne, če je registracijski zavezanec ne dopolni v predpisanem roku.
The Agency shall reject the registration if the registrant fails to complete his registration within the deadline set.
Agencija pošlje registracijsko dokumentacijo skupaj s številko registracije, datumom registracije, rezultatom pregleda popolnosti ter vsemi zahtevki za dodatne informacije in rokom, določenim v skladu z drugim pododstavkom odstavka 2, pristojnemu organu zadevne države članice v 30 dneh po datumu registracije.
The Agency shall communicate the registration dossier together with the registration number, the registration date, the result of the completeness check and any request for further information and deadline set in accordance with the second subparagraph of paragraph 2 to the competent authority of the relevant Member State within 30 days of the registration date.
Zadevna država članica je država članica, v kateri poteka proizvodnja ali v kateri ima uvoznik svoj sedež.
The relevant Member State shall be the Member State within which the manufacture takes place or the importer is established.
Agencija vse dodatne informacije, ki jih predloži registracijski zavezanec, takoj sporoči pristojnemu organu zadevne države članice.
The Agency shall forthwith communicate to the competent authority of the relevant Member State any further information submitted by the registrant.
Proizvodnja in uvoz snovi
Manufacturing and import of substances
Ob upoštevanju
Subject to
se snovi v Skupnosti ne smejo proizvajati ali vanjo uvoziti, če niso bile registrirane v skladu z ustreznimi določbami tega naslova.
, substances shall not be manufactured in the Community or imported unless they have been registered in accordance with the relevant provisions of this Title.
Registracijski zavezanec lahko začne snov proizvajati ali uvažati, če Agencija v treh tednih po datumu registracije ne navede drugače v skladu s
A registrant may start the manufacture or import of a substance, if there is no indication to the contrary from the Agency in accordance with
členom 20(2)
Article 20(2)
, kar ne vpliva na
within the three weeks after the registration date, without prejudice to
člen 28(10).
Article 28(10)
, lahko registracijski zavezanec v skladu s
as referred to in
nadaljuje proizvodnjo ali uvoz snovi tri mesece po tem roku ali do
, a registrant may continue the manufacture or import of the substance for 3 months from that deadline or until
zavrnitve Agencije, kar nastopi prej.
rejection by the Agency, whichever is the earlier.
Če je Agencija registracijskega zavezanca obvestila, da mora predložiti dodatne informacije v skladu z drugim pododstavkom
If the Agency has informed the registrant that he is to submit further information in accordance with the second subparagraph of
člena 20(2)
Article 20(2)
, lahko registracijski zavezanec, če Agencija ne navede drugače in brez vpliva na
, the registrant may start the manufacture or import if there is no indication to the contrary from the Agency, within the three weeks after receipt by the Agency of the further information necessary to complete his registration, without prejudice to
člen 28(10),
Article 28(10)
Če en proizvajalec ali uvoznik predloži del registracije v imenu drugih proizvajalcev in/ali uvoznikov, kot predvideva
If one manufacturer or importer submits parts of the registration on behalf of other manufacturers and/or importers, as provided for in
Odstavki 1, 2 in 3 se uporabljajo za na mestu izolirane vmesne proizvode ali prepeljane izolirane vmesne proizvode.
Paragraphs 1, 2 and 3 shall apply to on-site isolated intermediates or transported isolated intermediates.
Nadaljnje obveznosti registracijskih zavezancev
Further duties of registrants
Po registraciji mora registracijski zavezanec Agencijo na svojo pobudo takoj pisno obvestiti v obliki, ki jo določi Agencija v skladu s
Following registration, a registrant shall be responsible on his own initiative for immediately informing the Agency in writing of the following in the format specified by the Agency in accordance with
o spremembi svojega statusa, kot je proizvajalec ali uvoznik, ali svojih podatkov, kot je ime ali naslov;
any change in his status, such as manufacturer or importer, or in his identity, such as his name or address;
o spremembi sestave snovi v skladu s Prilogo IV;
any change in the composition of the substance as given in Annex IV;
o večjih spremembah letnih ali skupnih količin, ki jih proizvede ali uvozi;
significant changes in the annual or total quantities manufactured or imported by him;
o novih uporabah, za katere se snov proizvaja ali uvaža in za katere se lahko upravičeno pričakuje, da jih pozna;
new uses for which the substance is manufactured or imported of which he may reasonably be expected to have become aware;
o pomembnih novih spoznanjih glede nevarnosti snovi za zdravje ljudi in/ali okolje, za katera se lahko upravičeno pričakuje, da je z njimi seznanjen;
significant new knowledge of the risks of the substance for human health and/or the environment of which he may reasonably be expected to have become aware;
o spremembi v razvrstitvi in označitvi snovi;
any change in the classification and labelling of the substance;
Agencija sporoči te informacije pristojnemu organu zadevne države članice.
The Agency shall communicate this information to the competent authority of the relevant Member State.
V primerih iz
In cases covered by
predloži informacije iz odstavka 1(c) vsak registracijski zavezanec ločeno.
, each registrant shall submit separately the information specified in paragraph 1(c).
POGLAVJE 6
CHAPTER 6
PREHODNE DOLOČBE, KI SE UPORABLJAJO ZA SNOVI V POSTOPNEM UVAJANJU IN PRIJAVLJENE SNOVI
TRANSITIONAL PROVISIONS APPLICABLE TO PHASE-IN SUBSTANCES AND NOTIFIED SUBSTANCES
Posebne določbe za snovi v postopnem uvajanju
Specific provisions for phase-in substances
Tri leta po začetku veljavnosti te uredbe.
Three years after the date of entry into force of this Regulation.
snovi v postopnem uvajanju, ki so v skladu z Direktivo 67/548/EGS razvrščene kot kancerogene, mutagene ali strupene za razmnoževanje v skupino 1 ali 2 in so bile vsaj enkrat po začetku veljavnosti te uredbe v Skupnosti proizvedene ali v Skupnost uvožene v količini, ki je znašala eno tono ali več na leto na proizvajalca ali uvoznika;
phase-in substances classified as carcinogenic, mutagenic or toxic to reproduction, categories 1 and 2, in accordance with Directive 67/548/EEC and manufactured in the Community or imported, in quantities reaching 1 tonne or more per year per manufacturer or per importer, at least once following the entry into force of this Regulation;
snovi v postopnem uvajanju, ki so razvrščene kot zelo strupene za vodne organizme in imajo lahko dolgoročne škodljive vplive na vodno okolje (R50/53) v skladu z Direktivo 67/548/EGS in proizvedene v Skupnosti ali uvožene v količini 100 ton ali več na leto na proizvajalca ali uvoznika;
phase-in substances classified as very toxic to aquatic organisms that may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC and manufactured in the Community or imported in quantities reaching 100 tonnes or more per year per manufacturer or per importer;
snovi v postopnem uvajanju, ki so bile vsaj enkrat po začetku veljavnosti te uredbe v Skupnosti proizvedene ali v Skupnost uvožene v količini, ki je znašala 1000 ton ali več na leto na proizvajalca ali uvoznika.
phase-in substances manufactured in the Community or imported, in quantities reaching 1 000 tonnes or more per year per manufacturer or per importer, at least once following the entry into force of this Regulation.
se ne uporablja
shall not apply
Šest let po začetku veljavnosti te uredbe.
Six years after the date of entry into force of this Regulation.
za snovi v postopnem uvajanju, ki so razvrščene kot zelo strupene za vodne organizme in imajo lahko dolgoročne škodljive vplive na vodno okolje (R50/53) v skladu z Direktivo 67/548/EGS in proizvedene v Skupnosti ali uvožene v količini 1 tone ali več na leto na proizvajalca ali uvoznika, ali
to phase-in substances classified as very toxic to aquatic organisms that may cause long-term adverse effects in the aquatic environment (R50/53) in accordance with Directive 67/548/EEC and manufactured in the Community or imported in quantities reaching 1 tonne or more per year per manufacturer or per importer or
za snovi v postopnem uvajanju, ki so bile vsaj enkrat po začetku veljavnosti te uredbe proizvedene v Skupnosti ali v Skupnost uvožene v količini, ki je znašala 100 ton ali več na leto na proizvajalca ali uvoznika.
to phase-in substances manufactured in the Community or imported, in quantities reaching 100 tonnes or more per year per manufacturer or per importer, at least once following the entry into force of this Regulation.
Enajst let po začetku veljavnosti te uredbe.
11 years after the date of entry into force of this Regulation.
* za snovi v postopnem uvajanju, ki so bile vsaj enkrat po začetku veljavnosti te uredbe proizvedene v Skupnosti ali v Skupnost uvožene v količini, ki je znašala eno tono ali več na leto na proizvajalca ali uvoznika.
* to phase-in substances manufactured in the Community or imported, in quantities reaching 1 tonne or more per year per manufacturer or per importer, at least once following the entry into force of this Regulation.
Obvestilo iz odstavka 1 je obvezno:
The notification referred to in paragraph 1 shall be forwarded:
12 mesecev pred iztekom roka, določenem v členu 23(1), za snovi v postopnem uvajanju, ki so proizvedene ali uvožene v količinah 1.000 ton ali več na leto;
12 months before the deadline laid down in Article 23(1) for phase-in substances manufactured or imported in quantities reaching 1 000 tonnes or more per year;
24 mesecev pred iztekom roka, določenem v členu 23(2), za snovi v postopnem uvajanju, ki so proizvedene ali uvožene v količinah 100 ton ali več na leto;
24 months before the deadline laid down in Article 23(2) for phase-in substances manufactured or imported in quantities reaching 100 tonnes or more per year;
36 mesecev pred iztekom roka, določenem v členu 23(3), za snovi v postopnem uvajanju, ki so proizvedene ali uvožene v količinah 1 tone ali več na leto.
36 months before the deadline laid down in Article 23(3) for phase-in substances manufactured or imported in quantities reaching 1 tonne or more per year.
Prijavljene snovi
Notified substances
Prijava, predložena v skladu z Direktivo 67/548/EGS, se šteje za registracijo za namene iz tega naslova, Agencija pa ji
A notification submitted in accordance with Directive 67/548/EEC shall be regarded as a registration for the purposes of this Title and the Agency shall assign a registration number
Če količina prijavljene snovi, proizvedene ali uvožene, na proizvajalca oziroma uvoznika, doseže naslednji količinski prag v skladu s
If the quantity of a notified substance manufactured or imported per manufacturer or importer reaches the next tonnage threshold under
členoma 11
s 11
CILJI IN SPLOŠNA PRAVILA
OBJECTIVES AND GENERAL RULES
Proizvajalci ali uvozniki si za namene registracije medsebojno izmenjujejo in dajejo na voljo informacije iz člena 11(a)(vii) in (viii), da se prepreči podvajanje študij.
Manufacturers or importers shall share between them and make available the information specified in Article 11(a) (vii) and (viii) for the purposes of registration, so that the duplication of studies is avoided.
V okoliščinah (razen pri tistih zadevah, ki zahtevajo podatke iz preskusov na živalih), kjer:
In circumstances (other than in matters requiring data from animal testing) where:
bi bili stroški izmenjave informacij nesorazmerni;
the costs of sharing the information would be disproportionate;
podatek ni pomemben za snov ali
the data is not relevant for a substance; or
je informacija poslovna skrivnost in registracijski zavezanec upravičeno meni, da mu zahteva po izmenjavi zadevnih informacij lahko prinese znatno poslovno izgubo;
the information is commercially confidential and the registrant justifiably considers that he may suffer loss of business as a result of requirements to share the information concerned,
registracijski zavezanec Agenciji predloži obrazložitev, zakaj delno ali v celoti ne izmenja informacij.
the registrant shall submit to the Agency a justification for not sharing the information in part or in whole.
Na zahtevo drugega potencialnega registracijskega zavezanca in proti plačilu pristojbine Agencija preuči, ali je obrazložitev utemeljena.
At the request of another potential registrant, and on payment of a fee, the Agency shall consider wheher a justification is well-founded.
MSP plačajo nižjo pristojbino.
SMEs shall pay only a reduced fee.
Če Agencija meni, da je obrazložitev neutemeljena, prvotni registracijski zavezanec ni upravičen do izjeme glede izmenjave informacij in stroške, ki jih ima Agencija s preučitvijo, nosi sam.
If the Agency finds that a justification is not well-founded, the exemption from sharing shall not be allowed to the original registrant, and the costs of the Agency related to its consideration shall be borne by him.
V takih primerih se plačana pristojbina povrne.
In such cases, the fee paid shall be reimbursed.
Če ne pride do izmenjave fizikalno-kemijskih informacij, določenih v oddelku 5 prilog V in VII, se obrazložitev ne zahteva.
No justification shall be required for not sharing physicochemical information specified in section 5 of Annexes V and VII.
Da se prepreči nepotrebno preskušanje na živalih, se preskušanje na vretenčarjih za to uredbo sprejme samo kot skrajni
In order to avoid unnecessary animal testing, testing on vertebrate animals for the purposes of this Regulation shall be undertaken only as a last
Izmenjava informacij in njihova skupna predložitev v skladu s to uredbo sta povezani s tehničnimi podatki in zlasti z informacijami o notranjih lastnostih snovi.
The sharing and joint submission of information in accordance with this Regulation shall concern technical data and in particular information related to the intrinsic properties of substances.
Registracijski zavezanci si ne izmenjujejo informacij o svojem tržnem ravnanju, zlasti o proizvodnih zmogljivostih, obsegu proizvodnje ali prodaje, uvoženi količini ali tržnih deležih.
Registrants shall refrain from exchanging information concerning their market behaviour, in particular as regards production capacities, production or sales volumes, import volumes or market shares.
Povzetke ali zanesljive študijske povzetke študij
Any summaries or robust study summaries of studies
v zvezi s preskusi na živalih in preskusi, ki ne vključujejo živali
relating to both animal and to non-animal tests
, predloženih v okviru registracije vsaj
submitted in the framework of a registration at least
let prej, lahko Agencija da prosto na razpolago drugim registracijskim zavezancem ali potencialnim registracijskim
previously may be made freely available by the Agency to any other registrants or potential
Vsak proizvajalec, uvoznik ali uporabnik na nižji stopnji lahko imenuje tretjo stranko za predstavnika pri vseh sporih pod tem naslovom.
Any producer, importer or downstream user may appoint a third party as representative in all proceedings under this Title.
Obvezno poizvedovanje pred registracijo
Duty to inquire prior to registration
preskusi za
testing is
izpolnitev informacijskih zahtev zaradi registracije, se uporabijo odstavki 2, 3 in 4.
carried out in order to meet information requirements for the purposes of registration, paragraphs 2, 3 and 4 shall apply.
Potencialni registracijski zavezanec preveri zbirko podatkov iz
The potential registrant shall consult the database referred to in
, zato da ugotovi, ali je bila enaka snov že registrirana.
in order to find out whether the same substance has already been registered.
Potencialni registracijski zavezanec poizve pri Agenciji, ali je bila za enako snov že vložena registracija.
The potential registrant shall inquire from the Agency whether a registration has already been submitted for the same substance.
Hkrati s poizvedbo predloži Agenciji vse naslednje informacije:
He shall submit all the following information to the Agency with the inquiry:
svoje podatke;
his identity;
podatke o snovi v skladu z oddelkoma 2.1 in 2.3 Priloge IV;
the identity of the substance, as referred to in sections 2.1 and 2.3 of Annex IV;
za katere zahtevane informacije bo moral izvesti nove študije, ki bodo vključevale preskuse na
which information requirements would require new studies involving vertebrate animals to be carried out by
je bila enaka snov registrirana
the same substance has
pred manj kot desetimi leti
previously been
potencialnemu registracijskemu zavezancu
less than 10 years earlier
Dostopne študije je treba deliti s potencialnim registracijskim zavezancem v skladu s členom 28.
The available studies must be shared with the potential registrant in accordance with Article 28.
drug potencialni registracijski zavezanec poizveduje o enaki snovi, Agencija oba potencialna registracijska zavezanca
another potential registrant has made an inquiry in respect of the same substance, the Agency shall inform both potential registrants,
ali svojega predstavnika tretje strani po členu 26(5),
or their third party representative appointed under Article 26(5),
takoj obvesti o imenu in naslovu drugega potencialnega registracijskega
without delay of the name and address of the other potential
Izmenjava obstoječih podatkov med registracijskimi zavezanci
Sharing of existing data between registrants
Pri snoveh, ki so bile registrirane manj kot
In the case of substances previously registered less than
15 let poprej
15 years earlier,
, potencialni registracijski zavezanec predhodnega(e) registracijskega(e) zavezanca(e) zaprosi za
the potential registrant shall ask the previous registrant(s) for the
v skladu s členom 11(a)(vii) in (viii)
with respect to Article 11(a)(vii) and (viii)
potrebuje za
in order to
Potencialni in predhodni registracijski zavezanec(ci) za enako snov sprejme(jo) vse razumne ukrepe za dosego sporazuma o izmenjavi in dajanju na razpolago študij, ki vključujejo katero koli vrsto preskusa.
The potential and the previous registrant(s) for the same substance shall take all reasonable steps to reach an agreement on the sharing and making available of studies involving any type of test.
Takšen sporazum se lahko nadomesti s predložitvijo zadeve razsodišču in sprejetjem njegove odredbe.
Such an agreement may be replaced by submission of the matter to an arbitration board and acceptance of the arbitration order.
Če se doseže sporazum o izmenjavi študij, predhodni registracijski zavezanec(ci) potencialnemu registracijskemu zavezancu izda(jo) izjavo o dostopnosti za zadevne študije v dveh tednih po prejemu plačila.
If an agreement on the sharing of studies has been reached, the previous registrant(s) shall grant a letter of access to the potential registrant for the studies concerned within two weeks of receipt of payment.
Novi registracijski zavezanec se sklicuje na te študije v svoji registracijski dokumentaciji in predloži izjavo o dostopnosti prejšnjega(ih) registracijskega(ih) zavezanca(ev).
The new registrant shall refer to these studies in his registration dossier and shall submit the letter of access from the previous registrant(s).
Če se takšen sporazum ne doseže, lahko potencialni registracijski zavezanec o tem obvesti Agencijo in predhodnega registracijskega zavezanca oziroma predhodne registracijske zavezance vsaj en mesec potem, ko od Agencije prejme ime in naslov predhodnega(ih) registracijskega(ih) zavezanca(ev).
If there is failure to reach such an agreement, the potential registrant may inform the Agency and the previous registrant(s) thereof at least 1 month after receipt, from the Agency, of the name and address of the previous registrant(s).
Po prejemu informacij iz odstavka 4 ima(jo) predhodni registracijski zavezanec(ci) na voljo en mesec, da obvesti(jo) potencialnega registracijskega zavezanca in Agencijo o stroških, ki jih je imel (so jih imeli) z zadevno študijo.
The previous registrant(s) shall have 1 month from the receipt of the information referred to in paragraph 4 to inform the potential registrant and the Agency of the cost incurred by him for the study concerned.
Na zahtevo potencialnega registracijskega zavezanca se Agencija odloči, da mu po prejemu dokazila, da je predhodnemu(im) registracijskemu(im) zavezancu(em) plačal
At the request of the potential registrant, the Agency shall take the decision to make available to him the summaries or robust study summaries, as the case may be, of the studies concerned, or the results thereof, on receipt of proof that he has paid the previous registrant(s)
prikazanih stroškov,
of the cost shown by the latter
izračunan v skladu z odstavkom 6,
, calculated in accordance with paragraph 6
Delitev dejanskih stroškov prvotnega(ih) registracijskega(ih) zavezanca(ev) za zadevne študije se izračuna sorazmerno z obsegom proizvodnje/uvoza vsake stranke.
The sharing of the actual costs incurred by the original registrant(s) for the study concerned shall be calculated in a way which is proportional to each party's production/import volume.
Kjer so bili prvotni skupni stroški že razdeljeni med dva ali več registracijskih zavezancev, vsak (vsi) nadaljnji morebitni registracijski zavezanec(ci) plača(jo) vsakemu registracijskemu zavezancu pravičen delež njegovega prispevka k stroškom.
Where the original total cost has already been shared between two or more registrants, any subsequent potential registrant(s) shall pay each registrant a fair share of his contribution to costs.
Če potencialni registracijski zavezanec ne plača svojega deleža stroškov študije s preskusi na vretenčarjih ali druge študije, ki lahko prepreči preskuse na živalih, ne more registrirati svoje snovi.
If the potential registrant fails to pay his share of the cost of a study involving tests on vertebrate animals or another study that may prevent animal testing, he shall not be able to register his substance.
Če predhodni registracijski zavezanec(ci) potencialnega registracijskega zavezanca in Agencijo v roku iz odstavka 5 ne obvesti(jo) o stroških, se Agencija na zahtevo odloči, da potencialnemu registracijskemu zavezancu da na razpolago povzetke ali zanesljive študijske povzetke, odvisno od primera, zadevnih študij, kot je ta zahteval.
If the previous registrant(s) fail(s) to inform the potential registrant and the Agency of the cost within the deadline set in paragraph 5, the Agency, on request, shall take the decision to make available to the potential registrant the summaries or robust study summaries, as the case may be, of the studies concerned as required by him.
Predhodni registracijski zavezanec(ci) ima(jo) do potencialnega registracijskega zavezanca terjatev
The previous registrant(s) shall have a claim on the potential registrant for
za delež
a share
, izračunan v skladu z odstavkom 6
calculated in accordance with paragraph 6,
, ki je izterljiv na nacionalnih sodiščih.
which shall be enforceable in the national courts.
Proti odločitvam Agencije iz
An appeal may be brought, in accordance with
Čakalna doba za registracijo se v skladu s
The registration waiting period in accordance with
za novega registracijskega zavezanca podaljša za štiri mesece, če to zahteva predhodni registracijski zavezanec.
for the new registrant shall be extended by a period of 4 months, if the previous registrant so requests.
Obvezno predregistriranje snovi v postopnem uvajanju
Duty to pre-register for phase-in substances
Potencialni registracijski zavezanec snovi v postopnem uvajanju, ki želi biti upravičen do prehodnega režima iz
In order to benefit from the transitional regime provided for in
, predloži Agenciji v obliki, ki jo ta določi v skladu s
each potential registrant of a phase-in substance shall submit all the following information to the Agency in the format specified by the Agency in accordance with
svoje ime in naslov ter ime osebe za stike
his name and address and the name of the contact person