natgillin/translations-raw huggingface dataset:
Ustreza predlogu spremembe 368, sprejetem v prvi obravnavi.
Corresponds to Amendment 368 adopted in First Reading.
V okviru REACH uporabnik na nižji stopnji zahteva podatke o snovi (ki jo uporablja v svojih pripravkih), kot so, kdo in kdaj registrira snov ter katere nezaupne uporabe so bile opredeljene.
Under REACH the Downstream users requires the data of a substance he uses in his preparations like who will register which substance and when it will be registered and which non-confidential uses are identified.
Če uporabnik na nižji stopnji nima dostopa do teh podatkov ali pa zelo pozno, se lahko sooči z 'neregistrirano' ali 'neopredeljeno uporabo' in je zato premalo časa, da njegov dobavitelj ponovno pregleda registracijo, ali za vključitev dodatne opredeljene uporabe, ter za ponovno formulacijo in odobritev naslednji stranki.
If the downstream user has no access to all these data or only in a very late stage he may be confronted with a `non registration´ or a ´not identified use´ and therewith left with a too short time frame to make his supplier reconsider the registration or the incorporation of an additional identified use, to run the cycle of reformulation and the consequent customer approval.
ČLEN 28, ODSTAVEK 1 A (novo)
ARTICLE 28, PARAGRAPH 1 A (new)
Vsakdo, ki ima študije ali informacije o snovi, pridobljene pri poskusih na živalih, mora predložiti take podatke Agenciji najkasneje v 18 mesecih pred rokom iz člena 23(1).
Anyone in possession of studies or information on a substance derived through experiments on animals shall be required to forward such information to the Agency at the latest 18 months before the deadline laid down in Article 23(1).
(Predlog spremembe 140 – prva obravnava)
(Amendment 140 - first reading)
Z določitvijo roka za predložitev podatkov, pridobljenih pri poskusih na živalih, se je mogoče izogniti podvajanju takih poskusov in hkrati zmanjšati breme za podjetja, zlasti za MSP.
Bringing forward the deadline for forwarding information derived from animal experimentation enables duplication of such experiments to be avoided and at the same time reduces the burden on businesses, particularly SMEs.
ČLEN 28, ODSTAVEK 2 A (novo)
ARTICLE 28, PARAGRAPH 2 A (new)
Po poteku obdobja iz odstavka 2 Agencija na zahtevo nižjestopenjskega uporabnika snovi, ki ni bila predhodno registrirana, katerikoli 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 period referred to in paragraph 2 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 iz poglavja 5 naslova II.
Such notification shall enable the potential registrant to benefit from the transitional regime set out in Chapter 5 of Title II.
(Predlog spremembe 369 delno spremenjen – prva obravnava)
(Amendment 369/rev. (partially) - first reading))
Proizvajalci in uvozniki Agenciji predložijo kakršne koli informacije, pridobljene pri poskusih na vretenčarjih, in druge informacije, s katerimi bi se lahko izognili poskusom na živalih, tudi o snoveh, 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 pridobivanja 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 dobi rezultate študij ali druge informacije o snovi, pridobljene pri poskusih na vretenčarjih, po preteku roka iz odstavka 1a take podatke predloži 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 1a, shall forward such information to the Agency.
(Predlog spremembe 143 – prva obravnava)
(Amendment 143 - first reading)
Agencija do …* na svoji spletni strani objavi seznam snovi iz odstavkov 1(a) in (d).
The Agency shall by … * publish on its website a list of the substances referred to in paragraph 1(a) and (d).
Ta seznam vsebuje le imena snovi, vključno z njihovo številko EINECS in CAS, če sta na voljo, in drugimi oznakami.
That list shall comprise only the names of the substances, including their EINECS and CAS number if available and other identity codes.
Agencija vodi seznam snovi, ki vsebuje podatke iz odstavka 1 .
The Agency shall operate a register of substances containing the information specified in paragraph 1.
En mesec po poteku roka, določenega v odstavku 2, Agencija na svoji spletni strani objavi seznam snovi, ki vsebuje:
The Agency shall publish on its website the register of substances within one month after the expiry of the period laid down in paragraph 2, indicating:
(a) ime snovi, informacije, ki so na voljo po odstavkih 1 in 4a, in, po potrebi, skupino snovi, vključno s številkama EINECS in CAS, če sta na voljo;
(a) the name of the substance and the information made available under paragraphs 1 and 4a and, where applicable, the group of substances, including EINECS and CAS numbers, if available;
(b) ime in naslov proizvajalca ali uvoznika ter po potrebi ime in naslov osebe, ki ga zastopa v skladu s členom 4, kakor je določeno v oddelku 1 Priloge VI;
(b) the name and address of the manufacturer or importer or, where appropriate, the name and address of the person representing him in accordance with Article 4 as specified in section 1 of Annex VI;
(c) splošen opis opredeljenih uporab; kot minimalne začetne informacije o uporabi in izpostavljenosti v skladu s odstavkom 1(da);
(c) a general description of identified uses; as a minimum, initial information on use and exposure in accordance with paragraph 1(da);
(d) prvi rok za registracijo posamezne snovi v skladu s členom 23.
(d) the first deadline for the registration of each substance in accordance with Article 23.
Agencija objavi ime snovi in, kjer je to primerno, skupine snovi, vključno s številkama EINECS in CAS, če sta na voljo, upoštevajoč prošnje za poznejšo prijavo, in sicer takoj po prejetju takšnih prošenj.
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 skladu s odstavkom 2a Agencija v enem mesecu po izteku roka za poznejšo prijavo prilagodi seznam snovi, s tem da vključi tiste snovi, za katere so bile pridobljene poznejše predhodne registracije.
Within one month of the expiry of the late notification period pursuant to paragraph 2a, 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 izda prošnjo, naj vsakdo, ki poseduje študije o vretenčarjih, ki niso javno dostopne, predloži podatke o tem, kako priti do teh študij.
The Agency shall publish together with the publication of the register of substances a request to anyone who owns studies on vertebrate animals which are not publicly available to submit indications on the availability of such studies.
Vsakdo, ki poseduje takšne študije, lahko Agenciji pošlje podatke o tem, kako priti do teh študij, v šestih mesecih od objave seznama snovi, Agencija pa bo v skladu s odstavkom 5 te informacije vključila v zbirko podatkov.
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, and the Agency shall include this information in the database in accordance with paragraph 5.
Takšne študije bodo uporabljene v skladu s členom 30.
Such studies shall be used in accordance with Article 30.
Agencija do …* na svoji spletni strani objavi tudi seznam snovi v postopnem uvajanju, ki so bile že registrirane brez predhodne registracije.
The Agency shall by ...* also publish on its website a list of phase-in substances already registered without pre-registration.
Ta seznam vsebuje imena snovi, njihove številke EINECS in CAS, če so na voljo, in druge oznake, ter, kjer je ustrezno, skupino snovi.
That list shall comprise the names of the substances, their EINECs and CAS number if available and other identity codes, and, where applicable, the group of the substances.
* 19 mesecev po začetku veljavnosti te uredbe.
* 19 months after the entry into force of this Regulation.
To je potrebno, da imajo uporabniki na nižji stopnji dostop do ustreznih podatkov o predhodni registraciji, ki jim omogočajo pravočasno izpolnjevanje njihovih obveznosti v okviru REACH.
This is necessary to enable downstream users access to adequate pre-registration data, thus enabling them to fulfil their obligations under REACH on time.
Malo predrugačeno besedilo predloga spremembe 371 iz prve obravnave ob upoštevanju pojasnila, da mora seznam snovi dati na voljo Svet.
Slight rewording of first reading amendment 371, taking into account the clarifying that the register should be made available by the Council.
Obstoječe podatke iz testiranj na živalih in druge informacije, s katerimi bi se lahko izognili testom na živalih, bi bilo treba objaviti čim prej, da bi preprečili podvajanje testiranj na živalih in prihranili stroške za industrijo, zlasti MSP.
Existing data from animal tests and other information that could prevent animal experimentation should be published as early as possible in order to prevent duplicate animal testing and save costs for industry, particularly SMEs.
Uporabnik na nižji stopnji zahteva naslednje podatke o snovi, ki jo uporablja v svojih pripravkih:
A downstream user (DU) requires the following data of a substance he uses in his preparations:
· ali bo snov registrirana,
· is the substance going to be registered,
· kdo bo registriral snov,
· who will register the substance,
· kdaj bo registrirana
· when will it be registered
· in katere uporabe so opredeljene.
· which uses are identified
Če uporabnik na nižji stopnji nima dostopa do vseh teh podatkov ali pride do njih zelo pozno, se lahko sooči z 'neregistrirano' ali 'neopredeljeno uporabo' in je premalo časa, da njegov dobavitelj ponovno pregleda registracijo ali opredeljeno uporabo ali izvede ponovno formulacijo (brez neregistrirane snovi).
If the DU has no access to all of these data or only in a very late stage he may be confronted with a ’non-registration’ or a ’not identified use’ and therewith left with a too short time frame to make his supplier reconsider the registration or identified use, or run the cycle of reformulation (without the non-registered substance)
Povezano s predlogom spremembe člena 28(5).
Linked to the amendment to Article 28(5).
Vsi proizvajalci in uvozniki, ki so Agenciji predložili informacije v skladu s členom 28 za enako snov v postopnem uvajanju, so udeleženci foruma za izmenjavo informacij o snoveh (SIEF).
All manufacturers and importers who have submitted information to the Agency in accordance with Article 28 for the same phase-in substance shall be participants in a substance information exchange forum (SIEF).
Vsi proizvajalci , uvozniki in formulatorji , ki so Agenciji predložili informacije v skladu s členom 28 za enako snov v postopnem uvajanju, so udeleženci foruma za izmenjavo informacij o snoveh (SIEF).
All manufacturers , importers and formulators who have submitted information to the Agency in accordance with Article 28 for the same phase-in substance shall be participants in a substance information exchange forum (SIEF).
Preden se opravi test za pridobitev informacij, zahtevanih za registracijo, udeleženec SIEF v okviru svojega SIEF preveri, ali je na voljo ustrezna študija.
Before testing is carried out in order to meet the information requirements for the purposes of registration, a SIEF participant shall inquire whether a relevant study is available by communicating within his SIEF.
Če je v okviru SIEF na voljo ustrezna študija, ki vključuje teste na vretenčarjih , udeleženec tega SIEF zanjo zaprosi do …** .
If a relevant study involving tests on vertebrate animals is available within the SIEF , a participant of that SIEF shall request that study by ...**.
Če je v okviru SIEF na voljo ustrezna študija, ki ne vključuje testov na vretenčarjih, udeleženec tega SIEF zanjo zaprosi do …**.
If a relevant study not involving tests on vertebrate animals is available within the SIEF, a SIEF participant may request that study by ...**.
Preden se opravi test za pridobitev informacij, zahtevanih za registracijo, udeleženec SIEF v okviru svojega SIEF preveri, ali je na voljo ustrezna študija , in pregleda sezname, ki jih je Agencija objavila v skladu s členom 28(5) in (5a) .
Before testing is carried out in order to meet the information requirements for the purposes of registration, a SIEF participant shall inquire whether a relevant study is available by communicating within his SIEF and consulting the lists published by the Agency in accordance with Article 28(5) and (5a) .
Če je na voljo ustrezna študija, ki vključuje teste, udeleženec SIEF zanjo zaprosi.
If a relevant study involving tests is available, a participant of SIEF shall request that study.
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 storijo vse za zagotovitev, da se stroški souporabe informacij določijo na pošten, pregleden in nediskriminatoren način.
The participant(s) and the owner shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non discriminatory way.
To se lahko olajša z upoštevanjem navodil za delitev stroškov, ki temeljijo na omenjenih načelih in jih je Agencija sprejela v skladu s členom 76(2)(f).
This may be facilitated by following any cost sharing guidance which is based on those principles and is adopted by the Agency in accordance with Article 76(2)(f).
Če takšnega sporazuma ne morejo doseči, se stroški razdelijo enakomerno .
If they cannot reach such an agreement, the cost shall be shared equally .
Lastnik dovoli sklicevanje na celovito poročilo o študiji za namene registracije v dveh tednih po prejemu plačila.
The owner shall give permission to refer to the full study report for the purpose of registration within two weeks of receipt of payment.
Registracijski zavezanci morajo deliti le stroške tistih informacij, ki jih morajo pridobiti za izpolnitev zahtev za svojo registracijo.
Registrants are only required to share in the costs of information that they are required to submit to satisfy their registration requirements.
V enem mesecu po oddaji zahtevka lastnik študije zagotovi udeležencu (-em), ki je (so) to zahteval(i), dokazilo o svojih stroških.
Within one month of the request, the owner of the study shall provide proof of its cost to the participant(s) requesting it.
Udeleženec(-ci) in lastnik storijo vse za zagotovitev, da se stroški souporabe informacij določijo na pošten, pregleden in nediskriminatoren način ter sorazmerno z obsegom proizvodnje vsake stranke .
The participant(s) and the owner shall make every effort to ensure that the costs of sharing the information are determined in a fair, transparent and non discriminatory way and in proportion to each party’s production volume .
Če takšnega sporazuma ne morejo doseči, se stroški razdelijo pravično .
If they cannot reach such an agreement, the cost shall be shared in a fair way .
** Dvajset mesecev po začetku veljavnosti te uredbe.
** 20 months after entry into force of this Regulation.
Zato ni treba določiti roka.
Therefore it is not necessary to set a deadline.
Spremenjena ponovna vložitev besedila Komisije.
Modified reinstatement of the Commission text.
Povezano s predlogom spremembe člena 28(5) in 28(5a).
Linked to the amendment of Article 28(5) and 28(5a).
Za preprečitev podvajanja testiranja na živalih in prihranek stroškov za industrijo ter zlasti za MSP mora SIEF tudi pregledati sezname, ki jih je objavila Agencija, da zagotovi izmenjavo podatkov in po potrebi navzkrižno branje pri razvrščanju snovi.
In order to prevent duplication of animal testing and save costs for industry, particularly SMEs, SIEFs should also be required to consult the lists published by the Agency to ensure data sharing and, where applicable, read-across from the grouping of substances.
Vzpostavlja mehanizem za pošteno delitev prvotnih stroškov za testiranja po analogiji z ustreznimi spremembami člena 27.
Establishes a mechanism for sharing in a fair way the original costs of tests in analogy with the corresponding modifications to Article 27.
Izmenjati je treba vse podatke, pridobljene pri testih (na vretenčarjih in nevretenčarjih).
All tests (vertebrates and non-vertebrates) should be shared.
Enako predlogu spremembe 149 iz prve obravnave.
Identical to first reading amendment 149.
Če zadevna študija, ki vključuje teste, v okviru SIEF ni na voljo, eden od njegovih udeležencev v imenu ostalih v okviru posameznega SIEF izvede eno samo študijo na zahtevano informacijo.
If a relevant study involving tests is not available within the SIEF , only one study shall be conducted per information requirement within each SIEF by one of its participants acting on behalf of the others.
Sprejmejo vse razumne ukrepe, da se v roku, ki ga je določila Agencija, dogovorijo o tem, kdo bo opravil test v imenu drugih udeležencev, in povzetek ali grob povzetek študije predložijo Agenciji.
They shall take all reasonable steps to reach an agreement within a deadline set by the Agency as to who is to carry out the test on behalf of the other participants and to submit a summary or robust study summary to the Agency.
Če dogovor ni dosežen, Agencija določi registracijskega zaveznika ali uporabnika na nižji stopnji, ki opravi est.
If no agreement is reached, the Agency shall specify which registrant or downstream user shall perform the test.
K stroškom izvajanja študije prispevajo vsi udeleženci SIEF, ki zahtevajo študijo, njihov delež pa je sorazmeren s številom udeleženih potencialnih registracijskih zaveznikov.
All participants of the SIEF who require a study shall contribute to the costs for the elaboration of the study with a share corresponding to the number of participating potential registrants.
Udeleženci, ki študije ne izvajajo, imajo pravico prejeti celovito poročilo o študiji v dveh tednih po plačilu udeležencu, ki je izvedel študijo.
Those participants that do not carry out the study themselves shall have the right to receive the full study report within two weeks following payment to the participant that carried out the study.
Če zadevna študija, ki vključuje teste, ni na voljo, eden od njegovih udeležencev v imenu ostalih v okviru posameznega SIEF izvede eno samo študijo na zahtevano informacijo.
If a relevant study involving tests is not available, only one study shall be conducted per information requirement within each SIEF by one of its participants acting on behalf of the others.
Zmanjšanje podvajanja testiranja na živalih.
Reducing duplication of animal tests.
Povezano s predlogom spremembe člena 30(1).
Linked to Amendment of Article 30(1).
Dobavitelj snovi ali pripravka dostavi prejemniku snovi ali pripravka varnostni list, izpolnjen v skladu s Prilogo II:
The supplier of a substance or a preparation shall provide the recipient of the substance or preparation with a safety data sheet compiled in accordance with Annex II:
(a) kadar snov ali pripravek izpolnjuje kriterije za razvrstitev kot nevarna v skladu z direktivama 67/548/EGS ali 1999/45/ES ali
(a) where a substance or preparation meets the criteria for classification as dangerous in accordance with Directives 67/548/EEC or 1999/45/EC; or
(b) kadar je snov obstojna, se kopiči v organizmih in je strupena ali zelo obstojna in se zelo lahko kopiči v organizmih v skladu s kriteriji iz Priloge XIII.
(b) where a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII.
(b) kadar je snov obstojna, se kopiči v organizmih in je strupena ali zelo obstojna in se zelo lahko kopiči v organizmih v skladu s kriteriji iz Priloge XIII ; ali
(b) where a substance is persistent, bioaccumulative and toxic or very persistent and very bioaccumulative in accordance with the criteria set out in Annex XIII ; or
(ba) kadar je snov določena v skladu s členom 56(f) .
(ba) where a substance has been identified in accordance with Article 56 (f) .
(Spremenjen predlog spremembe 157 – prva obravnava)
(Amendment 157 revised - first reading)
Z varnostnimi listi se informacije o snovi prenesejo v dobavno verigo v skladu z zahtevami REACH.
With the help of Safety Data Sheets information about a substance shall be passed on in the supply chain according to the requirements of REACH.
Obseg snovi, za katere je potreben varnostni list, je treba razširiti na vse snovi, ki vzbujajo zelo veliko skrb, omenjene v členu 56 o avtorizaciji.
The scope of substances that require a safety data sheet needs to be expanded to include all substances of very high concern that are mentioned in Article 56 on authorisation.
ČLEN 31, ODSTAVEK 9 A (novo)
ARTICLE 31, PARAGRAPH 9 A (new)
Komisija organizira razvoj tehničnih smernic, ki določajo najmanjše zahteve za varnostne liste, da bi zagotovili jasne in primerne informacije 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.
(Predlog spremembe 162 – prva obravnava)
(Amendment 162 - first reading)
Varnostni listi so lahko dobro orodje za sporočanje informacij za snovi in pripravke po dobavni verigi navzgor in navzdol.
Safety data sheets (SDS) can be a good tool to communicate information up and down the supply chain for both substances and preparations.
Vseeno varnostni listi dosežejo namen le, če so primerno izpolnjeni.
However, SDS will achieve their purpose only if they are completed adequately.
Zato mora Komisija oblikovati tehnična navodila, ki zagotavljajo najmanjše zahteve o izpolnjevanju varnostnih listov.
Thus, the Commission should develop technical guidance that provide minimum requirements on the completion of SDS.
ČLEN 32, ODSTAVEK 4
ARTICLE 32, PARAGRAPH 4
Vsak proizvajalec ali uvoznik izdelka, ki vsebuje snov v koncentraciji nad 0,1 % mas. m/m, ki izpolnjuje kriterije iz člena 56 in je opredeljena v skladu s členom 58(1), zagotovi prejemniku pripravka dovolj informacij za varno uporabo pripravka, najmanj vključno z imenom snovi.
Any producer or importer of an article containing a substance meeting the criteria in Article 56 and identified according to Article 58(1) in a concentration above 01 % weight by weight (w/w), shall provide the recipient of the article with sufficient information to allow safe use of the article including, as a minimum, the name of the substance.
Ta obveznost se razširi na vse prejemnike izdelkov v dobavni verigi.
This obligation shall extend to all recipients of articles in the supply chain.
Vse določbe o obveznem sporočanju informacij o snoveh v izdelkih, je treba združiti v en sam člen (glej člen 33a).
All provisions relating to duty to communicate information on substances in articles should be grouped in a single article (see new Article 33a).