natgillin/translations-raw huggingface dataset:
Države članice lahko Agenciji predložijo pripombe o vsebini osnutka tekočega načrta Skupnosti, skupaj s predlogi, da se vključijo dodatne snovi, in predlagajo, da prevzame vrednotenje z uporabo nacionalnih organov do 31. januarja vsako leto.
Member States may provide their comments, including proposals to include additional substances, on the content of the draft Community rolling plan to the Agency, and propose to take charge of an evaluation through national bodies by 31 January of each year.
Država članica ne sme predlagati, da prevzame vrednotenje snovi, za katero je že predlagala, da se doda v osnutek tekočega načrta Skupnosti.
A Member State may not propose to take charge of the evaluation of a substance which it has itself proposed to add to the draft Community rolling plan.
Agencija je odgovorna za vrednotenje snovi, vključene v tekoči načrt Komisije.
The Agency shall be responsible for the evaluation of the substances included in the Community rolling plan.
Za izvajanje teh vrednotenj se lahko Agencija opira na organ(e), ki so jih za ta namen ustanovile države članice in so uvrščene na seznam v skladu s členom 94(3), pri čemer jih izbire na podlagi predlogov držav članic v skladu z odstavkom 2 tega člena.
To perform these evaluations the Agency may rely on the body(ies) designated for that purpose by each Member State and appearing on the list drawn up pursuant to Article 94(3), selecting them on the basis of Member States' proposals formulated in accordance with paragraph 2 of this Article.
iz odstavka 1 zajema obdobje treh let in se vsako leto prilagodi zadnjemu stanju, v njem pa so navedene snovi,
rolling plan as referred to in paragraph 1 shall cover a period of three years, updated annually, and shall specify the substances which
za katere je načrtovano, da jih ovrednoti Agencija
are planned to be evaluated
vsako leto
each year
na ravni Skupnosti, ali, kjer je to ustrezno, države članice, ki so za to zaprosile v skladu z odstavkom 2.
at Community level either by the Agency, or, where applicable, in the Member States who have made a proposal in accordance with paragraph 2
Če ni pripomb k tekočemu načrtu
In cases where there have been no comments on
ta tekoči načrt sprejme.
shall adopt this rolling plan.
Drugače Agencija pripravi nov osnutek tekočega načrta, ki ga predloži državam članicam.
Otherwise, the Agency shall prepare a new draft rolling plan that shall be submitted to the Member States.
Če se v 30 dneh ne izdajo nove pripombe k vsebini tekočega načrta Skupnosti, ga Agencija sprejme.
If within 30 days no new comments have been issued on the content of the Community rolling plan, the Agency shall adopt it.
Če se mnenja razlikujejo, ne le če več držav članic predlaga različne organe za ocenjevanje iste snovi, Agencija predloži tekoči načrt Komisiji, ki ga sprejme v skladu s postopkom iz člena 141(3).
If differences of opinion subsist, not least in the event of several Member States proposing different bodies for the evaluation of the same substance, the Agency shall submit the rolling plan to the Commission, which shall adopt it in accordance with the procedure referred to in Article 141(3).
dokončne tekoče načrte objavi na svoji spletni
Agency shall publish the definitive rolling plans on its
Država članica lahko kadar koli obvesti Agencijo o novi snovi, kadar ima informacije, ki kažejo na to, da obstaja nevarnost za okolje ali zdravje ljudi.
A Member State may notify the Agency at any time of a new substance, whenever it is in possession of information which suggests that there is a danger to the environment or to human health.
Agencija doda, če je upravičeno, to snov na seznam snovi, ki jih je treba vrednotiti na podlagi tekočega načrta.
The Agency shall, if justified, add that substance to the list of substances to be evaluated under the rolling plan.
Zahteve za dodatne informacije
Requests for further information
Če so po mnenju
If the
člena 51(1)
Article 51(1)
Odločitev se sprejme v skladu s postopki iz
The decision shall be taken in accordance with the procedure laid down in
Registracijski zavezanec predloži Agenciji zahtevane informacije.
The registrant shall submit the information required to the Agency.
Osnutek odločitve, ki zahteva od registracijskega(ih) zavezanca(ev) dodatne informacije, se pripravi v 12 mesecih po objavi tekočega načrta na spletni strani Agencije.
A draft decision requiring further information from registrant(s) shall be prepared within 12 months of the publication of the rolling plan on the Agency's website.
zaključi svoje vrednotenje snovi v skladu z odstavki 1, 2 in 3, o tem obvesti
finishes its evaluation activities under paragraphs 1, 2 and 3, it shall notify the
v 12 mesecih po začetku vrednotenja.
accordingly within 12 months of the start of the evaluation of the substance.
Če se ta rok preseže, se vrednotenje šteje za končano.
If this deadline is exceeded, the evaluation shall be deemed to be finished.
Usklajenost z drugimi dejavnostmi
Coherence with other activities
se pri svojem vrednotenju snovi opre na predhodna vrednotenja v skladu s tem naslovom.
shall base its evaluation of a substance on any previous evaluation under this Title.
Vsak osnutek odločitve, ki zahteva dodatne informacije v skladu s
Any draft decision requiring further information under
členom 52
Article 52
, se lahko utemelji samo s spremembo okoliščin ali novimi spoznanji.
may be justified only by a change of circumstances or acquired knowledge.
je ustrezno, se sprejmejo izvedbeni ukrepi v skladu s postopkom iz
appropriate, implementing measures shall be adopted in accordance with the procedure referred to in
Preverjanje predloženih informacij in nadaljevanje vrednotenja snovi
Check of information submitted and follow-up to substance evaluation
preveri vse informacije, ki so predložene na podlagi odločitve, sprejete v skladu s
shall examine any information submitted in consequence of a decision taken under
, ter po potrebi pripravi ustrezne osnutke odločitev v skladu s
, and shall draft any appropriate decisions in accordance with
Ko je vrednotenje snovi končano,
Once the substance evaluation has been completed, the
uporabi informacije, pridobljene pri tem vrednotenju, za namene
shall use the information obtained from this evaluation for the purposes of
Komisiji in državam
Commission and the Member
registracijskega zavezanca
registrant and
in države
the Member
VREDNOTENJE VMESNIH PROIZVODOV
EVALUATION OF INTERMEDIATES
Dodatne informacije o na mestu izoliranih vmesnih proizvodih
Further information on on-site isolated intermediates
Za na mestu izolirane vmesne proizvode se ne uporablja niti ocenjevanje dokumentacije niti vrednotenje snovi.
For on-site isolated intermediates, neither dossier nor substance evaluation shall apply.
od registracijskega zavezanca zahteva, da predloži dodatne informacije, neposredno povezane z ugotovljeno nevarnostjo.
require the registrant to submit further information directly related to the risk identified.
Tej zahtevi je treba priložiti pisno utemeljitev;
This request shall be accompanied by a written justification;
preuči vse predložene informacije in po potrebi sprejme ustrezne ukrepe za zmanjšanje nevarnosti, ugotovljene v zvezi z zadevnim mestom.
examine any information submitted and, if necessary, take any appropriate risk reduction measures to address the risks identified in relation to the site in question.
Postopek iz prvega odstavka lahko izvede samo
The procedure provided for in the first paragraph may be undertaken only by the
SKUPNE DOLOČBE
COMMON PROVISIONS
vse osnutke odločitev v skladu s
shall communicate any draft decision under
upošteva vse prejete pripombe in lahko v skladu z njimi spremeni osnutek odločitve.
shall take any comments received into account and may amend the draft decision accordingly.
Če je registracijski zavezanec
If a registrant has
prenehal proizvajati ali uvažati snov, o tem obvesti
ceased the manufacture or import of the substance, he shall inform the
, kar ima za posledico prenehanje veljavnosti njegove registracije in da se v zvezi s to snovjo ne more več zahtevati dodatnih informacij, razen če se ne predloži nova registracija.
of this fact with the consequence that his registration shall no longer be valid, and no further information may be requested with respect to that substance, unless he submits a new registration.
Registracijski zavezanec lahko
The registrant may
preneha proizvajati ali uvažati snovi po sprejetju osnutka odločitve.
cease the manufacture or import of the substance upon receipt of the draft decision.
V tem primeru o tem obvesti
In such cases, he shall inform the
Ne glede na odstavka 2 in 3 se dodatne informacije lahko zahtevajo v skladu s
Notwithstanding paragraphs 2 and 3, further information may be required in accordance with
v enem ali obeh naslednjih primerih:
in either or both of the following cases:
za ljudi ali okolje, ki upravičuje potrebo po dodatnih informacijah;
prepares a dossier in accordance with Annex XIV concluding that there is a potential long-term risk to man or the environment justifying the need for further information;
če izpostavljenost snovi, ki jo izdeluje(jo) ali uvaža(jo) zadevni registracijski zavezanec(ci), bistveno prispeva k tej nevarnosti.
where the exposure to the substance manufactured or imported by the registrant(s) concerned contributes significantly to that risk.
Sprejetje odločitev med vrednotenjem
Adoption of decisions under evaluation
osnutek odločitve
Agency shall circulate
V 30 dneh po tem, ko je bil osnutek razposlan,
Within 30 days of circulation,
lahko države
the Member
Če Agencija v 30 dneh ne prejme nobenega predloga ali če sama ne da nobenega
If the Agency does not receive any
odločitev v različici iz odstavka 1.
30 days, it shall take the decision in the version notified under paragraph 1.
Če Agencija prejme predlog spremembe, lahko spremeni osnutek odločitve.
If the Agency receives a proposal for amendment, it may modify the draft decision.
Agencija osnutek odločitve skupaj s predlaganimi spremembami predloži Odboru držav članic v 15 dneh po poteku 30-dnevnega roka iz
The Agency shall refer a draft decision, together with any amendments proposed, to the Member State Committee within 15 days of the end of the 30-day period referred to in
odstavka 2.
paragraph 2
Agencija vsak predlog spremembe takoj sporoči vsem zadevnim registracijskim zavezancem ali uporabnikom na nižji stopnji in jim omogoči, da v 30 dneh predložijo svoje pripombe.
The Agency shall forthwith communicate any proposal for amendment to any registrants or downstream users concerned and allow them to comment within 30 days.
Odbor držav članic upošteva vse prejete pripombe.
The Member State Committee shall take any comments received into account.
Če Odbor držav članic doseže soglasje o osnutku odločitve v 60 dneh po tem, ko mu je bila zadeva predložena, Agencija v skladu s tem sprejme odločitev.
If, within 60 days of the referral, the Member State Committee reaches a unanimous agreement on the draft decision, the Agency shall take the decision accordingly.
Če Odbor držav članic ne doseže soglasja, sprejme mnenje v skladu s
If the Member State Committee fails to reach a unanimous agreement, it shall adopt an opinion in accordance with
členom 92(7)
Article 92(7)
v 60 dneh po tem, ko mu je bila zadeva predložena.
within 60 days of the referral.
Agencija to mnenje sporoči Komisiji.
The Agency shall transmit that opinion to the Commission.
V 60 dneh po prejemu mnenja Komisija pripravi osnutek odločitve, ki se sprejme v skladu s postopkom iz
Within 60 days of receipt of the opinion, the Commission shall prepare a draft decision to be taken in accordance with the procedure referred to in
Delitev stroškov za preskuse na vretenčarjih brez sporazuma med registracijskimi zavezanci
Cost sharing for tests involving vertebrate animals without an agreement between registrants
Če registracijski zavezanec ali uporabnik na nižji stopnji izvede preskus v imenu drugih, si stroške te študije vsi enakomerno porazdelijo.
If a registrant or downstream user performs a test on behalf of others, they shall all share the cost of that study equally.
Če se takšen dogovor ne doseže in študija vključuje preskuse na vretenčarjih, Agencija imenuje enega od registracijskih zavezancev ali uporabnikov na nižji stopnji za izvedbo študije.
If there is a failure to reach such an agreement and the study involves tests on vertebrate animals, the Agency shall designate one of the registrants or downstream users to carry out the study.
Registracijski zavezanec ali uporabnik na nižji stopnji, ki je izvedel študijo, Agenciji omogoči dostop do nje in predloži dokazilo o stroških.
The registrant or downstream user that has carried out the study shall make available to the Agency the study and proof of the cost of that study.
Agencija omogoči drugim registracijskim zavezancem in/ali uporabnikom na nižji stopnji dostop do kopije zadevne študije ob prejetju dokazila, da so drugi registracijski zavezanci in/ali uporabniki na nižji stopnji plačali registracijskemu zavezancu ali uporabniku na nižji stopnji, ki je izvedel študijo, delež stroškov, ki jih je slednji dokazal.
The Agency shall make available to the other registrants and/or downstream users a copy of the study concerned, on receipt of proof that the other registrants and/or downstream users have paid the registrant or downstream user that has carried out the study a share of the cost shown by the latter.
Če kdo od drugih registracijskih zavezancev in/ali uporabnikov na nižji stopnji ne plača svojega deleža stroškov, ne bo mogel registrirati svoje snovi.
If any of the other registrants and/or downstream users fail to pay their share of the cost, they shall not be able to register their substance.
V primeru iz odstavka 1 registracijski zavezanec ali uporabnik na nižji stopnji, ki izvede preskus, vsem zadevnim udeležencem priskrbi en izvod preskusa.
In the case referred to in paragraph 1, the registrant or downstream user who performs the test shall provide each of the others concerned with a copy of the test.
Udeleženec, ki izvede in predloži študijo, ima v skladu s tem terjatev do drugih.
The person performing and submitting the study shall have a claim against the others accordingly.
Drugi lahko zahtevajo en izvod študije.
The others shall have a claim for a copy of the study.
Vsak zadevni udeleženec lahko vloži zahtevek, zato da se drugemu udeležencu prepove proizvodnja, uvoz ali dajanje snovi v promet, če ta drugi udeleženec ne plača svojega deleža stroškov oziroma za ta znesek ne zagotovi jamstva ali ne izroči enega izvoda izvedene študije.
Any person concerned shall be able to make a claim in order to prohibit another person from manufacturing, importing or placing the substance on the market if that other person either fails to pay his share of the cost or to provide security for that amount or fails to hand over a copy of the study performed.
Vsi zahtevki so izterljivi na nacionalnih sodiščih.
All claims shall be enforceable in the national courts.
Vsak udeleženec se lahko odloči, da svoje zahtevke za povračilo stroškov predloži razsodišču in sprejme njegovo odredbo.
Any person may choose to submit their claims for remuneration to an arbitration board and accept the arbitration order.
Objava informacij o vrednotenju
Publication of information on the evaluation
o napredku, doseženem v primerjavi s predhodnim koledarskim letom pri izvajanju obveznosti,
on the progress made over the previous calendar year towards discharging the obligations incumbent upon
v zvezi s preučevanjem predlogov za
in relation to the examination of testing
NASLOV VII DOVOLJENJE
TITLE VII AUTHORISATION
ZAHTEVA ZA DOVOLJENJE
AUTHORISATION REQUIREMENT
Namen dovoljenja
Aim of authorisation
Kjer takih nadomestnih snovi ni na voljo in kadar koristi za družbo prevladajo nad nevarnostjo v zvezi z uporabo take snovi, je namen tega naslova zagotoviti ustrezen nadzor uporabe snovi, ki vzbujajo zelo veliko skrb, in spodbujanje nadomestnih možnosti.
Where no such alternatives are available, and where the benefits to society outweigh the risks connected with the use of such substances, the aim of this Title is to ensure that the use of substances of very high concern is properly controlled and that alternatives are encouraged.
Proizvajalec, uvoznik ali uporabnik na nižji stopnji snovi ne sme dati v promet za uporabo niti je ne sme sam uporabljati, če je ta snov vključena v Prilogo XIII, razen če:
A manufacturer, importer or downstream user shall not place on the market a substance for a use or use it himself if that substance is included in Annex XIII, unless:
je bilo za uporabo(e) te snovi kot take ali v pripravku ali vgrajene v izdelek, za katero(e) se snov daje v promet ali za katero(e) jo sam uporablja, izdano dovoljenje v skladu s
the use(s) of that substance on its own, in a preparation or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been authorised in accordance with
če je (so) bila(e) uporaba(e) te snovi kot take ali v pripravku ali vgrajene v izdelek, za katero(e) je bila snov dana v promet ali za katero(e) jo sam uporablja, izvzeta iz zahteve za pridobitev dovoljenja iz Priloge XIII v skladu s
the use(s) of that substance on its own, in a preparation or the incorporation of the substance into an article for which the substance is placed on the market or for which he uses the substance himself has been exempted from the authorisation requirement in Annex XIII itself in accordance with
členom 64(2)
Article 64(2)
če datum iz
the date referred to in
člena 64(1)(d)(i)
Article 64(1)(d)(i)
še ni bil dosežen; ali
has not been reached; or
če je bil datum iz
the date referred to in
če je bilo za snovi, dane v promet, dovoljenje za to uporabo izdano njegovemu neposrednemu uporabniku na nižji stopnji.
in cases where the substance is placed on the market, authorisation for that use has been granted to his immediate downstream user.
Uporabnik na nižji stopnji lahko uporablja snov, ki izpolnjuje merila iz odstavka 1, če je uporaba v skladu s pogoji iz dovoljenja, izdanega za to uporabo udeležencu, ki je v dobavni verigi na višji
A downstream user may use a substance meeting the criteria set out in paragraph 1 provided that the use is in accordance with the conditions of an authorisation granted to an actor up his supply chain for that
1 in 2 se ne uporabljata za snovi, ki se uporabljajo za znanstvene raziskave in razvoj ali v proizvod in postopek usmerjene raziskave in razvoj v količinah, ki ne presegajo ene tone na
1 and 2 shall not apply to the use of substances in scientific research and development or in product and process orientated research and development in quantities not exceeding 1 tonne per
1 in 2 se ne uporabljata za uporabo snovi v pripravkih, in sicer za:
1 and 2 shall not apply to the use of substances when they are present in preparations:
snovi iz
for substances referred to in
člena 63(d)
Article 63(d),
za vse druge snovi, katerih koncentracija je nižja od mejnih vrednosti iz Direktive 1999/45/ES, zaradi katerih se preparat razvrsti kot nevaren.
for all other substances, below the concentration limits specified in Directive 1999/45/EC which result in the classification of the preparation as dangerous.
Seznam snovi, za katere je treba pridobiti dovoljenje
List of substances subject to authorisation
Snovi, za katere je znano, da izpolnjujejo merila iz člena 63, se navedejo v Prilogi XIII(a) v času postopka izdaje dovoljenja.
Substances that are known to fulfil the criteria of Article 63 shall be listed in Annex XIII(a) pending the procedure for authorisation.
Takoj ko se postopek za pridobitev dovoljenja zaključi, se snovi dodajo na seznam v Prilogi XIII(b) v skladu s postopkom iz člena 64(1).
Once the authorisation procedure has been initiated, the substances shall be listed in Annex XIII(b), in accordance with the procedure laid down in Article 64(1).
Snovi, ki se vključijo v Prilogo
Substances to be included in
Brez poseganja v obstoječe ali prihodnje omejitve
Without prejudice to existing or future restrictions
člena 65
Article 65
snovi, ki izpolnjujejo merila za razvrstitev kot kancerogene iz skupine 1 ali 2 v skladu z Direktivo 67/548/EGS;
substances meeting the criteria for classification as carcinogenic category 1 or 2 in accordance with Directive 67/548/EEC;
snovi, ki izpolnjujejo merila za razvrstitev kot mutagene iz skupine 1 ali 2 v skladu z Direktivo 67/548/EGS;
substances meeting the criteria for classification as mutagenic category 1 or 2 in accordance with Directive 67/548/EEC;
snovi, ki izpolnjujejo merila za razvrstitev kot strupene za razmnoževanje iz skupine 1 ali 2 v skladu z Direktivo 67/548/EGS;
substances meeting the criteria for classification as toxic for reproduction category 1 or 2 in accordance with Directive 67/548/EEC;
snovi, ki so v skladu z merili iz Priloge XII obstojne, strupene in se lahko kopičijo v organizmih;
substances which are persistent, bioaccumulative and toxic in accordance with the criteria set out in Annex XII;
snovi, ki so sestavine, dodane tobačnim izdelkom v smislu člena 2(1) in (5) Direktive 2001/37/ES.
substances which are ingredients added to tobacco products within the meaning of Article 2(1) and (5) of Directive 2001/37/EC.
Vključitev snovi v
Inclusion of substances in
Prilogo XIII(b)
Annex XIII(b)
notranjo(e) lastnost(i) snovi iz
the intrinsic property (properties) of the substance referred to in
člena 63
Article 63
omejitve v skladu s členom 74;
any restrictions, in accordance with Article 74;
prehodne ureditve:
transitional arrangements:
datum ali datume vsaj 18 mesecev pred datumom(i) poteka, do katerega(ih) morajo prispeti vloge, če želi vlagatelj nadaljevati uporabo ali dajanje snovi v promet za določene uporabe po datumu(ih) poteka; te nadaljnje uporabe se dovolijo po datumu poteka do sprejetja odločitve glede vloge za pridobitev dovoljenja;
a date or dates at least 18 months before the sunset date(s) by which applications must be received if the applicant wishes to continue to use the substance or place it on the market for certain uses after the sunset date(s); these continued uses shall be allowed after the sunset date until a decision on the application for authorisation is taken;
roke za preverjanje
review periods
, ki ne smejo presegati 5 let,
, which must not exceed 5 years,
uporabe ali skupine uporab, ki so izvzete iz zahteve za pridobitev dovoljenja, če obstajajo, in pogoje za takšne izjeme, če obstajajo.
uses or categories of uses exempted from the authorisation requirement, if any, and conditions for such exemptions, if any.
Uporabe ali skupine uporab so lahko izvzete iz zahteve za pridobitev dovoljenja.
Uses or categories of uses may be exempted from the authorisation requirement.
veljavna posebna zakonodaja Skupnosti, ki določa za uporabo snovi v zvezi z varovanjem zdravja ali okolja minimalne zahteve, kot so omejitve poklicne izpostavljenosti, emisijske omejitve itd.;
existing specific Community legislation imposing minimum requirements relating to the protection of health or the environment for the use of the substance, such as binding occupational exposure limits, emission limits and so forth;
veljavne zakonske obveznosti za sprejetje ustreznih tehničnih in upravljavskih ukrepov, da se pri uporabi snovi zagotovi skladnost z vsemi ustreznimi zdravstvenimi, varnostnimi in okoljskimi standardi.
existing legal obligations to take appropriate technical and management measures to ensure compliance with any relevant health, safety and environmental standards in relation to the use of the substance.
Takšne izjeme se ne dodelijo uporabam ali skupinam uporab za snovi iz člena 63, ki so sestavine, dodane tobačnim izdelkom v smislu člena 2(1) in (5) Direktive 2001/37/ES, ne glede na člen 12 te direktive.
Such exemptions shall not be granted to uses or categories of uses for substances referred to in Article 63 which are ingredients added to tobacco products within the meaning of Article 2(1) and (5) of Directive 2001/37/EC, notwithstanding Article 12 of that Directive.
prednostne snovi
priority substances
prenesejo iz Priloge XIII(a) v Prilogo XIII(b),
be transferred from Annex XIII(a) to Annex XIII(b),
in pri tem za vsako snov navede podatke iz odstavka 1.
specifying for each substance the items set out in paragraph 1.