natgillin/translations-raw huggingface dataset:
Dokler pritožba ni rešena ali dokler se pritožba še lahko vloži, Agencija in pristojni organi države članice še naprej hranijo zadevne informacije kot zaupne.
While an appeal is pending or while an appeal may yet be introduced, the Agency and any competent authority of a Member State shall continue to keep the information in question confidential.
Agencija in pristojni organi države članice uporabijo
The Agency and any competent authority of a Member State shall apply
člen 127
Article 127
te uredbe pri sprejetju odločitve v skladu s členom 4 Uredbe (ES) št. 1049/2001 oziroma členom 4 Direktive 2003/4/ES.
of this Regulation when taking a decision under Article 4 of Regulation (EC) No 1049/2001 and Article 4 of Directive 2003/4/EC, respectively.
Če države članice prejmejo informacije prek Agencije, Agencija odloči o tem, ali se v skladu s členom 4(4) in (5) Uredbe (ES) št. 1049/2001 dostop dovoli ali zavrne.
However, where Member States have received information through the Agency, the Agency shall take the decision whether to grant or refuse access in accordance with Article 4(4) and (5) of Regulation (EC) No 1049/2001.
Upravni odbor sprejme predpise za izvajanje Uredbe (ES) št. 1049/2001
The Management Board shall adopt the arrangements for implementing Regulation (EC) No 1049/2001
Šest mesecev po začetku veljavnosti te uredbe.
Six months after the date of entry into force of this Regulation.
Naslednje informacije se ne štejejo za
The following information shall not be considered as
ime snovi iz seznama Einecs, če je ustrezno;
if applicable, the name of the substance as given in Einecs;
fizikalno-kemijski podatki o snovi ter njeni porazdelitvi in obnašanju v okolju
physicochemical data concerning the substance and on pathways and environmental fate;
rezultati toksikoloških in ekotoksikoloških študij;
the result of each toxicological and ecotoxicological study;
vrednosti DNEL (mejna vrednost, pod katero snov nima učinka) ali vrednosti PKBU (predvidena koncentracija brez učinka), določene v skladu s Prilogo I;
any derived no-effect level (Dnel) or predicted no-effect concentration (Pnec) established in accordance with Annex I;
če je bistveno za razvrstitev in označitev, stopnja čistosti snovi ter določitev nečistoč in/ali dodatkov, za katere je znano, da so nevarni;
if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous;
navodila za varno uporabo v skladu z oddelkom 4 Priloge IV;
the guidance on safe use provided in accordance with section 4 of Annex IV;
informacije iz varnostnega lista, razen imena podjetja ali če veljajo informacije za zaupne na podlagi uporabe odstavka 2;
the information contained in the safety data sheet, except for the name of the company/undertaking or where the information is considered confidential by application of paragraph 2;
analitske metode, če se zahtevajo v skladu s prilogo VII ali VIII, ki omogočajo zaznavanje nevarne snovi pri spuščanju v okolje ali določitev neposredne izpostavljenosti ljudi;
analytical methods if requested in accordance with Annex VII or VIII which make it possible to detect a dangerous substance when discharged into the environment as well as to determine the direct exposure of humans;
dejstvo, da so bili opravljeni preskusi na vretenčarjih.
the fact that testing on vertebrate animals has been carried out.
Naslednje informacije se štejejo za
The following information shall be considered as
podrobni podatki o popolni sestavi pripravka;
details of the full composition of a preparation;
točen opis uporabe ali delovanja snovi ali
the precise use, function or application of a substance or
med proizvajalcem ali uvoznikom in njegovimi uporabniki na nižji stopnji
between a manufacturer or importer and his downstream users
V izjemnih primerih, ko so neposredno ogroženi zdravje ljudi, varnost ali okolje, kot so izredne razmere, Agencija lahko razkrije informacije iz tega odstavka.
In exceptional cases, where there are immediate risks to human health, safety or the environment, such as emergency situations, the Agency may disclose the information referred to in this paragraph.
Vse druge informacije so dostopne v skladu s
All other information shall be accessible in accordance with
členom 126
Article 126
Sodelovanje s tretjimi državami in mednarodnimi organizacijami
Cooperation with third countries and international organisations
Ne glede na
Articles 126
se informacije, ki jih prejme Agencija v skladu s to uredbo, lahko razkrijejo vladi ali organu tretje države ali mednarodni organizaciji na podlagi sporazuma, sklenjenega med Skupnostjo in zadevno tretjo stranjo v skladu z Uredbo Evropskega parlamenta in Sveta (ES) št. 304/2003 UL L 63, 6.3.2003, str.
, information received by the Agency under this Regulation may be disclosed to any government or body of a third country or an international organisation in accordance with an agreement concluded between the Community and the third party concerned under Regulation (EC) No 304/2003 of the European Parliament and of the Council OJ L 63, 6.3.2003, p.
ali členom 181a(3) Pogodbe ES, če sta izpolnjena oba naslednja pogoja:
or under Article 181a (3) of the Treaty, provided that both the following conditions are met:
namen sporazuma je sodelovanje pri izvajanju ali upravljanju zakonodaje o kemikalijah iz te uredbe;
the purpose of the agreement is cooperation on the implementation or management of legislation concerning chemicals covered by this Regulation;
tretja stran varuje zaupnost informacij na podlagi medsebojnega dogovora.
the third party protects the confidential information as mutually agreed.
NASLOV XII
TITLE XII
PRISTOJNI ORGANI
COMPETENT AUTHORITIES
Države članice imenujejo pristojni organ ali pristojne organe, odgovorne za izvajanje nalog, ki se jim dodelijo v skladu s to uredbo, ter za sodelovanje
Member States shall appoint the competent authority or competent authorities responsible for performing the tasks allotted to competent authorities under this Regulation and for co-operating with
s Komisijo
the Commission
in Agencijo pri izvajanju te uredbe.
and the Agency in the implementation of this Regulation.
Države članice dajo pristojnim organom na razpolago ustrezne vire, ki jim omogočajo pravočasno izvajanje njihovih nalog iz te uredbe.
Member States shall place adequate resources at the disposal of the competent authorities to enable them to fulfil their tasks under this Regulation in a timely manner.
Sodelovanje med pristojnimi organi
Co-operation between competent authorities
Pristojni organi medsebojno sodelujejo pri izvajanju svojih nalog iz te uredbe ter dajo pristojnim organom drugih držav članic v ta namen vso potrebno in koristno podporo.
The competent authorities shall co-operate with each other in the performance of their tasks under this Regulation and shall give the competent authorities of other Member States all the necessary and useful support to this end.
Obveščanje javnosti o nevarnostih snovi
Communication to the public of information on risks of substances
V skladu s smernicami, ki jih mora izdelati Agencija,
In accordance with the guidelines to be drawn up by the Agency,
Druge odgovornosti pristojnih organov
Other responsibilities of the competent authorities
Pristojni organi proizvajalcem, uvoznikom, uporabnikom na nižji stopnji in vsem drugim zainteresiranim stranem svetujejo o njihovih ustreznih nalogah in obveznostih iz te uredbe, Agencija pa zagotovi v skladu s
The competent authorities shall provide advice to manufacturers, importers, downstream users and any other interested parties on their respective responsibilities and obligations under this Regulation, in addition to the operational guidance documents provided by the Agency under
členom 83(4)(g)
Article 83(4)(g)
NASLOV XIII
TITLE XIII
v skladu s smernicami, ki jih mora sestaviti Agencija.
in accordance with the guidelines to be drawn up by the Agency
Države članice Agenciji dajo dovoljenje, da uvede nadzore in dejavnosti ter določi smernice za usklajevanje sistema nadzorov in poveča njegovo učinkovitost.
The Agency shall be authorised by the Member States to initiate controls and activities and shall establish guidelines for the control system's harmonisation and effectiveness.
Države članice,
The Member States shall
na podlagi skupine smernic, ki jih oblikuje Agencija,
, on the basis of a set of guidelines drawn up by the Agency,
Če določbe držav članic zahtevajo denarno kazen, se znesek te kazni določi v skladu s težo in trajanjem kršitve, obsegom škode za okolje in zdravje ljudi ter vsemi oteževalnimi ali olajševalnimi okoliščinami, kot je na primer ustrezno upoštevanje dobrega počutja živali.
In cases where the provisions of the Member States require a fine, the amount of the fine shall be determined according to the gravity and duration of the infringement, the extent of damage to the environment and human health and any aggravating or attenuating circumstances, such as consideration of animal welfare, as appropriate.
Določi se v višini, ki zagotavlja njen odvračilni učinek.
It shall be set at a level which ensures that it has a deterrent effect.
Države članice do 1. julija vsako leto Agenciji predložijo poročilo o rezultatih uradnih preverjanj, o opravljenem spremljanju, določenih denarnih kaznih in drugih ukrepih, sprejetih v predhodnem koledarskem letu v skladu s
Member States shall submit a report to the Agency by 1 July each year on the results of the official checks, the monitoring carried out, fines set and the other measures taken pursuant to Article
členoma 133
s 133
NASLOV XIV
TITLE XIV
Klavzula o prostem pretoku
Free movement clause
Države članice ne prepovedo, omejijo ali ovirajo proizvodnje, uvoza, dajanja v promet ali uporabe snovi kot take, v pripravku ali izdelku, ki spada na področje uporabe te uredbe in je v skladu s to uredbo in, kjer je ustrezno, z akti Skupnosti, sprejetimi za izvajanje te uredbe.
Member States shall not prohibit, restrict or impede the manufacturing, import, placing on the market or use of a substance, on its own, in a preparation or in an article, falling within the scope of this Regulation, which complies with this Regulation and, where appropriate, with Community acts adopted in implementation of this Regulation.
Odstavek 1 ne vpliva na pravico držav članic do ohranjanja ali uvajanja strožjih varnostnih ukrepov v skladu z zakonodajo Skupnosti o varnosti delavcev, če ocena kemijske varnosti za uporabo snovi ni bila opravljena v skladu s to uredbo.
Paragraph 1 shall not affect the right of Member States to maintain or introduce more stringent protective measures in accordance with Community legislation on worker protection, if a chemical safety assessment has not been carried out in accordance with this Regulation for a use of a substance.
Zaščitna klavzula
Safeguard Clause
Če ima država članica utemeljene razloge za mnenje, da pomeni snov kot taka, v pripravku ali izdelku, čeprav izpolnjuje zahteve iz te uredbe, nevarnost za zdravje ljudi ali okolje, lahko sprejme ustrezne začasne ukrepe.
Where a Member State has justifiable grounds for believing that a substance, on its own, in a preparation or in an article, although satisfying the requirements of this Regulation, constitutes a risk to human health or the environment, it may take appropriate provisional measures.
Država članica o tem takoj obvesti Komisijo, Agencijo in druge države članice, pri tem navede razloge za svojo odločitev ter predloži znanstvene ali tehnične informacije, na katerih temelji začasni ukrep.
The Member State shall immediately inform the Commission, the Agency and the other Member States thereof, giving reasons for its decision and submitting the scientific or technical information on which the provisional measure is based.
Komisija sprejme odločitev v skladu s postopkom iz
The Commission shall take a decision in accordance with the procedure referred to in
v 90 dneh po prejemu obvestila države članice.
within 90 days of receipt of the information from the Member State.
S to odločitvijo se:
This decision shall either:
začasni ukrep dovoli do roka, določenega v odločitvi; ali
authorise the provisional measure for a time period defined in the decision; or
od države članice zahteva, da začasni ukrep prekliče.
require the Member State to revoke the provisional measure.
Utemeljitev odločitev
Statement of reasons for decisions
Pristojni organi, Agencija in Komisija navedejo razloge za vse odločitve, ki jih sprejmejo v skladu s to uredbo.
The Competent Authorities, the Agency and the Commission shall state the reasons for all decisions they take under this Regulation.
Priloge se lahko spremenijo v skladu s postopkom iz
The Annexes may be amended in accordance with the procedure referred to in Article
Najpozneje do ...
Not later than ...
18 mesecev po začetku veljavnosti te uredbe.
18 months after the date of entry into force of this Regulation.
se vstavi oddelek na začetku Priloge II, ki določa objektivna merila za izvzetje snovi in/ali skupin snovi.
, a section shall be inserted at the beginning of Annex II which lays down objective criteria for the exemption of substances and/or groups of substances.
Izvedbeni predpisi
Implementing legislation
Ukrepi, potrebni za učinkovito izvajanje te uredbe, se sprejmejo v skladu s postopkom iz
The measures necessary for the efficient implementation of this Regulation shall be adopted in accordance with the procedure referred to in
Komisiji pomaga odbor, ki ga sestavljajo predstavniki držav članic, predseduje pa mu predstavnik Komisije.
The Commission shall be assisted by a Committee composed of representatives of the Member States and chaired by the representative of the Commission.
Pri sklicevanju na ta odstavek se
Where reference is made to this paragraph,
uporabita člena 3 in 7
Articles 3 and 7
Sklepa 1999/468/ES
of Decision 1999/468/EC shall apply,
, ob upoštevanju člena 8
having regard to the provisions of Article 8
uporabita člena 5 in 7
Articles 5 and 7
imenuje osebje, vključno s osebjem, ki začasno izvaja naloge izvršnega direktorja; in
appoint personnel, including a person who shall fulfil the functions of the Executive Director on an interim basis; and
sklepa druge pogodbe.
conclude other contracts.
po potrebi pripravi osnutek spremembe Priloge XVI v skladu z:
, the Commission shall, if necessary, prepare a draft amendment to Annex XVI in accordance with either of the following:
vsemi ocenami tveganja in priporočenimi strategijami za omejitev tveganja, sprejetimi na ravni Skupnosti v skladu s členom 11 Uredbe (EGS) št. 793/93, za katere še niso bili sprejeti ukrepi Skupnosti za omejitev tega tveganja;
any risk evaluation and recommended strategy for limiting risks that has been adopted at Community level in accordance with Article 11 of Regulation (EEC) No 793/93 but for which Community measures to limit those risks have not yet been taken;
vsemi predlogi, predloženimi ustreznim institucijam, ki še niso bili sprejeti in se nanašajo na uvedbo omejitev v skladu z Direktivo 76/769/EGS.
any proposal, which has been submitted to the relevant institutions but has not yet been adopted, concerning the introduction of restrictions under Directive 76/769/EEC.
Vmesna naknadna presoja vplivov
Intermediary ex post impact assessment
Pet let po začetku veljavnosti te uredbe, brez poseganja v določbe člena 145, Komisija izvede vmesno naknadno presojo vplivov uredbe.
Five years after the entry into force of this Regulation, without prejudice to the provisions of Article 145, the Commission shall carry out an intermediary ex post impact assessment of the Regulation.
Naknadna presoja vplivov analizira stanje izvajanja te uredbe, primerja dosežene rezultate s predhodnimi pričakovanji ter oceni vpliv te uredbe na delovanje notranjega trga in konkurence na tem trgu.
The impact assessment shall analyse the state of play as regards implementation of the Regulation, shall confront the achieved results with the previous expectations, and shall evaluate the impact of the Regulation on the functioning of, and competition within, the internal market.
Komisija predloži naknadno presojo vplivov Evropskemu parlamentu in Svetu najpozneje do ...
The Commission shall submit the ex post impact assessment to the European Parliament and the Council by ...
Komisija predstavi tiste predloge za spremembo te uredbe, ki se zdijo potrebni na podlagi naknadne presoje vplivov.
The Commission shall introduce a proposal for any amendments to the Regulation that appear necessary on the basis of the ex post impact assessment.
let po začetku veljavnosti te uredbe Komisija preveri, ali se uporablja obveznost izvajanja ocen kemijske varnosti in njihovega dokumentiranja v poročilih o kemijski varnosti tudi za snovi, ki niso zajete v to obveznost, ker jih ni treba
after entry into force of this Regulation, the Commission shall carry out a review with a view to the application of the obligation to perform a chemical safety assessment and to document it in a chemical safety report to substances not covered by this obligation because they are not subject to
podlagi tega preverjanja lahko Komisija v skladu s postopkom iz
the basis of this review, the Commission may, in accordance with the procedure referred to in
to obveznost razširi.
, extend this obligation.
prilagodi v skladu s postopkom iz
, in accordance with the procedure referred to in
nevarnostih, ki jih pomenijo polimeri v primerjavi z drugimi snovmi;
the risks posed by polymers in comparison with other substances;
potrebi, če je, po registriranju določenih vrst polimerov, ob upoštevanju konkurenčnosti in inovativnosti na eni strani ter varovanja zdravja in okolja na drugi.
the need, if any, of registering certain types of polymer, taking account of competitiveness and innovation on the one hand and the protection of health and the environment on the other.
Poročilo iz
The report, referred to in
člena 124(3)
Article 124 (3)
o izkušnjah, pridobljenih pri uporabi te uredbe, vključuje pregled zahtev za
, on the experience acquired with the operation of this Regulation shall include a review of the
za registracijo
requirements relating to registration of
spremeni zahteve za informacije iz
, modify the information requirements specified in
, ob upoštevanju najnovejšega razvoja dogodkov,
taking into account the latest developments,
še zlasti
in particular
v zvezi z nadomestnimi preskusi in odnosi (količinske) strukturne dejavnosti ((Q)SAR).
in relation to alternative testing and (quantitative) structure-activity relationships ((Q)SARs).
Poročilu, omenjenemu v drugem odstavku člena 124(3), mora biti priložen, če je to upravičeno, zakonodajni predlog za pregled meril, določenih v členih 5, 6, 17 in 18, v zvezi z izbiro snovi za namen registracije, da bi vključili podatke, med drugim o tveganjih zaradi izpostavljenosti in predvidenih potekih pri izpostavljenosti.
The report referred to in the second subparagraph of Article 124(3) shall be accompanied, where justified, by a legislative proposal for reviewing the criteria laid down in Articles 5, 6, 17 and 18 relating to the selection of substances for registration purposes with a view to including, inter alia, data relating to exposure risks and scenarios.
Sedem let po začetku veljavnosti te uredbe.
Seven years after the date of entry into force of this Regulation.
izvede Komisija pregled delovanja člena 6, ob upoštevanju področja uporabe in vloge navodil in prijave, za vključitev snovi, razvrščene kot nevarne v skladu z Direktivo 67/548/EGS.
, the Commission shall carry out a review of the functioning of Article 6, taking into account the scope and the role of the guidance and notification, with a view to including substances classified as dangerous according to Directive 67/548/EEC.
Direktive 76/769/EGS,
Directives 76/769/EEC,
in 2000/21/ES ter uredbi (EGS) št. 793/93 in (ES) št. 1488/94 se razveljavijo.
and 2000/21/EC, and Regulations (EEC) No 793/93 and (EC) No 1488/94 are repealed.
Sklicevanje na razveljavljene akte se šteje za sklicevanje na to uredbo.
References to the repealed acts shall be construed as references to this Regulation.
Sprememba Direktive 1999/45/ES
Amendment of Directive 1999/45/EC
Člen 14 Direktive 1999/45/ES se črta.
Article 14 of Directive 1999/45/EC is deleted.
Direktiva 1999/45/ES se spremeni, da se potrošnikom zagotovi potrebne informacije za sprejetje ustreznih ukrepov za varno uporabo snovi in pripravkov.
Directive 1999/45/EC shall be amended to ensure consumers are provided with the information needed to take appropriate measures for the safe use of substances and preparations.
Naslova II in XII se začneta uporabljati
Titles II and XII shall apply
Členi 75 do 79
Articles 75
Členi 52, 53 in 54
Articles 52, 53
SPLOŠNE DOLOČBE ZA OCENJEVANJE SNOVI IN PRIPRAVO POROČIL O KEMIJSKI VARNOSTI
GENERAL PROVISIONS FOR ASSESSING SUBSTANCES AND PREPARING CHEMICAL SAFETY REPORTS
Namen te priloge je prikazati, kako morajo proizvajalci in uvozniki oceniti in dokumentirati, da so tveganja, izhajajoča iz snovi, ki jih proizvajajo ali uvažajo, med proizvodnjo in njihovo lastno uporabo(-ami) pod ustreznim nadzorom in da so drugi v dobavni verigi sposobni ustrezno obvladovati tveganja.
The purpose of this Annex is to set out how manufacturers and importers are to assess and document that the risks arising from the substance they manufacture or import are adequately controlled during manufacture and their own use(s) and that others further down the supply chain can adequately control the risks.
Ocenjevanje kemijske varnosti obravnava vse opredeljene uporabe.
The chemical safety assessment shall address all the identified uses.
Obravnava uporabo same snovi (vključno z vsemi pomembnejšimi nečistočami in dodatki) v pripravku ali izdelku.
It shall consider the use of the substance on its own (including any major impurities and additives), in a preparation or in an article.
Ocenjevanje upošteva vse stopnje življenjskega cikla
The assessment shall consider all stages of the life-cycle
(vključno s fazo odpadkov, ne glede na člen 2(1)(d) te uredbe)
(including the waste phase, notwithstanding Article 2(1)(d) of this Regulation)
snovi, kot je določeno z opredeljenimi uporabami.
of the substance as defined by the identified uses.
Ocenjevanje kemijske varnosti temelji na primerjavi potencialnih škodljivih učinkov snovi z znano ali razumno predvidljivo izpostavljenostjo ljudi in/ali okolja tej snovi.
The chemical safety assessment shall be based on a comparison of the potential adverse effects of a substance with the known or reasonably foreseeable exposure of man and/or the environment to that substance.
Če po mnenju proizvajalca ali uvoznika ocenjevanje kemijske varnosti ene snovi zadostuje za oceno in dokumentacijo, da so tveganja, ki izhajajo iz druge snovi ali skupine snovi, pod ustreznim nadzorom, potem lahko uporabi to oceno kemijske varnosti za druge snovi ali skupine snovi.
If the manufacturer or importer considers that the chemical safety assessment carried out for one substance is sufficient to assess and document that the risks arising from another substance or from a group of substances are adequately controlled then he can use that chemical safety assessment for the other substance or group of substances.
Proizvajalec ali uvoznik to utemelji.
The manufacturer or importer shall provide a justification for this.
Ocenjevanje kemijske varnosti temelji na podatkih o snovi, ki so zajeti v tehnični dokumentaciji, ter drugih razpoložljivih in ustreznih podatkih.
The chemical safety assessment shall be based on the information on the substance contained in the technical dossier and on other available and relevant information.
Vključijo se razpoložljivi podatki iz ocenjevanja, izvedenega v okviru drugih mednarodnih in nacionalnih programov.
Available information from assessments carried out under other international and national programmes shall be included.
Kadar je na razpolago in primerno, se pri pripravi poročila o kemijski varnosti upošteva in odraža ocenjevanje, izvedeno na podlagi zakonodaje Skupnosti (npr. ocene tveganj, izvedene po Uredbi
Where available and appropriate, an assessment carried out under Community legislation (e.g. risk assessments completed under Regulation
Odstopanja od takšnih ocen se utemeljijo.
Deviations from such assessments shall be justified.