natgillin/translations-raw huggingface dataset:
Vse snovi, za lastno uporabo, v pripravkih ali izdelkih, ki izpolnjujejo pogoje iz člena 63, se označijo in se jim vedno priloži varnostni list.
All substances, for use on their own, in preparations or in articles, that fulfil the conditions set out in Article 63 shall be labelled and accompanied, at all times, by a safety data sheet.
ime snovi,
the name of the substance;
potrdilo, da je snov vključena v Prilogo XIII, in
attestation that the substance is included in Annex XIII; and
vsako posebno uporabo, za katero je bila snov odobrena.
each specific use for which the substance has been authorised.
Uporabniki na nižji stopnji
Downstream Users
Uporabniki na nižji stopnji, ki uporabljajo snov v skladu s
Downstream users using a substance in accordance with
členom 62(2)
Article 62(2)
, o tem obvestijo Agencijo v treh mesecih po prvi dostavi snovi.
shall notify the Agency within 3 months of the first supply of the substance.
Za to uporabijo izključno obliko, ki jo Agencija določi v skladu s
They shall use only the format specified by the Agency in accordance with
Agencija vzpostavi in sproti dopolnjuje register uporabnikov na nižji stopnji, ki so poslali obvestilo v skladu z odstavkom 1.
The Agency shall establish and keep up to date a register of downstream users who have made a notification in accordance with paragraph 1.
Agencija zagotovi dostop do tega registra pristojnim organom držav članic.
The Agency shall grant access to this register to the competent authorities of the Member States.
NASLOV VIII OMEJITVE ZA PROIZVODNJO, DAJANJE V PROMET IN UPORABO NEKATERIH NEVARNIH SNOVI IN PRIPRAVKOV
TITLE VIII RESTRICTIONS ON THE MANUFACTURING, MARKETING AND USE OF CERTAIN DANGEROUS SUBSTANCES AND PREPARATIONS
SPLOŠNA VPRAŠANJA
GENERAL ISSUES
Snov kot taka, v pripravku ali izdelku, za katero vsebuje Priloga XVI omejitev, se ne sme proizvajati, dajati v promet ali uporabljati, če ne izpolnjuje pogojev iz te omejitve.
A substance on its own, in a preparation or in an article, for which Annex XVI contains a restriction shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction.
so potrebne za namene raziskav, usmerjenih v izdelek in postopek
required for the purposes of product and process orientated research and development
Direktive 91/689/EGS
or 91/689/EEC
, kar ne vpliva na Uredbo (ES) št.
, without prejudice to Regulation (EC)
POSTOPEK ZA OMEJITVE
THE RESTRICTIONS PROCESS
Uvedba novih in sprememba veljavnih omejitev
Introducing new and amending current restrictions
ali zdravje ljudi, vključno z občutljivimi skupinami prebivalstva in prebivalci, dodatno ali nenehno izpostavljenimi mešanicam onesnaževal
human health, including that of vulnerable populations and citizens exposed early in life or continuously to mixtures of pollutants,
, ki jo je treba obravnavati v celi Skupnosti, se Priloga XVI spremeni v skladu s postopkom iz
arising from the manufacture, use or placing on the market of substances, which needs to be addressed on a Community-wide basis, Annex XVI shall be amended in accordance with the procedure referred to in
, tako da se sprejmejo nove omejitve ali spremenijo veljavne omejitve iz Priloge XVI za proizvodnjo, uporabo ali dajanje v promet snovi kot take, v pripravkih ali izdelkih v skladu s postopkom iz
by adopting new restrictions, or amending current restrictions in Annex XVI, for the manufacture, use or placing on the market of substances on their own, in preparations or in articles, pursuant to the procedure set out in
Prvi pododstavek se ne uporablja za uporabo snovi kot na mestu izoliranega vmesnega
The first subparagraph shall not apply to the use of a substance as an on-site isolated
Za snovi, ki izpolnjujejo merila za razvrstitev kot kancerogene, mutagene ali strupene za razmnoževanje iz skupin 1 in 2 ter za katere je Komisija predlagala omejitve potrošniške uporabe, se Priloga XVI spremeni v skladu s postopkom iz
For substances which meet the criteria for classification as carcinogenic, mutagenic or toxic to reproduction, categories 1 and 2, and for which restrictions to consumer use are proposed by the Commission, Annex XVI shall be amended in accordance with the procedure referred to in
ki obravnavajo izključno nevarnosti za zdravje ljudi, ki izhajajo iz uporabe snovi v kozmetičnih proizvodih na področju uporabe Direktive 76/768/EGS, se ne vključijo v
addressing only the risks to human health of the use of a substance in cosmetics products within the scope of Directive 76/768/EEC shall not be included in
Če po mnenju Komisije pomeni proizvodnja, dajanje v promet ali uporaba snovi kot take, v pripravku ali izdelku nevarnost za zdravje ljudi ali okolje, ki ni ustrezno nadzorovana in bi jo bilo treba obravnavati v Skupnosti, Komisija zaprosi Agencijo, da pripravi dokumentacijo, ki je v skladu z zahtevami iz Priloge XIV.
If the Commission considers that the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed at Community level, it shall ask the Agency to prepare a dossier which conforms to the requirements of Annex XIV.
Če se s to dokumentacijo dokaže, da je treba poleg že uvedenih ukrepov sprejeti ukrepe v celotni Skupnosti, Agencija predlaga omejitve, da sproži postopek za določitev omejitev.
If this dossier demonstrates that action on a Community-wide basis is necessary, beyond any measures already in place, the Agency shall suggest restrictions, in order to initiate the restrictions process.
Agencija upošteva dokumentacijo držav članic, poročila o kemijski varnosti ali ocene tveganja, ki so predložene v skladu s to uredbo.
The Agency shall refer to any Member State dossier, chemical safety report or risk assessment submitted to it under this Regulation.
Upošteva tudi ustrezne ocene tveganja, ki so jih predložile tretje osebe za namene drugih uredb ali direktiv Skupnosti.
It shall also refer to any relevant risk assessment submitted by third persons for the purposes of other Community Regulations or Directives.
Zato Agenciji na zahtevo zagotovijo informacije drugi organi, kot so agencije, ustanovljene na podlagi zakonodaje Skupnosti, ki izvajajo podobne naloge.
To this end other bodies, such as agencies, established under Community law and carrying out a similar task shall provide information to the Agency on request.
Če po mnenju države članice proizvodnja, dajanje v promet ali uporaba snovi kot take, v pripravku ali izdelku pomeni nevarnost za zdravje ljudi ali okolje, ki ni ustrezno nadzorovana in bi jo bilo treba obravnavati v Skupnosti, ta država članica pripravi dokumentacijo, ki je v skladu z zahtevami iz Priloge XIV.
If a Member State considers that the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article poses a risk to human health or the environment that is not adequately controlled and needs to be addressed at Community level, it shall prepare a dossier which conforms to the requirements of Annex XIV.
Če se s to dokumentacijo dokaže, da je treba poleg že uvedenih ukrepov sprejeti ukrepe na ravni celotne Skupnosti, država članica to dokumentacijo predloži Agenciji v obliki iz Priloge XIV, da sproži postopek za določitev omejitev.
If this dossier demonstrates that action on a Community-wide basis is necessary, beyond any measures already in place, the Member State shall submit it to the Agency in the format outlined in Annex XIV, in order to initiate the restrictions process.
Države članice upoštevajo tudi ustrezne ocene tveganja, predložene za namene drugih uredb ali direktiv Skupnosti.
Member States shall also refer to any relevant risk assessment submitted for the purposes of other Community Regulations or Directives.
Zato na zahtevo zagotovijo informacije zadevni državi članici drugi organi, kot so agencije, ustanovljene na podlagi zakonodaje Skupnosti, ki izvajajo podobne naloge.
To this end other bodies, such as agencies, established under Community law and carrying out a similar task shall provide information to the Member State concerned on request.
Odbor za oceno tveganja in
The Committee for Risk
Odbor za socialno-ekonomsko analizo preverita, ali je predložena dokumentacija v skladu z zahtevami iz Priloge XIV.
Assessment and the Committee for Socio-economic Analysis shall check whether the dossier submitted conforms to the requirements of Annex XIV.
V 30 dneh po prejemu Agencija državo članico, ki je predlagala omejitve, obvesti o tem, ali je dokumentacija po mnenju odborov v skladu z zahtevami.
Within 30 days of receipt, the Agency shall inform the Member State suggesting restrictions, as to whether the Committees find that the dossier conforms.
Če dokumentacija ni v skladu z zahtevami, se državo članico o tem pisno obvesti v 45 dneh po prejemu in pri tem navede razloge.
If the dossier does not conform, the reasons shall be given to the Member State in writing within 45 days of receipt.
Država članica dokumentacijo uskladi z zahtevami v 30 dneh po prejemu obvestila Agencije o razlogih, sicer se postopek iz tega poglavja zaključi.
The Member State shall bring the dossier into conformity within 30 days of the date of receipt of the reasons from the Agency, otherwise the procedure under this Chapter shall be terminated.
Agencija takoj /brez odlašanja/ na svoji spletni strani objavi obvestilo, da država članica ali Komisija namerava sprožiti postopek za določitev omejitev, in obvesti vse tiste, ki so objavili registracijo za zadevno snov.
The Agency shall announce immediately/without delay/post on its website that a Member State or the Commission intends to initiate a restrictions process, and shall inform those who are registering the substance concerned.
Agencija vse dokumentacije, ki so v skladu s Prilogo XIV in vključujejo omejitve, predlagane v skladu z odstavkoma 1 in 2, takoj objavi na svoji spletni strani in pri tem jasno navede datum objave.
The Agency shall make publicly available on its website all dossiers conforming with Annex XIV including the restrictions suggested pursuant to paragraphs 1 and 2 without delay, clearly indicating the date of publication.
Agencija pozove vse zainteresirane strani, da v treh mesecih po datumu objave posamezno ali skupno predložijo:
The Agency shall invite all interested parties to submit individually or jointly within 3 months of the date of publication:
pripombe k dokumentacijam in predlaganim omejitvam;
comments on dossiers and the suggested restrictions;
socialno-ekonomsko analizo predlaganih omejitev ali informacije, ki se lahko uporabijo za takšno analizo, s katero se preučijo prednosti in slabosti predlaganih omejitev.
a socio-economic analysis, or information which can contribute to one, of the suggested restrictions, examining the advantages and drawbacks of the proposed restrictions.
Biti mora v skladu z zahtevami iz Priloge XV.
It shall conform to the requirements in Annex XV.
Mnenje Agencije: Odbor za oceno tveganja
Agency opinion: Committee for
in nadomestnih možnosti
Risk and Alternative Assessment
V devetih mesecih po datumu objave iz
Within 9 months of the date of publication referred to in
člena 75(4)
Article 75(4)
Odbor za oceno tveganja
, the Committee for Risk
in nadomestnih možnosti
and Alternative
na podlagi preučitve ustreznih delov dokumentacije oblikuje mnenje o predlaganih omejitvah.
Assessment shall formulate an opinion on the suggested restrictions based on its consideration of the relevant parts of the dossier.
Pri tem mnenju upošteva dokumentacijo države članice in stališča zainteresiranih strani iz točke (a)
This opinion shall take account of the Member State dossier and the views of interested parties referred to in point (a) of
V dvanajstih mesecih po datumu objave iz
Within 12 months of the date of publication referred to in
Odbor za socialno-ekonomsko analizo na podlagi preučitve ustreznih delov dokumentacije in socialno-ekonomskega vpliva oblikuje mnenje o predlaganih omejitvah.
, the Committee for Socio-economic Analysis shall formulate an opinion on the suggested restrictions, based on its consideration of the relevant parts of the dossier and the socio-economic impact.
Pripravi osnutek mnenja o predlaganih omejitvah in njihovem socialno-ekonomskem vplivu, pri čemer upošteva analize ali informacije v skladu s točko
It shall prepare a draft opinion on the suggested restrictions and on the related socio-economic impact, taking account of the analyses or information according to point (b) of
(b) člena 75(4)
Article 75(4)
, če so bile predložene.
, if there are any.
Agencija osnutek mnenja takoj objavi na svoji spletni strani.
The Agency shall publish the draft opinion on its website without delay.
Agencija pozove zainteresirane strani, da predložijo svoje pripombe o osnutku mnenja v roku, ki ga določi sama.
The Agency shall invite interested parties to give their comments on the draft opinion by a deadline set by the Agency.
Odbor za socialno-ekonomsko analizo takoj sprejme svoje mnenje, pri čemer ustrezno upošteva dodatne pripombe, prejete v predpisanem roku.
The Committee for Socio-economic Analysis shall without delay adopt its opinion, taking into account where appropriate further comments received by the deadline set.
Pri tem mnenju se upoštevajo pripombe in socialno-ekonomske analize zainteresiranih strani, predložene v skladu s točko (b)
This opinion shall take account of the comments and socio-economic analyses of interested parties submitted under point (b) of
odstavkom 1 tega člena
paragraph 1 of this Article
Če mnenje Odbora za oceno tveganja
Where the opinion of the Committee for Risk
bistveno odstopa od omejitev, ki jih je predlagala država članica ali Komisija, lahko Agencija rok za sprejetje mnenja Odbora za socialno-ekonomsko analizo podaljša za največ 90 dni.
Assessment diverges significantly from the restrictions suggested by a Member State or the Commission, the Agency may postpone the deadline for the opinion of the Committee for Socio-economic Analysis by a maximum of 90 days.
Predložitev mnenja Komisiji
Submission of an opinion to the Commission
Če en ali oba odbora ne oblikujeta mnenja do roka iz
If one or both of the Committees do not formulate an opinion by the deadline set in
Agencija mnenji obeh odborov takoj objavi na svoji spletni strani.
The Agency shall publish the opinions of the two Committees on its website without delay.
Agencija Komisiji na zahtevo zagotovi vse dokumente in dokazila, ki so ji bila predložena ali ki jih je upoštevala.
The Agency shall provide the Commission on request with all documents and evidence submitted to or considered by it.
Odločitev Komisije
Commission decision
Če so izpolnjeni pogoji iz
If the conditions laid down in
člena 74
Article 74
členom 77
Article 77
, če ta odbor ne sprejme mnenja, kar nastopi prej.
if that Committee does not form an opinion, whichever is the earlier.
Če osnutek spremembe ni v skladu z mnenji Agencije, Komisija priloži podrobno utemeljitev razlogov za neskladja.
Where the draft amendment is not in accordance with any of the opinions of the Agency, the Commission shall annex a detailed explanation of the reasons for the differences.
Končna odločitev se sprejme v skladu s postopkom iz
A final decision shall be taken in accordance with the procedure referred to in
Če snov že ureja Priloga XVI in če so izpolnjeni pogoji iz člena 74, Komisija pripravi osnutek predloga spremembe Priloge XVI v 3 mesecih po prejetju mnenja Odbora za socialno-ekonomsko analizo ali poteku roka, ki je določen po členu 77, če ta odbor ne oblikuje mnenja, kar nastopi prej.
Where a substance is already regulated in Annex XVI, and the conditions laid down in Article 74 are fulfilled, the Commission shall prepare a draft amendment to Annex XVI, within 3 months of receipt of the opinion of the Committee for Socio-economic Analysis or by the deadline established under Article 77 if that Committee does not form an opinion, whichever is the earlier.
Kadar osnutek predloga spremembe ni v skladu z mnenji Agencije, Komisija priloži podrobno obrazložitev razlogov za neskladja.
Where the draft amendment is not in accordance with any of the opinions of the Agency, the Commission shall annex a detailed explanation of the reasons for the differences.
Če snovi še ne ureja Priloga XVI, Komisija namesto tega v nekem časovnem okviru predloži predlog za spremembo Priloge XVI Evropskemu parlamentu in Svetu.
Where a substance has not been regulated before in Annex XVI, the Commission shall, within the time limit specified in the first subparagraph, submit a proposal to the European Parliament and the Council to amend Annex XVI.
Ustanovi se Evropska agencija za kemikalije.
A European Chemicals Agency is established.
Država članica gostiteljica olajša in finančno podpre ustanovitev in delovanje agencije.
The host Member State shall facilitate and financially contribute to the setting up and running of the Agency.
Naloga Agencije
Mission of the Agency
Agencija je zadolžena za celotno upravljanje postopka REACH.
The Agency shall be in charge of the overall management of the REACH process.
Mednarodna odgovornost
International responsibilities
Agencija si v največji možni meri prizadeva za pospeševanje mednarodnega sprejetja standardov REACH in na enak način dosledno upošteva obstoječe standarde, ki so jih določile druge mednarodne ustanove, če je prepričana, da ti standardi lahko zaščitijo okolje in zdravje.
The Agency shall make every possible effort to promote the international acceptability of REACH standards, and shall also take full account of existing standards established by other international institutions provided it is convinced of those standards" capacity to safeguard the environment and health.
V primerih, ki jih predvideva Uredba, Agencija sprejema pravno zavezujoče odločitve.
In the cases covered by this Regulation, the Agency shall take legally binding decisions.
Agencija zlasti skozi svoje odbore
The Agency shall, in particular through its committees
razvije merila za določanje prednostnih snovi za ocenjevanje in naredi seznam prednostnih snovi za ocenjevanje v skladu z naslovom VI
develop criteria for prioritising substances for evaluation and compile a list of priority substances for evaluation, pursuant to Title VI
pripravi mnenja o prošnjah za odobritev v skladu z naslovom VII
draw up opinions on applications for authorisation, pursuant to Title VII
sodeluje v postopku sprejemanja omejitev za določene nevarne snovi in pripravke, tako da pripravi dokumentacijo in mnenja v skladu z naslovom VIII
take part in the procedure for adopting restrictions in respect of certain dangerous substances and preparations by preparing dossiers and drawing up opinions, pursuant to Title VIII
opravlja naloge, ki so ji bile dodeljene v naslovu VI;
perform the tasks allotted to it under Title VI;
pripravi predloge za usklajevanje razvrščanja in označevanja na ravni Skupnosti, v skladu z naslovom X
draw up proposals with a view to harmonising classifications and labelling at Community level, pursuant to Title X
na zahtevo Komisije zagotavlja tehnično in znanstveno podporo za ukrepe izboljšanja sodelovanja med Skupnostjo, njenimi državami članicami, mednarodnimi organizacijami in tretjimi državami glede znanstvenih in tehničnih vprašanj v zvezi z varnostjo snovi, kot tudi dejavno sodelovanje pri tehnični pomoči in dejavnostih za vzpostavitev institucij in kadrov za ustrezno ravnanje s kemikalijami v državah v razvoju
at the request of the Commission, provide technical and scientific support for steps to improve cooperation between the Community, its Member States, international organisations and third countries on scientific and technical issues relating to the safety of substances, as well as active participation in technical assistance and capacity-building activities on sound management of chemicals in developing countries
na zahtevo Komisije ali Evropskega parlamenta pripravi mnenje o katerih koli drugih vidikih glede varnosti snovi samih, v pripravkih ali v izdelkih
at the request of the Commission or the European Parliament, draw up an opinion on any other aspects concerning the safety of substances on their own, in preparations or in articles
svetuje Sekretariatu glede tehnične pomoči in dejavnostih za vzpostavitev institucij in kadrov za ustrezno ravnanje s kemikalijami ter za skladnost standardov kemijske varnosti v državah v razvoju.
provide advice to the Secretariat regarding its technical assistance and capacity building activities on sound management of chemicals and compliance with chemical safety standards in developing countries.
širi dobro prakso in poudarja težave na ravni Skupnosti
spread good practice and highlight problems at Community level
predlaga, koordinira in ocenjuje usklajene projekte izvajanja in skupne inšpekcije
propose, coordinate and evaluate harmonised enforcement projects and joint inspections
koordinira izmenjave inšpektorjev
coordinate exchanges of inspectors
določa izvedbene strategije in najmanjše izvedbene kriterije ter upošteva zlasti posebne težave malih in srednje velikih podjetij
identify enforcement strategies and minimum enforcement criteria, taking particular account of the specific problems for SMEs
razvija delovne metode in pripomočke za lokalne inšpektorje
develop working methods and tools of use to local inspectors
razvija postopek za elektronsko izmenjavo podatkov;
develop an electronic information-exchange procedure;
se povezuje z industrijo in drugimi interesnimi skupinami, vključno z ustreznimi mednarodnimi organizacijami, če je potrebno;
liaise with industry and other stakeholders, including those in third countries and relevant international organisations as necessary;
sodeluje s Komisijo in državami članicami z namenom spodbujanja prostovoljnih sporazumov med industrijo in drugimi zainteresiranimi strankami.
cooperate with the Commission and the Member States with a view to promoting voluntary agreements between industry and other interested parties.
Ob tem Agencija
In addition, the Agency shall
opravlja naloge, ki so ji dodeljene v naslovu II, vključno s pospeševanjem učinkovite registracije uvoženih snovi na način, ki je skladen z mednarodnimi obveznostmi trgovanja Skupnosti do tretjih držav
perform the tasks allotted to it under Title II, including facilitating the efficient registration of imported substances, in a way consistent with the Community's international trading obligations towards third countries
opravlja naloge, ki so ji dodeljene v zvezi s skupno rabo podatkov in preprečevanjem izvajanja odvečnih poskusov v skladu z naslovom III
perform the tasks allotted to it as regards the sharing of data and preventing superfluous experiments from being carried out, pursuant to Title III
opravlja naloge, ki so ji dodeljene v zvezi s podatki v dobavni verigi v skladu z naslovom VI
perform the tasks allotted to it as regards information in the supply chain, pursuant to Title VI
vzpostavitev in vzdrževanje zbirke (zbirk) podatkov z informacijami o vseh registriranih snoveh, popisom razvrstitev in oznak ter usklajenim seznamom razvrstitev in oznak, pri čemer da informacije iz zbirke (zbirk) podatkov, ki je (so) določena(e) v členu 127(1), na voljo javnosti na spletnih straneh v petnajstih delovnih dneh, druge informacije iz zbirk podatkov pa so dostopne na zahtevo v skladu s členom 126(3)
establish and maintain database(s) with information on all registered substances, the classification and labelling inventory and the harmonised classification and labelling list, make the information identified in Article 127(1) in the data base(s) publicly available within 15 working days, and make other information in the databases available on request in accordance with Article 126(3)
javnosti da na razpolago informacije o tem, katere snovi se trenutno vrednotijo ali so bile ovrednotene v 15 delovnih dneh po tem, ko je Agencija prejela informacije, v skladu s členom 127(1)
make publicly available information as to which substances are being, and have been, evaluated within 15 working days of receipt of the information at the Agency, in accordance with Article 127(1)