natgillin/translations-raw huggingface dataset:
If the downstream user considers the hazard and PBT assessments reported in the Safety Data Sheet supplied to him to be appropriate, then no further hazard assessment or PBT and vPvB assessment is necessary.
Če so po mnenju nadaljnjega uporabnika ocene nevarnosti in PBT, sporočene v varnostnem listu, ki ga je prejel, primerne, nadaljnje ocene nevarnosti ali PBT in vPvB niso potrebne.
In this case he shall use the relevant information reported by the supplier for the risk characterisation.
V tem primeru za opredelitev tveganja uporabi ustrezne informacije, ki jih je sporočil dobavitelj.
This shall be stated in the Chemical Safety Report.
To se navede v poročilu o kemijski varnosti.
If the downstream user considers the assessments reported in the Safety Data Sheet supplied to him to be inappropriate, then he shall carry out the relevant assessments in accordance with Sections 1 to 4 of Annex I as appropriate to him.
Če nadaljnji uporabnik meni, da so ocene z varnostnega lista, ki ga je prejel, neustrezne, opravi ustrezne ocene v skladu z oddelki od 1 do 4 Priloge I, odvisno od njegovega primera.
In those cases where the downstream user considers that information in addition to that provided by the supplier is necessary for producing his Chemical Safety Report the downstream user shall gather this information.
V primerih, v katerih so po mnenju nadaljnjega uporabnika informacije poleg informacij, ki jih je zagotovil dobavitelj, nujne za izdelavo poročila o kemijski varnosti, jih nadaljnji uporabnik pridobi.
Where this information can only be obtained by testing on vertebrate animals, he shall submit a proposal for a testing strategy to the Agency in accordance with Article 38.
Kadar se te informacije lahko pridobijo le s testiranjem na vretenčarjih, predloži Agenciji v skladu s členom 38 predlog strategije testiranja.
He shall explain why he considers that additional information is necessary.
Pojasni, zakaj meni, da so dodatne informacije nujne.
While waiting for results of further testing, he shall record in his chemical safety report the risk management measures intended to manage the risks being explored that he has put in place.
Nadaljnji uporabnik med čakanjem na rezultate nadaljnjih testov v svojem poročilu o kemijski varnosti evidentira ukrepe za obvladovanje tveganj, katerih namen je obvladovati tveganja, ki jih je predvidel in se jih preiskuje.
On completion of any additional testing, the downstream user shall revise the Chemical Safety Report, and his Safety Data Sheet if he is required to prepare one, as appropriate.
Ob zaključku vseh dodatnih testiranj nadaljnji uporabnik revidira poročilo o kemijski varnosti in svoj varnostni list, če ga mora pripraviti, kakor je primerno.
STEP 3: RISK CHARACTERISATION
KORAK 3: OPREDELITEV TVEGANJA
A risk characterisation shall be carried out for each new exposure scenario as prescribed in Section 6 of Annex I. The risk characterisation shall be presented under the relevant heading of the Chemical Safety Report and summarised in the Safety Data Sheet under the relevant heading(s).
Za vsak nov scenarij izpostavljenosti je treba opredeliti tveganje, kot je predpisano v oddelku 6 Priloge I. Opredelitev tveganja se predstavi v ustreznem poglavju poročila o kemijski varnosti in povzame v ustrezni rubriki ali ustreznih rubrikah na varnostnem listu.
When generating an exposure scenario it will be necessary to make initial assumptions about the operating conditions and risk managements measures.
Pri pripravi scenarija izpostavljenosti je treba določiti začetne predpostavke o delovnih pogojih in ukrepih za obvladovanje tveganj.
If the initial assumptions lead to a risk characterisation indicating inadequate protection of human health and the environment, then it shall be necessary to carry out an iterative process with amendment of one or a number of factors until adequate control can be demonstrated.
Če iz začetnih predpostavk izhaja opredelitev tveganja, po kateri naj zdravje ljudi in okolje ne bi bila dovolj zaščitena, je nujno opraviti iterativni postopek ob spremembi enega ali več dejavnikov, dokler se ne dokaže, da je nadzor primeren.
This may require the generation of additional hazard or exposure information or appropriate alteration of the process, operating conditions or risk management measures.
Zaradi tega se lahko zahteva ustvarjanje dodatnega tveganja ali podatki o izpostavljenosti ali ustrezna sprememba postopka, delovnih pogojev ali ukrepov za obvladovanje tveganj.
Therefore, iterations may be made between on the one hand developing and revising an (initial) exposure scenario, which includes developing and implementing risk management measures, and on the other hand generating further information to produce the definitive exposure scenario.
Ponovitve se tako lahko opravijo med izdelavo in revizijo predvidenega scenarija (začetne) izpostavljenosti, ki vključuje razvijanje in izvajanje ukrepov za obvladovanje tveganja, in pripravo nadaljnjih informacij za izdelavo dokončnega predvidenega scenarija izpostavljenosti.
The purpose of generating further information is to establish a more precise risk characterisation, based on a refined hazard assessment and/or exposure assessment.
Namen priprave nadaljnjih informacij je izdelati natančnejšo opredelitev tveganja, ki temelji na izboljšani oceni nevarnosti in/ali oceni izpostavljenosti.
The downstream user shall produce a Chemical Safety Report detailing his chemical safety assessment using Part B, Sections 9 and 10, of the format set out in Section 7 of Annex I and the other sections of this format, if appropriate.
Nadaljnji uporabnik izdela poročilo o kemijski varnosti, v katerem natančno navede svoje ocene kemijske varnosti in pri tem uporabi del B oddelkov 9 in 10 obrazca iz oddelka 7 Priloge I in drugih oddelkov tega obrazca, če je primerno.
Part A of the Chemical Safety Report shall include a declaration that the risk management measures outlined in the relevant exposure scenarios are implemented by the downstream user for his own uses and that the risk management measures outlined in the exposure scenarios for the identified uses are communicated down the supply chain.
Del A poročila o kemijski varnosti vključuje izjavo, da nadaljnji uporabnik za svoje lastne uporabe izvaja ukrepe za obvladovanje tveganja, ki so opisani v ustreznih predvidenih scenarijih izpostavljenosti, in da se ukrepi za obvladovanje tveganja, ki so opisani v predvidenih scenarijih izpostavljenosti, za opredeljene uporabe sporočajo naprej po dobavni verigi.
This Annex lays down the criteria for the identification of:
Ta priloga določa kriterije za opredelitev:
persistent, bioaccumulative and toxic substances (PBT-substances), and
snovi, ki so obstojne, se kopičijo v organizmih in so strupene (PBT snovi); in
very persistent and very bioaccumulative substances (vPvB-substances).
snovi, ki so zelo obstojne in se zelo lahko kopičijo v organizmih (vPvB snovi).
A substance is identified as a PBT substance if it fulfils the criteria in Sections 1.1, 1.2 and 1.3.
Neka snov se opredeli kot PBT snov, če izpolnjuje kriterije iz oddelkov 1.1, 1.2 in 1.3.
A substance is identified as a vPvB substance if it fulfils the criteria in Sections 2.1 and 2.2.
Neka snov se opredeli kot vPvB snov, če izpolnjuje kriterije iz oddelkov 2.1 in 2.2.
This annex shall not apply to inorganic substances, but shall apply to organo-metals.
Ta priloga se ne uporablja za anorganske snovi, uporablja pa se za organokovinske spojine.
PBT-SUBSTANCES
PBT SNOVI
A substance that fulfils all three of the criteria of the sections below is a PBT substance.
Med PBT snovi štejemo snovi, ki izpolnjujejo vse tri kriterije iz spodnjih oddelkov.
Persistence
Obstojnost
A substance fulfils the persistence criterion (P-) when:
Snov izpolnjuje kriterij obstojnosti (P-), če:
the half-life in marine water is higher than 60 days, or
je razpolovna doba v morski vodi daljša od 60 dni, ali
the half-life in fresh- or estuarine water is higher than 40 days, or
je razpolovna doba v sladki vodi ali vodi rečnega ustja daljša od 40 dni, ali
the half-life in marine sediment is higher than 180 days, or
je razpolovna doba v morskem sedimentu daljša od 180 dni, ali
the half-life in fresh- or estuarine water sediment is higher than 120 days, or
je razpolovna doba v sladkovodnem sedimentu ali sedimentu rečnega ustja daljša od 120 dni, ali
the half-life in soil is higher than 120 days.
je razpolovna doba v tleh daljša od 120 dni.
The assessment of the persistency in the environment shall be based on available half-life data collected under the adequate conditions, which shall be described by the registrant.
Ocena obstojnosti v okolju temelji na razpoložljivih podatkih o razpolovni dobi, zbranih pod ustreznimi pogoji, ki jih opiše registracijski zavezanec.
A substance fulfils the bioaccumulation criterion (B-) when:
Snov izpolnjuje kriterij kopičenja v organizmih (B-), če:
the bioconcentration factor (BCF) is higher than 2000.
je biokoncentracijski faktor (BCF) višji od 2000.
The assessment of bioaccumulation shall be based on measured data on bioconcentration in aquatic species.
Ocena kopičenja v organizmih temelji na izmerjenih podatkih o biokoncentraciji v vodnih vrstah.
Data from freshwater as well as marine water species can be used.
Lahko se uporabi podatke za sladkovodne ali morske vrste rib.
Toxicity
Strupenost
A substance fulfils the toxicity criterion (T-) when:
Snov izpolnjuje kriterij strupenosti v organizmih (T-), če:
the long-term no-observed effect concentration (Noec) for marine or freshwater organisms is less than 0,01 mg/l, or
je dolgodobna koncentracija brez opaženega učinka (NOEC) za morske ali sladkovodne organizme manj kot 0,01 mg/l, ali
the substance is classified as carcinogenic (category 1 or 2), mutagenic (category 1 or 2), or toxic for reproduction (category 1, 2, or 3), or
je snov razvrščena med rakotvorne (skupini 1 in 2), mutagene (skupini 1 in 2) snovi ali snovi, strupene za razmnoževanje (skupine 1, 2 in 3), ali
there is other evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.
obstajajo drugi dokazi kronične strupenosti, kot se opredeli na podlagi razvrstitev: T, R48, ali Xn, R48 skladno z Direktivo 67/548/EGS.
vPvB-SUBSTANCES
vPvB SNOVI
A substance that fulfils the criteria of the sections below is a vPvB substance.
Med vPvB snovi štejemo snovi, ki izpolnjujejo kriterije iz spodnjih oddelkov.
A substance fulfils the very persistence criterion (vP-) when:
Snov izpolnjuje kriterij dolge obstojnosti (vP-), če:
the half-life in marine, fresh- or estuarine water is higher than 60 days, or
je razpolovna doba v morski, sladki vodi ali vodi rečnega ustja daljša od 60 dni, ali
the half-life in marine, fresh- or estuarine water sediment is higher than 180 days, or
je razpolovna doba v morski, sladkovodnem sedimentu ali sedimentu rečnega ustja daljša od 180 dni, ali
the half-life in soil is higher than 180.
je razpolovna doba v tleh daljša od 180 dni.
A substance fulfils the very bioaccumulative criterion (vB-) when:
Snov izpolnjuje kriterij visokega kopičenja v organizmih (vB-), če:
the bioconcentration factor is greater than 5000.
je biokoncentracijski faktor (BCF) višji od 5000.
I. INTRODUCTION AND GENERAL PROVISIONS
I. UVOD IN SPLOŠNE DOLOČBE
This Annex lays down general principles for preparing dossiers to propose and justify:
Ta priloga določa splošna načela za pripravo dokumentacije za predlog in utemeljitev:
harmonised classification and labelling of CMRs, respiratory sensitisers and other effects,
usklajene razvrstitve in označitve CMR dražil dihal in drugih vplivov,
the identification of PBTs, vPvBs, or a substance of equivalent concern,
identifikacije PBT, vPvB ali snovi, ki vzbuja enakovredno zaskrbljenost,
restrictions of the manufacture, placing on the market or use of a substance within the Community.
omejitev proizvodnje, dajanja v promet ali uporabe snovi znotraj Skupnosti.
The relevant parts of Annex I shall be used for the methodology and format of any dossier according to this Annex.
Ustrezni deli Priloge I se uporabijo za metodologijo in obliko vsake dokumentacije v skladu s to prilogo.
For all dossiers any relevant information from registration dossiers shall be considered and other available information may be used.
Za vso dokumentacijo se upoštevajo vse ustrezne informacije iz registracijske dokumentacije in se lahko uporabijo druge razpoložljive informacije.
For hazard information which has not been previously submitted to the Agency, a robust study summary shall be included in the dossier.
Za informacije o nevarnosti, ki predhodno še niso bile predložene Agenciji, se v dokumentacijo vključi grobi povzetek študije.
CONTENT OF DOSSIERS
VSEBINA DOKUMENTACIJE
Dossier for harmonised classification and labelling for CMRs, respiratory sensitisers and other effects
Dokumentacija za usklajeno razvrstitev in označitev CMR, dražil dihal in drugih vplivov
Proposal
Predlog
The proposal shall include the identity of the substance(s) concerned and the harmonised classification and labelling proposed.
Predlog vključuje identiteto(-e) zadevne(-ih) snovi ter predlagano usklajeno razvrstitev in označitev.
A comparison of the available information with the criteria for CMRs, respiratory sensitisers and other effects on a case by case basis in Directive 67/548/EEC according to the relevant parts of Section 1 of Annex I shall be completed and documented in the format set out in Part B of the Chemical Safety Report in Annex I.
Primerjava razpoložljivih informacij s kriteriji iz Direktive 67/548/EGS za CMR snovi in snovi, ki povzročajo preobčutljivost dihal, in drugih vplivov na podlagi posameznega primera se v skladu z ustreznimi deli oddelka 1 Priloge I dopolni in dokumentira v obliki, ki je določena v delu B poročila o kemijski varnosti iz Priloge I.
Justification for other effects at Community Level
Utemeljitev za druge vplive na ravni Skupnosti
Justification shall be provided that there is a need for action demonstrated at Community Level.
Utemeljitev se zagotovi, če se izkaže potreba po dejavnosti na ravni Skupnosti.
Dossier for the identification of a substance as a CMR, PBT, vPvB or a substance of equivalent concern according to Article 59
Dokumentacija za identifikacijo snovi kot CMR, PBT, vPvB ali snovi, ki vzbuja enakovredno zaskrbljenost v skladu s členom 59
The proposal shall include the identity of substance(s) concerned and whether it is proposed to be identified as a CMR according to Article 57(a), (b) or (c), a PBT according to Article 57(d), a vPvB according to Article 57(e), or a substance of equivalent concern according to Article 57(f).
Predlog vključuje identiteto zadevne(-ih) snovi ter ali je predlagano, da se opredeli(-jo) kot PBT v skladu s členom 57(d), CMR v skladu s členom 57(a), (b) in (c), vPvB v skladu s členom 57(e) ali snov, ki vzbuja enakovredno zaskrbljenost v skladu s členom 57(f).
A comparison of the available information with the criteria in Annex XIII for PBT according to Article 57(d), and vPvBs according to Article 57(e), or an assessment of the hazards and a comparison with Article 57(f), according to the relevant parts of Sections 1 to 4 of Annex I shall be completed. This shall be documented in the format set out in Part B of the Chemical Safety Report in Annex I.
Dopolni se primerjava razpoložljivih informacij s kriteriji iz Priloge XIII za PBT v skladu s členom 57(d) in vPvB v skladu s členom 57(e) ali ocena nevarnosti in primerjava s členom 57(f) v skladu z ustreznimi deli oddelkov 1 do 4 Priloge I. To se dokumentira v obliki, ki je določena v delu B poročila o kemijski varnosti iz Priloge I.
Information on exposures, alternative substances and risks
Informacije o izpostavljenosti, alternativnih snoveh in tveganjih
The available use and exposure information and information on alternative substances and techniques shall be provided.
Zagotovijo se razpoložljive informacije o uporabi in izpostavljenosti ter informacije o alternativnih snoveh in tehnikah.
Dossiers for restrictions proposal
Dokumentacija za predlog omejitev
The proposal shall include the identity of the substance and the restriction(s) proposed for the manufacture, placing on the market or use(s) and a summary of the justification.
Predlog vključuje identiteto snovi in predlagano(-e) omejitev(-ve) proizvodnje, dajanja v promet ali uporab(-e) ter povzetek utemeljitve.
Information on hazard and risk
Informacije o nevarnosti in tveganju
The risks to be addressed with the restriction shall be described based on an assessment of the hazard and risks according to the relevant parts of Annex I and shall be documented in the format set out in Part B of that Annex for the Chemical Safety Report.
Opišejo se tveganja, ki jih bo omejitev obravnavala, na podlagi ocene nevarnosti in tveganj v skladu z ustreznimi deli Priloge I ter se dokumentirajo v obliki, ki je določena v delu B te priloge za poročilo o kemijski varnosti.
Evidence shall be provided that implemented risk management measures (including those identified in registrations under Articles 10 to 14) are not sufficient.
Zagotovi se dokaz, da izvajani ukrepi za obvladovanje tveganja (vključno s tistimi, ki so opredeljeni v registracijah v okviru členov 10 do 14) ne zadostujejo.
Information on alternatives
Informacije o alternativah
Available information on alternative substances and techniques shall be provided, including:
Zagotovijo se informacije o alternativnih snoveh in tehnikah, vključno z:
information on the risks to human health and the environment related to the manufacture or use of the alternatives,
informacijami o tveganju za ljudi in okolje, ki je povezano s proizvodnjo ali uporabo alternativ,
availability, including the time scale,
razpoložljivostjo, vključno s časovnim okvirjem,
technical and economical feasibility.
tehnično in ekonomsko združljivostjo.
Justification for Restrictions at Community Level
Utemeljitev omejitev na ravni Skupnosti
Justification shall be provided that:
Zagotovi se utemeljitev, da:
action is required on a Community-wide basis,
se zahteva ukrepanje na ravni celotne Skupnosti,
a restriction is the most appropriate Community wide measure which shall be assessed using the following criteria:
je omejitev najprimernejši ukrep na ravni celotne Skupnosti, ki bo ocenjen z uporabo naslednjih kriterijev:
effectiveness: the restriction must be targeted to the effects or exposures that cause the risks identified, capable of reducing these risks to an acceptable level within a reasonable period of time and proportional to the risk;
učinkovitost: omejitev mora biti osredotočena na učinke ali izpostavljenosti, ki povzročajo opredeljena tveganja, in mora ta tveganja v ustreznem časovnem obdobju in sorazmerno tveganju znižati do sprejemljive ravni;
practicality: the restriction must be implementable, enforceable and manageable;
uporabnost: omejitev mora biti izvedljiva, izvršljiva in obvladljiva;
monitorability: it must be possible to monitor the result of the implementation of the proposed restriction.
nadzorljivost: zmožnost nadzorovanja rezultatov izvajanja predlagane omejitve.
Socio-economic assessment
Socialno-ekonomska ocena
The socio-economic impacts of the proposed restriction may be analysed with reference to Annex XVI.
Socialno-ekonomski vplivi predlagane omejitve se smejo preučiti z ozirom na Prilogo XVI.
To this end, the net benefits to human health and the environment of the proposed restriction may be compared to its net costs to manufacturers, importers, downstream users, distributors, consumers and society as a whole.
V ta namen se dejanske koristi predlagane omejitve za zdravje ljudi in okolje lahko primerjajo z njenimi dejanskimi stroški, ki jih povzroči proizvajalcem, uvoznikom, nadaljnjim uporabnikom, distributerjem, potrošnikom ter družbi kot celoti.
Information on stakeholder consultation
Informacije o posvetovanju zainteresiranih strani
Information on any consultation of stakeholders and how their views have been taken into account shall be included in the dossier.
V dokumentacijo so vključene informacije o posvetovanju zainteresiranih strani in o tem, kako so bila upoštevana njihova stališča.
This Annex outlines the information that may be addressed by those submitting a socio-economic analysis (SEA) with an application for authorisation, as specified in Article 62(5)(a), or in connection with a proposed restriction, as specified in Article 69(6)(b).
Ta priloga navaja informacije, ki jih lahko upoštevajo predlagatelji socialno-ekonomske analize (SEA) z vlogo za avtorizacijo, kakor je navedeno v členu 62(5)(a), ali v povezavi s predlagano omejitvijo, kakor je navedeno v členu 69(6)(b).
The Agency shall prepare guidance for the preparation of SEAs.
Agencija pripravi navodila za pripravo socialno-ekonomskih analiz.
SEAs, or contributions to them, shall be submitted in the format specified by the Agency in accordance with Article 111.
Socialno-ekonomske analize ali prispevki k tem analizam se predložijo v obliki, ki jo določi Agencija v skladu s členom 111.
However, the level of detail and scope of the SEA, or contributions to them, shall be the responsibility of the applicant for authorisation, or, in the case of a proposed restriction, the interested party.
Vendar pa je vlagatelj za avtorizacijo odgovoren za raven podrobnosti in področje uporabe SEA ali prispevkov k tej analizi; v primeru predlagane omejitve je za to odgovorna zainteresirana stran.
The information provided can address the socio-economic impacts at any level.
Zagotovljene informacije lahko na vsaki stopnji obravnavajo socialno-ekonomske vplive.
An SEA may include the following elements:
SEA lahko vključuje naslednje elemente:
impact of a granted or refused authorisation on the applicant(s), or, in the case of a proposed restriction, the impact on industry (e.g. manufacturers and importers).
Vpliv odobrene ali zavrnjene avtorizacije na vlagatelja(-e) ali, v primeru predlagane omejitve, vpliv na industrijo (npr. proizvajalce in uvoznike).
The impact on all other actors in the supply chain, downstream users and associated businesses in terms of commercial consequences such as impact on investment, research and development, innovation, one-off and operating costs (e.g. compliance, transitional arrangements, changes to existing processes, reporting and monitoring systems, installation of new technology, etc.) taking into account general trends in the market and technology,
Vpliv na vse druge udeležence dobavne verige, nadaljnje uporabnike in povezane posle z vidika ekonomskih posledic, kot so vpliv na vlaganja, raziskave in razvoj, inovacije, enkratne in obratovalne stroške (npr. skladnost; prehodne ureditve; spremembe obstoječih postopkov, sistemi sporočanja in spremljanja; vgradnja novih tehnologij itd.), ob upoštevanju splošnih gibanj na trgu in v tehnologiji.
impacts of a granted or refused authorisation, or a proposed restriction, on consumers.
Vplive odobrene ali zavrnjene avtorizacije ali predlagane omejitve na potrošnike.
For example, product prices, changes in composition or quality or performance of products, availability of products, consumer choice, as well as effects on human health and the environment to the extent that these affect consumers,
Na primer cene izdelkov, spremembe v sestavi ali kakovosti izdelkov, dosegljivost izdelkov, potrošniška izbira ter učinki na zdravje ljudi in okolje, če ti vplivajo na potrošnike.
social implications of a granted or refused authorisation, or a proposed restriction.
Družbene posledice odobrene ali zavrnjene avtorizacije ali predlagane omejitve.
For example job security and employment,
Na primer varnost delovnega mesta in zaposlovanje.
availability, suitability, and technical feasibility of alternative substances and/or technologies, and economic consequences thereof, and information on the rates of, and potential for, technological change in the sector(s) concerned.
Razpoložljivost, primernost in tehnično združljivost alternativnih snovi in/ali tehnologij in njihove ekonomske posledice ter informacije o stopnjah tehnoloških sprememb in možnostih za te spremembe v zadevnem(-ih) sektorju(-ih).