natgillin/translations-raw huggingface dataset:
No 793/93 of 23 March 1993 on the evaluation and control of the risks of existing substances (4), identified a number of problems in the functioning of Community legislation on chemicals, resulting in disparities between the laws, regulations and administrative provisions in Member States directly affecting the functioning of the internal market in this field, and the need to do more to protect public health and the environment in accordance with the precautionary principle.
(13) je opredelila številne težave pri uporabi zakonodaje Skupnosti o kemikalijah, zaradi česar prihaja do razlik med zakoni in drugimi predpisi držav članic, kar neposredno vpliva na delovanje notranjega trga na tem področju in potrebo, da se stori več za varovanje javnega zdravja in okolja v skladu z načelom previdnosti.
This Regulation should apply without prejudice to the prohibitions and restrictions laid down in Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (7) in so far as substances are used and marketed as cosmetic ingredients and are within the scope of this Regulation.
Ta uredba bi se morala uporabljati brez poseganja v prepovedi in omejitve, določene v Direktivi Sveta 76/768/EGS z dne 27. julija 1976 o približevanju zakonodaj držav članico kozmetičnih izdelkih (7), v kolikor se snovi uporabljajo in tržijo kot kozmetične sestavine in sodijo na področje uporabe te uredbe.
An important objective of the new system to be established by this Regulation is to encourage and in certain
Eden od pomembnih ciljev novega sistema, ki naj bi ga vzpostavila ta uredba, je spodbuditi in v nekaterih
There is a need to ensure effective management of the technical, scientific and administrative aspects of this Regulation at Community level.
Obstaja potreba po zagotovitvi učinkovitega upravljanja tehničnih, znanstvenih in upravnih vidikov te uredbe naravni Skupnosti.
Regulation as amended by Regulation (EC) No 1882/2003 of the European Parliament and of the Council (OJ
Uredba, kakor je bila spremenjena z Uredbo (ES) št. 1882/2003 Evropskega parlamenta in Sveta (UL L 284,
(16) turers and importers to manage the risks related to their substances, it may also be used to initiate the authorisation or restrictions procedures under this Regulation or risk management procedures under other Community legislation.
(16) avtorizacije ali določitev omejitev v skladu s to uredbo ali postopkov obvladovanja tveganja v skladu z drugo zakonodajo Skupnosti.
This Regulation is based on the principle that industry should manufacture, import or use substances or place them on the market with such responsibility and care as may be required to ensure that, under reasonably foreseeable conditions, human health and the environment are not adversely affected.
Uredba temelji na načelu, da bi morala industrija proizvajati, uvažati, uporabljati snovi ali jih dajati na trg z v so potrebno odgovornostjo in skrbnostjo, ki zagotavlja, da pod razumno predvidljivimi pogoji uporabe nimajo negativnega učinka na zdravje ljudi ali okolje.
Authorisations for the placing on the market and use should be granted by the Commission only if the risks arising from their use are adequately controlled, where this is possible, or the use can be justified for socioeconomic reasons and no suitable alternatives are available, which are economically and technically viable.
Avtorizacijo za dajanje v promet in uporabo bi morala Komisija izdati le, če se tveganje, ki izhaja iz njihove uporabe, ustrezno nadzoruje, kjer je to mogoče, ali če se lahko njihova uporaba utemelji s socialno-ekonomskimi razlogi in ni na voljo ustreznih drugih možnosti, ki so ekonomsko in tehnično izvedljive.
The responsibility to assess the risks and hazards of substances should be given, in the first place, to the natural or legal persons that manufacture or import substances, but only when they do so in quantities exceeding a certain volume, to enable them to carry the associated burden.
V določbah o evalvaciji bi moralo biti predvideno spremljanje registracije, in sicer z omogočanjem preverjanja, ali so registracije v skladu z zahtevami iz te uredbe, in po potrebi z omogočanjem pridobivanja dodatnih informacijo lastnostih snovi.
Natural or legal persons handling chemicals should take the necessary risk management measures in accordance with the assessment of the risks of substances and pass on relevant recommendations along the supply chain. This should include describing, documenting and notifying in an appropriate and transparent fashion the risks stemming from the production, use and disposal of each substance.
Če Agencija v sodelovanju z državo članico upravičeno meni, daje snov nevarna za zdravje ljudi ali okolje, bi morala Agencija, potem ko vključi snov v tekoč akcijski načrt Skupnosti za evalvacijo snovi, zagotoviti, da se te snovi evalvirajo, pri čemer se zanaša na pristojne organe držav članic.
The evaluation provisions should provide for follow-up to registration, by allowing for checks on whether registrations are in compliance with the requirements of this Regulation and if necessary by allowing for generation of more information on the properties of substances.
Odgovornost za ocenitev tveganj in nevarnosti snovi bi bilo zato treba zaupati predvsem fizičnim in pravnim osebam, ki te snovi proizvajajo ali uvažajo, vendar samo če to delajo v obsegu, ki presega določeno količino, da lahko tako nosijo s tem povezano obremenitev.
If the Agency in cooperation with the Member States considers that there are grounds for considering that a substance constitutes a risk to human health or the environment, the Agency should, after having included the substance in the Community rolling action plan for substance evaluation, relying on the competent authorities of Member States, ensure that this substance is evaluated.
Fizične in pravne osebe, ki ravnajo s kemikalijami, bi morale sprejeti potrebne ukrepe za obvladovanje tveganja v skladu z oceno tveganja snovi, ki jih proizvajajo, in ustrezna sporočila posredovati po dobavni verigi. Med drugim bi to moralo vključevati ustrezen in pregleden opis ter uradno obvestilo o tveganjih, ki izvirajo iz proizvodnje, uporabe in odstranjevanja posamezne snovi.
Although the information yielded on substances through evaluation should be used in the first place by manufac-
Čeprav so informacije o snoveh, pridobljene med evalvacijo, namenjene predvsem proizvajalcem in uvoznikom za uporabo pri obvladovanju tveganja, povezanega s temi snovmi, se te lahko uporabijo tudi za uvedbo postopkov
The Commission, in close cooperation with industry, Member States and other relevant stakeholders, should develop guidance to fulfil the requirements under this Regulation related to preparations (in particular with regard to safety data sheets incorporating exposure scenarios) including assessment of substances incorporated into special preparations — such as metals incorporated in alloys.
skupinami oblikovati navodila za izpolnjevanje zahtev iz te uredbe v zvezi s pripravki (zlasti glede varnostnih listov, ki vključujejo scenarije izpostavljenosti), vključno z oceno snovi, vgrajenih v posebne pripravke – kakor npr. kovine v zlitinah.
In doing so, the Commission should take full account of the work that will have been carried out within the framework of the RIPs and should include the necessary guidance on this matter in the overall REACH guidance package.
Pri tem bi morala Komisija popolnoma upoštevati opravljeno delov okviru RIP in bi morala v celotni sklop navodil REACH vključiti potrebna navodila na tem področju.
A chemical safety assessment should not need to be performed for substances in preparations in certain very small concentrations which are considered as not giving rise to concern.
Ocene kemijske varnosti ne bi bilo treba izvesti za snovi, ki jih vsebujejo pripravki v določenih, zelo majhnih koncentracijah, za katere velja, dane zbujajo skrbi.
These provisions should apply equally to preparations that are solid mixtures of substances until a specific shape is given to such a preparation that transforms it into an article.
Poleg tega je primerno, da se podobno izvzetje zagotovi za nadaljnje uporabnike, ki snovi uporabljajo za v proizvode in postopke usmerjene raziskave in razvoj, če so tveganja za zdravje ljudi in okolje ustrezno obvladovana v skladu z zahtevami zakonodaje za varovanje delavcev in okolja.
Joint submission and the sharing of information on substances should be provided for in order to increase the efficiency of the registration system, to reduce costs and to reduce testing on vertebrate animals.
Zagotoviti bi bilo treba skupno predložitev in souporabo informacijo snoveh, da bi se povečala učinkovitost registracijskega sistema ter zmanjšali stroški in testiranja na vretenčarjih.
Requirements for generation of information on substances should be tiered according to the volumes of manufacture or importation of a substance, because these provide an indication of the potential for exposure of man and the environment to the substances, and should be described in detail.
Agencija bi morala biti obveščena glede snovi, ki zbujajo veliko skrb, količina in vsebnost katerih v izdelkih presegata zgornjo mejo, če se ne more izključiti izpostavljenosti snovem in kjer nihče ni registriral snovi za zadevno uporabo.
To reduce the possible impact on low volume substances, new toxicological and ecotoxicological information should only be required for priority substances between 1 and 10 tonnes.
Agencija bi morala biti pooblaščena tudi, da zahteva predložitev registracije, če utemeljeno sumi, da lahko sproščanje snovi iz izdelka škoduje zdravju ljudi in okolju ter dati izdelki vsebujejo snov v količini, ki znaša skupaj več kot eno tono na leto na izdelovalca ali uvoznika.
For other substances in that quantity range there should be incentives to encourage manufacturers and importers to provide this information.
Agencija bi morala razmisliti o predlogu za omejevanje za primere, v katerih meni, da uporaba takšnih snovi v izdelkih ogroža zdravje ljudi ali okolje in to ni ustrezno nadzorovano.
Since producers and importers of articles should be responsible for their articles, it is appropriate to impose a registration requirement on substances which are intended to be released from articles and have not been registered for that use.
Zahteve za pridobivanje informacijo snoveh bi bilo treba podrobno opisati in razvrstiti v skladu s proizvedeno ali uvoženo količino snovi, ker se na podlagi teh količin lahko določi, kakšna je verjetnost za izpostavljenost ljudi in okolja.
In the case of substances of very high concern which are present in articles above tonnage and concentration thresholds, where exposure to the substance cannot be excluded and where the substance has not been registered by any person for this use, the Agency should be notified.
Da bi zmanjšali morebiten vpliv na snovi v manjših količinah, se nove informacije o ekotoksikoloških in toksikoloških testih zahteva samo za prednostne snovi med 1 in 10 tonami.
The Agency should consider the need for a proposal for a restriction where it considers that the use of such substances in articles poses a risk to human health or the environment that is not adequately controlled.
Za druge snovi v tem količinskem razponu morajo obstajati pobude za spodbujanje proizvajalcev in uvoznikov, da zagotavljajo te informacije.
The Member States, the Agency and all interested parties should take full account of the results of the RIPs, in particular with regard to the registration of substances which occur in nature.
V tehnični prilogi bi bilo treba podrobno določiti zahteve za ocene kemijske varnosti, ki jih izvedejo proizvajalci in uvozniki, da lahko izpolnijo svoje obveznosti.
It is necessary to consider the application of Article 2(7)(a) and (b) and Annex XI to substances derived from mineralogical processes and the review of Annexes IV and V should fully take this into account.
Komisija bi morala v tesnem sodelovanju z industrijo, državami članicami in drugimi ustreznimi interesnimi
The requirements for undertaking chemical safety assessments by manufacturers and importers should be defined in detail in a technical annex to allow them to meet their obligations.
Treba je preučiti uporabo člena 2(7)(a) in (b) ter Priloge XI glede snovi, pridobljenih z mineraloškimi procesi, in pregled prilogI I in III bi moral to v celoti upoštevati.
To avoid overloading authorities and natural or legal persons with the work arising from the registration of phase-in substances already on the internal market, that registration should be spread over an appropriate period of time, without introducing undue delay.
Da se prepreči prevelika obremenitev organov in fizičnih ali pravnih oseb z delom, povezanim z registracijo snovi v postopnem uvajanju, ki so žena notranjem trgu, bi bilo treba to registracijo razporediti v ustreznem časovnem obdobju, brez povzročanja nepotrebnih zamud.
Directive as amended by Directive 2003/65/EC of the European Parliament and of the Council (OJ L 230,
Direktiva, kakor je bila spremenjena z Direktivo 2003/65/ES Evropskega parlamenta in Sveta (UL L 230,
(49) potential registrants, who must provide and be supplied with any information relevant to the registration of their substances, and other participants, who may receive financial compensation for studies they hold but are not entitled to request information.
Da se prepreči podvajanje dela in predvsem zmanjša obseg testov na vretenčarjih, bi morale določbe za pripravo in predložitev registracij in njihove posodobitve zahtevati souporabo informacij, če registracijski zavezanec to zahteva.
In order to ensure the smooth functioning of that system they should fulfil certain obligations.
Če se informacije navezujejo na vretenčarje, bi jih registracijski zavezanec moral zahtevati.
If a member of a SIEF does not fulfil his obligations, he should be penalised accordingly but other members should be enabled to continue preparing their own registration.
informacije o isti snovi v postopnem uvajanju. Sodelovati bi morali potencialni registracijski zavezanci, ki morajo zagotavljati in prejemati vse za registracijo svojih snovi pomembne informacije, in drugi udeleženci, ki utegnejo za svoje študije prejemati finančno nadomestilo, vendar nimajo pravice zahtevati informacij.
In cases where a substance has not been pre-registered, measures should be taken to help downstream users find alternative sources of supply.
Da se zagotovi nemoteno delovanje takšnega sistema, bi morali izpolnjevati določene obveznosti.
In order to avoid duplication of work, and in particular to reduce testing involving vertebrate animals, the provisions concerning preparation and submission of registrations and updates should require sharing of information where this is requested by any registrant.
Če član SIEF ne izpolnjuje svojih obveznosti, bi ga bilo treba ustrezno kaznovati, drugim članom pa bi bilo treba omogočiti, da nadaljujejo pripravo svoje registracije.
If the information concerns vertebrate animals, the registrant should be obliged to request it.
Če snov še ni predhodno registrirana, bi bilo treba sprejeti ukrepe za pomoč nadaljnjemu uporabniku pri iskanju alternativnih virov za oskrbo.
Manufacturers and importers of a substance on its own or in a preparation should be encouraged to communicate with the downstream users of the substance with regard to whether they intend to register the substance.
V javnem interesu je zagotoviti, da so o rezultatih testov v zvezi z nevarnostjo določenih snovi za zdravje ljudi ali okolje čim prej obveščene tiste fizične in pravne osebe, ki takšne snovi uporabljajo, da se omeji vsako tveganje, povezano z njihovo uporabo.
Such information should be provided to a downstream user sufficiently in advance of the relevant registration deadline if the manufacturer or importer does not intend to register the substance, in order to enable the downstream user to look for alternative sources of supply.
Informacije bi bilo treba izmenjati, če tako zahteva registracijski zavezanec, zlasti ko informacije vključujejo teste na vretenčarjih, in sicer pod pogoji pravičnega nadomestila podjetju, ki je opravilo teste.
It is in the public interest to ensure the quickest possible circulation of test results on human health or environmental hazards of certain substances to those natural or legal persons which use them, in order to limit any risks associated with their use.
Proizvajalce in uvoznike snovi kot take ali v pripravku bi bilo treba spodbujati, da nadaljnje uporabnike snovi obveščajo, ali nameravajo snov registrirati.
Sharing of information should occur where this is requested by any registrant, in particular in the case of information involving tests on vertebrate animals, under conditions that ensure a fair compensation for the company that has undertaken the tests.
Če proizvajalec ali uvoznik snovi ne namerava registrirati, bi moralo tem pravočasno pred pretekom roka za registracijo obvestiti nadaljnjega uporabnika, da lahko nadaljnji uporabnik poišče alternativne vire za oskrbo.
Part of the responsibility of manufacturers or importers for the management of the risks of substances is the communication of information on these substances to other professionals such as downstream users or distributors.
Sestavni del odgovornosti proizvajalcev ali uvoznikov za obvladovanje tveganja v zvezi s snovmi je sporočanje informacijo teh snoveh drugim, ki jih to poklicno zadeva, kot na primer nadaljnjim uporabnikom ali distributerjem.
For non-phase-in substances, the Agency may ask for evidence that a potential registrant has paid the owner of a study before the Agency gives permission for the potential registrant to use that information in his registration.
Za snov, ki ni v postopnem uvajanju, lahko Agencija zahteva dokazilo, ki izkazuje, daje morebitni registracijski zavezanec plačal lastniku študije, preden iz da Agencija dovoljenje morebitnemu registracijskemu zavezancu za uporabo podatkov iz njegove registracije.
A system should be established in order to provide for the establishment of Substance Information Exchange Forums (SIEF) to help exchange of information on the substances that have been registered.
Treba bi bilo vzpostaviti sistem, ki bo vzpostavil forume za izmenjavo informacijo snoveh (SIEF) in pomagal izmenjavati informacije o registriranih snoveh.
SIEF participants should include all relevant actors submitting information to the Agency on the same phase-in substance. They should include both
V SIEF bi morali sodelovati vsi zadevni udeleženci, ki Agenciji posredujejo
The requirements for undertaking chemical safety assessments by downstream users should also be prescribed in detail to allow them to meet their obligations.
Podrobno bi bilo treba predpisati tudi zahteve za ocene kemijske varnosti, ki jih izvedejo nadaljnji uporabniki, dati lahko izpolnijo svoje obveznosti.
If one or more Member States or the Agency do not agree to a draft decision, it should be adopted subject to a centralised procedure.
Če se ena ali več držav članic ali Agencija z osnutkom odločitve ne strinjajo, bijo bilo treba sprejeti v skladu s centraliziranim postopkom.
The Commission should develop a system categorising brief general descriptions of uses taking into account the outcomes of the RIPs.
Komisija bi morala oblikovati sistem, s katerim se razvrstijo kratki splošni opisi uporabo b upoštevanju rezultatov RIP.
It is also necessary to ensure that generation of information is tailored to real information needs. To this end evaluation should require the Agency to decide on the programmes of testing proposed by manufacturers and importers.
Evalvacija lahko pripelje do zaključka, da bi bilo treba sprejeti ukrepe v okviru omejevalnega postopka ali postopka avtorizacije ali da bi bilo treba preučiti ukrepe za obvladovanje tveganja v okviru druge ustrezne zakonodaje.
In cooperation with Member States, the Agency should give priority to certain substances, for instance those which may be of very high concern.
Zato bi morale biti informacije o poteku postopkov evalvacije objavljene.
Evaluation may lead to the conclusion that action should be taken under the restriction or authorisation procedures or that risk management action should be considered in the framework of other appropriate legislation.
Prav tako je treba zagotoviti, da se pridobivanje takšnih informacij prilagodi dejanskim potrebam po informacijah.
Information on the progress of evaluation proceedings should therefore be made public.
Zato bi se morala Agencija odločiti glede programov testiranja, ki jih za takšne snovi predlagajo proizvajalci in uvozniki.
In order to prevent unnecessary animal testing, interested parties should have a period of 45 days during which they may provide scientifically valid information and studies that address the relevant substance and hazard endpoint, which is addressed by the testing proposal.
Za preprečitev nepotrebnega testiranja na živalih bi morale zainteresirane strani imeti 45-dnevno obdobje, v katerem lahko predložijo znanstveno veljavne informacije in študije, ki obravnavajo zadevno snov in končno točko nevarnosti, kar obravnava predlog za test.
In addition, it is necessary to instil confidence in the general quality of registrations and to ensure that the publicat large as well as all stakeholders in the chemicals industry have confidence that natural or legal persons are meeting the obligations placed upon them.
Treba je tudi vzpostaviti zaupanje v splošno kakovost registracij ter zagotoviti, da javnost in vse interesne skupine v kemijski industriji zaupajo, da fizične in pravne osebe izpolnjujejo predpisane obveznosti.
Otherwise, uses may still be authorised if it can be shown that the socioeconomic benefits from the use of the substance outweigh the risks connected with its use and there are no suitable alternative substances or technologies that are economically and technically viable.
Uporabo se lahko vseeno odobri, če se dokaže, da socialnoekonomske koristi zaradi uporabe snovi prevladajo nad tveganjem, povezanim z njihovo uporabo, in dani na voljo ustreznih alternativnih snovi ali tehnologij, ki so ekonomsko in tehnično izvedljive.
(70) tions of uses of such substances on their own, in preparations or for incorporation of substances into articles by making an analysis of alternatives, the risks involved in using any alternative and the technical and economic feasibility of substitution.
(70) kot takih, v pripravkih ali v izdelkih, tako da izvedejo analizo alternativ, tveganj pri uporabi alternativnih snovi ter tehnične in ekonomske izvedljivosti nadomestitve.
Risk management measures should be applied to ensure, when substances are manufactured, placed on the market and used, that exposure to these substances including discharges, emissions and losses, throughout the whole lifecycle is below the threshold level beyond which adverse effects may occur.
Uporabiti bi bilo treba ukrepe za obvladovanje tveganja, da se pri proizvodnji, dajanju na trg in uporabi snovi zagotovi, daje izpostavljenost tem snovem, vključno z izpusti, emisijami in izgubami, v celotnem življenjskem ciklu pod mejno vrednostjo, nad katero se lahko pojavijo škodljivi učinki.
Furthermore, authorisations should be subject to timelimited review whose periods would be determined on a case-by-case basis and normally be subject to conditions, including monitoring.
Hkrati bi morale biti avtorizacije predmet časovno omejenih pregledov, katerih trajanje bi se določilo na podlagi posameznega primera in pod določenimi pogoji, vključno z monitoringom.