natgillin/translations-raw huggingface dataset:
iz prilog V do VIII
Annexes V to VIII
, bi bilo treba pri preskusih za njihovo izpolnitev uporabiti večje število živali.
, if those information requirements were automatically applied.
Takšni preskusi lahko pomenijo za podjetja precejšnje stroške.
Significant costs for enterprises may be associated with testing.
Za oceno predlogov glede preskušanja snovi mora biti odgovorna država članica, v kateri poteka proizvodnja ali ima uvoznik svoj sedež.
Member State in which the manufacture takes place or the importer is established should be responsible for the evaluation of testing proposals.
Za preprečitev podvajanja preskusov na živalih morajo imeti zainteresirane strani 90-dnevno obdobje, v katerem lahko predložijo pripombe o predlogih za preskuse, ki vključujejo preskuse na vretenčarjih.
In order to prevent duplication of animal testing, interested parties should have a period of 90 days during which they may comment on testing proposals that include vertebrate animal tests.
Za preprečitev preskusov na živalih in prihranek stroškov se morajo posvetovati z ECVAM pri obravnavanju predlogov preskusov, ki vključujejo preskuse na vretenčarjih.
To prevent animal testing and save costs, ECVAM should be consulted on testing proposals that include vertebrate animal tests.
v splošno kakovost registracij
in the general quality of registrations
se lahko poveča le tako, da se Agencija v celoti obveže za vodenje nove politike o kemikalijah.
can only be improved by giving the Agency full responsibility for the management of the new chemicals policy.
V ta namen je treba uredbo o kemikalijah obravnavati in upravljati enotno v vseh državah članicah, potrošniška in kemična industrija pa morata uveljavljati izpolnjena pravila in nadzorovano usklajenost.
To this end, this Regulation must be dealt with and monitored in a uniform way in all the Member States, and both consumers and the chemicals industry must be able to rely on the rules being complied with, and compliance monitored.
Pri ocenjevanju registracij v skladu s pravili morajo organi oblasti v državah članicah delovati v tesnem sodelovanju z Agencijo.
In evaluating registrations in compliance with the rules, the authorities in the Member States should work in close collaboration with the Agency.
Oblikovati je treba tekoči načrt Skupnosti za vrednotenje snovi.
A Community rolling plan for substance evaluation should be established.
Če je nevarnost, ki izhaja iz uporabe izoliranih vmesnih proizvodov na mestu, enakovredna nevarnosti, ki izhaja iz uporabe snovi, za katere je treba pridobiti dovoljenje, je treba tudi državam članicam omogočiti, da lahko zahtevajo dodatne informacije, kadar je to upravičeno.
If a risk equivalent to the level of concern arising from the use of substances subject to authorisation arises from the use of isolated intermediates on site, Member States should also be allowed to require further information, when justified.
Dogovor z Odborom
Agreement within the Agency's
držav članic
Member State
Agencije o osnutku odločitve
Committee on a draft decision
zagotavlja podlago učinkovitega sistema, ki upošteva načelo subsidiarnosti, hkrati pa ohranja notranji trg.
provides the basis for an efficient system that respects the principle of subsidiarity, while maintaining the internal market.
Če se ena ali več držav članic ali Agencija z osnutkom odločitve ne strinjajo, je treba zanjo uporabiti centralizirani postopek.
If one or more Member States or the Agency do not agree to a draft decision, it should be made subject to a centralised procedure.
Odločitve, ki izhajajo iz uporabe teh postopkov, mora sprejeti Agencija.
The Agency should take the decisions following from the application of these procedures.
Rezultat ovrednotenja je lahko sklep, da je treba sprejeti ukrepe v okviru omejevalnega postopka ali postopka izdaje dovoljenja ali da je treba preučiti ukrepe za obvladovanje tveganja v okviru druge ustrezne zakonodaje.
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.
Zato morajo biti informacije o poteku postopkov vrednotenja objavljene.
Information on the progress of evaluation proceedings should therefore be made public.
Da se zagotovi dovolj visoka raven varovanja zdravja ljudi
To ensure a sufficiently high level of protection for human health
, še zlasti občutljivih skupin prebivalstva,
, in particular that of vulnerable populations,
in varstva okolja, je treba snovi, katerih lastnosti zbujajo zelo veliko skrb, obravnavati previdno
and the environment, substances with properties of very high concern should be treated in a precautionary manner
da ni na voljo ustreznih nadomestnih snovi ali tehnologij, da koristi, ki jih ima družba zaradi uporabe snovi, prevladajo nad nevarnostjo, povezano z njihovo uporabo, ter da je nevarnost ustrezno nadzorovana.
there are no suitable alternative substances or technologies, that the benefits to society deriving from the use of the substance outweigh the risks connected with its use and that the risks are adequately controlled
Ker je treba z izdajanjem dovoljenj zagotoviti visoko raven varstva na celotnem notranjem trgu, je ustrezno, da prevzame vlogo organa za izdajo dovoljenj Komisija.
Since authorisations should ensure a high level of protection throughout the internal market, it is appropriate that the Commission should be the granting authority.
Izkušnje na mednarodni ravni kažejo, da snovi, ki so po svojih lastnostih obstojne, strupene in se lahko kopičijo v organizmih ali zelo obstojne in se zelo lahko kopičijo v organizmih, zbujajo veliko skrb, zato so bila razvita merila, ki omogočajo prepoznavanje takšnih snovi.
Experience at the international level shows that substances with characteristics rendering them persistent, liable to bioaccumulate and toxic, or very persistent and very liable to bioaccumulate, present a very high concern, while criteria have been developed allowing the identification of such substances.
Nekatere druge snovi zbujajo dovolj veliko skrb, da se obravnavajo enako po posameznih primerih.
For certain other substances concerns are sufficiently high to address them in the same way on a case-by-case basis.
Glede na pomisleke o izvedljivosti in uporabnosti tako za podjetja, ki morajo pripraviti dokumentacijo za vlogo in sprejeti ustrezne ukrepe za obvladovanje tveganja, kot za organe oblasti, ki morajo obravnavati vloge za izdajo dovoljenja, je treba zagotoviti, da teče postopek za izdajo dovoljenja hkrati samo za omejeno število snovi, določiti stvarne roke za vloge, hkrati pa omogočiti, da se nekatere uporabe izvzamejo.
In view of workability and practicality considerations, both as regards enterprises, who have to prepare application files and take appropriate risk management measures, and as regards the authorities, who have to process authorisation applications, only a limited number of substances should be subjected to the authorisation procedure at the same time and realistic deadlines should be set for applications, while allowing certain uses to be exempted.
Agencija mora
The Agency
samostojno določiti,
, acting on its own authority,
Popolna prepoved snovi pomeni, da se za nobeno njeno uporabo ne sme izdati dovoljenja.
A total ban on a substance would mean that none of its uses could be authorised.
Zato bi bilo nesmiselno dovoliti predložitev vlog za izdajo dovoljenja; v takšnih primerih je treba snov umakniti s seznama snovi, za katere se lahko oddajo vloge za izdajo dovoljenja.
It would therefore be pointless to allow the submission of applications for authorisation; in such cases the substance should be removed from the list of substances for which applications can be submitted.
Da se zagotovi usklajen pristop k izdaji dovoljenj za uporabe določenih snovi, Agencija izda mnenje o nevarnosti, ki izhaja iz teh uporab, in vsaki socialno-ekonomski analizi, ki ji jo predložijo tretje strani.
In order to provide a harmonised approach to the authorisation of the uses of particular substances, the Agency should issue opinions on the risks arising from those uses and on any socio-economic analysis submitted to it by third parties.
Da se omogoči učinkovito spremljanje in izvajanje zahtev za izdajo dovoljenja, morajo uporabniki na nižji stopnji, ki imajo koristi od dovoljenj, izdanih njihovim dobaviteljem, Agencijo obvestiti o svoji uporabi snovi.
To allow effective monitoring and enforcement of the authorisation requirement, downstream users benefiting from an authorisation granted to their supplier should inform the Agency of their use of the substance.
Da se pospeši sedanji sistem, je treba postopek omejevanja preoblikovati, Direktivo 76/769/EGS, ki je bila večkrat bistveno spremenjena in prilagojena, pa nadomestiti.
In order to accelerate the current system the restriction procedure should be restructured and should replace Directive 76/769/EEC, which has been substantially amended and adapted several times.
Pravni red usklajenih pravil v skladu s prilogo k navedeni direktivi je treba zaradi jasnosti prevzeti v prenovljeni različici kot izhodišče tega novega pospešenega postopka omejevanja.
The acquis of the harmonised rules under the Annex to that Directive should be taken over in a recast version in the interests of clarity and as a starting point for this new accelerated restriction procedure.
Ta preoblikovana različica upošteva pravila iz medinstitucionalnega sporazuma o tehnikah preoblikovanja.
This recast follows the rules set out within the Interinstitutional Agreement concerning recasting techniques.
Proizvajalec, uvoznik in uporabnik na nižji stopnji so odgovorni, da za zagotovitev visoke ravni varovanja zdravja ljudi in okolja poiščejo ustrezne ukrepe za obvladovanje tveganja, ki izhaja iz proizvodnje, dajanja v promet ali uporabe snovi kot take, v pripravkih ali izdelkih.
It is the responsibility of the manufacturer, importer and the downstream user to identify the appropriate risk management measures needed to ensure a high level of protection for human health and the environment from the manufacturing, placing on the market or use of a substance on its own, in a preparation or in an article.
Če se meni, da to ni dovolj, in če to upravičuje zakonodaja Skupnosti, je treba določiti ustrezne omejitve.
However, where this is considered to be insufficient and where Community legislation is justified, appropriate restrictions should be laid down.
Da se zavaruje zdravje ljudi in okolje, lahko omejitve proizvodnje, dajanja v promet ali uporabe snovi kot take, v pripravku ali izdelku, vključujejo pogoje za proizvodnjo, dajanje v promet ali uporabo ali prepoved tega.
In order to protect human health and the environment, restrictions on the manufacture, placing on the market or use of a substance on its own, in a preparation or in an article may include any condition for, or prohibition of, the manufacture, placing on the market or use.
Zato je treba sestaviti seznam takšnih omejitev in vseh njihovih sprememb.
Therefore it is necessary to list such restrictions and any amendments thereto.
Ta uredba mora prispevati k preprečevanju poklicnih bolezni, povezanih z izpostavljenostjo kemikalijam in njihovo uporabo.
This Regulation should contribute to the prevention of occupational diseases related to exposure to and the use of chemicals.
Evropska unija mora vlagati v metode razstrupljanja za zdravljenje poklicnih bolezni, povezanih s kemikalijami.
The European Union should invest in detoxification methods to cure professional diseases related to chemicals.
Priprava predloga omejitev in učinkovita uporaba takšne zakonodaje zahtevata od držav članic, Agencije, drugih organov Skupnosti, Komisije in zainteresiranih strani dobro medsebojno sodelovanje, usklajevanje in obveščanje.
In order to prepare a restrictions proposal and in order for such legislation to operate effectively, there should be good co-operation, co-ordination and information between the Member States, the Agency, other bodies of the Community, the Commission and the interested parties.
Da se državam članicam zagotovi možnost, da oddajo predloge za obravnavanje določene nevarnosti za zdravje ljudi in okolje, morajo te pripraviti dokumentacijo v skladu s podrobno opisanimi zahtevami.
In order to give Member States the opportunity to submit proposals to address a specific risk for human health and the environment, they should prepare a dossier in conformity with detailed requirements.
V dokumentaciji je treba navesti utemeljitev za sprejetje ukrepov v celotni Skupnosti.
The dossier should set out the justification for Community-wide action.
Da se zagotovi usklajen pristop k omejitvam, mora Agencija dobro odigrati svojo vlogo koordinatorja tega postopka, na primer z imenovanjem ustreznih poročevalcev in preverjanjem skladnosti z zahtevami iz zadevnih prilog.
In order to provide a harmonised approach to restrictions, the Agency should fulfil a role as co-ordinator of this procedure, for example by appointing the relevant rapporteurs and verifying conformity with the requirements of the relevant Annexes.
Da se Komisiji zagotovi možnost obravnavanja posebne nevarnosti za zdravje ljudi in okolje, ki jo je treba obravnavati v celotni Skupnosti, ji je treba omogočiti, da lahko Agenciji zaupa pripravo dokumentacije za omejitve.
In order to give the Commission the opportunity to address a specific risk for human health and the environment that needs to be addressed Community wide, it should be able to entrust the Agency with the preparation of a restriction dossier.
Zaradi preglednosti mora Agencija zadevno dokumentacijo objaviti, vključno s predlaganimi omejitvami, in zaprositi za pripombe.
For reasons of transparency, the Agency should publish the relevant dossier including the suggested restrictions while requesting comments.
Da se postopek pravočasno zaključi, mora Agencija predložiti svoje mnenje o predlaganih ukrepih in njihovem vplivu na podlagi osnutka mnenja, ki ga pripravi poročevalec.
In order to finalise the procedure in due time, the Agency should submit its opinions on the suggested action and its impact on the basis of a draft opinion prepared by a rapporteur.
Da se pospeši postopek za določitev omejitev, mora Komisija pripraviti svoj osnutek spremembe v treh mesecih po prejemu mnenja Agencije.
In order to speed up the procedure for restrictions, the Commission should prepare its draft amendment within three months of receiving the Agency's opinions.
Agencija ima osrednjo vlogo pri zagotavljanju zaupanja vseh zainteresiranih strani in javnosti v zakonodajo o kemikalijah in postopke odločanja v zvezi z njimi ter v znanstveno podlago, na kateri temeljijo
The Agency should be central to ensuring that the chemicals law and the decision-making processes and scientific basis underlying it have credibility with all stakeholders and the public
, tako da javnost in vse zadevne stranke zaupajo v varnost snovi ter pripravkov, ki jih uporabljajo
so that the public and all parties concerned have confidence in the safety of the substances and preparations they use.
Zaradi tega je zelo pomembno, da institucije Skupnosti, države članice, splošna javnost in zainteresirane strani Agenciji zaupajo.
The confidence in the Agency of the Community institutions, the Member States, the general public and interested parties is therefore essential.
Zato ji je treba zagotoviti neodvisnost ter velike znanstvene, tehnične in regulativne zmogljivosti, zagotoviti pa je treba tudi
For this reason, it is vital to ensure its independence, high scientific, technical and regulatory capacities
zanesljive komunikacijske spretnosti,
and sound communication skills
Organiziranost Agencije mora ustrezati nalogam, ki jih opravlja.
The structure of the Agency should be suitable for the tasks that it should fulfil.
Pri tem je treba v okviru Agencije ustanoviti center odličnosti za obveščanje o tveganjih in nevarnostih, povezanih z nekaterimi snovmi in pripravki.
In this respect, a centre of excellence should be created within the Agency, specialised in communication of the risks and dangers associated with certain substances and preparations.
Zaradi učinkovitosti mora
In the interests of efficiency, the staff of the
osebje Agencije
Agency should
opravljati ključne tehnično-administrativne in znanstvene naloge brez uporabe znanstvenih in tehničnih virov držav članic; izvršni direktor mora zagotavljati učinkovito in neodvisno izvajanje nalog Agencije.
perform essentially technical-administrative and scientific tasks without calling on the scientific and technical resources of the Member States; the Executive Director should ensure the efficient execution of the Agency's tasks in an independent manner.
Da se zagotovi učinkovito izvajanje nalog Agencije, mora biti upravni odbor sestavljen tako, da zagotavlja izpolnjevanje najvišjih zahtev glede usposobljenosti ter širok razpon strokovnega znanja s področja kemijske varnosti in pravne ureditve kemikalij.
To ensure that the Agency fulfils its role, the composition of the Management Board should be designed to secure the highest standard of competence and a broad range of relevant expertise in chemicals safety or the regulation of chemicals.
Agencija mora imeti sredstva za izvajanje vseh zahtevanih nalog, da lahko tako izpolnjuje svoje poslanstvo.
The Agency should have the means to perform all the tasks required to enable it to carry out its role.
Upravni odbor mora imeti potrebna pooblastila za določitev proračuna, pregled njegovega izvrševanja, določitev ustroja in zneska pristojbin, oblikovanje notranjih poslovnikov, sprejetje finančnih predpisov in imenovanje izvršnega direktorja.
The Management Board should have the necessary powers to establish the budget, check its implementation, set the structure and amount of the fees, draw up internal rules, adopt financial regulations and appoint the Executive Director.
V skladu s ciljem za spodbujanje testiranja brez preskusov na živalih mora biti del pristojbin namenjen razvoju testiranja brez preskusov na živalih.
In line with the objective to promote non-animal testing, part of the fees should be allocated to the development of non-animal test methods.
Ustrezno je, da so v upravnem odboru Agencije predstavniki drugih zainteresiranih strani, na primer industrije, nevladnih organizacij in akademskih svetov, da se zagotovi vključitev interesnih skupin.
It is appropriate for the Management Board of the Agency to include representatives from other interested parties, such as industry, non-governmental organisations and academia, in order to ensure the involvement of stakeholders.
Prek Odbora za oceno tveganja in
Through the Committee for Risk
nadomestnih možnosti ter
and Alternative
Odbora za socialno-ekonomsko analizo Agencija prevzame nalogo znanstvenih odborov, ustanovljenih pri Komisiji, pri izdajanju znanstvenih mnenj s področja svojih pristojnosti.
Assessment and the Committee for Socio-economic Analysis, the Agency should take over the role of the Scientific Committees attached to the Commission in issuing scientific opinions in its field of competence.
Treba je zagotoviti tesno sodelovanje med Agencijo in pristojnimi organi, ki delujejo v državah članicah, da bodo znanstvena mnenja Odbora za oceno tveganja in
It is necessary to ensure close co-operation between the Agency and the competent authorities working within the Member States so that the scientific opinions of the Committee for Risk
Odbora za socialno-ekonomsko analizo temeljila na najširšem mogočem ustreznem znanstvenem in tehničnem znanju, ki je na voljo v Skupnosti; zato je treba odborom omogočiti, da se lahko oprejo na dodatno posebno strokovno znanje.
Assessment and the Committee for Socio-economic Analysis are based on the broadest possible scientific and technical expertise appropriate which is available within the Community; to the same end, the Committees should be able to rely on additional particular expertise.
Za spodbujanje testiranja brez preskusov na živalih mora imeti Agencija za nalogo razvoj in izvajanje razvojne politike, potrjevanje in sprejetje metod testiranja brez preskusov na živalih in zagotovitev njihove uporabe v postopni preudarni oceni tveganja za izpolnitev zahtev te uredbe.
In order to promote non-animal testing, the Agency should have the task of developing and implementing a policy for the development, validation and legal acceptance of non-animal test methods and to ensure their use in intelligent stepwise risk assessment to meet the requirements of this Regulation.
Zato mora Agencija vključiti Odbor za nadomestne preskusne metode, sestavljen iz strokovnjakov iz Evropskega centra za validacijo alternativnih metod, organizacije za dobro počutje živali in druge zainteresirane strani za zagotovitev čim širšega ustreznega znanstvenega in tehničnega znanja, ki je na voljo v Skupnosti.
To this end, the Agency should include a Committee for Alternative Test Methods, consisting of experts from ECVAM, animal welfare organisations and other relevant stakeholders, to ensure the broadest possible appropriate scientific and technical expertise which is available within the Community.
Agencija državam članicam zagotavlja tudi pristojno mesto za izmenjavo informacij o svojih dejavnostih v zvezi z izvajanjem zakonodaje o kemikalijah in za usklajevanje takšnih dejavnosti.
The Agency should also provide a Forum for Member States to exchange information on and to co-ordinate their activities related to the enforcement of chemicals legislation.
Sedanjemu neformalnemu sodelovanju med državami članicami na tem področju bi koristil bolj formalen okvir.
The currently informal co-operation between Member States in this respect would benefit from a more formal framework.
Pri Agenciji je treba ustanoviti Komisijo za pritožbe, ki bo zagotavljala zakonite pravice do pritožbe subjektom, ki jih prizadenejo odločitve Agencije.
A Board of Appeal should be set up within the Agency to guarantee legal rights of appeal for the operators affected by decisions taken by the Agency.
Agencija se delno financira s pristojbinami, ki jih plačajo podjetja, delno pa s splošnim proračunom Evropskih skupnosti.
The Agency should be financed partly by fees paid by enterprises and partly by the general budget of the European Communities.
Proračunski postopek Skupnosti se mora uporabljati za subvencije iz splošnega proračuna Evropskih skupnosti.
The Community budgetary procedure should remain applicable as far as any subsidies chargeable to the general budget of the European Communities are concerned.
Revizijo finančnih poročil izvaja Računsko sodišče v skladu s členom 91 Uredbe Komisije (ES, Euratom) št. 2343/2002 z dne 23. decembra 2002 o okvirni finančni uredbi za organe iz člena 185 Uredbe Sveta (ES, Euratom) št. 1605/2002 o finančni uredbi, ki se uporablja za splošni proračun Evropskih skupnosti UL L 357, 31.12.2002, str.
Moreover, the auditing of accounts should be undertaken by the Court of Auditors in accordance with Article 91 of Commission Regulation (EC, Euratom) No 2343/2002 of 23 December 2002 on the framework Financial Regulation for the bodies referred to in Article 185 of Council Regulation (EC, Euratom) No 1605/2002 on the Financial Regulation applicable to the general budget of the European Communities OJ L 357, 31.12.2002, p.
Če je po mnenju Komisije in Agencije ustrezno, je treba drugim državam omogočiti sodelovanje pri delu Agencije.
Where the Commission and Agency consider it appropriate, it should be possible for other countries to participate in the work of the Agency.
Agencija prek sodelovanja z organizacijami, ki si prizadevajo uskladiti mednarodne predpise, krepi vlogo Skupnosti in držav članic pri takšnih usklajevalnih dejavnostih.
The Agency should contribute, through co-operation with organisations having interests in the harmonisation of international regulations, to the role of the Community and the Member States in such harmonisation activities.