natgillin/translations-raw huggingface dataset:
(18) Določbe o odobritvi omogočajo odobritev z omejenim trajanjem za dajanje v promet in uporabo snovi, ki zbujajo veliko skrb , ki jo Komisija izda le, če ne obstajajo ustrezne nadomestne snovi ali tehnologije, če se lahko njihova uporaba utemelji s socialno-ekonomskimi razlogi in če se tveganje, ki izhaja iz njihove uporabe, ustrezno nadzoruje.
(18) The authorisation provisions provide for authorisations, of limited duration, for the placing on the market and use of substances of very high concern to be granted by the Commission where no suitable alternative substances or technologies exist, where the use of such substances can be justified on socio ‑economic grounds and where the risks arising from their use are adequately controlled.
(Predlog spremembe 15 – prva obravnava)
(Amendment 15 - first reading)
(35a) Glede na posebne okoliščine MSP je priporočljivo, da države članice sprejmejo ukrepe, s katerimi tem podjetjem zagotovijo posebno podporo pri opravljanju testov, potrebnih za zbiranje podatkov, ki jih zahteva ta uredba.
(35a) In the light of the particular circumstances of SMEs, Member States should adopt measures to provide special assistance to such enterprises for conducting the tests needed to collect the information required under this Regulation.
Da bi olajšali izvajanje te uredbe, je treba zagotoviti ustrezne ukrepe pomoči, še posebej za MSP.
It is important to provide the appropriate assistance measures, particularly to SMEs, to facilitate the implementation of this regulation.
Predlog spremembe 363 na prvi obravnavi.
Amendment 363 at first reading.
Obnovitev predloga spremembe 22 iz prve obravnave, da bi pomagali MSP pri izvajanju te uredbe.
Reinstates Amendment 22 at first reading in order to help SMEs to cope with the challenge of implementing the regulation.
UVODNA IZJAVA 43 A (novo)
RECITAL 43 A (new)
(43a) Boljše usklajevanje sredstev na ravni Skupnosti bo prispevalo k naraščanju znanstvenih dognanj, potrebnih za razvoj metod, ki bodo nadomestile poskuse na vretenčarjih.
(43a) Better coordination of resources at Community level will contribute to increasing the scientific knowledge indispensable for the development of alternative methods to that of experimentation on vertebrate animals.
Zato je bistvenega pomena, da Skupnost nadaljuje in poveča prizadevanja ter sprejme potrebne ukrepe za spodbujanje raziskav in razvoja novih nadomestnih metod, ki ne vključujejo živali, še zlasti v okviru sedmega okvirnega programa za raziskave in tehnološki razvoj.
It is essential, for this purpose, that the Community continue and increase its efforts and take the measures necessary for the promotion of research and the development of new non-animal alternative methods, in particular within its Seventh Framework Programme for Research and Technological Development.
(Predlog spremembe 24 – prva obravnava)
(Amendment 24 - first reading)
Predlog spremembe se Sklicuje na dolžnost Skupnosti, da spodbuja metode, s katerimi se bodo nadomestili preskusi na živalih, ki je bila že omenjena v Direktivi 2003/15/ES o kozmetiki.
This recalls the Community’s duty to promote alternative methods to that of animal experimentation, already introduced in Directive 2003/15/EC on cosmetics.
Uporaba testiranja, ki ne vključuje živali, je priporočljiva tako z etičnega kot z znanstvenega vidika.
The use of non-animal tests is preferable from both an ethical and a scientific view.
Za spodbujanje testiranja, ki ne vključuje živali, da bi se izpolnjevale zahteve iz te uredbe za predložitev informacij, je treba zagotoviti več sredstev za razvoj, potrjevanje in sprejemanje metod testiranja, ki ne vključuje živali.
To promote non-animal testing to meet the information requirements of this Regulation, it is necessary to make available more resources for the development, validation and acceptance of non-animal test methods.
Predlog spremembe 27 iz prve obravnave.
Amendment 27 in first reading.
UVODNA IZJAVA 51 A (novo)
RECITAL 51 A (new)
(51a) Če proizvajalec snovi ali uvoznik snovi, kot take ali v pripravku, ne namerava predložiti registracije za snov, o tem ustrezno obvesti Agencijo in svoje uporabnike na nižji stopnji.
(51a) If a manufacturer of a substance or an importer of a substance, either on its own or in a preparation, does not intend to submit a registration for a substance, he must notify the Agency and his downstream users accordingly.
Obveščanje o neregistraciji je pomembno zato, da so uporabniki na nižji stopnji seznanjeni z umikom nekaterih snovi iz prometa.
Communication of non-registration is important to inform downstream users about the withdrawal of certain substances from the market.
Obveščanje o tveganju zahteva razumevanje potreb uporabnikov po podatkih s strani proizvajalca ter naknadno zagotovitev teh podatkov, nasvetov in pomoči za podporo varne uporabe snovi ali pripravka s strani končnega uporabnika.
Risk communication requires an understanding by the manufacturer of the information needs of users, and the subsequent provision of that information, advice and help to support the safe use of the substance or preparation by the end user.
Treba si je prizadevati za razvoj ustreznega sistema obveščanja o tveganju, vključno z zagotovitvijo dodatnih informacij, na primer z uporabo spletnih strani in izobraževalnih kampanj, da bi zadostili pravici potrošnikov, da so obveščeni o snoveh in pripravkih, ki jih uporabljajo.
The development of an appropriate risk-based communication system, including the provision of complementary information using, for example, websites and educational campaigns, should be pursued to satisfy the right of consumers to know about the substances and preparations they use.
To bo dodatno okrepilo varno uporabo snovi in pripravkov ter zaupanje vanje.
This will further enhance the safe use of, and confidence in, substances and preparations.
Takšen sistem bo pomemben za potrošniške organizacije pri oblikovanju okvira, ki bo prek REACH obravnaval dejanske skrbi potrošnikov, ter za industrijo pri krepitvi zaupanja potrošnikov v uporabo snovi in pripravkov, ki vsebujejo kemikalije.
Such a system will be valuable to consumer organisations in setting a framework that will address the true concerns of consumers through REACH and to industry in building consumer confidence in the use of substances and preparations containing chemicals.
Ustreza predlogu spremembe 30 s prve obravnave.
Corresponds to Amendment 30 First Reading .
Ustrezen in skladen komunikacijski sistem, ki temelji na tveganju, bo potrošnikom zagotovil potrebne podatke in nasvete, da bodo lahko varno in učinkovito obvladovali tveganje pri uporabi snovi ali pripravka.
An appropriate and consistent communication system based on risk will provide consumers with the necessary information and advice to enable them to manage their risk safely and effectively when using a substance or preparation.
Te zahteve bi morale veljati samo nad skupno količino eno tono za snov ali pripravek.
These requirements should only apply above a total quantity of 1 tonne of substance or preparation.
Vendar pa bi moral uporabnik na nižji stopnji v vsakem primeru premisliti o uporabi in določiti ter uporabiti ustrezne ukrepe za obvladovanje tveganja.
In any case , however, the downstream users should consider the use and identify and apply appropriate risk management measures.
Uporabniki na nižji stopnji bi morali Agenciji posredovati določene osnovne informacije o uporabi.
Downstream users should report certain basic information on use to the Agency.
(54) Podrobno bi bilo treba predpisati tudi zahteve za ocene kemijske varnosti, ki jih izvedejo uporabniki na nižji stopnji, da ti lahko izpolnijo svoje obveznosti.
(54) The requirements for undertaking chemical safety assessments by downstream users should also be prescribed in detail to allow them to meet their obligations.
Uporabnik na nižji stopnji bi moral v vsakem primeru premisliti o uporabi in določiti ter uporabiti ustrezne ukrepe za obvladovanje tveganja.
In any case the downstream users should consider the use and identify and apply appropriate risk management measures.
Uporabniki na nižji stopnji morajo sporočiti tveganje, kot je poudarjeno v oceni kemijske varnosti, na najučinkovitejši in najustreznejši možni način za uporabnika snovi ali pripravka v nekem trenutku v dobavni verigi/življenjskem ciklu ter potrošnikom zagotoviti nasvete za varno uporabo.
Downstream users should report the risks as highlighted in the chemical safety assessment by the most effective and relevant means possible for the user of the substance or preparation at a given point in the supply chain/life cycle and provide advice on safe use for consumers.
(Nov predlog spremembe – člen 62(2)(c) in predlog spremembe 33 iz prve obravnave)
(New amendment - Rule 62(2)(c), and amendment 33 - first reading)
(Povezano z odstavkom 36(4)(c))
(Linked to paragraph 36(4)(c))
Z določitvijo mejne vrednosti za poročilo o kemijski varnosti (CSR) uporabnikov na nižji stopnji bi proizvajalce nehote spodbudili k izključevanju uporabe pod eno tono iz CSR, saj bi tako uporabniki na nižji stopnji ne imeli nobenih obveznosti.
A threshold for the chemical safety report (CSR) of downstream users would create a perverse incentive for manufacturers to exclude uses below 1 tonne from their CSR, as it would not result in any obligations for downstream users.
S tem nastane velika vrzel glede podatkov o varnosti za manjšo uporabo.
This creates a serious loophole with regard to safety information for small uses.
Poleg tega je v predlogu spremembe določena obveznost uporabnikov na nižji stopnji, da obveščajo člene v dobavni verigi ter potrošnike.
This amendment furthermore reflects the duty of downstream users to inform the supply chain as well as consumers.
UVODNA IZJAVA 58 A (novo)
RECITAL 58 A (new)
(58a) Za preprečitev podvajanja poskusov na živalih morajo imeti zainteresirane strani čas 90 dni, ko lahko predložijo pripombe o predlogih za testiranje, ki vključuje testiranje na vretenčarjih.
(58a) 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.
Registracijski zavezanec ali uporabnik na nižji stopnji mora upoštevati vse pripombe, prejete v tem obdobju.
Comments received during this period should be taken into account by the registrant or the downstream user.
(Predlog spremembe 36 – prva obravnava)
(Amendment 36 - first reading)
V okviru ameriškega programa za kemikalije, ki se proizvajajo v velikih količinah (HPV), so dokazali, da lahko rok za dajanje pripomb interesnih skupin pozitivno vpliva na preprečevanje poskusov na živalih in prihranek stroškov.
The High Production Volume (HPV) chemicals programme in the United States has proven the positive effect a stakeholder commenting period can have towards preventing animal tests and saving costs.
(Predlog spremembe 37 – prva obravnava)
(Amendment 37 - first reading)
ECVAM je vodilni organ EU za alternativne testne metode.
ECVAM is the EU's leading institution on alternative test methods.
Ker se nenehno razvijajo nove alternativne testne metode, bi se bilo treba o predlogih za testiranje na vretenčarjih posvetovati z ECVAM-om, saj se s tem zagotovi, da se upoštevajo najnovejša spoznanja.
As new alternative test methods are constantly being developed, ECVAM should be consulted on testing proposals on vertebrate animals to ensure that the latest knowledge is made use of.
Odobritev bi bilo treba dodeliti, če fizične ali pravne osebe, ki zaprosijo za odobritev, organom za dodelitev odobritve dokažejo, da so tveganja za zdravje ljudi ali okolje, ki izhajajo iz uporabe snovi, ustrezno nadzorovana.
Authorisation should be granted where natural or legal persons applying for an authorisation demonstrate to the granting authority that the risks to human health and the environment arising from the use of the substance are adequately controlled.
Uporabo se lahko vseeno odobri, če se dokaže, da socialno-ekonomske koristi zaradi uporabe snovi prevladajo nad tveganjem, povezanim z njihovo uporabo, in da ni na voljo ustreznih alternativnih snovi ali tehnologij, ki so ekonomsko in tehnično izvedljive.
Otherwise, uses may still be authorised if it can be shown that the socio-economic 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.
Ob upoštevanju dobrega delovanja notranjega trga je primerno, da bi bil organ za dodelitev odobritve Komisija.
Taking into account the good functioning of the internal market it is appropriate that the Commission should be the granting authority.
(63) Da se zagotovi dovolj visoka raven varovanja zdravja ljudi, zlasti ranljivih skupin populacije, in varstva okolja, je treba snovi , katerih lastnosti zbujajo veliko skrb, obravnavati previdno ter jih odobriti le, če podjetja, ki jih uporabljajo, dokažejo, 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 so tveganja ustrezno nadzorovana .
(63) To ensure a sufficiently high level of protection for human health , in particular that of vulnerable populations, and the environment, substances with properties of very high concern should be treated in a precautionary manner and should only be authorised if enterprises using them demonstrate to the granting authority that 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.
Organ za dodelitev odobritve nato s postopkom, ki temelji na vlogah podjetij, preveri, ali so te zahteve izpolnjene.
The granting authority should then verify that these requirements are met through an authorisation procedure on the basis of applications by enterprises.
Ker naj bi odobritve zagotovile visoko raven varovanja na celotnem notranjem trgu, je primerno, da bi bil organ za dodelitev odobritve 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.
(Predlog spremembe 41 – prva obravnava)
(Amendment 41 - first reading)
Zelo nevarne snovi je treba vedno, kadar je to mogoče, nadomestiti z varnejšimi, pri njihovi uporabi je treba upoštevati socialno-ekonomske koristi, tveganja pa je treba "ustrezno nadzorovati".
Very high-risk substances shall be replaced, whenever possible, with other, safer, ones and, when used, the socio-economic benefits shall be taken into account and the risk ‘adequately controlled’.
Pri dodeljevanju odobritve je treba posebno pozornost nameniti ranljivim populacijam.
Specific attention needs to be paid to vulnerable populations in authorisation.
Ustrezna priloga se lahko spremeni na podlagi teh metodologij, s čimer se po potrebi omogoči uporaba pragov v smislu odobritve uporabe rakotvornih in mutagenih snovi.
The relevant Annex may be amended on the basis of these methodologies to allow thresholds where appropriate to be used in the context of authorising the use of carcinogenic and mutagenic substances.
Črta se nova določba v skupnem stališču, saj naj bi se za odobritev snovi, ki vzbujajo veliko zaskrbljenost, uporabljal en sam postopek.
Deletes a new provision in the common position, since one single procedure should be used for the authorisation of substances of high concern.
Izkušnje s podobnimi agencijami Skupnosti so lahko smernice, vendar pa je treba organiziranost prilagoditi, da se izpolnijo posebne potrebe iz te uredbe.
Experience with similar Community agencies provides some guidance in this respect but the structure should be adapted to meet the specific needs of this Regulation.
(85) Organiziranost Agencije bi morala ustrezati nalogam, ki naj bi jih opravljala.
(85) The structure of the Agency should be suitable for the tasks that it should fulfil.
V zvezi s 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 specialised in communication of the risks and dangers associated with certain substances and preparations should be created within the Agency.
Ustreza predlogu spremembe 45, sprejetem v prvi obravnavi.
Corresponds to Amendment 45 First Reading.
Zato bi bilo treba odboroma omogočiti, da se lahko opreta na dodatno posebno strokovno znanje.
To the same end, these Committees should be able to rely on additional particular expertise.
(92) Treba je zagotoviti tesno sodelovanje med Agencijo in pristojnimi organi, ki delujejo v državah članicah, da bodo znanstvena mnenja Odbora za oceno tveganja , Odbora za socialno-ekonomsko analizo in Odbora za alternativne testne metode temeljila na najširšem mogočem ustreznem znanstvenem in tehničnem znanju, ki je na voljo v Skupnosti.
(92) It is necessary to ensure close cooperation between the Agency and the competent authorities working within the Member States so that the scientific opinions of the Committee for Risk Assessment , the Committee for Socio-economic Analysis and the Committee for Alternative Test Methods are based on the broadest possible scientific and technical expertise appropriate which is available within the Community.
(Nov predlog spremembe, katerega namen je doseči usklajenost)
(New amendment to achieve coherence
Če se v okviru Agencije ustanovi nov odbor, ga je treba omeniti tudi tukaj, ker so določbe v tej uvodni izjavi enako pomembne za delo Odbora za alternativne testne metode.
If such a new committee is established at the Agency, it should also be mentioned here, as the provisions in this recital are equally relevant to the work of the Committee for Alternative Test Methods.
UVODNA IZJAVA 92 A (novo)
RECITAL 92 A (new)
(92a) Za spodbujanje poskusov, ki ne vključujejo živali, mora imeti agencija nalogo razviti in izvajati politiko za razvoj, potrjevanje in pravno sprejetje poskusnih metod, ki ne vključujejo živali, ter zagotoviti njihovo uporabo v postopni preudarni oceni tveganja za izpolnitev zahtev te uredbe.
(92a) 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 alternativne testne metode, sestavljen iz strokovnjakov iz Evropskega centra za validacijo alternativnih metod (ECVAM), organizacij za dobro počutje živali in drugih zainteresiranih strani, za zagotovitev čim širšega ustreznega strokovnega 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 the European Centre for the Validation of Alternative Methods (ECVAM), animal welfare organisations and other relevant stakeholders, to ensure the broadest possible appropriate scientific and technical expertise which is available within the Community.
(Predlog spremembe 361 – prva obravnava)
(Amendment 361 - first reading)
Cilj te uredbe, spodbujanje poskusov, ki ne vključujejo živali, je treba vključiti v pooblastila in delo agencije, da se zagotovi učinkovito izvajanje Uredbe.
The objective of this Regulation to promote non-animal testing should be included in the mandate and work of the Agency to ensure its effective implementation.
(104a) V svojem mnenju z dne 10. marca 2006 o primernosti obstoječih metod za ocenjevanje možnih tveganj, povezanih s prilagojenimi in naključnimi nanotehnološkimi proizvodi, je Znanstveni odbor za nastajajoča in na novo odkrita zdravstvena tveganja (Scientific Committee on Emerging and Newly Identified Health Risks - SCENIHR) opozoril na največje vrzeli v znanju, potrebnem za oceno tveganj, vključno z opredelitvijo nanodelcev, odkrivanjem in meritvami nanodelcev, razmerjem med odmerkom in odzivom, obnašanjem in obstojnostjo v človekovem telesu in okolju ter vsemi vidiki toksikologije in okoljske toksikologije v povezavi z nanodelci.
(104a) In its opinion of 10 March 2006 on the appropriateness of existing methodologies to assess the potential risks associated with engineered and adventitious products of nanotechnologies, the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) pointed to major gaps in the knowledge necessary for risk assessment, including nanoparticle characterisation, the detection and measurement of nanoparticles, the dose-response, fate and persistence of nanoparticles in humans and in the environment, and all aspects of toxicology and environmental toxicology related to nanoparticles.
Odbor je zaključil, da je treba obstoječe metode za oceno tveganja nekoliko spremeniti, da bi lahko obravnavali nevarnosti, povezane z nanotehnologijo, ter zlasti, da obstoječe toksikološke in ekotoksikološke metode morda ne zadostujejo za reševanje vseh vprašanj v zvezi z nanodelci.
It concluded that current risk assessment methodologies require some modifications in order to deal with the hazards associated with nanotechnology, and in particular that existing toxicological and ecotoxicological methods may not be sufficient to address all of the issues arising with nanoparticles.
Z določbami te uredbe je treba zagotoviti ustrezno oceno varnosti nanodelcev kot predpogoj za njihovo proizvodnjo in dajanje v promet.
The provisions of this Regulation should ensure an adequate safety evaluation of nanoparticles as a precondition for their manufacture and placing on the market.
(Nov predlog spremembe - člen 62(2)(d), z namenom, da se upošteva mnenje odbora SCENIHR z dne 10. marca 2006)
(New amendment - Rule 62(2)(d) to take account of the opinion of SCENIHR of 10 March 2006)
Treba je izrecno omeniti ugotovitve odbora SCENIHR glede večjih vrzeli v znanju v povezavi z oceno tveganja pri nanodelcih, kot tudi zaključke omenjenega odbor, da je treba spremeniti obstoječe metode.
The major gaps in the knowledge for risk assessment of nanoparticles, as stated by SCENIHR, as well as their conclusions stating a need for modifications of existing methods, need to be stated explicitly.
(114a) Za pomoč potrošnikom, da varno in trajnostno uporabljajo snovi in pripravke, morajo proizvajalci prek oznake na embalaži vsake enote, dane v promet za prodajo potrošnikom, dati na razpolago informacije, ki temeljijo na oceni tveganja in razložijo tveganje, povezano s priporočeno uporabo ali predvidljivimi situacijami, v katerih bi lahko bili napačno uporabljeni.
(114a) To help consumers to use substances and preparations in a safe and sustainable manner, manufacturers must make available, by means of a label on the packaging of each unit placed on the market for sale to consumers, information based on risk and identifying the risks associated with their recommended use or with the foreseeable situations in which they might be improperly used.
Oznake na embalaži bodo po potrebi dopolnjevala še druga sredstva obveščanja, na primer spletne strani, ki bodo zagotovila podrobnejše informacije v zvezi z varnostjo in uporabo snovi ali pripravkov.
The labelling of the packaging will also be complemented, if appropriate, by the use of other means of communication, such as websites, to provide more detailed information on safety and the use of the substance or preparation.
Direktivi 1999/45/ES in 67/548/EGS se zato ustrezno spremenita.
Directives 1999/45/EC and 67/548/EEC should be amended accordingly.
Razvoj ustreznega in skladnega sistema obveščanja o tveganjih bo potrošnikom zagotovil potrebne informacije in nasvete, da bodo lahko varno in učinkovito uporabljali kemikalije in pripravke, ki jih vsebujejo.
The development of an appropriate and consistent communication system based on risk will provide consumers with the necessary information and advice to enable them to use chemicals and preparations containing them safely and effectively.