natgillin/translations-raw huggingface dataset:
Po potrebi bi bilo treba zaradi varovanja zdravja ljudi in živali za aktivne snovi v biocidnem proizvodu določiti najvišje mejne vrednosti ostankov za hrano in krmo.
Where appropriate, maximum residue limits for food and feed should be established with respect to active substances contained in a biocidal product to protect human and animal health.
Če te zahteve niso izpolnjene, se dovoljenje za biocidne proizvode ne izda, razen če je izdaja dovoljenja upravičena zaradi nesorazmernih negativnih učinkov, ki bi jih neizdaja dovoljenja imela za družbo v primerjavi s tveganjem zaradi uporabe biocidnih proizvodov.
When these requirements are not met, biocidal products shall not be authorised unless their authorisation is justified because of the disproportionate negative impact for society of not authorising them when compared to the risks arising from their use.
Kadar je mogoče, bi se bilo treba prisotnosti škodljivih organizmov izogniti z ustreznimi previdnostnimi ukrepi, na primer z ustreznim skladiščenjem blaga, upoštevanjem zadevnih higienskih standardov in takojšnjim odstranjevanjem odpadkov.
Where possible, the presence of harmful organisms should be avoided by means of suitable precautionary steps, such as proper warehousing of goods, compliance with relevant hygiene standards and immediate disposal of waste.
Biocidne proizvode z manjšim tveganjem za ljudi, živali in okolje bi bilo treba, kadar je to mogoče, uporabiti vedno, ko so ustrezno učinkoviti, medtem ko bi bilo treba biocidne proizvode, ki lahko ubijejo ali uničijo živali, ki so sposobne čutiti bolečino in stisko, ali jim škodujejo, uporabljati samo v skrajni sili.
As far as possible, biocidal products that pose lower risks for humans, animals and the environment should be used whenever they provide an effective remedy, and biocidal products that are intended to harm, kill or destroy animals that are capable of experiencing pain and distress should be used only as a last resort.
Nekateri dovoljeni biocidni proizvodi lahko predstavljajo določeno tveganje, če bi jih uporabljala splošna javnost.
Some authorised biocidal products may present certain risks if used by the general public.
Zato je primerno določiti, da za določene biocidne proizvode ne bi smelo biti splošno dovoljeno, da so dostopni na trgu za uporabo s strani splošne javnosti.
It is therefore appropriate to provide that certain biocidal products should not generally be authorised for making available on the market for use by the general public.
Da bi se izognili podvajanju postopkov ocenjevanja in zagotovili prost pretok biocidnih proizvodov v Uniji, bi bilo treba uvesti postopke, ki bodo zagotavljali, da se dovoljenja za proizvode, ki jih izda ena država članica, priznajo v drugih državah članicah.
To avoid duplication of the evaluation procedures and to ensure free movement of biocidal products within the Union, procedures should be established to ensure that product authorisations granted in one Member State are recognised in other Member States.
Da bi državam članicam omogočili tesnejše sodelovanje pri ocenjevanju biocidnih proizvodov in olajšali dostop biocidnih proizvodov do trga, bi bilo treba omogočiti začetek postopka medsebojnega priznavanja ob vlogi za prvo nacionalno dovoljenje.
To enable closer cooperation between Member States in the evaluation of biocidal products and to facilitate biocidal products' market access, it should be possible to launch the mutual recognition procedure when applying for the first national authorisation.
Primerno je določiti postopke za medsebojno priznavanje nacionalnih dovoljenj in zlasti za reševanje nesporazumov brez nepotrebnega odlašanja.
It is appropriate to lay down procedures for the mutual recognition of national authorisations and, in particular, to resolve any disagreements without undue delay.
Če pristojni organ zavrne medsebojno priznavanje dovoljenja ali predlaga njegovo omejitev, bi si morala koordinacijska skupina prizadevati za dosego dogovora o ustreznem ukrepanju.
If a competent authority refuses mutual recognition of an authorisation or proposes to restrict it, a co-ordination group should try to reach an agreement on the action to be taken.
Če koordinacijski skupini v določenem roku ne uspe doseči dogovora, bi morala biti za sprejetje odločitve pooblaščena Komisija.
If the coordination group does not succeed in finding an agreement within a specified time, the Commission should be empowered to take a decision.
Preden Komisija pripravi odločitev, se lahko o morebitnih tehničnih in znanstvenih vprašanjih posvetuje z Agencijo.
In case of technical or scientific questions, the Commission may consult the Agency before preparing its decision.
Vendar bi pomisleki v zvezi z javnim redom in javno varnostjo, varstvom okolja, zdravja človeka in živali, varstvom nacionalnega bogastva in odsotnostjo ciljnih organizmov lahko bili upravičeni razlogi, zaradi katerih lahko država članica po dogovoru z vlagateljem zavrne izdajo dovoljenja ali se odloči prilagoditi določila in pogoje za izdajo dovoljenja.
However, considerations related to public policy or public security, environmental and human and animal health protection, the protection of national treasures and the absence of the target organisms might justify, following agreement with the applicant, Member States' refusal to grant an authorisation or decision to adjust the terms and conditions of the authorisation to be granted.
Če dogovora z vlagateljem ni mogoče doseči, bi morala biti Komisija pooblaščena za sprejetje odločitve.
If no agreement with the applicant can be found, the Commission should be empowered to take a decision.
Pri uporabi določenih vrst biocidnih proizvodov bi se lahko pojavili pomisleki glede dobrega počutja živali.
The use of biocidal products of certain product-types might give rise to animal welfare concerns.
Zato bi bilo treba državam članicam dovoliti odstopanja od načela medsebojnega priznavanja biocidnih proizvodov, ki spadajo med takšne vrste proizvodov, če je tako odstopanje utemeljeno in ne ogroža cilja te uredbe glede ustrezne ravni varstva notranjega trga.
Therefore, Member States should be allowed to derogate from the principle of mutual recognition for biocidal products falling under such product-types, in so far as such derogations are justified and do not jeopardise the purpose of this Regulation regarding an appropriate level of protection of the internal market.
Za olajšanje postopkov izdaje dovoljenj in medsebojnega priznavanja je primerno vzpostaviti sistem za medsebojno izmenjavo informacij.
In order to facilitate the functioning of the authorisation and mutual recognition procedures, it is appropriate to establish a system for the mutual exchange of information.
Za ta namen bi bilo treba vzpostaviti register biocidnih proizvodov.
To accomplish this, a Register for Biocidal Products should be established.
Države članice, Komisija in Agencija bi morale uporabljati ta register, ki bi jim omogočil dostop do podatkov in znanstvene dokumentacije, predložene v zvezi z vlogami za izdajo dovoljenj za biocidne proizvode.
Member States, the Commission and the Agency should use this Register to make available to each other the particulars and scientific documentation submitted in connection with applications for authorisation of biocidal products.
Če je uporaba biocidnega proizvoda v interesu države članice, vendar v državi članici ni vlagatelja, ki bi bil zainteresiran za dostopnost takšnega proizvoda na trgu, bi morali imeti uradni ali znanstveni organi možnost, da vložijo vlogo za izdajo dovoljenja.
If the use of a biocidal product is in the interests of a Member State, but there is no applicant interested in making available on the market such a product in the Member State, official or scientific bodies should be able to apply for an authorisation.
Če dovoljenje dobijo, bi morali imeti enake pravice in dolžnosti kot vsak drug imetnik dovoljenja.
If they are granted an authorisation, they should have the same rights and obligations as any other authorisation holder.
Zaradi upoštevanja znanstvenega in tehnološkega napredka ter potreb imetnikov dovoljenj bi bilo primerno določiti, pod kakšnimi pogoji se dovoljenja lahko prekličejo, pregledajo ali spremenijo.
To take account of scientific and technical developments as well as the needs of authorisation holders, it is appropriate to specify under which conditions authorisations can be cancelled, reviewed or amended.
Potrebne so tudi priglasitve in izmenjava informacij, ki lahko vplivajo na izdajo dovoljenj, da lahko pristojni organi in Komisija ustrezno ukrepajo.
The notification and exchange of information which may affect authorisations is also necessary to enable competent authorities and the Commission to take appropriate action.
Ob nepredvideni nevarnosti, ki ogroža javno zdravje ali okolje in ki je z drugimi sredstvi ni mogoče obvladati, bi morale države članice imeti možnost, da za omejeno obdobje dovolijo dostopnost biocidnih proizvodov na trgu, ki ne izpolnjujejo zahtev iz te uredbe.
In the event of an unforeseen danger threatening public health or the environment which cannot be contained by other means, it should be possible for Member States to permit, for a limited period of time, the making available on the market of biocidal products which do not comply with the requirements of this Regulation.
Zaradi spodbujanja raziskav in razvoja aktivnih snovi in biocidnih proizvodov je treba določiti pravila glede dostopnosti na trgu in uporabe nedovoljenih biocidnih proizvodov in neodobrenih aktivnih snovi za namene raziskav in razvoja.
To encourage research and development in active substances and biocidal products, it is necessary to establish rules concerning the making available on the market and use of unauthorised biocidal products and non-approved active substances for the purposes of research and development.
Glede na koristi za notranji trg in potrošnika je zaželeno, da se oblikujejo usklajena pravila za vzporedno trgovino za enake biocidne proizvode, ki so dovoljeni v različnih državah članicah.
In view of the benefits for the internal market and for the consumer, it is desirable to establish harmonised rules for parallel trade in identical biocidal products authorised in different Member States.
Kadar je to potrebno, je za določitev podobnosti aktivnih snovi primerno oblikovati pravila o tehnični ekvivalenci.
To determine, where necessary, the similarity of active substances, it is appropriate to lay down rules concerning technical equivalence.
Za varovanje zdravja človeka in živali ter okolja in zaradi izogibanja razlikovanju med tretiranimi izdelki, ki izvirajo iz Unije, in tretiranimi izdelki, ki se uvozijo iz tretjih držav, bi morali vsi tretirani izdelki, ki se dajejo na notranji trg, vsebovati le odobrene aktivne snovi.
To protect human and animal health and the environment, and to avoid discrimination between treated articles originating in the Union and treated articles imported from third countries, all treated articles placed on the internal market should contain only approved active substances.
Da bi potrošnikom omogočili izbiro po najboljši presoji, da bi olajšali izvajanje in imeli pregled nad njihovo uporabo, bi morali biti tretirani izdelki ustrezno označeni.
To enable consumers to make informed choices, to facilitate enforcement and to provide an overview of their use, treated articles should be appropriately labelled.
Vlagateljem, ki so vložili denar zaradi odobritve aktivne snovi ali izdaje dovoljenja za biocidni proizvod v skladu s to uredbo ali Direktivo 98/8/ES, bi bilo treba omogočiti, da dobijo nazaj del svoje naložbe s prejetjem pravičnega nadomestila, kadar koli se zaščitena informacija, ki so jo predložili v podporo takšne odobritve ali izdaje dovoljenja, uporabi v korist poznejših vlagateljev.
Applicants that have invested in supporting the approval of an active substance or the authorisation of a biocidal product in accordance with this Regulation or Directive 98/8/EC should be able to recover part of their investment by receiving equitable compensation whenever use of proprietary information which they submitted in support of such approval or authorisation is made for the benefit of subsequent applicants.
Da bi bile vse zaščitene informacije, predložene v podporo odobritve aktivne snovi ali izdaje dovoljenja za biocidni proizvod, zaščitene od trenutka njihove predložitve in da bi se izognili primerom, ko bi bile nekatere informacije nezaščitene, bi bilo treba določbe o obdobjih za varstvo podatkov uporabljati tudi za informacije, predložene za namene Direktive 98/8/ES.
With a view to ensuring that all proprietary information submitted in support of the approval of an active substance or the authorisation of a biocidal product is protected from the moment of its submission and to prevent situations where some information is without protection, the data protection periods should also apply to information submitted for the purposes of Directive 98/8/EC.
Za spodbujanje razvoja novih aktivnih snovi in biocidnih proizvodov, ki te aktivne snovi vsebujejo, je treba določiti varstveno obdobje v zvezi z zaščitenimi informacijami, predloženih v podporo odobritve takih aktivnih snovi ali izdaje dovoljenja za biocidne proizvode, ki jih vsebujejo, pri čemer je to obdobje daljše od obdobja varstva informacij o obstoječih aktivnih snoveh in biocidnih proizvodih, ki jih vsebujejo.
To encourage the development of new active substances and biocidal products containing them, it is necessary to provide for a period of protection with respect to the proprietary information submitted in support of the approval of such active substances or the authorisation of biocidal products containing them which is longer than the period of protection for information concerning existing active substances and biocidal products containing them.
Pomembno je zmanjšati število preskusov na živalih in preskuse z biocidnimi poizvodi ali aktivnimi snovmi, ki jih vsebujejo biocidni proizvodi, izvajati samo tedaj, kadar je to potrebno zaradi namena in uporabe proizvoda.
It is essential to minimise the number of tests on animals and for testing with biocidal products, or active substances contained in biocidal products, to be carried out only when the purpose and use of a product so requires.
Vlagatelji bi morali v zameno za ustrezno nadomestilo izmenjevati študije o vretenčarjih in jih ne podvajati.
Applicants should share, and not duplicate, vertebrate animal studies in exchange for equitable compensation.
Če do dogovora o izmenjavi študij o vretenčarjih med lastnikom podatkov in zadevnim vlagateljem ne pride, bi morala Agencija morebitnemu vlagatelju omogočiti uporabo študij ne glede na odločitev o nadomestilu, ki jo sprejmejo nacionalna sodišča.
In the absence of an agreement on sharing of vertebrate animal studies between the data owner and the prospective applicant, the Agency should allow the use of the studies by the prospective applicant without prejudice to any decision on compensation made by national courts.
Pristojni organi in Agencija bi morali imeti prek registra Unije dostop do kontaktnih podatkov lastnikov takih študij, da bi lahko obveščali morebitne vlagatelje.
Competent authorities and the Agency should have access to the contact details of the owners of such studies via a Union register so as to inform prospective applicants.
Na trgu za obstoječe aktivne snovi bi bilo treba čim prej vzpostaviti enake konkurenčne pogoje, pri tem pa upoštevati cilje glede čim večjega zmanjšanja nepotrebnih preskusov in stroškov, zlasti za mala in srednja podjetja, preprečevanja nastajanja monopolov, ohranjanja svobodne konkurence med gospodarskimi akterji in poštenega povračila stroškov lastnikom podatkov.
A level playing field should be established as quickly as possible on the market for existing active substances, taking into account the objectives of reducing unnecessary tests and costs to the minimum, in particular for SMEs, of avoiding the establishment of monopolies, of sustaining free competition between economic operators and of a fair compensation of the costs borne by data owners.
Prav tako bi bilo treba spodbujati pridobivanje informacij z drugimi sredstvi, ki ne vključujejo preskusov na živalih in ki so enakovredna predpisanim preskusom in preskusnim metodam.
The generation of information by alternative means not involving tests on animals which are equivalent to prescribed tests and test methods should also be encouraged.
Poleg tega bi bilo treba prilagoditve zahtevanih podatkov uporabiti za preprečevanje nepotrebnih stroškov v zvezi s preskusi.
In addition, the adaptation of data requirements should be used to prevent unnecessary costs related to testing.
Države članice bi morale sprejeti ukrepe za ustrezno ureditev nadzora in inšpekcije, da bi zagotovile izpolnjevanje predpisanih zahtev glede varnosti in kakovosti dovoljenih biocidnih proizvodov, ko so dostopni na trgu, proizvajalci pa bi morali vzdrževati ustrezen in sorazmeren sistem nadzora kakovosti.
To ensure that the requirements laid down with respect to the safety and quality of authorised biocidal products are satisfied when they are made available on the market, Member States should take measures for appropriate control and inspection arrangements and manufacturers should maintain a suitable and proportionate quality control system.
V ta namen je lahko primerno, da države članice ukrepajo skupaj.
To this end, it may be appropriate for Member States to take action together.
Učinkovito obveščanje o tveganjih glede biocidnih proizvodov in ukrepih za obvladovanje tveganj je pomemben del sistema, ki ga vzpostavlja ta uredba.
Effective communication of information on risks resulting from biocidal products and risk management measures is an essential part of the system established by this Regulation.
Ob lajšanju dostopa do informacij bi morali pristojni organi, Agencija in Komisija spoštovati načelo zaupnosti in preprečiti vsako razkritje informacij, ki bi utegnilo ogroziti tržne interese zadevne osebe, razen kadar je to potrebno zaradi varovanja človekovega zdravja, varnosti ali okolja ali kadar zaradi drugih razlogov prevlada javni interes.
While facilitating access to information, competent authorities, the Agency and the Commission should respect the principle of confidentiality and avoid any disclosure of information which could be harmful to the commercial interests of the person concerned, except where it is necessary for the protection of human health, safety or the environment or for other reasons of overriding public interest.
Zaradi povečanja učinkovitosti spremljanja in nadzora ter zagotovitve informacij, pomembnih pri obravnavanju tveganj biocidnih proizvodov, bi morali imetniki dovoljenj voditi evidence o proizvodih, ki jih dajo na trg.
To increase the efficiency of monitoring and control, and to provide information relevant for addressing the risks of biocidal products, authorisation holders should keep records of the products they place on the market.
Potrebno je podrobno določiti, da bi se morale določbe glede Agencije iz Uredbe (ES) št. 1907/2006 ustrezno uporabljati za biocidne aktivne snovi in proizvode.
It is necessary to specify that provisions concerning the Agency laid down in Regulation (EC) No 1907/2006 should apply accordingly in the context of biocidal active substances and products.
Kadar so v zvezi z nalogami in delovanjem Agencije v skladu s to uredbo potrebne ločene določbe, bi jih bilo treba opredeliti v tej uredbi.
Where separate provisions need to be made with respect to the tasks and functioning of the Agency under this Regulation, they should be specified in this Regulation.
Stroške postopkov v zvezi z uporabo te uredbe morajo prevzeti tisti, ki skrbijo za dostopnost biocidnih proizvodov na trgu, in tisti, ki si za to prizadevajo, polet tistih, ki skrbijo za odobritev aktivnih snovi.
The costs of the procedures associated with the operation of this Regulation need to be recovered from those making biocidal products available on the market and those seeking to do so in addition to those supporting the approval of active substances.
Za spodbuditev nemotenega delovanja notranjega trga je primerno uvesti določena skupna načela, ki se uporabljajo tako za pristojbine, ki se plačujejo Agenciji, kot za pristojbine, ki se plačujejo pristojnim organom držav članic, pri čemer je treba po potrebi upoštevati posebne potrebe MSP.
To promote the smooth operation of the internal market, it is appropriate to establish certain common principles applicable both to fees payable to the Agency and to Member States' competent authorities, including the need to take into account, as appropriate, the specific needs of SMEs.
Zagotoviti bi bilo treba možnost pritožbe proti določenim odločitvam Agencije.
It is necessary to provide for the possibility of an appeal against certain decisions of the Agency.
Odbor za pritožbe, ustanovljen znotraj agencije z Uredbo (ES) št. 1907/2006, bi moral obravnavati tudi pritožbe proti odločitvam, ki jih sprejme Agencija na podlagi te uredbe.
The Board of Appeal set up within the Agency by Regulation (EC) No 1907/2006 should also process appeals against decisions adopted by the Agency under this Regulation.
Obstaja znanstvena negotovost glede varnosti nanomaterialov za človekovo zdravje in okolje.
There is scientific uncertainty about the safety of nanomaterials for human health and the environment.
Za visoko raven varstva potrošnikov, prost pretok blaga in pravno varnost proizvajalcev je treba oblikovati enotno opredelitev nanomaterialov, in sicer, če je mogoče, na podlagi dela ustreznih mednarodnih forumov, ter določiti, da odobritev aktivnih snovi ne vključuje nanooblik, razen če je tako izrecno navedeno.
In order to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials, if possible based on the work of appropriate international fora, and to specify that the approval of an active substance does not include the nanomaterial form unless explicitly mentioned.
Za zagotovitev nemotenega prehoda
To ensure a smooth transition,
je primerno odložiti uporabo te uredbe
it is appropriate to provide for a deferred application of this Regulation
in določiti posebne ukrepe za oceno vlog, ki so bile predložene
and for specific measures concerning the assessment of applications
za odobritev aktivnih snovi in izdajo dovoljenj za biocidne proizvode
for the approval of active substances and authorisation of biocidal products
pred začetkom uporabe te uredbe
submitted before the application of this Regulation
Agencija bi morala z dnevom začetka uporabe te uredbe prevzeti naloge za usklajevanje in olajšanje sprejemanja novih vlog za odobritev aktivnih snovi.
The Agency should take over the coordination and facilitation tasks for new submissions for approval of active substances as of the date of applicability of this Regulation.
Zaradi velikega obsega arhivske dokumentacije je ustrezno, da ima Agencija na voljo dovolj časa, da se pripravi na nove naloge v zvezi z dokumentacijo, predloženo na podlagi Direktive 98/8/ES.
However, in view of the high number of historical dossiers it is appropriate to allow some time for the Agency to prepare for the new tasks related to dossiers submitted under Directive 98/8/EC.
Zaradi upoštevanja utemeljenih pričakovanj podjetij v zvezi z dajanjem na trg in uporabo biocidnih proizvodov z manjšim tveganjem iz Direktive 98/8/ES bi bilo treba podjetjem omogočiti, da naredijo take proizvode dostopne na trgu, če so v skladu s pravili o registraciji biocidnih proizvodov z manjšim tveganjem na podlagi navedene direktive.
To respect the legitimate expectations of companies with respect to the placing on the market and use of low-risk biocidal products covered by Directive 98/8/EC, those companies should be allowed to make such products available on the market if they comply with the rules on the registration of low-risk biocidal products under that Directive.
Vendar bi se morala po izteku prve registracije uporabljati ta uredba.
However, this Regulation should apply after the expiry of the first registration.