natgillin/translations-raw huggingface dataset:
vsebuje nanomaterial;
it contains a nanomaterial;
je eksploziven;
it is explosive;
vsebuje problematične snovi;
it contains any substance of concern;
je lahko vnetljiv;
it is highly flammable;
je samovnetljiv pri temperaturi uporabe.
it is self-igniting at application temperature.
Poleg aktivnih snovi iz člena 15(2) Uredbe (ES) št. 1907/2006 aktivne snovi, proizvedene ali uvožene za uporabo v biocidnih pripravkih z manjšim tveganjem, katerim je bilo izdano dovoljenje skladno s členom 15, štejejo, da so bile registrirane in da je njihova registracija zaključena za proizvodnjo ali uvoz za uporabo v biocidnih pripravkih z manjšim tveganjem ter tako izpolnjujejo zahteve iz poglavij 1 in 5 naslova II navedene uredbe.
In addition to the active substances referred to in Article 15(2) of Regulation (EC) No 1907/2006, active substances manufactured or imported for use in low-risk biocidal products that are authorised for placing on the market in accordance with Article 15 shall be regarded as being registered, and the registration as completed, for manufacture or import for use in a low-risk biocidal product, and therefore as fulfilling the requirements of Chapters 1 and 5 of Title II of that Regulation.
dokumentacijo ali izjavo o dostopnosti za biocidni pripravek, ki izpolnjuje zahteve iz Priloge III;
a dossier or letter of access for the biocidal product satisfying the requirements set out in Annex III;
predlog za povzetek značilnosti biocidnega pripravka, ki vključuje informacije iz točk (a), (b) in (e) do (m) člena 20(2);
a proposal for a summary of the biocidal product characteristics that includes the information referred to in points (a), (b) and (e) to (m) of Article 20(2);
za biocidne pripravke, ki niso biocidni pripravki z manjšim tveganjem, dokumentacijo ali izjavo o dostopnosti do dokumentacije, ki izpolnjuje zahteve iz Priloge II, za vsako aktivno snov v biocidnem pripravku;
for biocidal products other than low-risk biocidal products, a dossier or a letter of access to a dossier satisfying the requirements set out in Annex II for each active substance in the biocidal product;
Ob vložitvi vloge za dovoljenje se plačajo tudi pristojbine iz člena 71.
The application for authorisation shall be accompanied by the fees payable under Article 71.
Če se vloga nanaša na biocidni pripravek, ki ga je proizvajalec namenil med drugim tudi za uporabo v namene iz člena 2(7), ji mora biti priložena izjava o skladnosti glede izpolnjevanja ustreznih bistvenih zahtev iz direktiv 90/385/EGS, 93/42/EGS ali 98/79/ES.
If the application concerns a biocidal product that is intended by its manufacturer to be used inter alia for the purposes referred to in Article 2(7), it shall be accompanied by a declaration of conformity regarding the compliance with the relevant essential requirements of Directives 90/385/EEC, 93/42/EEC or 98/79/EC.
Komisija v skladu s postopkom iz člena 76(2) pripravi tehnične opombe kot napotke za lažje izvajanje točke (d) odstavka 1.
The Commission shall, in accordance with the procedure referred to in Article 76(2), draw up technical notes for guidance to facilitate the implementation of point (d) of paragraph 1.
Komisija v skladu s postopkom iz člena 72(2) zagotovi tehnične in znanstvene smernice in orodja, ki so v pomoč zlasti malim in srednjim podjetjem predvsem pri vložitvi vloge za dovoljenje v skladu s členi 18, 19 in 20.
The Commission shall, in accordance with the procedure set out in Article 76(2), provide technical and scientific guidance and tools, in particular to support applications for authorisation under Articles 18, 19 and 20, above all for SMEs.
zaradi izpostavljenosti, povezane s predlagano uporabo, informacije niso nujne;
the information is not necessary owing to the exposure associated with the proposed uses;
z znanstvenega vidika ni potrebno predložiti informacij;
it is not scientifically necessary to supply the information;
Predlagatelj lahko predlaga prilagoditev zahtevanih podatkov iz člena 18 v skladu s Prilogo IV.
The applicant may propose to adapt the data required under Article 18 in accordance with Annex IV.
Pristojni organ obvesti predlagatelja o možnosti, da predlaga prilagoditev zahtevanih podatkov, o pogojih, pod katerimi lahko zaprosi za tako prilagoditev, in mu po potrebi zagotovi pomoč pri pripravi takega predloga.
The competent authority shall inform the applicant about the possibility of proposing the adaptation of data requirements, the grounds on which such an adaptation can be requested and, where possible, shall provide assistance in preparing such a proposal.
, kaj je ustrezna utemeljitev za prilagoditev podatkov, ki se zahtevajo v skladu s členom 18, pod pogoji iz točke (a) odstavka 1
what constitutes adequate justification to adapt the data required under Article 18 on the grounds referred to in point (a) of paragraph 1
, Komisija prilagodi merila z delegiranimi akti v skladu s členom 73 in pod pogoji iz členov 74 in 75
, the Commission shall adapt the criteria by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75
V dovoljenju so določeni pogoji v zvezi z dajanjem v promet in uporabo biocidnih pripravkov.
An authorisation shall stipulate the terms and the conditions relating to the placing on the market and use of the biocidal product.
Dovoljenje vključuje povzetek značilnosti biocidnega pripravka, kjer so naštete naslednje informacije:
An authorisation shall include the summary of the biocidal product characteristics listing the following information:
trgovsko ime biocidnega pripravka;
trade name of the biocidal product;
ime in naslov imetnika dovoljenja;
name and address of the authorisation holder;
datum dovoljenja in datum izteka dovoljenja;
date of the authorisation and its date of expiry;
številka dovoljenja;
authorisation number;
če so ti podatki potrebni za pravilno uporabo biocidnega pripravka,
where required for proper use of the biocidal product, the
kakovostna in količinska sestava aktivnih in neaktivnih snovi
qualitative and quantitative composition in terms of the active substances and non-active substances,
ob upoštevanju koncentracijskih območij iz člena 16(4)
taking account of the concentration limits in Article 16(4)
proizvajalci biocidnega pripravka (imena in naslovi, vključno s krajem proizvodnih obratov);
manufacturers of the biocidal product (names and addresses including location of manufacturing sites);
proizvajalci aktivnih snovi (imena in naslovi, vključno s krajem proizvodnih obratov);
manufacturers of the active substances (names and addresses including location of manufacturing sites);
fizikalno stanje in narava biocidnega pripravka;
physical state and nature of the biocidal product;
izjave o nevarnosti in previdnostne izjave;
hazard and precautionary statements;
vrsta pripravka v skladu s Prilogo V in ciljni škodljivi organizmi;
the product-type in accordance with Annex V and the target harmful organisms;
odmerki in navodila za uporabo;
application doses and instructions for use;
kategorije uporabnikov;
categories of users;
podatki o verjetnih neposrednih ali posrednih neželenih učinkih in navodila za prvo pomoč;
particulars of likely direct or indirect adverse effects and first aid instructions;
navodila za varno odstranjevanje pripravka in njegove embalaže;
instructions for safe disposal of the product and its packaging;
Poleg odstavka 2 mora dovoljenje v primeru okvirne formulacije navajati, če je to primerno, naslednje informacije:
In addition to paragraph 2, in the case of a frame formulation, the authorisation shall indicate, as appropriate, the following information:
referenčni biocidni pripravek v skupini pripravkov, ki vključuje okvirno formulacijo ▌;
the reference biocidal product within the group of products comprising the frame formulation ▌;
dovoljena sprememba sestave tega referenčnega biocidnega pripravka, izražena
the permitted alteration of the composition of this reference biocidal product expressed
neaktivnih snovi v biocidnih pripravkih,
active substances or as an alteration in the percentage of the
neaktivne snovi, ki se lahko nadomestijo v dovoljenih biocidnih pripravkih iz navedene okvirne formulacije.
the non-active substances that may be substituted in the authorised biocidal products belonging to that frame formulation.
V primeru okvirne formulacije se za vse biocidne pripravke, ki spadajo v okvirno formulacijo, določi enotna številka dovoljenja.
In the case of a frame formulation, one single authorisation number shall be provided for all biocidal products which belong to that frame formulation.
Pristojni organ prejemnik ali v primeru ocene vloge za dovoljenje Unije, ocenjevalni pristojni organ, opravi primerjalno oceno kot del ocene vloge za dovoljenje ali obnove dovoljenja za biocidni pripravek, ki vsebuje aktivno snov kot možno snov za zamenjavo v skladu s členom 9(1).
The receiving competent authority or, in the case of evaluation of an application for a Union authorisation, the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for an authorisation or a renewal of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with Article 9(1).
Primerjalno oceno je treba opraviti za vse biocidne pripravke, ki se uporabljajo za enak namen, kadar se zbere dovolj izkušenj in so bili v uporabi najmanj pet let.
The comparative assessment shall be carried out in relation to all biocidal products that have the same purpose, when sufficient experience has been gained in their use and they have been in use for at least five years.
Rezultate primerjalne ocene je treba nemudoma poslati pristojnim organom drugih držav članic in agenciji ter v primeru ocene vloge za dovoljenje Unije tudi Komisiji.
The results of the comparative assessment shall be forwarded, without delay, to the competent authorities of other Member States and the Agency and, in the case of evaluation of an application for a Union authorisation, also to the Commission.
Pristojni organ prejemnik ali Komisija v primeru odločitve glede vloge za dovoljenje Unije prepove ali omeji dajanje v promet ali uporabo biocidnega pripravka, ki vsebuje aktivno snov kot možno snov za zamenjavo, če primerjalna ocena, s katero se presoja tveganja in prednosti v skladu s Prilogo VI, dokazuje, da so izpolnjena vsa naslednja merila:
The receiving competent authority or, in the case of a decision on an application for a Union authorisation, the Commission shall prohibit or restrict the placing on the market or use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment weighing up the risks and benefits in accordance with Annex VI demonstrates that all the following criteria are met:
za zdravje ljudi ali živali ali za okolje
significantly lower risk for human or animal health or the environment
in ki so enako učinkoviti ter po vseh ostalih parametrih ne vključujejo bistveno večjega tveganja
and which prove equally effective and involve no significant increase in the risks for any other parameter
biocidni pripravek ali ne-kemična kontrolna ali preventivna metoda iz točke (a) ne pomeni bistvenih gospodarskih ali praktičnih izgub;
the biocidal product or non-chemical control or prevention method referred to in point (a) does not present significant economic or practical disadvantages;
kemijska raznolikost aktivnih snovi je ustrezna za čim večje zmanjšanje nastanka odpornosti v ciljnem škodljivem organizmu.
the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target harmful organism.
Komisija na podlagi odstavka 3 sprejme ukrepe, s katerimi natančneje določi postopek, potreben za opredelitev prošnje za primerjalno oceno biocidnih pripravkov.
The Commission shall, on the basis of paragraph 3, adopt measures laying down the procedure necessary for the definition of an application for comparative assessment of biocidal products.
S temi ukrepi opredeli merila in algoritme, ki se uporabijo v primerjalni oceni za zagotovitev enotnega izvajanja po vsej Uniji.
Those measures shall define the criteria and algorithms to be used in a comparative assessment to ensure that there is uniform application throughout the Union.
Če vključuje primerjalna ocena vprašanje, ki bi se zaradi svojega obsega ali posledic bolje obravnavalo na ravni Unije, zlasti če se nanaša na najmanj dva pristojna organa, lahko pristojni organ prejemnik naslovi vprašanje na Komisijo.
Where the comparative assessment involves a question which, by reason of its scale or consequences, would be better addressed at Union level, in particular where it is relevant to two or more competent authorities, the receiving competent authority may refer the question to the Commission for a decision.
Komisija sprejme odločitev v skladu s členom 76(3).
The Commission shall adopt its decision in accordance with Article 76(3).
Za določitev postopkov
In order to specify
v zvezi s primerjalnimi ocenami, pri katerih se pojavijo vprašanja v interesu Unije
the procedures relating to comparative assessments involving questions of Union interest,
, Komisija prilagodi merila z delegiranimi akti v skladu s členom 73 in pod pogoji iz členov 74 in 75
the Commission shall adapt the criteria by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75
Ne glede na člen 15(4) se dovoljenje za biocidni pripravek, ki vsebuje aktivno snov kot možno snov za zamenjavo, izda za
Notwithstanding Article 15(4), an authorisation for a biocidal product containing an active substance that is a candidate for substitution shall be granted for
največ petih let.
not exceeding five years.
Države članice pripravijo in izvedejo načrt za zamenjavo, s katerim zagotovijo, da se uporaba zadevnega biocidnega pripravka ukine v obdobju veljavnosti dovoljenja in da bo aktivna snov ali pripravek zamenjan s smotrno kemično ali nekemično nadomestno možnostjo.
Member States shall establish and implement a substitution plan in order to ensure that the application of the relevant biocidal product is phased out within the authorisation period and that the relevant active substance or product can be replaced with sound chemical or non-chemical alternatives.
Če se sprejme odločitev, da se ne dovoli ali omeji uporaba biocidnega pripravka v skladu z odstavkom 3, začne navedeni preklic ali sprememba dovoljenja veljati
Where it is decided not to authorise or to restrict the use of a biocidal product pursuant to paragraph 3, that cancellation or modification of the authorisation shall take effect
po odločitvi ali na koncu obdobja vključitve možne snovi za zamenjavo, če to nastopi prej.
after the decision or at the end of the inclusion period of the candidate for substitution, whichever is the earlier.
Agencija v treh tednih po prejetju vloge validira vlogo, če so izpolnjene aslednje zahteve:
Within three weeks after receipt of an application, the Agency shall validate the application if it complies with the following requirements:
da so bili predloženi dokumenti iz člena 18;
the documents referred to in Article 18 have been submitted;
da so bile plačane pristojbine iz člena 71.
it is accompanied by the fees payable under Article 71.
Če agencija
If the Agency
meni, da je vloga
considers that the application is
, katere dodatne informacije so potrebne za validacijo vloge ter določi razumen rok za predložitev navedenih informacij
what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information
Agencija v treh tednih po prejetju dodatnih informacij ugotovi, ali so predložene dodatne informacije zadostne za validacijo vloge.
The Agency shall, within three weeks after receipt of the additional information, determine whether the additional information submitted is sufficient to validate the application.
Če predlagatelj vloge ne dopolni v roku, agencija zavrne vlogo in o tem obvesti predlagatelja in pristojni sprejemni organ.
The Agency shall reject the application if the applicant does not submit the required additional information on time, and shall notify the applicant and the receiving competent authority of the rejection.
V takšnih primerih se del pristojbine, plačane agenciji v skladu s členom 71, povrne.
In such cases, part of the fees payable to the Agency under Article 71 shall be reimbursed.
Predlagatelj lahko v skladu s členom 68 vložijo pritožbo proti odločitvam agencije na podlagi tretjega pododstavka odstavka 3.
An applicant may, in accordance with Article 68, submit an appeal against the decision of the Agency under the third subparagraph of paragraph 3.
Če agencija na podlagi validacije, opravljene v skladu z odstavkom 2, meni, da je vloga popolna, o tem nemudoma obvesti predlagatelja in sprejemni pristojni organ.
If the Agency considers, on the basis of the validation made pursuant to paragraph 2, that the application is complete, it shall without delay inform the applicant and the receiving competent authority to that effect.
Pristojni organ prejemnik mora v
The receiving competent authority shall, within
po validaciji iz člena 22 sprejeti odločitev o vlogi v skladu s členom 16.
of the validation referred to in Article 22, decide on the application in accordance with Article 16.
Če pristojni organ druge države članice preučuje vlogo v zvezi z istim biocidnim pripravkom ali če je pristojni organ druge države članice že izdal dovoljenje za isti biocidni pripravek, mora pristojni organ prejemnik prekiniti ocenjevanje vloge in o tem obvestiti predlagatelja.
If an application relating to the same biocidal product is being examined by the competent authority of another Member State or if the competent authority of another Member State has already authorised the same biocidal product, the receiving competent authority shall decline to assess the application and inform the applicant thereof.
Vendar lahko predlagatelj zahteva, da se njegova vloga oceni v skladu s členom 25 ali členom 28.
However, the applicant may request that his application be assessed in accordance with Article 25 or Article 28.
obdobje iz odstavka 1 se prekine od dneva izdaje vloge, pa do dneva prejema informacij.
period referred to in paragraph 1 shall be suspended from the date of issue of the request until the date the information is received.
Pristojni organ prejemnik napiše poročilo, v katerem povzame ugotovitve svoje ocene in razloge za izdajo dovoljenja za biocidni pripravek ali za zavrnitev izdaje dovoljenja.
The receiving competent authority shall draft a report summarising the conclusions of its assessment and the reasons for authorising a biocidal product or for refusing to grant an authorisation.
Pristojni organ prejemnik pošlje osnutek poročila o oceni predlagatelju, ki mora imeti priložnost, da v enem mesecu v pisni ali ustni obliki predloži opombe.
The receiving competent authority shall send the draft assessment report to the applicant who shall be provided with the opportunity to submit oral or written comments within one month.
Pristojni organ prejemnik te opombe ustrezno upošteva pri zaključevanju svoje ocene.
The receiving competent authority shall take due account of these comments when finalising its assessment.
Pristojni organ prejemnik odobri povzetek značilnosti biocidnega pripravka v skladu s členom 20(2).
The receiving competent authority shall approve the summary of the biocidal product characteristics referred to in Article 20(2).
Predlagatelju pošlje kopijo zaključnega poročila o oceni.
It shall forward the applicant a copy of the final assessment report.
Ob sprejetju odločitve o vlogi vnese pristojni organ prejemnik v Register biocidnih pripravkov Unije naslednje informacije:
As soon as the receiving competent authority has taken a decision on an application, it shall enter the following information in the Union Register of Biocidal Products:
povzetek značilnosti biocidnega pripravka;
the summary of biocidal product characteristics;
poročilo, v katerem so povzete ugotovitve ocene biocidnega pripravka, in razlogi za izdajo dovoljenja za biocidni pripravek ali za zavrnitev izdaje dovoljenja;
the report summarising the conclusions of the assessment of the biocidal product and the reasons for authorising, or refusing to authorise, the biocidal product;
sprejete upravne odločitve pristojnega organa prejemnika v zvezi z vlogo.
the administrative decisions taken by the receiving competent authority concerning the application.
Imetnik dovoljenja ali njegov zastopnik vloži vlogo za obnovitev nacionalnega dovoljenja pri pristojnem organu prejemniku najmanj
The authorisation holder or his representative shall submit an application for renewal of a national authorisation to the receiving competent authority at least
pred potekom dovoljenja.
before the expiry date of the authorisation.
Pristojni organ prejemnik obnovi nacionalno dovoljenje, če so pogoji iz člena 16 še vedno izpolnjeni.
The receiving competent authority shall renew the national authorisation, provided that the conditions set out in Article 16 are still satisfied.
Ko predlagatelj zaprosi za obnovitev, predloži seznam vseh podatkov v zvezi z biocidnim pripravkom, ki je bil proizveden po prejšnjem dovoljenju, ter utemeljitev, da še veljajo ugotovitve prvotne ocene biocidnega pripravka.
When applying for renewal, the applicant shall submit a list of all data relating to the biocidal product that have been generated since the previous authorisation and a justification as to whether the conclusions of the initial assessment of the biocidal product are still valid.
Pristojni organ prejemnik lahko kadar koli od predlagatelja zahteva, da predloži podatke, navedene v seznamu.
The receiving competent authority may require the applicant to submit the data referred to in the list at any time.
V roku enega meseca po prejemu vloge za obnovitev nacionalnega dovoljenja mora pristojni organ prejemnik preveriti, ali vloga izpolnjuje naslednje zahteve:
Within one month after receipt of an application for a renewal of a national authorisation, the receiving competent authority shall validate the application if it complies with the following requirements:
da so bile predložene informacije iz odstavka 3;
the information referred to in paragraph 3 has been submitted;
Če pristojni organ prejemnik meni, da vloga ni popolna, predlagatelja obvesti, katere dodatne informacije so potrebne za validacijo vloge ter določi razumen rok za predložitev navedenih informacij.
If the receiving competent authority considers that the application is incomplete, it shall inform the applicant what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information.
Pristojni organ prejemnik v enem mesecu po prejemu dodatnih informacij ugotovi, ali predložene dodatne informacije zadostujejo za validacijo vloge.
The receiving competent authority shall, within one month of receipt of the additional information, determine whether the additional information submitted is sufficient to validate the application.
Če pristojni organ prejemnik na podlagi validacije, opravljene v skladu z odstavkom 4, meni, da je vloga popolna, o tem nemudoma obvesti predlagatelja.
If the receiving competent authority considers, on basis of the validation made pursuant to paragraph 4, that the application is complete, it shall without delay inform the applicant thereof.
Odločitev o vlogi za obnovitev nacionalnega dovoljenja se sprejme v šestih mesecih po validaciji.
The decision on the application for renewal of the national authorisation shall be taken within six months of the validation.
Če se pri oceni vloge za obnovitev pokaže, da so potrebne dodatne informacije za popolno oceno vloge, pristojni organ prejemnik od predlagatelja zahteva, da jih predloži.
If, when the application for renewal is evaluated, it appears that additional information is necessary in order to carry out a full evaluation of the application, the receiving competent authority shall ask the applicant to submit such information.