natgillin/translations-raw huggingface dataset:
podatke o verjetnih neposrednih ali posrednih škodljivih učinkih, navodila za prvo pomoč in izredni ukrepi za varstvo okolja;
particulars of likely direct or indirect adverse effects and first aid instructions and emergency measures to protect the environment;
navodila za varno odstranjevanje proizvoda in njegove embalaže;
instructions for safe disposal of the product and its packaging;
pogoje skladiščenja in rok uporabe biocidnih proizvodov pod običajnimi pogoji skladiščenja;
conditions of storage and shelf-life of the biocidal product under normal conditions of storage;
po potrebi druge informacije o biocidnem proizvodu.
where relevant, other information about the biocidal product.
Primerjalna ocena biocidnih proizvodov
Comparative assessment of biocidal products
Pristojni organ prejemnik ali, v primeru ocenjevanja vloge za dovoljenje Unije, ocenjevalni pristojni organ opravi primerjalno oceno kot del ocenjevanja vloge za dovoljenje ali obnovo dovoljenja za biocidni proizvod, ki vsebuje aktivno snov kot možno snov za zamenjavo v skladu s členom 10(1).
The receiving competent authority or, in the case of an 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 authorisation or for renewal of authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with Article 10(1).
Rezultati primerjalne ocene se nemudoma pošljejo pristojnim organom drugih držav članic in Agenciji ter v primeru ocenjevanja 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, v primeru odločitve glede vloge za dovoljenje Unije, Komisija prepove ali omeji dostopnost na trgu ali uporabo biocidnega proizvoda, ki vsebuje aktivno snov kot možno snov za zamenjavo, če primerjalna ocena v skladu s Prilogo VI (v nadaljnjem besedilu: primerjalna ocena), dokazuje, da sta izpolnjeni obe naslednji merili:
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 making available on the market or the use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment in accordance with Annex VI (‘comparative assessment’) demonstrates that both of the following criteria are met:
za načine uporabe, navedene v vlogi, že obstaja drugi dovoljeni biocidni proizvod ali nekemična nadzorna ali preventivna metoda, ki je v splošnem bistveno varnejša za zdravje človeka in živali ter za okolje in je dovolj učinkovita ter ne predstavlja drugih bistvenih gospodarskih ali praktičnih izgub;
for the uses specified in the application, another authorised biocidal product or a non-chemical control or prevention method already exists which presents a significantly lower overall risk for human and animal health and the environment, is sufficiently effective and presents no other significant economic or practical disadvantages;
kemijska raznolikost aktivnih snovi je zadostna, da se čim bolj zniža tveganje 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.
Z odstopanjem od odstavka 1 se za biocidni proizvod, ki vsebuje aktivno snov kot možno snov za zamenjavo, v izjemnih primerih lahko izda dovoljenje brez primerjalne ocene za obdobje do štirih let, kadar je treba najprej pridobiti izkušnje z uporabo tega proizvoda v praksi.
By way of derogation from paragraph 1, a biocidal product containing an active substance that is a candidate for substitution may be authorised for a period of up to four years without comparative assessment in exceptional cases where it is necessary to acquire experience first through using that product in practice.
Če vključuje primerjalna ocena vprašanje, ki bi se zaradi svojega obsega ali posledic bolje obravnavalo na ravni Unije, zlasti če se nanaša na dva ali več pristojnih organov, lahko pristojni organ prejemnik za odločanje o vprašanju zaprosi 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 to odločitev z izvedbenimi akti v skladu s postopkom pregleda iz člena 82(3).
The Commission shall adopt that decision by means of implementing acts in accordance with the examination procedure referred to in Article 82(3).
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 83, ki podrobno določijo
The Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying
merila o tem
the criteria for determining
, kdaj primerjalne ocene obravnavajo vprašanja, ki bi jih bilo bolje obravnavati na ravni Unije, in postopke za takšne primerjalne ocene.
when comparative assessments involve questions better addressed at Union level and the procedures for such comparative assessments.
Ne glede na člen 17(4) in brez poseganja v odstavek 4 tega člena se dovoljenje za biocidni proizvod, ki vsebuje aktivno snov kot možno snov za zamenjavo, izda za obdobje največ pet let in se obnovi za obdobje največ petih let.
Notwithstanding Article 17(4), and without prejudice to paragraph 4 of this Article, an authorisation for a biocidal product containing an active substance that is a candidate for substitution shall be granted for a period not exceeding five years and renewed for a period not exceeding five years.
Če se sprejme odločitev, da se uporabe biocidnega proizvoda v skladu z odstavkom 3 ne dovoli ali se jo omeji, začne navedeni preklic ali sprememba dovoljenja učinkovati
Where it is decided not to authorise or to restrict the use of a biocidal product pursuant to paragraph 3, that cancellation or amendment of the authorisation shall take effect
po tej odločitvi.
years after that decision.
Komisija pripravi tehnična navodila za lažje izvajanje tega poglavja, zlasti členov 22(2) in 23(3).
The Commission shall draw up technical guidance notes to facilitate the implementation of this Chapter and, in particular, Articles 22(2) and 23(3).
POENOSTAVLJENI POSTOPEK ZA IZDAJO DOVOLJENJA
SIMPLIFIED AUTHORISATION PROCEDURE
Izpolnjevanje pogojev za poenostavljeni postopek za izdajo dovoljenja
Eligibility for the simplified authorisation procedure
Za biocidne proizvode, ki izpolnjujejo pogoje, se vloga za dovoljenje lahko vloži po poenostavljenem postopku za izdajo dovoljenja.
For eligible biocidal products, an application for authorisation may be made under a simplified authorisation procedure.
Biocidni proizvod izpolnjuje pogoje, če so izpolnjeni vsi naslednji pogoji:
A biocidal product shall be eligible if all the following conditions are met:
vse aktivne snovi v biocidnem proizvodu so na seznamu iz Priloge I in izpolnjujejo vse omejitve, navedene v navedeni prilogi;
all the active substances contained in the biocidal product appear in Annex I and satisfy any restriction specified in that Annex;
biocidni proizvod ne vsebuje nobene nevarne snovi;
the biocidal product does not contain any substance of concern;
biocidni proizvod ne vsebuje nanomateriala;
the biocidal product does not contain a nanomaterial;
biocidni proizvod je dovolj učinkovit in
the biocidal product is sufficiently effective; and
za ravnanje z biocidnim proizvodom in njegovo predvideno uporabo ni potrebna osebna zaščitna oprema.
the handling of the biocidal product and its intended use do not require personal protective equipment.
Postopek, ki se uporablja
Applicable procedure
Vlagatelji, ki zaprosijo za dovoljenje za biocodni proizvod, ki izpolnjuje pogoje iz člena 25, vložijo vlogo pri Agenciji in jo obvestijo o imenu pristojnega organa države članice, ki ga predlagajo za ocenjevanje vloge in priložijo pisno potrdilo, da se pristojni organ s tem strinja.
Applicants seeking the authorisation of a biocidal product meeting the conditions of Article 25 shall submit an application to the Agency, informing it of the name of the competent authority of the Member State that it proposes should evaluate the application and providing written confirmation that that competent authority agrees to do so.
Ocenjevalni pristojni organ vlagatelja obvesti o pristojbinah, ki se plačujejo na podlagi člena 80
The evaluating competent authority shall inform the applicant of the fees payable under Article 80
in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
and shall reject the application if the applicant fails to pay the fees within 30 days.
Po prejemu pristojbin, ki se plačujejo v skladu s členom 80
Upon receipt of the fees payable under Article 80
, ocenjevalni pristojni organ sprejme vlogo in o tem ustrezno obvesti vlagatelja.
, the evaluating competent authority shall accept the application and inform the applicant accordingly.
Ocenjevalni pristojni organ v 90 dneh po sprejetju vloge odobri biocidni proizvod, če se prepriča, da ta proizvod izpolnjuje pogoje iz člena 25.
Within 90 days of accepting an application, the evaluating competent authority shall authorise the biocidal product if satisfied that the product meets the conditions laid down in Article 25.
Kadar ocenjevalni pristojni organ meni, da je vloga nepopolna, vlagatelja obvesti, katere dodatne informacije so potrebne, in določi razumen rok za predložitev teh informacij.
Where the evaluating competent authority considers that the application is incomplete, it shall inform the applicant as to what additional information is required and shall set a reasonable time limit for the submission of that information.
Ocenjevalni pristojni organ v 90 dneh po prejemu dodatnih informacij odobri biocidni proizvod, če se na podlagi predloženih dodatnih informacij prepriča, da ta proizvod izpolnjuje pogoje iz člena 25.
The evaluating competent authority shall, within 90 days of receipt of the additional information, authorise the biocidal product if satisfied, on the basis of the additional information submitted, that the product meets the conditions laid down in Article 25.
, ko so plačane pristojbine,
where fees have been paid,
se del pristojbine, plačane v skladu s členom 80
part of the fee paid in accordance with Article 80
Dostopnost biocidnih proizvodov na trgu, za katere je bilo dovoljenje izdano v skladu s poenostavljenim postopkom za izdajo dovoljenja
Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure
Biocidni proizvod, odobren v skladu s členom 26, je lahko dostopen na trgu v vseh državah članicah brez medsebojnega priznavanja.
A biocidal product authorised in accordance with Article 26 may be made available on the market in all Member States without the need for mutual recognition.
Vendar imetnik dovoljenja uradno obvesti vsako državo članico
However, the authorisation holder shall notify each Member State
najpozneje 30 dni
no later than 30 days
, preden biocidni proizvod da na trg na ozemlju te države članice, in na oznaki proizvoda uporabi uradni jezik ali uradne jezike te države članice, razen če ta določi drugače.
before placing the biocidal product on the market within the territory of that Member State and shall use the official language or languages of that Member State in the product's labelling, unless that Member State provides otherwise.
Kadar država članica, ki ni država ocenjevalnega pristojnega organa, meni, da o biocidnem proizvodu, za katerega je bilo dovoljenje izdano v skladu s členom 26, ni bilo uradnega obvestila ali biocidni proizvod ni bil označen v skladu z odstavkom 1 tega člena ali ne izpolnjuje zahtev iz člena 25, lahko to zadevo predloži koordinacijski skupini, ustanovljeni v skladu s členom 35(1).
Where a Member State other than that of the evaluating competent authority considers that a biocidal product authorised in accordance with Article 26 has not been notified or labelled in accordance with paragraph 1 of this Article or does not meet the requirements of Article 25, it may refer that matter to the coordination group established in accordance with Article 35(1).
Smiselno se uporabljata člena 35(3) in 36.
Article 35(3) and Article 36 shall apply
Sprememba Priloge I
Amendment of Annex I
Na Komisijo se prenese pooblastilo za sprejetje delegiranih aktov v skladu s členom 83 o spremembi Priloge I po prejemu mnenja Agencije, da bi se vključile aktivne snovi, pod pogojem, da obstajajo dokazi, da aktivne snovi ne vzbujajo zaskrbljenosti v skladu z odstavkom 2.
The Commission shall be empowered to adopt delegated acts in accordance with Article 83 amending Annex I, after receiving the opinion of the Agency, in order to include active substances provided that there is evidence that they do not give rise to concern according to paragraph 2.
Aktivne snovi vzbujajo zaskrbljenost, če:
Active substances give rise to concern where:
izpolnjujejo merila za razvrstitev v skladu z Uredbo (ES) št. 1272/2008 kot:
they fulfil the criteria for classification according to Regulation (EC) No 1272/2008 as:
eksplozivne/zelo vnetljive;
explosive/highly flammable;
organski peroksid;
organic peroxide;
akutno toksične kategorije 1, 2 ali 3;
acutely toxic of category 1, 2 or 3;
jedke kategorije IA, IB ali IC;
corrosive of category IA, IB or IC;
povzročitelji preobčutljivosti dihal;
respiratory sensitizer;
povzročitelji preobčutljivosti kože;
skin sensitizer;
mutageni za zarodne celice kategorije 1 ali 2;
germ cell mutagen of category 1 or 2;
rakotvorne kategorije 1 ali 2;
carcinogen of category 1 or 2;
strupene za razmnoževanje ljudi kategorije 1 ali 2 ali z učinki na dojenje ali prek dojenja;
human reproductive toxicant of category 1 or 2 or with effects on or via lactation;
strupene snovi za posamezne organe ob enkratni ali ponavljajoči se izpostavljenosti ali
specific target organ toxicant by single or repeated exposure; or
strupene za življenje v vodi akutne kategorije 1;
toxic to aquatic life of acute category 1;
izpolnjujejo katero koli od meril za zamenjavo iz člena 10(1) ali ali
they fulfil any of the substitution criteria set out in Article 10(1); or
imajo nevrotoksične ali imunotoksične lastnosti.
they have neurotoxic or immunotoxic properties.
Aktivne snovi vzbujajo zaskrbljenost, tudi če ni izpolnjeno nobeno od specifičnih meril iz točk (a) do (c), kadar je na podlagi zanesljivih informacij mogoče utemeljeno dokazati stopnjo zaskrbljenosti, enakovredno tisti iz točk (a) do (c).
Active substances also give rise to concern, even if none of the specific criteria in points (a) to (c) are met, where a level of concern equivalent to that arising from points (a) to (c) can be reasonably demonstrated based on reliable information.
Na Komisijo se prenese pooblastilo za sprejetje delegiranih aktov v skladu s členom 83 o spremembi Priloge I po prejemu mnenja Agencije, da bi se omejil ali odstranil vnos za aktivno snov, če obstajajo dokazi, da biocidni proizvod, ki to snov vsebuje, v določenih okoliščinah ne izpolnjuje pogojev iz odstavka 1 tega člena ali člena 25.
The Commission shall also be empowered to adopt delegated acts in accordance with Article 83 amending Annex I, after receiving the opinion of the Agency, in order to restrict or to remove the entry for an active substance if there is evidence that biocidal products containing that substance do not, in certain circumstances, satisfy the conditions set out in paragraph 1 of this Article or in Article 25.
Kadar to zahtevajo nujni razlogi, se za delegirane akte, sprejete v skladu s tem odstavkom, uporabi postopek iz člena 84.
Where imperative grounds of urgency so require, the procedure provided for in Article 84 shall apply to delegated acts adopted pursuant to this paragraph.
Komisija uporabi odstavek 1 ali 2 na lastno pobudo ali na zahtevo gospodarskega subjekta ali države članice, ki predloži potrebne dokaze, navedene v teh dveh odstavkih.
The Commission shall apply paragraph 1 or 2 at its own initiative or at the request of an economic operator or a Member State providing the necessary evidence as referred to in those paragraphs.
Kadar Komisija spremeni Prilogo I, sprejme delegirani akt za vsako snov posebej.
Whenever the Commission amends Annex I it shall adopt a separate delegated act in respect of each substance.
NACIONALNA DOVOLJENJA ZA BIOCIDNE PROIZVODE
NATIONAL AUTHORISATIONS OF BIOCIDAL PRODUCTS
Vlagatelji, ki želijo vložiti vlogo za nacionalno dovoljenje v skladu s členom 17, vložijo vlogo pri pristojnem organu prejemniku.
Applicants wishing to apply for a national authorisation in accordance with Article 17 shall submit an application to the receiving competent authority.
Pristojni organ prejemnik vlagatelja obvesti o pristojbinah, ki se plačujejo na podlagi člena 80
The receiving competent authority shall inform the applicant of the fees payable under Article 80
, in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
, and shall reject the application if the applicant fails to pay the fees within 30 days.
Po [pravočasnem] prejemu pristojbin, ki se plačujejo v skladu s členom 80
Upon receipt of the fees payable under Article 80
, pristojni organ prejemnik sprejme vlogo in vlagatelja obvesti o točnem datumu sprejetja.
, the receiving competent authority shall accept the application and inform the applicant indicating the exact date of the acceptance.
V 30 dneh po sprejetju pristojni organ prejemnik validira vlogo, če ta izpolnjuje naslednje zahteve:
Within 30 days of acceptance, the receiving competent authority shall validate the application if it complies with the following requirements:
ustrezne informacije iz člena 20 so bile predložene in
the relevant information referred to in Article 20 has been submitted; and
vlagatelj izjavi, da vloge za nacionalno dovoljenje za enak biocidni proizvod za enako(e) uporabo(e) ali uporabe ni vložil pri nobenem drugem pristojnem organu.
the applicant states that it has not applied to any other competent authority for a national authorisation for the same biocidal product for the same use(s).
Pristojni organ prejemnik v okviru validacije iz prvega pododstavka ne opravi ocene kakovosti ali ustreznosti predloženih podatkov ali utemeljitev.
In the context of the validation referred to in the first subparagraph, the receiving competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.
Če pristojni organ prejemnik meni, da je vloga nepopolna, vlagatelja obvesti o dodatnih informacijah, potrebnih za validacijo vloge, in določi razumen rok za predložitev teh informacij.
Where the receiving competent authority considers that the application is incomplete, it shall inform the applicant as to 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 30 dneh po prejemu dodatnih informacij validira vlogo, če odloči, da predložene dodatne informacije zadostujejo za izpolnitev zahtev iz odstavka 1.
The receiving competent authority shall, within 30 days of receipt of the additional information, validate the application if it determines that the additional information submitted is sufficient to comply with the requirements laid down in paragraph 1.
Če vlagatelj zahtevanih informacij ne predloži v roku, pristojni organ prejemnik vlogo zavrne in vlagatelja ustrezno obvesti.
The receiving competent authority shall reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly.
Če je iz registra biocidnih proizvodov razvidno, da pristojni organ, ki ni pristojni organ prejemnik, preučuje vlogo za isti biocidni proizvod ali je že izdal dovoljenje za isti biocidni proizvod, pristojni organ prejemnik zavrne ocenjevanje vloge.
Where the Register for Biocidal Products shows that a competent authority other than the receiving competent authority is examining an application relating to the same biocidal product or has already authorised the same biocidal product, the receiving competent authority shall decline to evaluate the application.
V tem primeru pristojni organ prejemnik vlagatelja obvesti o možnosti medsebojnega priznanja v skladu s členom 33 ali 34.
In that event, the receiving competent authority shall inform the applicant of the possibility of seeking mutual recognition in accordance with Article 33 or 34.
Če se odstavek 3 ne uporablja in pristojni organ prejemnik meni, da je vloga popolna, jo validira ter nemudoma ustrezno obvesti vlagatelja in navede datum validacije.
If paragraph 3 does not apply and the receiving competent authority considers that the application is complete, it shall validate the application and without delay inform the applicant accordingly and indicate the date of the validation.
Pristojni organ prejemnik v 365 dneh po validaciji vloge v skladu s členom 29 sprejme odločitev o izdaji dovoljenja v skladu s členom 19.
The receiving competent authority shall, within 365 days of the validation of an application in accordance with Article 29, decide whether to grant an authorisation in accordance with Article 19.
Pri tem upošteva rezultate primerjalne ocene, ki se opravi v skladu s členom 23, če je primerno.
It shall take into account the results of the comparative assessment carried out in accordance with Article 23, if applicable.
Če se izkaže, da so za izvedbo ocene potrebne dodatne informacije, pristojni organ prejemnik od vlagatelja zahteva, da v določenem roku predloži take informacije.
Where it appears that additional information is necessary to carry out the evaluation, the receiving competent authority shall ask the applicant to submit such information within a specified time limit.
Obdobje 365 dni iz odstavka 1 se prekine od dneva izdaje zahtevka do dneva prejema informacij.
The 365-day period referred to in paragraph 1 shall be suspended from the date of issue of the request until the date the information is received.
V obdobju 365 dni iz odstavka 1 pristojni organ prejemnik:
Within the 365-day period referred to in paragraph 1, the receiving competent authority shall:
sestavi poročilo, v katerem povzame ugotovitve ocenjevanja in razloge za izdajo dovoljenja za biocidni proizvod ali za zavrnitev njegove izdaje (v nadaljnjem besedilu: poročilo o oceni);
draft a report summarising the conclusions of its assessment and the reasons for authorising the biocidal product or for refusing to grant an authorisation (the ‘assessment report’);
vlagatelju pošlje elektronsko kopijo osnutka poročila o oceni in mu da možnost, da v 30 dneh predloži pripombe in
send an electronic copy of the draft assessment report to the applicant and provide it with the opportunity to submit comments within 30 days; and
te pripombe ustrezno upošteva pri končni oceni.
take due account of those comments when finalising its assessment.
Podaljšanje nacionalnega dovoljenja
Renewal of a national authorisation
Vloga s strani ali v imenu imetnika dovoljenja, ki želi podaljšati nacionalno dovoljenje za eno ali več vrst proizvodov, se vloži pri pristojnem organu prejemniku najmanj 550 dni pred iztekom veljavnosti dovoljenja.
An application by or on behalf of an authorisation holder wishing to seek the renewal of a national authorisation for one or more product-types shall be submitted to the receiving competent authority at least 550 days before the expiry date of the authorisation.
Za podaljšanje dovoljenja za več kot eno vrsto proizvoda se vloga vloži najmanj 550 dni pred iztekom tistega dovoljenja, ki se izteče najprej.
Where renewal is sought for more than one product-type, the application shall be submitted at least 550 days before the earliest expiry date.