natgillin/translations-raw huggingface dataset:
Where appropriate, the prospective authorisation holder or its representative shall apply for the establishment of maximum residue limits with respect to active substances contained in a biocidal product in accordance with Regulation (EEC) No 315/93, Regulation (EC) No 1935/2004, Regulation (EC) No 396/2005, Regulation (EC) No 470/2009 or Directive 2002/32/EC.
Morebitni imetnik dovoljenja ali njegov zastopnik po potrebi zaprosi za določitev najvišjih mejnih vrednosti ostankov aktivnih snovi v biocidnem proizvodu v skladu z Uredbo (EGS) št. 315/93, Uredbo (ES) št. 1935/2004, Uredbo (ES) št. 396/2005, Uredbo (ES) št. 470/2009 ali Direktivo 2002/32/ES.
Where, for active substances covered by Article 10(1)(a) of Regulation (EC) No 470/2009, no maximum residue limit has been established in accordance with Article 9 of that Regulation at the time of the approval of the active substance, or where a limit established in accordance with Article 9 of that Regulation needs to be amended, the maximum residue limit shall be established or amended in accordance with the procedure referred to in Article 10(1)(b) of that Regulation.
Kjer za aktivne snovi, ki so zajete s členom 10(1)(a) Uredbe (ES) št. 470/2009, v skladu s členom 9 navedene uredbe ob odobritvi aktivne snovi ni bila določena najvišja mejna vrednost ostankov ali kjer je treba spremeniti mejno vrednost, določeno v skladu s členom 9 navedene uredbe, se najvišja mejna vrednost ostankov določi ali spremeni v skladu s postopkom iz člena 10(1)(b) navedene uredbe.
Where a biocidal product is intended for direct application to the external parts of the human body (epidermis, hair system, nails, lips and external genital organs), or to the teeth and the mucous membranes of the oral cavity, it shall not contain any non-active substance that may not be included in a cosmetic product pursuant to Regulation (EC) No 1223/2009.
Kadar je biocidni proizvod namenjen za neposredno uporabo na zunanjih delih človeškega telesa (povrhnjica, lasišče, nohti, ustnice in zunanji spolni organi) ali zobeh in sluznici v ustni votlini, ne vsebuje nobene neaktivne snovi, ki je ne sme vsebovati kozmetični izdelek v skladu z Uredbo (ES) št. 1223/2009.
Requirements for applications for authorisation
Zahteve za vloge za dovoljenje
The applicant for an authorisation shall submit the following documents together with the application:
Vlagatelj, ki zaprosi za dovoljenje, skupaj z vlogo predloži naslednje dokumente:
for biocidal products other than biocidal products meeting the conditions laid down in Article 25:
za biocidne proizvode, ki ne izpolnjujejo pogojev iz člena 25:
a dossier or letter of access for the biocidal product satisfying the requirements set out in Annex III;
dokumentacijo ali izjavo o dostopnosti za biocidni proizvod, ki izpolnjuje zahteve iz Priloge III;
a summary of the biocidal product characteristics including the information referred to in points (a), (b) and (e) to (q) of Article 22(2), as applicable;
povzetek značilnosti biocidnega proizvoda, ki vključuje informacije iz točk (a), (b) in (e) do (q) člena 22(2), kot je potrebno;
a dossier or a letter of access for the biocidal product satisfying the requirements set out in Annex II for each active substance in the biocidal product;
dokumentacijo ali izjavo o dostopnosti za biocidni proizvod, ki izpolnjuje zahteve iz Priloge II, za vsako aktivno snov v biocidnem proizvodu;
for biocidal products that the applicant considers meet the conditions laid down in Article 25:
za biocidne proizvode, za katere vlagatelj meni, da izpolnjujejo pogoje iz člena 25:
a summary of the biocidal product characteristics as referred to in point (a)(ii) of this paragraph;
povzetek značilnosti biocidnega proizvoda iz točke (a)(ii) tega odstavka;
efficacy data; and
podatke o učinkovitosti in
any other relevant information in support of the conclusion that the biocidal product meets the conditions laid down in Article 25.
kakršne koli druge ustrezne informacije v podporo sklepu, da biocidni proizvod izpolnjuje pogoje iz člena 25.
The receiving competent authority may require that applications for national authorisation be submitted in one or more of the official languages of the Member State where that competent authority is situated.
Pristojni organ prejemnik lahko zahteva, da se vloge za nacionalno dovoljenje predložijo v enem ali več uradnih jezikih države članice, v kateri ima ta pristojni organ svoj sedež.
For applications for Union authorisations submitted under Article 43, the applicant shall submit the summary of the biocidal product characteristics referred to in point (ii) of paragraph (1)(a) of this Article in one of the official languages of the Union accepted by the evaluating competent authority at the time of application and in all official languages of the Union before the authorisation of the biocidal product.
Za vloge za izdajo dovoljenja Unije, predložene v skladu s členom 43, vlagatelj predloži povzetek značilnosti biocidnega proizvoda iz točke (ii) odstavka 1(a) tega člena ob oddaji vloge v enem od uradnih jezikov Unije, sprejemljivem za ocenjevalni pristojni organ, in v vseh uradnih jezikih Unije pred izdajo dovoljenja za biocidni proizvod.
Waiving of data requirements
Odstop od zahtev glede podatkov
By way of derogation from Article 20, the applicant need not provide data required under that Article where any of the following applies:
Z odstopanjem od člena 20 vlagatelju ni treba predložiti podatkov, ki se zahtevajo po navedenem členu, kadar je izpolnjen kateri od naslednjih pogojev:
The applicant may propose to adapt the data requirements of Article 20 in accordance with Annex IV.
Vlagatelj lahko v skladu s Prilogo IV predlaga prilagoditev zahtev po podatkih iz člena 20.
The justification for the proposed adaptations to the data requirements shall be clearly stated in the application with reference to the specific rules in Annex IV.
Utemeljitev za predlagane prilagoditve zahtev glede podatkov se v vlogi jasno navede s sklicevanjem na posebna pravila v Prilogi IV.
In order to ensure the harmonised application of paragraph 1(a) of this Article, the Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying criteria for defining when the exposure associated with the proposed uses would justify adapting the data requirements of Article 20.
Da bi se zagotovila usklajena uporaba odstavka 1(a) tega člena, se na Komisijo prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 83, ki določa merila za opredelitev, kdaj bi bila zaradi izpostavljenosti, povezane s predlagano uporabo, utemeljena prilagoditev zahtev glede podatkov iz člena 20.
Content of authorisation
Vsebina dovoljenja
An authorisation shall stipulate the terms and conditions relating to the making available on the market and use of the single biocidal product or the biocidal product family and include a summary of the biocidal product characteristics.
V dovoljenju so določena določila in pogoji v zvezi z dostopnostjo na trgu in uporabo posameznega biocidnega proizvoda ali družine biocidnih proizvodov ter naveden povzetek značilnosti biocidnega proizvoda.
Without prejudice to Articles 66 and 67, the summary of the biocidal product characteristics for a single biocidal product or, in the case of a biocidal product family, the biocidal products within that biocidal product family, shall include the following information:
Brez poseganja v člena 66 in 67 povzetek značilnosti biocidnega proizvoda pri posameznem biocidnem proizvodu ali, v primeru družine biocidnih proizvodov, biocidnih proizvodov v okviru te družine biocidnega proizvoda, vsebuje naslednje podatke:
trade name of the biocidal product;
trgovska imena biocidnih proizvodov iz družine biocidnih proizvodov;
name and address of the authorisation holder;
ime in naslov imetnika dovoljenja;
date of the authorisation and its date of expiry;
datum dovoljenja in datum izteka veljavnosti dovoljenja;
authorisation number of the biocidal product, together with, in the case of a biocidal product family, the suffixes to apply to individual biocidal products within the biocidal product family;
številko dovoljenja biocidnega proizvoda skupaj s, v primeru družine biocidnega proizvoda, priponami za posamezne biocidne proizvode iz družine biocidnih proizvodov;
qualitative and quantitative composition in terms of the active substances and non-active substances, knowledge of which is essential for proper use of biocidal products; and in the case of a biocidal product family, the quantitative composition shall indicate a minimum and maximum percentage for each active and non-active substance, where the minimum percentage indicated for certain substances may be 0 %;
kakovostno in količinsko sestavo aktivnih in neaktivnih snovi, poznavanje katere je potrebno za pravilno uporabo biocidnih proizvodov in, v primeru družine biocidnih proizvodov, je iz količinske sestave razviden najnižji in najvišji odstotek za vsako aktivno in neaktivno snov, pri čemer je najnižji navedeni odstotek za določene snovi lahko 0 %;
manufacturers of the biocidal product (names and addresses including location of manufacturing sites);
proizvajalce biocidnih proizvodov (imena in naslovi, vključno s krajem proizvodnih obratov);
manufacturers of the active substances (names and addresses including location of manufacturing sites);
proizvajalce aktivnih snovi (imena in naslovi, vključno s krajem proizvodnih obratov);
type of formulation of the biocidal product;
vrsto formulacije biocidnih proizvodov;
hazard and precautionary statements;
izjave o nevarnosti in previdnostne izjave;
product-type and, where relevant, an exact description of the authorised use;
vrsto proizvoda in po potrebi natančen opis dovoljene uporabe;
target harmful organisms;
ciljne škodljive organizme;
application doses and instructions for use;
odmerke in navodila za uporabo;
categories of users;
skupine uporabnikov;
particulars of likely direct or indirect adverse effects and first aid instructions and emergency measures to protect the environment;
podatke o verjetnih neposrednih ali posrednih škodljivih učinkih, navodila za prvo pomoč in izredni ukrepi za varstvo okolja;
instructions for safe disposal of the product and its packaging;
navodila za varno odstranjevanje proizvoda in njegove embalaže;
conditions of storage and shelf-life of the biocidal product under normal conditions of storage;
pogoje skladiščenja in rok uporabe biocidnih proizvodov pod običajnimi pogoji skladiščenja;
where relevant, other information about the biocidal product.
po potrebi druge informacije o biocidnem proizvodu.
Comparative assessment of biocidal products
Primerjalna ocena biocidnih proizvodov
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).
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 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.
Rezultati primerjalne ocene se nemudoma pošljejo pristojnim organom drugih držav članic in Agenciji ter, v primeru ocenjevanja vloge za dovoljenje Unije, tudi Komisiji.
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:
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:
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 health, animal health and the environment, is sufficiently effective and presents no other significant economic or practical disadvantages;
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, zdravje živali in okolje in je dovolj učinkovita ter ne predstavlja drugih bistvenih gospodarskih ali praktičnih izgub;
the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target harmful organism.
kemijska raznolikost aktivnih snovi je zadostna, da se čim bolj zniža tveganje nastanka odpornosti v ciljnem škodljivem organizmu.
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.
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.
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.
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.
The Commission shall adopt that decision by means of implementing acts in accordance with the examination procedure referred to in Article 82(3).
Komisija sprejme to odločitev z izvedbenimi akti v skladu s postopkom pregleda iz člena 82(3).
The Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying the criteria for determining when comparative assessments involve questions better addressed at Union level and the procedures for such comparative assessments.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 83, ki podrobno določijo merila o tem, kdaj primerjalne ocene obravnavajo vprašanja, ki bi jih bilo bolje obravnavati na ravni Unije, in postopke za takšne primerjalne ocene.
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.
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 petih let in se obnovi za obdobje največ petih let.
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 four years after that decision.
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 štiri leta po tej odločitvi.
However, where the approval of the active substance which is a candidate for substitution expires on an earlier date, the cancellation of the authorisation shall take effect on that earlier date.
Če pa se rok za odobritev aktivne snovi, ki je možna snov za zamenjavo, pred tem izteče, začne preklic dovoljenja učinkovati na ta zgodnejši datum.
The Commission shall draw up technical guidance notes to facilitate the implementation of this Chapter and, in particular, Article 22(2) and Article 23(3).
Komisija pripravi tehnična navodila za lažje izvajanje tega poglavja, zlasti člena 22(2) in člena 23(3).
SIMPLIFIED AUTHORISATION PROCEDURE
POENOSTAVLJENI POSTOPEK ZA IZDAJO DOVOLJENJA
Eligibility for the simplified authorisation procedure
Izpolnjevanje pogojev za poenostavljeni postopek za izdajo dovoljenja
For eligible biocidal products, an application for authorisation may be made under a simplified authorisation procedure.
Za biocidne proizvode, ki izpolnjujejo pogoje, se vloga za dovoljenje lahko vloži po poenostavljenem postopku za izdajo dovoljenja.
A biocidal product shall be eligible if all the following conditions are met:
Biocidni proizvod izpolnjuje pogoje, če so izpolnjeni vsi naslednji pogoji:
all the active substances contained in the biocidal product appear in Annex I and satisfy any restriction specified in that Annex;
vse aktivne snovi v biocidnem proizvodu so na seznamu iz Priloge I in izpolnjujejo vse omejitve, navedene v navedeni prilogi;
the biocidal product does not contain any substance of concern;
biocidni proizvod ne vsebuje nobene nevarne snovi;
the biocidal product does not contain any nanomaterials;
biocidni proizvod ne vsebuje nobenih nanomaterialov;
the biocidal product is sufficiently effective; and
biocidni proizvod je dovolj učinkovit in
the handling of the biocidal product and its intended use do not require personal protective equipment.
za ravnanje z biocidnim proizvodom in njegovo predvideno uporabo ni potrebna osebna zaščitna oprema.
Applicable procedure
Postopek, ki se uporablja
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.
Vlagatelji, ki zaprosijo za dovoljenje za biocidni 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.
The evaluating competent authority shall inform the applicant of the fees payable under Article 80(2) and shall reject the application if the applicant fails to pay the fees within 30 days.
Ocenjevalni pristojni organ vlagatelja obvesti o pristojbinah, ki se plačujejo v skladu s členom 80(2), in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
Upon receipt of the fees payable under Article 80(2), the evaluating competent authority shall accept the application and inform the applicant accordingly, indicating the date of the acceptance.
Po prejemu pristojbin, ki se plačujejo v skladu s členom 80(2), ocenjevalni pristojni organ sprejme vlogo in o tem ustrezno obvesti vlagatelja z navedbo datuma prejema.
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.
Ocenjevalni pristojni organ v 90 dneh po prejemu vloge odobri biocidni proizvod, če se prepriča, da ta proizvod izpolnjuje pogoje iz člena 25.
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.
Kadar ocenjevalni pristojni organ meni, da je vloga nepopolna, vlagatelja obvesti, katere dodatne informacije so potrebne, in določi razumen rok za predložitev teh informacij.
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.
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 reject the application if the applicant fails to submit the requested information within the deadline and shall inform the applicant accordingly.
Če vlagatelj zahtevanih informacij ne predloži v roku, ocenjevalni pristojni organ vlogo zavrne in vlagatelja o tem ustrezno obvesti.
In such cases, where fees have been paid, part of the fees paid in accordance with Article 80(2) shall be reimbursed.
V takšnih primerih, ko so plačane pristojbine, se del pristojbine, plačane v skladu s členom 80(2), povrne.
Making available on the market of biocidal products authorised in accordance with the simplified authorisation procedure
Dostopnost biocidnih proizvodov na trgu, za katere je bilo dovoljenje izdano v skladu s poenostavljenim postopkom za izdajo dovoljenja
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.
Biocidni proizvod, odobren v skladu s členom 26, je lahko dostopen na trgu v vseh državah članicah brez medsebojnega priznavanja.
However, the authorisation holder shall notify each Member State no later than 30 days 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.
Vendar imetnik dovoljenja obvesti vsako državo članico najpozneje 30 dni, 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 država članica določi drugače.
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).
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 podano obvestilo 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).
Article 35(3) and Article 36 shall apply mutatis mutandis.
Smiselno se uporabljata člen 35(3) in člen 36.
Where a Member State has valid reasons to consider that a biocidal product authorised in accordance with Article 26 does not meet the criteria laid down in Article 25 and a decision pursuant to Articles 35 and 36 has not yet been taken, that Member State may provisionally restrict or prohibit making available on the market or use of that product on its territory.
Kadar država članica utemeljeno meni, da biocidni proizvod, za katerega je bilo dovoljenje izdano v skladu s členom 26, ne izpolnjuje meril iz člena 25 in še ni bila sprejeta odločitev v skladu s členoma 35 in 36, lahko ta država članica začasno omeji ali prepove dostopnost na trgu ali uporabo tega proizvoda na svojem ozemlju.
Amendment of Annex I
Sprememba Priloge I