natgillin/translations-raw huggingface dataset:
„nacionalno dovoljenje“ pomeni upravni akt, s katerim pristojni organ države članice dovoli dostopnost na trgu in uporabo biocidnega proizvoda
‘national authorisation’ means an administrative act by which the competent authority of a Member State authorises the making available on the market and the use of a biocidal product
ali družine biocidnih proizvodov
or a biocidal product family
na njenem ozemlju ali delu njenega ozemlja;
in its territory or in a part thereof;
„dovoljenje Unije“ pomeni upravni akt, s katerim Komisija dovoli dostopnost na trgu in uporabo biocidnega proizvoda
‘Union authorisation’ means an administrative act by which the Commission authorises the making available on the market and the use of a biocidal product
na ozemlju Unije ali delu ozemlja Unije;
in the territory of the Union or in a part thereof;
„dovoljenje“ pomeni nacionalno dovoljenje, dovoljenje Unije ali dovoljenje v skladu s členom 26;
‘authorisation’ means national authorisation, Union authorisation or authorisation in accordance with Article 26;
„imetnik dovoljenja“ pomeni osebo, ki
‘authorisation holder’ means the person
ima sedež v Uniji in
established within the Union who is
je odgovorna za
responsible for the
„vrsta proizvoda“ pomeni eno od vrst proizvodov, navedenih v Prilogi V;
‘product-type’ means one of the product-types specified in Annex V;
„posamezen biocidni proizvod“ pomeni biocidni proizvod brez predvidenih odstopanj pri odstotku aktivnih ali neaktivnih snovi, ki jih vsebuje;
‘single biocidal product’ means a biocidal product with no intended variations as to the percentage of the active or non-active substances it contains;
„družina biocidnih proizvodov“ pomeni skupino biocidnih proizvodov za podobno uporabo, katerih aktivne snovi imajo enake specifikacije, in z določenimi odstopanji v njihovi sestavi, ki ne vplivajo škodljivo na raven tveganja ali znatno ne zmanjšajo učinkovitosti teh proizvodov;
‘biocidal product family’ means a group of biocidal products having similar uses, the active substances of which have the same specifications, and presenting specified variations in their composition which do not adversely affect the level of risk or significantly reduce the efficacy of the products;
„izjava o dostopnosti podatkov“ pomeni izvorni dokument, ki ga podpiše lastnik podatkov ali njegov zastopnik in v katerem je navedeno, da lahko pristojni organi, Agencija ali Komisija podatke uporabljajo v korist tretje strani za namene te uredbe;
‘letter of access’ means an original document, signed by the data owner or its representative, which states that the data may be used for the benefit of a third party by competent authorities, the Agency, or the Commission for the purposes of this Regulation;
„hrana“ in „krma“ pomenita hrano, kot je opredeljena v členu 2 Uredbe (ES) št. 178/2002, in krmo, kot je opredeljena v členu 3(4) navedene uredbe;
‘food’ and ‘feed’ mean food as defined in Article 2 of Regulation (EC) No 178/2002 and feed as defined in Article 3(4) of that Regulation;
„pomožna tehnološka sredstva“ pomenijo kakršno koli snov, ki sodi v opredelitev iz točke (b) člena 3(2) Uredbe (ES) št. 1333/2008 ali točke (h) člena 2(2) Uredbe (ES) št. 1831/2003;
‘processing aid’ means any substance falling within the definition of point (b) of Article 3(2) of Regulation (EC) No 1333/2008 or point (h) of Article 2(2) of Regulation (EC) No 1831/2003;
„tehnična ekvivalenca“ pomeni podobnost glede kemične sestave in profila nevarnosti snovi, ki se proizvede iz vira, različnega od referenčnega vira, ali iz referenčnega vira, vendar po spremembi proizvodnega postopka in/ali proizvodnega mesta, v primerjavi s snovjo iz referenčnega vira v zvezi s katero je bila opravljena prvotna ocena tveganja, kot je določeno v členu 54;
‘technical equivalence’ means similarity, as regards the chemical composition and hazard profile, of a substance produced either from a source different to the reference source, or from the reference source but following a change to the manufacturing process and/or manufacturing location, compared to the substance of the reference source in respect of which the initial risk assessment was carried out, as established in Article 54;
„Agencija“ pomeni Evropsko agencijo za kemikalije, ustanovljeno z Uredbo (ES) št. 1907/2006;
‘Agency’ means the European Chemicals Agency established by Regulation (EC) No 1907/2006;
„oglaševanje“ pomeni način promoviranja prodaje ali uporabe biocidnih proizvodov prek tiskanih, elektronskih ali drugih medijev;
‘advertisement’ means a means of promoting the sale or use of biocidal products by printed, electronic or other media;
naravno ali umetno aktivno snov ali neaktivno snov, ki vsebuje delce v nevezanem stanju ali v obliki agregatov ali aglomeratov in pri kateri je ena ali več zunanjih dimenzij za 50 % ali več delcev pri razporeditvi snovi po velikosti glede na število v razponu velikosti od 1 nm do 100 nm;
a natural or manufactured active substance or non-active substance containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for 50 % or more of the particles in the number size distribution, one or more external dimensions is in the size range 1 nm-100 nm;
za nanomateriale se štejejo fulereni, plasti grafena in enostenske ogljikove nanocevke z eno ali več zunanjih dimenzij pod 1 nm;
Fullerenes, graphene flakes and single wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials.
za namene opredelitve nanomaterialov so pojmi „delec“, „aglomerat“ in „agregat“ opredeljeni na naslednji način:
For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows:
„delec“ pomeni zelo majhen del snovi, ki ima določene fizikalne meje;
‘particle’ means a minute piece of matter with defined physical boundaries;
„aglomerat“ pomeni skupek šibko povezanih delcev ali agregatov, katerih skupna zunanja površina je podobna vsoti površin posameznih sestavnih delov;
‘agglomerate’ means a collection of weakly bound particles or aggregates where the resulting external surface area is similar to the sum of the surface areas of the individual components;
„agregat“ pomeni delec, sestavljen iz močno povezanih ali zlitih delcev;
‘aggregate’ means a particle comprising of strongly bound or fused particles;
„upravna sprememba“ pomeni izključno upravno spremembo obstoječega dovoljenja, ki nima za posledico nobene spremembe lastnosti ali učinkovitosti biocidnega proizvoda ali družine biocidnih proizvodov;
‘administrative change’ means an amendment of an existing authorisation of a purely administrative nature involving no change to the properties or efficacy of the biocidal product or biocidal product family;
„manjša sprememba“ pomeni spremembo obstoječega dovoljenja, ki ni izključno upravne narave in ki zahteva le omejeno ponovno oceno lastnosti ali učinkovitosti biocidnega proizvoda ali družine biocidnih proizvodov;
‘minor change’ means an amendment of an existing authorisation that is not of a purely administrative nature and requires only a limited re-assessment of the properties or efficacy of the biocidal product or biocidal product family;
„večja sprememba“ pomeni spremembo obstoječega dovoljenja, ki ni niti upravna niti manjša sprememba;
‘major change’ means an amendment of an existing authorisation which is neither an administrative change nor a minor change;
„ranljive skupine“ pomenijo osebe, za katere je pri ocenjevanju akutnih in kroničnih učinkov biocidnih proizvodov na zdravje potrebna posebna obravnava.
‘vulnerable groups’ means persons needing specific consideration when assessing the acute and chronic health effects of biocidal products.
To so med drugim nosečnice in doječe matere, nerojeni otroci, dojenčki in otroci, ostareli ter delavci in prebivalci, ki so dolgoročno izpostavljeni visokim koncentracijam biocidnih proizvodov;
These include pregnant and nursing women, the unborn, infants and children, the elderly and, when subject to high exposure to biocidal products over the long term, workers and residents;
„mala in srednja podjetja“ ali „MSP“ pomenijo mala in srednja podjetja, kakor so opredeljena v Priporočilu Komisije 2003/361/ES z dne 6. maja 2003 o opredelitvi mikro, malih in srednjih podjetij UL L 124, 20.5.2003, str.
‘small and medium-sized enterprises’ or ‘SMEs’ means small and medium-sized enterprises as defined in Commission Recommendation 2003/361/EC of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises OJ L 124, 20.5.2003, p.
Za namene te uredbe se uporabljajo naslednje opredelitve izrazov iz člena 3 Uredbe (ES) št. 1907/2006:
For the purposes of this Regulation, the definitions laid down in Article 3 of Regulation (EC) No 1907/2006 shall apply for the following terms:
„v proizvod in proces usmerjene raziskave in razvoj“;
‘product and process-orientated research and development’;
„znanstvene raziskave in razvoj“.
‘scientific research and development’.
Komisija lahko na zahtevo države članice z izvedbenimi akti odloči, ali je določena snov nanomaterial, zlasti v zvezi s Priporočilom 2011/696.
The Commission may, at the request of a Member State, decide, by means of implementing acts, whether a substance is a nanomaterial, having regard, in particular to Recommendation 2011/696.
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 82(3).
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).
Na zahtevo države članice lahko Komisija v skladu s postopkom pregleda iz člena 81(3) z izvedbenimi akti odloči, ali je določen proizvod ali skupina proizvodov bodisi biocidni proizvod ali tretirani izdelek ali nič od navedenega.
The Commission may, at the request of a Member State, decide, by means of implementing acts, whether a specific product or group of products is a biocidal product or a treated article or neither.
Komisija je v skladu s členom 83 pooblaščena za sprejetje delegiranih aktov, da bi prilagodila opredelitev nanomaterialov iz odstavka 1(aa) tega člena ob upoštevanju tehničnega in znanstvenega napredka ter Priporočila Komisije 2011/696/EU.
The Commission shall be empowered to adopt delegated acts in accordance with Article 83 in order to adapt the definition of nanomaterial set out in paragraph 1(z) of this Article in view of technical and scientific progress and taking into account the Commission Recommendation 2011/696/EU.
ODOBRITEV AKTIVNIH SNOVI
APPROVAL OF ACTIVE SUBSTANCES
Pogoji za odobritev
Conditions for approval
Aktivna snov se odobri za začetno obdobje največ 10 let, če se lahko pričakuje, da vsaj en biocidni proizvod, ki to aktivno snov vsebuje, izpolnjuje merila iz točke (b) člena 19(1), ob upoštevanju dejavnikov iz člena 19(2) in (5).
An active substance shall be approved for an initial period not exceeding 10 years if at least one biocidal product containing that active substance may be expected to meet the criteria laid down in point (b) of Article 19(1) taking into account the factors set out in Article 19(2) and (5).
Aktivna snov iz člena 5 se lahko odobri le za začetno obdobje največ 5 let.
An active substance referred to in Article 5 may only be approved for an initial period not exceeding 5 years.
Odobritev aktivne snovi se omeji na tiste vrste proizvodov, za katere so bili v skladu s členom 6 predloženi ustrezni podatki.
The approval of an active substance shall be restricted to those product-types for which relevant data have been submitted in accordance with Article 6.
Odobritev navaja naslednje pogoje, kot je to ustrezno:
The approval shall specify the following conditions, as appropriate:
najmanjšo stopnjo čistote aktivne snovi;
the minimum degree of purity of the active substance;
vrsto in najvišjo vsebnost določenih nečistot;
the nature and maximum content of certain impurities;
vrsto proizvoda;
the product-type;
način in področje uporabe, po potrebi tudi uporabo v tretiranih izdelkih;
manner and area of use including, where relevant, use in treated articles;
oznako skupin uporabnikov;
designation of categories of users;
kadar je to ustrezno, opredelitev kemijske identitete glede na stereoizomere;
where relevant, characterisation of the chemical identity with regard to stereoisomers;
druge posebne pogoje na podlagi ocene informacij o tej aktivni snovi;
other particular conditions based on the evaluation of the information related to that active substance;
datum odobritve aktivne snovi in datum izteka odobritve aktivne snovi.
the date of approval and the expiry date of the approval of the active substance.
Odobritev aktivne snovi ne vključuje nanomaterialov, razen kadar je to izrecno navedeno.
The approval of an active substance shall not cover nanomaterials except where explicitly mentioned.
aktivne snovi, ki so bile v skladu z Uredbo (ES) št. 1272/2008 razvrščene kot rakotvorne snovi kategorije 1A ali 1B oziroma izpolnjujejo merila za tako razvrstitev;
active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, carcinogen category 1A or 1B;
aktivne snovi, ki so bile v skladu z Uredbo (ES) št. 1272/2008 razvrščene kot mutagene snovi kategorije 1A ali 1B oziroma izpolnjujejo merila za tako razvrstitev;
active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, mutagen category 1A or 1B;
aktivne snovi, ki so bile v skladu z Uredbo (ES) št. 1272/2008 razvrščene kot strupene snovi za razmnoževanje kategorije 1A ali 1B oziroma izpolnjujejo merila za tako razvrstitev;
active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, toxic for reproduction category 1A or 1B;
aktivne snovi,
active substances
ki so na podlagi meril iz pododstavka 1 odstavka 3, pred vzpostavitvijo teh meril pa na podlagi navedb iz pododstavkov 2 in 3 istega odstavka, opredeljene kot snovi, ki lahko povzročijo endokrine motnje in imajo tako negativne učinke na ljudi, ali ki so
which on the basis of the criteria referred to in subparagraph 1 of paragraph 3 or, pending the establishment of these criteria, the indications given in subparagraphs 2 and 3 of the same paragraph, are considered as having endocrine-disrupting properties that may cause adverse effects in humans or which are
opredeljene v skladu s členoma 57(f) in 59(1) Uredbe (ES) št. 1907/2006 kot snovi, ki so po svojih lastnostih endokrini motilci.
identified in accordance with Articles 57(f) and 59(1) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties;
aktivne snovi, ki izpolnjujejo merila, da se štejejo za obstojne, bioakumulativne in strupene (PBT), ali snovi, ki so zelo obstojne, ter zelo bioakumulativne (vPvB) v skladu s Prilogo XIII k Uredbi (ES) št. 1907/2006.
active substances which fulfil the criteria for being persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) according to Annex XIII to Regulation (EC) No 1907/2006.
v realno najslabših možnih pogojih uporabe je tveganje za ljudi ali okolje zaradi izpostavljenosti aktivni snovi v biocidnem proizvodu zanemarljiva, zlasti če se proizvod uporablja v zaprtih sistemih ali
the risk to humans or the environment from exposure to the active substance in a biocidal product, under realistic worst case conditions of use, is negligible, in particular where the product is used in closed systems or
pod drugimi
under other
, kjer se prizadeva za preprečevanje stika z ljudmi in sproščanja v okolje
which aim at excluding contact with humans and release to the environment
dokazano je, da je
it is shown by evidence that
aktivna snov nujna za preprečevanje ali obvladovanje resne nevarnosti za javno zdravje ali zdravje živali ali
the active substance is essential to prevent or to control a serious danger to public or animal health or
neodobritev aktivne snovi bi imela v primerjavi s tveganjem za zdravje človeka ali okolje, ki izhaja iz uporabe snovi, nesorazmerne negativne posledice za družbo.
not approving the active substance would cause disproportionate negative impacts for society when compared with the risk to human health or the environment arising from the use of the substance.
Pri odločitvi, ali se aktivna snov lahko odobri v skladu s prvim pododstavkom, se
When deciding whether an active substance may be approved in accordance with the first subparagraph, the availability of suitable and sufficient alternative substances or technologies shall ▌ be
Za uporabo v skladu s tem odstavkom vseh biocidnih proizvodov, ki vsebujejo aktivne snovi, odobrene v skladu s tem odstavkom, veljajo ustrezni ukrepi za zmanjšanje tveganja, da bi se zagotovila najmanjša izpostavljenost ljudi in okolja.
The use pursuant to this paragraph of any biocidal product containing active substances approved in accordance with this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment is minimised.
Uporaba biocidnih pripravkov z zadevno aktivno snovjo se omeji na tiste države članice, ki izpolnjujejo pogoje iz tega odstavka.
The use of the biocidal product with the active substance concerned shall be restricted to those Member States where the conditions of this paragraph are met.
Komisija najpozneje 13. decembra 2013
No later than 13 December 2013, the
▌sprejme delegirane akte v skladu s členom 83, ki določajo znanstvena merila za odkrivanje lastnosti endokrinih motilcev.
Commission shall ▌ adopt delegated acts in accordance with Article 83 specifying scientific criteria for the determination of endocrine disrupting properties.
Podatki, ki se zahtevajo za vlogo
Data requirements for an application
Vloga za odobritev aktivne snovi vsebuje najmanj naslednje elemente:
An application for approval of an active substance shall contain at least the following elements:
dokumentacijo o aktivni snovi, ki izpolnjuje zahteve iz Priloge II;
a dossier for the active substance satisfying the requirements set out in Annex II;
dokumentacijo, ki izpolnjuje zahteve iz Priloge III, o najmanj enem reprezentativnem biocidnem proizvodu, ki vsebuje zadevno aktivno snov, in
a dossier satisfying the requirements set out in Annex III for at least one representative biocidal product that contains the active substance; and
če aktivna snov izpolnjuje vsaj eno od meril za izključitev iz člena 5(1), dokaz, da se uporablja člen 5(2).
if the active substance meets at least one of the exclusion criteria listed in Article 5(1), evidence that Article 5(2) is applicable.
Ne glede na odstavek 1 vlagatelju ni treba predložiti podatkov kot del dokumentacije, ki se zahteva v točkah (a) in (b) odstavka 1, če velja karkoli od naslednjega:
Notwithstanding paragraph 1, the applicant need not provide data as part of the dossiers required under points (a) and (b) of paragraph 1 where any of the following applies:
podatki zaradi izpostavljenosti, povezane s predlagano uporabo, niso potrebni;
the data are not necessary owing to the exposure associated with the proposed uses;
predložitev podatkov z znanstvenega vidika ni potrebna ali
it is not scientifically necessary to supply the data; or
podatkov tehnično ni mogoče pridobiti.
it is not technically possible to generate the data.
Vendar se zagotovi dovolj podatkov, da je možno ugotoviti, ali aktivna snov izpolnjuje merila iz člena 5(1) ali 10(1), če to zahteva ocenjevalni pristojni organ na podlagi člena 8(2).
However, sufficient data shall be provided in order to make it possible to determine whether an active substance meets the criteria referred to in Article 5(1) or 10(1), if required by the evaluating competent authority under Article 8(2).
Vlagatelj lahko predlaga, da se podatki kot del dokumentacije, ki se zahteva v točkah (a) in (b) odstavka 1, prilagodijo v skladu s Prilogo IV.
An applicant may propose to adapt the data as part of the dossiers required under points (a) and (b) of paragraph 1 in accordance with Annex IV.
Utemeljitev za predlagane prilagoditve zahtev glede podatkov se v vlogi jasno navede in v ta namen navede sklicevanje na posebna pravila iz Priloge IV.
The justification for the proposed adaptations to the data requirements shall be clearly stated in the application with a reference to the specific rules in Annex IV.
pod pogoji iz točke (a) odstavka 2
on the grounds referred to in point (a) of paragraph 2
Vložitev in validacija vlog
Submission and validation of applications
Vlagatelj pri agenciji vloži vlogo za odobritev aktivne snovi ali za naknadne spremembe pogojev za odobritev aktivne snovi ter Agencijo obvesti o nazivu pristojnega organa države članice, ki ga predlaga za ocenjevanje vloge, in predloži pisno potrdilo pristojnega organa, da se s tem strinja.
The applicant shall submit an application for approval of an active substance, or for making subsequent amendments to the conditions of approval of an active substance, 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.
Ta pristojni organ je ocenjevalni pristojni organ.
That competent authority shall be the evaluating competent authority.
▌ Agencija vlagatelja obvesti o pristojbinah, ki se plačujejo v skladu s členom 80(1), in vlogo zavrne, če vlagatelj teh pristojbin ne plača v 30 dneh.
▌ The Agency shall inform the applicant of the fees payable under Article 80(1) and shall reject the application if the applicant fails to pay the fees within 30 days.
Agencija ustrezno obvesti vlagatelja in ocenjevalni pristojni organ.
It shall inform the applicant and the evaluating competent authority accordingly.
Po prejemu pristojbin, ki se plačujejo v skladu s členom 80(1), Agencija sprejme vlogo in o tem ustrezno obvesti vlagatelja in ocenjevalni pristojni organ, pri čemer navede točni datum sprejetja vloge in njeno enkratno identifikacijsko kodo.
Upon receipt of the fees payable under Article 80(1), the Agency shall accept the application and inform the applicant and the evaluating competent authority accordingly, indicating the exact date of the acceptance of the application and its unique identification code.
Ocenjevalni pristojni organ v 30 dneh po tem, ko Agencija sprejme vlogo, validira vlogo, če so bili predloženi podatki, ki se zahtevajo v skladu s točkama (a) in (b) in, po potrebi, točko (c) člena 6(1) ter predložene kakršne koli utemeljitve za prilagoditev zahtev glede podatkov.
Within 30 days of the Agency accepting an application, the evaluating competent authority shall validate the application if the data required in accordance with points (a) and (b) and, where relevant, point (c) of Article 6(1), and any justifications for the adaptation of data requirements, have been submitted.
Ocenjevalni pristojni organ 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 evaluating competent authority shall not make an assessment of the quality or the adequacy of the data or justifications submitted.
Potem ko je agencija sprejela vlogo, ocenjevalni pristojni organ čim prej obvesti vlagatelja o pristojbinah, ki se plačujejo na podlagi člena 80(2), in zavrne vlogo, če vlagatelj ne plača pristojbin v 30 dneh.
The evaluating competent authority shall, as soon as possible after the Agency has accepted an application, 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.
Kadar ocenjevalni pristojni organ meni, da je vloga nepopolna, vlagatelja obvesti, katere dodatne informacije so potrebne za validacijo vloge, 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 for the validation of the application and shall set a reasonable time limit for the submission of that information.
Ta rok običajno ne presega 90 dni.
That time limit shall not normally exceed 90 days.