natgillin/translations-raw huggingface dataset:
‘use’ means all operations carried out with a biocidal product, including storage, handling, mixing and application, except any such operation carried out with a view to exporting the biocidal product or the treated article outside the Union;
„uporaba“ pomeni vse dejavnosti v zvezi z biocidnim proizvodom, vključno s skladiščenjem, ravnanjem, mešanjem in uporabo, razen kakršnih koli takih dejavnosti, ki se opravijo z namenom izvoza biocidnega proizvoda ali tretiranega izdelka iz Unije;
‘treated article’ means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products;
„tretirani izdelek“ pomeni kakršno koli snov, zmes ali izdelek, ki je bil tretiran z enim ali več biocidnimi proizvodi oziroma jih namenoma vsebuje;
‘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 or a biocidal product family in its territory or in a part thereof;
„nacionalno dovoljenje“ pomeni upravni akt, s katerim pristojni organ države članice dovoli dostopnost na trgu in uporabo biocidnega proizvoda ali družine biocidnih proizvodov na njenem ozemlju ali delu njenega ozemlja;
‘Union authorisation’ means an administrative act by which the Commission authorises the making available on the market and the use of a biocidal product or a biocidal product family in the territory of the Union or in a part thereof;
„dovoljenje Unije“ pomeni upravni akt, s katerim Komisija dovoli dostopnost na trgu in uporabo biocidnega proizvoda ali družine biocidnih proizvodov na ozemlju Unije ali delu ozemlja Unije;
‘authorisation’ means national authorisation, Union authorisation or authorisation in accordance with Article 26;
„dovoljenje“ pomeni nacionalno dovoljenje, dovoljenje Unije ali dovoljenje v skladu s členom 26;
‘authorisation holder’ means the person established within the Union who is responsible for the placing on the market of a biocidal product in a particular Member State or in the Union and specified in the authorisation;
„imetnik dovoljenja“ pomeni osebo, ki ima sedež v Uniji in je odgovorna za dajanje biocidnega proizvoda na trg v določeni državi članici ali Uniji in ki je navedena na dovoljenju;
‘product-type’ means one of the product-types specified in Annex V;
„vrsta proizvoda“ pomeni eno od vrst proizvodov, navedenih v Prilogi V;
‘single biocidal product’ means a biocidal product with no intended variations as to the percentage of the active or non-active substances it contains;
„posamezen biocidni proizvod“ pomeni biocidni proizvod brez predvidenih odstopanj pri odstotku aktivnih ali neaktivnih snovi, ki jih vsebuje;
‘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;
„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 negativno na raven tveganja ali znatno ne zmanjšajo učinkovitosti teh proizvodov;
‘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;
„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 za namene te uredbe podatke uporabljajo v korist tretje strani;
‘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;
„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;
‘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;
„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;
‘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;
„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;
‘Agency’ means the European Chemicals Agency established by Regulation (EC) No 1907/2006;
„Agencija“ pomeni Evropsko agencijo za kemikalije, ustanovljeno z Uredbo (ES) št. 1907/2006;
‘advertisement’ means a means of promoting the sale or use of biocidal products by printed, electronic or other media;
„oglaševanje“ pomeni način promoviranja prodaje ali uporabe biocidnih proizvodov prek tiskanih, elektronskih ali drugih medijev;
‘nanomaterial’ means 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 1-100 nm.
„nanomaterial“ pomeni naravno ali umetno aktivno snov ali neaktivno snov, ki vsebuje delce v nevezanem stanju ali v obliki agregatov ali v obliki 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.
Fullerenes, graphene flakes and single-wall carbon nanotubes with one or more external dimensions below 1 nm shall be considered as nanomaterials.
Za nanomateriale se štejejo fulereni, plasti grafena in enostenske ogljikove nanocevke z eno ali več zunanjih dimenzij pod 1 nm.
For the purposes of the definition of nanomaterial, ‘particle’, ‘agglomerate’ and ‘aggregate’ are defined as follows:
Za namene opredelitve nanomateriala se za „delec“, „aglomerat“ in „agregat“ uporabljajo naslednje opredelitve:
‘particle’ means a minute piece of matter with defined physical boundaries,
„delec“ pomeni zelo majhen del snovi, ki ima določene fizikalne meje,
‘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,
„aglomerat“ pomeni skupek šibko povezanih delcev ali agregatov, katerih skupna zunanja površina je podobna vsoti površin posameznih sestavnih delov,
‘aggregate’ means a particle comprising strongly bound or fused particles;
„agregat“ pomeni delec, sestavljen iz močno povezanih ali zlitih delcev;
(aa) ‘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;
(aa) „upravna sprememba“ pomeni izključno upravno spremembo obstoječega dovoljenja, ki nima za posledico nobene spremembe lastnosti ali učinkovitosti biocidnega proizvoda ali družine biocidnih proizvodov;
(ab) ‘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;
(ab) „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;
(ac) ‘major change’ means an amendment of an existing authorisation which is neither an administrative change nor a minor change;
(ac) „večja sprememba“ pomeni spremembo obstoječega dovoljenja, ki ni niti upravna niti manjša sprememba;
(ad) ‘vulnerable groups’ means persons needing specific consideration when assessing the acute and chronic health effects of biocidal products.
(ad) „ranljive skupine“ pomenijo osebe, za katere je pri ocenjevanju akutnih in kroničnih učinkov biocidnih proizvodov na zdravje potrebna posebna obravnava.
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;
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;
(ae) ‘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 [40].
(ae) „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 [40].
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:
Za namene te uredbe se glede naslednjih izrazov uporabljajo opredelitve iz člena 3 Uredbe (ES) št. 1907/2006:
‘substance’;
„snov“;
‘article’;
„izdelek“;
‘product and process-orientated research and development’;
„v proizvod in proces usmerjene raziskave in razvoj“;
‘scientific research and development’.
„znanstvene raziskave in razvoj“.
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 Commission Recommendation 2011/696/EU of 18 October 2011 on the definition of nanomaterial [41], and whether a specific product or group of products is a biocidal product or a treated article or neither.
Komisija lahko na zahtevo države članice z izvedbenimi akti odloči, ali je določena snov nanomaterial, zlasti v zvezi s Priporočilom Komisije 2011/696/EU z dne 18. oktobra 2011 o opredelitvi nanomateriala [41] in glede tega, ali je določen proizvod ali skupina proizvodov bodisi biocidni proizvod ali tretirani izdelek ali nič od navedenega.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 82(3).
Ti izvedbeni akti se sprejmejo v skladu s postopkom pregleda iz člena 82(3).
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 point (z) of paragraph 1 of this Article in view of technical and scientific progress and taking into account the Recommendation 2011/696/EU.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 83, da se prilagodi opredelitev nanomateriala iz točke (z) odstavka 1 tega člena ob upoštevanju tehničnega in znanstvenega napredka ter Priporočila 2011/696/EU.
APPROVAL OF ACTIVE SUBSTANCES
ODOBRITEV AKTIVNIH SNOVI
Conditions for approval
Pogoji za odobritev
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 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 that falls under Article 5 may only be approved for an initial period not exceeding five years.
Aktivna snov, ki spada v člen 5, se lahko odobri le za začetno obdobje največ 5 let.
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 aktivne snovi se omeji na tiste vrste proizvodov, za katere so bili v skladu s členom 6 predloženi ustrezni podatki.
The approval shall specify the following conditions, as appropriate:
Odobritev navaja naslednje pogoje, kot je to ustrezno:
the minimum degree of purity of the active substance;
najmanjšo stopnjo čistote aktivne snovi;
the nature and maximum content of certain impurities;
vrsto in najvišjo vsebnost določenih nečistot;
the product-type;
vrsto proizvoda;
manner and area of use including, where relevant, use in treated articles;
način in področje uporabe, po potrebi tudi uporabo v tretiranih izdelkih;
designation of categories of users;
oznako skupin uporabnikov;
where relevant, characterisation of the chemical identity with regard to stereoisomers;
kadar je to ustrezno, opredelitev kemijske identitete glede na stereoizomere;
other particular conditions based on the evaluation of the information related to that active substance;
druge posebne pogoje na podlagi ocene informacij o tej aktivni snovi;
the date of approval and the expiry date of the approval of the active substance.
datum odobritve in datum izteka odobritve aktivne snovi.
The approval of an active substance shall not cover nanomaterials except where explicitly mentioned.
Odobritev aktivne snovi ne vključuje nanomaterialov, razen kadar je to izrecno navedeno.
Subject to paragraph 2, the following active substances shall not be approved:
Ob upoštevanju odstavka 2 se naslednje aktivne snovi ne odobrijo:
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 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, mutagen 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, toxic for reproduction 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, on the basis of the criteria specified pursuant to the first subparagraph of paragraph 3 or, pending the adoption of those criteria, on the basis of the second and third subparagraphs of paragraph 3, are considered as having endocrine-disrupting properties that may cause adverse effects in humans or which are identified in accordance with Articles 57(f) and 59(1) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties;
aktivne snovi, ki so na podlagi meril, določenih v skladu s prvim pododstavkom odstavka 3, pred sprejetjem teh meril pa na podlagi drugega in tretjega pododstavka odstavka 3, opredeljene kot snovi, ki lahko povzročijo endokrine motnje in imajo tako negativne učinke na ljudi, ali ki so opredeljene v skladu s členom 57(f) in členom 59(1) Uredbe (ES) št. 1907/2006 kot snovi, ki so po svojih lastnostih endokrini motilci;
active substances which meet the criteria for being PBT or vPvB according to Annex XIII to Regulation (EC) No 1907/2006.
aktivne snovi, ki izpolnjujejo merila, da se štejejo za PBT ali vPvB v skladu s Prilogo XIII k Uredbi (ES) št. 1907/2006.
Without prejudice to Article 4(1), active substances referred to in paragraph 1 of this Article may be approved if it is shown that at least one of the following conditions is met:
Aktivne snovi iz odstavka 1 tega člena se brez poseganja v člen 4(1) lahko odobrijo, če je dokazano, da je izpolnjen vsaj eden od naslednjih pogojev:
the risk to humans, animals 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 under other conditions which aim at excluding contact with humans and release into the environment;
v realno najslabših možnih pogojih uporabe je tveganje za ljudi, živali ali okolje zaradi izpostavljenosti aktivni snovi v biocidnem proizvodu zanemarljivo, zlasti če se proizvod uporablja v zaprtih sistemih ali pod drugimi pogoji, kjer se prizadeva za preprečevanje stika z ljudmi in sproščanja v okolje;
it is shown by evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment; or
dokazano je, da je aktivna snov nujna za preprečevanje ali obvladovanje resne nevarnosti za zdravje človeka, zdravje živali ali okolje, ali
not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance.
neodobritev aktivne snovi bi imela v primerjavi s tveganjem za zdravje človeka, zdravje živali ali okolje, ki izhaja iz uporabe snovi, nesorazmeren negativni učinek za družbo.
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 a key consideration.
Pri odločitvi, ali se aktivna snov lahko odobri v skladu s prvim pododstavkom, se predvsem upošteva, ali so na voljo primerne in zadostne nadomestne snovi ali tehnologije.
The use of a 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, animals and the environment to those active substances is minimised.
Za uporabo biocidnega proizvoda, ki vsebuje aktivne snovi, odobrene v skladu s tem odstavkom, veljajo ustrezni ukrepi za zmanjšanje tveganja, da bi se zagotovila čim manjša izpostavljenost ljudi, živali in okolja tem aktivnim snovem.
The use of the biocidal product with the active substances concerned shall be restricted to Member States in which at least one of the conditions set out in this paragraph is met.
Uporaba biocidnih proizvodov z zadevnimi aktivnimi snovmi se omeji na države članice, ki izpolnjujejo vsaj enega izmed pogojev iz tega odstavka.
No later than 13 December 2013, the Commission shall adopt delegated acts in accordance with Article 83 specifying scientific criteria for the determination of endocrine-disrupting properties.
Komisija najpozneje 13. decembra 2013 sprejme delegirane akte v skladu s členom 83, ki določajo znanstvena merila za odkrivanje lastnosti endokrinih motilcev.
Pending the adoption of those criteria, active substances that are classified in accordance with Regulation (EC) No 1272/2008 as, or meet the criteria to be classified as, carcinogen category 2 and toxic for reproduction category 2, shall be considered as having endocrine-disrupting properties.
Aktivne snovi, ki so razvrščene v skladu z Uredbo (ES) št. 1272/2008 kot rakotvorne kategorije 2 in strupene za razmnoževanje kategorije 2 ali izpolnjujejo merila za tako razvrstitev, do sprejetja teh meril štejejo za snovi, ki imajo lastnosti endokrinih motilcev.
Substances such as those that are classified in accordance with Regulation (EC) No 1272/2008 as, or that meet the criteria to be classified as, toxic for reproduction category 2 and that have toxic effects on the endocrine organs, may be considered as having endocrine-disrupting properties.
Snovi, kot so snovi, razvrščene v skladu z Uredbo (ES) št. 1272/2008 kot strupene za razmnoževanje kategorije 2 in ki imajo strupen učinek na endokrine žleze ali izpolnjujejo merila za tako razvrstitev, lahko štejejo za snovi, ki imajo lastnosti endokrinih motilcev.
Data requirements for an application
Podatki, ki se zahtevajo za vlogo
An application for approval of an active substance shall contain at least the following elements:
Vloga za odobritev aktivne snovi vsebuje najmanj naslednje elemente:
a dossier for the active substance satisfying the requirements set out in Annex II;
dokumentacijo o aktivni snovi, ki izpolnjuje zahteve iz Priloge II;
a dossier satisfying the requirements set out in Annex III for at least one representative biocidal product that contains the active substance; and
dokumentacijo, ki izpolnjuje zahteve iz Priloge III, o najmanj enem reprezentativnem biocidnem proizvodu, ki vsebuje zadevno aktivno snov, in
if the active substance meets at least one of the exclusion criteria listed in Article 5(1), evidence that Article 5(2) is applicable.
če aktivna snov izpolnjuje vsaj eno od meril za izključitev iz člena 5(1), dokaz, da se uporablja člen 5(2).
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:
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:
the data are not necessary owing to the exposure associated with the proposed uses;
podatki zaradi izpostavljenosti, povezane s predlagano uporabo, niso potrebni;
it is not scientifically necessary to supply the data; or
predložitev podatkov z znanstvenega vidika ni potrebna ali
it is not technically possible to generate the data.
podatkov tehnično ni mogoče pridobiti.
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 Article 10(1), if required by the evaluating competent authority under Article 8(2).
Vendar se zagotovi dovolj podatkov, da je možno ugotoviti, ali aktivna snov izpolnjuje merila iz člena 5(1) ali člena 10(1), če to zahteva ocenjevalni pristojni organ na podlagi člena 8(2).
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.
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.
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.
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 Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying criteria for determining what constitutes adequate justification to adapt the data requirements under paragraph 1 of this Article on the grounds referred to in point (a) of paragraph 2 of this Article.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 83, ki določajo merila za odločitev, kaj predstavlja ustrezno utemeljitev za prilagoditev zahtev glede podatkov v skladu z odstavkom 1 tega člena pod pogoji iz točke (a) odstavka 2 tega člena.
Submission and validation of applications
Vložitev in validacija vlog