natgillin/translations-raw huggingface dataset:
predloži poročilo, v katerem navede, kako ta uredba prispeva k trajnostni rabi biocidnih proizvodov, vključno s potrebo po uvedbi dodatnih ukrepov, zlasti za poklicne uporabnike, da bi zmanjšali tveganja za zdravje ljudi in živali ter za okolje, ki jih predstavljajo biocidnimi proizvodi.
the Commission shall, on the basis of experience gained with the application of this Regulation, present to the Council and the European Parliament a report on how this Regulation contributes to a sustainable use of biocidal products, including on the need to introduce additional measures, in particular for professional users, to reduce the risks posed to human and animal health and the environment by biocidal products.
V tem poročilu se med drugim obravnava:
That report shall, inter alia, examine:
spodbujanje zgledov najboljše prakse, da bi bila uporaba biocidnih proizvodov minimalna;
the promotion of best practices as a means of reducing the use of biocidal products to the minimum;
najučinkovitejši pristopi za spremljanje uporabe biocidnih proizvodov;
the most effective approaches for monitoring the use of biocidal products;
oblikovanje in izvajanje načel celostnega zatiranja škodljivcev pri uporabi biocidnih proizvodov;
the development and application of integrated pest management principles with respect to the use of biocidal products;
tveganja, povezana z uporabo biocidnih proizvodov na določenih območjih, kot so šole, delovna mesta, vrtci, javni prostori, domovi za ostarele, ali v bližini površinske vode ali podtalnice, ter vprašanje, ali so v zvezi s tem potrebni dodatni ukrepi;
the risks posed by the use of biocidal products in specific areas such as schools, workplaces, kindergartens, public spaces, geriatric care centres or in the vicinity of surface or groundwater and whether additional measures are needed to address them;
morebitno vlogo izboljšanega delovanja opreme za uporabo biocidnih proizvodov pri trajnostni rabi.
the role that the improved performance of the equipment used for the application of biocidal products could make to sustainable use.
Na podlagi tega poročila Komisija po potrebi predloži zakonodajni predlog.
On basis of that report, the Commission shall, if appropriate, present a legislative proposal.
Pogoji za izdajo dovoljenja
Conditions for granting an authorisation
Za biocidni proizvod, ki ne izpolnjuje pogojev za poenostavljeni postopek za izdajo dovoljenja v skladu s členom 25, se dovoljenje izda, če izpolnjuje naslednje pogoje:
A biocidal product other than those eligible for the simplified authorisation procedure in accordance with Article 25 shall be authorised provided the following conditions are met:
aktivne snovi za zadevno vrsto proizvoda so odobrene in izpolnjeni so vsi pogoji, ki so določeni za te aktivne snovi;
the active substances are approved for the relevant product-type and any conditions specified for those active substances are met;
v skladu s splošnimi načeli za ocenjevanje dokumentacije o biocidnih proizvodih, določenimi v Prilogi VI, je ugotovljeno, da biocidni proizvod tedaj, ko se uporablja, kot je dovoljeno, in ob upoštevanju dejavnikov iz odstavka 2 tega člena izpolnjuje naslednja merila:
it is established, according to the common principles for the evaluation of dossiers for biocidal products laid down in Annex VI, that the biocidal product, when used as authorised and having regard to the factors referred to in paragraph 2 of this Article, fulfils the following criteria:
je biocidni proizvod dovolj učinkovit;
the biocidal product is sufficiently effective;
biocidni proizvod nima nesprejemljivih učinkov na ciljne organizme, predvsem nesprejemljive odpornosti ali navzkrižne rezistence, oziroma pri vretenčarjih ne povzroča nepotrebnega trpljenja in bolečine;
the biocidal product has no unacceptable effects on the target organisms, in particular unacceptable resistance or cross-resistance or unnecessary suffering and pain for vertebrates;
biocidni proizvod sam po sebi ali zaradi njegovih ostankov nima takojšnjih ali zapoznelih nesprejemljivih učinkov na zdravje živali ali človeka, vključno z ranljivimi skupinami, bodisi neposredno ali prek pitne vode, hrane, krme, zraka ali prek drugih posrednih učinkov;
the biocidal product has no immediate or delayed unacceptable effects itself, or as a result of its residues, on human or animal health, including that of vulnerable groups directly or through drinking water, food, feed, air, or through other indirect effects;
biocidni proizvod sam po sebi ali zaradi svojih ostankov nima nesprejemljivih učinkov na okolje, pri čemer je treba predvsem upoštevati naslednje:
the biocidal product has no unacceptable effects itself, or as a result of its residues, on the environment, having particular regard to the following considerations:
usodo in porazdelitev biocidnega proizvoda v okolju,
the fate and distribution of the biocidal product in the environment;
onesnaženje površinskih voda (vključno s somornico in morsko vodo), podtalnice in pitne vode, zraka in tal, ob upoštevanju lokacij, oddaljenih od kraja njegove uporabe zaradi prenosa v okolju na velike razdalje;
contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil, taking into account locations distant from its use following long-range environmental transportation;
vpliv biocidnega proizvoda na neciljne organizme,
the impact of the biocidal product on non-target organisms;
vpliv biocidnega proizvoda na biotsko raznovrstnost in ekosistem;
the impact of the biocidal product on biodiversity and the ecosystem;
v skladu z ustreznimi zahtevami iz prilog II in III je mogoče določiti njegovo kemijsko identiteto, količino in tehnično ekvivalenco aktivnih snovi v biocidnem proizvodu in, kadar je to primerno, vse toksikološko ali ekotoksikološko znatne in pomembne nečistote in neaktivne snovi, in njegove ostanke toksikološkega ali okoljskega pomena, ki so posledica uporabe, ki je dovoljena;
the chemical identity, quantity and technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant and relevant impurities and non-active substances, and its residues of toxicological or environmental significance, which result from uses to be authorised, can be determined according to the relevant requirements in Annexes II and III;
fizikalne in kemijske lastnosti biocidnega proizvoda so določene in sprejemljive za primerno uporabo in prevoz proizvoda;
the physical and chemical properties of the biocidal product have been determined and deemed acceptable for the purposes of the appropriate use and transport of the product;
po potrebi se za aktivne snovi v biocidnem proizvodu določijo najvišje mejne vrednosti ostankov za hrano in krmo v skladu z Uredbo Sveta(EGS) št. 315/93 z dne 8. februarja 1993 o določitvi postopkov Skupnosti za kontaminate v hrani UL L 37, 13.2.1993, str.
where appropriate, maximum residue limits for food and feed have been established with respect to active substances contained in a biocidal product in accordance with Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food OJ L 37, 13.2.1993, p.
, Uredbo (ES) št. 1935/2004, Uredbo (ES) št. 396/2005 Evropskega parlamenta in Sveta z dne 23. februarja 2005 o mejnih vrednostih ostankov pesticidov v ali na hrani in krmi rastlinskega in živalskega izvora UL L 70, 16.3.2005, str.
, Regulation (EC) No 1935/2004, Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin OJ L 70, 16.3.2005, p.
, Uredbo (ES) št. 470/2009 Evropskega parlamenta in Sveta z dne 6. maja 2009 o določitvi postopkov Skupnosti za določitev mejnih vrednosti ostankov farmakološko aktivnih snovi v živilih živalskega izvora UL L 152, 16.6.2009, str.
, Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin OJ L 152, 16.6.2009, p.
in Direktivo 2002/32/ES Evropskega parlamenta in Sveta z dne 7. maja 2002 o nezaželenih snoveh v živalski krmi UL L 140, 30.5.2002, str.
and Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed OJ L 140, 30.5.2002, p.
pri uporabi nanomaterialov v tem proizvodu je bilo posebej ocenjeno tveganje za okolje in zdravje.
where nanomaterials are used in that product, the risk to the environment and to health has been assessed separately.
Pri ocenjevanju, ali biocidni proizvod izpolnjuje merila iz točke (b) odstavka 1, se upoštevajo zlasti naslednji dejavniki:
The evaluation of whether a biocidal product fulfils the criteria set out in point (b) of paragraph 1 shall take into account the following factors:
realno najslabši možni pogoji, v katerih se biocidni proizvod lahko uporablja;
realistic worst case conditions under which the biocidal product may be used;
način, na kateri se lahko uporabijo tretirani izdelki, ki so tretirani z biocidnim proizvodom ali biocidni proizvod vsebujejo;
the way in which treated articles treated with the biocidal product or containing the biocidal product may be used;
posledice uporabe in odstranjevanja biocidnega proizvoda;
the consequences of use and disposal of the biocidal product;
sinergijski učinki.
synergistic effects.
Biocidni proizvod se dovoli samo za načine uporabe, za katere so bile skladno s členom 20 predložene ustrezne informacije.
A biocidal product shall only be authorised for uses for which relevant information has been submitted in accordance with Article 20.
Dostopnost biocidnega proizvoda na trgu in njegova splošna uporaba se ne dovolita, kadar:
A biocidal product shall not be authorised for making available on the market for use by the general public where:
biocidni proizvod izpolnjuje merila v skladu z Direktivo 1999/45/ES za razvrstitev kot:
it fulfils the criteria according to Directive 1999/45/EC for classification as:
strupen ali zelo strupen;
toxic or very toxic;
rakotvoren kategorije 1 ali 2;
a category 1 or 2 carcinogen;
mutagen kategorije 1 ali 2, ali
a category 1 or 2 mutagen; or
strupen za razmnoževanje kategorije 1 ali 2;
toxic for reproduction category 1 or 2;
biocidni proizvod izpolnjuje merila v skladu z Uredbo (ES) št. 1272/2008 za razvrstitev kot:
it fulfils the criteria according to Regulation (EC) No 1272/2008 for classification as:
z akutno oralno toksičnostjo kategorije 1 ali 2 ali 3;
acute oral toxicity category 1 or 2 or 3;
z akutno dermalno toksičnostjo kategorije 1 ali 2 ali 3;
acute dermal toxicity category 1 or 2 or 3;
z akutno toksičnostjo pri vdihavanju (plini in prah/meglice) kategorije 1 ali 2 ali 3;
acute inhalation toxicity (gases and dust/mist) category 1 or 2 or 3;
z akutno toksičnostjo pri vdihavanju (pare) kategorije 1 ali 2;
acute inhalation toxicity (vapours) category 1 or 2;
rakotvoren kategorije 1A ali 1B;
a category 1A or 1B carcinogen;
mutagen kategorije 1A ali 1B ali
a category 1A or 1B mutagen; or
strupen za razmnoževanje kategorije 1A ali 1B;
toxic for reproduction category 1A or 1B;
biocidni proizvod izpolnjuje merila za PBT ali vPvB, v skladu s Prilogo XIII k Uredbi (ES) št. 1907/2006;
it fulfils the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006;
ima lastnosti hormonskih motilcev ali
it has endocrine-disrupting properties; or
ima nevrotoksične in imunotoksične učinke na razvoj.
it has developmental neurotoxic or immunotoxic effects.
Ne glede na odstavka 1 in 4 se biocidni proizvod lahko dovoli, če pogoji iz odstavka 1(b)(iii) in (iv) niso v celoti izpolnjeni, ali pa se zanj lahko izda dovoljenje za dostopnost na trgu in v splošno uporabo, če so merila iz odstavka 4(c) izpolnjena, kadar bi neizdaja dovoljenja za biocidni proizvod v primerjavi s tveganjem za zdravje človeka ali živali ali za okolje, ki izhaja iz uporabe biocidnega proizvoda pod pogoji, določenimi v dovoljenju, imela nesorazmerne negativne posledice za družbo.
Notwithstanding paragraphs 1 and 4, a biocidal product may be authorised when the conditions laid down in paragraph 1(b)(iii) and (iv) are not fully met, or may be authorised for making available on the market for use by the general public when the criteria referred to in paragraph 4(c) are met, where not authorising the biocidal product would result in disproportionate negative impacts for society when compared to the risks to human or animal health or to the environment arising from the use of the biocidal product under the conditions laid down in the authorisation.
Uporaba biocidnih pripravkov, odobrenih v skladu s tem odstavkom, se omeji na tiste države članice, ki izpolnjujejo pogoje iz tega odstavka.
The use of any biocidal product authorised pursuant to this paragraph shall be restricted to those Member States where the conditions of this paragraph are met.
Pri družini biocidnih proizvodov je dopustno zmanjšanje odstotka ene ali več aktivnih snovi in/ali sprememba odstotka sestave ene ali več neaktivnih snovi in/ali nadomestitev ene ali več neaktivnih snovi z drugimi navedenimi snovmi, ki imajo enako ali manjše tveganje.
In the case of a biocidal product family, a reduction in the percentage of one or more active substances may be allowed, and/or a variation in percentage of one or more non-active substances, and/or the replacement of one or more non-active substances by other specified substances presenting the same or lower risk.
Razvrstitev, stavki o nevarnosti in previdnostni stavki so za vsak proizvod v družini biocidnih proizvodov enaki (razen v družini biocidnih proizvodov, ki zajema koncentrat za poklicno uporabo in proizvode za takojšnjo uporabo, dobljene z redčenjem tega koncentrata).
The classification, hazard and precautionary statements for each product within the biocidal product family shall be the same (with the exception of a biocidal product family comprising a concentrate for professional use and ready-for-use products obtained through dilution of that concentrate).
Družina biocidnih proizvodov se dovoli samo, če se pričakuje, da vsi biocidni proizvodi, ki jo sestavljajo, ob upoštevanju dovoljenih odstopanj iz prvega pododstavka, izpolnjujejo pogoje iz odstavka 1.
A biocidal product family shall be authorised only if all the biocidal products within it, taking into account the permitted variations referred to in the first subparagraph, are expected to comply with the conditions set out in paragraph 1.
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 in Direktivo 2002/32/ES.
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 and Directive 2002/32/EC.
Kjer za aktivne snovi iz člena 10(1)(a) Uredbe (ES) št. 470/2009 v skladu s členom 9 te uredbe ob odobritvi aktivne snovi ni bila določena najvišja mejna vrednost ali kjer je treba spremeniti mejno vrednost, določeno v skladu s členom 9 te uredbe, se najvišja mejna vrednost določi ali spremeni v skladu s postopkom iz člena 10(1)(b) te uredbe.
Where, for active substances covered by Article 10(1)(a) of Regulation (EC) No 470/2009, a maximum residue limit has not 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 following the procedure referred to in Article 10 (1) (b) of that Regulation.
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.
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.
Zahteve za vloge za dovoljenje
Requirements for applications for authorisation
Vlagatelj, ki zaprosi za dovoljenje, skupaj z vlogo predloži naslednje dokumente:
The applicant for an authorisation shall submit the following documents together with the application:
za biocidne proizvode, ki ne izpolnjujejo pogojev iz člena 25:
for biocidal products other than biocidal products meeting the conditions laid down in Article 25:
dokumentacijo ali izjavo o dostopnosti za biocidni proizvod, ki izpolnjuje zahteve iz Priloge III;
a dossier or letter of access for the biocidal product satisfying the requirements set out in Annex III;
povzetek značilnosti biocidnega proizvoda, ki vključuje informacije iz točk (a), (b) in (e) do (m) člena 22(2), kot je potrebno;
a summary of the characteristics of the biocidal product including the information referred to in points (a), (b) and (e) to (m) of Article 22(2), as applicable;
dokumentacijo ali izjavo o dostopnosti za biocidni proizvod, ki izpolnjuje zahteve iz Priloge II, za vsako aktivno snov v biocidnem proizvodu;
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;
za biocidne proizvode, za katere vlagatelj meni, da izpolnjujejo pogoje iz člena 25:
for biocidal products that the applicant considers meet the conditions laid down in Article 25:
povzetek značilnosti biocidnega proizvoda iz točke (a)(ii) tega odstavka;
a summary of the characteristics of the biocidal product as referred to in point (a)(ii) of this paragraph;
podatke o učinkovitosti in
efficacy data; and
kakršne koli druge ustrezne informacije v podporo sklepu, da biocidni proizvod izpolnjuje pogoje iz člena 25.
any other relevant information in support of the conclusion that the biocidal product meets the conditions laid down in Article 25.
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.
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.
Za vloge za izdajo dovoljenja Unije, predložene v skladu s členom 43, se povzetek značilnosti biocidnega proizvoda iz točke (ii) odstavka 1(a) tega člena ob oddaji vloge zagotovi v enem od uradnih jezikov Unije, sprejemljivem za ocenjevalni pristojni organ, in v vseh uradnih jezikih Unije pred izdajo dovoljenja za izdelek.
For applications for Union authorisations submitted under Article 43, the summary of the characteristics of the biocidal product referred to in point (ii) of paragraph(1)(a) of this Article shall be provided 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 product.
Odstop od zahtev glede podatkov
Waiving of data requirements
Z odstopanjem od člena 20 vlagatelju ni treba predložiti podatkov, ki se zahtevajo po navedenem členu, kadar je izpolnjen kateri od naslednjih pogojev:
By way of derogation from Article 20, the applicant need not provide data required under that Article where any of the following applies:
Vlagatelj lahko v skladu s Prilogo IV predlaga prilagoditev zahtev po podatkih iz člena 20.
The applicant may propose to adapt the data requirements of Article 20 in accordance with Annex IV.
Utemeljitev za predlagane prilagoditve zahtev glede podatkov se v vlogi jasno navede s sklicevanjem na posebna pravila v Prilogi IV.
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.
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.
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.
Vsebina dovoljenja
Content of authorisation
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.
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.
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:
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:
trgovska imena biocidnih proizvodov iz družine biocidnih proizvodov;
trade name of the biocidal product;
datum dovoljenja in datum izteka veljavnosti dovoljenja;
date of the authorisation and its date of expiry;
številko dovoljenja biocidnega proizvoda skupaj s, v primeru družine biocidnega proizvoda, priponami za posamezne biocidne proizvode iz družine biocidnih proizvodov;
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;
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 %;
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 %;
proizvajalce biocidnih proizvodov (imena in naslovi, vključno s krajem proizvodnih obratov);
manufacturers of the biocidal product (names and addresses including location of manufacturing sites);
proizvajalce aktivnih snovi (imena in naslovi, vključno s krajem proizvodnih obratov);
manufacturers of the active substances (names and addresses including location of manufacturing sites);
vrsto formulacije biocidnih proizvodov;
type of formulation of the biocidal product;
vrsto proizvoda in po potrebi natančen opis dovoljene uporabe;
product-type and, where relevant, an exact description of the authorised use;
ciljne škodljive organizme;
target harmful organisms;
odmerke in navodila za uporabo;
application doses and instructions for use;
skupine uporabnikov;
categories of users;