natgillin/translations-raw huggingface dataset:
Articles 48 and 52 shall apply accordingly.
Ustrezno se uporabljata člena 48 in 52.
Review of approval of an active substance
Pregled odobritve aktivne snovi
The Commission may review the approval of an active substance for one or more product-types at any time where there are significant indications that the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2) are no longer met.
Komisija lahko kadar koli pregleda odobritev aktivne snovi za eno ali več vrst proizvodov, če se pojavijo pomenljivi znaki, da pogoji iz člena 4(1) ali, kjer je to ustrezno, pogoji iz člena 5(2) niso več izpolnjeni.
The Commission may also review the approval of an active substance for one or more product-types at the request of a Member State if there are indications that the use of the active substance in biocidal products or treated articles raises significant concerns about the safety of such biocidal products or treated articles.
Komisija lahko na zahtevo države članice pregleda tudi odobritev aktivne snovi za eno ali več vrst proizvodov, če se pojavijo pomenljivi znaki, da uporaba aktivne snovi v biocidnem proizvodu ali tretiranem izdelku povzroča resno zaskrbljenost glede varnosti tega biocidnega proizvoda ali tretiranega izdelka.
The Commission shall make publicly available the information that it is carrying out a review and shall provide an opportunity for applicant to submit comments.
Komisija javnost obvesti o informaciji, da opravlja pregled, in vlagatelju omogoči predložitev pripomb.
The Commission shall take due account of those comments in its review.
Komisija te pripombe pri pregledu ustrezno upošteva.
Where those indications are confirmed, the Commission shall adopt an implementing Regulation amending the conditions of approval of an active substance or cancelling its approval.
Kadar so ti znaki potrjeni, Komisija sprejme izvedbeno uredbo o spremembi pogojev za odobritev aktivne snovi ali o preklicu odobritve.
That implementing Regulation shall be adopted in accordance with the examination procedure referred to in Article 82(3).
Ta izvedbena uredba se sprejme v skladu s postopkom pregleda iz člena 82(3).
The Commission shall inform the initial applicants for the approval accordingly.
Komisija ustrezno obvesti začetne vlagatelje vloge za odobritev.
On duly justified imperative grounds of urgency the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 82(4).
V ustrezno utemeljenih nujnih primerih lahko Komisija v skladu s postopkom iz člena 82(4) sprejme izvedbene akte, ki se začnejo nemudoma uporabljati.
The Commission may consult the Agency on any questions of a scientific or technical nature related to the review of approval of an active substance.
Komisija se lahko o katerih koli znanstvenih ali tehničnih vprašanjih, povezanih s pregledom odobritve aktivne snovi, posvetuje z Agencijo.
The Agency shall, within 270 days of the request, prepare an opinion and submit it to the Commission.
Agencija v 270 dneh od datuma zahteve pripravi mnenje in ga predloži Komisiji.
Where the Commission decides to cancel or amend the approval of an active substance for one or more product-types, the Member States or, in the case of a Union authorisation, the Commission shall cancel or, where appropriate, amend the authorisations of biocidal products of the product-type(s) concerned containing that active substance.
Kadar Komisija odloči, da prekliče ali spremeni odobritev aktivne snovi za eno ali več vrst proizvodov, države članice ali, v primeru dovoljenja Unije, Komisija prekličejo ali, kjer je primerno, spremenijo dovoljenja biocidnih proizvodov zadevne vrste oziroma vrst proizvodov, ki vsebujejo to aktivno snov.
The Commission may adopt, by means of implementing acts, detailed measures for the implementation of Articles 12 to 15, further specifying the procedures for the renewal and review of the approval of an active substance.
Komisija lahko z izvedbenimi akti sprejme podrobne ukrepe za izvajanje členov 12 do 15, s katerimi se podrobneje določijo postopki za podaljšanje in pregled odobritve aktivne snovi.
GENERAL PRINCIPLES CONCERNING THE AUTHORISATION OF BIOCIDAL PRODUCTS
SPLOŠNA NAČELA ZA DOVOLJENJA ZA BIOCIDNE PROIZVODE
Making available on the market and use of biocidal products
Dostopnost na trgu in uporaba biocidnih proizvodov
Biocidal products shall not be made available on the market or used unless authorised in accordance with this Regulation.
Biocidni proizvodi niso dostopni na trgu oziroma se ne uporabljajo, razen če je bilo za to izdano dovoljenje v skladu s to uredbo.
Applications for authorisation shall be made by, or on behalf of, the prospective authorisation holder.
Vloge za dovoljenje vloži morebitni imetnik dovoljenja ali se vložijo v njegovem imenu.
Applications for national authorisation in a Member State shall be submitted to the competent authority of that Member State (‘the receiving competent authority’).
Vloge za nacionalno dovoljenje v državi članici se vložijo pri pristojnem organu te države članice (v nadaljnjem besedilu: pristojni organ prejemnik).
Applications for Union authorisation shall be submitted to the Agency.
Vloge za dovoljenje Unije se vložijo pri Agenciji.
An authorisation may be granted for a single biocidal product or a biocidal product family.
Dovoljenje se lahko izda za posamezen biocidni proizvod ali družino biocidnih proizvodov.
An authorisation shall be granted for a maximum period of 10 years.
Dovoljenje se izda za največ 10 let.
Biocidal products shall be used in compliance with the terms and conditions of the authorisation stipulated in accordance with Article 22(1) and the labelling and packaging requirements laid down in Article 69.
Biocidni proizvodi se uporabljajo v skladu z določili in pogoji za izdajo dovoljenja, določenimi v skladu s členom 22(1), ter z zahtevami glede označevanja in pakiranja iz člena 69.
Proper use shall involve the rational application of a combination of physical, biological, chemical or other measures as appropriate, whereby the use of biocidal products is limited to the minimum necessary and appropriate precautionary steps are taken.
Pravilna uporaba vključuje racionalno izvajanje skupka fizikalnih, bioloških, kemijskih ali po potrebi drugih ukrepov, pri čemer je uporaba biocidnih proizvodov omejena na najmanjšo potrebno mero, ki jo spremljajo sprejeti varnostni ukrepi.
Member States shall take necessary measures to provide the public with appropriate information about the benefits and risks associated with biocidal products and ways of minimising their use.
Države članice sprejmejo potrebne ukrepe, da javnosti zagotovijo ustrezne informacije o koristih in tveganjih, povezanih z biocidnimi proizvodi, ter informacije o načinih za čim manjšo uporabo biocidnih proizvodov.
The authorisation holder shall notify each competent authority that has granted a national authorisation for a biocidal product family of each product within the biocidal product family at least 30 days before placing it on the market, except where a particular product is explicitly identified in the authorisation or the variation in composition concerns only pigments, perfumes and dyes within the permitted variations.
Imetnik dovoljenja obvesti vsak pristojni organ, ki je izdal nacionalno dovoljenje za družino biocidnih proizvodov, o vsakem proizvodu te družine biocidnih proizvodov, najmanj 30 dni, preden ga da na trg, razen takrat, kadar je določeni proizvod izrecno opredeljen v dovoljenju ali kadar se odstopanje v sestavi nanaša le na pigmente, dišave in barvila, in sicer v okviru dovoljenih odstopanj.
The notification shall indicate the exact composition, trade name and suffix to the authorisation number.
V obvestilu navede točno sestavo, trgovsko ime in pripono k številki dovoljenja.
In the case of a Union authorisation, the authorisation holder shall notify the Agency and the Commission.
V primeru dovoljenja Unije imetnik dovoljenja obvesti Agencijo in Komisijo.
The Commission shall, by means of an implementing act, specify procedures for the authorisation of the same biocidal products by the same or different enterprises under the same terms and conditions.
Komisija z izvedbenim aktom določi postopke za izdajo dovoljenja za iste biocidne proizvode istega ali drugega podjetja pod enakimi določili in pogoji.
That implementing act shall be adopted in accordance with the examination procedure referred to in Article 82(3).
Ta izvedbeni akt se sprejme v skladu s postopkom pregleda iz člena 82(3).
Measures geared to the sustainable use of biocidal products
Ukrepi za trajnostno uporabo biocidnih proizvodov
By 18 July 2015 the Commission shall, on the basis of experience gained with the application of this Regulation, submit to the European Parliament and the Council a report on how this Regulation is contributing to the 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 health, animal health and the environment by biocidal products.
Komisija na podlagi izkušenj, pridobljenih z uporabo te uredbe, Evropskemu parlamentu in Svetu do 18. julija 2015 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 človeka, zdravje živali ter okolje, ki jih predstavljajo biocidnimi proizvodi.
That report shall, inter alia, examine:
V tem poročilu se med drugim obravnava:
the promotion of best practices as a means of reducing the use of biocidal products to a minimum;
spodbujanje zgledov najboljše prakse, da bi bila uporaba biocidnih proizvodov čim manjša;
the most effective approaches for monitoring the use of biocidal products;
najučinkovitejši pristopi za spremljanje uporabe biocidnih proizvodov;
the development and application of integrated pest management principles with respect to the use of biocidal products;
oblikovanje in izvajanje načel celostnega zatiranja škodljivcev pri uporabi biocidnih proizvodov;
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 water or groundwater and whether additional measures are needed to address those risks;
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 temi tveganji potrebni dodatni ukrepi;
the role that improved performance of the equipment used for applying biocidal products could play in sustainable use.
morebitno vlogo izboljšanega delovanja opreme za uporabo biocidnih proizvodov pri trajnostni rabi.
On basis of that report, the Commission shall, if appropriate, submit a proposal for adoption in accordance with the ordinary legislative procedure.
Na podlagi tega poročila Komisija po potrebi predloži v sprejetje predlog v skladu z rednim zakonodajnim postopkom.
Conditions for granting an authorisation
Pogoji za izdajo dovoljenja
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:
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:
the active substances are approved for the relevant product-type and any conditions specified for those active substances are met;
aktivne snovi za zadevno vrsto proizvoda so odobrene in izpolnjeni so vsi pogoji, ki so določeni za te aktivne snovi;
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:
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:
the biocidal product is sufficiently effective;
je biocidni proizvod dovolj učinkovit;
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 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 immediate or delayed unacceptable effects itself, or as a result of its residues, on the health of humans, including that of vulnerable groups, or animals, directly or through drinking water, food, feed, air, or through other indirect effects;
biocidni proizvod sam po sebi ali zaradi njegovih ostankov nima takojšnjih ali zapoznelih nesprejemljivih učinkov na zdravje ljudi, vključno z ranljivimi skupinami, ali živali, bodisi neposredno ali prek pitne vode, hrane, krme, zraka ali prek drugih posrednih učinkov;
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:
biocidni proizvod sam po sebi ali zaradi svojih ostankov nima nesprejemljivih učinkov na okolje, pri čemer je treba predvsem upoštevati naslednje:
the fate and distribution of the biocidal product in the environment,
usodo in porazdelitev biocidnega proizvoda v okolju,
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,
onesnaženje površinskih voda (vključno s somornico in morsko vodo), podtalnice in pitne vode, zraka ter tal ob upoštevanju lokacij, oddaljenih od kraja uporabe snovi zaradi prenosa v okolju na velike razdalje,
the impact of the biocidal product on non-target organisms,
vpliv biocidnega proizvoda na neciljne organizme,
the impact of the biocidal product on biodiversity and the ecosystem;
vpliv biocidnega proizvoda na biotsko raznovrstnost in ekosistem;
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;
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 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;
fizikalne in kemijske lastnosti biocidnega proizvoda so določene in sprejemljive za primerno uporabo in prevoz proizvoda;
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 [42], Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food [43], 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 [44], 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 [45] or Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed [46];
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 [42], Uredbo (ES) št. 1935/2004 Evropskega parlamenta in Sveta z dne 27. oktobra 2004 o materialih in izdelkih, namenjenih za stik z živili [43], 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 [44], 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 [45] ali Direktivo 2002/32/ES Evropskega parlamenta in Sveta z dne 7. maja 2002 o nezaželenih snoveh v živalski krmi [46];
where nanomaterials are used in that product, the risk to human health, animal health and the environment has been assessed separately.
pri uporabi nanomaterialov v tem proizvodu je bilo posebej ocenjeno tveganje za zdravje človeka, zdravje živali in okolje.
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:
Pri ocenjevanju, ali biocidni proizvod izpolnjuje merila iz točke (b) odstavka 1, se upoštevajo zlasti naslednji dejavniki:
realistic worst case conditions under which the biocidal product may be used;
realno najslabši možni pogoji, v katerih se biocidni proizvod lahko uporablja;
the way in which treated articles treated with the biocidal product or containing 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 consequences of use and disposal of the biocidal product;
posledice uporabe in odstranjevanja biocidnega proizvoda;
cumulative effects;
kumulativni učinki;
synergistic effects.
sinergijski učinki.
A biocidal product shall only be authorised for uses for which relevant information has been submitted in accordance with Article 20.
Biocidni proizvod se dovoli samo za načine uporabe, za katere so bile skladno s členom 20 predložene ustrezne informacije.
A biocidal product shall not be authorised for making available on the market for use by the general public where:
Dostopnost biocidnega proizvoda na trgu in njegova splošna uporaba se ne dovolita, kadar:
it meets the criteria according to Directive 1999/45/EC for classification as:
biocidni proizvod izpolnjuje merila v skladu z Direktivo 1999/45/ES za razvrstitev kot:
toxic or very toxic,
strupen ali zelo strupen,
a category 1 or 2 carcinogen,
rakotvoren kategorije 1 ali 2,
a category 1 or 2 mutagen, or
mutagen kategorije 1 ali 2 ali
toxic for reproduction category 1 or 2;
strupen za razmnoževanje kategorije 1 ali 2;
it meets the criteria according to Regulation (EC) No 1272/2008 for classification as:
biocidni proizvod izpolnjuje merila v skladu z Uredbo (ES) št. 1272/2008 za razvrstitev kot:
acute oral toxicity category 1 or 2 or 3,
z akutno oralno toksičnostjo kategorije 1 ali 2 ali 3,
acute dermal toxicity category 1 or 2 or 3,
z akutno dermalno toksičnostjo kategorije 1 ali 2 ali 3,
acute inhalation toxicity (gases and dust/mist) category 1 or 2 or 3,
z akutno toksičnostjo pri vdihavanju (plini in prah/meglice) kategorije 1 ali 2 ali 3,
acute inhalation toxicity (vapours) category 1 or 2,
z akutno toksičnostjo pri vdihavanju (pare) kategorije 1 ali 2,
a category 1A or 1B carcinogen,
rakotvoren kategorije 1A ali 1B,
a category 1A or 1B mutagen, or
mutagen kategorije 1A ali 1B ali
toxic for reproduction category 1A or 1B;
strupen za razmnoževanje kategorije 1A ali 1B;
it meets the criteria for being PBT or vPvB in accordance with Annex XIII to Regulation (EC) No 1907/2006;
biocidni proizvod izpolnjuje merila za PBT ali vPvB v skladu s Prilogo XIII k Uredbi (ES) št. 1907/2006;
it has endocrine-disrupting properties; or
ima biocidni proizvod lastnosti hormonskih motilcev ali
it has developmental neurotoxic or immunotoxic effects.
ima biocidni proizvod nevrotoksične ali imunotoksične učinke na razvoj.
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 health, animal health or the environment arising from the use of the biocidal product under the conditions laid down in the authorisation.
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, zdravje živali ali okolje, ki izhaja iz uporabe biocidnega proizvoda pod pogoji, določenimi v dovoljenju, imela nesorazmerni negativni učinek za družbo.
The use of a biocidal product authorised pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment to that biocidal product is minimised.
Za uporabo biocidnega proizvoda, odobrenega v skladu s tem odstavkom, veljajo ustrezni ukrepi za zmanjšanje tveganja, da bi se zagotovila najmanjša izpostavljenost ljudi in okolja temu biocidnemu proizvodu.
The use of a biocidal product authorised pursuant to this paragraph shall be restricted to Member States in which the condition of the first subparagraph is met.
Uporaba biocidnega proizvoda, odobrenega v skladu s tem odstavkom, se omeji na države članice, ki izpolnjujejo pogoj iz prvega pododstavka.
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.
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.
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).
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).
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.
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.