natgillin/translations-raw huggingface dataset:
a draft label for the biocidal product intended to be made available on the market in the Member State of introduction in the official language or languages of the Member State of introduction, unless that Member State provides otherwise;
osnutek oznake za biociden proizvod, ki je namenjen dostopnosti na trgu v državi članici vnosa, v uradnem jeziku ali jezikih države članice vnosa, razen če slednja določi drugače;
a sample of the biocidal product which is intended to be introduced if it is considered as necessary by the competent authority of the Member State of introduction;
vzorec biocidnega proizvoda, ki je namenjen za vnos, če pristojni organ države članice vnosa meni, da je to potrebno;
name and authorisation number of the reference product in the Member State of introduction.
ime in številko dovoljenja za referenčni proizvod v državi članici vnosa.
The competent authority of the Member State of introduction may require a translation of the relevant parts of the original instructions for the use referred to in point (d).
Pristojni organ države članice vnosa lahko zahteva prevod zadevnih delov izvirnih navodil za uporabo iz točke (d).
The parallel trade permit shall prescribe the same conditions for making available on the market and use as the authorisation of the reference product.
Dovoljenje za vzporedno trgovanje določa iste pogoje za dostopnost na trgu in uporabo kot dovoljenje za referenčni proizvod.
The parallel trade permit shall be valid for the duration of authorisation of the reference product in the Member State of introduction.
Dovoljenje za vzporedno trgovanje velja v obdobju veljavnosti dovoljenja za referenčni proizvod v državi članici vnosa.
If the authorisation holder of the reference product applies for cancellation of authorisation in accordance with Article 49 and the requirements of Article 19 are still fulfilled, the validity of the parallel trade permit shall expire on the date on which the authorisation of the reference product would normally have expired.
Če imetnik dovoljenja za referenčni proizvod zaprosi za preklic dovoljenja v skladu s členom 49 in so zahteve iz člena 19 še vedno izpolnjene, veljavnost dovoljenja za vzporedno trgovanje poteče na dan, ko bi običajno potekla veljavnost dovoljenja za referenčni proizvod.
Without prejudice to specific provisions in this Article, Articles 47 to 50 and Chapter XV shall apply mutatis mutandis to biocidal products made available on the market under a parallel trade permit.
Brez poseganja v posebne določbe iz tega člena veljajo členi 47 do 50 in poglavje XV smiselno za biocidne proizvode, ki so dostopni na trgu na podlagi dovoljenja za vzporedno trgovanje.
The competent authority of the Member State of introduction may withdraw a parallel trade permit if the authorisation of the introduced biocidal product is withdrawn in the Member State of origin because of safety or efficacy reasons.
Pristojni organ države članice vnosa lahko umakne dovoljenje za vzporedno trgovanje, če se dovoljenje za vneseni biocidni proizvod v državi članici porekla umakne zaradi razlogov varnosti ali učinkovitosti.
TECHNICAL EQUIVALENCE
TEHNIČNA EKVIVALENCA
Assessment of technical equivalence
Ocenjevanje tehnične ekvivalence
Where it is necessary to establish the technical equivalence of active substances, the person seeking to establish that equivalence (‘the applicant’) shall submit an application to the Agency and pay the applicable fees in accordance with Article 80(1).
Kadar je potrebno, da se ugotovi tehnična ekvivalenca aktivnih snovi, oseba, ki želi ugotoviti zadevno enakovrednost (v nadaljnjem besedilu: vlagatelj), vloži vlogo pri Agenciji in v skladu s členom 80(1) plača pristojbine, ki se uporabljajo.
The applicant shall submit all data that the Agency requires to assess technical equivalence.
Vlagatelj predloži vse podatke, ki jih Agencija zahteva za ocenitev tehnične ekvivalence.
After giving the applicant the opportunity to submit comments, the Agency shall take a decision within 90 days of receipt of the application referred to in paragraph 1 and shall communicate it to Member States and to the applicant.
Agencija po tem, ko je vlagatelju dala možnost predložitve pripomb, v 90 dneh po prejetju vloge iz odstavka 1 sprejme sklep in o njem obvesti države članice in vlagatelja.
Where, in the opinion of the Agency, additional information is necessary to carry out the assessment of technical equivalence, the Agency shall ask the applicant to submit such information within a time limit specified by the Agency.
Kadar so po mnenju Agencije potrebne dodatne informacije za izvedbo ocene tehnične ekvivalence, Agencija pozove vlagatelja, naj predloži takšne informacije v roku, ki ga določi Agencija.
The Agency shall reject the application if the applicant fails to submit the additional information within the specified time limit.
Agencija vlogo zavrne, če vlagatelj v določenem roku ni predložil dodatnih informacij.
The 90-day period referred to in paragraph 4 shall be suspended from the date of issue of the request until the information is received.
Obdobje 90 dni iz odstavka 4 se prekine od dneva izdaje zahtevka do prejema informacij.
The suspension shall not exceed 180 days except where justified by the nature of the data requested or in exceptional circumstances.
Prekinitev ne presega 180 dni, razen če je to upravičeno zaradi narave zahtevanih podatkov ali izrednih okoliščin.
Where appropriate, the Agency may consult the competent authority of the Member State which acted as the evaluating competent authority for the evaluation of the active substance.
Agencija se lahko po potrebi posvetuje s pristojnim organom države članice, ki je bil ocenjevalni pristojni organ za ocenjevanje aktivne snovi.
An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraphs 3, 4 and 5 of this Article.
V skladu s členom 77 se lahko proti sklepom Agencije na podlagi odstavkov 3, 4 in 5 tega člena vloži pritožba.
The Agency shall draw up technical guidance notes to facilitate the implementation of this Article.
Agencija pripravi tehnična navodila zaradi lažje uporabe tega člena.
Derogation from the requirements
Odstopanje od zahtev
By way of derogation from Articles 17 and 19, a competent authority may permit, for a period not exceeding 180 days, the making available on the market or use of a biocidal product which does not fulfil the conditions for authorisation laid down in this Regulation, for a limited and controlled use under the supervision of the competent authority, if such a measure is necessary because of a danger to public health, animal health or the environment which cannot be contained by other means.
Z odstopanjem od členov 17 in 19 lahko pristojni organ dovoli za obdobje, ki ni daljše od 180 dni, dostopnost na trgu ali uporabo biocidnega proizvoda, ki ne izpolnjuje pogojev za dovoljenje iz te uredbe, in sicer za omejeno in nadzorovano uporabo pod nadzorom pristojnega organa, če je takšen ukrep potreben zaradi nevarnosti za javno zdravje, zdravje živali ali okolje, ki je ni mogoče obvladati z drugimi sredstvi.
The competent authority referred to in the first subparagraph shall, without delay, inform the other competent authorities and the Commission of its action and the justification for it.
Pristojni organ iz prvega pododstavka nemudoma obvesti druge pristojne organe in Komisijo o svojem ukrepu in razlogih zanj.
The competent authority shall, without delay, inform the other competent authorities and the Commission of the revocation of such action.
Pristojni organ nemudoma obvesti druge pristojne organe in Komisijo o preklicu takšnega ukrepa.
On receipt of a reasoned request from the competent authority, the Commission shall, without delay and by means of implementing acts, decide whether, and under what conditions, the action taken by that competent authority may be extended, for a period not exceeding 550 days.
Na podlagi prejema utemeljene zahteve pristojnega organa Komisija z izvedbenimi akti nemudoma odloči, ali in pod kakšnimi pogoji je mogoče ukrep, ki ga je sprejel ta pristojni organ, podaljšati za obdobje, ki ni daljše od 550 dni.
By way of derogation from point (a) of Article 19(1) and until an active substance is approved, competent authorities and the Commission may authorise, for a period not exceeding three years, a biocidal product containing a new active substance.
Z odstopanjem od točke (a) člena 19(1) lahko pristojni organi in Komisija do odobritve aktivne snovi za obdobje, ki ni daljše od treh let, izdajo dovoljenje za biocidni proizvod, ki vsebuje novo aktivno snov.
Such a provisional authorisation may be issued only if, after dossiers have been evaluated in accordance with Article 8, the evaluating competent authority has submitted a recommendation for approval of the new active substance and the competent authorities which received the application for the provisional authorisation or, in the case of a provisional Union authorisation, the Agency, consider that the biocidal product is expected to comply with points (b), (c) and (d) of Article 19(1) taking into account the factors set out in Article 19(2).
Takšno začasno dovoljenje se lahko izda le, če ocenjevalni pristojni organ po oceni dokumentacije v skladu s členom 8 predloži priporočilo za odobritev nove aktivne snovi in pristojni organi, ki so prejeli vlogo za začasno dovoljenje, ali, v primeru začasnega dovoljenja Unije, Agencija menijo, da se od biocidnega proizvoda ob upoštevanju dejavnikov iz člena 19(2) pričakuje skladnost s točkami (b), (c) in (d) člena 19(1).
If the Commission decides not to approve the new active substance, the competent authorities which granted the provisional authorisation or the Commission shall cancel that authorisation.
Če Komisija odloči, da nove aktivne snovi ne odobri, pristojni organi, ki so izdali začasno dovoljenje, ali Komisija to dovoljenje prekličejo.
Where a decision on the approval of the new active substance has not yet been adopted by the Commission when the period of three years expires, the competent authorities which granted the provisional authorisation, or the Commission, may extend the provisional authorisation for a period not exceeding one year, provided that there are good reasons to believe that the active substance will satisfy the conditions laid down in Article 4(1) or, where applicable, the conditions set out in Article 5(2).
Če Komisija po preteku treh let še ni sprejela odločitve o odobritvi nove aktivne snovi, lahko pristojni organi, ki so izdali začasno dovoljenje, ali Komisija podaljšajo začasno dovoljenje za obdobje, ki ni daljše od enega leta, pod pogojem, da obstajajo tehtni razlogi za predpostavko, da bo aktivna snov ustrezala pogojem iz člena 4(1) ali, kadar je ustrezno, pogojem iz člena 5(2).
Competent authorities which extend the provisional authorisation shall inform the other competent authorities and the Commission of such action.
Pristojni organi, ki podaljšajo začasno dovoljenje, o tem obvestijo druge pristojne organe in Komisijo.
By way of derogation from point (a) of Article 19(1), the Commission may, by means of implementing acts, allow a Member State to authorise a biocidal product containing a non-approved active substance if it is satisfied that that active substance is essential for the protection of cultural heritage and that no appropriate alternatives are available.
Z odstopanjem od točke (a) člena 19(1) lahko Komisija z izvedbenimi akti dovoli državi članici, da izda dovoljenje za biocidni proizvod, ki vsebuje neodobreno aktivno snov, če je ta aktivna snov bistvena za zaščito kulturne dediščine in da ni na voljo ustreznih nadomestnih možnosti.
A Member State wishing to obtain such a derogation shall apply to the Commission, providing due justification.
Država članica, ki želi zaprositi za takšno odstopanje, pri Komisiji vloži vlogo in navede ustrezno utemeljitev.
By way of derogation from Article 17, an experiment or a test for the purposes of research or development involving an unauthorised biocidal product or a non-approved active substance intended exclusively for use in a biocidal product (‘experiment’ or ‘test’) may take place only under the conditions laid down in this Article.
Z odstopanjem od člena 17 se lahko poskus ali preskus, namenjen za raziskave ali razvoj, ki vključuje biocidni proizvod, za katerega ni bilo izdano dovoljenje, ali neodobreno aktivno snov, ki je namenjena izključno za uporabo v biocidnem proizvodu (v nadaljnjem besedilu: poskus ali preskus), izvede le pod pogoji iz tega člena.
Persons carrying out an experiment or test shall draw up and maintain written records detailing the identity of the biocidal product or active substance, labelling data, quantities supplied and the names and addresses of those persons receiving the biocidal product or active substance, and shall compile a dossier containing all available data on possible effects on human or animal health or impact on the environment.
Osebe, ki izvajajo poskus ali preskus, sestavijo in hranijo pisno evidenco, ki vsebuje podroben opis biocidnega proizvoda ali aktivne snovi, podatke o označevanju, dobavljene količine ter imena in naslove prejemnikov biocidnega proizvoda ali aktivne snovi, ter zberejo dokumentacijo, ki vsebuje vse razpoložljive podatke o možnih učinkih na zdravje človeka ali živali ali vplivu na okolje.
They shall make this information available to the competent authority on request.
Te podatke na zahtevo dajo na voljo pristojnemu organu.
Any person intending to carry out an experiment or test that may involve, or result in, release of the biocidal product into the environment shall first notify the competent authority of the Member State where the experiment or test will occur.
Katera koli oseba, ki namerava izvesti poskus ali preskus, ki lahko vključuje ali ima za posledico sproščanje biocidnega proizvoda v okolje, o tem najprej obvesti pristojni organ države članice, v kateri bo poskus ali preskus izveden.
The notification shall include the identity of the biocidal product or active substance, labelling data and quantities supplied, and all available data on possible effects on human or animal health or impact on the environment.
To obvestilo vključuje opis biocidnega proizvoda ali aktivne snovi, podatke o označevanju in dobavljene količine ter vse razpoložljive podatke o možnih učinkih na zdravje človeka ali živali ali vplivu na okolje.
The person concerned shall make available any other information requested by the competent authorities.
Zadevna oseba da na razpolago kakršne koli druge informacije, ki jih zahtevajo pristojni organi.
In the absence of an opinion from the competent authority within 45 days of the notification referred to in the first subparagraph, the notified experiment or test may take place.
Če pristojni organ v 45 dneh po prejemu obvestila iz prvega pododstavka ne predloži mnenja, se priglašeni poskus ali preskus lahko izvede.
If the experiments or tests could have harmful effects, whether immediate or delayed, on the health of humans, particularly of vulnerable groups, or animals, or any unacceptable adverse effect on humans, animals or the environment, the relevant competent authority of the Member State concerned may prohibit them or allow them subject to such conditions as it considers necessary to prevent those consequences.
Če bi poskusi ali preskusi lahko imeli takojšnje ali zapoznele škodljive učinke na zdravje ljudi, zlasti ranljivih skupin, ali živali ali kakršen koli nesprejemljiv neželen vpliv na ljudi, živali ali okolje, jih lahko ustrezni pristojni organ zadevne države članice prepove ali pa dovoli pod pogoji, za katere meni, da so potrebni za preprečitev teh posledic.
The competent authority shall, without delay, inform the Commission and other competent authorities of its decision.
Pristojni organ o svoji odločitvi nemudoma obvesti Komisijo in druge pristojne organe.
The Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying detailed rules supplementing this Article.
Na Komisijo se prenesejo pooblastila za sprejetje delegiranih aktov v skladu s členom 83, ki določijo podrobna pravila za dopolnitev tega člena.
Exemption from registration under Regulation (EC) No 1907/2006
Izjema od obveznosti registracije v skladu z Uredbo (ES) št. 1907/2006
In addition to the active substances referred to in Article 15(2) of Regulation (EC) No 1907/2006, active substances manufactured or imported for use in biocidal products authorised for placing on the market in accordance with Article 27, 55 or 56 shall be regarded as being registered and the registration as completed for manufacture or import for use in a biocidal product and therefore as fulfilling the requirements of Chapters 1 and 5, Title II of Regulation (EC) No 1907/2006.
Poleg aktivnih snovi iz člena 15(2) Uredbe (ES) št. 1907/2006 se za aktivne snovi, proizvedene ali uvožene za uporabo v biocidnih proizvodih, za katere je dovoljeno, da se v skladu s členom 27, členom 55 ali členom 56 dajo na trg, šteje, da so registrirane in da je njihova registracija končana za proizvodnjo ali uvoz za uporabo v biocidnem proizvodu ter so s tem izpolnjene zahteve iz poglavij 1 in 5 naslova II Uredbe (ES) št. 1907/2006.
TREATED ARTICLES
TRETIRANI IZDELKI
Placing on the market of treated articles
Dajanje tretiranih izdelkov na trg
This Article shall apply exclusively to treated articles that are not biocidal products.
Ta člen se uporablja izključno za tretirane izdelke, ki niso biocidni proizvodi.
It shall not apply to treated articles where the sole treatment undertaken was the fumigation or disinfection of premises or containers used for storage or transport and where no residues are expected to remain from such treatment.
Ne uporablja se za tretirane izdelke, ki so bili tretirani izključno zaradi zaplinjevanja ali razkužitve prostorov ali posod, uporabljenih za hrambo ali prevoz, ter ki naj ne bi vsebovali ostankov po takšnem tretiranju.
A treated article shall not be placed on the market unless all active substances contained in the biocidal products that it was treated with or incorporates are included in the list drawn up in accordance with Article 9(2), for the relevant product-type and use, or in Annex I, and any conditions or restrictions specified therein are met.
Tretirani izdelek se ne daje na trg, razen če so vse aktivne snovi v biocidnem proizvodu, ki se uporabi za tretiranje izdelka ali ga tretirani izdelek vsebuje, vključene v seznam, sestavljen v skladu s členom 9(2), za ustrezno vrsto proizvoda in uporabo, ali pa v Prilogo I ter so izpolnjeni vsi pogoji ali omejitve iz Priloge I.
The person responsible for the placing on the market of such a treated article shall ensure that the label provides the information listed in the second subparagraph, where:
Oseba, ki je odgovorna za dajanje tega tretiranega izdelka na trg, zagotovi, da so v oznaki navedene informacije, naštete v drugem pododstavku, pri čemer:
in the case of a treated article containing a biocidal product, a claim is made by the manufacturer of that treated article regarding the biocidal properties of the article, or
v primeru tretiranega izdelka, ki vsebuje biocidni proizvod, proizvajalec tega tretiranega izdelka poda navedbo glede biocidnih lastnosti tega izdelka, ali
in relation to the active substance(s) concerned, having particular regard to the possibility of contact with humans or the release into the environment, the conditions associated with the approval of the active substance(s) so require.
v zvezi z zadevno aktivno oziroma aktivnimi snovmi, ob upoštevanju možnosti stika z ljudmi ali sproščanja v okolje, to zahtevajo pogoji, povezani z odobritvijo te aktivne oziroma aktivnih snovi.
The label referred to in the first subparagraph shall provide the following information:
V oznaki iz prvega pododstavka so navedene naslednje informacije:
a statement that the treated article incorporates biocidal products;
izjava, da tretirani izdelek vsebuje biocidne proizvode;
where substantiated, the biocidal property attributed to the treated article;
biocidna lastnost tretiranega izdelka, če je utemeljena;
without prejudice to Article 24 of Regulation (EC) No 1272/2008, the name of all active substances contained in the biocidal products;
brez poseganja v člen 24 Uredbe (ES) št. 1272/2008 imena vseh aktivnih snovi, ki jih vsebujejo biocidni proizvodi;
the name of all nanomaterials contained in the biocidal products, followed by the word ‘nano’ in brackets;
imena vseh nanomaterialov, ki jih vsebujejo biocidni proizvodi, ki jim sledi beseda „nano“ v oklepaju;
any relevant instructions for use, including any precautions to be taken because of the biocidal products with which a treated article was treated or which it incorporates.
vsa zadevna navodila za uporabo, vključno z vsemi previdnostnimi ukrepi, ki jih je treba sprejeti zaradi biocidnih proizvodov, s katerimi je bil tretirani izdelek tretiran ali jih tretirani izdelek vsebuje.
This paragraph shall not apply where at least equivalent labelling requirements already exist under sector-specific legislation for biocidal products in treated articles to meet information requirements concerning those active substances.
Ta odstavek se ne uporablja, če v sektorski zakonodaji že obstajajo vsaj enakovredne zahteve za označevanje za biocidne proizvode v tretiranih izdelkih, da se izpolnijo zahteve po informacijah v zvezi z zadevnimi aktivnimi snovmi.
Notwithstanding the labelling requirements set out in paragraph 3, the person responsible for the placing on the market of a treated article shall label it with any relevant instructions for use, including any precautions to be taken, if this is necessary to protect humans, animals and the environment.
Ne glede na zahteve za označevanje iz odstavka 3 oseba, pristojna za dajanje na trg določenega tretiranega izdelka, na tem izdelku navede vsa zadevna navodila za uporabo, vključno z vsemi potrebnimi previdnostnimi ukrepi za zaščito ljudi, živali in okolja.
Notwithstanding the labelling requirements set out in paragraph 3, the supplier of a treated article shall, where a consumer so requests, provide that consumer, within 45 days, free of charge, with information on the biocidal treatment of the treated article.
Ne glede na zahteve za označevanje iz odstavka 3 dobavitelj tretiranega izdelka potrošniku na njegovo zahtevo v 45 dneh brezplačno zagotovi informacije o biocidni obravnavi tretiranega izdelka.
The labelling shall be clearly visible, easily legible and appropriately durable.
Oznaka mora biti jasno vidna, lahko čitljiva in dovolj obstojna.
Where necessary because of the size or the function of the treated article, the labelling shall be printed on the packaging, on the instructions for use or on the warranty in the official language or languages of the Member State of introduction, unless that Member State provides otherwise.
Kadar je to potrebno zaradi velikosti ali funkcije tretiranega izdelka, se oznaka natisne na embalažo, na navodila za uporabo ali na garancijski list v uradnem jeziku ali jezikih države članice vnosa, razen če ta država članica določi drugače.
In the case of treated articles that are not produced as part of a series but rather designed and manufactured to meet a specific order, the manufacturer may agree other methods of providing the customer with the relevant information.
V primeru tretiranih izdelkov, ki niso proizvedeni serijsko, temveč so zasnovani in proizvedeni na podlagi posebnega naročila, se lahko proizvajalec dogovori o drugih načinih zagotavljanja ustreznih informacij potrošnikom.
The Commission may adopt implementing acts for the application of paragraph 2 of this Article, including appropriate notification procedures, possibly involving the Agency, and further specifying the labelling requirements under paragraphs 3, 4 and 6 of this Article.
Komisija lahko, po možnosti v sodelovanju z Agencijo, sprejme izvedbene akte za uporabo odstavka 2 tega člena, vključno z ustreznimi postopki priglasitve, in podrobneje določi zahteve glede označevanja iz odstavkov 3, 4 in 6 tega člena.