natgillin/translations-raw huggingface dataset:
Ti pristojni organi ali, v primeru dovoljenja Unije, Agencija preuči, in Komisija odloči, ali so pogoji iz člena 19
Those competent authorities shall decide, or, in the case of a Union authorisation, the Agency shall examine and the Commission decide whether the conditions of Article 19
ali, kjer pomembno, člena 25
or, where relevant, Article 25,
še izpolnjeni in ali je treba spremeniti določila in pogoje za izdajo dovoljenja.
are still met and whether the terms and conditions of the authorisation need to be amended.
Ob vložitvi vloge se plačajo tudi pristojbine iz člena 80
The application shall be accompanied by the fees payable under Article 80
Za zagotovitev usklajenega pristopa pri preklicu in spremembi dovoljenj Komisija z izvedbenimi akti določi podrobna pravila za uporabo členov 47 do 50.
In order to ensure a harmonised approach to the cancellation and amendment of authorisations, the Commission shall lay down detailed rules for the application of Articles 47 to 50 by means of implementing acts.
za upravne spremembe se uporablja poenostavljeni postopek priglasitve;
a simplified notification procedure shall be applied for administrative changes;
za manjše spremembe se določi krajše obdobje ocenjevanja;
a reduced evaluation period shall be established for minor changes;
v primeru večjih sprememb je obdobje ocenjevanja sorazmerno z obsegom predlagane spremembe.
in the case of major changes, the evaluation period shall be proportionate to the extent of the proposed change.
Prehodno obdobje
Period of grace
Kadar pristojni organ ali, v primeru biocidnega proizvoda, odobrenega na ravni Unije, Komisija prekliče ali spremeni dovoljenje ali odloči, da ga ne bo obnovila, ne glede na člen 89 odobri prehodno obdobje za odstranitev, dostopnost na trgu in uporabo obstoječih zalog, razen v primerih, kadar bi nadaljnja dostopnost na trgu ali uporaba biocidnega proizvoda pomenila nesprejemljivo tveganje za zdravje človeka ali okolje.
Notwithstanding Article 89, where the competent authority or, in the case of a biocidal product authorised at Union level, the Commission, cancels or amends an authorisation or decides not to renew it, it shall grant a period of grace for the disposal, making available on the market and use of existing stocks, except in cases where continued making available on the market or use of the biocidal product would constitute an unacceptable risk to human health or the environment.
Prehodno obdobje ne sme biti daljše od 180 dni za dostopnost na trgu in dodatnih največ 180 dni za odstranitev in uporabo obstoječih zalog zadevnih biocidnih proizvodov.
The period of grace shall not exceed 180 days for the making available on the market and an additional maximum period of 180 days for the disposal and use of existing stocks of the biocidal products concerned.
VZPOREDNO TRGOVANJE
PARALLEL TRADE
Vzporedno trgovanje
Parallel trade
Pristojni organ države članice (v nadaljnjem besedilu: država članica vnosa) na zahtevo vlagatelja izda dovoljenje za vzporedno trgovanje z biocidnim proizvodom, za katerega je bilo izdano dovoljenje v drugi državi članici (v nadaljnjem besedilu: država članica porekla), zaradi dostopnosti na trgu in uporabe v državi članici vnosa, če v skladu z odstavkom 3 ugotovi, da je biocidni proizvod identičen biocidnemu proizvodu, ki je že dovoljen v državi članici vnosa (v nadaljnjem besedilu: referenčni proizvod).
A competent authority of a Member State (‘Member State of introduction’) shall, at the request of the applicant, grant a parallel trade permit for a biocidal product that is authorised in another Member State (‘Member State of origin’) to be made available on the market and used in the Member State of introduction, if it determines in accordance with paragraph 3 that the biocidal product is identical to a biocidal product already authorised in the Member State of introduction (‘the reference product’).
Vlagatelj, ki namerava dati biocidni proizvod na trg v državi članici vnosa, vloži vlogo za dovoljenje za vzporedno trgovanje pri pristojnemu organu države članice vnosa.
The applicant who intends to place the biocidal product on the market in the Member State of introduction shall submit the application for a parallel trade permit to the competent authority of the Member State of introduction.
Vlogi se priložijo informacije iz odstavka 4 in vse druge informacije, ki so potrebne, da se dokaže, da je biocidni proizvod identičen referenčnemu proizvodu, določenemu v odstavku 3.
The application shall be accompanied by the information referred to in paragraph 4 and all other information necessary to demonstrate that the biocidal product is identical to the reference product as defined in paragraph 3.
Če pristojni organ države članice vnosa ugotovi, da je biocidni proizvod identičen referenčnemu proizvodu, izda dovoljenje za vzporedno trgovanje v 60 dneh po prejemu pristojbin, ki se plačujejo v skladu s členom 80
Where the competent authority of the Member State of introduction determines that a biocidal product is identical to the reference product, it shall grant a parallel trade permit within 60 days of receipt of the fees payable under Article 80
Pristojni organ države članice vnosa lahko od pristojnega organa države članice porekla zahteva dodatne informacije, ki so potrebne za ugotovitev, ali je proizvod identičen referenčnemu proizvodu.
The competent authority of the Member State of introduction may request from the competent authority of the Member State of origin additional information necessary to determine whether the product is identical to the reference product.
Pristojni organ države članice porekla zagotovi zahtevane informacije v 30 dneh po prejemu zahteve.
The competent authority of the Member State of origin shall provide the requested information within 30 days of receiving the request.
Biocidni proizvod se šteje za identičnega referenčnemu proizvodu le, če so izpolnjeni vsi naslednji pogoji:
A biocidal product shall be considered as identical to the reference product only if all the following conditions are met:
proizvedla ju je ista družba, povezano podjetje ali pa sta bila proizvedena po licenci v skladu z istim proizvodnim postopkom;
they have been manufactured by the same company, by an associated undertaking or under license in accordance with the same manufacturing process;
identična sta po specifikaciji in vsebini, kar zadeva aktivne snovi, ter po vrsti formulacije;
they are identical in specification and content in respect of the active substances and the type of formulation;
sta enaka glede na vsebnost neaktivnih snovi in
they are the same in respect of the non-active substances present; and
sta enaka ali enakovredna glede velikosti, materiala ali oblike embalaže v smislu možnega neželenega vpliva na varnost proizvoda, kar zadeva zdravje človeka ali živali ali okolje.
they are either the same or equivalent in packaging size, material or form, in terms of the potential adverse impact on the safety of the product with regard to human or animal health or the environment.
Vloga za dovoljenje za vzporedno trgovanje vsebuje naslednje informacije in točke:
An application for a parallel trade permit shall include the following information and items:
ime in številko dovoljenja za biocidni proizvod v državi članici porekla;
name and authorisation number of the biocidal product in the Member State of origin;
naziv in naslov pristojnega organa države članice porekla;
name and address of the competent authority of the Member State of origin;
ime in naslov imetnika dovoljenja v državi članici porekla;
name and address of the authorisation holder in the Member State of origin;
izvirno oznako in navodila za uporabo, ki se priložijo biocidnemu proizvodu za prodajo v državi članici porekla, če pristojni organ države članice vnosa meni, da so potrebni za preučitev;
original label and instructions for use with which the biocidal product is distributed in the Member State of origin if it is considered as necessary for the examination by the competent authority of the Member State of introduction;
ime in naslov vlagatelja;
name and address of the applicant;
ime biocidnega proizvoda, ki naj bi se prodajal v državi članici vnosa;
name to be given to the biocidal product to be distributed in the Member State of introduction;
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 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;
vzorec biocidnega proizvoda, ki je namenjen za vnos, če pristojni organ države članice vnosa meni, da je to potrebno;
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;
ime in številko dovoljenja za referenčni proizvod v državi članici vnosa.
name and authorisation number of the reference product in the Member State of introduction.
Pristojni organ države članice vnosa lahko zahteva prevod zadevnih delov izvirnih navodil za uporabo iz točke (d).
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).
Dovoljenje za vzporedno trgovanje določa iste pogoje za dostopnost na trgu in uporabo kot dovoljenje za referenčni proizvod.
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 velja za enako obdobje kot dovoljenje za referenčni proizvod v državi članici vnosa.
The parallel trade permit shall be valid for the duration of authorisation of the reference product in the Member State of introduction.
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.
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.
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.
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.
TEHNIČNA EKVIVALENCA
TECHNICAL EQUIVALENCE
Ocenjevanje tehnične ekvivalence
Assessment of technical equivalence
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 plača ustrezno pristojbino
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 fee
v skladu s členom 80(1)
in accordance with Article 80(1)
Vlagatelj predloži vse podatke, ki
The applicant shall submit all data
jih Agencija potrebuje za ocenitev
that the Agency requires
tehnične ekvivalence.
to assess technical equivalence.
Agencija da vlagatelju možnost predložitve pripomb, nato pa v 90 dneh po prejetju vloge sprejme sklep in o njem obvesti države članice in vlagatelja.
After giving the applicant the opportunity to submit comments, the Agency shall take a decision within 90 days of receipt of the application and shall communicate it to Member States and to the applicant.
Kadar so po mnenju Agencije potrebne dodatne informacije za izvedbo ocene tehnične enakovrednosti, Agencija pozove vlagatelja, naj predloži takšne informacije v roku, ki ga določi Agencija.
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.
Obdobje 90 dni iz odstavka 4 se prekine od dneva izdaje zahtevka do dneva prejema 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.
Agencija se lahko po potrebi posvetuje s pristojnim organom države članice, ki je bil ocenjevalni pristojni organ za ocenjevanje aktivne snovi.
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.
V skladu s členom 77 se lahko proti sklepom Agencije na podlagi odstavka 4 tega odstavka vloži pritožba.
An appeal may be brought, in accordance with Article 77, against decisions of the Agency under paragraph 4 of this Article.
pripravi tehnična navodila zaradi lažje uporabe tega člena.
draw up technical guidance notes to facilitate the implementation of this Article.
Odstopanje od zahtev
Derogation from the requirements
Z odstopanjem od členov 17 in 19 lahko pristojni organ dovoli za obdobje, ki ni daljše od
By way of derogation from Articles 17 and 19, a competent authority may permit, for a period not exceeding
dni, dostopnost na trgu ali uporaba biocidnega proizvoda, ki ne izpolnjuje pogojev za dovoljenje iz te uredbe, in sicer za omejeno in nadzorovano uporabo
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
pod nadzorom pristojnega organa
under the supervision of the competent authority
, če je takšen ukrep potreben zaradi nevarnosti za javno zdravje
, if such a measure is necessary because of a danger to public health
, zdravje živali
, animal health
ali okolje, ki je ni mogoče obvladati z drugimi sredstvi.
or the environment which cannot be contained by other means.
Pristojni organ iz prvega pododstavka nemudoma obvesti druge pristojne organe in Komisijo o svojem ukrepu in razlogih zanj.
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 nemudoma obvesti druge pristojne organe in Komisijo o preklicu takšnega ukrepa.
The competent authority shall, without delay, inform the other competent authorities and the Commission of the revocation of such action.
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.
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.
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 zabiocidni proizvod, ki vsebuje novo aktivno snov.
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 Komisija z izvedbenimi aktidovoli državi članici, da izda dovoljenje za biocidni proizvod, ki vsebuje neodobreno aktivno snov, pod pogojem, da je ta aktivna snov bistvena za zaščito kulturne dediščine in da ni na voljo ustreznih nadomestnih možnosti.
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.
Država članica, ki želi zaprositi za takšno odstopanje, pri Komisiji vloži vlogo in navede ustrezno utemeljitev.
A Member State wishing to obtain such a derogation shall apply to the Commission, providing due justification.
raziskave in razvoj
Research and development
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.
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.
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.
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.
Te podatke na zahtevo dajo na voljo pristojnemu organu.
They shall make this information available to the competent authority on request.
Uradno obvestilo vključuje
The notification shall include
podatke o biocidnem proizvodu ali aktivni snovi, podatke o označevanju in dobavljene količine ter vse razpoložljive podatke o možnih učinkih na zdravje človeka ali živali ali vplivu na okolje
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.
Če bi poskusi ali preskusi lahko imeli škodljive takojšnje ali zapoznele učinke na zdravje človeka ali živali, zlasti na ranljive skupine, ali nesprejemljiv neželen učinek na okolje, ljudi ali živali, jih lahko ustrezni pristojni organ zadevne države članice prepove ali pa dovoli pod pogoji, za katere meni, da so potrebni za preprečitev teh posledic.
If the experiments or tests could have harmful effects, whether immediate or delayed, on human or animal health, in particular on vulnerable groups, or any unacceptable adverse effect on the environment, humans or animals, 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.
Pristojni organ o svoji odločitvi nemudoma obvesti Komisijo in druge pristojne organe.
The competent authority shall, without delay, inform the Commission and other competent authorities of its decision.
Na Komisijo se prenesejo pooblastila za sprejetje delegiranih aktov v skladu s členom 83, ki določijo podrobna pravila
The Commission shall be empowered to adopt delegated acts in accordance with Article 83 specifying detailed rules
tega člena.
this Article.
Izjema od obveznosti registracije v skladu z Uredbo (ES) št. 1907/2006
Exemption from registration under Regulation (EC) No 1907/2006
Poleg aktivnih snovi iz člena 17(2) Uredbe (ES) št. 1907/2006 se za aktivne snovi, proizvedene ali uvožene za uporabo v biocidnih proizvodih, ki se lahko v skladu s členi 27, člena 55 ali člena 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.
In addition to the active substances referred to in Article 17(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, Article 55 or Article 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.
TRETIRANI IZDELKI
TREATED ARTICLES
Dajanje tretiranih izdelkov na trg
Placing on the market of treated articles
Ta člen se uporablja izključno za tretirane izdelke, kot so opredeljeni v členu 3(1)(l), ki niso biocidni proizvodi v smislu člena 3(1)(a).
This Article shall apply exclusively to treated articles within the meaning of Article 3(1)(l) that are not biocidal products within the meaning of Article 3(1)(a).
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.
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.
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.
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.
▌Oseba, ki je odgovorna za dajanje tega tretiranega izdelka na trg, zagotovi, da so
▌The person responsible for the placing on the market of that treated article shall ensure that
v primeru tretiranega izdelka, ki vsebuje biocidni proizvod, proizvajalec tretiranega izdelka uvede zahtevek glede biocidnih lastnosti tega izdelka, ali
where, 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, da glede na zadevno aktivno snov(-i), v zvezi z možnostjo stika z ljudmi ali sproščanja v okolje, to zahtevajo pogoji, povezani z odobritvijo te aktivne snovi,
where, in relation to the active substance(s) concerned, having particular regard to the possibility of contact with humans or the release to the environment, the conditions associated with the approval of the active substance(s) so require,
na oznaki navedene naslednje informacije:
the label provides the following information:
izjava, da tretirani izdelek vsebuje biocidne proizvode;
a statement that the treated article incorporates biocidal products;
biocidna lastnost tretiranega izdelka, če je utemeljena;
where substantiated, the biocidal property attributed to the treated article;
brez poseganja v člen 24 Uredbe (ES) št. 1272/2008 imena vseh aktivnih snovi, ki jih vsebujejo biocidni proizvodi;
without prejudice to Article 24 of Regulation (EC) No 1272/2008, the name of all active substances contained in the biocidal products;