natgillin/translations-raw huggingface dataset:
Zahtevek imetnika dovoljenja za spremembo pogojev za dovoljenje se vloži pri pristojnih organih vseh držav članic, ki so prej odobrile zadevni biocidni pripravek, ali, v primeru dovoljenja Unije, pri agenciji.
An application by an authorisation holder to amend the terms and conditions of an authorisation shall be submitted to the competent authorities of all the Member States which have previously authorised the biocidal product concerned, or in the case of a Union authorisation, to the Agency.
Ob vložitvi vloge se plačajo tudi pristojbine iz člena 70.
The application shall be accompanied by the fees payable under Article 71.
Sprememba obstoječega dovoljenja mora spadati v eno od naslednjih kategorij sprememb:
A modification of an existing authorisation shall fall under one of the following categories of changes:
upravna sprememba;
administrative change;
manjša sprememba;
minor change;
večja sprememba.
major change.
Podrobni postopki za odpoved in spremembe
Detailed procedures on cancellation and modifications
Za zagotovitev nemotenega delovanja postopkov za odpoved in spremembe
In order to ensure the smooth functioning of the cancellation and modification procedures,
Komisija sprejme
the Commission shall adopt
nadaljnje podrobne
further detailed
ukrepe, ki določajo merila in postopke v zvezi s preklicem dovoljenja ali spremembami pogojev za dovoljenje iz členov od 39 do 41, vključno z mehanizmom za reševanje sporov
measures specifying the criteria and procedures relating to a cancellation of an authorisation or modifications of the terms and conditions of an authorisation under Articles 39 to 41, including a dispute settlement mechanism
, z delegiranimi akti v skladu s členom 73 in pod pogoji iz členov 74 in 75
, by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75
Merila in postopki iz odstavka 1 temeljijo na sledečih načelih, vendar nanje niso omejeni:
The criteria and the procedures referred to in paragraph 1 shall be based on, but not limited to, the following principles:
za upravne spremembe dovoljenja se uporablja poenostavljen postopek priglasitve,
a simplified notification procedure shall be applied for administrative changes to the authorisation;
za manjše spremembe dovoljenja se določi krajše obdobje ocenjevanja,
a reduced evaluation period shall be established for minor changes to the authorisation;
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.
Ne glede na člen 82, kadar pristojni organ ali v primeru biocidnega pripravka, odobrenega na ravni Unije, Komisija prekliče ali spremeni dovoljenje ali se odloči, da ga ne obnovi, odobri prehodno obdobje za odstranitev, skladiščenje, dajanje v promet in uporabo obstoječih zalog, razen v primerih, kadar bi nadaljnje dajanje v promet ali uporaba pripravka pomenilo nesprejemljivo tveganje za zdravje ljudi ali okolje.
Notwithstanding Article 82, 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, storage, placing on the market and use of existing stocks except in cases where continued placing on the market or use of the product would constitute an unacceptable risk to human health or the environment.
Prehodno obdobje ne sme presegati šest mesecev za dajanje v promet in dodatnega obdobja največ dvanajst mesecev za odstranitev, skladiščenje in uporabo obstoječih zalog zadevnega biocidnega pripravka.
The period of grace shall not exceed six months for the placing on the market and an additional maximum period of twelve months for the disposal, storage, and use of existing stocks of the biocidal products concerned.
Vlogi se priložijo vse informacije, ki so potrebne, da se dokaže, da je biocidni pripravek podoben referenčnemu biocidnemu pripravku, kot je določeno v odstavku 3.
The application shall be accompanied by all the information necessary to demonstrate that the biocidal product is ▌identical to the reference product as defined in paragraph 3.
Dovoljenje za vzporedno trgovanje se izda v dveh mesecih od vložitve vloge.
A parallel trade permit shall be granted within two months from submission of an application.
Pristojni organ države članice vnosa lahko od pristojnega organa države članice porekla zahteva dodatne informacije, ki so potrebne za ugotovitev, ali je pripravek podoben referenčnemu biocidnemu pripravku.
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 enem mesecu od prejema vloge.
The competent authority of the Member State of origin shall provide the requested information within one month of receiving the request.
Biocidni pripravek se šteje za
A biocidal product shall be considered as ▌identical to the reference product if
je enak ali enakovreden
it is either the same or equivalent
po prisotnih pomožnih snoveh v formulaciji in po velikosti, materialu in obliki embalaže,
with regard to the co-formulants present and the packaging size, material or form,
v smislu možnega neželenega učinka na varnost pripravka, kar zadeva zdravje ljudi ali živali ali okolje.
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 dokazila:
An application for a parallel trade permit shall include the following information and items:
ime in številko dovoljenja za biocidni pripravek v državi članici porekla;
name and authorisation number of the biocidal product in the Member State of origin;
številka vključitve aktivnih snovi, ki jih vsebuje pripravek, in izjava o dostopu v skladu s členom 50, ki jo predloži predlagatelj iz člena 7;
the registration numbers of the active substances contained in the product and a letter of access in accordance with Article 50 from the applicant referred to in Article 7;
pristojni organ države članice porekla, ki je odobril referenčni pripravek;
the competent authority of the Member State of origin that authorised the reference product;
ime in naslov imetnika dovoljenja za biocidni pripravek v državi članici porekla
name and address of the authorisation holder in the Member State of origin
in izjavo o dostopu v skladu s členom 50, ki jo predloži predlagatelj
and a letter of access in accordance with Article 50 from the authorisation holder
izvirno etiketo in izvirna navodila za uporabo, ki se priložijo biocidnemu pripravku za distribucijo v državi članici porekla, če jih mora preučiti pristojni organ države članice vnosa.
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 predlagatelja;
name and address of the applicant;
ime za biocidni pripravek, ki naj bi se distribuiral v državi članici vnosa;
name to be given to the biocidal product to be distributed in the Member State of introduction;
osnutek etikete za pripravek, ki je namenjen dajanju v promet v državi članici vnosa;
a draft label for the product intended to be placed on the market in the Member State of introduction;
vzorec pripravka, ki je namenjen za vnos, če pristojni organ države članice vnosa meni, da je to potrebno,
a sample of the 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 pripravek 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 (e).
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 (e).
Dovoljenje za vzporedno trgovanje določa iste pogoje za dajanje v promet in uporabo kot dovoljenje za referenčni proizvod.
The parallel trade permit shall prescribe the same conditions for placing on the market and use as the authorisation of the reference product.
Dovoljenje za vzporedno trgovanje velja v enakem obdobju kot dovoljenje za referenčni pripravek 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 pripravek zaprosi za preklic dovoljenja v skladu s členom 40 in so zahteve iz člena 16 še vedno izpolnjene, veljavnost dovoljenja za vzporedno trgovanje poteče na dan, ko bi dovoljenje za referenčni biocidni pripravek normalno izteklo.
If the authorisation holder of the reference product applies for cancellation of authorisation in accordance with Article 40 and the requirements of Article 16 are still fulfilled, the validity of the parallel trade permit shall expire on the date on which the authorisation of the reference product would have normally expired.
Pristojni organ države članice vnosa lahko umakne dovoljenje za vzporedno trgovanje, če se dovoljenje za vnesen biocidni pripravek v državi članici porekla umakne zaradi 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.
Kadar se odločitev v zvezi z vlogo za dovoljenje za vzporedno trgovanje sprejme v skladu z določbami tega člena, pristojni organi držav članic, ki so sprejele takšno odločitev, vnesejo informacije iz člena 23(5) v Register biocidnih pripravkov Unije.
Where a decision concerning the application for a parallel trade permit is taken in accordance with the provisions of this Article, the competent authorities of Member States which have taken such a decision shall enter the information referred to in Article 23(5) in the Union Register of Biocidal Products.
Ne glede na člena 15 in 16 lahko pristojni organ dovoli za obdobje, ki ne presega
By way of derogation from Articles 15 and 16, a competent authority may authorise, for a period not exceeding
štirih mesecev
four months
, dajanje v promet biocidnega pripravka, ki ni v skladu z določbami te uredbe, in sicer za omejeno in nadzorovano uporabo, če
, the placing on the market of a biocidal product not complying with the provisions of this Regulation for a limited and controlled use if
so izpolnjeni vsi naslednji pogoji:
all of the following conditions are met:
takšen ukrep je potreben zaradi nevarnosti za javno zdravje in okolje, ki je ni mogoče obvladati z drugimi sredstvi;
such a measure is necessary because of a danger to public health or the environment which cannot be contained by other means;
zadevne aktivne snovi je dovoljeno vključiti v Prilogo I ali se jih oceni v skladu s členom 4, zagotovi pa se tudi popolna dokumentacija;
the active substances concerned are approved for inclusion in Annex I or evaluated according to Article 4 and a full dossier is provided;
če so zadevne aktivne snovi spadajo v člen 5 ali so razvrščene kot snovi, ki bodo zamenjane v skladu s členom 9, predlagatelj ali pristojni organ pripravi in izvede obvezen načrt nadomestitve, da zadevne snovi zamenja z nenevarnimi kemičnimi snovmi ali drugimi nekemičnimi možnostmi v dveh letih po datumu odobritve; ter
if the relevant active substances fall under Article 5 or are classified as candidates for substitution according to Article 9, a mandatory substitution plan has been established and implemented by the applicant or competent authority in order to replace the relevant substances with non-hazardous chemical or non-chemical alternatives within two years of the date of approval; and
uporaba pripravka je omejena na pooblaščene poklicne uporabnike v skladu z zahtevami za celostno zatiranje škodljivcev, poleg tega pa se jo ustrezno nadzoruje
the application of the product is restricted to professional users who are certified pursuant to the requirements for integrated pest management and the use is appropriately monitored
Pristojni organ iz prvega pododstavka nemudoma obvesti druge pristojne organe in Komisijo o svojih ukrepih in razlogih zanje.
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 a revocation of such action.
Komisija nemudoma odloči, ali je mogoče ukrep, ki ga je sprejel pristojni organ, podaljšati za obdobje, ki ne presega 18 mesecev v skladu s postopkom iz člena 76(3), in pod kakšnimi pogoji.
The Commission shall without delay decide whether, and under what conditions, the action taken by the competent authority may be extended for a period not exceeding 18 months in accordance with the procedure referred to in Article 76(3).
Poleg aktivnih snovi iz člena 15(2) Uredbe (ES) št. 1907/2006, se za aktivne snovi, izdelane ali uvožene za uporabo v biocidnih pripravkih, za katere je bilo izdano dovoljenje za dajanje v promet v skladu s tem členom, šteje, da so registrirane, za registracijo pa se šteje, da je zaključena za proizvodnjo ali uvoz za uporabo v biocidnem pripravku ter da s tem izpolnjuje zahteve iz poglavij 1 in 5 Naslova II Uredbe (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 which are authorised for placing on the market in accordance with this Article shall be regarded as being registered and the registration as completed for manufacture or import for the use in a biocidal product and therefore as fulfilling the requirements of Chapters 1 and 5 of Title II of Regulation (EC) No 1907/2006.
Oseba sestavi in hrani pisno evidenco, ki vsebuje podroben opis biocidnega pripravka ali aktivne snovi, podatke o označevanju, dobavljene količine ter imena in naslove prejemnikov biocidnega pripravka ali aktivne snovi, ter zbere dokumentacijo, ki vsebuje vse razpoložljive podatke o možnih učinkih na zdravje človeka ali živali, ali vplivu na okolje.
The person 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.
Zadevna oseba mora te podatke dati na voljo pristojnemu organu, če jih zahteva.
The persons concerned shall, if requested, make this information available to the competent authority
Pristojni organ nemudoma obvesti Komisijo in druge pristojne organe o izdanem nacionalnem dovoljenju.
The competent authority shall without delay inform the Commission and other competent authorities about the issued national authorisation.
Če imajo predlagani poskusi ali preskusi iz odstavkov 1 in 2
If the proposed experiments or tests referred to in paragraphs 1 and 2 may have harmful effects
takojšnje ali poznejše
, whether immediate or delayed,
človeka ali živali,
, humans, or animals
jih pristojni organ zadevne države članice lahko prepove ali pa dovoli ob pogojih, za katere meni, da so potrebni za preprečitev teh posledic.
, the 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.
Za spodbujanje raziskav in razvoja aktivnih snovi in biocidnih pripravkov
In order to encourage research and development in active substances and biocidal products,
sprejme ukrepe za natančno določitev splošno veljavnih največjih količin aktivnih snovi ali biocidnih pripravkov ali biocidnih pripravkov, ki se jih sme sprostiti med preskusi, ter najnujnejše podatke, ki jih je treba predložiti v skladu z odstavkom 2 tega člena.
measures to specify the overall applicable maximum quantities of active substances or biocidal products that may be released during experiments and the minimum data to be submitted in accordance with paragraph 2 of this Article.
Tretirane snovi ali izdelki, ki vsebujejo enega ali več biocidnih pripravkov, se ne smejo dajati v promet, razen če so
Treated materials or articles that incorporate one or more biocidal products shall not be placed on the market unless the
navedene v Prilogi I
included in Annex I
Oseba, odgovorna za dajanje tretiranih izdelkov ali materialov v promet, mora pridobiti izjavo o certifikaciji, ki jo izda imetnik dovoljenja, za vse biocidne pripravke, ki so bili uporabljeni za tretiranje ali so bili dodani izdelkom ali materialom.
The person responsible for placing treated articles or materials on the market shall obtain a letter of certification by the authorisation holder in respect of all biocidal products which have been used in the treatment of those articles or materials or which have been inserted into the articles or materials.
vseh aktivnih snovi, uporabljenih za tretiranje izdelka ali snovi ali iz katerih so izdelki ali snovi sestavljene
of all active substances that were used to treat the article or materials or that were incorporated in the articles or materials
biocidna lastnost tretiranega izdelka ali snovi,
▌the biocidal property attributed to treated articles or materials
če pride biocidni pripravek, ki ga vsebujejo, v neposreden stik s človekom ali okoljem
, if the biocidal product contained therein will come into direct contact with people and the environment
stavki o nevarnosti ali previdnostni stavki, navedeni v dovoljenju za biocidni pripravek
any hazard statement or precautionary statement set out in the authorisation for the biocidal product
, če se biocidni pripravek sprosti ob običajnih ali predvidljivih pogojih uporabe
if the biocidal product is intended to be released under normal or reasonably foreseeable conditions of use
Označba mora biti jasno vidna, čitljiva
The labelling shall be clearly visible, easily legible
primerno obstojna
appropriately durable
izdelek ali snov,
on the article or material,
embalažo, na navodila za uporabo ali na garancijski list tretiranega izdelka ali snovi
on the packaging, on the instructions for use or on the warranty of the treated article or material
v nacionalnem jeziku ali jezikih države članice, na katere trg se daje tretirani izdelek ali snov
in the national language or languages of the Member State on whose market the treated article or material is to be placed
Pri tretiranih snoveh ali izdelkih, ki niso načrtovani in proizvedeni serijsko, temveč na podlagi posebnega naročila, se lahko proizvajalec s stranko dogovori o drugih načinih zagotavljanja informacij.
In the case of treated materials or articles which 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.
Ta odstavek se uporabi, razen če druga zakonodaja Unije že ne predpisuje zahtev o tovrstnem označevanju.
This paragraph shall not apply where such labelling requirements already exist under other Union legislation.
Poglavje XI
Chapter XI
Informacij, predloženih za namene te uredbe, pristojni organi ali Agencija ne uporabljajo v korist poznejšega predlagatelja, razen v naslednjih primerih:
Information submitted for the purposes of this Regulation shall not be used by competent authorities or the Agency for the benefit of a subsequent applicant, except in one of the following cases:
poznejši predlagatelj je ▌pridobil pisni dogovor v obliki izjave o dostopu
the subsequent applicant has written agreement in the form of a letter of access
v skladu s členom 50
in accordance with Article 50
Ko predlagatelj predloži informacije pristojnemu organu ali Agenciji, zagotovi tudi seznam vseh predloženih informacij.
When an applicant submits any information to a competent authority or to the Agency, he shall also provide a list of all the information submitted.
Na seznamu navede, ali je lastnik podatkov oz. ali ima izjavo o dostopnosti do teh podatkov.
In the list he shall specify whether he is the owner of the information or whether he only holds a letter of access to that information.
V drugem primeru v seznam vključi ime in kontaktne podatke lastnika.
In the latter case, the list shall contain the name and contact details of the owner.
Predlagatelj obvesti pristojni organ ali Agencijo o kakršni koli spremembi lastništva informacij.
The applicant shall inform the competent authority or the Agency about any changes in the ownership of the information.
Po prejemu seznama iz odstavka 2 ga pristojni organi pošljejo Agenciji.
On receipt of the list referred to in paragraph 2, the competent authorities shall send it to the Agency.
Agencija vse podatke na seznamu
Each item of information in
iz odstavka 2
the list referred to in paragraph 2 shall be
označi z enkratno kodo in jih z vsemi podrobnostmi
identified by a unique code and
vnese v register za izmenjavo podatkov o biocidih
entered by the Agency,
, skupaj z identiteto prvega predlagatelja in lastnika podatkov
with all relevant details and linked to the identity of the initial applicant and the information owner,
Komisija, Agencija, svetovalni znanstveni odbori, ustanovljeni s Sklepom Komisije 2004/210/ES z dne 3. marca 2004 o ustanovitvi znanstvenih odborov na področju varstva potrošnikov, javnega zdravja in okolja UL L 66, 4.3.2004, str.
The Commission, the Agency, the advisory scientific committees set up under Commission Decision 2004/210/EC of 3 March 2004 setting up Scientific Committees in the field of consumer safety, public health and the environment OJ L 66, 4.3.2004, p.
, in pristojni organi imajo dostop do informacij iz odstavka 1.
and the competent authorities shall have access to the information referred to in paragraph 1.
Informacije, predložene za namen te Direktive 98/8/ES ali te uredbe, bodo varovane v skladu s pogoji iz tega člena.
Information submitted for the purposes of Directive 98/8/EC or of this Regulation shall benefit from data protection under the conditions laid down in this Article.
Informacije, varovane v skladu z Direktivo 98/8/ES ▌za katere obdobje varovanja poteče v skladu z Direktivo 98/8/ES ali
Information protected under Directive 98/8/EC ▌for which the protection period expired under Directive 98/8/EC or
informacije, varovane po tem členu
information protected under this Article
na zahtevo
, on application,
Obdobje varovanja informacij, predloženih zaradi vključitve obstoječe aktivne snovi v Prilogo I, se konča 10 let po datumu vključitve zadevne aktivne snovi v Prilogo I za določeno vrsto pripravka.
The protection period for information submitted in view of the inclusion of an existing active substance in Annex I shall end 10 years after the date of the inclusion of the relevant active substance in Annex I for the particular product-type.
Obdobje varovanja informacij, predloženih zaradi vključitve nove aktivne snovi v Prilogo I, se konča 15 let po datumu vključitve zadevne aktivne snovi v Prilogo I za določeno vrsto pripravka.
The protection period for information submitted in view of the inclusion of a new active substance in Annex I shall end 15 years after the date of the inclusion of the relevant active substance in Annex I for the particular product-type.