natgillin/translations-raw huggingface dataset:
Where there are significant indications that an active substance contained in a biocidal product with which a treated article is treated or which it incorporates does not meet the conditions laid down in Article 4(1), Article 5(2) or Article 25, the Commission shall review the approval of that active substance or its inclusion in Annex I in accordance with Article 15(1) or Article 28(2).
Če obstajajo pomenljivi znaki, da aktivna snov v biocidnem proizvodu, s katero je bil tretirani izdelek tretiran ali jo tretirani izdelek vsebuje, ne izpolnjuje pogojev iz člena 4(1), člena 5(2) ali člena 25, Komisija v skladu s členom 15(1) ali členom 28(2) pregleda odobritev te aktivne snovi ali njeno vključitev v Prilogo I.
DATA PROTECTION AND DATA-SHARING
VARSTVO PODATKOV IN IZMENJAVA PODATKOV
Protection of data held by competent authorities or the Agency
Varstvo podatkov, ki jih hranijo pristojni organi ali Agencija
Without prejudice to Articles 62 and 63, data submitted for the purposes of Directive 98/8/EC or of this Regulation shall not be used by competent authorities or the Agency for the benefit of a subsequent applicant, except where:
Brez poseganja v člena 62 in 63 pristojni organi ali Agencija podatkov, predloženih za namene Direktive 98/8/ES ali te uredbe, ne uporabljajo v korist poznejšega vlagatelja, razen če:
the subsequent applicant submits a letter of access; or
poznejši vlagatelj predloži izjavo o dostopnosti ali
the relevant time limit for data protection has expired.
poteče zadevni rok za varstvo podatkov.
When submitting data to a competent authority or to the Agency for the purposes of this Regulation the applicant shall, where relevant, indicate the name and contact details of the data owner for all data submitted.
Pri predložitvi podatkov pristojnemu organu ali Agenciji za namene te uredbe vlagatelj po potrebi navede ime in kontaktne podatke lastnika vseh predloženih podatkov.
The applicant shall also specify whether it is the data owner or holds a letter of access.
Vlagatelj navede tudi, ali je lastnik podatkov oziroma ima izjavo o dostopnosti.
The applicant shall, without delay, inform the competent authority or the Agency about any changes to the ownership of the data.
Vlagatelj nemudoma obvesti pristojni organ ali Agencijo o kakršni koli spremembi lastništva podatkov.
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 [47] shall also have access to the data referred to in paragraph 1 of this Article.
Dostop do podatkov iz odstavka 1 tega člena imajo tudi 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 [47].
Data protection periods
Obdobja varovanja podatkov
Data 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.
Podatki, predloženi za namen Direktive 98/8/ES ali te uredbe, bodo varovani v skladu s pogoji iz tega člena.
The protection period for the data shall start when they are submitted for the first time.
Obdobje varovanja teh podatkov se začne ob njihovi prvi predložitvi.
Data protected under this Article or for which the protection period under this Article has expired shall not be protected again.
Podatki, ki so varovani v skladu s tem členom ali za katere obdobje varovanja poteče v skladu s tem členom, se ponovno ne zavarujejo.
The protection period for data submitted with a view to the approval of an existing active substance shall end 10 years from the first day of the month following the date of adoption of a decision in accordance with Article 9 on the approval of the relevant active substance for the particular product-type.
Obdobje varovanja podatkov, predloženih zaradi odobritve obstoječe aktivne snovi, se izteče 10 let po prvem dnevu v mesecu po datumu sprejetja odločitve v skladu s členom 9 o odobritvi zadevne aktivne snovi za določeno vrsto proizvoda.
The protection period for data submitted with a view to the approval of a new active substance shall end 15 years from the first day of the month following the date of adoption of a decision in accordance with Article 9 on the approval of the relevant active substance for the particular product-type.
Obdobje varovanja podatkov, predloženih zaradi odobritve nove aktivne snovi, se izteče 15 let po prvem dnevu v mesecu po datumu sprejetja odločitve v skladu s členom 9 o odobritvi zadevne aktivne snovi za določeno vrsto proizvoda.
The protection period for new data submitted with a view to the renewal or review of the approval of an active substance shall end five years from the first day of the month following the date of the adoption of a decision in accordance with Article 14(4) concerning the renewal or the review.
Obdobje varovanja novih podatkov, predloženih zaradi podaljšanja ali pregleda odobritve aktivne snovi, se izteče 5 let po prvem dnevu v mesecu po datumu sprejetja odločitve v skladu s členom 14(4) o podaljšanju ali pregledu.
The protection period for data submitted with a view to the authorisation of a biocidal product containing only existing active substances shall end 10 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 30(4), Article 34(6) or Article 44(4).
Obdobje varovanja podatkov, predloženih zaradi izdaje dovoljenja za biocidni proizvod, ki vsebuje le obstoječe aktivne snovi, se izteče 10 let po prvem dnevu v mesecu po sprejetju prve odločitve o izdaji dovoljenja za proizvod v skladu s členom 30(4), členom 34(6) ali členom 44(4).
The protection period for data submitted with a view to the authorisation of a biocidal product containing a new active substance shall end 15 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 30(4), Article 34(6) or Article 44(4).
Obdobje varovanja podatkov, predloženih zaradi izdaje dovoljenja za biocidni proizvod, ki vsebuje novo aktivno snov, se izteče 15 let po prvem dnevu v mesecu po sprejetju prve odločitve o izdaji dovoljenja za proizvod v skladu s členi 30(4), 34(6) ali 44(4).
The protection period for new data submitted with a view to the renewal or amendment of the authorisation of a biocidal product shall end five years from the first day of the month following the decision concerning the renewal or amendment of the authorisation.
Obdobje varovanja novih podatkov, predloženih zaradi podaljšanja ali spremembe dovoljenja za biocidni proizvod, se izteče 5 let po prvem dnevu v mesecu po sprejetju odločitve o podaljšanju ali spremembi dovoljenja.
Letter of access
Izjava o dostopnosti podatkov
A letter of access shall contain at least the following information:
Izjava o dostopnosti podatkov vsebuje vsaj naslednje informacije:
the name and contact details of the data owner and the beneficiary;
ime in kontaktne podatke lastnika podatkov in upravičenca;
the name of the active substance or biocidal product for which access to the data is authorised;
ime aktivne snovi ali biocidnega proizvoda, za katerega je odobren dostop do podatkov;
the date on which the letter of access takes effect;
datum začetka učinkovanja izjave o dostopnosti podatkov;
a list of the submitted data to which the letter of access grants citation rights.
seznam predloženih podatkov, katerih citiranje je mogoče z izjavo o dostopnosti podatkov.
Revocation of a letter of access shall not affect the validity of the authorisation issued on the basis of the letter of access in question.
Preklic izjave o dostopnosti podatkov ne vpliva na veljavnost dovoljenja, izdanega na podlagi zadevne izjave o dostopnosti podatkov.
In order to avoid animal testing, testing on vertebrates for the purposes of this Regulation shall be undertaken only as a last resort.
Da se preprečijo preskusi na živalih, se preskusi na vretenčarjih za namene te uredbe opravijo samo v skrajni sili.
Testing on vertebrates shall not be repeated for the purposes of this Regulation.
Preskusi na vretenčarjih se za namene te uredbe ne ponavljajo.
Any person intending to perform tests or studies (‘the prospective applicant’)
Vsaka oseba, ki namerava izvesti preskuse ali študije (v nadaljnjem besedilu: morebitni vlagatelj),
shall, in the case of data involving tests on vertebrates; and
v primeru podatkov, ki vključujejo preskuse na vretenčarjih, in
may, in the case of data not involving tests on vertebrates,
v primeru podatkov, ki ne vključujejo preskusov na vretenčarjih,
submit a written request to the Agency to determine whether such tests or studies have already been submitted to the Agency or to a competent authority in connection with a previous application under this Regulation or Directive 98/8/EC.
predloži pisno zahtevo Agenciji, da ta določi, ali so bili takšni preskusi ali študije že predloženi Agenciji, ali pristojnemu organu v povezavi s prejšnjo vlogo v skladu s to uredbo ali Direktivo 98/8/ES.
The Agency shall verify whether such tests or studies have already been submitted.
Agencija preveri, ali so bili takšni preskusi ali študije že predloženi.
Where such tests or studies have already been submitted to the Agency or to a competent authority in connection with a previous application, under this Regulation or Directive 98/8/EC, the Agency shall, without delay, communicate the name and contact details of the data submitter and data owner to the prospective applicant.
Če so bili takšni preskusi ali študije že predloženi Agenciji ali pristojnemu organu v povezavi s prejšnjo vlogo v skladu s to uredbo ali Direktivo 98/8/ES, Agencija morebitnemu vlagatelju nemudoma sporoči ime in kontaktne podatke predlagatelja podatkov in lastnika podatkov.
The data submitter shall, where relevant, facilitate contacts between the prospective applicant and the data owner.
Predlagatelj podatkov po potrebi olajšuje stike med morebitnim vlagateljem in lastnikom podatkov.
Where the data acquired under those tests or studies are still protected under Article 60, the prospective applicant:
Kadar so podatki, pridobljeni s temi preskusi ali študijami, še vedno varovani v skladu s členom 60, morebitni vlagatelj:
request from the data owner all the scientific and technical data related to the tests and studies concerned as well as the right to refer to these data when submitting applications under this Regulation.
lahko zaprosi lastnika podatkov za vse znanstvene in tehnične podatke, povezane z zadevnimi preskusi in študijami, ter za pravico do sklicevanja na te podatke pri vložitvi vlog v skladu s to uredbo.
Compensation for data sharing
Nadomestilo za izmenjavo podatkov
Where a request has been made in accordance with Article 62(2), the prospective applicant and the data owner shall make every effort to reach an agreement on the sharing of the results of the tests or studies requested by the prospective applicant.
Kadar je bil zahtevek vložen v skladu s členom 62(2), si morata morebitni vlagatelj in lastnik podatkov prizadevati za dosego dogovora o izmenjavi rezultatov preskusov ali študij, za katere je zaprosil morebitni vlagatelj.
Such an agreement may be replaced by submission of the matter to an arbitration body and a commitment to accept the arbitration order.
Namesto takšnega dogovora se lahko zadeva predloži razsodišču z zavezo, da se odločitev razsodišča sprejme.
Where such agreement is reached, the data owner shall make all the scientific and technical data related to the tests and studies concerned available to the prospective applicant or shall give the prospective applicant permission to refer to the data owner’s tests or studies when submitting applications under this Regulation.
Če se doseže tak dogovor, lastnik podatkov morebitnemu vlagatelju da na voljo vse znanstvene in tehnične podatke, povezane z zadevnimi preskusi in študijami, ali mu dovoli, da se sklicuje na preskuse ali študije pri vložitvi vlog v skladu s to uredbo.
Where no agreement is reached with respect to data involving tests or studies on vertebrates, the prospective applicant shall inform the Agency and the data owner thereof, at the earliest one month after the prospective applicant receives the name and address of the data submitter from the Agency.
Če se dogovor v zvezi s podatki, ki vključujejo preskuse na vretenčarjih ali študije o njih, ne doseže, morebitni vlagatelj o tem obvesti Agencijo in lastnika podatkov najprej v enem mesecu po tem, ko Agencija prejme potrdilo o imenu in naslovu predlagatelja podatkov.
Within 60 days of being informed, the Agency shall give the prospective applicant permission to refer to the requested tests or studies on vertebrates, provided that the prospective applicant demonstrates that every effort has been made to reach an agreement and that the prospective applicant has paid the data owner a share of the costs incurred.
Agencija v 60 dneh od prejema obvestila morebitnemu vlagatelju dovoli, da se sklicuje na zahtevane preskuse na vretenčarjih ali študije o njih, pod pogojem, da morebitni vlagatelj dokaže, da je bilo storjeno vse za dosego dogovora, in da je lastniku podatkov plačal delež nastalih stroškov.
Where the prospective applicant and data owner cannot agree, national courts shall decide on the proportionate share of the cost that the prospective applicant is to pay to the data owner.
Če se morebitni vlagatelj in lastnik podatkov ne moreta dogovoriti, nacionalna sodišča odločijo o sorazmernem deležu stroškov, ki jih morebitni vlagatelj plača lastniku podatkov.
The data owner shall not refuse to accept any payment offered pursuant to the second subparagraph.
Lastnik podatkov ne zavrne sprejema kakršnega koli plačila, ponujenega v skladu z drugim pododstavkom.
Any acceptance is without prejudice, however, to his right to have the proportionate share of the cost determined by a national court, in accordance with the second subparagraph.
Kakršen koli sprejem pa ne posega v njegovo pravico, da v skladu z drugim pododstavkom sorazmerni delež stroškov določi nacionalno sodišče.
Compensation for data sharing shall be determined in a fair, transparent and non-discriminatory manner, having regard to the guidance established by the Agency [48].
Nadomestilo za izmenjavo podatkov se določi pošteno, pregledno in nediskriminatorno ob upoštevanju smernic, ki jih določi Agencija [48].
The prospective applicant shall be required to share only in the costs of information that it is required to submit for the purposes of this Regulation.
Morebitni vlagatelj krije samo del stroškov za informacije, ki jih mora predložiti za namene te uredbe.
Use of data for subsequent applications
Uporaba podatkov za naslednje vloge
Where the relevant data protection period according to Article 60 has expired in relation to an active substance, the receiving competent authority or the Agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant in so far as the subsequent applicant can provide evidence that the active substance is technically equivalent to the active substance for which the data protection period has expired, including the degree of purity and the nature of any relevant impurities.
Kadar je ustrezno obdobje varstva podatkov v skladu s členom 60 v zvezi z aktivno snovjo poteklo, lahko pristojni organ prejemnik ali Agencija soglaša, da se poznejši vlagatelj za izdajo dovoljenja sklicuje na podatke, ki jih je predložil prvi vlagatelj, če poznejši vlagatelj dokaže, da je aktivna snov tehnično ekvivalentna aktivni snovi, za katero je obdobje varstva podatkov poteklo, vključno s stopnjo čistote in vrsto pomembnih nečistot.
Where the relevant data protection period according to Article 60 has expired in relation to a biocidal product, the receiving competent authority or the Agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant in so far as the subsequent applicant can provide evidence that the biocidal product is the same as the one already authorised, or the differences between them are not significant in relation to the risk assessment and the active substance(s) in the biocidal product are technically equivalent to those in the biocidal product already authorised, including the degree of purity and the nature of any impurities.
Kadar je ustrezno obdobje varstva podatkov v skladu s členom 60 v zvezi z biocidnim proizvodom poteklo, lahko pristojni organ prejemnik ali Agencija soglaša, da se poznejši vlagatelj za izdajo dovoljenja sklicuje na podatke, ki jih je predložil prvi vlagatelj, če poznejši vlagatelj dokaže, da je biocidni proizvod enak tistemu, za katerega je že bilo izdano dovoljenje, ali da razlike med njima niso bistvene za oceno tveganja, ter da je aktivna oziroma so aktivne snovi biocidnega proizvoda tehnično ekvivalentne aktivnim snovem biocidnega proizvoda, za katerega je že bilo izdano dovoljenje, vključno s stopnjo čistote in vrsto nečistot.
An appeal may be brought, in accordance with Article 77, against decisions of the Agency under the first and second subparagraphs of this paragraph.
V skladu s členom 77 se lahko proti sklepom Agencije na podlagi prvega in drugega pododstavka tega odstavka vloži pritožba.
Notwithstanding paragraph 1, subsequent applicants shall provide the following data accordingly to the receiving competent authority or the Agency, as applicable:
Ne glede na odstavek 1 poznejši vlagatelji pristojnemu organu prejemniku ali Agenciji, kot je primerno, po potrebi predložijo naslednje podatke:
all necessary data for the identification of the biocidal product, including its composition;
vse potrebne podatke za določitev biocidnega proizvoda, vključno z njegovo sestavo;
the data needed to identify the active substance and to establish technical equivalence of the active substance;
podatke, potrebne za določitev aktivne snovi in opredelitev tehnične ekvivalence aktivne snovi;
the data needed to demonstrate the comparability of the risk from and efficacy of the biocidal product to that of the authorised biocidal product.
podatke, ki so potrebni, da se dokaže, da je biocidni proizvod glede tveganja in učinkovitosti primerljiv z biocidnim proizvodom, za katerega je bilo izdano dovoljenje.
INFORMATION AND COMMUNICATION
OBVEŠČANJE IN KOMUNIKACIJA
Monitoring and reporting
Nadzor in poročanje
Member States shall make the necessary arrangements for the monitoring of biocidal products and treated articles which have been placed on the market to establish whether they comply with the requirements of this Regulation.
Države članice uredijo vse potrebno za nadzor biocidnih proizvodov in tretiranih izdelkov, ki so bili dani na trg, da se ugotovi, ali izpolnjujejo zahteve iz te uredbe.
Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products [49] shall apply accordingly.
Ustrezno se uporablja Uredba (ES) št. 765/2008 Evropskega parlamenta in Sveta z dne 9. julija 2008 o določitvi zahtev za akreditacijo in nadzor trga v zvezi s trženjem proizvodov [49].
Member States shall make the necessary arrangements for official controls to be carried out in order to enforce compliance with this Regulation.
Države članice uredijo vse potrebno za izvajanje uradnega nadzora za zagotavljanje skladnosti s to uredbo.
In order to facilitate such enforcement, manufacturers of biocidal products placed on the Union market shall maintain, in relation to the manufacturing process, appropriate documentation in paper or electronic format relevant for the quality and safety of the biocidal product to be placed on the market and shall store production batch samples.
Zaradi lažjega tozadevnega zagotavljanja proizvajalci biocidnih proizvodov, ki so dani na trg Unije, v zvezi s proizvodnim postopkom v papirni ali elektronski obliki vzdržujejo ustrezno dokumentacijo, pomembno za kakovost in varnost biocidnih proizvodov, ki se dajo na trg, ter shranjujejo vzorce proizvodnih serij.
The documentation shall include as a minimum:
Dokumentacija vsebuje vsaj:
safety data sheets and specifications of active substances and other ingredients used for manufacturing the biocidal product;
varnostne liste in specifikacije aktivnih snovi ter drugih sestavin, uporabljenih za proizvodnjo biocidnih proizvodov;
records of the various manufacturing operations performed;
evidence o različnih izvedenih proizvodnih operacijah;
results of internal quality controls;
rezultate o notranjem nadzoru kakovosti;
identification of production batches.
identifikacijo proizvodnih serij.
Where necessary in order to ensure uniform application of this paragraph, the Commission may adopt implementing acts in accordance with the examination procedure referred to in Article 82(3).
Komisija lahko sprejme izvedbene akte v skladu s postopkom pregleda iz člena 82(3), če je to potrebno za zagotavljanje enotnega izvajanja tega odstavka.
Measures taken pursuant to this paragraph shall avoid causing disproportionate administrative burden to economic operators and Member States.
Ukrepi, sprejeti v skladu s tem odstavkom, ne povzročajo nesorazmernega upravnega bremena za gospodarske subjekte in države članice.
Every five years, from 1 September 2015, Member States shall submit to the Commission a report on the implementation of this Regulation in their respective territories.
Države članice od 1. septembra 2015 vsakih pet let Komisiji predložijo poročilo o izvajanju te uredbe na njihovih ozemljih.
The report shall include in particular:
Poročilo vključuje zlasti:
information on the results of official controls carried out in accordance with paragraph 2;
informacije o rezultatih uradnega nadzora, izvedenega v skladu z odstavkom 2;
information on any poisonings and, where available, occupational diseases involving biocidal products, especially regarding vulnerable groups, and any specific measures taken to mitigate the risk of future cases;
informacije o vseh zastrupitvah in poklicnih boleznih, če so te na voljo, v zvezi z biocidnimi proizvodi, zlasti pri ranljivih skupinah, ter o posebnih ukrepih, ki so bili sprejeti za zmanjšanje tveganja prihodnjih primerov;
any available information on adverse environmental effects experienced through using biocidal products;
vse informacije, ki so na voljo o neželenih vplivih na okolje zaradi uporabe biocidnih proizvodov;
information on the use of nanomaterials in biocidal products and the potential risks thereof.
informacije o uporabi nanomaterialov v biocidnih proizvodih in morebitnih tveganjih takšne uporabe.
Reports shall be submitted by 30 June of the relevant year and shall cover the period until 31 December of the year preceding their submission.
Poročila se predložijo do 30. junija zadevnega leta in zajemajo obdobje do 31. decembra leta, ki je pred letom njihove predložitve.
The reports shall be published on the relevant website of the Commission.
Poročila se objavljajo na ustreznem spletnem mestu Komisije.
On the basis of the reports received in accordance with paragraph 3, and within 12 months from the date referred to in the second subparagraph of that paragraph, the Commission shall draw up a composite report on the implementation of this Regulation, in particular Article 58.
Komisija na podlagi poročil, prejetih v skladu z odstavkom 3, v 12 mesecih po datumu iz drugega pododstavka navedenega odstavka pripravi zbirno poročilo o izvajanju te uredbe, zlasti člena 58.
The Commission shall submit the report to the European Parliament and to the Council.
Komisija to poročilo predloži Evropskemu parlamentu in Svetu.