natgillin/translations-raw huggingface dataset:
beseda „nano“ se postavi v oklepaju pred imeni vseh nanomaterialov, ki jih vsebujejo biocidni proizvodi;
the name of all nanomaterials contained in biocidal products, followed by the word ‘nano’ in brackets;
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.
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.
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 za informacije v zvezi z aktivnimi snovmi.
This paragraph shall not apply where at least equivalent labelling requirements for biocidal products in treated articles to meet information requirements concerning those active substances already exist under sector-specific legislation.
Ne glede na odstavek 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 in okolja.
Notwithstanding paragraph 3, the person responsible for 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 and the environment.
Ne glede na odstavek 3 dobavitelj tretiranega izdelka na potrošniku na zahtevo v 45 dneh brezplačno zagotovi informacije o biocidni obravnavi tretiranega izdelka.
Notwithstanding paragraph 3, the supplier of a treated article shall, upon request by a consumer, provide, within 45 days, free of charge, information on the biocidal treatment of the treated article.
Kadar je to potrebno zaradi velikosti ali funkcije tretiranega izdelka, se oznaka natisne na embalažo, na navodila za uporabo ali na garancijski list
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
Pri tretiranih 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 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.
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.
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 paragraph 3, 4 and 6 of this Article.
Če obstajajo
Where there are
znaki, da aktivna snov v biocidnem proizvodu, s katero je bil tretirani izdelek tretiran ali jo tretirani izdelek vsebuje, ne izpolnjuje pogojev iz členov 4(1), 5(2) ali 25, Komisija v skladu s členom 15(1) ali 28(2) pregleda odobritev te aktivne snovi ali njeno vključitev v Prilogo I.
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), 5(2) or 25, the Commission shall review the approval of that active substance or its inclusion in Annex I in accordance with Article 15(1) or 28(2).
POGLAVJE XIV
CHAPTER XIV
VARSTVO IN IZMENJAVA PODATKOV
DATA PROTECTION AND DATA-SHARING
Varstvo podatkov, ki jih hranijo pristojni organi ali Agencija
Protection of data held by competent authorities or the Agency
Brez poseganja v člena 62 in 63 pristojni organi ali Agencija podatkov, predloženih za namene
Without prejudice to Articles 62 and 63, data submitted for the purposes of
Direktive 98/8/ES ali
Directive 98/8/EC or of
te uredbe, ne uporabljajo v korist poznejšega vlagatelja, razen če:
this Regulation shall not be used by competent authorities or the Agency for the benefit of a subsequent applicant, except where:
je poznejši vlagatelj pridobil
the subsequent applicant has
in predložil
and submits
izjavo o dostopnosti; ali
a letter of access; or
je potekel zadevni rok za varstvo podatkov.
the relevant time limit for data protection has expired.
Pri predložitvi podatkov pristojnemu organu ali Agenciji za namene te uredbe vlagatelj po potrebi navede ime in kontaktne podatke lastnika vseh predloženih 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.
Vlagatelj navede tudi, ali je lastnik podatkov oziroma ima izjavo o dostopnosti.
The applicant shall also specify whether it is the data owner or holds a letter of access.
Vlagatelj nemudoma obvesti pristojni organ ali Agencijo o kakršni koli spremembi lastništva podatkov.
The applicant shall, without delay, inform the competent authority or the Agency about any changes to the ownership of the data.
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 UL L 66, 4.3.2004, str.
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.
Obdobja varovanja podatkov
Data protection periods
Podatki, predloženi za namen Direktive 98/8/ES ali te uredbe, bodo varovani v skladu s pogoji iz tega člena.
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.
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 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 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 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 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 new data submitted with a view to the renewal or review of the approval of an active substance shall end 5 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 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), 34(6) ali 44(4).
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 novo aktivno snov, se izteče 15 let po prvem dnevu v mesecu po sprejetju prve odločitve o izdaji dovoljenja za proizvod v skladu s členom 30(4), 34(6) ali 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), 34(6) or 44(4).
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.
The protection period for new data submitted with a view to the renewal or amendment of the authorisation of a biocidal product shall end 5 years from the first day of the month following the decision concerning the renewal or amendment of the authorisation.
Izjava o dostopnosti podatkov
Letter of access
ime in kontaktne podatke lastnika podatkov in upravičenca;
the name and contact details of the data owner and the beneficiary;
ime aktivne snovi ali biocidnega proizvoda, za katerega je odobren dostop do podatkov;
the name of the active substance or biocidal product for which access to the data is authorised;
datum začetka učinkovanja izjave o dostopnosti podatkov;
the date on which the letter of access takes effect;
seznam predloženih podatkov, katerih citiranje je mogoče z izjavo o dostopnosti podatkov.
a list of the submitted data to which the letter of access grants citation rights.
Preklic izjave o dostopnosti podatkov ne vpliva na veljavnost dovoljenja, izdanega na podlagi zadevne izjave 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.
v primeru podatkov, ki ne vključujejo preskusov na vretenčarjih, lahko
may, in the case of data not involving tests on vertebrate animals,
, ali so bili takšni preskusi ali študije že predloženi
whether such tests or studies have already been submitted
Agenciji, ali pristojnemu organu
to the Agency or to a competent authority
Če so bili takšni preskusi ali študije že predloženi
Where such tests or studies have already been submitted
Agenciji ali pristojnemu organu
to the Agency or to a competent authority
predlagatelja in
submitter(s) and data
Predlagatelj podatkov po potrebi omogoči stike med morebitnim vlagateljem in lastnikom podatkov.
The data submitter(s) shall where relevant, facilitate contacts between the prospective applicant and the data owner(s).
Kadar so podatki, pridobljeni s temi preskusi ali študijami, še vedno varovani v skladu s členom 60, morebitni vlagatelj:
Where the data acquired under those tests or studies are still protected under Article 60, the prospective applicant:
v primeru podatkov, ki vključujejo preskuse na vretenčarjih, ▌in
shall, in the case of data involving tests on vertebrate animals, ▌ and
v primeru podatkov, ki ne vključujejo preskusov na vretenčarjih, lahko zaprosi lastnika podatkov za
may, in the case of data not involving tests on vertebrate animals, request from the data owner
vse znanstvene in tehnične podatke, povezane z zadevnimi preskusi in študijami, ter za
(s) all the scientific and technical data related to the tests and studies concerned as well as
pravico do sklicevanja na te
the right to refer to
podatke pri vložitvi vlog v skladu s to uredbo
these data when submitting applications within the framework of this Regulation
Nadomestilo za izmenjavo podatkov
Compensation for data sharing
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.
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.
vse znanstvene in tehnične
scientific and technical
, povezane z zadevnimi preskusi in študijami, ali
related to the tests and studies concerned
pri vložitvi vlog v skladu s to uredbo
when submitting applications under this Regulation
ali študije o njih
or studies
na vretenčarjih
the requested
Če se morebitni vlagatelj in lastnik podatkov ne moreta dogovoriti, nacionalna sodišča odločijo o sorazmernem deležu stroškov, ki jih morebitni vlagatelj plača lastniku podatkov.
Where the prospective applicant and data owner cannot agree, national courts shall decide on the proportionate share of the cost that the prospective applicant shall pay to the data owner.
Lastnik podatkov ne zavrne plačila, ponujenega v skladu s tem členom, kar pa ne posega v njegovo pravico, da v skladu s prejšnjim pododstavkom sorazmerni delež stroškov določi nacionalno sodišče.
The data owner shall not refuse to accept any payment offered pursuant to this Article, such acceptance being without prejudice, however, to his right to have the proportionate share of the cost determined by a national court, in accordance with the previous sub-paragraph.
Nadomestilo za izmenjavo podatkov se določi pošteno, pregledno in nediskriminatorno ob upoštevanju smernic, ki jih določi Agencija Poglavje 7 smernic o izmenjavi podatkov, določenih v skladu z Uredbo (ES) št. 1907/2006.
Compensation for data sharing shall be determined in a fair, transparent and non-discriminatory manner, having regard to the guidance established by the Agency Chapter 7 of the guidance on data sharing established in accordance with Regulation (EC) No 1907/2006.
Morebitni vlagatelj krije samo del stroškov za informacije, ki jih mora predložiti za namene te uredbe.
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.
Uporaba podatkov za naslednje vloge
Use of data for subsequent applications
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 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 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 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.
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.
V skladu s členom 77 se lahko proti sklepom Agencije na podlagi prvega in drugega pododstavka tega odstavka vloži pritožba.
An appeal may be brought, in accordance with Article 77, against decisions of the Agency under the first and second subparagraphs of this paragraph.
Ne glede na odstavek 1 poznejši vlagatelji pristojnemu organu prejemniku ali Agenciji, kot je primerno, po potrebi predložijo naslednje podatke:
Notwithstanding paragraph 1, subsequent applicants shall provide the following data accordingly to the receiving competent authority or the Agency, as applicable:
vse potrebne podatke za določitev biocidnega proizvoda, vključno z njegovo sestavo;
all necessary data for the identification of the biocidal product, including its composition;
podatke, potrebne za določitev aktivne snovi in opredelitev tehnične ekvivalence aktivne snovi;
the data needed to identify the active substance and to establish technical equivalence of the active substance;
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.
the data needed to demonstrate the comparability of the risk from and efficacy of the biocidal product to that of the authorised biocidal product.
POGLAVJE XV
CHAPTER XV
OBVEŠČANJE IN KOMUNIKACIJA
INFORMATION AND COMMUNICATION
Nadzor in poročanje
Monitoring and reporting
Skladnost z zahtevami
Compliance with requirements
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.
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.
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 UL L 218, 13.8.2008, str.
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 OJ L 218, 13.8.2008, p.
Države članice uredijo vse potrebno za izvajanje uradnega nadzora za zagotavljanje skladnosti s to uredbo.
Member States shall make the necessary arrangements for official controls to be carried out in order to enforce compliance with this Regulation.
Zaradi lažjega tozadevnega zagotavljanja proizvajalci biocidnih proizvodov, ki so dani na trg Unije,
In order to facilitate such enforcement, manufacturers of biocidal products placed on the Union market shall maintain
v zvezi s proizvodnim postopkom v papirni ali elektronski obliki
, in relation to
Dokumentacija vsebuje vsaj:
The documentation shall include as a minimum:
varnostne liste in specifikacije aktivnih snovi ter drugih sestavin, uporabljenih za proizvodnjo biocidnih proizvodov;
safety data sheets and specifications of active substances and other ingredients used for manufacturing the biocidal product;
evidence o različnih izvedenih proizvodnih operacijah;
records of the various manufacturing operations performed;
rezultate o notranjem nadzoru kakovosti;
results of internal quality controls;
identifikacijo proizvodnih serij.
identification of production batches.
Komisija lahko sprejme izvedbene akte v skladu s postopkom iz člena 82(3), če je to potrebno za zagotavljanje enotnega izvajanja tega odstavka.
Where necessary in order to ensure uniform application of this paragraph, the Commission may adopt implementing acts in accordance with the procedure referred to in Article 82(3).
Ukrepi, sprejeti v skladu s tem odstavkom, preprečujejo nesorazmerno upravno breme za gospodarske subjekte in države članice.
Measures taken pursuant to this paragraph shall avoid causing disproportionate administrative burden to economic operators and Member States.
Poročilo vključuje
The report shall include
informacije o rezultatih uradnega nadzora, izvedenega v skladu z odstavkom 2;
information on the results of official controls carried out in accordance with paragraph 2;
informacije o vseh zastrupitvah in poklicnih boleznih, če so te na voljo, v zvezi z biocidnimi proizvodi
information on any poisonings and, where available, occupational diseases involving biocidal products
, zlasti pri ranljivih skupinah, ter o posebnih ukrepih, ki so bili sprejeti za zmanjšanje tveganja prihodnjih primerov;
, especially regarding vulnerable groups, and any specific measures taken to mitigate the risk of future cases;
informacije o uporabi nanomaterialov v biocidnih proizvodih in morebitnih tveganjih
information on the use of nanomaterials in biocidal products and the potential risks
se predložijo
be submitted
do 30. junija
by 30 June
zadevnega leta in zajemajo obdobje do 31. decembra
of the relevant year and shall cover the period until 31 December
leta, ki je pred letom njihove predložitve.
of the year preceding their submission.
Poročila se objavljajo na ustreznem spletnem mestu Komisije.
The reports shall be published on the relevant website of the Commission.
poročilo o izvajanju te uredbe, zlasti člena 58.
report on the implementation of this Regulation, in particular Article 58 ▌.
Uredba (ES) št. 1049/2001 Evropskega parlamenta in Sveta z dne 30. maja 2011 o dostopu javnosti do dokumentov Evropskega parlamenta, Sveta in Komisije UL L 145, 31.5.2001, str.
Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents OJ L 145, 31.5.2001, p.
in pravila upravnega odbora Agencije, sprejeta v skladu s členom 118(3) Uredbe (ES) št. 1907/2006, se uporabljajo za dokumente, ki jih ima Agencija za namene te uredbe.
and the rules of the Management Board of the Agency, adopted in accordance with Article 118(3) of Regulation (EC) No 1907/2006, shall apply to documents held by the Agency for the purposes of this Regulation.
Agencija in pristojni organi zavrnejo dostop do informacij, kadar bi njihovo razkritje ogrozilo zaščito poslovnih interesov ali zasebnost ali varnost zadevnih oseb.
The Agency and the competent authorities shall refuse access to information where disclosure would undermine the protection of the commercial interests or the privacy or safety of the persons concerned.
Razkritje naslednjih informacij se običajno šteje, da ogroža zaščito poslovnih interesov ali zasebnost ali varnost zadevnih oseb:
Disclosure of the following information shall normally be deemed to undermine the protection of the commercial interests or the privacy or safety of the persons concerned:
podrobnosti o celotni sestavi biocidnega proizvoda;
details of the full composition of a biocidal product;
natančna tonaža aktivne snovi ali biocidnega proizvoda, ki se proizvede ali je dostopna na trgu;
the precise tonnage of the active substance or biocidal product manufactured or made available on the market;
povezave med proizvajalcem aktivne snovi in osebo, odgovorno za dajanje biocidnega proizvoda na trg, ali povezave med osebo, odgovorno za dajanje biocidnega proizvoda na trg, in distributerji proizvoda;
links between a manufacturer of an active substance and the person responsible for the placing of a biocidal product on the market or between the person responsible for the placing of a biocidal product on the market and the distributors of the product;