natgillin/translations-raw huggingface dataset:
Obdobje varovanja informacij, predloženih za obnovitev ali pregled vključitve aktivne snovi v Prilogo I, se konča 5 let po datumu sprejetja odločitve o obnovitvi ali pregledu.
The protection period for information submitted in view of the renewal or review of the inclusion of an active substance in Annex I shall end 5 years after the date of the decision concerning the renewal or the review being taken.
Obdobje varovanja podatkov, predloženih za izdajo dovoljenja za biocidni pripravek, ki vsebuje le obstoječe aktivne snovi, se konča 10 let po datumu prve izdaje dovoljenja za pripravek.
The protection period for information submitted in view of the authorisation of a biocidal product containing only existing active substances shall end 10 years after the date of the first authorisation of the product.
Obdobje varovanja informacij, predloženih za izdajo dovoljenja za biocidni pripravek, ki vsebuje novo aktivno snov, se konča 15 let po datumu prve izdaje dovoljenja za pripravek.
The protection period for information submitted in view of the authorisation of a biocidal product containing a new active substance shall end 15 years after the date of the first authorisation of the product.
Obdobje varovanja informacij, predloženih zaradi obnovitve ali spremembe dovoljenja za biocidni pripravek, se konča 5 let po datumu obnovitve ali spremembe dovoljenja.
The protection period for information submitted in view of the renewal or modification of the authorisation of a biocidal product shall end 5 years after the date of the renewal or modification of the authorisation.
Izjava o dostopnosti podatkov vsebuje vsaj naslednje informacije:
A letter of access shall contain at least the following information:
ime in kontaktne podatke lastnika podatkov in upravičenca;
name and contact details of the data owner and the beneficiary;
datum začetka veljave izjave o dostopnosti podatkov in datum poteka veljave;
date on which the letter of access takes effect and its expiry date;
predložene informacije, katerih citiranje je mogoče z izjavo o dostopnosti podatkov;
the submitted information to which the letter of access grants citation rights;
naslov proizvodnega objekta, kjer se proizvaja aktivna snov ali biocidni pripravek;
the address of the manufacturing facility where the active substance or biocidal product is produced;
pogoji, pod katerimi se izjava lahko razveljavi.
the conditions under which it may be revoked.
Preklic izjave o dostopnosti podatkov pred datumom poteka veljave ne vpliva na veljavnost dovoljenja, izdanega na podlagi zadevne izjave o dostopnosti podatkov.
Revocation of a letter of access prior to its expiry date shall not affect the validity of the authorisation issued on the basis of the letter of access in question.
in če ni alternativnih rešitev, ki ne vplivajo na ljudi ali živali
where no alternative solution can be employed without producing an impact on humans or animals
Vsaka oseba, ki namerava izvesti preskuse ali študije, ki vključujejo vretenčarje ali nevretenčarje, v nadaljnjem besedilu: bodoči predlagatelj, pristojni organ ali Agencijo vpraša, ali so bili takšni preskusi ali študije že predloženi v prejšnji vlogi.
Any person intending to perform tests or studies involving vertebrate animals or non-vertebrate animals (hereinafter the ‘prospective applicant’), shall ask the competent authority or the Agency whether such tests or studies have already been submitted in connection with a previous application.
Pristojni organ ali Agencija preveri, ali so v registru za izmenjavo podatkov o biocidih podatki o takšnih preskusih ali študijah.
The competent authority or the Agency shall verify if there is any data on such tests or studies in the Biocides Data Sharing Register.
Če so bili navedeni preskusi ali študije že predloženi v povezavi s prejšnjo vlogo, pristojni organ ali Agencija
Where those tests or studies have already been submitted in connection with a previous application,
nemudoma oceni tehnično enakovrednost primerjalnega vira.
the competent authority or the Agency shall, without delay, assess technical equivalence in relation to the comparison source.
Če je ocena tehnične enakovrednosti pozitivna, pristojni organ ali Agencija
If the technical equivalence assessment is positive,
bodočemu predlagatelju nemudoma sporoči ime in kontaktne podatke lastnika podatkov.
the competent authority or the Agency shall without delay communicate the name and contact details of the owner of the information to the prospective applicant.
Če so podatki, pridobljeni z navedenimi preskusi ali študijami, še vedno zaščiteni v skladu s členom 49 in vključujejo preskusov na vretenčarjih, bodoči predlagatelj zaprosi lastnika podatkov za dovoljenje za uporabo teh preskusov ali študij.
Where the data acquired under those tests or studies are still protected under Article 49, and involve tests on vertebrate animals, the prospective applicant shall request from the owner of the information the right to refer to the tests or studies.
Če so podatki, pridobljeni z navedenimi preskusi ali študijami, še vedno zaščiteni v skladu s členom 49 in ne vključujejo preskusov na vretenčarjih, lahko bodoči predlagatelj zaprosi lastnika podatkov za dovoljenje za uporabo teh preskusov ali študij.
Where the data acquired under those tests or studies are still protected under Article 49, and do not involve tests on vertebrate animals, the prospective applicant may request from the owner of the information the right to refer to the tests or studies.
Če je bil zahtevek vložen v skladu s členom 51(2), si morata bodoči predlagatelj in lastnik informacij prizadevati za dosego dogovora o souporabi rezultatov preskusov in študij, za katere je zaprosil bodoči predlagatelj.
Where a request has been made in accordance with Article 51(2), the prospective applicant and the owner of the information shall make every effort to reach an agreement on the sharing of the results of the tests or studies requested by the prospective applicant.
Namesto takšnega dogovora se lahko zadeva predloži razsodišču in sprejme njegova odločitev.
Such an agreement may be replaced by submission of the matter to an arbitration body and a commitment to accept the arbitration order.
Če se sprejme tak dogovor, lastnik informacij bodočemu predlagatelju da na voljo informacij in mu dovoli uporabo preskusov ali študij.
Where such agreement is reached, the owner of the information shall make available to the prospective applicant the information and shall give the prospective applicant permission to refer to the data owner's tests or studies.
Če se dogovor ne sprejme v dveh mesecih po vložitvi zahtevka v skladu s členom 51(2), bodoči predlagatelj o tem nemudoma obvesti Agencijo in lastnika informacij.
Where no such agreement is reached two months after the request was made according to Article 51(2), the prospective applicant shall without delay inform the Agency and the owner of the information thereof.
Stroški izmenjave preskusov ali študij se določijo pošteno, pregledno in nediskriminatorno.
The costs of sharing the tests or studies shall be determined in a fair, transparent and non-discriminatory manner.
V skladu s členom 68 se lahko proti odločitvam Agencije na podlagi odstavka 3 tega člena vloži pritožba.
An appeal may be brought, in accordance with Article 68, against Agency decisions under paragraph 3 of this Article.
Za biocidni pripravek, za katerega je že bilo izdano dovoljenje v skladu s členom 15, 25 ali 28, in za katerega so potekla vsa obdobja varovanja informacij v skladu s členom 49, lahko pristojni organ prejemnik ali Agencija soglaša, da se poznejši predlagatelj za izdajo dovoljenja sklicuje na podatke, ki jih je dal prvi predlagatelj
In the case of a biocidal product which has already been authorised in accordance with Articles 15, 25 or 28, and where all periods of protection of information according to Article 49 have expired, the receiving competent authority or the Agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant
; če obdobja varovanja informacij v skladu s členom 49 še niso potekla, lahko pristojni organ prejemnik ali Agencija soglaša, da se poznejši predlagatelj v skladu s členom 52 v obeh primerih
, and if the periods of protection of information according to Article 49 have not expired, the receiving competent authority or the Agency may agree that a subsequent applicant for authorisation may refer to data provided by the first applicant pursuant to Article 52, in both cases
sklicuje na podatke, ki jih je dal prvi predlagatelj, če poznejši predlagatelj dokaže, da gre za podoben biocidni pripravek in da so njegove aktivne snovi tehnično enakovredne kot pri pripravku, za katerega je že bilo izdano dovoljenje, vključno s stopnjo čistote in vrsto nečistot.
in so far as the subsequent applicant can provide evidence that the biocidal product is similar to, and its active substances technically equivalent to, the one formerly authorised, including in terms of degree of purity and nature of impurities.
Na podlagi člena 68 se lahko proti odločitvam Agencije na podlagi prvega pododstavka tega odstavka vloži pritožba.
An appeal may be brought, in accordance with Article 68, against Agency decisions under the first subparagraph of this paragraph.
Ne glede na odstavek 1 poznejši predlagatelji pristojnemu organu prejemniku ali Agenciji, kot je primerno, predložijo naslednje informacije:
Notwithstanding paragraph 1, subsequent applicants shall provide the following information accordingly to the receiving competent authority or the Agency:
vse potrebne podatke za identifikacijo biocidnega pripravka, vključno z njegovo sestavo;
all data necessary for the identification of the biocidal product, including its composition;
informacije, potrebne za identifikacijo aktivne snovi in določitev tehnične enakovrednosti aktivne snovi;
the information needed to identify the active substance and to establish technical equivalence of the active substance;
vse potrebne podatke za oceno zadevnih snovi, ki jih vsebuje biocidni pripravek;
all data necessary for the evaluation of substances of concern contained in the biocidal product;
podatke, potrebne za dokazilo, da ima biocidni pripravek primerljive učinke kot biocidni pripravek, za katerega je že bilo izdano dovoljenje v skladu s členom 15, 25 ali 28.
the data needed to demonstrate that the biocidal product has comparable efficacy to the biocidal product formerly authorised in accordance with Articles 15, 25 or 28.
Pristojni organi izvajajo uradne preglede, da bi zagotovili, da so proizvajalci aktivnih snovi, ki so na trgu za uporabo v biocidnih pripravkih, Komisiji predložili informacije o aktivnih snoveh iz Priloge II ali da imajo izjavo o dostopu do dokumentacije, ki izpolnjuje pogoje iz Priloge II.
Competent authorities shall perform official controls in order to ensure that manufacturers of active substances which are placed on the market for use in biocidal products have submitted to the Commission the information about the active substances referred to in Annex II or are in the possession of a letter of access to a dossier which complies with the requirements of Annex II.
Pristojni organi uredijo vse potrebno za nadzor biocidnih pripravkov, ki so bili dani v promet sami ali kot del tretirane snovi, da se ugotovi, ali izpolnjujejo zahteve te uredbe.
Competent authorities shall make the necessary arrangements for biocidal products which have been placed on the market on their own or incorporated in treated materials to be monitored to establish whether they comply with the requirements of this Regulation.
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 pripravkov 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.
se uporablja temu ustrezno.
shall apply accordingly.
Pristojni organi izvajajo uradni nadzor za zagotavljanje skladnosti s to uredbo.
Competent authorities shall carry out official controls in order to enforce compliance with this Regulation.
, začenši leta 2013, pristojni organi predložijo Komisiji poročilo o izvajanju te uredbe na njihovem ozemlju.
, starting in 2013, competent authorities shall submit to the Commission a report on the implementation of this Regulation in their respective territories.
Poročilo vključuje:
The reports shall include:
informacije o rezultatih uradnega nadzora, izvedenega v skladu z odstavkom 3;
information on the results of official controls carried out in accordance with paragraph 3;
informacije o zastrupitvah z biocidnimi pripravki
information on any poisonings involving biocidal products
Komisija bo do
The Commission shall draw up a report on the implementation of this Regulation and, in particular, on the functioning of the Union authorisation procedure and mutual recognition, by
1. januarja 2019 in nato vsaka tri leta
1 January 2019 and every three years thereafter
Komisija to poročilo predloži Evropskemu parlamentu in Svetu
The Commission shall submit the report to the European Parliament and the Council.
Komisija najkasneje ...
Not later than ...
UL: Dve leti po začetku veljavnosti te uredbe.
Two years after the entry into force of this Regulation.
predloži Evropskemu parlamentu in Svetu poročilo o oceni tveganja glede uporabe nanomaterialov v biocidnih pripravkih za zdravje ljudi in okolje ter o posebnih ukrepih, ki bi jih bilo treba sprejeti v zvezi z njimi.
, the Commission shall submit to the European Parliament and Council a report on the assessment of the risks to human health and the environment presented by the use of nanomaterials in biocidal products and on specific measures to be taken with regard to them.
Komisija najkasneje ...
Not later than...
UL: Pet let po začetku veljavnosti te uredbe.
Five years after the entry into force of this Regulation.
pripravi poročilo o vplivu sproščanja biocidov v okolje.
, the Commission shall draw up a report on the impact of the spread of biocidal products in the environment.
Uredba (ES) št. 1049/2001 Evropskega parlamenta in Sveta z dne 30. maja 2001 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.
ter predpisi upravnega odbora Agencije, sprejeti v skladu s členom 118(3) Uredbe (ES) št. 1907/2006, veljajo 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) Regulation (EC) No 1907/2006, shall apply to documents held by the Agency for the purposes of this Regulation.
Za razkritje naslednjih informacij običajno velja, da ogroža zaščito poslovnih interesov zadevne osebe:
Disclosure of the following information shall be deemed to undermine the protection of the commercial interests of the person concerned:
podrobni podatki o celotni sestavi biocidnega pripravka;
details of the full composition of a biocidal product;
točna uporaba ali funkcija snovi ali mešanice;
the precise use, function or application of a substance or mixture;
natančna tonaža snovi ali mešanice, ki se proizvede ali da v promet;
the precise tonnage of the substance or mixture manufactured or placed on the market;
imena in naslovi proizvajalcev aktivnih snovi, vključno s krajem proizvodnih obratov;
names and addresses of manufacturers of the active substances, including location of manufacturing sites;
Kadar je nujno takojšnje ukrepanje za zaščito zdravja ljudi, varnosti ali okolja, ▌Agencija ali pristojni organi
However, where urgent action is essential to protect human health, safety or the environment, the Agency or the competent authorities
sprejmejo potrebne ukrepe za razkritje informacij
shall take the necessary measures to
iz tega odstavka.
disclose the information referred to in this paragraph.
Vsaka oseba, ki predloži informacije o aktivni snovi
Any person who submits information related to an active substance
ali biocidnem pripravku
or a biocidal product
Agenciji ali pristojnemu organu za namene te uredbe, lahko s pojasnilom, zakaj bi bilo razkritje informacij lahko škodljivo za njene tržne interese te osebe ali interese katere druge zadevne strani, zahteva, da se podatki iz člena 56(2) ne dajo na voljo.
to the Agency or a competent authority for the purposes of this Regulation can request that the information in Article 56(2) not be made available including a justification as to why the disclosure of the information could be harmful for his or any other concerned party's commercial interests.
Informacije, ki jih pristojni organ prejemnik potrdi kot zaupne, drugi pristojni organi, države članice in Komisija obravnavajo kot zaupne.
Information accepted as confidential by a competent authority or the Agency shall be treated as confidential by the other competent authorities, the Agency and the Commission.
ne glede na točko (f) odstavka 2 ime po nomenklaturi Mednarodne zveze za čisto in uporabno kemijo IUPAC za aktivne snovi, ki izpolnjuje kriterije za razvrstitev v katerega koli od razredov ali kategorij nevarnosti iz Priloge I k Uredbi (ES) št. 1272/2008:
without prejudice to point (f) of paragraph 2, the name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature for active substances fulfilling the criteria for any of the following hazard classes or categories set out in Annex I to Regulation (EC) No 1272/ 2008:
razredi nevarnosti 2.1 do 2.4, 2.6 in 2.7, 2.8 vrsti A in B, 2.9, 2.10, 2.12, 2.13 kategorij 1 in 2, 2.14 kategorij 1 in 2, 2.15 vrste A do F;
hazard classes 2.1 to 2.4, 2.6 and 2.7, 2.8 types A and B, 2.9, 2.10, 2.12, 2.13 categories 1 and 2, 2.14 categories 1 and 2, 2.15 types A to F;
razredi nevarnosti 3.1 do 3.6, 3.7 (neželeni učinki na spolno delovanje in plodnost ali razvoj), 3.8 (razen narkotičnih učinkov), 3.9 in 3.10;
hazard classes 3.1 to 3.6, 3.7 adverse effects on sexual function and fertility or on development, 3.8 effects other than narcotic effects, 3.9 and 3.10;
razred nevarnosti 4.1;
hazard class 4.1;
razred nevarnosti 5.1;
hazard class 5.1;
če je to ustrezno, ime aktivne snovi, kot je navedeno v Evropskem seznamu obstoječih snovi (EINECS);
if applicable, the name of the active substance as given in European Inventory of Existing Commercial Chemical Substances (EINECS);
razvrstitev in označitev aktivne snovi;
the classification and labelling of the active substance;
fizikalno-kemijski podatki o aktivni snovi ter podatki o njeni porazdelitvi in obnašanju v okolju;
physicochemical data concerning the active substance and data on pathways and environmental fate;
jasna navedba, ali se aktivna snov šteje za snov, ki je obstojna, kopiči v organizmih in je strupena, ali za snov, ki je zelo obstojna in se zelo lahko kopiči v organizmih v skladu s Prilogo XIII Uredbe (ES) št. 1907/2006, ali za snov, ki je endokrini motilec ali ki je bila v skladu z Uredbo (ES) št. 1272/2008 razvrščena kot karcinogena, mutagena, nevrotoksična, imunotoksična, strupena za razmnoževanje ali kot snov, ki povzroča preobčutljivost;
where the active substance qualifies as persistent, bio-accumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) in accordance with Annex XIII to Regulation (EC) No 1907/2006 or as an endocrine disrupter or where it has been classified in accordance with Regulation (EC) No 1272/2008 as carcinogenic, mutagenic, neurotoxic, immunotoxic, toxic to reproduction or sensitising, a clear reference to that effect;
rezultati vsake toksikološke in ekotoksikološke študije;
the result of each toxicological and ecotoxicological study;
sprejemljive ravni izpostavljenosti ali predvidene koncentracije brez učinka, določene v skladu s Prilogo VI k tej uredbi;
acceptable exposure level or predicted no-effect concentration established in accordance with Annex VI to this Regulation;
smernice o varni uporabi, ki so določene v skladu s Prilogo II in Prilogo III k tej uredbi;
the guidance on safe use provided in accordance with Annex II and Annex III to this Regulation;
analitske metode, če se zahtevajo v skladu s Prilogo II ali III k tej uredbi, ki omogočajo zaznavanje nevarne snovi pri sproščanju v okolje
analytical methods if requested in accordance with Annex II or III to this Regulation which make it possible to detect a dangerous substance when discharged into the environment
(vključno z vodnimi viri in pitno vodo)
, including water resources and drinking water,
ali določitev neposredne izpostavljenosti ljudi.
as well as to determine the direct exposure of humans.
Če informacije iz prvega pododstavka zadevajo novo aktivno snov, se te informacije dajo na voljo javnosti šele po datumu, ko začne veljati vključitev nove aktivne snovi v Prilogo I k tej uredbi.
If the information listed in the first subparagraph concerns a new active substance, it shall be made publically available only after the date on which the inclusion of the new active substance in Annex I to this Regulation becomes effective.
Naslednje informacije o aktivnih snoveh v samostojni obliki, v mešanicah ali snoveh ali izdelkih ali informacije o biocidnih pripravkih se dajo brezplačno na voljo javnosti, razen kadar stranka, ki predloži informacije, predloži utemeljitev v skladu s členom 55(3), ki jo pristojni organ, Agencija ali Komisija, kjer je to ustrezno, sprejme kot veljavno, v kateri utemelji, zakaj lahko takšna objava škoduje komercialnim interesom predlagatelja ali druge zadevne stranke:
The following information on active substances whether on their own, in mixtures or in materials or articles, or information on biocidal products shall be made publicly available, free of charge, except where a party submitting the information submits a justification in accordance with Article 55(3), accepted as valid by the competent authority, the Agency or, as appropriate, the Commission, as to why such publication is potentially harmful for the commercial interests of the applicant or any other party concerned:
če je to bistveno za razvrščanje in označevanje, stopnja čistosti snovi ter določitev nečistot in/ali dodatkov, za katere je znano, da so nevarni;
if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives which are known to be dangerous;
povzetki ali okvirni povzetki študij informacij iz odstavkov 1(d) in (e);
the study summaries or robust study summaries of the information referred to in paragraph 1(d) and (e);
informacije iz varnostnega lista, ki niso naštete v odstavku 1;
information, other than that listed in paragraph 1, contained in the safety data sheet;
trgovska imena snovi;
the trade name(s) of the substance;
ob upoštevanju člena 24 Uredbe (ES) št. 1272/2008 ime po nomenklaturi IUPAC za aktivne snovi iz točke (a) odstavka 1 tega člena, ki se uporabljajo samo za enega ali več naslednjih namenov:
subject to Article 24 of Regulation (EC) No 1272/2008, the name in the IUPAC nomenclature for active substances referred to in point (a) of paragraph 1 that are only used as one or more of the following:
pri znanstvenih raziskavah in razvoju;
in scientific research and development;
pri raziskavah in razvoju, usmerjenih v proizvode in postopke.
in product and process orientated research and development.
Po izdaji dovoljenja se tajnost podatkov v nobenem primeru ne uporablja za:
After the authorisation has been granted, confidentiality shall not in any case apply to:
ime in naslov proizvajalca biocidnega pripravka;
the name and address of the biocidal product manufacturer;
ime in naslov proizvajalca aktivne snovi;
the name and address of the active substance manufacturer;
vsebnost aktivne(-ih) snovi v biocidnem pripravku ter ime biocidnega pripravka;
the content of the active substance or substances in the biocidal product and the name of the biocidal product;
fizikalne in kemijske podatke o biocidnem pripravku;
physical and chemical data concerning the biocidal product;