natgillin/translations-raw huggingface dataset:
imena in naslovi oseb, ki so povezane z izvajanjem preskusov na vretenčarjih.
names and addresses of persons involved in testing on vertebrate animals.
Vendar kadar je nujno takojšnje ukrepanje za zaščito zdravja človeka, varnosti ali okolja ali kadar zaradi drugih razlogov prevlada javni interes, Agencija ali pristojni organi razkrijejo informacije iz tega odstavka.
However, where urgent action is essential to protect human health, safety or the environment or for other reasons of overriding public interest, the Agency or the competent authorities shall disclose the information referred to in this paragraph.
Ne glede na odstavek 2 se po izdaji dovoljenja v nobenem primeru ne sme zavrniti dostop do naslednjih informacij:
Notwithstanding paragraph 2, after the authorisation has been granted, access to the following information shall not in any case be refused:
ime in naslov imetnika dovoljenja;
the name and address of the authorisation holder;
ime in naslov proizvajalca biocidnega proizvoda;
the name and address of the biocidal product manufacturer;
vsebnost aktivne(-ih) snovi v biocidnem proizvodu in ime biocidnega proizvoda;
the content of the active substance or substances in the biocidal product and the name of the biocidal product;
fizikalni in kemijski podatki o biocidnem proizvodu;
physical and chemical data concerning the biocidal product;
kakršne koli metode, s katerimi aktivna snov ali biocidni proizvod postaneta neškodljiva;
any methods for rendering the active substance or biocidal product harmless;
povzetek rezultatov preskusov, ki se zahteva v skladu s členom 20 za določitev učinkovitosti proizvoda ter učinkov na ljudi, živali in okolje, ter, kadar je to primerno, njegove sposobnosti za izboljšanje odpornosti;
a summary of the results of the tests required pursuant to Article 20 to establish the product's efficacy and effects on humans, animals and the environment and, where applicable, its ability to promote resistance;
priporočeni postopki in previdnostni ukrepi za zmanjšanje nevarnosti pri ravnanju, prevozu in uporabi, kot tudi za preprečevanje požara ali drugih nevarnosti;
recommended methods and precautions to reduce dangers from handling, transport and use as well as from fire or other hazards;
varnostni listi;
safety data sheets;
metode analize iz člena 19(1)(c);
methods of analysis referred to in Article 19(1)(c);
metode za odstranjevanje proizvoda in njegove embalaže;
methods of disposal of the product and of its packaging;
postopki, ki jih je treba uporabiti, in ukrepi, ki jih je treba sprejeti v primeru izlitja ali iztekanja;
procedures to be followed and measures to be taken in the case of spillage or leakage;
prva pomoč in zdravstveni nasveti, ki jih je treba nuditi v primeru poškodb ljudi.
first aid and medical advice to be given in the case of injury to persons.
Vsaka oseba, ki Agenciji ali pristojnemu organu za namene te uredbe predloži informacije v zvezi z aktivno snovjo ali biocidnim proizvodom, lahko zahteva, da se podatki iz člena 67(3) ne dajo na voljo, vključno z utemeljitvijo razlogov iz katerih bi lahko bilo razkritje informacij škodljivo za njene poslovne interese ali interese druge zadevne strani.
Any person submitting information related to an active substance or a biocidal product to the Agency or a competent authority for the purposes of this Regulation can request that the information in Article 67(3) shall not be made available, including a justification as to why the disclosure of the information could be harmful for their commercial interests or those of any other party concerned.
Elektronski dostop javnosti
Electronic public access
Od dneva odobritve aktivne snovi se
From the date on which an active substance is approved,
če je to ustrezno, imena, kot je navedeno v Evropskem seznamu obstoječih komercialnih kemičnih snovi;
if applicable, the name as given in European Inventory of Existing Commercial Chemical Substances;
razvrstitve in označitve, vključno s tem, ali aktivna snov izpolnjuje katero od meril iz člena 5(1);
the classification and labelling, including whether the active substance meets any of the criteria set out in Article 5(1);
ter podatkov o porazdelitvi in vplivu v okolju ter obnašanju;
and data on pathways and environmental fate and behaviour;
rezultatov 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;
acceptable exposure level or predicted no-effect concentration established in accordance with Annex VI;
smernic o varni uporabi, ki so določene v skladu s Prilogo II in Prilogo III;
the guidance on safe use provided in accordance with Annex II and Annex III;
analitskih metod
analytical methods
iz oddelkov 5.2 in 5.3 naslova I ter oddelka 4.2 naslova II
referred to under sections 5.2 and 5.3 of Title I, and section 4.2 of Title II of
Priloge II▌.
Annex II ▌.
Od dneva odobritve biocidnega proizvoda Agencija javnosti omogoči lahko dosegljiv in brezplačen dostop do naslednjih najnovejših informacij:
From the date on which a biocidal product is authorised, the Agency shall make publicly and easily available free of charge the following up-to-date information:
pogojev za odobritev;
the terms and conditions of the authorisation;
povzetka značilnosti biocidnega proizvoda; in
the summary of the biocidal product characteristics; and
analitskih metod iz oddelkov 5.2 in 5.3 naslova I ter oddelka 5,2 naslova II Priloge III.
analytical methods referred to under sections 5.2 and 5.3 of Title I, and section 5.2 of Title II of Annex III.
Od dneva odobritve aktivne snovi Agencija javnosti omogoči brezplačen dostop do naslednjih najnovejših informacij o aktivnih snoveh, razen če pošiljatelj podatkov
From the date on which an active substance is approved, except where the data supplier
predloži utemeljitev v skladu s
submits a justification in accordance with Article
, ki jo pristojni organ
, accepted as valid by the competent authority
druge zadevne strani:
or any other party concerned
če je to bistveno za razvrščanje in označevanje, stopnja čistote snovi ter opis nečistot in/ali dodatkov
if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives
aktivnih snovi
of active substances
, za katere je znano, da so
which are known to be
povzetki ali okvirni povzetki študij
the study summaries or robust study summaries of
, predloženih za odobritev aktivne snovi
studies submitted in view of the active substance approval
informacije iz varnostnega lista, ki niso naštete v odstavku 1 tega člena;
information, other than that listed in paragraph 1 of this Article, contained in the safety data sheet;
poročilo o oceni
the assessment report
Od dneva odobritve biocidnega proizvoda Agencija javnosti omogoči brezplačen dostop do naslednjih najnovejših informacij o aktivnih snoveh, razen če pošiljatelj podatkov predloži utemeljitev v skladu s členom 66(4), ki jo pristojni organ ali Agencija sprejme kot veljavno, v kateri utemelji, zakaj bi takšna objava lahko škodovala njegovim poslovnim interesom ali poslovnim interesom druge zadevne strani:
From the date on which a biocidal product is authorised, except where the data supplier submits a justification in accordance with Article 66(4), accepted as valid by the competent authority or the Agency, as to why such publication is potentially harmful for its commercial interests or any other party concerned, the Agency shall make publicly available, free of charge, the following up-to date information:
povzetki ali okvirni povzetki študij, predloženih za odobritev biocidnega proizvoda, in
study summaries, or robust study summaries, of studies submitted to support the biocidal product authorisation; and
poročilo o oceni.
the assessment report.
Vodenje evidence in poročanje
Record-keeping and reporting
Imetniki dovoljenja vodijo evidenco o biocidnih proizvodih, ki jih dajejo na trg, vsaj deset let po tem, ko so jih dali na trg, ali deset let po datumu preklica ali poteka dovoljenja, kar je prej.
Authorisation holders shall keep records of the biocidal products they place on the market for at least ten years after placing on the market, or ten years after the date on which the authorisation was cancelled or expired, whichever is the earlier.
Na zahtevo dajo pristojnemu organu na voljo ustrezne informacije iz te evidence.
They shall make available the relevant information contained in these records to the competent authority on request.
Za zagotovitev enotne uporabe odstavka 1 tega člena Komisija sprejme izvedbene akte za določitev oblike in vsebine informacij v evidencah.
To ensure the uniform application of paragraph 1 of this Article, the Commission shall adopt implementing acts to specify the form and content of the information in records.
Informacije o biocidnih proizvodih
Information about biocidal products
Razvrščanje, pakiranje in označevanje biocidnih proizvodov
Classification, packaging and labelling of biocidal products
Imetniki dovoljenja zagotovijo, da se biocidni proizvodi razvrstijo, zapakirajo in označijo v skladu z v povezavi z odobrenim povzetkom značilnosti biocidnega proizvoda, zlasti izjavami o nevarnosti in previdnostnimi izjavami iz točke (i) člena 22(2), in z Direktivo 1999/45/ES ter, kjer je ustrezno, Uredbo (ES) št. 1272/2008.
Authorisation holders shall ensure that biocidal products are classified, packaged and labelled in accordance with the approved summary of biocidal product characteristics, in particular the hazard statements and the precautionary statements, as referred to in point (i) of Article 22(2), and with Directive 1999/45/EC and, where applicable, Regulation (EC) No 1272/2008.
Poleg tega se proizvode, ki bi se lahko zamenjali za hrano, vključno s pijačo, ali krmo, zapakira tako, da se zmanjša verjetnost zamenjave.
In addition, products which may be mistaken for food, including drink, or feed shall be packaged to minimise the likelihood of such a mistake being made.
Če so dostopni splošni javnosti, vsebujejo komponente za odvračanje od njihovega uživanja, zlasti pa niso privlačni za otroke.
If they are available to the general public, they shall contain components to discourage their consumption and, in particular, shall not be attractive to children.
Imetniki dovoljenja zagotovijo, da je oznaka skladna z odstavkom 1 ter ni zavajajoča glede tveganja, ki ga proizvod predstavlja za človekovo zdravje ali okolje, ali njegove učinkovitosti, in da v nobenem primeru ne vsebuje navedb „biocidni proizvod z manjšim tveganjem“, „nestrupen“, „neškodljiv“, „naraven“, „okolju prijazen“, „živalim prijazen“ ali podobno.
In addition to compliance with paragraph 1, authorisation holders shall ensure that labels are not misleading in respect of the risks from the product to human health or the environment or its efficacy and, in any case, do not mention the indications ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or similar indications.
številko dovoljenja, ki jo je biocidnemu proizvodu dodelil pristojni organ ali Komisija;
the authorisation number allocated to the biocidal product by the competent authority or the Commission;
vrsto formulacije;
the type of formulation;
dovoljene uporabe biocidnega proizvoda;
the uses for which the biocidal product is authorised;
za vsako uporabo, določeno v skladu s pogoji iz dovoljenja, navodila za uporabo, pogostost uporabe in razmerje odmerka, izraženo v merskih enotah na smiseln in uporabniku razumljiv način;
directions for use, frequency of application and dose rate, expressed in metric units, in a manner which is meaningful and comprehensible to the user, for each use provided for under the terms of the authorisation;
podatke o verjetnih neposrednih ali posrednih neželenih stranskih učinkih ter navodila za prvo pomoč;
particulars of likely direct or indirect adverse side effects and any directions for first aid;
če so navodila priložena, se pripiše stavek „Pred uporabo preberite priložena navodila“, po potrebi pa tudi opozorila za ranljive skupine;
if accompanied by a leaflet, the sentence ‘Read attached instructions before use’ and, where applicable, warnings for vulnerable groups;
navodila za varno odstranjevanje biocidnega proizvoda in njegove embalaže, vključno s prepovedjo ponovne uporabe embalaže, kadar je to primerno;
directions for the safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on the reuse of packaging;
številko ali oznako serije formulacije in rok uporabe v običajnih pogojih skladiščenja;
the formulation batch number or designation and the expiry date relevant to normal conditions of storage;
kadar je to ustrezno, časovno obdobje, potrebno, da biocidni proizvod doseže učinek, časovni presledek, ki ga je treba upoštevati med posameznimi uporabami biocidnega proizvoda ali med uporabo biocidnega proizvoda in naslednjo uporabo tretiranega izdelka ali ponovnim dostopom ljudi ali živali na območje, na katerem se je uporabljal biocidni proizvod, vključno s podatki o sredstvih in ukrepih za dekontaminacijo ter trajanju potrebnega prezračevanja tretiranih površin; navodila za ustrezno čiščenje opreme; podrobnosti v zvezi s previdnostnimi ukrepi med uporabo in prevozom;
where applicable, the period of time needed for the biocidal effect, the interval to be observed between applications of the biocidal product or between application and the next use of the product treated, or the next access by man or animals to the area where the biocidal product has been used, including particulars concerning decontamination means and measures and duration of necessary ventilation of treated areas; particulars for adequate cleaning of equipment; particulars concerning precautionary measures during use and transport;
kadar je to ustrezno, skupine uporabnikov, ki smejo uporabljati ta biocidni proizvod;
where applicable, the categories of users to which the biocidal product is restricted;
kadar je to ustrezno, informacije o katerikoli posebni nevarnosti za okolje, zlasti v zvezi z zaščito neciljnih organizmov in preprečevanjem onesnaženja vode;
where applicable, information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water;
za biocidne proizvode, ki vsebujejo mikroorganizme, zahteve glede označevanja v skladu z Direktivo 2000/54/ES.
for biocidal products containing micro-organisms, labelling requirements in accordance with Directive 2000/54/EC.
Z odstopanjem od prvega pododstavka se lahko, kadar je to potrebno zaradi velikosti ali funkcije biocidnega proizvoda, informacije iz točk (e), (g), (h), (j), (k), (l) in (n) navedejo na embalaži ali priloženih navodilih, ki so sestavni del embalaže.
By way of derogation from the first subparagraph, where this is necessary because of the size or the function of the biocidal product, the information referred to in points (e), (g), (h), (j), (k), (l) and (n) may be indicated on the packaging or on an accompanying leaflet integral to the packaging.
Države članice lahko zahtevajo:
Member States may require:
predložitev modelov ali osnutkov embalaže, oznak in navodil;
the provision of models or drafts of the packaging, labelling and leaflets;
da se biocidni proizvodi, dostopni na trgu na njihovem ozemlju, označijo v njihovem uradnem jeziku ali jezikih.
that biocidal products made available on the market in their territories be labelled in their official language or languages.
Varnostni listi
Safety Data Sheets
Varnostni listi za aktivne snovi in biocidne proizvode se pripravijo in dajo na voljo v skladu s členom 31 Uredbe (ES) št. 1907/2006, kadar je to ustrezno.
Safety data sheets for active substances and biocidal products shall be prepared and made available in accordance with Article 31 of Regulation (EC) No 1907/2006, where applicable.
Register biocidnih proizvodov
Register for Biocidal Products
Agencija vzpostavi in vzdržuje informacijski sistem, ki se imenuje register biocidnih proizvodov.
The Agency shall establish and maintain an information system which shall be referred to as the Register for Biocidal Products.
Register biocidnih proizvodov se uporablja za izmenjavo informacij med pristojnimi organi, Agencijo in Komisijo ter med vlagatelji in pristojnimi organi, Agencijo in Komisijo.
The Register for Biocidal Products shall be used for the exchange of information between competent authorities, the Agency and the Commission and between applicants and competent authorities, the Agency and the Commission.
vlog in podatkov
applications and data
za vse postopke
for all procedures
, ki jih zajema ta uredba
covered by this Regulation
Ko vlagatelji oddajo vloge in podatke, Agencija preveri, ali so bili vloženi v pravilnem formatu, in nato o tem nemudoma ustrezno obvesti pristojni organ.
Upon the submission of applications and data by applicants, the Agency shall check that these have been submitted in the correct format and notify the relevant competent authority accordingly without delay.
Če Agencija odloči, da vloga ni bila vložena v pravilnem formatu, jo zavrne in o tem ustrezno obvesti vlagatelja.
In the case where the Agency decides that the application has not been submitted in the correct format, it shall reject the application and inform the applicant accordingly.
Ko zadevni pristojni organ validira ▌ali potrdi vlogo▌, se ta prek registra biocidnih proizvodov da na voljo vsem drugim pristojnim organom in Agenciji.
Once the relevant competent authority has validated ▌ or accepted an application ▌, it shall be made available via the Register for Biocidal Products to all other competent authorities and to the Agency.
Pristojni organi in Komisija uporabijo register biocidnih proizvodov za registriranje in posredovanje odločitev, sprejetih v zvezi z odobritvami biocidnih proizvodov, ter posodobijo informacije v registru, kadar se takšna odločitev sprejme.
The competent authorities and the Commission shall use the Register for Biocidal Products to record and communicate the decisions they have taken in relation to the authorisations of biocidal products and shall update the information in the Register for Biocidal Products at the time such decisions are taken.
posodabljajo informacije o biocidnih proizvodih, ki so dovoljeni na njihovem ozemlju ali za katere je bilo nacionalno dovoljenje zavrnjeno, spremenjeno, obnovljeno ali preklicano
update the information in the Register for Biocidal Products relating to biocidal products which have been authorised within their territory or for which a national authorisation has been refused, amended, renewed or cancelled
, ali za katere je bilo odobreno, zavrnjeno ali preklicano dovoljenje za vzporedno trgovanje
, or for which a parallel trade permit has been granted, refused or cancelled
posodablja informacije v zvezi z biocidnimi proizvodi, ki so dovoljeni v Uniji ali za katere je bilo dovoljenje Unije zavrnjeno, spremenjeno, obnovljeno ali preklicano.
update the information relating to biocidal products which have been authorised in the Union or for which a Union authorisation has been refused, amended, renewed or cancelled.
Informacije, ki se vnesejo v register biocidnih proizvodov, vključujejo, kjer je primerno:
The information to be introduced into the Register for Biocidal Products shall include, as appropriate:
pogoje za odobritev;
the terms and conditions of the authorisation;
povzetek značilnosti biocidnega proizvoda iz člena 22(2);
the summary of the biocidal product characteristics referred to in Article 22(2);
poročilo o oceni biocidnega proizvoda.
the assessment report of the biocidal product.
Informacije iz tega odstavka se prek registra biocidnih proizvodov posredujejo tudi vlagatelju.
The information referred to in this paragraph shall also be made available to the applicant through the Register for Biocidal Products.
Če register biocidnih proizvodov do ...
In the event that the Register for Biocidal Products is not fully operational by ...
ne bo popolnoma deloval ali bo po tem datumu prenehal delovati, za države članice, pristojne organe, Komisijo in vlagatelje še naprej veljajo vse obveznosti iz te uredbe.
or ceases to be operational after that date, all obligations in relation to submissions and communication placed upon Member States, competent authorities, the Commission and applicants by this Regulation shall continue to apply.
Da bi bila zagotovljena enotna uporaba tega odstavka, zlasti glede formata, v katerem se predložijo ali izmenjajo informacije, Komisija sprejme potrebne ukrepe v skladu s postopkom pregleda iz člena 82(3).
With a view to ensuring the uniform application of this paragraph, particularly with regard to the format in which information may be submitted and exchanged, the Commission shall adopt the necessary measures in accordance with the examination procedure referred to in Article 82(3).
Ti ukrepi so časovno omejeni na obdobje, ki je nujno za popolno delovanje registra biocidnih proizvodov.
Those measures shall be limited in time to the period strictly necessary for the Register for Biocidal Products to become fully operational.
Komisija lahko sprejme izvedbene akte, ki določajo podrobna pravila o vrstah informacij, ki se vnesejo v register biocidnih proizvodov.
The Commission may adopt implementing acts laying down detailed rules on the types of information to be entered in the Register for Biocidal Products.
Na Komisijo se prenese pooblastilo za sprejemanje delegiranih aktov v skladu s členom 83, ki
The Commission shall be empowered to adopt delegated acts in accordance with Article 83
določajo dodatna pravila
laying down supplementary rules
za uporabo registra.
for the use of the Register.
Vsak oglas za biocidne proizvode je skladen z Uredbo (ES) št. 1272/2008, poleg tega pa vključuje tudi stavka: „Biocide uporabljajte varno.
Any advertisement for biocidal products shall, in addition to complying with Regulation (EC) No 1272/2008, include the sentences ‘Use biocides safely.
Oglaševalci lahko v predpisanih stavkih besedo „biocidi“ nadomestijo z jasnim sklicevanjem na vrsto oglaševanega proizvoda.
Advertisers may replace the word ‘biocides’ in the prescribed sentences with a clear reference to the product-type being advertised.
Oglasi za biocidne proizvode ne predstavljajo proizvoda na način, ki je zavajajoč glede tveganja, ki ga proizvod predstavlja za človekovo zdravje ali okolje, ali njegove učinkovitosti.
Advertisements for biocidal products shall not refer to the product in a manner which is misleading in respect of the risks from the product to human health or the environment or its efficacy.
V nobenem primeru oglasi za biocidni proizvod ne smejo vsebovati navedb „biocidni proizvod z manjšim tveganjem“, „nestrupen“, „neškodljiv“, „naraven“, „okolju prijazen“, „živalim prijazen“ ali katero drugo podobno oznako.
In any case, the advertising of a biocidal product shall not mention ‘low-risk biocidal product’, ‘non-toxic’, ‘harmless’, ‘natural’, ‘environmentally friendly’, ‘animal friendly’ or any similar indication.
Nadzor strupov
Poison control
Za namene te uredbe se uporablja člen 45 Uredbe (ES) št. 1272/2008.
Article 45 of Regulation (EC) No 1272/2008 shall apply for the purposes of this Regulation.
POGLAVJE XVI
CHAPTER XVI
Vloga Agencije
Role of the Agency
Agencija opravlja naloge, ki so ji dodeljene s to uredbo.
The Agency shall carry out the tasks conferred on it by this Regulation.
Odbor za biocidne proizvode
Biocidal Products Committee
Znotraj Agencije se ustanovi Odbor za biocidne proizvode.
A Biocidal Products Committee is hereby established within the Agency.
Odbor za biocidne proizvode je odgovoren za pripravo mnenja Agencije o naslednjih vprašanjih:
The Biocidal Products Committee shall be responsible for preparing the opinion of the Agency on the following issues:
vloge za odobritev ali podaljšanje odobritve aktivnih snovi;
applications for approval and renewal of approval of active substances;
pregled odobritve aktivnih snovi;
review of approval of active substances;