natgillin/translations-raw huggingface dataset:
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 [50] 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.
Uredba (ES) št. 1049/2001 Evropskega parlamenta in Sveta z dne 30. maja 2001 o dostopu javnosti do dokumentov Evropskega parlamenta, Sveta in Komisije [50] 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.
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.
Agencija in pristojni organi zavrnejo dostop do informacij, kadar bi njihovo razkritje ogrozilo 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:
Razkritje naslednjih informacij se običajno šteje, da ogroža zaščito poslovnih interesov ali zasebnost ali varnost zadevnih oseb:
details of the full composition of a biocidal product;
podrobnosti o celotni sestavi biocidnega proizvoda;
the precise tonnage of the active substance or biocidal product manufactured or made available on the market;
natančna tonaža aktivne snovi ali biocidnega proizvoda, ki se proizvede ali je dostopna na trgu;
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;
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;
names and addresses of persons involved in testing on vertebrates.
imena in naslovi oseb, ki so povezane z izvajanjem preskusov na vretenčarjih.
However, where urgent action is essential to protect human health, animal 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.
Vendar kadar je nujno takojšnje ukrepanje za zaščito zdravja človeka, zdravja živali, varnosti ali okolja ali kadar zaradi drugih razlogov prevlada javni interes, Agencija ali pristojni organi razkrijejo informacije iz tega odstavka.
Notwithstanding paragraph 2, after the authorisation has been granted, access to the following information shall not in any case be refused:
Ne glede na odstavek 2 se po izdaji dovoljenja v nobenem primeru ne sme zavrniti dostop do naslednjih informacij:
the name and address of the authorisation holder;
ime in naslov imetnika dovoljenja;
the name and address of the biocidal product manufacturer;
ime in naslov proizvajalca biocidnega proizvoda;
the name and address of the active substance manufacturer;
ime in naslov proizvajalca aktivne snovi;
the content of the active substance or substances in the biocidal product and the name of the biocidal product;
vsebnost aktivne oziroma aktivnih snovi v biocidnem proizvodu in ime biocidnega proizvoda;
physical and chemical data concerning the biocidal product;
fizikalni in kemijski podatki o biocidnem proizvodu;
any methods for rendering the active substance or biocidal product harmless;
kakršne koli metode, s katerimi aktivna snov ali biocidni proizvod postaneta neškodljiva;
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;
povzetek rezultatov preskusov, ki se zahteva v skladu s členom 20 za določitev učinkovitosti proizvoda ter vplivov na ljudi, živali in okolje, ter, kadar je to primerno, njegove sposobnosti za izboljšanje odpornosti;
recommended methods and precautions to reduce dangers from handling, transport and use as well as from fire or other hazards;
priporočeni postopki in previdnostni ukrepi za zmanjšanje nevarnosti pri ravnanju, prevozu in uporabi, kot tudi za preprečevanje požara ali drugih nevarnosti;
safety data sheets;
varnostni listi;
methods of analysis referred to in Article 19(1)(c);
metode analize iz člena 19(1)(c);
methods of disposal of the product and of its packaging;
metode za odstranjevanje proizvoda in njegove embalaže;
procedures to be followed and measures to be taken in the case of spillage or leakage;
postopki, ki jih je treba uporabiti, in ukrepi, ki jih je treba sprejeti v primeru izlitja ali iztekanja;
first aid and medical advice to be given in the case of injury to persons.
prva pomoč in zdravstveni nasveti, ki jih je treba nuditi v primeru poškodb ljudi.
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.
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 informacije 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.
From the date on which an active substance is approved, the following up-to-date information held by the Agency or the Commission on active substances shall be made publicly and easily available free of charge:
Od dneva odobritve aktivne snovi se javnosti omogoči lahko dosegljiv in brezplačen dostop do naslednjih najnovejših informacij o aktivnih snoveh, ki jih ima Agencija ali Komisija:
where available, the ISO name and the name in the International Union of Pure and Applied Chemistry (IUPAC) nomenclature;
imena ISO, če je na voljo, in imena po nomenklaturi Mednarodne zveze za čisto in uporabno kemijo (IUPAC);
if applicable, the name as given in the European Inventory of Existing Commercial Chemical Substances;
če je to ustrezno, imena, kot je navedeno v Evropskem seznamu obstoječih komercialnih kemičnih snovi;
the classification and labelling, including whether the active substance meets any of the criteria set out in Article 5(1);
razvrstitve in označitve, vključno s tem, ali aktivna snov izpolnjuje katero od meril iz člena 5(1);
physicochemical endpoints and data on pathways and environmental fate and behaviour;
fizikalno-kemijskih končnih točk ter podatkov o porazdelitvi in vplivu v okolju ter obnašanju;
the result of each toxicological and ecotoxicological study;
rezultatov vsake toksikološke in ekotoksikološke študije;
acceptable exposure level or predicted no-effect concentration established in accordance with Annex VI;
sprejemljive ravni izpostavljenosti ali predvidene koncentracije brez učinka, določene v skladu s Prilogo VI;
the guidance on safe use provided in accordance with Annexes II and III;
smernic o varni uporabi, ki so določene v skladu s Prilogo II in Prilogo III;
analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 4.2 of Title 2 of Annex II.
analitskih metod iz oddelkov 5.2 in 5.3 naslova 1 ter oddelka 4.2 naslova 2 Priloge II.
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:
Od dneva izdaje dovoljenja za biocidni proizvod Agencija javnosti omogoči lahko dosegljiv in brezplačen dostop do naslednjih najnovejših informacij:
the terms and conditions of the authorisation;
določila in pogoje za izdajo dovoljenja;
the summary of the biocidal product characteristics; and
povzetka značilnosti biocidnega proizvoda in
analytical methods referred to under Sections 5.2 and 5.3 of Title 1, and Section 5.2 of Title 2 of Annex III.
analitskih metod iz oddelkov 5.2 in 5.3 naslova 1 ter oddelka 5.2 naslova 2 Priloge III.
From the date on which an active substance is approved, the Agency shall, 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, make publicly available, free of charge, the following up-to-date information on active substances:
Od dneva odobritve aktivne snovi 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 drugi zadevni strani:
if essential to classification and labelling, the degree of purity of the substance and the identity of impurities and/or additives of active substances which are known to be hazardous;
če je to bistveno za razvrščanje in označevanje, stopnja čistote snovi ter identiteta nečistot in/ali dodatkov aktivnih snovi, za katere je znano, da so nevarni;
the study summaries or robust study summaries of studies submitted to support the approval of the active substance;
povzetki študij ali okvirni povzetki študij, predloženih v podporo odobritve aktivne snovi;
information, other than that listed in paragraph 1 of this Article, contained in the safety data sheet;
informacije iz varnostnega lista, ki niso naštete v odstavku 1 tega člena;
the trade name(s) of the substance;
trgovsko oziroma trgovska imena snovi;
the assessment report.
poročilo o oceni.
From the date on which a biocidal product is authorised, the Agency shall, 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, make publicly available, free of charge, the following up-to date information:
Agencija od dneva izdaje dovoljenja za biocidni proizvod javnosti omogoči brezplačen dostop do naslednjih najnovejših informacij, 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 drugi zadevni strani:
study summaries, or robust study summaries, of studies submitted to support the biocidal product authorisation; and
povzetki študij ali okvirni povzetki študij, predloženih v podporo odobritve biocidnega proizvoda, in
Record-keeping and reporting
Vodenje evidence in poročanje
Authorisation holders shall keep records of the biocidal products they place on the market for at least 10 years after placing on the market, or 10 years after the date on which the authorisation was cancelled or expired, whichever is the earlier.
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.
They shall make available the relevant information contained in these records to the competent authority on request.
Na zahtevo dajo pristojnemu organu na voljo ustrezne informacije iz te evidence.
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.
Za zagotovitev enotne uporabe odstavka 1 tega člena Komisija sprejme izvedbene akte za določitev oblike in vsebine informacij v evidencah.
Information about biocidal products
Informacije o biocidnih proizvodih
Classification, packaging and labelling of biocidal products
Razvrščanje, pakiranje in označevanje biocidnih proizvodov
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.
Imetniki dovoljenja zagotovijo, da se biocidni proizvodi razvrstijo, zapakirajo in označijo v skladu 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.
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.
Poleg tega se proizvode, ki bi se lahko zamenjali za hrano, vključno s pijačo, ali krmo, zapakira tako, da se zmanjša verjetnost zamenjave.
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.
Če so dostopni splošni javnosti, vsebujejo komponente za odvračanje od njihovega uživanja, zlasti pa niso privlačni za otroke.
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, animal 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.
Imetniki dovoljenja zagotovijo, da je oznaka skladna z odstavkom 1 ter ni zavajajoča glede tveganja, ki ga proizvod predstavlja za zdravje človeka, zdravje živali 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, the label must show clearly and indelibly the following information:
Poleg tega je treba na oznaki jasno in neizbrisno navesti:
the identity of every active substance and its concentration in metric units;
opis vsake aktivne snovi posebej in njeno vsebnost v merskih enotah;
the nanomaterials contained in the product, if any, and any specific related risks, and, following each reference to nanomaterials, the word ‘nano’ in brackets;
nanomateriale, ki jih proizvod vsebuje, če jih sploh vsebuje, in vsa s tem povezana posebna tveganja, ob vsaki navedbi nanomaterialov pa v oklepaju tudi besedo „nano“;
the authorisation number allocated to the biocidal product by the competent authority or the Commission;
številko dovoljenja, ki jo je biocidnemu proizvodu dodelil pristojni organ ali Komisija;
the type of formulation;
vrsto formulacije;
the uses for which the biocidal product is authorised;
dovoljene uporabe biocidnega proizvoda;
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;
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;
particulars of likely direct or indirect adverse side effects and any directions for first aid;
podatke o verjetnih neposrednih ali posrednih neželenih stranskih učinkih ter navodila za prvo pomoč;
if accompanied by a leaflet, the sentence ‘Read attached instructions before use’ and, where applicable, warnings for vulnerable groups;
če so navodila priložena, se pripiše stavek „Pred uporabo preberite priložena navodila“, po potrebi pa tudi opozorila za ranljive skupine;
directions for the safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on the reuse of packaging;
navodila za varno odstranjevanje biocidnega proizvoda in njegove embalaže, vključno s prepovedjo ponovne uporabe embalaže, kadar je to primerno;
the formulation batch number or designation and the expiry date relevant to normal conditions of storage;
številko ali oznako serije formulacije in rok uporabe v običajnih pogojih skladiščenja;
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 humans 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, 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; podrobnosti za ustrezno čiščenje opreme; podrobnosti v zvezi s previdnostnimi ukrepi med uporabo in prevozom;
where applicable, the categories of users to which the biocidal product is restricted;
kadar je to ustrezno, kategorije uporabnikov, na katere je uporaba biocidnega proizvoda omejena;
where applicable, information on any specific danger to the environment particularly concerning protection of non-target organisms and avoidance of contamination of water;
kadar je to ustrezno, informacije o kakršni koli posebni nevarnosti za okolje, zlasti v zvezi z zaščito neciljnih organizmov in preprečevanjem onesnaženja vode;
for biocidal products containing micro-organisms, labelling requirements in accordance with Directive 2000/54/EC.
za biocidne proizvode, ki vsebujejo mikroorganizme, zahteve glede označevanja v skladu z Direktivo 2000/54/ES.
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.
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.
Member States may require:
Države članice lahko zahtevajo:
the provision of models or drafts of the packaging, labelling and leaflets;
predložitev modelov ali osnutkov embalaže, oznak in navodil;
that biocidal products made available on the market in their territories be labelled in their official language or languages.
da se biocidni proizvodi, dostopni na trgu na njihovem ozemlju, označijo v njihovem uradnem jeziku ali jezikih.
Safety data sheets
Varnostni listi
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.
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.
Register for Biocidal Products
Register biocidnih proizvodov
The Agency shall establish and maintain an information system which shall be referred to as the Register for Biocidal Products.
Agencija vzpostavi in vzdržuje informacijski sistem, ki se imenuje register biocidnih proizvodov.
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.
Register biocidnih proizvodov se uporablja za izmenjavo informacij med pristojnimi organi, Agencijo in Komisijo ter med vlagatelji in pristojnimi organi, Agencijo in Komisijo.
Applicants shall use the Register for Biocidal Products to submit applications and data for all procedures covered by this Regulation.
Vlagatelji uporabljajo register biocidnih proizvodov za oddajo vlog in podatkov za vse postopke, ki jih zajema ta uredba.
Upon 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.
Ko vlagatelji vložijo vloge in podatke, Agencija preveri, ali so bili vloženi v pravilnem formatu, in nato o tem nemudoma ustrezno uradno obvesti zadevni pristojni organ.
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.
Če Agencija odloči, da vloga ni bila vložena v pravilnem formatu, jo zavrne in o tem ustrezno obvesti vlagatelja.
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.
Ko zadevni pristojni organ validira ali sprejme vlogo, se ta prek registra biocidnih proizvodov da na voljo vsem drugim pristojnim organom in Agenciji.
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.
Pristojni organi in Komisija uporabijo register biocidnih proizvodov za registriranje in obveščanje o odločitvah, ki so jih sprejeli v zvezi z izdajo dovoljenj biocidnih proizvodov, ter posodobijo informacije v registru, kadar se takšne odločitve sprejmejo.
The competent authorities shall, in particular, 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, or for which a parallel trade permit has been granted, refused or cancelled.
Pristojni organi v registru biocidnih proizvodov zlasti posodabljajo informacije v zvezi z biocidnimi proizvodi, za katere so bila izdana dovoljenja na njihovem ozemlju ali za katere je bilo nacionalno dovoljenje zavrnjeno, spremenjeno, obnovljeno ali preklicano, ali za katere je bilo odobreno, zavrnjeno ali preklicano dovoljenje za vzporedno trgovanje.
The Commission shall, in particular, 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.
Komisija zlasti posodablja informacije v zvezi z biocidnimi proizvodi, za katere so bila izdana dovoljenja v Uniji ali za katere je bilo dovoljenje Unije zavrnjeno, spremenjeno, podaljšano ali preklicano.
The information to be introduced into the Register for Biocidal Products shall include, as appropriate:
Informacije, ki se vnesejo v register biocidnih proizvodov, vključujejo, kjer je primerno:
the summary of the biocidal product characteristics referred to in Article 22(2);
povzetek značilnosti biocidnega proizvoda iz člena 22(2);
the assessment report of the biocidal product.
poročilo o oceni biocidnega proizvoda.
The information referred to in this paragraph shall also be made available to the applicant through the Register for Biocidal Products.
Informacije iz tega odstavka se prek registra biocidnih proizvodov dajo na voljo tudi vlagatelju.