natgillin/translations-raw huggingface dataset:
vse načine, s katerimi aktivna snov ali biocidni pripravek postaneta neškodljiva;
any ways of rendering the active substance or biocidal product harmless;
povzetek rezultatov preskusov, ki se zahteva v skladu s členom 18 za določitev učinkovitosti pripravka ter učinkov na človeka, živali in okolje ter, kadar je to primerno, njegove sposobnosti, da povečuje odpornost;
a summary of the results of the tests required pursuant to Article 18 to establish the product's efficacy and effects on humans, animals and the environment and, where applicable, its ability to promote resistance;
priporočene postopke in previdnostne ukrepe za zmanjševanje nevarnosti v zvezi z ravnanjem, shranjevanjem, prevozom in uporabo, kot tudi za preprečevanje požara ali drugih nevarnosti;
recommended methods and precautions to reduce dangers from handling, storage, transport and use as well as from fire or other hazards;
varnostne liste;
safety data sheets;
metode analize iz točke (c) člena 16(1);
methods of analysis referred to in point (c) of Article 16(1);
metode za odstranjevanje pripravka in njegove embalažo;
methods of disposal of the product and of its packaging;
postopke, ki jih je treba uporabiti, in ukrepe, 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;
prvo pomoč in zdravstvene nasvete, ki jih je treba nuditi v primeru poškodb oseb.
first aid and medical advice to be given in the case of injury to persons.
Brezplačno se zagotovi javen dostop do seznama, na katerem so navedeni biocidni pripravki, ki so odobreni v skladu s členom 16(3), ter ustrezni proizvajalci.
Public access shall be granted free of charge to an inventory containing details of biocidal products authorised pursuant to Article 16(5) and of the corresponding manufacturers.
Proizvajalci, uvozniki in poklicni uporabniki biocidnih pripravkov vsaj
Producers, importers and professional users of biocidal products shall keep records of the biocidal products they produce, place on the market or use for at least
Komisija sprejme izvedbene ukrepe za določitev oblike in vsebine informacij v evidencah ter za zagotovitev enotne uporabe odstavka 1 v skladu s postopkom iz člena 76(3).
The Commission shall adopt implementing measures to specify the form and content of the information in the records, and to ensure the uniform application of paragraph 1 in accordance with the procedure referred to in Article 76(3).
Biocidni pripravki se razvrstijo, zapakirajo in označijo v skladu z Direktivo 1999/45/ES in, kjer je to ustrezno, Uredbo (ES) št. 1272/2008 ter odobrenim povzetkom lastnosti biocidnega pripravka, zlasti stavki o nevarnosti in previdnostnimi stavki iz točke (i) člena 20(2).
Biocidal products shall be classified, packaged and labelled in accordance with Directive 1999/45/EC and, where applicable, Regulation (EC) No 1272/2008 and the approved summary of the biocidal product characteristics, in particular the hazard statements and the precautionary statements, as referred to in point (i) of Article 20(2).
Poleg tega se pripravke, ki bi jih lahko zamenjali za hrano, pijačo ali krmo, zapakira tako, da se zmanjša verjetnost, da bi prišlo do zamenjave.
In addition, products which may be mistaken for food, drink or feedingstuffs shall be packaged to minimise the likelihood of such a mistake being made.
Če so dostopni splošni javnosti, vsebujejo komponente za odvračanje od njihove porabe.
If they are available to the general public, they shall contain components to discourage their consumption.
Oznaka ne sme biti zavajajoča in ne sme v nobenem primeru vsebovati navedb, kot so „biocidni pripravek z manjšim tveganjem“, „nestrupen“ ali „neškodljiv“.
Labels shall not be misleading and, in any case, shall not mention indications such as ‘low-risk biocidal product’, ‘non-toxic’ or ‘harmless’.
vsako aktivno snov posebej in njeno vsebnost v merskih enotah;
the identity of every active substance and its concentration in metric units;
številko dovoljenja, ki jo je biocidnemu pripravku dodelil pristojni organ;
the authorisation number allocated to the biocidal product by the competent authority;
ali izdelek vsebuje nanomateriale ter vsa s tem povezana posebna tveganja, ob vsaki navedbi nanomateriala pa v oklepaju tudi besedo „nano“;
whether the product contains nanomaterials and any specific related risks, and, following each reference to nanomaterials, the word ‘nano’ in brackets;
vrsto mešanice;
the type of mixture;
dovoljene uporabe biocidnega pripravka;
the uses for which the biocidal product is authorised;
navodila za uporabo in razmerje odmerka, izraženo v merskih enotah
directions for use and the dose rate, expressed in metric units
oziroma na drug način, ki bo potrošniku jasen in razumljiv
or in another manner which is meaningful and comprehensible to the user
, za vsako uporabo, določeno v skladu s pogoji iz dovoljenja;
, for each use provided for under the terms of the authorisation;
podatke o morebitnih 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 na oznaki pripiše stavek „Pred uporabo preberite priložena navodila“;
if accompanied by a leaflet, the sentence ‘Read attached instructions before use’;
po potrebi opozorila za ranljive skupine;
where applicable, warnings for vulnerable groups;
navodila za varno odstranjevanje biocidnega pripravka in njegove embalaže, vključno s prepovedjo ponovne uporabe embalaže, kadar je to primerno;
directions for safe disposal of the biocidal product and its packaging, including, where relevant, any prohibition on reuse of packaging;
številko ali oznako serije formulacije in rok uporabnosti v običajnih pogojih skladiščenja;
the formulation batch number or designation and the expiry date relevant to normal conditions of storage;
časovno obdobje, potrebno, da biocidni pripravek doseže učinek, časovni presledek, ki ga je treba upoštevati med posameznimi uporabami biocidnega pripravka ali med uporabo biocidnega pripravka in uporabo tretiranega proizvoda, ter karenca za dostop človeka ali živali na območje, kjer se je uporabljal biocidni pripravek, vključno s podatki o sredstvih za dekontaminacijo in ukrepih ter trajanju potrebnega prezračevanja tretiranih površin; navodila za ustrezno čiščenje opreme; posebnosti v zvezi s previdnostnimi ukrepi med uporabo, skladiščenjem in prevozom;
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, storage and transport;
kjer je to ustrezno, vrste uporabnikov, ki smejo uporabljati ta biocidni pripravek;
where applicable, the categories of users to which the biocidal product is restricted;
kjer je to ustrezno, informacije o katerikoli posebni nevarnosti za okolje, zlasti o zaščiti neciljnih organizmov in preprečevanju 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 pripravke, 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.
Ne glede na prvi pododstavek se lahko, kjer je to potrebno zaradi velikosti ali funkcije biocidnega pripravka, informacije iz točk (d), (f), (g), (j), (k), (l) in (n) navedejo na embalaži ali priloženih navodilih.
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 (d), (f), (g), (j), (k), (l) and (n) may be indicated on the packaging or on an accompanying leaflet integral to the packaging.
države, v kateri so dani v promet
of the country where they are marketed
Varnostni listi se pripravijo in dajo na voljo v skladu s Prilogo II Uredbe (ES) št. 1907/2006 za biocidne pripravke, ki so razvrščeni kot nevarni ter v skladu z zahtevami člena 31 te uredbe, za aktivne snovi, ki se uporabljajo izključno za biocidne pripravke.
The safety-data sheets shall be prepared and made available in accordance with Annex II of Regulation (EC) No 1907/2006, for biocidal products classified as hazardous, and in accordance with the requirements of Article 31 of that Regulation, for active substances used exclusively in biocidal products.
ustrezne kategorije proizvoda, katerega aktivna snov je bila vključena v Prilogo I;
important categories of product whose active substance has been included in Annex I;
ime vsaj ene države članice, v kateri je bilo izdano dovoljenje za biocidni pripravek;
the name of at least one Member State where the biocidal product has been authorised;
številka dovoljenja biocidnega pripravka kot takega ali prisotnega v izdelku ali obdelani snovi.
the authorisation number of the biocidal product as such or present in a treated article or material.
Komisija pripravi Register biocidnih pripravkov Unije in ga vzdržuje.
A Union Register for Biocidal Products shall be established and maintained by the Commission.
Register biocidnih pripravkov Unije se uporablja za izmenjavo informacij med pristojnimi organi, Agencijo in Komisijo.
The Union Register for Biocidal Products shall be used for the exchange of information between competent authorities, the Agency and the Commission.
Predlagatelji uporabljajo Register biocidnih pripravkov Unije za pripravo obrazca vloge za vse postopke v zvezi z dovoljenjem za biocidne pripravke, vzajemnim priznanjem in dovoljenjem za vzporedno trgovanje.
Applicants shall use the Union Register for Biocidal Products to generate the application form for all procedures relating to the authorisation of biocidal products, the mutual recognition and the parallel trade permit.
Pristojni organi posodabljajo v Registru biocidnih pripravkov Unije informacije o biocidnih pripravkih, ki so dovoljeni na njihovem ozemlju ali za katere je bilo nacionalno dovoljenje zavrnjeno, spremenjeno, obnovljeno ali preklicano.
Competent authorities shall update in the Union Register for Biocidal Products the information relating to biocidal products which have been authorised within their territory or for which a national authorisation has been refused, amended, renewed or cancelled.
Komisija posodablja informacije v zvezi z biocidnimi pripravki, ki so dovoljeni v Uniji ali za katere je bilo dovoljenje Unije zavrnjeno, spremenjeno, obnovljeno ali preklicano.
The Commission shall 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.
Za zagotovitev pravilnega delovanja registra biocidnih pripravkov Unije lahko
In order to ensure the proper functioning of the Union Register for Biocidal Products,
z delegiranimi akti v skladu s členom 73 ter pod pogoji iz členov 74 in 75
, by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75,
sprejme natančna pravila o vrstah informacij, ki se vnesejo v register biocidnih pripravkov ▌, in o postopkih, ki so povezani s tem ▌.
detailed rules on the types of information to be entered in the ▌Register ▌and the procedures related to it ▌.
Agencija pripravi register za izmenjavo podatkov o biocidih in ga vzdržuje.
The Biocides Data Sharing Register shall be established and maintained by the Agency.
Register za izmenjavo podatkov o biocidih vsebuje informacije, ki jih posredujejo pristojni organi in Agencija v skladu z odstavkoma 3 in 4 člena 48.
The Biocides Data Sharing Register shall contain information provided by competent authorities and the Agency in accordance with paragraphs 3 and 4 of Article 48.
Register je dostopen le pristojnim organom, Agenciji in Komisiji.
The Register shall only be accessible to competent authorities, the Agency and the Commission.
Pristojni organi in Agencija odgovorijo na vsa vprašanja bodočih predlagateljev v zvezi z informacijami, ki so vključene v register za izmenjavo podatkov o biocidih, da se olajša izmenjava podatkov, ter na zahtevo posredujejo kontaktne podatke lastnika zadevne informacije in izjavo, ali za te informacije veljajo določbe o varstvu podatkov na podlagi te uredbe in kako dolgo.
Competent authorities and the Agency shall respond to all enquiries by prospective applicants concerning information contained in the Biocides Data Sharing Register in order to facilitate sharing of information and shall on request provide the contact details of the owner of the information in question and a statement whether and for how long the information is subject to data protection under this Regulation.
Države članice zagotovijo, da imajo vsi poklicni uporabniki, distributerji in svetovalci dostop do ustreznih podatkov o koristih in tveganjih ter varni uporabi biocidov.
Member States shall ensure that all professional users, distributors and advisers have access to appropriate information on the benefits, risks and safe use of biocidal products.
Osebe, odgovorne za dajanje biocidnih pripravkov v promet, na internetu objavijo seznam teh pripravkov.
The persons responsible for the placing on the market of biocidal products shall make a list of such products available on the internet.
Dostop do teh spletnih mest ni z ničimer omejen, njihova vsebina pa se posodablja.
Access to those websites shall not be subject to any restriction or condition and their content shall be kept up to date.
Pri vsakem oglaševanju biocidnih pripravkov se navedeta stavka: „Biocide uporabljajte varno.
Any advertisement for biocidal products shall be accompanied by the sentences ‘Use biocides safely.
Pred uporabo vedno preberite oznako in informacije o pripravku“.
Always read the label and product information before use’.
Stavka sta jasno vidna glede na celoten oglas.
The sentences shall be clearly distinguishable in relation to the whole advertisement.
Oglaševalci lahko v predpisanih stavkih besedo „biocidi“ nadomestijo z jasnim sklicem na vrsto oglaševanega pripravka, kot je določena v Prilogi V.
Advertisers may replace the word ‘biocides’ in the prescribed sentences with a clear reference to the product-type as set out in Annex V being advertised.
V nobenem primeru oglasi za biocidni pripravek ne smejo vsebovati navedb, kot so „biocidni pripravek z manjšim tveganjem“, „nestrupen“ ali „neškodljiv“.
In any case, the advertising of a biocidal product shall not mention indications such as ‘low-risk biocidal product’, ‘non-toxic’ or ‘harmless’.
Države članice imenujejo organ ali organe, ki so odgovorni za sprejemanje informacij o biocidnih pripravkih v prometu, vključno z informacijami o kemijski sestavi teh pripravkov, ter za razpoložljivost informacij v primerih, kadar nastopi domnevna zastrupitev zaradi biocidnih pripravkov.
Member States shall appoint a body or bodies responsible for receiving information on biocidal products which have been placed on the market, including information on the chemical composition of such products, and for making such information available in cases where suspected poisoning arises from biocidal products.
Države članice se lahko odločijo za imenovanje organa ali organov, ki so že bili imenovani v skladu s členom 45 Uredbe (ES) št. 1272/2008 za izvajanje nalog iz tega člena.
Member States may decide to appoint the body or bodies that have already been appointed in accordance with Article 45 of Regulation (EC) No 1272/2008 to carry out the tasks under this Article.
Organi, ki jih imenujejo države članice, zagotovijo vsa potrebna jamstva za varovanje tajnosti prejetih informacij.
The bodies appointed by the Member States shall provide all the requisite guarantees for maintaining the confidentiality of the information received.
Takšne informacije se lahko uporabljajo le v naslednje namene:
Such information may only be used for the following purposes:
v zdravstvene namene z oblikovanjem preventivnih in kurativnih ukrepov, zlasti v nujnih primerih,
to meet medical demand by formulating preventive and curative measures, in particular in case of emergency;
če zanje zaprosi država članica, da bi opravila statistično analizo in ugotovila, ali so potrebni boljši ukrepi za obvladovanje tveganja.
where requested by the Member State, to undertake statistical analysis to identify where improved risk management measures may be needed.
Poglavje XIII
Chapter XIII
Agencija opravlja naloge, ki so ji dodeljene v Poglavjih II, III, IV, VI, VII, VIII, IX, X, XI, XII in XIV te uredbe.
The Agency shall carry out the tasks conferred on it by Chapters II, III, IV, VI, VII, VIII, IX, X, XI, XII and XIV of this Regulation.
Znotraj Agencije se ustanavlja Odbor za biocidne pripravke.
A Biocidal Products Committee is hereby established within the Agency.
Odbor za biocidne pripravke 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 vključitev in obnovo vključitve aktivne snovi v Prilogo I;
applications for inclusion and renewal of inclusion of active substances in Annex I;
pregled vključitve aktivnih snovi v prilogo I;
review of inclusion of active substances in Annex I;
določevanje aktivnih snovi, ki izpolnjujejo pogoje za zamenjavo;
identification of active substances which are candidates for substitution;
vloge za dovoljenje Unije za biocidne pripravke ter za obnovo, preklic ali spremembo dovoljenja Unije;
applications for Union authorisation of biocidal products and for renewal, cancellation and modifications of Union authorisation;
znanstvene in tehnične zadeve ob ugovorih na vzajemno priznavanje;
scientific and technical matters in the case of objections to mutual recognition;
vsa druga vprašanja, ki izhajajo iz izvajanja te uredbe v zvezi z tveganji za zdravje ljudi in okolje.
any other questions that arise from the operation of this Regulation relating to risks to human health or the environment.
Odbor za biocidne pripravke lahko ustanovi delovne skupine in prenese nekatere naloge na te delovne skupine.
The Biocidal Products Committee may establish working groups and delegate certain tasks to those working groups.
Članom Odbora za biocidne pripravke so v pomoč znanstveni in tehnični viri, ki so na razpolago državam članicam.
The members of the Biocidal Products Committee shall be supported by the scientific and technical resources available to the Member States.
Države članice članom Odbora za biocidne pripravke, ki so jih imenovale, zagotovijo zadostna znanstvena in tehnična sredstva.
Member States shall provide adequate scientific and technical resources to the members of the Biocidal Products Committee that they have nominated.
Pristojni organi držav članic olajšajo dejavnosti Odbora za biocidne pripravke in njegovih delovnih skupin.
Competent authorities of Member States shall facilitate the activities of the Biocidal Products Committee and their working groups.
Členi od 78 do 84 ter 89 in 90 Uredbe (ES) št. 1907/2006 veljajo smiselno
Articles 78 to 84, 89 and 90 of Regulation (EC) No 1907/2006 shall apply
pri čemer se upošteva vloga Agencije iz te uredbe.
taking into account the role of the Agency with respect to this Regulation.
Tajništvo Agencije iz točke (g) člena 76(1) Uredbe (ES) št. 1907/2006 opravlja naslednje naloge:
The Secretariat of the Agency referred to in point (g) of Article 76(1) of Regulation (EC) No 1907/2006 shall undertake the following tasks:
priprava in vzdrževanje registra za izmenjavo podatkov o biocidih;
establishing and maintaining the Biocides Data Sharing Register;
opravljanje nalog v zvezi z validacijo vlog iz členov 7(4), 11(3) in 34(2) te uredbe;
performing the tasks relating to the validation of the applications referred to in Articles 7(4), 11(3) and 34(2) of this Regulation;
zagotavljanje tehničnih in znanstvenih smernic ter orodij za uporabo te uredbe Komisije in pristojnih organov držav članic;
providing technical and scientific guidance and tools for the application of this Regulation by the Commission and the competent authorities of Member States;
svetovanje in pomoč predlagateljem
providing advice and assistance to applicants
, predvsem MSP,
, and in particular to SMEs,
za vključitev aktivne snovi v Prilogo I te uredbe ali za dovoljenje Unije;
for the inclusion of an active substance in Annex I of this Regulation or for a Union authorisation;
priprava pojasnil o tej uredbi;
preparing explanatory information on this Regulation;
priprava in vzdrževanje zbirk podatkov z informacijami o aktivnih snoveh in biocidnih pripravkih;
establishing and maintaining database(s) with information on active substances and biocidal products;
na zahtevo Komisije zagotavljanje tehnične in znanstvene podpore za izboljšanje sodelovanja med Unijo, pristojnimi organi, mednarodnimi organizacijami in tretjimi državami glede znanstvenih in tehničnih vprašanj v zvezi z biocidnimi pripravki;
at the request of the Commission, providing technical and scientific support to improve cooperation between the Union, the competent authorities, international organisations and third countries on scientific and technical issues relating to biocidal products;
obveščanje o odločitvah Agencije;
notification of decisions taken by the Agency;
priprava oblike za predložitev informacij Agenciji;
provision of formats for submission of information to the Agency;
svetovanje in zagotavljanje orodij za fazo uporabe, zlasti:
providing guidance and tools for the use phase, particularly:
ukrepi za celostno zatiranje natančno določenih škodljivcev,
measures for integrated pest management, for specified vermin,
spremljanje uporabe biocidnih pripravkov,
monitoring biocidal product use,
najboljše prakse za uporabo biocidnih pripravkov, da bi njihovo uporabo omejili na najmanjši potrebni odmerek,
best practice of biocidal product use to limit use of such products to the minimum necessary dose,
zatiranje škodljivcev na občutljivih območjih, kot so šole, delovna mesta, vrtci, javni prostori, jezera, kanali in rečna obrežja, domovi za ostarele,
pest management in sensitive areas like schools, workplaces, kindergartens, public spaces, lake, canal and river sides, geriatric care centres,
tehnična oprema za uporabo biocidnih pripravkov in njihov pregled.
technical equipment for biocidal product application and its inspection.
Tajništvo da informacije iz zbirk podatkov, ki so določene v členu 56(1) in (2), brezplačno na razpolago javnosti na internetu, razen kadar je zahtevek na podlagi člena 55(3) utemeljen.
The Secretariat shall make the information identified in Article 56(1) and (2) in the database(s) publicly available, free of charge, over the internet, except where a request made under Article 55(3) is considered justified.
Agencija na zahtevo omogoči dostop do drugih informacij iz zbirk podatkov v skladu s členom 55.
The Agency shall make other information in the databases available on request in accordance with Article 55.
Pritožba proti odločitvam Agencije, sprejetim v skladu s členi 7(5), 11(4), 34(3), 36(6), 52(3) in 53(1), se vloži pri Odboru za pritožbe.
An appeal against decisions of the Agency taken pursuant to Articles 7(5), 11(4), 34(3), 36(6), 52(3) and 53(1) shall lie with the Board of Appeal.
Člen 92(1) in (2) ter člena 93 in 94 Uredbe (ES) št. 1907/2006 se uporabljajo za pritožbene postopke, vložene na podlagi te uredbe.
Articles 92(1) and (2), 93 and 94 of Regulation (EC) No 1907/2006 shall apply to appeal procedures lodged under this Regulation.
Pristojbino lahko plača oseba, ki vloži pritožbo v skladu s členom 71(2) te uredbe.
A fee may be payable by a person bringing an appeal in accordance with Article 71(2) of this Regulation.
Za namene te uredbe prihodki Agencije vključujejo:
For the purposes of this Regulation, the revenues of the Agency shall consist of: