natgillin/translations-raw huggingface dataset:
(dd) doziranje in navodila za uporabo.
(dd) doses and instructions for use.
K informacijam, ki veljajo za zaupne, ker so poslovno občutljive, je treba dodati tudi podatke o datumu izdaje in datumu poteka dovoljenja, doziranju, navodilih za uporabo ter kraju obratov za proizvodnjo biocidnega pripravka.
The information to be treated as confidential, because it is commercially sensitive, should also include the date of issue of an authorisation and the expiry date, the stated doses and also instructions for use, and the location of the site where a biocidal product is manufactured.
Člen 55 – odstavek 2 – pododstavek 2
Article 55 – paragraph 2 – subparagraph 2
Kadar je nujno takojšnje ukrepanje za zaščito zdravja ljudi, varnosti ali okolja, lahko agencija ali pristojni organi razkrijejo informacije iz tega odstavka.
However, where urgent action is essential to protect human health, safety or the environment, the Agency or the competent authorities may disclose the information referred to in this paragraph.
Kadar je nujno takojšnje ukrepanje za zaščito zdravja ljudi, varnosti ali okolja, agencija ali pristojni organi sprejmejo potrebne ukrepe za razkritje informacij iz tega odstavka.
However, where urgent action is essential to protect human health, safety or the environment, the Agency or the competent authorities shall take the necessary measures to disclose the information referred to in this paragraph.
V nujnih primerih je bistveno zagotoviti preglednost, da bi zaščitili zdravje in varnost ljudi ali okolja.
It is essential to ensure transparency in urgent cases to protect health, the safety of persons or the environment.
Člen 55 – odstavek 3
Article 55 - paragraph 3
Vsaka oseba, ki predloži informacije o aktivni snovi 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.
Any person submitting information related to an active substance to the Agency or a competent authority for the purposes of this Regulation can request that the information in Article 56(2) shall 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.
Vsaka oseba, ki predloži informacije o aktivni snovi ali biocidnem pripravku 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.
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 56(2) shall 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.
Člen se mora nanašati tudi na podatke o biocidnih pripravkih.
This article should also apply to information concerning biocidal products.
Člen 56 – odstavek 1 – uvodni del
Article 56 – paragraph 1 – introductory part
Javnosti se omogoči brezplačen dostop do naslednjih informacij o aktivnih snoveh, ki jih imajo pristojni organi, agencija ali Komisija, kjer je to ustrezno:
The following information held by the competent authorities, the Agency or, as appropriate, the Commission on active substances shall be made, free of charge, publicly available:
Javnosti se v eni sami podatkovni bazi, v strukturirani obliki vsaj na ustreznem spletnem mestu Komisije, omogoči brezplačen dostop do naslednjih informacij o aktivnih snoveh, ki jih imajo pristojni organi, agencija ali Komisija, kjer je to ustrezno:
The following information held by the competent authorities, the Agency or, as appropriate, the Commission on active substances shall be made, free of charge, publicly available in a single database, in a structured format at least on the relevant website of the Commission :
Informacije o biocidnih pripravkih se objavijo v strukturirani obliki, ki omogoča enostavno iskanje, na internetu, predvsem na spletem mestu Komisije, ki se nanaša na biocidne pripravke.
Information on biocidal products shall be published in structured, researchable way on the internet, first of all on the website of the Commission dealing with biocidal products.
Člen 56 – odstavek 1 – točka d a (novo)
Article 56 – paragraph 1 – point d a (new)
(da) jasna navedba, ali aktivna snov šteje za snov, ki je obstojna, se 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.
(da) a clear reference if 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 if it has been classified in accordance with Regulation (EC) No 1272/2008 as carcinogenic , mutagenic , neurotoxic , immunotoxic , toxic to reproduction or sensitising.
Navesti je treba razvrstitev določenih biocidnih snovi v skladu z veljavno zakonodajo Skupnosti.
A reference on the classification of certain biocidal substances according to the community legislation in force is necessary.
Predlog spremembe
Amendment 21
Člen 56 – odstavek 1 – točka h
Article 56 – paragraph 1 – point h
h) analitske metode, če se zahtevajo v skladu s Prilogo II ali III k tej uredbi, ki omogočajo zaznavanje nevarne snovi pri sproščanju v okolje ali določitev neposredne izpostavljenosti ljudi.
h) 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 as well as to determine the direct exposure of humans.
h) analitske metode, če se zahtevajo v skladu s Prilogo II ali III k tej uredbi, ki omogočajo zaznavanje nevarne snovi pri sproščanju v okolje (vključno z vodnimi viri in pitno vodo) ali določitev neposredne izpostavljenosti ljudi.
h) 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 (including water resources and drinking water) as well as to determine the direct exposure of humans.
Jasno je treba navesti, da bi morale biti na voljo tudi analitske metode za analizo voda in pitne vode.
In order to make clear that there should be also analytical methods available to analyse waters and drinking water.
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(3) and of the corresponding manufacturers.
Končni uporabnik mora imeti možnost, da lahko razlikuje med biocidnimi pripravki z nizkim tveganjem in tistimi z visokim tveganjem in se na podlagi tega odloči za nakup.
Final users must be able to distinguish between low-risk and high-risk biocidal products and make purchasing decisions accordingly.
Proizvajalci, uvozniki in poklicni uporabniki biocidnih pripravkov vsaj tri leta vodijo evidence o biocidnih pripravkih, ki jih proizvedejo, dajo v promet ali uporabljajo.
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 three years .
Na zahtevo pristojnega organa dajo na voljo ustrezne informacije iz teh evidenc.
They shall make available the relevant information contained in these records to the competent authority on request.
Proizvajalci, uvozniki in poklicni uporabniki biocidnih pripravkov vsaj deset let vodijo evidence o biocidnih pripravkih, ki jih proizvedejo, dajo v promet ali uporabljajo.
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 ten years .
Evidence se morajo voditi dovolj dolgo, da lahko pristojni organ izvaja nadzor.
The period for which records are kept must be sufficiently long to enable the competent authority to perform checks.
Predlagano obdobje desetih let je enako obdobju, določenemu v uredbi REACH.
The proposed period of ten years is the same as provided for by the REACH Regulation.
Člen 58 – odstavek 2 – točka b a (novo)
Article 58 – paragraph 2 – point b a (new)
(ba) ali izdelek vsebuje nanomateriale ter vsa s tem povezana posebna tveganja, ob vsaki navedbi nanomateriala pa v oklepaju tudi besedo „nano“;
(ba) whether the product contains nanomaterials and any specific related risks , and, following each reference to nanomaterials , the word "nano" in brackets;
Člen 58 – odstavek 2 – prvi pododstavek – točka e
Article 58 – paragraph 2 – first subparagraph – point e
(e) navodila za uporabo in razmerje odmerka, izraženo v merskih enotah, za vsako uporabo, določeno v skladu s pogoji iz dovoljenja;
(e) directions for use and the dose rate, expressed in metric units, for each use provided for under the terms of the authorisation;
(e) navodila za uporabo in razmerje odmerka, izraženo v merskih enotah oziroma na drug način, ki bo potrošniku jasen in razumljiv , za vsako uporabo, določeno v skladu s pogoji iz dovoljenja;
(e) directions for use and the dose rate, expressed in metric units or in a nother manner which is meaningful and comprehensible to the user , for each use provided for under the terms of the authorisation;
Doziranje mora biti navedeno na potrošniku jasen in razumljiv način.
The dose must be expressed in a manner which is meaningful and comprehensible to the user.
Zlasti pri nepoklicnih potrošnikih je doziranje, izraženo v metričnih enotah, nerazumljivo.
Particularly in the case of non-professional users, a dose in metric units is sometimes hard for users to understand.
Če je potrebno, se doziranje v metričnih enotah prenese v jasen in razumljiv jezik, ki bo ustrezen za potrošnika.
The dose in metric units should be translated into terms which are significant, comprehensible and appropriate for the consumer if necessary.
Člen 58 – odstavek 2 – točka g
Article 58 – paragraph 2 – point g
(g) če so navodila priložena, se na oznaki pripiše stavek „Pred uporabo preberite priložena navodila.“;
(g) if accompanied by a leaflet, the sentence "Read attached instructions before use";
(g) če so navodila priložena, se na oznaki pripiše stavek „Pred uporabo preberite priložena navodila .“, po potrebi pa tudi opozorila za ranljive skupine ;
(g) if accompanied by a leaflet, the sentence "Read attached instructions before use" and , where applicable , warnings for vulnerable groups ;
Na oznakah biocidnih pripravkov je treba zagotoviti boljše napotke za ranljive skupine.
Better guidance on the labels of biocidal products for vulnerable groups should be provided
Države članice lahko zahtevajo, da se biocidni pripravki, dani v promet na njihovem ozemlju, označijo v njihovem uradnem jeziku ali jezikih.
Member States may require that biocidal products placed on the market of their territories are labelled in their national language or languages.
Biocidni pripravki, dani v promet na ozemlju držav članic , se označijo v uradnem jeziku ali jezikih države, v kateri so dani v promet .
Biocidal products placed on the market of the territories of the Member States shall be labelled in the national language or languages of the country where they are marketed.
Potrošniki in uslužbenci nadzornega organa morajo imeti možnost dostopa do informacij v svojem maternem jeziku.
Both consumers and those acting on behalf of supervisory authorities must be able to gain access to the information in their mother tongue.
Člen 59 – odstavek 1 a (novo)
Article 59 – paragraph 1 a (new)
Varnostni listi vsebujejo naslednje informacije:
Safety data sheets shall contain the following information:
(a) ustrezne kategorije proizvoda, katerega aktivna snov je bila vključena v Prilogo I;
(a) important categories of product whose active substance has been included in Annex I;
(b) ime vsaj ene države članice, v kateri je bilo izdano dovoljenje za biocidni pripravek;
(b) the name of at least one Member State where the biocidal product has been authorised;
(c) številka dovoljenja biocidnega pripravka kot takega ali prisotnega v izdelku ali obdelani snovi.
(c) the authorisation number of the biocidal product as such or present in a treated article or material.
V skladu z zahtevanimi informacijami o proizvajalcih aktivnih snovi morajo tudi varnostni listi, ki so priloženi biocidnim pripravkom, vsebovati informacije, ki bodo nadzornim in pristojnim organom pomagale nadzorovati poreklo snovi v proizvodih na trgu.
Consistently with the information requested concerning manufacturers of active substances, safety data sheets accompanying biocidal products too should contain such information to help the supervisory authorities and competent authorities to check the origin of the substances in products placed on the market.
Člen 60 – odstavek 5
Article 60 – paragraph 5
Komisija lahko sprejme natančna pravila o vrstah informacij, ki se vnesejo v register biocidnih pripravkov Skupnosti , in o postopkih, ki so povezani s tem , in sicer v skladu s postopkom iz člena 72(2) .
The Commission may adopt detailed rules on the types of information to be entered in the Community Register for Biocidal Products and the procedures related to it , in accordance with the procedure referred to in Article 72(2) .
Za zagotovitev pravilnega delovanja registra biocidnih pripravkov Unije lahko Komisija z delegiranimi akti v skladu s členom 71 a ter pod pogoji iz členov 71b in 71c sprejme natančna pravila o vrstah informacij, ki se vnesejo v register, in o postopkih, ki so povezani s tem.
In order to ensure the proper functioning of the Union Register for Biocidal Products, the Commission may adopt , by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, detailed rules on the types of information to be entered in the Register and the procedures related to it.
Za pravilno delovanje registra biocidnih pripravkov Skupnosti po vsej EU morajo biti podrobna pravila za delovanje registra določena z delegiranimi akti.
The proper functioning of the Community Register for Biocidal Products throughout the EU requires that detailed measure related to the running of the Register are established by delegated acts.
Člen 61 a (novo)
Article 61 a (new)
Člen 61a
Article 61a
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.
Države članice sprejmejo potrebne ukrepe, da zagotovijo javnosti podatke o koristih in tveganjih glede biocidov ter informacije o možnostih za čim manjšo uporabo biocidnih pripravkov.
Member States shall take the necessary measures to provide the public with information about the benefits and risks associated with biocidal products and ways of minimising the use of those products.
Komisija na internetu objavi seznam vseh aktivnih snovi, ki so na voljo na notranjem trgu.
The Commission shall make available on the internet a list of all active substances available within the internal market.
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 available on the internet a list of such products.
Spletno mesto je treba uporabiti za izboljšanje preglednosti za potrošnike ter omogočiti lahko in hitro zbiranje podatkov o lastnostih in pogojih uporabe teh pripravkov.
This website shall serve to increase transparency for consumers and to facilitate an easy and fast collection of data on the properties and conditions of use of these products.
Dostop do omenjenih spletnih mest ni z ničimer omejen, njihova vsebina pa se posodablja.
Access to the aforementioned websites shall not be subject to any restriction or condition and their content shall be kept up to date.
Ustrezni naslovi spletnih mest so navedeni na oznaki biocidnega pripravka na jasno vidnem mestu.
The relevant website addresses shall be indicated on the labelling of the biocidal products in a visible manner.
Namen predloga spremembe je doseči, da so poklicni uporabniki in potrošniki obveščeni o varni uporabi pripravkov, sprejemljivih alternativah in nenevarnih biocidnih pripravkih.
This will help to inform professional users and consumers about the safe use of products and about compatible alternatives and harmless biocidal products.
Predlog spremembe
Amendment 22
Člen 66 – odstavek 2 – točka d
Article 66 – paragraph 2 – point d
(d) svetovanje in pomoč predlagateljem za vključitev aktivne snovi v Prilogo I ali za dovoljenje Skupnosti ;
(d) providing advice and assistance to applicants for the inclusion of an active substance in Annex I or for a Community authorisation;
(d) svetovanje in pomoč predlagateljem , predvsem MSP, za vključitev aktivne snovi v Prilogo I ali za dovoljenje Unije ;
(d) providing advice and assistance to applicants , and in particular to SMEs , for the inclusion of an active substance in Annex I or for a Union authorisation;
Omeniti je treba, da bodo mala in srednje velika podjetja pri vlogah pogosteje potrebovala pomoč, ki jo morajo Komisija, agencija ali države članice zagotoviti, kadar koli je to mogoče.
It should be noted that SMEs will more often be in a position to require assistance with their applications and this should be provided whenever possible by Commission, Agency and Member States.
Člen 66 – odstavek 2 – točka i a (novo)
Article 66 – paragraph 2 – point i a (new)
(ia) svetovanje in zagotavljanje orodij za fazo uporabe, zlasti:
(ia) 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.
a) znižana pristojbina se določi za mala in srednje velika podjetja v smislu Priporočila 2003/361/ES o opredelitvi mikro, malih in srednje velikih podjetij;
a) a reduced fee shall be set for small and medium-sized enterprises within the meaning of Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises;
a) znižana pristojbina se določi za mala in srednje velika podjetja v smislu Priporočila 2003/361/ES o opredelitvi mikro, malih in srednje velikih podjetij; to nikakor ne vpliva na odgovornost ustreznega pristojnega organa, da opravi natančno oceno v skladu z določbami te uredbe;
a) a reduced fee shall be set for small and medium-sized enterprises within the meaning of Recommendation 2003/361/EC concerning the definition of micro, small and medium-sized enterprises; this shall have no bearing on the responsibility of the relevant competent authority to carry out a careful assessment in accordance with the provisions of this Regulation;
Pristojbine bi se morale nanašati na delo, ki je bilo potrebno in je bilo opravljeno ustrezno in učinkovito.
Fees should reflect the work required and the fact that it has been performed in an appropriate and efficient manner.
Letna pristojbina brez utemeljitve zato ni sprejemljiva, pristojbine pa bi bilo treba zahtevati le, če je to dejansko potrebno.
An annual fee is therefore not acceptable without a justification, and fees should only be charged when they are genuinely necessary.
(ba) v strukturi pristojbin se upošteva, ali izdelek, za katerega se vloži vloga za izdajo dovoljenja, ustreza merilom za izdelek z manjšim tveganjem;
(ba) the fee structure shall take into account whether the product submitted for authorisation complies with the criteria for a low-risk product;
Struktura pristojbin lahko spodbudi proizvodnjo izdelkov z manjšim tveganjem.
The fee structure may make it possible to provide incentives for production of low-risk products.
Člen 70 – odstavek 2 – točka d
Article 70 – paragraph 2 – point d
(d) letno pristojbino plačajo tisti, ki dajo biocidne pripravke v promet, ter
(d) an annual fee shall be paid by persons placing biocidal products on the market; and
Pristojbine bi se morale nanašati na delo, ki je bilo potrebno in je bilo opravljeno ustrezno in učinkovito.
Fees should be related to the required work which has been performed in an appropriate and efficient manner.
Člen 71 a (novo)
Article 71 a (new)
Člen 71a
Article 71a
Pooblastilo za sprejemanje delegiranih aktov iz členov 6(4), 8(5), 12(5), 13(1), 14, 19(3), 21(5), 42, 46(4), 60(5), 70(1), 73 in 77(1) se Komisiji podeli za obdobje petih let po začetku veljavnosti te direktive.
The power to adopt the delegated acts referred to in Articles 6(4), 8(5), 12(5), 13(1), 14, 19(3), 21(5), 42, 46(4), 60(5), 70(1), 73 and 77(1) shall be conferred on the Commission for a period of 5 years following the entry into force of this Directive.
Prenos pooblastil se samodejno podaljša za enako dolgo obdobje, razen če ga Evropski parlament ali Svet ne prekliče v skladu s členom 71b.
The delegation of powers shall be automatically extended for periods of an identical duration, unless the European Parliament and the Council revokes it in accordance with Article 71b.
Ko Komisija sprejme delegirani akt, o tem istočasno uradno obvesti Evropski parlament in Svet.
As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council .
Pooblastilo za sprejemanje delegiranih aktov se na Komisijo prenese pod pogoji iz členov 71b in 71c.
The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in Articles 71b and 71c.
V skladu s členom 290 PDEU morajo biti v uredbi natančne določbe o prenosu pooblastil.
Pursuant to Article 290 TFEU, detailed provisions on the delegation of powers have to be set out in the Regulation.
Člen 71 b (novo)
Article 71 b (new)
Člen 71b
Article 71b
Evropski parlament ali Svet lahko kadarkoli prekliče prenos pooblastil iz členov 6(4), 8(5), 12(5), 13(1), 14, 19(3), 21(5), 42, 46(4), 60(5), 70(1), 73 in 77(1).
The delegation of powers referred to in Articles 6(4), 8(5), 12(5), 13(1), 14, 19(3), 21(5), 42, 46(4), 60(5), 70(1), 73 and 77(1) may be revoked at any time by the European Parliament or by the Council.
Odločitev začne učinkovati nemudoma ali na dan, ki je v njej naveden.
It shall take effect immediately or at a later date specified therein.
Člen 71 c (novo)
Article 71 c (new)
Člen 71c
Article 71c
Če po izteku tega obdobja niti Evropski parlament niti Svet ne nasprotuje delegiranemu aktu, se ta objavi v Uradnem listu Evropske unije in začne veljati na tam navedeni datum.
If, on expiry of that period, neither the European Parliament nor the Council has objected to the delegated act , it shall be published in the Official Journal of the European Union and shall enter into force on the date stated therein.