natgillin/translations-raw huggingface dataset:
V skladu z nacionalnimi predpisi lahko dovoli, da je na njenem ozemlju na trgu dostopen samo biocidni proizvod, ki vsebuje obstoječe aktivne snovi, ki so bile ocenjene ali se ocenjujejo na podlagi Uredbe Komisije (ES) št. 1451/2007 z dne 4. decembra 2007 o drugi fazi desetletnega delovnega programa iz člena 16(2) Direktive 98/8/ES UL L 325, 11.12.2007, str.
It may, according to its national rules, authorise the making available on the market in its territory only of a biocidal product containing existing active substances which have been or are being evaluated under Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC OJ L 325, 11.12.2007, p.
, vendar še niso odobrene za zadevno vrsto proizvoda.
, but which have not yet been approved for that product-type.
Z odstopanjem od prvega pododstavka lahko država članica, če je bila sprejeta odločitev, da se aktivna snov ne odobri, še naprej uporablja svoj obstoječi sistem ali prakso dostopnosti biocidnih proizvodov na trgu, in sicer do največ dvanajst mesecev po datumu odločitve, da se aktivna snov ne odobri v skladu s tretjim pododstavkom odstavka 1.
By way of derogation from the first subparagraph, in the case of a decision not to approve an active substance, a Member State may continue to apply its current system or practice of making biocidal products available on the market for up to twelve months after the date of the decision not to approve an active substance in accordance with the third subparagraph of paragraph 1.
Po odločitvi za odobritev določene aktivne snovi za določeno vrsto proizvoda države članice zagotovijo, da se dovoljenja za biocidne proizvode te vrste, ki vsebujejo to aktivno snov, izdajo, spremenijo ali prekličejo, kar je ustrezno, v skladu s to uredbo v dveh letih po datumu odobritve.
Following a decision to approve a particular active substance for a specific product-type Member States shall ensure that authorisations for biocidal products of that product-type and containing that active substance are granted, modified or cancelled as appropriate in accordance with this Regulation within two years of the date of approval.
Če vloga za izdajo dovoljenja ali vzporedno medsebojno priznanje ni bila vložena v skladu z drugim pododstavkom:
Where no application for authorisation or mutual recognition in parallel has been submitted in accordance with the second subparagraph:
biocidni proizvod 180 dni po datumu odobritve aktivne oziroma aktivnih snovi ni več dostopen na trgu in
the biocidal product shall no longer be made available on the market with effect from 180 days after the date of approval of the active substance(s); and
odstranitev in uporaba obstoječih zalog biocidnega proizvoda sta še naprej dovoljeni največ 365 dni po datumu odobritve aktivne oziroma aktivnih snovi.
disposal and use of existing stocks of the biocidal product may continue until 365 days after the date of approval of the active substance(s).
Kadar pristojni organ države članice zavrne vlogo za izdajo dovoljenja za biocidni proizvod, vloženo na podlagi odstavka 3, ali se je odloči, da ne izda dovoljenja, ta biocidni proizvod ni več dostopen na trgu 180 dni po tej zavrnitvi ali odločitvi.
Where a Member State's competent authority rejects the application for authorisation of a biocidal product submitted under paragraph 3 or decides not to grant authorisation, that biocidal product shall no longer be made available on the market 180 days after the date of such rejection or decision.
Odstranitev in uporaba obstoječih zalog takih biocidnih proizvodov lahko traja do 365 dni po takšni zavrnitvi ali odločitvi.
Disposal and use of existing stocks of such biocidal products may continue until 365 days after the date of such rejection or decision.
Prehodni ukrepi v zvezi z aktivnimi snovmi, ocenjenimi na podlagi Direktive 98/8/ES
Transitional measures concerning active substances evaluated under Directive 98/8/EC
in olajša ocenjevanje, tako da zagotavlja organizacijsko in tehnično podporo državam članicam in Komisiji.
and shall facilitate the evaluation by providing organisational and technical support to the Member States and the Commission.
v državah članicah v skladu s členom 11(2) Direktive 98/8/ES
in accordance with Article 11 paragraph 2 of Directive 98/8/EC
se ne konča do …
has not been completed by …
in, kadar je to primerno, Uredbe (ES) št. 1451/2007.
and, where relevant, Regulation (EC) No 1451/2007.
Ocenjevanje se izvede na podlagi informacij v dokumentaciji, predloženi na podlagi Direktive 98/8/ES.
The evaluation shall be carried out on the basis of the information provided in the dossier as submitted under Directive 98/8/EC
Stori se vse za preprečitev dodatnih preskusov na vretenčarjih.
Every effort shall be made to avoid additional testing on vertebrate animals.
Stori se vse za preprečitev zamud pri programu preverjanja, določenem v Uredbi (ES) št. 1451/2007, do katerih lahko pride zaradi te prehodne ureditve.
Every effort shall be made to avoid causing delays to the review programme laid down in Regulation (EC) No 1451/2007 as a result of these transitional arrangements.
Ne glede na odstavek 1 je Agencija prav tako odgovorna za usklajevanje ocenjevanja dokumentacije, ki se predloži za namene Direktive 98/8/ES in katere ocenjevanje se ne konča do …*, ter olajša pripravo ocenjevanja, tako da državam članicam in Komisiji od
Notwithstanding paragraph 1, the Agency shall also be responsible for coordinating the evaluation process of dossiers submitted for the purposes of Directive 98/8/EC for which the evaluation has not been completed by …* and shall facilitate the preparation of the evaluation by providing organisational and technical support to the Member States and the Commission from
1. januarja 2014
1 January 2014
Prehodni ukrepi v zvezi z vlogami za izdajo dovoljenj za biocidne proizvode, vloženimi v skladu z Direktivo 98/8/ES
Transitional measures concerning applications for biocidal product authorisations submitted under Directive 98/8/EC
Vloge za izdajo dovoljenj za biocidne proizvode, ki se vložijo za namene Direktive 98/8/ES in katerih ocenjevanje se ne konča do …
Applications for biocidal product authorisations submitted for the purposes of Directive 98/8/EC for which the evaluation has not been completed by …
, ocenjujejo pristojni organi v skladu s to direktivo.
shall be evaluated by the competent authorities in accordance with that Directive.
Kadar ocena tveganja aktivne snovi ne glede na prejšnji odstavek pokaže, da
Notwithstanding the previous paragraph, when the risk assessment of the active substance indicated that
je izpolnjeno eno ali več meril iz člena 5(1), se biocidni proizvod odobri v skladu z določbami člena 19;
one or more of the criteria listed under Article 5 (1) is met, the biocidal product shall be authorised in accordance with the provisions of Article 19;
je izpolnjeno eno ali več meril iz člena 10, se biocidni proizvod odobri v skladu s členom 23.
one or more of the criteria listed under Article 10 is met, the biocidal product shall be authorised in accordance with Article 23.
Kadar se v oceni ugotovijo pomisleki zaradi uporabe določb sedanje uredbe, ki niso bili vključeni v Direktivo 98/8/ES, ima vlagatelj možnost, da zagotovi dodatne informacije.
Where the evaluation identifies concerns arising from the application of provisions of the present Regulation, which were not included in Directive 98/8/EC, the applicant shall be given the opportunity to provide additional information.
Prehodni ukrepi v zvezi z biocidnimi proizvodi, dovoljenimi
Transitional measures concerning biocidal products authorised
na podlagi Direktive 98/8/ES
under Directive 98/8/EC
Biocidni proizvodi, za katere je bilo izdano dovoljenje
Biocidal products for which an authorisation
ali ki so bili registrirani
or registration
v skladu s členi 3, 4, 15 ali 17 Direktive 98/8/ES še pred
in accordance with Articles 3, 4, 15 or 17 of Directive 98/8/EC was granted before ▌
* UL: vstaviti datum
* OJ: Insert the date -
– dan začetka uporabe te uredbe.
the day of application of this Regulation
ali registracijo
or registration
iz navedene direktive, do datuma izteka veljavnosti dovoljenja
stipulated under that Directive until the expiry date of the authorisation
ali registracije
or registration
ali njegovega preklica.
or its cancellation.
* UL: vstaviti datum – dan začetka uporabe te uredbe.
* OJ: Insert the date - the day of application of this Regulation.
Prehodni ukrepi v zvezi z
Transitional measures concerning
biocidnimi proizvodi, ki niso zajeti v Direktivi 98/8/ES
biocidal products not covered by the scope of Directive 98/8/EC
Brez poseganja v člen 89 se
Without prejudice to Article 89,
UL: vstaviti datum –
OJ: Insert the date -
, ▌vložijo najpozneje do ...
shall be submitted at the latest by …
UL: vstaviti datum – štiri leta po dnevu začetka uporabe te uredbe.
OJ: Insert the date - four years after the day of the application of this Regulation.
Z odstopanjem od člena 17(1) so lahko
By way of derogation from Article 17(1),
biocidni proizvodi
biocidal products
iz odstavka 1 tega člena, ▌za katere je bila vložena vloga v skladu z odstavkom 1 tega člena, še naprej
referred to in paragraph 1 of this Article
na trgu do dne, ko se sprejme odločitev o izdaji.
for which an application was submitted in accordance with paragraph 1 of this Article may continue to be made available on the market until the date of the decision granting the authorisation.
V primeru odločitve o zavrnitvi dovoljenja biocidni proizvod ni več dostopen na trgu 180 dni po sprejetju te odločitve.
In the case of a decision refusing to grant the authorisation, the biocidal product shall no longer be made available on the market 180 days after such a decision.
Odstranitev in uporaba obstoječih zalog biocidnih proizvodov, ki jih pristojni organi ali Komisija niso dovolili za zadevno uporabo, sta še naprej dovoljeni do 365 dni po datumu odločitve iz prvega pododstavka ali dvanajst mesecev po datumu iz drugega pododstavka, odvisno od tega, kateri datum je poznejši.
Disposal and use of existing stocks of biocidal products which are not authorised for the relevant use by the competent authority or the Commission may continue until 365 days after the date of the decision referred to in the first subparagraph or twelve months after the date referred to in the second subparagraph, whichever is the later.
Prehodni ukrepi v zvezi s tretiranimi izdelki
Transitional measures concerning treated articles
Z odstopanjem od člena 58 in brez poseganja v člen 89 se lahko tretirani izdelki, ki so bili dostopni na trgu dne …
By way of derogation from Article 58 and without prejudice to Article 89, treated articles that were available on the market on …
UL: vstaviti datum – dan začetka veljavnosti te uredbe.
OJ: Insert the date - the day of the entry into force of this Regulation.
, še naprej dajejo na trg do datuma odločitve o odobritvi aktivnih snovi, ki jih vsebujejo biocidni proizvodi, s katerimi so bili tretirani izdelki tretirani ali ki jih vsebujejo, za zadevno vrsto proizvoda, in sicer če je vloga za odobritev aktivnih snovi za zadevno vrsto proizvoda vložena najpozneje …
may, until the date of a decision concerning the approval for the relevant product type of the active substance(s) contained in the biocidal products with which the treated articles were treated or which they incorporate, continue to be placed on the market if the application for the approval of the active substance(s) for the relevant product type is submitted at the latest by …
UL: vstaviti datum – tri leta po dnevu začetka uporabe te uredbe.
OJ: Insert the date - three years after the day of application of this Regulation.
V primeru odločitve, da se aktivna snov za zadevno vrsto proizvoda ne odobri, tretirani izdelki, ki so bili tretirani z ali ki vsebujejo biocidni proizvod oziroma biocidne proizvode, ki vsebuje(-jo) to aktivno snov, 180 dni po datumu te odločitve ali od …** niso več dostopni na trgu, odvisno od tega, kateri datum je poznejši, razen če je bila vložena vloga za odobritev v skladu z odstavkom 1.
In the case of a decision not to approve an active substance for the relevant product type, treated articles which were treated with, or which incorporate, biocidal product(s) containing that active substance shall no longer be placed on the market 180 days after such a decision or as of …**, whichever is the later, unless an application for the approval has been submitted in accordance with paragraph 1.
UL: vstaviti datum – dan začetka uporabe te uredbe.
OJ: Insert the date - the day of the application of this Regulation.
vsaka oseba, ki želi dati na trg Unije aktivno snov v samostojni obliki ali kot sestavino biocidnega proizvoda, (v nadaljnjem besedilu: zadevna oseba) Agenciji za vsako aktivno snov, ki jo proizvaja ali uvaža za uporabo v biocidnih proizvodih, predloži:
, any person wishing to place active substance(s) on the Union market on its own or in biocidal products (the ‘relevant person’) shall, for every active substance that they manufacture or import for use in biocidal products, submit to the Agency:
dokumentacijo, ki je skladna z zahtevami iz Priloge II
a dossier complying with the requirements of Annex II
, ali, kjer je primerno, iz Priloge IIA k Direktivi 98/8/ES
, or where appropriate, with Annex IIA of Directive 98/8/EC
izjavo o dostopnosti do dokumentacije
a letter of access to a dossier
iz točke (a)
as referred to under (a)
napotilo na dokumentacijo
a reference to a dossier
iz točke (a),
as referred to under (a)
za katero so potekla vsa obdobja varstva podatkov.
and for which all data protection periods have expired.
Če zadevna oseba ni fizična ali pravna oseba s sedežem v Uniji, informacije, ki se zahtevajo na podlagi prvega pododstavka, predloži uvoznik biocidnega proizvoda, ki vsebuje takšno aktivno snov.
If the relevant person is not a natural or legal person established within the Union, the importer of the biocidal product containing such active substance(s) shall submit the information required under the first subparagraph.
Za namene tega odstavka in za obstoječe aktivne snovi, navedene v Prilogi II k Uredbi (EC) št. 1451/2007, se za vse toksikološke in ekotoksikološke študije,
For the purposes of this paragraph and for existing active substances listed in Annex II to Regulation (EC) No 1451/2007,
uporablja člen 63(3)
Article 63(3)
Zadevna oseba, ki ji je bila podeljena izjava o dostopnosti do dokumentacije o aktivni snovi, sme vlagateljem vloge za dovoljenje za biocidni proizvod, ki vsebuje to aktivno snov, dovoliti, da se za namene člena 20(1) sklicujejo na to izjavo o dostopnosti.
The relevant person to whom a letter of access to the dossier on the active substance has been issued shall be entitled to allow applicants for the authorisation of a biocidal product containing that active substance to make reference to that letter of access for the purposes of Article 20(1).
Z odstopanjem od člena 60 te uredbe vsa obdobja varstva podatkov za kombinacije snovi/vrst proizvodov iz Priloge II k Uredbi (ES) št. 1451/2007, ki še niso odobrene v skladu s to uredbo, potečejo 31. decembra 2025.
By way of derogation from Article 60 of this Regulation, all data protection periods for substance/product-type combinations listed in Annex II to Regulation (EC) No 1451/2007, but not yet approved under this Regulation shall end on 31 December 2025.
Agencija da javnosti na voljo seznam oseb, ki so predložile dokumentacijo v skladu z odstavkom 1 ali za katere je sprejela odločitev v skladu s členom 63(3).
The Agency shall make publicly available the list of persons that have made a submission in accordance with paragraph 1 or for whom it has taken a decision in accordance with Article 63(3).
Seznam vsebuje tudi imena oseb, ki sodelujejo v delovnem programu, opredeljenem v prvem pododstavku člena 89(1), ali so prevzeli vlogo udeležencev.
The list shall also contain the names of persons who are participants in the work programme established under the first subparagraph of Article 89(1) or have taken over the role of the participant.
v seznam iz odstavka 2 ▌. ▌
included in the list referred to in paragraph 2. ▌
Brez poseganja v člena 52 in 89 sta odstranitev in uporaba obstoječih zalog biocidnih proizvodov, ki vsebujejo aktivno snov, za katero nobena zadevna oseba ni vključena v seznam iz odstavka 2, še naprej dovoljeni do …
Without prejudice to Articles 52 and 89, disposal and use of existing stocks of biocidal products containing an active substance, for which no relevant person is included in the list referred to in paragraph 2, may continue until …
UL: vstaviti datum – tri leta po dnevu začetka uporabe te uredbe.
OJ: Insert the date - three years after the day of the application of this Regulation.
Ta člen se ne uporablja za aktivne snovi s seznama v Prilogi I iz kategorij 1 do 5 in 7 ali za biocidne proizvode, ki vsebujejo le takšne aktivne snovi.
This Article shall not apply to active substances listed in Annex I in categories 1 to 5 and 7 or to biocidal products containing only such active substances.
Brez poseganja v člene 86, 89, 90, 91 in 92 te uredbe se Direktiva 98/8/ES razveljavi z učinkom od ... ** UL: vstaviti datum – datum začetka uporabe te uredbe.
Without prejudice to Articles 86, 89, 90, and 92 of this Regulation, Directive 98/8/EC is hereby repealed with effect from ... ** OJ: Insert the date - date of application of this Regulation.
Sklicevanja na razveljavljeno direktivo se razumejo kot sklicevanja na to uredbo in razumejo v skladu s korelacijsko tabelo iz Priloge VII.
References to the repealed Directive shall be construed as references to this Regulation and read in accordance with the correlation table in Annex VII.
SEZNAM AKTIVNIH SNOVI IZ ČLENA 25
LIST OF ACTIVE SUBSTANCES REFERRED TO IN ARTICLE 25
Številka EC
EC number
Kategorija 1 − Snovi, ki so v skladu z Uredbo (ES) št. 1333/2008 odobrene kot aditivi za živila
Category 1 - Substances authorised as food additives according to Regulation (EC) No 1333/2008
Mlečna kislina
Lactic acid
Natrijev acetat
Sodium acetate
Natrijev benzoat
Sodium benzoate
(+)-Vinska kislina
(+)-Tartaric acid
Kategorija 2 − Snovi, vključene v Prilogo IV k Uredbi (ES) št. 1907/2006
Category 2 - Substances included in Annex IV to Regulation (EC) No 1907/2006
Kategorija 3 −Šibke kisline
Category 3 - Weak acids
Kategorija 4 −Snovi naravnega izvora, ki se uporabljajo tradicionalno
Category 4 - Traditionally used substances of natural origin
Naravno olje
Natural oil
Olje sivke
Lavender oil
Olje poprove mete
Peppermint oil
Kategorija 5 −Feromoni
Category 5 – Pheromones
Feromon tekstilnih moljev
Webbing clothes moths pheromone
Kategorija 6 −Snovi, vključene v Prilogo I ali IA k Direktivi 98/8/ES
Category 6 – Substances included in Annex I or IA to Directive 98/8/EC
Samo za uporabo v plinskih posodah za takojšnjo uporabo, ki delujejo skupaj s pastjo
Only for use in ready-for-use gas canisters functioning together with a trapping device
Samo za uporabo v omejenih količinah v posodah za takojšnjo uporabo
Only for use in limited quantities in ready-for-use canisters
(Z,E)-tetradeka-9,12-dienil acetat
(Z,E)-Tetradec-9,12-dienyl acetate
Kategorija 7 – Drugo
Category 7 – Other
Železov sulfat
Iron sulphate
ZAHTEVE GLEDE INFORMACIJ O AKTIVNIH SNOVEH
INFORMATION REQUIREMENTS FOR ACTIVE SUBSTANCES
V tej prilogi so navedene zahteve glede informacij za pripravo dokumentacije iz točke (a) člena 6(1).
This Annex sets out the information requirements for the preparation of the dossier referred to in point (a) of Article 6(1).
Podatki, navedeni v tej prilogi, sestavljajo zbirko osnovnih podatkov (ZOP) in zbirko dodatnih podatkov (ZDP).
The data elements set down in this Annex comprise a Core Data Set (CDS) and an Additional Data Set (ADS).
Podatki, ki spadajo v ZOP, štejejo za osnovne podatke, ki bi morali biti načeloma na voljo za vse aktivne snovi.
The data elements belonging to the CDS are considered as the basic data which should, in principle, be provided for all active substances.
V nekaterih primerih pa fizikalne ali kemijske lastnosti snovi lahko pomenijo, da je nemogoče ali nepotrebno zagotoviti specifične podatke, ki spadajo v ZOP.
However, in some cases the physical or chemical properties of the substance may mean that it is impossible or unnecessary to provide specific data elements belonging to the CDS.
Kar zadeva ZDP, se podatki, ki se navedejo za določeno aktivno snov, določijo z obravnavo vsakega od podatkov iz ZDP, navedenih v tej prilogi, med drugim ob upoštevanju fizikalnih in kemijskih lastnosti snovi, obstoječih podatkov, informacij, ki so del ZOP, in vrst proizvodov, v katerih bo aktivna snov uporabljena, ter vzorcev izpostavljenosti, povezanih s to uporabo.
With regard to the ADS, the data elements to be provided for a specific active substance shall be determined by considering each of the ADS data elements indicated in this Annex taking into account, inter alia, the physical and chemical properties of the substance, existing data, information which is part of the CDS and the types of products in which the active substance will be used and the exposure patterns related to these uses.
Posebne določbe za vključitev nekaterih podatkov so v stolpcu 1 tabele v Prilogi II.
Specific indications for the inclusion of some data elements are provided in column 1 of the Annex II table.
Uporabljajo se tudi splošni preudarki za prilagoditev zahtev glede informacij, kot so navedeni v Prilogi IV.
The general considerations regarding adaptation of information requirements as set out in Annex IV shall also apply.
Zaradi pomembnosti zmanjšanja števila preskusov na vretenčarjih so v stolpcu 3 tabele iz Priloge II navedene posebne določbe o prilagoditvi zahtev glede nekaterih podatkov, za katere bi lahko bili potrebni takšni preskusi na vretenčarjih.
In light of the importance of reducing testing on vertebrate animals, column 3 of the Annex II table gives specific indications for the adaptation of some of the data elements which might require the use of such tests on vertebrate animals.
Predložene informacije morajo biti v vsakem primeru zadostne, da se opravi ocena tveganja, ki naj bi pokazala, da so merila iz člena 4(1) izpolnjena.
The information submitted shall, in any case, be sufficient to support a risk assessment demonstrating that the criteria referred to in Article 4(1) are met.
Vlagatelj bi moral pri uporabi te priloge in pripravi dokumentacije iz točke (a) člena 6(1) upoštevati podrobne tehnične smernice, ki so na voljo na spletni strani Agencije.
The applicant should consult the detailed technical guidance regarding the application of this Annex and the preparation of the dossier referred to in point (a) of Article 6 (1), which is available on the web-site of the Agency.
Vlagatelj se mora pred oddajo posvetovati.
The applicant has the obligation to initiate a pre-submission consultation.
Poleg obveznosti iz člena 62(2) se lahko vlagatelji prav tako posvetujejo s pristojnim organom, ki bo ocenil dokumentacijo glede na predlagane zahteve glede informacij in zlasti glede preskusov na vretenčarjih, za katere vlagatelj predlaga, da jih bo izvedel.
In addition to the obligation set down in Article 62(2), applicants may also consult with the competent authority that will evaluate the dossier with regard to the proposed information requirements and in particular the testing on vertebrate animals that the applicant proposes to carry out.
Če je treba opraviti oceno iz člena 8(2), utegnejo biti potrebne dodatne informacije.
Additional information may need to be submitted if it is necessary to carry out the evaluation as indicated in Article 8(2).
Vključi se podroben in popoln opis opravljenih ali navedenih študij in uporabljenih metod.
A detailed and full description of the studies conducted or referred to and of the methods used shall be included.
Pomembno je zagotoviti, da so razpoložljivi podatki primerni in zadostne kakovosti za izpolnjevanje zahtev.
It is important to ensure that the data available is relevant and is of sufficient quality to fulfil the requirements.