natgillin/translations-raw huggingface dataset:
(e) kakovostna in količinska sestava aktivnih in neaktivnih snovi, poznavanje katerih je potrebno za pravilno uporabo biocidnega pripravka;
(e) qualitative and quantitative composition in terms of the active substances and non-active substances, knowledge of which is essential for proper use of the biocidal product;
(e) kakovostna in količinska sestava aktivnih in neaktivnih snovi ob upoštevanju najvišjih dovoljenih koncentracij iz člena 16, če je njihovo poznavanje potrebno za pravilno uporabo biocidnega pripravka;
(e) qualitative and quantitative composition in terms of the active substances and non-active substances, taking into consideration the concentration limit values given in Article 16, in so far as knowledge of these is essential for proper use of the biocidal product;
Zaradi skladnosti s členom 16(2a).
In the interests of consistency with Article 16(2a).
Člen 20 – odstavek 2 – točka g
Article 20 – paragraph 2 – point g
(g) proizvajalci aktivnih snovi (imena in naslovi, vključno s krajem proizvodnih obratov);
(g) manufacturers of the active substances (names and addresses including location of manufacturing sites);
(g) proizvajalci aktivnih snovi (imena in naslovi, vključno s krajem proizvodnih obratov) in številka vključitve aktivne snovi v skladu s členom 8(5a);
(g) manufacturers of the active substances (names and addresses including location of manufacturing sites) and registration number of the active substance, in accordance with Article 8(5a) ;
Da bi se izognili širitvi zaupnih podatkov, če morata po vpisu v Prilogo I ime izdelovalca aktivne snovi in kraj izdelave ostati zaupna in ne smeta biti vključena v informacije o dovoljenju za biocidni pripravek.
To avoid disseminating confidential information, if the manufacturer of the active substance is authorised through registration in Annex I, the location of the manufacturing site should remain confidential and should not be included in the information linked to the biocidal product authorisation.
V skladu s členom 8(5a) pa mora biti objavljena številka vključitve.
However, the registration number must be published, in accordance with Article 8(5a).
(b) dovoljena sprememba sestave tega referenčnega biocidnega pripravka, izražena v odstotku neaktivnih snovi v biocidnih pripravkih, za katere velja, da pripadajo navedeni okvirni formulaciji;
(b) the permitted alteration of the composition of this reference biocidal product expressed in percentage of the non-active substances contained in the biocidal products which are considered to belong to that frame formulation;
(b) dovoljena sprememba sestave tega referenčnega biocidnega pripravka, izražena kot zmanjšanje odstotka aktivnih snovi ali sprememba odstotka neaktivnih snovi v biocidnih pripravkih, za katere velja, da pripadajo navedeni okvirni formulaciji;
(b) the permitted alteration of the composition of this reference biocidal product expressed as a percentage reduction in the active substances or as a percentage alteration of the non-active substances contained in the biocidal products which are considered to belong to that frame formulation;
Odstavek mora biti v točki b popolnoma skladen s členom 16(6).
Paragraph 3b needs to be fully consistent with Article 16(6).
Pri vsebini dovoljenja je treba upoštevati tudi to možnost.
The substance of the authorisation must also make provision for this possibility.
V primeru okvirne formulacije se za vse biocidne pripravke, ki spadajo k tej okvirni formulaciji, določi enotna številka dovoljenja.
In the case of a framework formulation, a single authorisation number shall be assigned to all biocidal products belonging to the frame formulation.
Potreben je dodaten odstavek, da bi se poudarilo, da se v primeru okvirne formulacije vsem biocidnim pripravkom, ki sodijo v to okvirno formulacijo, dodeli enotna številka dovoljenja.
A new paragraph is needed to stipulate that, in the case of a frame formulation, a single authorisation number should be assigned to all biocidal products belonging to the frame formulation.
Te pojasnitve v sedanjem predlogu uredbe ni.
This is not clear from the existing text of the proposal.
Pristojni organ prejemnik ali v primeru ocene vloge za obnovitev dovoljenja Skupnosti, ocenjevalni pristojni organ, opravi primerjalno oceno kot del ocene vloge za obnovitev dovoljenja za biocidni pripravek, ki vsebuje aktivno snov kot možno snov za zamenjavo v skladu s členom 9(1).
The receiving competent authority or, in the case of evaluation of an application for renewal of a Community authorisation, the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for a renewal of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with Article 9(1).
Menimo, da je treba pri primerjalni oceni najprej upoštevati zadostne izkušnje pri uporabi.
The comparative assessment should take account first and foremost of whether sufficient experience has been gained in the use of the product.
Izvajanje primerjalne ocene je treba torej omejiti zgolj na obnovo dovoljenja za tiste biocidni pripravke, ki vsebujejo aktivne snovi, ki po členu 9 sodijo med kandidate za zamenjavo.
Use of comparative assessment should therefore be confined to the renewal of authorisations for those biocidal products which contain active principles that have been identified as candidates for substitution in accordance with Article 9.
Primerjalna ocena se opravi na vseh istonamenskih biocidnih pripravkih po vsaj petih letih izkušenj z uporabo.
The comparative assessment shall be carried out for all biocidal products having the same purpose, once they have been in use for at least five years.
Pet let je zadostno obdobje za zbiranje izkušenj pri uporabi proizvoda.
Five years is an appropriate period for this purpose.
Člen 21 – odstavek 1 – pododstavek 1 b (novo)
Article 21 – paragraph 1 – subparagraph 1 b (new)
Ne glede na odstavek 1 se primerjalna ocena ne zahteva za biocidne pripravke, katerih uporaba se je izkazala za varno.
By way of derogation from paragraph 1, a comparative assessment shall not be required for biocidal products whose use has been shown to be safe.
Za oceno, ali naj se proizvod umakne s trga po opravljeni primerjalni oceni, je treba pri oceni njegovih tveganj in koristi (glej odstavek 3) vedno upoštevati učinkovitost proizvoda in razpoložljivost proizvodov, obstoječih v zadostnem številu in vrstah za poseg pri okužbi ali napadu škodljivcev.
To assess whether a product may be removed from the market after being the subject of a comparative evaluation, consideration should always be given in the risk/benefit assessment (see paragraph 3) to the effectiveness of the product and the availability of existing products in sufficient numbers and variety to treat the contamination or infestation concerned.
Primerjava se mora osredotočiti na biocidne pripravke, za katere obstaja dokazano tveganje in so zanje nujne zamenjave.
The comparison should focus on biocidal products for which there is an identified risk and where alternatives are needed.
Rezultate primerjalne ocene je treba nemudoma poslati pristojnim organom drugih držav članic in agenciji ter v primeru ocene vloge za dovoljenje Skupnosti tudi Komisiji.
The results of the comparative assessment shall be forwarded, without delay, to the competent authorities of other Member States and the Agency and, in the case of evaluation of an application for a Community authorisation, also to the Commission.
Rezultate primerjalne ocene je treba nemudoma poslati pristojnim organom drugih držav članic in agenciji ter v primeru ocene vloge za obnovitev dovoljenja Skupnosti tudi Komisiji.
The results of the comparative assessment shall be forwarded, without delay, to the competent authorities of other Member States and the Agency and, in the case of evaluation of an application for renewal of a Community authorisation, also to the Commission.
Primerjalne ocene bi se morale uporabljati samo za vloge za obnovitev dovoljenja.
Comparative evaluations should apply only to applications for renewal of an authorisation.
Člen 21 – odstavek 3 – uvodni del
Article 21 – paragraph 3 – introductory part
Pristojni organ prejemnik ali Komisija v primeru odločitve glede vloge za dovoljenje Skupnosti prepove ali omeji dajanje v promet ali uporabo biocidnega pripravka, ki vsebuje aktivno snov kot možno snov za zamenjavo, če primerjalna ocena, s katero se presoja tveganja in prednosti v skladu s Prilogo VI, dokazuje, da so izpolnjena vsa naslednja merila:
The receiving competent authority or, in the case of a decision on an application for a Community authorisation, the Commission shall prohibit or restrict the placing on the market or use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment weighing up the risks and benefits in accordance with Annex VI demonstrates that all the following criteria are met:
Pristojni organ prejemnik ali Komisija v primeru odločitve glede vloge za obnovitev dovoljenja Skupnosti prepove ali omeji dajanje v promet ali uporabo biocidnega pripravka, ki vsebuje aktivno snov kot možno snov za zamenjavo, če primerjalna ocena, s katero se presoja tveganja in prednosti v skladu s Prilogo VI, dokazuje, da so izpolnjena vsa naslednja merila:
The receiving competent authority or, in the case of a decision on an application for renewal of a Community authorisation, the Commission shall prohibit or restrict the placing on the market or use of a biocidal product containing an active substance that is a candidate for substitution where the comparative assessment weighing up the risks and benefits in accordance with Annex VI demonstrates that all the following criteria are met:
Člen 21 – odstavek 3 – točka a
Article 21 – paragraph 3 – point a
(a) za načine uporabe, navedene v vlogi, že obstaja drugi dovoljeni biocidni pripravek ali ne-kemična kontrolna ali preventivna metoda, ki je bistveno varnejša za zdravje ljudi ali živali ali za okolje;
(a) for the uses specified in the application, another authorised biocidal product or a non-chemical control or prevention method already exists which presents significantly lower risk for human or animal health or the environment;
(a) za načine uporabe, navedene v vlogi, že obstaja drugi dovoljeni biocidni pripravek ali ne-kemična kontrolna ali preventivna metoda, ki je bistveno varnejša za zdravje ljudi ali živali ali za okolje oziroma predstavlja manjše tveganje in ki je dokazano enako učinkovita ter nobeden drugi parameter pri njej ne kaže občutnega povišanja tveganja ;
(a) for the uses specified in the application, another authorised biocidal product or a non-chemical control or prevention method already exists which presents significantly lower or reduced risk for human or animal health or the environment and which proves equally effective and involves no significant increase in the risks for any other parameter ;
Ker se mora primerjalna ocena osredotočiti na tiste biocidne pripravke, za katere obstaja dokazano tveganje in jih je treba zamenjati, je nujno, da je zamenjava enako učinkovita in nič bolj tvegana.
As the comparative evaluation should focus on those biocidal products for which there is an identified risk and for which alternatives are needed, any substitute product must be equally efficient and involve a similar level of risk.
Člen 21 – odstavek 7 a (novo)
Article 21 – paragraph 7 a (new)
Komisija sprejme delegirane akte v skladu s členom [...], pri čemer navede postopek, ki se uporabi za primerjalno ocenjevanje biocidnih pripravkov za namene odločitve iz odstavka 3, ter merila in algoritme, ki jih je treba uporabiti pri takem ocenjevanju.
The Commission shall adopt delegated acts, in accordance with Article [...], specifying the procedure to be followed in the comparative assessement of biocidal products for the purposes of the decision referred to in paragraph 3 and the criteria and algorithms to be used when undertaking such assessment.
Oseba, ki je odgovorna za dajanje biocidnih pripravkov v promet, ali njen zastopnik vloži pri agenciji vlogo za nacionalno dovoljenje ali dovoljenje Skupnosti in obvesti agencijo o imenu pristojnega organa države članice, ki ga sam izbere in ki je odgovoren za oceno vloge (v nadaljnjem besedilu: ocenjevalni pristojni organ).
The person responsible for the placing of a biocidal product on the market, or his representative, shall submit an application for a national or Community authorisation to the Agency and inform the Agency of the name of the competent authority of the Member State of his choice which shall be responsible for the evaluation of the application (hereinafter 'the evaluating competent authority').
Agencija v enem mesecu po prejemu vloge obvesti ocenjevalni pristojni organ, da je vloga na voljo v zbirki podatkov agencije.
The Agency shall, one month after the receipt of the application, notify the evaluating competent authority that the application is available in the Agency database.
V treh tednih po prejemu vloge agencija validira vlogo, če:
Within three weeks of the receipt of an application, the Agency shall validate the application if:
(a) so bile predložene informacije iz člena 18 ter
(a) the information referred to in Article 18 has been submitted; and
(b) so bile plačane pristojbine iz člena 70.
(b) it is accompanied by the fees payable under Article 70.
Če pristojni organ prejemnik na podlagi validacije, opravljene v skladu z odstavkom 1, meni, da je vloga popolna, o tem nemudoma obvesti predlagatelja.
If the receiving competent authority, on basis of the validation made pursuant to paragraph 1, considers that the application is complete, it shall without delay inform the applicant thereof.
Če agencija meni, da je vloga nepopolna, predlagatelja obvesti, katere dodatne informacije so potrebne za validacijo vloge, ter določi razumen rok za predložitev navedenih informacij.
If the Agency considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for forwarding that information.
Agencija v treh tednih po prejemu dodatnih informacij ugotovi, ali so predložene dodatne informacije zadostne za validacijo vloge.
The Agency shall, within three weeks of receipt of the additional information, determine whether the additional information submitted is sufficient to validate the application.
Na podlagi člena 67 se lahko proti odločitvam agencije na podlagi tretjega pododstavka odstavka 2 vloži pritožba.
An appeal may be brought, in accordance with Article 67, against Agency decisions under the third subparagraph of paragraph 2.
Če agencija na podlagi validacije, opravljene v skladu z odstavkom 2, meni, da je vloga popolna, o tem nemudoma obvesti predlagatelja in ocenjevalni pristojni organ.
If the Agency, on the basis of the validation made pursuant to paragraph 2, considers that the application is complete, it shall without delay inform the applicant and the evaluating competent authority thereof.
Aktivne snovi, ki se uporabljajo v biocidnih pripravkih, so že v celoti ocenjene pri njihovi vključitvi v Prilogo I uredbe.
The active substances used in the biocidal products have already been fully evaluated by their inclusion in Annex I of the regulation.
Tako dolgo obdobje ocenjevanja za pridobitev dovoljenja za biocidni pripravek, ki temelji na odobrenih aktivnih snoveh, ni potrebno.
There is no need to provide for such a long evaluation period to authorise a biocidal product based on authorised active substances.
Člen 24 – odstavek 1– pododstavek 1
Article 24 – paragraph 1 – subparagraph 1
Imetnik dovoljenja ali njegov zastopnik vloži vlogo za obnovitev nacionalnega dovoljenja pri pristojnem organu prejemniku najmanj 18 mesecev pred potekom dovoljenja.
The authorisation holder or his representative shall submit an application for renewal of a national authorisation to the receiving competent authority at least 18 months before the expiry date of the authorisation.
Razen če ni novih podatkov, ki jih je treba oceniti, obdobje 18 mesecev ni potrebno za oceno proizvoda.
An 18-month period is not necessary to renew a product's authorisation, unless there are new data to be evaluated.
12 mesecev je primernejše obdobje.
12 months is more appropriate.
Člen 25 – odstavek 6 a (novo)
Article 25 – paragraph 6 a (new)
Komisija sprejme delegirane akte v skladu s členom [...], pri čemer navede merila in postopke za dodeljevanje enotne številke dovoljenja iz odstavka 5 tega člena.
The Commission shall adopt delegated acts, in accordance with Article [...], specifying the criteria and procedures for assigning the single authorisation number referred to in paragraph 5 of this Article.
Člen 27 – odstavek 1– pododstavek 2
Article 27 – paragraph 1 – subparagraph 2
Člen 27 – odstavek 1 – pododstavek 2 a (novo)
Article 27 – paragraph 1 – subparagraph 2 a (new)
Ta odločitev se sprejme v treh mesecih od uradnega obvestila pristojnega organa iz prvega pododstavka.
This decision shall be taken within three months of the notification by the competent authority referred to in subparagraph 1.
Če Komisija v skladu s členom 30 prosi agencijo za mnenje, se obdobje treh mesecev prekine, dokler agencija ne sporoči svojega mnenja.
If the Commission requests an opinion from the Agency pursuant to Article 30, the three-month period shall be suspended until the Agency submits its opinion.
Zakonodajno besedilo mora jasno opredeliti potrebno časovno omejitev za učinkovit postopek reševanja sporov med državami članicami.
The legislative text should clearly specify the timeframe required for a procedure that can effectively resolve disputes between Member States.
Trije meseci so primerni, da Komisija predstavi predlog odločitve o tem, da bi se upravičilo nepriznanje ali priznanje z omejitvami pri dovoljenjih.
Three months is an adequate period of time for the Commission to make a proposal for a decision setting out the grounds for refusing to recognise authorisations or recognising them with restrictions.
Člen 28 – odstavek 8
Article 28 – paragraph 8
Referenčni pristojni organ in pristojni organi drugih zadevnih držav članic v enem mesecu po izteku obdobja iz odstavka 7 izdajo dovoljenje za biocidni pripravek na podlagi odobrenega poročila o oceni in povzetka značilnosti biocidnega pripravka.
The reference competent authority and the competent authorities of the other concerned Member States shall authorise the biocidal product on the basis of the approved assessment report and the summary of the biocidal product characteristics within one month after the end of the period referred to in paragraph 7.
Člen 28 – odstavek 9– pododstavek 2
Article 28 – paragraph 9 – subparagraph 2
Člen 28 – odstavek 9 – pododstavek 2 a (novo)
Article 28 – paragraph 9 – subparagraph 2 a (new)
Ta odločitev se sprejme v treh mesecih od sporočila pristojnega organa iz prvega pododstavka.
This decision shall be taken within three months of the notification by the competent authority referred to in subparagraph 1.
Člen 28 – odstavek 11 a (novo)
Article 28 – paragraph 11 a (new)
Komisija sprejme delegirane akte v skladu s členom [...], pri čemer navede merila in postopke za dodeljevanje enotne številke dovoljenja iz odstavka 8.
The Commission shall adopt delegated acts, in accordance with Article [...], specifying the criteria and procedures for assigning the single authorisation number referred to in paragraph 8.
Člen 29 – odstavek 2– pododstavek 2
Article 29 – paragraph 2 – subparagraph 2
Komisija po predhodnem posvetovanju s predlagateljem sprejme odločitev o predlagani prilagoditvi pogojev za nacionalno dovoljenje lokalnim okoliščinam v skladu s postopkom iz člena 72(3).
The Commission shall , following consultation of the applicant, adopt a decision on the proposed adjustment of the conditions of the national authorisation to local circumstances in accordance with the procedure referred to in Article 72(3).
Člen 29 – odstavek 2 – pododstavek 2 a (novo)
Article 29 – paragraph 2 – subparagraph 2 a (new)
Komisija v treh tednih od uradnega obvestila pripravi predlog odločitve.
Within three months of the notification, the Commission shall submit a proposal for a decision.
Zakonodajno besedilo mora jasno opredeliti potrebno časovno omejitev za reševanje sporov med državami članicami.
The legislative text should clearly specify the timeframe required to resolve disputes between Member States.
Člen 33 – odstavek 1 – točka b a (novo)
Article 33 – paragraph 1 – point b a (new)
(ba) biocidne pripravke, ki so namenjeni uporabi potrošnikov v domačem okolju ali poklicni uporabi, v skladu s pogoji in navodili za uporabo, ki so podobni v celotni Evropski uniji in ki izpolnjujejo merila iz člena 33a.
(ba) biocidal products designed to be used by consumers in domestic settings, or by professional users, according to conditions and instructions of use which are similar within the European Union, and which meet the criteria listed in Article 33a.
Eden ključnih ciljev sistema izdaje dovoljenj Unije je zagotavljanje skladnosti ocenjevanja varnosti pripravkov, enakih standardov varstva potrošnikov in usklajenega izvajanja zahtev v vseh državah članicah.
One of the key objectives of the Union authorisation system is to ensure consistent product safety assessments, equal standards of consumer protection and harmonised implementation of the requirements within all Member States.
Za biocidne pripravke, ki se v celotni EU uporabljajo na enak način, bi moral veljati sistem izdaje dovoljenj Unije.
Biocidal products, which are used in a similar way across the EU, should benefit from the Union authorisation scheme.
Ti pripravki se uporabljajo v domačem in poklicnem okolju kot stroškovno učinkovito sredstvo za varovanje javnega zdravja in posledično zmanjševanje bremena nalezljivih bolezni.
These products are used in domestic or in professional settings as a pragmatic and cost effective means to protect public health, thereby reducing the burden of infectious diseases.
Ti pripravki imajo preprosta in jasna navodila za uporabo.
These products have simple and clear use instructions.
(i) glede na navodila za uporabo se po vsej Evropski uniji uporablja pri podobnih pogojih;
(i) it has similar conditions of use across the European Union, according to use instructions;
Da bi Komisija opredelila ali prilagodila število držav članic iz točke (ii), sprejme delegirane akte v skladu s členom […].
In order to define or adapt the number of Member States referred to in point (ii), the Commission shall adopt delegated acts in accordance with Article [....].
V devetih mesecih od prejema zaključkov ocene agencija pripravi in predloži Komisiji mnenje o dovoljenju za biocidni pripravek.
Within nine months from the receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the authorisation of the biocidal product.
V treh mesecih od prejema zaključkov ocene agencija pripravi in predloži Komisiji mnenje o dovoljenju za biocidni pripravek.
Within three months from the receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the authorisation of the biocidal product.
Člen 36 – odstavek 1– pododstavek 1
Article 36 – paragraph 1 – subparagraph 1
Imetnik dovoljenja ali njegov zastopnik vloži vlogo za obnovitev dovoljenja Skupnosti agenciji najmanj 12 mesecev pred iztekom dovoljenja.
The authorisation holder or his representative shall submit an application for renewal of a Community authorisation to the Agency at least 12 months before the expiry date of the authorisation.
Člen 38 – odstavek 1 – točka c a (novo)
Article 38 – paragraph 1 – point c a (new)
Poročanje o spremembi porekla aktivne snovi je nujno, saj lahko vpliva na varnost proizvoda.
Notification of changes in the source of an active substance used in a biocidal product is required because it could have an impact on the product's safety.
Člen 41 – odstavek 2 – pododstavek 1 a (novo)
Article 41 – paragraph 2 – subparagraph 1 a (new)