natgillin/translations-raw huggingface dataset:
(f) 0,1 % mase na maso (m/m), če snov izpolnjuje merila iz Priloge XIII Uredbe (ES) št. 1907/2006.
(f) 0.1 % weight by weight (w/w), if the substance meets the criteria in Annex XIII to Regulation (EC) No 1907/2006.
Namen predloga spremembe je preprečiti nepotrebne preskuse na živalih in je glede mejnih vrednosti poročila o kemijski varnosti usklajen z zahtevami uredbe REACH.
The aim is to prevent unnecessary animal testing while also complying with the REACH requirement regarding Chemical Safety Report thresholds.
V primeru okvirne formulacije je dopustno zmanjšanje odstotka aktivne snovi v referenčnem biocidnem pripravku in/ali sprememba strukturnega odstotka ene ali več neaktivnih snovi in/ali nadomestitev ene ali več neaktivnih snovi z drugimi, ki pomenijo enako ali manjše tveganje .
In the case of a frame formulation, a reduction in the percentage of the active substance in the reference biocidal product may be allowed, and/or an alteration in percentage composition of one or more non-active substances , and/or the replacement of one or more non-active substances by others presenting the same or lower risk .
V primeru okvirne formulacije so v primerjavi z enim ali več referenčnimi biocidnimi pripravki mogoča naslednja odstopanja v sestavi :
In the case of a frame formulation, the following variations are permitted in respect of one or more reference biocidal products:
(a) opustitev aktivne snovi pri referenčnem biocidnem pripravku z vsaj dvema aktivnima snovema;
(a) elimination of an active substance in respect of a reference biocidal product with at least two active substances;
(b) zmanjšanje odstotka aktivnih snovi;
(b) reduction in the percentage of the active substances;
(d) odstopanja od strukturnega odstotka ene ali več neaktivnih snovi;
(d) variation in the percentage composition of one or more non-active substances ;
(e) nadomestitev ene ali več neaktivnih snovi;
(e) replacement of one or more non-active substances.
Komisija v skladu s postopkom iz člena 72(2) zagotovi tehnične in znanstvene smernice za izdajo dovoljenj za pripravke, ob tem pa zlasti upošteva usklajene zahteve za podatke, ocenjevalne postopke in odločitve držav članic.
In accordance with the procedure laid down in Article 72(2), the Commission shall provide scientific and technical guidance for the authorisation of products, particularly as regards uniform requirements for data, evaluation procedures and decisions by the Member States.
S tem je zagotovljeno enotno izvajanje uredbe na ozemlju Skupnosti.
The aim is to ensure uniform implementation of the Regulation within Community territory.
Biocidni pripravek šteje za biocidni pripravek z manjšim tveganjem, če sta izpolnjeni obe spodnji merili :
A biocidal product shall be considered a low-risk biocidal product if both the following conditions are fulfilled:
Biocidni pripravek šteje za biocidni pripravek z manjšim tveganjem, če je izpolnjeno vsaj eno od spodnjih meril :
A biocidal product shall be considered a low-risk biocidal product if at least one of the following conditions is fulfilled:
(a) za kateri koli dani ekosistem je mogoče izračunati razmerje med napovedano koncentracijo v okolju (PEC) in predvideno koncentracijo brez učinka (PNEC), navedeno razmerje pa ne presega 0,1;
(a) for any given environmental compartment, the ratio of the predicted environmental concentration (PEC) to predicted no-effect concentration (PNEC) may be derived and does not exceed 0.1;
(a) biocidni pripravek v Uredbi (ES) št. 1272/2008 ni opredeljen glede na vpliv na zdravje ljudi ali nevarnost za okolje;
(a) the biocidal product is not classified for human health or environmental hazards under Regulation (EC) No 1272/2008;
(b) za vsak učinek na zdravje človeka je stopnja izpostavljenosti (razmerje med koncentracijo, pri kateri ni opaznih neželenih učinkov (NOAEL) in koncentracijo izpostavljenosti) večja kot 1,000.
(b) for any effect to human health, the margin of exposure (the ratio of no observed adverse effect level (NOAEL) and exposure concentration) is higher than 1,000.
(b) razvrstitev biocidnega pripravka ni povezana z opozorilno besedo „nevarno“ na oznaki, ki je zahtevana v skladu z Uredbo (ES) št. 1272/2008, zahteve iz člena 16(1)(b), (c) in (d) pa so izpolnjene pod normalnimi in smiselno predvidljivimi pogoji uporabe pripravka brez uporabe osebne zaščitne opreme;
(b) the classification of the biocidal product is not associated with the signal word ‘danger’ on the label required under Regulation (EC) No 1272/2008 and under normal and reasonably foreseeable conditions of use of the product without the use of personal protective equipment, the requirements in Article 16(1)(b), (c) and (d) are met;
c) aktivna snov oziroma snovi so v biocidnem pripravku prisotne v taki obliki, da je pod normalnimi ali stvarno predvidljivimi pogoji uporabe izpostavljenost zanemarljiva, na vseh drugih stopnjah njegovega življenjskega ciklusa pa se s pripravkom ravna v strogo nadzorovanih pogojih.
c) the active substance(s) in the biocidal product are contained in such a way that under normal or reasonably foreseeable conditions of use the exposure is negligible and the product is handled under strictly controlled conditions during all other stages of its lifecycle.
Vendar pa biocidni pripravek ne šteje kot biocidni pripravek z manjšim tveganjem, če je izpolnjen kateri koli izmed naslednjih pogojev :
However, a biocidal product shall not be considered a low-risk biocidal product if at least one of the following conditions is present :
Vendar pa biocidni pripravek ne šteje kot biocidni pripravek z manjšim tveganjem, če vsebuje aktivno snov ali pogojno nevarno snov, ki :
However, a biocidal product shall not be considered a low-risk biocidal product if it contains an active substance or a substance of concern that :
(a) izpolnjuje merila, da šteje za snov, ki je obstojna, se kopiči v organizmih in je strupena (PBT) ali je zelo obstojna in se zelo kopiči v organizmih, kot je določeno v Prilogi XIII k Uredbi (ES) št. 1907/2006;
(a) fulfil s the criteria for being persistent, bio-accumulative and toxic (PBT) or very persistent and very bio-accumulative (vPvB) in accordance with Annex XIII of Regulation (EC) No 1907/2006;
(b) vsebuje eno ali več aktivnih snovi, opredeljenih kot snovi, ki so po svojih lastnostih endokrini motilci ;
(b) it contains one or more active substances qualified as endocrine disrupters;
(b) je v členu 57(f) Uredbe (ES) št. 1907/2006 opredeljena kot endokrini motilec ;
(b) is identified as endocrine disrupters under Article 57(f) of Regulation (EC) No 1907/2006 ;
(c) vsebuje eno ali več aktivnih snovi, ki so bile v skladu z Uredbo (ES) št. 1272/2008 razvrščene kot, oziroma izpolnjujejo merila za katero izmed naslednjih razvrstitev :
(c) it contains one or more active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as or which meets the criteria to be classified as one of the following:
(c) je bila v skladu z Uredbo (ES) št. 1272/2008 razvrščena kot katera izmed naslednjih razvrstitev oziroma izpolnjuje merila zanje :
(c) ha s been classified in accordance with Regulation (EC) No 1272/2008 as , or which meets the criteria to be classified as , one of the following:
(v) strupena za razmnoževanje;
(v) toxic to reproduction;
Za biocidni pripravek z manjšim tveganjem se dokaže, da je možnost razvoja odpornosti pri ciljnih organizmih zaradi njegove uporabe majhna.
For a low-risk biocidal product it shall be demonstrated that the potential for the development of resistance in target organisms due to the use of the biocidal product is low.
Poleg aktivnih snovi iz člena 15(2) Uredbe (ES) št. 1272/2008 aktivne snovi, proizvedene ali uvožene za uporabo v biocidnih pripravkih z manjšim tveganjem, katerim je bilo izdano dovoljenje skladno s členom 15, štejejo, da so bile registrirane in da je njihova registracija zaključena za proizvodnjo ali uvoz za uporabo v biocidnih pripravkih z manjšim tveganjem ter tako izpolnjujejo zahteve iz poglavij 1 in 5 naslova II navedene uredbe.
In addition to the active substances referred to in Article 15(2) of Regulation (EC) No 1907/2006, active substances manufactured or imported for use in low-risk biocidal products that are authorised for placing on the market in accordance with Article 15 shall be regarded as being registered and the registration as completed for manufacture or import for use in a low-risk biocidal product and therefore as fulfilling the requirements of Chapters 1 and 5 of Title II of that Regulation.
Opredelitev biocidnih pripravkov z manjšim tveganjem, ki jo predlaga Komisija, je preozka in omejuje možnosti za uporabo centraliziranega postopka.
The proposed by the Commission definition of low-risk biocidal products seems too restrictive and hence limits the occasions where the centralised procedure could apply.
Zato se predlaga razširitev opredelitve, da bi dovoljenje Skupnosti veljalo za večje število proizvodov in Evropski agenciji za kemikalije na začetku ne bi bilo treba obravnavati cele palete biocidnih pripravkov.
The definition is thus extended in order to allow for more products benefitting from Community authorisation while assuring that ECHA will not at first be overwhelmed with the entire range of biocidal products.
To bi lahko omogočili kasneje s predhodnim pregledom postopka (leta 2016) zaradi razširitve njegove uporabe za vse proizvode.
This could be allowed for at a later stage through an earlier (in 2016) review of the procedure in view of possibly extending it to all products.
Predlagatelj za dovoljenje predloži skupaj z vlogo naslednje dokumente:
The applicant for an authorisation shall submit the following documents together with the application:
Predlagatelj skupaj z vlogo za prvo dovoljenje predloži naslednje dokumente:
The applicant for a primary authorisation shall submit the following documents together with the application:
Ob vložitvi vloge za dovoljenje se plačajo tudi pristojbine iz člena 70.
The application for authorisation shall be accompanied by the fees payable under Article 70.
Ob vložitvi vloge za prvo dovoljenje se plačajo tudi pristojbine iz člena 70.
The application for primary authorisation shall be accompanied by the fees payable under Article 70.
Pristojni organ prejemnik lahko zahteva, da se vloge za nacionalno dovoljenje predložijo v enem od uradnih jezikov države članice, kjer ima navedeni pristojni organ svoj sedež.
The receiving competent authority may require that applications for a national authorisation be submitted in one of the official languages of the Member State where that competent authority is situated.
Komisija v skladu s postopkom iz člena 72(2) zagotovi tehnične in pravne smernice in orodja, ki so v pomoč zlasti malim in srednje velikim podjetjem in predvsem pri vlaganju vlog za dovoljenje v skladu s členi 18, 19 in 20.
In accordance with the procedure laid down in Article 72(2), the Commission shall provide a standard technical and legal guide and, in particular, assistance with authorisation applications in accordance with Articles 18, 19 and 20, particularly for SME s .
S tem se priznava dejstvo, da sta svetovanje in navodila, ki ju zagotavlja Komisija, zelo pomembna za mala in srednje velika podjetja, saj morda nimajo potrebnih sredstev ali izkušenj, da bi izpolnila obveznosti iz te uredbe.
This amendment recognises that assistance and guidelines from the Commission can be particularly important for SME, which may not have the appropriate resources and experience to adapt to the Regulation.
Člen 20 – odstavek 2 – točka e
Article 20 – paragraph 2 - point e
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;
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(5)(a) ;
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) ;
Zaradi uskladitve s postopkom ocenjevanja, opisanim v členu 8(5)(a).
In the interests of consistency with the evaluation procedure set out in Article 8(5a).
b) dovoljene razlike v skladu s členom 16(6).
b) the variations permitted in accordance with Article 16(6).
Člen 20 – odstavek 3 – točka (c)
Article 20 – paragraph 3 – point c
c) neaktivne snovi, ki se lahko nadomestijo v dovoljenih biocidnih pripravkih iz navedene okvirne formulacije.
c) the non-active substances that may be substituted in the authorised biocidal products belonging to that frame formulation.
Pristojni organ prejemnik ali v primeru ocene vloge za dovoljenje Skupnosti , ocenjevalni pristojni organ , opravi primerjalno oceno kot del ocene vloge za dovoljenje ali obnove 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 a Community authorisation, the evaluating competent authority shall perform a comparative assessment as part of the evaluation of an application for an authorisation or 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).
Pristojni organ prejemnik ali v primeru ocene vloge za dovoljenje Skupnosti ocenjevalni pristojni organ v skladu s to uredbo opravi primerjalno oceno 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 a Community authorisation, the evaluating competent authority shall perform a comparative assessment for the renewal , in accordance with this regulation, of an authorisation of a biocidal product containing an active substance that is a candidate for substitution in accordance with Article 9(1).
Primerjalna ocena se zahteva za vse biocidne pripravke, ki se uporabljajo za enak namen, kadar se zbere dovolj izkušenj in so bili v uporabi najmanj pet let.
A comparative assessment shall be required for all biocidal products having the same purpose when sufficient experience has been gained in their use and they have been in use for at least five years.
Z odstopanjem od odstavka 1 primerjalna ocena ni potrebna 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.
Rezultate primerjalne ocene je treba nemudoma poslati pristojnim organom drugih držav članic in agenciji ter v primeru obnovitve 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 a renewal of a Community authorisation, also to the Commission.
Pristojni organ prejemnik ali Komisija v primeru odločitve glede obnovitve 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 a 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:
(b) biocidni pripravek ali ne-kemična kontrolna ali preventivna metoda iz točke (a) ne pomeni bistvenih gospodarskih ali praktičnih izgub;
(b) the biocidal product or non-chemical control or prevention method referred to in point (a) does not present significant economic or practical disadvantages;
(b) biocidni pripravki iz točke (a) ne pomenijo bistvenih gospodarskih ali praktičnih izgub;
(b) the biocidal products referred to in point (a) do not present significant economic or practical disadvantages;
(c) kemijska raznolikost aktivnih snovi je ustrezna za čim večje zmanjšanje nastanka odpornosti v ciljnem škodljivem organizmu.
(c) the chemical diversity of the active substances is adequate to minimise the occurrence of resistance in the target harmful organism.
Ne glede na odstavek 1 se za biocidni pripravek, ki vsebuje aktivno snov kot možno snov za zamenjavo, izda dovoljenje brez primerjalne ocene, kadar je treba najprej pridobiti izkušnje z uporabo tega sredstva v praksi.
By way of derogation from paragraph 1, a biocidal product containing an active substance that is a candidate for substitution shall be authorised without comparative assessment in cases where it is necessary to acquire experience first through using that product in practice.
Komisija v skladu z določbami iz odstavka 3 sprejme izvedbene ukrepe, ki podrobno določajo zahtevani postopek za opredelitev vloge za primerjalno oceno za biocidne pripravke.
The Commission shall adopt implementing measures which specify the procedure required to define the application for comparative assessment for biocidal products in accordance with the provisions of paragraph 3.
Ti ukrepi določajo merila in algoritme, ki jih je treba uporabljati pri izvajanju primerjalnih ocen, da se zagotovi enotna uporaba v vsej Skupnosti.
These measures shall define the criteria and algorithms to be used for the comparative assessments so as to ensure uniform application throughout the Community.
Ukrepi se sprejmejo skladno s postopki iz člena 72(3).
These measures shall be adopted in accordance with the procedures laid down in Article 72(3).
Komisija bo morala pripraviti izvedbene ukrepe, da se zagotovi enotna uporaba primerjalne ocene biocidnih pripravkov po vsej Skupnosti.
In the interests of uniform application of the comparative assessment of biocidal products, the Commission should draw up implementing measures.
Article 21 a (new) – to be inserted at the end of Chapter IV
Article 21 a (new) – to be inserted at the end of Chapter IV
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 authorisation or an application for a 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 referred to as 'the evaluating competent authority').
a) da so bile predložene informacije iz člena 18;
a) the information referred to in Article 18 has been submitted;
Validacija ne vključuje ocene kakovosti ali primernosti predloženih podatkov ali obrazložitev zahtev za prilagoditev zahtevanih podatkov.
The validation shall not include an assessment of the quality or the adequacy of any data or justifications for the adaptation of data requirements submitted.
Če agencija meni, da je vloga nepopolna, predlagatelja obvesti, katere dodatne informacije so potrebne za validacijo vloge ter določi razumen rok za predložitev teh 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 the submission of that information.
Agencija v treh tednih po prejetju dodatnih informacij odloči, ali so zadostne za validacijo vloge.
The Agency shall, within three weeks from the receipt of the additional information, determine whether the additional information submitted is sufficient to validate the application.
Če predlagatelj zahtevanih informacij ne predloži v roku, agencija vlogo zavrne ter o tem obvesti predlagatelja in ocenjevalni pristojni organ.
The Agency shall reject the application if the applicant fails to submit the information required within the deadline and inform the applicant and the evaluating competent authority thereof.
V takšnih primerih se del pristojbine, plačane agenciji v skladu s členom 70, povrne.
In such cases a part of the fee paid to the Agency in accordance with Article 70 shall be reimbursed.
Na podlagi člena 67 se lahko proti odločitvam agencije na podlagi tretjega pododstavka odstavka 3 vloži pritožba.
An appeal may be brought, in accordance with Article 67, against Agency decisions under the third subparagraph of paragraph 3.
Prvo validacijo vseh vlog v vsej Skupnosti mora izvesti ECHA, da se ocenjevalni pristojni organi lahko osredotočijo na dejansko ocenjevanje vlog.
The ECHA should perform the initial validation of all applications throughout the Community, so that the evaluating competent authorities can concentrate on the actual assessment of applications.
Sedaj prihaja do neskladij tam, kjer ocenjevalni pristojni organi v dokumentaciji ocenjujejo tako upravne kot znanstvene elemente.
Currently, where evaluating competent authorities consider both the administrative and scientific aspects of applications, there have been inconsistencies in their approach.
Agencija mora pri validaciji vloge spoštovati enake roke, kot so bili določeni v okviru uredbe REACH (člen 20).
The Agency must abide by the same deadlines as those laid down under REACH (Article 20) for validating the application.
Člen 23 – odstavek 2 a (novo)
Article 23 – paragraph 2 a (new)
Če se pokaže, da so sestavine, ki jih vsebuje biocidni pripravek, že registrirane za uporabo v biocidni pripravkih v skladu z Uredbo št. 1907/2006, ocenjevalni pristojni organ ne izvede dodatne ocene.
If the ingredients contained in the biocidal product have already been registered for use in biocidal products in accordance with Regulation (EC) No 1907/2006, the evaluating competent authority shall not carry out a further assessment.
V preprečitev nepotrebnega podvajanja prizadevanj.
To avoid unnecessary duplication of effort.
Če se zdi, da so potrebne dodatne informacije za izvedbo popolne ocene vloge, pristojni organ prejemnik od predlagatelja zahteva, da predloži take informacije .
If it appears that additional information is necessary in order to carry out a full evaluation of the application, the receiving competent authority shall request the applicant to submit such information.
Dvanajstmesečno obdobje iz odstavka 1 se prekine od dneva izdaje vloge , pa do dneva prejema informacij.
The twelve-month period referred to in paragraph 1 shall be suspended from the date of issue of the request until the date the information is received.
Če se zdi, da so potrebne dodatne informacije za izvedbo popolne ocene vloge, pristojni organ prejemnik od predlagatelja zahteva, da jih predloži v roku, ki ne presega šestih mesecev .
If it appears that additional information is necessary in order to carry out a full evaluation of the application, the receiving competent authority shall request the applicant to submit such information within a specified time limit that shall not exceed six months.