natgillin/translations-raw huggingface dataset:
In order to ensure better access to information, assessment reports should be drafted on the basis of the reports submitted by the competent authorities of the Member States and should be covered by the same rules regarding access to information as the reports of the competent authorities.
Za lažji dostop do podatkov bi bilo treba na podlagi poročil, ki jih predložijo pristojni organi držav članic, pripraviti poročila o oceni, za katera bi morala veljati ista pravila glede dostopa do podatkov kakor za poročila pristojnih organov.
The assessment reports should be derived from the original competent authority report as amended in the light of all the documents, comments and information taken into account during the evaluation process.
Poročila o oceni bi morala izhajati iz prvotnega poročila pristojnega organa, kakor je bilo spremenjeno glede na vse dokumente, opombe in podatke, ki so bili upoštevani med procesom ocenjevanja.
It should be possible to suspend the procedures provided for in this Regulation in the light of the application of other Community acts, in particular as regards Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations [4], and after 1 June 2009, as regards Title VIII and Annex XVII of Regulation (EC) No 1907/2006.
Zaradi uporabe drugih aktov Skupnosti bi morala obstajati možnost za začasno ukinitev postopkov, predvidenih s to uredbo, zlasti v zvezi z Direktivo Sveta 76/769/EGS z dne 27. julija 1976 o približevanju zakonov in drugih predpisov držav članic v zvezi z omejitvami pri dajanju v promet in uporabi nekaterih nevarnih snovi in pripravkov [4], ter po 1. juniju 2009 v zvezi z naslovom VIII in Prilogo XVII k Uredbi (ES) št. 1907/2006.
In order to ensure the most efficient course of the review programme, a number of active substance/product type combinations have been reassigned to different rapporteur Member States.
Nekaj kombinacij aktivnih snovi/vrst pripravkov so dodelili drugim državam članicam poročevalkam, da bi program pregledovanja potekal čim bolj učinkovito.
These developments should be reflected in Annex II of this Regulation.
Priloga II k tej uredbi bi morala upoštevati te spremembe.
Regulation (EC) No 2032/2003 has been amended on several occasions [5] in order to take into consideration the accession of new Member States, lessons learned from the implementation to date of the review programme, and in particular in order to provide for the non-inclusion in Annex I, IA or IB to Directive 98/8/EC of a number of active substances, either because the requisite information was not submitted within the prescribed period or in cases where the requirements of Article 10 of the said Directive were not satisfied.
Uredba (ES) št. 2032/2003 je bila večkrat spremenjena [5], da bi upoštevala pristop novih držav članic in izkušnje iz dosedanjega izvajanja programa pregledovanja, zlasti da bi upoštevala nevključitev več aktivnih snovi v Prilogo I, IA ali IB k Direktivi 98/8/ES, bodisi ker zahtevani podatki niso bili predloženi v predpisanem roku ali ker zahteve člena 10 navedene direktive niso bile izpolnjene.
This practice of constantly updating Regulation (EC) No 2032/2003 in order to follow the evolution of the review programme has proven ineffectual and time-consuming; furthermore it could create confusion to stakeholders as to which rules apply and which active substances are currently under review.
Ta praksa nenehnega posodabljanja Uredbe (ES) št. 2032/2003, da bi sledili razvoju programa pregledovanja, se je pokazala za neučinkovito in zamudno; poleg tega bi lahko povzročila zmedo pri interesnih skupinah glede pravil, ki se uporabljajo, in glede aktivnih snovi, ki se trenutno pregledujejo.
In the interest of clarity, it is preferable to repeal and replace Regulation (EC) No 2032/2003 by a new simplified act which will lay down the rules for the review programme, and that the Commission should adopt separate acts for the future non-inclusion decisions.
Zaradi jasnosti je zato primernejše razveljaviti in nadomestiti Uredbo (ES) št. 2032/2003 z novim poenostavljenim aktom, ki bo določil pravila za program pregledovanja, ter da Komisija sprejme ločene akte za prihodnje odločbe o nevključitvi.
This Regulation lays down detailed rules for the implementation of the programme of work for the systematic examination of all active substances already on the market on 14 May 2000 as active substances of biocidal products, hereinafter ‘the review programme’, referred to in Article 16(2) of Directive 98/8/EC.
Ta uredba določa podrobna pravila za izvajanje delovnega programa za sistematično ocenjevanje vseh aktivnih snovi, ki so bile 14. maja 2000 že v prometu kot aktivne snovi v biocidnih pripravkih iz člena 16(2) Direktive 98/8/ES, v nadaljnjem besedilu „program pregledovanja“.
For the purposes of this Regulation the definitions in Article 2 of Directive 98/8/EC and Article 2 of Regulation (EC) No 1896/2000 shall apply.
Za namene te uredbe se uporabljajo opredelitve iz člena 2 Direktive 98/8/ES in člena 2 Uredbe (ES) št. 1896/2000.
In addition, ‘participant’ means a producer, formulator or association which has submitted a notification that has been accepted by the Commission in accordance with Article 4(2) of Regulation (EC) No 1896/2000 or a Member State which has indicated an interest in accordance with Article 5(3) of that Regulation.
„Udeleženec“ je proizvajalec, formulator ali združenje, ki je predložilo prijavo, ki jo je sprejela Komisija v skladu s členom 4(2) Uredbe (ES) št. 1896/2000, ali državo članico, ki je izrazila zanimanje v skladu s členom 5(3) navedene uredbe.
Existing active substances
Obstoječe aktivne snovi
The list of active substances identified as available on the market before 14 May 2000 as active substances of biocidal products for purposes other than those referred to in Article 2(2)(c) and (d) of Directive 98/8/EC is set out in Annex I.
Seznam aktivnih snovi, ki so bile identificirane kot dosegljive na trgu pred 14. majem 2000 kot aktivne snovi biocidnih pripravkov za druge namene, kot so navedeni v členu 2(2)(c) in (d) Direktive 98/8/ES, je naveden v Prilogi I.
The exhaustive list of existing active substances to be examined under the review programme is set out in Annex II.
Izčrpen seznam obstoječih aktivnih snovi, ki jih je treba oceniti v programu pregledovanja, je naveden v Prilogi II.
The list includes the following active substances:
Seznam vključuje naslednje aktivne snovi:
existing active substances notified in accordance with Article 4(1) of Regulation (EC) No 1896/2000 or Article 4(2) of Commission Regulation (EC) No 1687/2002 [6];
obstoječe aktivne snovi, prijavljene v skladu s členom 4(1) Uredbe (ES) št. 1896/2000 ali členom 4(2) Uredbe (ES) št. 1687/2002 [6];
existing active substances that were not notified, but in respect of which a Member State has indicated an interest in supporting their inclusion in Annex I, IA or IB to Directive 98/8/EC;
obstoječe aktivne snovi, ki niso bile prijavljene, a za katere je država članica izrazila zanimanje, da podpre njihovo vključitev v prilogo I, IA ali IB k Direktivi 98/8/ES;
existing active substances that were not notified, but for which a dossier was submitted to one of the Member States by 1 March 2006, which was found to comply with the requirements of Annex III to this Regulation and was accepted as complete.
obstoječe aktivne snovi, ki niso bile prijavljene, a za katere je bil do 1. marca 2006 eni od držav članic predložen dosje, ki je izpolnjeval zahteve iz Priloge III k tej uredbi in je bil sprejet kot popoln.
The list specifies, for each existing active substance included, the product types in respect of which the substance will be examined under the review programme, as well as the Rapporteur Member State designated to carry out the evaluation.
Seznam za vsako vključeno obstoječo aktivno snov opredeli vrste pripravkov, v katerih se snov oceni v programu pregledovanja, ter imenuje državo članico poročevalko, ki opravi ocene.
Non-inclusion
Nevključitev
Without prejudice to Articles 5 and 6 of this Regulation and paragraph 2 of this Article, biocidal products containing active substances not listed in Annex II to this Regulation or in Annex I or IA to Directive 98/8/EC shall no longer be placed on the market.
Ne glede na člena 5 in 6 te uredbe ter na odstavek 2 tega člena se biocidni pripravki, ki vsebujejo aktivne snovi, ki niso navedene v Prilogi II k tej uredbi ali v prilogi I ali IA k Direktivi 98/8/ES, ne smejo več dajati v promet.
In the case of an active substance listed in Annex II to this Regulation, the first subparagraph shall also apply to that substance in relation to any product type not listed in that Annex.
V primeru aktivne snovi iz Priloge II k tej uredbi se prvi pododstavek uporablja za navedeno snov tudi v zvezi s katero koli vrsto pripravka, ki je ni v navedeni prilogi.
Biocidal products containing active substances listed in Annex II to this Regulation for which a decision was taken not to include these active substances for certain or all of their notified product types in Annex I or IA to Directive 98/8/EC, shall no longer be placed on the market for the product types concerned, with effect from 12 months after the date of such a measure being published, unless otherwise stipulated therein.
Biocidni pripravki, ki vsebujejo aktivne snovi, navedene v Prilogi II k tej uredbi, za katere je bila sprejeta odločitev, da se navedene aktivne snovi za nekatere ali vse njihove prijavljene vrste pripravkov ne vključijo v prilogo I ali IA k Direktivi 98/8/ES, se ne smejo več dajati v promet za zadevne vrste pripravkov, pri čemer začne ta ukrep veljati 12 mesecev po objavi, razen če je v navedeni odločitvi določeno drugače.
Without prejudice to Articles 12(1)(b) and 15(2) of Directive 98/8/EC, from the day of entry into force of this Regulation, any active substance not listed in Annex I shall be deemed not to have been placed on the market for biocidal purposes before 14 May 2000.
Brez poseganja v člen 12(1)(b) in člen 15(2) Direktive 98/8/ES se od dneva začetka veljavnosti te uredbe za katero koli aktivno snov, ki ni navedena v Prilogi I, šteje, da ni bila dana v promet za biocidne namene pred 14. majem 2000.
Derogation for essential use
Odstopanje za uporabo bistvenega pomena
Member States may apply to the Commission for a derogation from Article 4(1) where they consider that an active substance is essential for them for reasons of health, safety or protection of cultural heritage or is critical for the functioning of society, and where there are no available technically and economically feasible alternatives or substitutes that are acceptable from the standpoint of environment and health.
Države članice lahko zaprosijo Komisijo za odstopanje od člena 4(1), če menijo, da jim je aktivna snov nujno potrebna zaradi zdravstvenih in varnostnih razlogov ali zaradi varovanja kulturne dediščine ali da je odločilnega pomena za delovanje družbe v odsotnosti tehnično in ekonomsko izvedljivih drugih možnosti ali nadomestkov, ki so sprejemljivi z okoljskega ali zdravstvenega vidika.
Applications shall be accompanied by a document stating the reasons and justifications.
Zahtevam se priloži dokument, ki navaja razloge in utemeljitve.
The applications referred to in paragraph 1 shall be forwarded by the Commission to the other Member States and shall be made publicly available by electronic means.
Zahteve iz odstavka 1 Komisija pošlje drugim državam članicam, javnosti pa so na voljo prek elektronskih sredstev.
Member States or any person may for a period of 60 days following reception of an application submit comments in writing to the Commission.
Države članice ali katera koli oseba lahko v 60 dneh po prejemu zahteve predloži pisne pripombe Komisiji.
Taking account of the comments received, the Commission may grant a derogation from Article 4(1) allowing the placing of the substance on the market of the requesting Member States until 14 May 2010 at the latest, provided that the Member States:
Ob upoštevanju prejetih pripomb lahko Komisija odobri odstopanje od člena 4(1) in dovoli, da se da snov v promet v državah članicah prosilkah najdlje do 14. maja 2010, če države članice:
ensure that continued use is possible only if products containing the substance are approved for the intended essential use;
zagotovijo, da je nadaljnja uporaba mogoča samo, če se pripravki, ki vsebujejo to snov, odobrijo za predvideno uporabo bistvenega namena;
conclude that, taking into account all available information, it is reasonable to assume that continued use does not have any unacceptable effect on human or animal health or on the environment;
sklenejo, da je ob upoštevanju vseh dosegljivih podatkov smiselno predpostaviti, da nadaljnja uporaba nima nikakršnih nesprejemljivih učinkov na zdravje ljudi ali živali ali na okolje;
impose all appropriate risk reduction measures when granting approval;
ob odobritvi dovoljenja uvedejo vse primerne ukrepe za zmanjšanje tveganja;
ensure that such approved biocidal products remaining on the market after 1 September 2006 are relabelled in order to match the use conditions laid down by the Member States in accordance with this paragraph; and
zagotovijo, da se tovrstni dovoljeni biocidni pripravki, ki so ostali v prometu po 1. septembru 2006, ponovno označijo v skladu s pogoji za uporabo, ki so jih določile države članice v skladu s tem odstavkom; in
ensure that, where appropriate, alternatives for such uses are being sought by the holders of the approvals or the Member States concerned, or a dossier is being prepared for submission in accordance with the procedure laid down in Article 11 of Directive 98/8/EC by 14 May 2008 at the latest.
zagotovijo, kjer je to potrebno, da si imetniki dovoljenj ali zadevne države članice prizadevajo najti tudi druge možnosti za tovrstne uporabe ali da v skladu s postopkom, določenim v členu 11 Direktive 98/8/ES, pripravljajo dosje, ki ga bodo predložile najpozneje 14. maja 2008.
The Member States concerned shall annually inform the Commission on the application of paragraph 3 and in particular on the actions taken pursuant to point (e).
Zadevne države članice vsako leto obvestijo Komisijo o uporabi odstavka 3 in zlasti o ukrepih, sprejetih v skladu s točko (e).
Member States may at any time review the approvals of biocidal products for which the period of placing on the market has been extended in accordance with paragraph 3.
Države članice lahko kadar koli ponovno ocenijo dovoljenja za biocidne pripravke, za katere je bilo podaljšano obdobje dajanja v promet v skladu z odstavkom 3.
Whenever there is reason to believe that any of the conditions set in points (a) to (e) of that paragraph are no longer satisfied, the Member States concerned shall without undue delay take steps to remedy the situation or if that is not possible, withdraw the approvals of the biocidal products concerned.
Kadar obstaja razlog za domnevo, da kateri koli od pogojev, navedenih v točkah (a) do (e) tega odstavka, ni več izpolnjen, zadevna država članica brez neutemeljenega odlašanja prevzame ukrepe za njegovo izpolnitev, če pa to ni mogoče, prekliče dovoljenja za zadevne biocidne pripravke.
Food and Feed
Hrana za ljudi in živali
By way of derogating from Article 4(1), Member States may allow until 14 May 2010 at the latest the placing on the market of active substances consisting solely of food or feed that are intended for use as repellents or attractants of product type 19.
Z odstopanjem od člena 4(1) lahko države članice najdlje do 14. maja 2010 dovolijo dajanje v promet aktivnih snovi, ki so sestavljene izključno iz hrane za ljudi ali živali in so namenjene za uporabo kot repelenti ali atraktanti vrste pripravkov 19.
For the purposes of this derogation, ‘food or feed’ means any edible substance or product of plant or animal origin, whether processed, partially processed or unprocessed, which is intended or reasonably expected to be ingested by humans or animals; this category does not comprise extracts or individual substances isolated from food or feed.
Za namene tega odstopanja je „hrana ali krma“ vsakršna užitna snov ali proizvod rastlinskega ali živalskega izvora, bodisi predelana, delno predelana ali nepredelana, ki je namenjena ali za katero je razumno domnevati, da jo bodo uživali ljudje ali živali; v ta razred niso vključeni izvlečki ali posamezne snovi, ki izhajajo iz hrane ali krme.
Examination of existing active substances under the review programme
Ocenjevanje obstoječih aktivnih snovi v programu pregledovanja
The review of an active substance listed in Annex II, in respect of the product types specified, shall be undertaken by the Rapporteur Member State designated for that purpose on the basis of the complete dossier for that substance/product type combination, provided that:
Pregled aktivne snovi iz Priloge II v zvezi z dano vrsto pripravka opravi država članica poročevalka, imenovana v ta namen, na podlagi popolnega dosjeja za to kombinacijo snovi/vrst pripravkov, pod pogojem:
the dossier complies with the requirements set out in Annex III to this Regulation;
da dosje izpolnjuje pogoje, določene v Prilogi III k tej uredbi;
the complete dossier is submitted within the period specified in Article 9 of this Regulation for the product type concerned, together with the summary dossier referred to in Article 11(1)(b) of Directive 98/8/EC and defined in Annex III to this Regulation.
da se popoln dosje za zadevno vrsto pripravka predloži v roku iz člena 9 te uredbe skupaj s povzetkom dosjeja iz člena 11(1)(b) Direktive 98/8/ES, ki je opredeljen v Prilogi III k tej uredbi.
An active substance listed in Annex II to this Regulation shall be reviewed exclusively in relation to the product types specified therein.
Aktivna snov, navedena v Prilogi II k tej uredbi, se pregleda izključno za vrste pripravkov iz Priloge.
For the active substance/product type combinations referred to in Article 3(2)(c), with the exception of product types 8 and 14, the evaluation of the dossiers shall commence at the same time as the evaluation of dossiers for active substances contained in the same product types.
Ocenjevanje dosjejev za kombinacije aktivnih snovi/vrst pripravkov iz člena 3(2)(c), razen vrst pripravkov 8 in 14, se začne istočasno kot ocenjevanje dosjejev za aktivne snovi v istih vrstah pripravkov.
A Member State which has indicated an interest in supporting the inclusion of an active substance in Annex I, IA or IB to the Directive shall not be designated as Rapporteur Member State in respect of that substance.
Država članica, ki je izrazila zanimanje, da podpre vključitev aktivne snovi v prilogo I, IA ali IB k Direktivi, ne sme biti imenovana za državo članico poročevalko v zvezi z navedeno snovjo.
Without prejudice to Articles 10, 11 and 12 of this Regulation, persons other than participants may apply, in accordance with Article 11 of Directive 98/8/EC, for the inclusion in Annex I, IA or IB thereto of an existing active substance/product type combination that is listed in Annex II to this Regulation.
Tudi druge osebe, ki niso udeleženci, lahko ne glede na člene 10, 11 in 12 te uredbe v skladu s členom 11 Direktive 98/8/ES zaprosijo, da se v prilogo I, IA ali IB k navedeni direktivi vključi kombinacija obstoječih aktivnih snovi/vrst pripravkov, ki je navedena v Prilogi II k tej uredbi.
These persons shall submit in that case a complete dossier within the time period specified in Article 9 for that substance/product type combination.
V takem primeru te osebe za to kombinacijo snovi/vrst pripravkov predložijo popoln dosje v roku iz člena 9.
Preparation of the complete dossier
Priprave popolnega dosjeja
In the preparation of the complete dossier, all reasonable efforts shall be made, inter alia, to avoid duplication of testing on vertebrate animals and, where appropriate, to establish a collective complete dossier.
Za pripravo popolnega dosjeja se naredi vse, kar je razumno mogoče, da se med drugim izogne podvojitvi poskusov na vretenčarjih, in, kadar je to primerno, pripravi skupen popolni dosje.
Before commencing compilation of the complete dossier, a participant shall:
Pred začetkom sestave popolnega dosjeja udeleženec:
inform the Rapporteur Member State of any testing on vertebrate animals that it has already carried out;
obvesti državo članico poročevalko o vseh poskusih na vretenčarjih, ki so že bili opravljeni;
contact the Rapporteur Member State for advice as to the acceptability of justifications for waiving certain studies;
zaprosi državo članico poročevalko za nasvet o sprejemljivosti utemeljitev za odstop nekaterih študij;
inform the Rapporteur Member State of any intention to carry out further testing on vertebrate animals for the purposes of the complete dossier;
obvesti državo članico o vsaki nameri za opravljanje nadaljnjih poskusov na vretenčarjih za namene priprave popolnega dosjeja;
when informed by the Rapporteur Member State that another participant has notified plans to carry out the same tests, make all reasonable efforts to cooperate with that participant in the performance of common testing.
kadar ga država članica poročevalka obvesti, da je drugi udeleženec prijavil svoje načrte za opravljanje istih poskusov, naredi vse, kar je razumno mogoče, da z navedenim udeležencem sodeluje pri opravljanju skupnih poskusov.
Advice given by Rapporteur Member States in accordance with point (b) of the first subparagraph shall not predetermine the outcome of the completeness check under Article 13(1).
Nasvet, ki ga dajo države članice poročevalke v skladu s točko (b) prvega pododstavka, ne določa vnaprej izida glede preverjanja popolnosti po členu 13(1).
A Rapporteur Member State may make available the reference to any test carried out on vertebrate animals in respect of an active substance listed in Annex II to this Regulation, save where that reference is to be treated as confidential in accordance with Article 19 of Directive 98/8/EC.
Država članica poročevalka lahko zagotovi navedbo vsakršnega poskusa, ki je bil opravljen na vretenčarjih v zvezi z aktivnimi snovmi, navedenimi v Prilogi II k tej uredbi, razen kadar gre za navedbe, ki jih je treba po členu 19 Direktive 98/8/ES obravnavati kakor zaupne.
Such reference may include the name of the active substance concerned, the end points of the tests, and the contact address of the data owner.
Taka navedba lahko vključuje ime zadevne aktivne snovi, končne izide poskusov in naslov imetnika podatkov.
Where a Rapporteur Member State is aware that more than one participant is seeking review of a particular active substance, it shall inform those participants accordingly.
Kadar je državi članici poročevalki znano, da več kakor eden udeleženec zahteva uvedbo pregleda za določeno aktivno snov, o tem obvesti tiste udeležence.
Participants seeking review of the same active substance for the same product types shall undertake all reasonable efforts to submit a collective complete dossier, while fully respecting the Community rules on competition.
Udeleženci, ki zahtevajo uvedbo pregleda iste aktivne snovi za iste vrste pripravkov, naredijo vse, kar je razumno mogoče, za predložitev skupnega popolnega dosjeja, ob popolnem upoštevanju pravil Skupnosti o konkurenci.
Where, in those circumstances, a collective dossier is not submitted, each individual dossier shall detail the efforts made to secure cooperation and the reasons for non-participation.
Kadar v takih okoliščinah skupni dosje ni predložen, mora vsak posamični dosje podrobno navesti prizadevanja, vložena za zagotovitev sodelovanja, in razloge za nesodelovanje.
Details shall be given in the complete dossier and in the summary dossier of the efforts made to avoid duplication of testing on vertebrate animals.
Podrobnosti o prizadevanjih, ki so bila vložena, da bi se izognili podvojitvi poskusov na vretenčarjih, se navedejo v popolnem dosjeju in v povzetku dosjeja.