natgillin/translations-raw huggingface dataset:
Ker trenutno ne obstajajo merila za odobritev povzročiteljev endokrinih motenj, jih je treba sprejeti v skladu z Uredbo 1107/2009/ES o dajanju fitofarmacevtskih sredstev v promet, ki velja od 24. novembra 2009.
Since no criteria exist at present for the approval of endocrine disrupters, these should be adopted pursuant to Regulation (EC) No 1107/2009 on the placing on the market of plant protection products, which entered into force on 24 November 2009.
Člen 6 – odstavek 1 – točki a in b
Article 6 – paragraph 1 – points a and b
(a) dokumentacijo o aktivni snovi, ki izpolnjuje zahteve iz Priloge II , ali, ko je to primerno, izjavo o dostopnosti teh podatkov ;
(a) a dossier or, where appropriate, a letter of access for the active substance satisfying the requirements set out in Annex II;
(b) dokumentacijo ali, ko je to primerno, izjavo o dostopnosti podatkov o najmanj enem reprezentativnem biocidnem pripravku, ki vsebuje aktivno snov, ki izpolnjuje zahteve iz Priloge III.
(b) a dossier or, where appropriate, a letter of access for at least one representative biocidal product that contains the active substance satisfying the requirements set out in Annex III.
Predlagatelji lahko niso zakoniti imetniki vseh podatkov, ki utemeljujejo vlogo: primerno je predvideti uporabo izjave dostopnosti podatkov.
Applicants may not be in legitimate possession of all the data in support of the application: it makes sense to provide for the possibility of using a letter of access to the data.
Predlagatelj vloži vlogo za vključitev aktivne snovi v Prilogo I ali za naknadne spremembe pogojev za vključitev aktivne snovi pri Evropski agenciji za kemikalije (v nadaljnjem besedilu: agencija).
The applicant shall submit an application to include an active substance in Annex I, or to make subsequent amendments to the conditions of inclusion of an active substance, to the European Chemicals Agency (hereinafter referred to as 'the Agency').
Agencija vsaki vlogi določi referenčno številko, ki se uporablja za vso korespondenco v zvezi z vlogo, dokler aktivna snov ni vključena v Prilogo I, in datum vložitve, ki ustreza datumu, ko je agencija prejela vlogo.
The Agency shall assign a reference number to each application, which shall be used for all correspondence concerning the application until the active substance is included in Annex I, and a submission date corresponding to the date of receipt by the Agency.
Številka protokola, ki se dodeli vsaki zahtevi, bo omogočilo jasno prepoznavnost posameznega upravnega postopka, da bi se zadevne informacije in podatki, ki se nanje nanašajo, hitro našli.
A reference number assigned to each application would enable the relevant administrative procedure to be clearly identified, thus permitting speedy detection and speedy access, if need be, to the relevant data and information.
Člen 7 – odstavek 3 – prvi pododstavek – uvodni del
Article 7 – paragraph 3 – first subparagraph – introductory part
V treh tednih po prejemu vloge agencija validira vlogo, če so izpolnjene naslednje zahteve:
Within three weeks of the receipt of an application, the Agency shall validate the application if it complies with the following requirements:
Agencija bi se morala pri potrjevanju zahtev držati rokov, določenih v uredbi REACH (člen 20), da bi bila bolj v skladu z obstoječo zakonodajo.
In order to ensure greater consistency with the existing legislation the Agency should keep to the same time limits as those laid down in the REACH Regulation (Article 20) where the validation of applications is concerned.
Člen 7 – odstavek 4 – pododstavek 2
Article 7 – paragraph 4 – subparagraph 2
Agencija v dveh mesecih po prejemu dodatnih informacij ugotovi, ali so predložene dodatne informacije zadostne za validacijo vloge.
The Agency shall, within two months from the receipt of the additional information, determine whether the additional information submitted is sufficient to validate the application.
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 the receipt of the additional information, determine whether the additional information submitted is sufficient to validate the application.
Mogoče je dovoliti dodatne roke za vpis vseh podatkov v register Skupnosti, to pa ne sme upočasniti ocenjevanje vlog.
Additional time may be allowed for entering all the data in the Community register, but this should not delay the evaluation of applications.
V dveh mesecih po prejetju vloge agencija vse dele podatkov v dokumentaciji označi z enkratno identifikacijsko kodo.
Within two months of receipt of an application, the Agency shall register each part of the information in the dossier with a unique identifying code.
Poleg vključitve aktivnih snovi v Prilogo I, ki se nanaša na podjetje, je vpis posameznih informacij dodaten, ustrezen in učinkovit način, da bi se izognili koristoljubju (free-riding).
Together with the inclusion of the active principles and the name of the firm in Annex 1, registering each part of the information is a further appropriate and effective means of preventing 'free-riding'.
S tem vpisom se povečata tudi preglednost in možnost širitve podatkov.
Registering this information will also provide for transparency and data sharing.
Ko se Komisija odloči za vključitev aktivne snovi v Prilogo I, se navede ime predlagatelja/predlagateljev.
When the Commission decides to include the active substance in Annex I, the name(s) of the applicant(s) shall be indicated.
Vključitev aktivne snovi, povezane s podjetjem, v Prilogo I, je ustrezno in učinkovito orodje, da bi se izognili koristoljubju (free-riding), saj omogoča, da se hitro ugotovi, katero podjetje je predložilo snov.
Including the active principle in Annex 1, together with the name of the firm, is an appropriate and effective way of preventing 'free-riding', since it makes it possible to quickly identify the firm which has supported the substance.
Vključitev v Prilogo I je namreč vedno posledica vloge predlagatelja.
The inclusion of a substance in Annex 1 is always the result of an application made by an applicant.
V skladu z uredbo REACH je treba načelo „brez podatkov ni trga“ uporabiti tudi v tej uredbi.
In accordance with REACH, the 'no data, no market' principle should also apply to this regulation.
Agencija pri odločitvi za vključitev aktivne snovi v Prilogo I pri posamezni snovi določi posebno številko vključitve za snov in za predlagatelja.
With the decision to include the active substance in Annex I, the Agency shall assign to the substance in question a specific registration number for the substance and for the applicant.
Agencija predlagatelju nemudoma sporoči številko in datum vključitve.
The Agency shall without delay inform the applicant of the number and the date of registration.
Vključitvena številka se uporablja za vso nadaljnjo komunikacijo v zvezi z aktivno snovjo in za izdajo dovoljenja za pripravek v skladu s poglavjem IV te uredbe.
This registration number shall be used in all further correspondence regarding the active substance and for product authorisation as referred to in Chapter IV of this Regulation.
Samo podjetja, ki so prosila za vključitev aktivne snovi v Prilogo I, imajo pravico izdajati izjave o dostopnosti podatkov o tej snovi.
Only firms which have requested inclusion of an active substance in Annex 1 are authorised to issue letters of access to the dossier for that substance.
Aktivne snovi štejejo za možne snovi za zamenjavo skladno s postopkom iz odstavka 2 , kadar :
Active substances shall be considered candidates for substitution in accordance with the procedure referred to in paragraph 2 , where :
(a) dopustni dnevni vnos, akutni referenčni odmerek ali sprejemljive ravni izpostavljenosti delavca so občutno nižje kot pri večini aktivnih snovi, vključenih v Prilogo I za isto vrsto pripravkov;
(a) its acceptable daily intake, acute reference dose or acceptable operator exposure level is significantly lower than those of the majority of the active substances included in Annex I for the same product type;
(a) so obstojne, se kopičijo v organizmih in so strupene v skladu z opredelitvijo v Prilogi XIII k Uredbi (ES) št. 1907/2006;
(a) they are persistent, bio-accumulative and toxic as defined in Annex XIII to Regulation (EC) No 1907/2006;
(b) so zelo obstojne in se kopičijo v organizmih v skladu z merili iz Priloge XIII k Uredbi (ES) št. 1907/2006;
(b) they are very persistent and bio-accumulative in accordance with the criteria set out in Annex XIII to Regulation (EC) No 1907/2006;
(c) izpolnjujejo merila za razvrstitev iz Uredbe (ES) št. 1272/2008 med kancerogene snovi kategorije 1A in 1B, mutagene snovi kategorije 1A in 1B ali snovi, ki so strupene za razmnoževanje iz kategorije 1A in 1B;
(c) they meet the criteria to be classified, in accordance with Regulation (EC) No 1271/2008, as category 1A or 1B carcinogens, category 1A or 1B mutagens or toxic for reproduction category 1A or 1B;
(d) vsebuje velik delež neaktivnih izomerov;
(d) it contains a significant proportion of non-active isomers;
(d) so aktivne snovi, kot so povzročitelji endokrinih motenj, snovi, ki se kopičijo v telesu in strupene snovi ali snovi, ki se močno kopičijo v telesu in ne sodijo pod točki a) in b), zanje pa obstajajo znanstveni dokazi o možnih resnih posledicah za zdravje ljudi in za okolje, ter ki so enako zaskrbljujoče kot snovi iz točk a) in b).
(d) they are active substances, such as those with endocrine disrupting properties or persistent, bioaccumulative and toxic properties or and very bioaccumulative properties which do not comply with the criteria referred to in points (a) or (b) – for which scientific evidence exists of probable serious effects on public health or the environment giving rise to a level of concern equivalent to that applicable to the substances referred to in points (a) or (b).
Merila za opredelitev snovi, ki bi se lahko zamenjale, je treba zaradi doslednosti in poenotenja pravilnikov uskladiti z merili iz uredbe REACH (člen 57).
The criteria for identifying active substances which are candidates for substitution should be aligned with the criteria laid down in the REACH Regulation (Article 57) for reasons of harmonisation between the two regulations.
Ker bo Evropska agencija za kemikalije morala preučiti, ali aktivna snov, ki jo vsebuje biocidni pripravek, ustreza kateremu od navedenih meril, je usklajenost z obema pravilnikoma priporočljiva.
As the Agency (ECHA) will have the task of examining whether an active substance meets the criteria, harmonisation between the two regulations is advisable.
Če v odločitvi o obnovitvi vključitve aktivne snovi v Prilogo I ni drugače določeno, velja obnovitev za neomejeno obdobje .
Unless otherwise specified in the decision to renew the inclusion of an active substance in Annex I, the renewal shall be for an unlimited period of time .
Če v odločitvi o obnovitvi vključitve aktivne snovi v Prilogo I ni drugače določeno, se obnovitev vključitve preveri vsakih deset let .
Unless otherwise specified in the decision to renew the inclusion of an active substance in Annex I, the renewal of the inclusion shall be reviewed every 10 years .
Člen 12 – odstavek 5 – pododstavek 1a (novo)
Article 12 – paragraph 5 – subparagraph 1a (new)
Če se Komisija odloči za obnovitev vključitve aktivne snovi v Prilogo I, se navede ime predlagatelja.
In the event that the Commission decides to renew the inclusion of the active substance in Annex I, the name of the applicant shall be indicated.
Tudi v primeru ponovne vključitve aktivne snovi, povezane s podjetjem, v Prilogo I, je treba zaradi boljše preglednosti in širitve podatkov omeniti imena predlagateljev, da bi bilo možno njihovo hitro prepoznavanje.
In the interests of greater transparency and data sharing mention should be made of the applicants' names to enable them to be swiftly identified, including in cases where inclusion of an active substance in Annex 1 is being renewed.
Vlogo za izdajo dovoljenja vloži oseba, ki bo odgovorna za dajanje biocidnega pripravka v promet v določeni državi članici oziroma v Skupnosti, ali se vloži v njenem imenu .
Application for authorisation shall be made by, or on behalf of, the person who shall be responsible for the placing on the market of a biocidal product in a particular Member State or in the Community.
Vlogo za izdajo dovoljenja vloži oseba, ki bo imetnik dovoljenja, ali se vloži v njenem imenu .
Application for authorisation shall be made by, or on behalf of, the person who will be the holder of the authorisation.
Ta oseba je lahko, ni pa nujno, oseba, ki je odgovorna za dajanje biocidnega pripravka v promet v določeni državi članici oziroma v Skupnosti.
This person may be, but is not necessarily, the person responsible for the placing on the market of a biocidal product in a particular Member State or in the Community.
Industrija zahteva večjo prilagodljivost dobavne verige.
The industry needs more flexibility in the supply chain.
Dejansko se ne zgodi redko, da je za uvoz pripravka v državo in njegovo dajanje v promet odgovoren distributer, ki pa ni imetnik dovoljenja, ali, v primeru večnacionalnih podjetij, da je vsako sestrsko podjetje odgovorno za dajanje pripravka v promet v svoji državi.
In fact it is not uncommon that a product is imported in one country and placed on the market under the responsibility of a distributor which is not the holder of the authorisation or, in case of multinational companies, that each individual sister company is responsible for placing the product on the market in their own country.
Določba, da sta imetnik dovoljenja in oseba, ki je odgovorna za dajanje pripravka v promet, ista oseba, bi povzročila zelo tog in nepraktičen okvir, v katerem bi morala industrija delovati.
The provision that the holder of the authorisation and the person responsible for placing the product on the market are the same would create a very rigid and unpractical framework for industry to work with.
Člen 15 – odstavek 2 – pododstavka 2 in 3
Article 15 – paragraph 2 – subparagraphs 2 and 3
Vloga za nacionalno dovoljenje v državi članici se vloži pri pristojnem organu navedene države članice (v nadaljnjem besedilu: pristojni organ prejemnik) .
Application for national authorisation in a Member State shall be submitted to the competent authority of that Member State (hereinafter referred to as 'the receiving competent authority').
Vloga za dovoljenje se vloži pri agenciji .
Application for authorisation shall be submitted to the Agency .
Če je potrebna dodelitev nacionalnega dovoljenja v državi članici, predlagatelj, ob predhodnem dogovoru z zadevno državo, v vlogi navede organ, pristojen za ocenjevanje.
When an application for national authorisation in a Member State is submitted, the applicant, in agreement with the Member State concerned, shall identify the evaluating competent authority in the application itself, as laid down in Article 22.
Evropska agencija za kemikalije mora opraviti začetno ocenjevanje vseh zahtev na ravni Skupnosti, da bi se nacionalni ocenjevalni organ lahko osredotočil na dejansko oceno vloge.
The ECHA should carry out the initial validation of all applications throughout the Community, so that the evaluating competent authorities can concentrate on the actual evaluation of applications.
Možnost izbire ocenjevalnega pristojnega organa je koristna zlasti za mala in srednja podjetja, ki lahko sodelujejo s svojimi nacionalnimi organi.
The possibility of choosing the evaluating competent authority is an advantage for small and medium-sized enterprises in particular, since they are able to work with their national authorities.
Vlagatelj, ki želi pridobiti dovoljenje za skupino pripravkov, ki je del okvirne formulacije, lahko predloži eno samo vlogo.
An applicant seeking authorisation for a group of products as part of a frame formulation may submit a single application for authorisation.
a) so aktivne snovi, ki jih vsebuje, vključene v Prilogo I in so izpolnjeni vsi pogoji, ki so za navedene aktivne snovi vključeni v isto prilogo;
a) the active substances included therein are listed in Annex I and any conditions included in that Annex together with those active substances are complied with;
a) so aktivne snovi, ki jih vsebuje, vključene v Prilogo I , jim je bila dodeljena številka vključitve v skladu s členom 8(5a) in so izpolnjeni vsi pogoji, ki so za navedene aktivne snovi vključeni v isto prilogo;
a) the active substances included therein are listed in Annex I , a registration number is assigned to them in accordance with Article 8(5a), and any conditions included in that Annex together with those active substances are complied with;
Zaradi skladnosti s postopkom ocenjevanja iz člena 8(5)(a).
In the interests of consistency with the evaluation procedure described in Article 8(5a).
Ocena, koliko biocidni pripravek izpolnjuje merila iz odstavka 1(b), mora čim bolj temeljiti na obstoječih informacijah o pogojno nevarnih snoveh v biocidnem pripravku, da bi se kar najbolj zmanjšali poskusi na živalih v skladu s postopki iz Direktive 1999/45/ES in Uredbe (ES) št. 1272/2008 na temo prepoznavanja nevarnosti, povezanih z biocidnimi pripravki, in posledično oceno tveganja.
The evaluation of the compliance of the biocidal products with the criteria set out in point (b) of paragraph 1 shall be based as far as possible on existing information on the substances of concern contained in the biocidal product in order to keep tests on animals to a minimum, in accordance with the procedures laid down in Directive 1999/45/EC or Regulation (EC) No 1272/2008 on identifying the danger posed by biocidal products and consequent risk assessment.
S spremembo se poskušamo izogniti nepotrebnim preskusom na živalih, in sicer prek boljše opredelitve postopkov primerjanja obstoječih informacij in v skladu z zahtevami iz uredbe REACH o mejnih vrednostih iz poročila o kemijski varnosti.
The aim is to prevent unnecessary animal testing, by providing a clearer definition of the procedures for comparing existing information, while also complying with the REACH requirement regarding Chemical Safety Report thresholds.
(b) mejnih koncentracij iz Priloge I k Direktivi 67/548/EGS,
(b) the concentration limit values given in Annex I to Directive 67/548/EEC;
(c) mejnih koncentracij iz dela B Priloge II k Direktivi 199/45/ES,
(c) the concentration limit values given in Part B of Annex II to Directive 1999/45/EC;
(d) mejnih koncentracij iz dela B Priloge III k Direktivi 199/45/ES,
(d) the concentration limit values given in Part B of Annex III to Directive 1999/45/EC;
(e) mejnih koncentracij iz rubrike, ki je bila sporazumno dodana v popis razvrstitev in označevanja v skladu z naslovom V Uredbe (ES) št. 1272/2008,
(e) the concentration limit values given in an agreed entry in the classification and labelling inventory established under Title V of Regulation (EC) No 1272/2008;
Člen 16 – odstavek 6 a (novo)
Article 16 – paragraph 6 a (new)
Komisija po potrebi in v sodelovanju z agencijo pristojnim organom držav članic zagotovi vso potrebno znanstveno in tehnično pomoč v zvezi z izdajo dovoljenj za pripravke, zlasti glede usklajenih zahtev za podatke, ocenjevalnih postopkov in odločitev držav članic.
The Commission, where necessary in cooperation with the Agency, shall provide all necessary scientific and technical assistance to the competent authorities of the Member States in respect of the authorisation of products, particularly as regards uniform requirements for data, evaluation procedures and decisions by Member States.
Komisija mora pristojnim organom v državah članicah omogočiti vso potrebno tehnično in znanstveno pomoč, da bi se zagotovilo enotno izvajanje pravil za dodeljevanja dovoljenj proizvodom na ozemlju Skupnosti.
In order to ensure uniform implementation of the regulation throughout the Community, the Commission must provide all necessary scientific and technical assistance to the competent authorities of the Member States in respect of the authorisation of products.
Predlagatelj za dovoljenje v okoliščinah, navedenih v odstavkih 1 in 2, pristojnim organom posreduje:
The applicant for an authorisation shall, in the circumstances defined in paragraphs 1 and 2, provide the competent authorities with:
(i) informacije, ki se posebej zagotovijo na prodajnem mestu;
(i) the information to be specifically provided at the point of sale;
(ii) posebna navodila za uporabo zaščitne opreme;
(ii) specific instructions on the use of protective equipment;
(iii) brošuro o tveganjih, koristih in odgovorni uporabi pripravka;
(iii) a brochure on the risks, benefits and responsible use of the product;
(iv) letno poročilo o nesrečah, če so se zgodile.
(iv) an annual report on incidents, if any.
Samo notranje lastnosti aktivne snovi ne bi smele določati njene primernosti za pripravke z majhnim tveganjem, saj tveganja lahko bolj kot iz nevarnosti aktivne snovi izvirajo iz izpostavljenosti pripravku.
The intrinsic characteristics of an active substance, alone, should not determine its suitability for low risk products since the risks may come more from the exposure to the product than from the hazard of the active substance.
Glede na to, da nekatere biocidne pripravke uporabljajo nepoklicni uporabniki, je treba zagotoviti varnost teh izdelkov z boljšim informiranjem in previdnostnimi ukrepi za njihovo uporabo.
Given that some biocides are used by non-professionals, it is important to guarantee the safety of these products through better information and precautions regarding their use.
Industrijo je treba spodbuditi, da prizadevanja na področju raziskav in inovacij usmeri v razvoj pripravkov z majhnim tveganjem.
Finally, industry needs to be encouraged to focus its research and innovation efforts towards developing low risk products.
Pristojni organ prejemnik lahko zahteva, da se vloge izključno 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 the sole purpose of a national authorisation be submitted in one of the official languages of the Member State where that competent authority is situated.
Vloge za nacionalno dovoljenje, ki vključujejo postopek vzajemnega priznavanja, je skupaj z dokumenti iz odstavka 1 mogoče oddati pristojnemu organu v angleščini.
Applications for a national authorisation which involve a mutual recognition procedure may be submitted, along with the documents referred to in paragraph 1, to the competent authority in English.
Če vloge vključujejo postopke vzajemnega priznavanja, je nujno, da pristojni organ, ki sprejema dokumentacijo, prejme vlogo in vse dokumente v angleščini.
It is critical that in the case of applications involving subsequent mutual recognition procedures the application and all related documents are accepted in English by the receiving competent authority.
To je zelo pomembno za preprečitev dolgotrajnih in dragih postopkov prevajanja istih dokumentov v več evropskih jezikov.
This is very important in order to avoid time-consuming and expensive translation procedures for the same documentation in several European languages.
Komisija, ko je to potrebno, v sodelovanju z agencijo pripravi tehnični in pravni neobvezujoč vodič, dostopen v vseh uradnih jezikih Unije in namenjen preprostejši predstavitvi vlog za dovoljenje iz členov 18, 19 in 20 zlasti za mala in srednja podjetja.
The Commission may, where necessary in cooperation with the Agency, provide a non-binding technical and legal guide available in all official languages of the European Union, intended to facilitate the submission of applications for authorisation under Articles 18, 19 and 20, particularly applications from SME.
Navodila in smernice Komisije so lahko še posebej pomembne za mala in srednja podjetja, saj morda nimajo potrebnih zmogljivosti ali izkušenj, da bi se prilagodila uredbi.
Assistances and guidelines from the Commission may be particularly important for SME as they may not have the necessary resources or experience to adapt to the regulation.
Komisija jim mora zagotoviti tudi jezikovno dostopnost.
The Commission should also ensure that this service is linguistically accessible to SME.
Člen 20 – odstavek 2 – točka e
Article 20 – paragraph 2 – point e