natgillin/translations-raw huggingface dataset:
in Uredbo (ES) št. 470/2009 Evropskega parlamenta in Sveta z dne 6. maja 2009 o določitvi postopkov Skupnosti za določitev mejnih vrednosti ostankov farmakološko aktivnih snovi v živilih živalskega izvora UL L 152, 16.6.2009, str.
and Regulation (EC) No 470/2009 of the European Parliament and the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin OJ L 152, 16.6.2009, p.
aktivne snovi
active substances ▌shall
vključijo v Prilogo I ▌:
be included in Annex I ▌:
aktivne snovi, ki so bile v skladu z Uredbo (ES) št. 1272/2008 razvrščene kot strupene za razmnoževanje kategorije 1A ali 1B, oziroma izpolnjujejo merila za tako razvrstitev;
active substances which have been classified in accordance with Regulation (EC) No 1272/2008 as, or which meet the criteria to be classified as, toxic for reproduction category 1A or 1B;
aktivne snovi, ki so na podlagi ocene Unije ali mednarodno dogovorjenih smernic za preskuse ali drugih strokovno pregledanih podatkov in informacij, vključno s pregledom znanstvene literature, ki ga pregleda agencija, opredeljene kot snovi, ki imajo lahko po svojih lastnostih kot endokrini motilci negativne učinke na ljudi, ali ki so opredeljene v členu 57(f) Uredbe (ES) št. 1907/2006 kot snovi, ki so po svojih lastnostih endokrini motilci.
active substances which, on the basis of the assessment of Union or internationally agreed test guidelines or other peer-reviewed scientific data and information, including a review of the scientific literature, reviewed by the Agency, are considered as having endocrine-disrupting properties that may cause adverse effect in humans, or which are identified under Article 57(f) of Regulation (EC) No 1907/2006 as having endocrine-disrupting properties.
Komisija z delegiranimi akti v skladu s členom 73 in pod pogoji iz členov 74 in 75 najkasneje do 13. decembra 2013 sprejme ukrepe o posebnih znanstvenih merilih za določanje lastnosti endokrinih motilcev.
Not later than 13 December 2013, the Commission shall adopt, by means of delegated acts in accordance with Articles 73 and subject to the conditions of Articles 74 and 75, measures on specific scientific criteria for determining endocrine-disrupting properties.
Do sprejetja teh meril snovi, ki so ali še morajo biti razvrščene v skladu z določbami iz Uredbe (ES) št. 1272/2008 kot rakotvorne kategorije 2 in strupene za razmnoževanje kategorije 2, štejejo za snovi, ki so po svojih lastnostih endokrini motilci.
Pending the adoption of those criteria, substances that are, or are to be, classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as carcinogenic category 2 and toxic for reproduction category 2, shall be considered as having endocrine-disrupting properties.
Poleg tega lahko na primer snovi, ki so ali še morajo biti razvrščene v skladu z določbami iz Uredbe (ES) št. 1272/2008 kot strupene za razmnoževanje kategorije 2 in ki imajo strupen učinek na endokrine organe, štejejo za snovi, ki so po svojih lastnostih endokrini motilci;
In addition, substances such as those that are, or are to be, classified, in accordance with the provisions of Regulation (EC) No 1272/2008, as toxic for reproduction category 2 and which have toxic effects on the endocrine organs, may be considered as having such endocrine-disrupting properties;
aktivne snovi, ki so obstojne, se kopičijo v organizmih in so strupene;
active substances that are persistent, bio-accumulative and toxic;
aktivne snovi, ki so zelo obstojne in se zelo kopičijo v organizmih;
active substances that are very persistent and very bio-accumulative;
obstojna organska onesnaževala (POP) v okviru Uredbe Evropskega parlamenta in Sveta (ES) št. 850/2004 z dne 29. aprila 2004 o obstojnih organskih onesnaževalih
persistent organic pollutants (POP) under Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants
▌Aktivne snovi
The ▌active substances
iz odstavka 1 se
referred to in paragraph 1 may
vključijo v Prilogo I
be included in Annex I
, če je izpolnjen vsaj eden od
at least one of the
dokazano je, da je aktivna snov potrebna za preprečitev ali nadziranje resne nevarnosti za javno zdravje ali zdravje živali ali okolje, varnosti hrane in krme ali za javni interes ter da ni na razpolago drugih učinkovitih snovi ali tehnologij.
it is shown by evidence that the active substance is necessary to prevent or control a serious danger to public or animal health or to the environment, to food and feed safety, or to the public interest and that there are no effective alternative substances or technologies available.
Za uporabo vseh biocidnih pripravkov, ki vsebujejo aktivne snovi iz Priloge I, v skladu s tem odstavkom veljajo ustrezni ukrepi za zmanjšanje tveganja, da bi se zagotovila najmanjša izpostavljenost ljudi in okolja.
The use of any biocidal product containing active substances included in Annex I pursuant to this paragraph shall be subject to appropriate risk mitigation measures to ensure that exposure of humans and the environment is minimised.
Država članica, ki odobri biocidni pripravek, ki vsebuje aktivne snovi iz Priloge I v skladu s tem odstavkom, sestavi načrt nadomestitve v zvezi z nadzorovanjem resnih nevarnosti z drugimi sredstvi, vključno z nekemičnimi metodami, ki so enako učinkovite kot zadevni biocidni pripravek, ter ta načrt nemudoma predloži Komisiji.
A Member State authorising a biocidal product containing an active substance included in Annex I pursuant to this paragraph shall draw up a substitution plan concerning the control of the serious danger by other means including non-chemical methods that are as effective as the biocidal product concerned, and shall without delay transmit that plan to the Commission.
Vloga za vključitev aktivne snovi v Prilogo I vsebuje najmanj naslednje elemente:
An application to include an active substance in Annex I shall contain at least the following elements:
dokumentacijo o aktivni snovi, ki izpolnjuje zahteve iz Priloge II
for the active substance satisfying the requirements set out in Annex II;
ali izjavo o dostopu do dokumentacije
, or a letter of access to a dossier,
o najmanj enem reprezentativnem biocidnem pripravku, ki vsebuje aktivno snov, ki izpolnjuje zahteve iz Priloge III.
for at least one representative biocidal product that contains the active substance satisfying the requirements set out in Annex III.
Ob vložitvi vloge se plačajo tudi pristojbine iz člena 71.
The application shall be accompanied by the fees payable under Article 71.
Ne glede na odstavek 1 predlagatelju ni treba predložiti podatkov, ki se zahtevajo v navedenem odstavku, če obstaja kateri od naslednjih razlogov:
Notwithstanding paragraph 1, the applicant need not provide data required under that paragraph if any of the following grounds applies:
informacije niso nujne
the information is not necessary
s predlagano uporabo;
the proposed uses;
z znanstvenega vidika ni potrebno, da se informacije predložijo;
it is not scientifically necessary to supply the information;
s tehničnega vidika informacij ni mogoče predložiti.
it is not technically possible to supply the information.
Predlagatelj lahko predlaga prilagoditev zahtevanih podatkov iz odstavka 1 v skladu s Prilogo IV.
An applicant may propose to adapt the data required under paragraph 1 in accordance with Annex IV.
Utemeljitev za predlagane prilagoditve zahtevanih podatkov mora biti v vlogi jasno navedena s sklicevanjem na posebna pravila v Prilogi IV.
The justification for the proposed adaptations to the data requirements shall be clearly stated in the application with a reference to the specific rules in Annex IV.
Pristojni organ obvesti predlagatelja o možnosti, da lahko predlaga prilagoditev zahtevanih podatkov, razlogih, na podlagi katerih lahko zaprosi za tako prilagoditev, in mu zagotovi pomoč pri pripravi takega predloga.
The competent authority shall inform the applicant about the possibility of proposing the adaptation of data requirements, the grounds on which such an adaptation can be requested and, where possible, shall provide assistance in preparing such a proposal.
Za opredelitev
In order to define
, kaj je ustrezna utemeljitev za prilagoditev podatkov, ki se zahtevajo v skladu z odstavkom 1, iz razlogov iz odstavka 2(a),
what constitutes adequate justification to adapt the data required under paragraph 1 on the ground referred to in paragraph 2(a)
Komisija prilagodi merila z delegiranimi akti v skladu s členom 73 in pod pogoji iz členov 74 in 75
, the Commission shall adapt the criteria by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75
Predlagatelj vloži vlogo za vključitev aktivne snovi v Prilogo I ali za naknadne spremembe pogojev za vključitev aktivne snovi pri Agenciji (v nadaljnjem besedilu: agencija)
The applicant shall submit an application for inclusion of an active substance in Annex I, or for subsequent amendments to the conditions of inclusion of an active substance, to the Agency
Agencija navede naziv
The Agency shall indicate
pristojnega organa države članice, ki ga je
the name of the competent authority of the Member State that
Navedeni pristojni organ (v nadaljnjem besedilu: ocenjevalni pristojni organ) je odgovoren za oceno vloge.
That competent authority (hereinafter the ‘evaluating competent authority’) shall be responsible for the evaluation of the application.
Agencija v enem mesecu od prejema vloge obvesti ocenjevalni pristojni organ, da je vloga na voljo v zbirki podatkov agencije.
The Agency shall, within one month from the receipt of the application, notify the evaluating competent authority that the application is available in the Agency database.
v treh tednih
three weeks
po prejemu vloge validira vlogo, če so izpolnjene naslednje zahteve:
after receipt of an application, the Agency shall validate the application if it complies with the following requirements:
dokumentacija iz točk (a) in (b) člena 6(1) je predložena;
dossiers referred to in points (a) and (b) of Article 6(1) have been submitted;
pristojbine iz člena 71 so plačane.
it is accompanied by the fees payable under Article 71.
Validacija ne vključuje ocene kakovosti ali primernosti katerih koli predloženih podatkov ali obrazložitev 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.
, ki ni daljši od dveh mesecev
for the submission of that information.
po prejemu dodatnih informacij ugotovi, ali so predložene dodatne informacije zadostne za validacijo vloge.
after 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 in o tem obvesti predlagatelja.
The Agency shall reject the application if the applicant fails to submit the requested information by the deadline and shall inform the applicant thereof.
V takšnih primerih se del pristojbine, plačane agenciji v skladu s členom 71, povrne.
In such cases a part of the fee paid to the Agency in accordance with Article 71 shall be reimbursed.
Na podlagi člena 68 se lahko proti odločitvam agencije na podlagi tretjega pododstavka odstavka 5 vloži pritožba.
An appeal may be brought, in accordance with Article 68, against Agency decisions under the third subparagraph of paragraph 5.
Če agencija na podlagi validacije, opravljene v skladu z odstavkom 4, 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 4, considers that the application is complete, it shall without delay inform the applicant and the evaluating competent authority thereof.
Ocenjevalni pristojni organ v dvanajstih mesecih po validaciji oceni dokumentacijo v skladu s členom 4, vključno s kakršnim koli predlogom za prilagoditev zahtevanih podatkov, ki je bil predložen v skladu s členom 6(3), če je to primerno.
The evaluating competent authority shall, within 12 months after the validation, evaluate the dossiers in accordance with Article 4, including, where relevant, any proposal to adapt data requirements submitted in accordance with Article 6(3).
Ocenjevalni pristojni organ da predlagatelju možnost, da v dveh mesecih pisno ali ustno predloži opombe v zvezi z ugotovitvami ocene.
The evaluating competent authority shall provide the applicant with an opportunity to provide written or oral comments on the conclusions of the evaluation within two months.
Ocenjevalni pristojni organ te opombe ustrezno upošteva pri zaključevanju svoje ocene.
The evaluating competent authority shall take due account of these comments when finalising its evaluation.
Ocenjevalni pristojni organ pošlje zaključke ocene agenciji.
The evaluating competent authority shall send the conclusions of the evaluation to the Agency.
Če se pri oceni dokumentacije pokaže, da so potrebne dodatne informacije za izvedbo ocene, ocenjevalni pristojni organ od predlagatelja zahteva, da v določenem roku
If, when the dossiers are evaluated, it appears that additional information is necessary to carry out the evaluation, the evaluating competent authority shall ask the applicant to submit such information within a specified time limit
, ki ne presega šestih mesecev.
that shall not exceed six months.
Ocenjevalni pristojni organ
The evaluating competent authority
obvesti agencijo
shall inform the Agency
o zahtevi, ki jo je podal predlagatelju, in o podaljšanju roka
about its request to the applicant and the extension of the time limit
Dvanajstmesečno obdobje iz odstavka 1 se od dneva izdaje zahtevka do dneva prejema informacij prekine.
The 12-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 ocenjevalni pristojni organ meni, da obstajajo pomisleki glede kumulativnih učinkov uporabe biocidnih pripravkov, ki vsebujejo isto aktivno snov,
If the evaluating competent authority considers that there are concerns with regard to the cumulative effects from the use of biocidal products containing the same active substance,
ali različne snovi s podobnimi ali enakimi učinki na iste končne točke, bodisi z enakim bodisi različnim mehanizmom delovanja,
or different substances with similar or common effects on the same endpoints, whether by the same or different mechanism of action,
svoje pomisleke dokumentira skladno z zahtevami ustreznih delov oddelka II.3 Priloge XV k Uredbi (ES) št. 1907/2006 in jih vključi med svoje zaključke.
it shall document its concerns in accordance with the requirements of the relevant parts of Section II.3 of Annex XV to Regulation (EC) No 1907/2006 and include this as part of its conclusions.
Agencija v devetih mesecih po prejemu zaključkov ocene pripravi in predloži Komisiji mnenje o vključitvi aktivne snovi v Prilogo I
Within nine months after receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the inclusion of the active substance in Annex I
, ob upoštevanju sklepov ocenjevalnega pristojnega organa
, having regard to the conclusions of the evaluating competent authority
Da bi bil seznam odobrenih aktivnih snovi vedno posodobljen,
In order to keep the list of authorised active substances updated,
Komisija po prejemu mnenja agencije
on receipt of the opinion of the Agency, the Commission shall adopt
z delegiranimi akti v skladu s členom 73 in pod pogoji iz členov 74 in 75 sprejme odločitev o vključitvi
, by means of delegated acts in accordance with Article 73 and subject to the conditions of Articles 74 and 75,
aktivne snovi v Prilogo I. ▌
a decision ▌to include the active substance in Annex I. ▌
Ne glede na člen 7(1) lahko vlogo oceni drug pristojni organ kot tisti, ki je prejel izvod vloge.
Notwithstanding Article 7(1), the evaluation of the application may be carried out by the competent authority other than the one which has received the copy of the application.
Pristojni organ, ki je bil obveščen o vlogi za oceno, lahko Komisiji v enem mesecu od prejema obvestila iz člena 7(3) predloži ustrezno utemeljeno zahtevo za imenovanje drugega ocenjevalnega pristojnega organa.
The competent authority that has been notified of the application for the evaluation may submit a duly substantiated request to appoint another evaluating competent authority to the Commission within one month after receipt of the notification referred to in Article 7(3).
Komisija odloči v skladu s postopkom iz člena 76(2).
The Commission shall take the decision in accordance with the procedure referred to in Article 76(2).
Dvanajstmesečno obdobje iz odstavka 1 se začne z dnevom sprejetja navedene odločitve.
The 12-month period referred to in paragraph 1 shall commence on the date when this decision is taken.
Aktivne snovi, ki izpolnjujejo vsaj eno izmed naslednjih meril, štejejo za možne snovi za zamenjavo skladno s postopkom iz odstavka 2:
An active substance that fulfils at least one of the following criteria shall be considered a candidate for substitution in accordance with the procedure referred to in paragraph 2:
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;
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;
ustreza dvema meriloma za to, da šteje za snov, ki je obstojna, se kopiči v organizmih in je strupena, kot je določeno v Prilogi XIII k Uredbi (ES) št. 1907/2006;
it meets two of the criteria to be considered as a persistent, bio-accumulative and toxic substance as set out in Annex XIII of Regulation (EC) No 1907/2006;
obstajajo razlogi za skrb v zvezi z naravo kritičnih učinkov, predvsem razvojnih nevrotoksičnih ali imunotoksičnih učinkov, ki v kombinaciji z vzorci uporabe povzročijo uporabo, ki lahko tudi ob zelo restriktivnih ukrepih za obvladovanje tveganja še vedno zbuja pomisleke
there are reasons for concern linked to the nature of the critical effects, in particular developmental neurotoxic or immunotoxic effects, which, in combination with the use patterns, amount to use that could still cause concern,
, npr. visoko raven tveganja za podtalnico
such as high potential of risk to groundwater,
je bila v skladu z Uredbo (ES) št. 1272/2008 razvrščena kot
it is classified or meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as
dražilo dihal,
respiratory sensitisers,
rakotvorna kategorije 1A ali 1B, mutagena kategorije 1A ali 1B ali strupena za razmnoževanje kategorije 1A ali 1B, oziroma izpolnjuje merila za tako razvrstitev;
carcinogen category 1A or 1B, mutagen category 1A or 1B or toxic for reproduction category 1A or 1B;
na podlagi ocene Unije ali mednarodno dogovorjenih smernic za preskuse ali drugih razpoložljivih podatkov velja za snov, ki je po svojih lastnostih endokrini motilec, ki ima lahko neželene učinke na ljudi
it is considered to have endocrine-disrupting properties that may cause adverse effect on humans
Agencija pri pripravljanju mnenja o vključitvi ali obnovitvi vključitve aktivne snovi v Prilogo I preuči, ali aktivna snov izpolnjuje katero izmed meril, naštetih v odstavku 1, in zadevo obravnava v svojem mnenju.
When preparing an opinion on the inclusion, or renewal of the inclusion, of an active substance in Annex I, the Agency shall examine whether the active substance fulfils any of the criteria listed in paragraph 1 and shall address the matter in its opinion.
Preden se mnenje o vključitvi ali obnovitvi vključitve aktivne snovi v Prilogo I predloži Komisiji, da agencija javnosti na voljo informacije o možnih snoveh za zamenjavo ter primeren rok, znotraj katerega lahko zainteresirane tretje strani predložijo ustrezne podatke, vključno s podatki o razpoložljivih nadomestkih.
Prior to submitting the opinion on the inclusion, or renewal of the inclusion, of an active substance in Annex I to the Commission, the Agency shall make publicly available information on potential candidates for substitution with a reasonable period during which relevant information, including information on available substitutes, may be submitted by interested third parties.
Agencija prejete informacije ustrezno upošteva pri zaključevanju svoje ocene.
The Agency shall take due account of the information received when finalising its opinion.
Ne glede na
By way of derogation from
člena 4(1) in
Articles 4(1) and
10(3) se vključitev aktivne snovi, ki je obravnavana kot možna snov za zamenjavo, v Prilogo I
10(3), the inclusion of an active substance in Annex I that is considered as a candidate for substitution shall be
odobri ali
granted or
obnovi za obdobje največ
renewed for a period not exceeding
Aktivne snovi, ki se obravnavajo kot možne snovi za zamenjavo v skladu z odstavkom 1, se kot take opredelijo v Prilogi I.
Active substances that are considered as candidates for substitution in accordance with paragraph 1 shall be identified as such in Annex I.
Če aktivna snov še vedno izpolnjuje zahteve iz člena 4
The Commission shall renew the inclusion of an active substance in Annex I if the active substance still complies with the requirements referred to in Articles 4
in člena 5
and 5
Na podlagi novih preučenih elementov ali prilagoditev tehničnemu napredku lahko, kjer je primerno, za obnovitev vključitve veljajo pogoji in omejitve.
Based on new elements examined or adaptations to technical progress, the renewal of the inclusion may be accompanied, as appropriate, by conditions and restrictions.
največ desetih let
not exceeding 10 years
Predlagatelj pri agenciji vloži vlogo za obnovitev vključitve aktivne snovi v Prilogo I najkasneje 18 mesecev pred iztekom vključitve v Prilogo I za dano vrsto pripravka.
The applicant shall submit the application for renewal of the inclusion of an active substance in Annex I to the Agency at least 18 months before the expiry of the inclusion in Annex I for a given product-type.
Ob vložitvi vloge za obnovitev predlagatelj predloži seznam vseh podatkov, ki so bili v zvezi z aktivno snovjo pridobljeni po njeni vključitvi v Prilogo I, ter utemeljitev nadaljnje veljavnosti ugotovitev iz prvotne ocene aktivne snovi.
When applying for renewal, the applicant shall submit a list of all data relating to the active substance that have been generated since the inclusion of the active substance in Annex I and a justification as to whether the conclusions of the initial assessment of the active substance are still valid.
Ocenjevalni pristojni organ lahko kadar koli od predlagatelja zahteva, da predloži podatke z navedenega sezama.
The evaluating competent authority may require the applicant to submit the data referred to in this list at any time.
Agencija v enem mesecu po prejemu vloge obvesti ocenjevalni pristojni organ, ki je opravil prvotno oceno vloge za vključitev v Prilogo I, da je vloga na voljo v zbirki podatkov agencije.
The Agency shall, within one month after receipt of the application, notify the evaluating competent authority that carried out the initial evaluation of the application for inclusion in Annex I that the application is available in the Agency database.
Agencija validira vlogo v dveh mesecih po prejemu, če izpolnjuje naslednje zahteve:
Within two months after receipt of an application, the Agency shall validate the application if it complies with the following requirements:
informacije iz odstavka 1 so predložene;
information referred to paragraph 1 has been submitted;
Agencija v dveh mesecih po prejemu dodatnih informacij ugotovi, ali so predložene dodatne informacije zadostne za validacijo vloge.
The Agency shall, within two months after receipt of the additional information, determine whether the additional information submitted is sufficient to validate the application.