natgillin/translations-raw huggingface dataset:
(d) aktivne snovi, opredeljene v členu 57(f) Uredbe (ES) št. 1907/2006 kot snovi, ki so po svojih lastnostih endokrini motilci.
(d) active substances identified under Article 57(f) of Regulation (EC) No 1907/2006 as having endocrine disrupting properties.
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, which are as effective as the biocidal product concerned and shall without delay transmit that plan to the Commission.
Uporaba biocidnih pripravkov z zadevno aktivno snovjo je omejena na tiste države članice, v katerih je treba resno nevarnost preprečiti ali, kadar že pride do nje, jo nadzirati.
The use of the biocidal product with the active substance concerned shall be restricted to those Member States where the serious danger has to be prevented or, if it occurs, controlled.
Člen 6 - odstavek 1 - točka a
Article 6 - paragraph 1 - point a
(a) dokumentacijo o aktivni snovi, ki izpolnjuje zahteve iz Priloge II;
(a) a dossier for the active substance satisfying the requirements set out in Annex II;
(a) dokumentacijo o aktivni snovi, ki izpolnjuje zahteve iz Priloge II , ali izjavo o dostopu do dokumentacije ;
(a) a dossier , or a letter of access to a dossier, for the active substance satisfying the requirements set out in Annex II;
Mogoče je, da predlagatelji niso lastniki podatkov, ki so potrebni za podporo vloge.
It is possible that the applicants will not own the data required to support an application.
Člen 6 - odstavek 1 - točka b
Article 6 - paragraph 1- point b
(b) dokumentacijo o najmanj enem reprezentativnem biocidnem pripravku, ki vsebuje aktivno snov, ki izpolnjuje zahteve iz Priloge III.
(b) a dossier for at least one representative biocidal product that contains the active substance satisfying the requirements set out in Annex III.
(b) dokumentacijo ali izjavo o dostopu o najmanj enem reprezentativnem biocidnem pripravku, ki vsebuje aktivno snov, ki izpolnjuje zahteve iz Priloge III.
(b) a dossier or a letter of access for at least one representative biocidal product that contains the active substance satisfying the requirements set out in Annex III.
(a) zaradi izpostavljenosti, povezane s predlagano uporabo, informacije niso nujne;
(a) the information is not necessary owing to the exposure associated with the proposed uses;
(a) informacije niso nujne , saj je vsa zadevna izpostavljenost lahko izključena s predlagano uporabo;
(a) the information is not necessary as all relevant exposure can be ruled out under the proposed uses;
Ta informacija bi se morala črtati samo, če ni zadevne izpostavljenosti.
This information should only be waived if there is no relevant exposure.
Komisija sprejme ukrepe za določitev meril, ki opredeljujejo, kaj je ustrezna utemeljitev za prilagoditev podatkov, ki se zahtevajo v skladu z odstavkom 1, iz razlogov iz odstavka 2(a).
The Commission shall adopt the measures designed to set the criteria defining what constitutes adequate justification to adapt the data required under paragraph 1 on the ground referred to in paragraph 2(a).
Za opredelitev, kaj je ustrezna utemeljitev za prilagoditev podatkov, ki se zahtevajo v skladu z odstavkom 1, pod pogoji iz odstavka 2(a), Komisija prilagodi merila z delegiranimi akti v skladu s členom 71a in pod pogoji iz členov 71b in 71c.
In order to define what constitutes adequate justification to adapt the data required under paragraph 1 on the ground referred to in paragraph 2(a) , the Commission shall adapt the criteria by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c .
Navedeni ukrepi, katerih namen je sprememba nebistvenih elementov te uredbe z njeno dopolnitvijo, se sprejmejo v skladu z regulativnim postopkom s pregledom iz člena 72(4).
Those measures designed to amend non-essential elements of this Regulation by supplementing it shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).
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) in jo obvesti o nazivu pristojnega organa države članice, ki ga je izbral za oceno njegove vloge.
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') and inform it of the name of the competent authority of the Member State that he chooses to evaluate his application.
Navedeni pristojni organ (v nadaljnjem besedilu: ocenjevalni pristojni organ) je odgovoren za oceno vloge.
That competent authority (hereinafter referred to as 'the evaluating competent authority') shall be responsible for the evaluation of the application.
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 navede naziv pristojnega organa države članice, ki ga je izbrala za oceno vloge.
The Agency shall indicate the name of the competent authority of the Member State that it has chosen to evaluate the application.
Agencija ob predložitvi določi številko, ki se uporablja za vso komunikacijo 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 provide a submission number to be used in all correspondence relating to the application until the active substance is included in Annex I, and a submission date, which shall be the date on which the application is received by the Agency.
Poleg vključevanja aktivnih snovi v Prilogo I je evidentiranje posameznih informacij primeren in učinkovit način za preprečevanje koristoljubnih teženj ter podjetjem pomaga pri povrnitvi naložb.
In addition to a reference to the name of the manufacturer in inclusions of active substances in Annex I, including individual information is another appropriate and effective means of avoiding free-riding and helps manufacturers to recoup their investments.
Poleg tega pripomore k preglednosti in olajša izmenjavo podatkov.
It also contributes to transparency and facilitates data sharing.
Člen 7 - odstavek 3 - uvodni del
Article 7 - paragraph 3 - introductory part
V dveh mesecih po prejemu vloge agencija validira vlogo, če so izpolnjene naslednje zahteve:
Within two months after the receipt of an application, the Agency shall validate the application if it complies with the following requirements:
Agencija v treh tednih po prejemu vloge validira vlogo, če so izpolnjene naslednje zahteve:
Within three weeks after the receipt of an application, the Agency shall validate the application if it complies with the following requirements:
Agencija bi morala za validacijo vlog upoštevati enaka merila, kot so navedena v uredbi REACH (člen 20).
The Agency should observe the same timeframes for the validation of applications as those introduced under REACH (Article 20).
Člen 7 – odstavek 4 – pododstavek 1
Article 7 – paragraph 4 - subparagraph 1
Če agencija meni, da je vloga nepopolna, predlagatelja obvesti, katere dodatne informacije so potrebne za validacijo vloge ter določi razumen rok za predložitev navedenih informacij.
If the Agency considers that the application is incomplete, it shall inform the applicant as to what additional information is required for the validation of the application and shall set a reasonable time limit for the submission of that information.
Če agencija meni, da je vloga nepopolna, predlagatelja obvesti, katere dodatne informacije so potrebne za validacijo vloge ter določi rok za predložitev navedenih informacij , ki ni daljši od dveh mesecev .
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 time limit of up to two months for the submission of that information.
Za predložitev dokumentacije, ki mora biti čim bolj zgoščena in jasna, da jo je mogoče hitro oceniti, je treba določiti rok.
A set time limit is needed for the provision of documentation which should be as concise as possible in order to quickly proceed with evaluation.
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 after 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 after the receipt of the additional information, determine whether the additional information submitted is sufficient to validate the application.
Člen 7 – odstavek 4 – pododstavek 3 a (novo)
Article 7 - paragraph 4 - subparagraph 3 a (new)
V dveh mesecih po prejetju vloge agencija vse podatke v dokumentaciji označi z enkratno identifikacijsko kodo.
Within two months of receiving the application, the Agency shall assign a unique identification code to all the information in the dossier.
Če se pri oceni dokumentacije pokaže, da so potrebne dodatne informacije za izvedbo ocene, ocenjevalni pristojni organ od predlagatelja zahteva, da v določenem roku predloži te informacije in o tem obvesti agencijo.
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 , and shall inform the Agency thereof .
Če se pri oceni dokumentacije pokaže, da so potrebne dodatne informacije za izvedbo ocene, ocenjevalni pristojni organ od predlagatelja zahteva, da te informacije predloži v določenem roku , ki ne presega šestih mesecev .
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 that shall not exceed six months.
V izjemnih okoliščinah in po ustrezni obrazložitvi se rok lahko podaljša za dodatno obdobje, ki ne presega šestih mesecev.
In exceptional circumstances and following proper justification, the time limit may be extended by up to a further six months.
Ocenjevalni pristojni organ obvesti agencijo o zahtevi, ki jo je podal predlagatelju, in o podaljšanju roka.
The evaluating competent authority shall inform the Agency about its request to the applicant and the extension of the time limit .
Kadar te dodatne informacije vključujejo preskuse na živalih, strokovnjaki iz agencije ali pristojni organi svetujejo vlagatelju glede ustreznih drugih metod in preskusnih strategij, da se nadomestijo, zmanjšajo ali izboljšajo preskusi na vretenčarjih.
Where such additional information includes animal testing, the applicant shall be advised by experts from the Agency or competent authorities regarding suitable alternative methods and testing strategies to replace, reduce or refine the use of vertebrate animals.
Če ocenjevalni pristojni organ meni, da obstajajo pomisleki glede kumulativnih učinkov uporabe biocidnih pripravkov, ki vsebujejo isto aktivno snov, 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.
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, 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.
Če ocenjevalni pristojni organ meni, da obstajajo pomisleki glede kumulativnih učinkov uporabe biocidnih pripravkov, ki vsebujejo isto aktivno snov, ali različne snovi s podobnimi ali enakimi učinki na iste končne točke, bodisi z enakim bodisi različnim mehanizmom delovanja, 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.
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, or different substances with similar or common effects on the same endpoints, whether by the same or different mechanism of action, 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 the 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.
Agencija v devetih mesecih po prejemu zaključkov ocene pripravi in predloži Komisiji mnenje o vključitvi aktivne snovi v Prilogo I , ob upoštevanju sklepov ocenjevalnega pristojnega organa.
Within nine months after the 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 having regard to the conclusions of the evaluating competent authority .
Treba je pojasniti, da je mnenje Agencije podano ob upoštevanju sklepov ocenjevalnega pristojnega organa.
It should be clarified that the opinion by the Agency is done with regard to the conclusions by the evaluating competent authority.
Da bi bil seznam odobrenih aktivnih snovi vedno posodobljen , Komisija po prejemu mnenja agencije z delegiranimi akti v skladu s členom 71 a in pod pogoji iz členov 71 b in 71 c sprejme odločitev o vključitvi aktivne snovi v Prilogo I.
In order to keep the list of authorised active substances updated, on receipt of the opinion of the Agency, the Commission shall adopt , by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, a decision to include the active substance in Annex I.
Člen 9 – odstavek 1 – uvodni del
Article 9 – paragraph 1 ‑ introductory part
Aktivne snovi , ki izpolnjujejo vsaj eno izmed naslednjih meril, štejejo za možne snovi za zamenjavo skladno s postopkom iz odstavka 2:
An active substance fulfilling at least one of the following criteria shall be considered a candidate for substitution in accordance with the procedure referred to in paragraph 2:
Aktivne snovi štejejo za možne snovi za zamenjavo skladno s postopkom iz odstavka 2 , kadar :
An active substance shall be considered a candidate for substitution in accordance with the procedure referred to in paragraph 2 where :
(b) 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;
(b) 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;
(b) ustreza enemu od meril , na podlagi katerih 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;
(b) it meets one 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;
(c) 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;
(c) 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, even with very restrictive risk management measures;
(c) 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 , npr. visoko raven tveganja za podtalnico ;
(c) 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, such as high potential of risk to groundwater, even with very restrictive risk management measures;
Upoštevanje varstva vodnih virov skladno z uredbo o dajanju fitofarmacevtskih sredstev v promet (1107/2209) Priloga II, točka 4, tretja alinea.
Considering water resources protection by analogy to the regulation concerning the placing of plant protection products on the market (1107/2009) Annex II, 4, 3rd indent.
Člen 9 – odstavek 1 – točka (c a) (novo)
Article 9 – paragraph 1 – point c a (new)
(ca) je glede na merila iz Priloge XIII k Uredbi (ES) št. 1907/2006 zelo obstojna in se zelo kopiči v organizmih;
( ca) it is very persistent and very bioaccumulative according to the criteria set out in Annex XIII to Regulation (EC) No 1907/2006 ;
Zaradi skladnosti dveh uredb se merila za identifikacijo možnih snovi za zamenjavo uskladijo z merili za snovi, ki jih je treba odobriti v skladu z Uredbo REACH (ES) št. 1907/2006 (člen 57).
For reasons of consistency between the two regulations, the criteria for identifying candidates of substitution are aligned with the criteria for substances to be authorised under Regulation (EC) No 1907/2006 (REACH) (Article 57).
Naloga agencije (ECHA) bo preverjanje, ali aktivna snov izpolnjuje merila, zato je skladnost uredb priporočena.
Since the Agency (ECHA) will own the task of examining if an active substance fulfils any of the criteria, consistency between the two regulations is advisable.
Člen 9 – odstavek 1 – točka d
Article 9 – paragraph 1 – point d
d) vsebuje velik delež neaktivnih izomerov;
d) it contains a significant proportion of non-active isomers;
Neaktivni izomeri niso nevarni za zdravje in za okolje, zato jih ni treba uvrstiti med možne snovi za zamenjavo.
There is therefore no need to include them among substances that are candidates for substitution.
(e) je bila v skladu z Uredbo (ES) št. 1272/2008 razvrščena kot rakotvorna kategorije 1A ali 1B, mutagena kategorije 1A ali 1B ali strupena za razmnoževanje kategorije 1A ali 1B, oziroma izpolnjuje merila za tako razvrstitev;
(e) it is classified or meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as carcinogen category 1A or 1B, mutagen category 1A or 1B or toxic for reproduction category 1A or 1B;
(e) je bila v skladu z Uredbo (ES) št. 1272/2008 razvrščena kot dražilo dihal , rakotvorna kategorije 1A ali 1B, mutagena kategorije 1A ali 1B ali strupena za razmnoževanje kategorije 1A ali 1B, oziroma izpolnjuje merila za tako razvrstitev;
(e) it is classified or meets the criteria to be classified, in accordance with Regulation (EC) No 1272/2008, as respiratory sensiti s ers, carcinogen category 1A or 1B, mutagen category 1A or 1B or toxic for reproduction category 1A or 1B;
(f) na podlagi ocene Skupnosti 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.
(f) it is considered to have endocrine disrupting properties that may cause adverse effect on humans on the basis of the assessment of Community or internationally agreed test guidelines or other available data.
(f) 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 ali okolje; ali
(f) it is considered to have endocrine disrupting properties that may cause adverse effect on humans or the environment on the basis of the assessment of Union or internationally agreed test guidelines or other available data ; or
(fa) za načine uporabe, navedene v dokumentaciji o aktivni snovi, že obstaja drugi dovoljeni biocidni pripravek ali nekemična kontrolna ali preventivna metoda, ki je bistveno varnejša za zdravje ljudi ali živali ali za okolje;
( fa) for the uses specified in the dossier of the active substance, an alternative authorised biocidal product or a non-chemical control or prevention method already exists which presents significantly lower risk for human or animal health or the environment .
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 address the matter in its opinion.
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 ali izpostavljenost ni zadosti nadzorovana glede na nevarne lastnosti snovi, ter 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 whether exposure is not adequately controlled, bearing in mind the intrinsic hazards of the substance, and shall address the matter in its opinion.
Ne glede na člen 10(3) se vključitev aktivne snovi, ki je obravnavana kot možna snov za zamenjavo, v Prilogo I obnovi za obdobje največ desetih let.
By way of derogation from Article 10(3), the inclusion of an active substance in Annex I that is considered as a candidate for substitution shall be renewed for a period not exceeding ten years.
Ne glede na člen 4(1) in člen 10(3) se vključitev aktivne snovi, ki je obravnavana kot možna snov za zamenjavo, v Prilogo I odobri ali obnovi za obdobje največ sedmih let.
By way of derogation from Article 4(1) and Article 10(3), the inclusion of an active substance in Annex I that is considered as a candidate for substitution shall be granted or renewed for a period not exceeding seven years.
Obdobje vključitve snovi, ki so možne snovi za zamenjavo, bi moralo biti enako kot v uredbi o fitofarmacevtskih sredstvih.
The inclusion period for substances that are candidates for substitution should be the same as in the PPP regulation.
Če aktivna snov še vedno izpolnjuje zahteve iz člena 4, Komisija njeno vključitev v Prilogo I obnovi.
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 Article 4.