natgillin/translations-raw huggingface dataset:
Če aktivna snov še vedno izpolnjuje zahteve iz člena 4 in člena 5 , 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 Articles 4 and 5 .
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 strožje določeno, se lahko obnovitev ponovno potrdi za obdobje največ desetih let .
Unless more strictly specified in the decision to renew the inclusion of an active substance in Annex I, the renewal may be renewed for a period not exceeding 10 years .
Neskončno podaljševanje novih aktivnih snovi bo omejilo spodbude za izvajanje novih raziskav in zagotavljanje novih znanstvenih podatkov.
Indefinite authorisations of new active substances will limit the incentive to conduct new research and provide new scientific data.
V skladu s sedanjo direktivo o biocidih ter pesticidih/zakonodajo o fitofarmacevtskih sredstvih je treba redno izvajati preglede aktivnih snovi.
In line with the current directive on biocides as well as the pesticides/plant protection legislation, there is a need for review of the active substances on a regular basis.
Člen 11 – odstavek 4 – pododstavek 1
Article 11 – paragraph 4 - subparagraph 1
Da bi bil seznam odobrenih aktivnih snovi vedno posodobljen, Komisija ob koncu obdobja iz odstavka 3 ali ob prejemu mnenja agencije z delegiranimi akti v skladu s členom 71a in pod pogoji iz členov 71b in 71c sprejme odločitev glede obnovitve vključitve aktivne snovi v Prilogo I.
In order to keep the list of authorised active substances updated, at the end of the period referred to in paragraph 3 or 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 concerning a renewal of the inclusion of the active substance in Annex I.
Uskladitev sistema komitologije z novim sistemom delegiranih aktov v skladu s členom 290 PDEU.
To align the comitology regime to the new system of delegated acts in accordance with Article 290 TFEU
Člen 13 – odstavek 1 – pododstavek 1
Article 13 - paragraph 1 - subparagraph 1
Komisija lahko kadarkoli pregleda vključitev aktivne snovi v Prilogo I, če obstajajo resni znaki, da ne izpolnjuje več zahtev iz odstavka 4 .
The Commission may review the inclusion of an active substance in Annex I at any time where there are serious indications that the requirements referred to in Article 4 are no longer complied with.
Če se ti znaki potrdijo, Komisija sprejme odločitev o spremembi vključitve aktivne snovi v Prilogo I ali pa jo iz navedene priloge odstrani.
Where those indications are confirmed, the Commission shall adopt a decision amending the inclusion of an active substance in Annex I or removing it from that Annex.
Da bi bil seznam odobrenih aktivnih snovi vedno posodobljen , lahko Komisija kadarkoli pregleda vključitev aktivne snovi v Prilogo I, če obstajajo znaki, da ne izpolnjuje več zahtev iz člena 4 in člena 5 .
In order to keep the list of authorised active substances updated, the Commission may review the inclusion of an active substance in Annex I at any time where there are indications that any of the requirements in Article s 4 and 5 are no longer complied with.
Vključitev pregleda tudi v primerih, ko obstajajo znaki, da cilji iz člena 4(1)(a)(iv), člena 4(1)(b)(i) ter člena 7(2) in (3) Direktive 2000/60/ES morda ne bodo doseženi.
It shall review inclusion also in cases where there are indications that the objectives of Article 4(1)(a)(iv) , Article 4(1) (b)(i) and Article 7(2) and (3) of Directive 2000/60/EC may not be achieved.
Če se ti znaki potrdijo, Komisija z delegiranimi akti v skladu s členom 71a in pod pogoji iz členov 71b in 71c sprejme odločitev o spremembi vključitve aktivne snovi v Prilogo I ali pa jo iz navedene priloge odstrani.
Where those indications are confirmed, 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 amending the inclusion of an active substance in Annex I or removing it from that Annex.
Sklicevanje na okvirno direktivo o vodah.
Reference to the Water Framework Directive.
Navedena odločitev, namenjena spreminjanju nebistvenih določb te uredbe, se sprejme v skladu z regulativnim postopkom s pregledom iz člena 72(4).
That decision, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 72(4).
V nujnih primerih lahko Komisija uporabi nujni postopek iz člena 72(5).
On imperative grounds of urgency, the Commission may have recourse to the urgency procedure referred to in Article 72(5).
Namen predloga spremembe je zagotovitev skladnosti, saj mora agencija povsod drugod v predlogu na zahtevo Komisije izdati mnenje v šestih mesecih.
Amendment for sake of consistency since everywhere else in the proposal the limit for issuing an opinion by the Agency at the request of the Commission is six months.
Podrobni postopki za obnovitev in pregled
Detailed procedures for renewal and review
Komisija lahko sprejme podrobne ukrepe za izvajanje členov 10 do 13 te uredbe, s katerimi se določijo postopki v zvezi z obnovitvijo in pregledom vključitve aktivne snovi v Prilogo I .
The Commission may adopt detailed measures for the implementation of Articles 10 to 13 of this Regulation specifying the procedures related to the renewal and review of an inclusion of an active substance in Annex I.
Za zagotovitev nemotenega delovanja postopkov za obnovo ali podaljšanje lahko Komisija sprejme nadaljnje podrobne ukrepe z delegiranimi akti v skladu s členom 71a in pod pogoji iz členov 71b in 71c.
In order to ensure the smooth functioning of the renewal and review procedures, the Commission may adopt further detailed measures by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c.
Ukrepi, določeni za spremembo 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).
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, odgovorna za dajanje biocidnega pripravka v promet v določeni državi članici oziroma v Uniji .
The 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 Union .
Oseba, ki je odgovorna za dajanje dovoljenega pripravka v promet, ni vedno imetnica dovoljenja.
The person responsible for placing an authorised product on the market is not always the holder of the authorisation.
Industrija potrebuje to prožnost v dobavni verigi.
The industry needs this flexibility in the supply chain.
Besedilo mora izrecno navesti, da mora predlagatelj v primeru, da bi rad pridobil dovoljenje za okvirno formulacijo, predložiti enotno vlogo za dovoljenje, v kateri zajame vse proizvode, ki jih je treba vključiti v to formulacijo.
The regulation should make it clear that, where the applicant wishes to obtain authorisation for a frame formulation, he must submit a single application for authorisation to cover all products to be included in the formulation.
Člen 15 – odstavek 2 – pododstavek 2
Article 15 - paragraph 2 - subparagraph 2
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 Skupnosti se vloži pri agenciji.
Application for Community authorisation shall be submitted to the Agency.
Vloga za dovoljenje se vloži pri agenciji.
Application for authorisation shall be submitted to the Agency.
Ko predlagatelj vloži vlogo za nacionalno dovoljenje, v dogovoru z zadevno državo članico, na ozemlju katere bo veljalo to dovoljenje, v vlogi navede organ, pristojen za ocenjevanje, kot je določeno v členu 22.
When an applicant submits an application for national authorisation, that applicant shall, with the agreement of the Member State concerned on whose territory the national authorisation would be applicable, identify the evaluating competent authority in the application itself, as laid down in Article 22.
(Opomba: Predlog spremembe velja za celotno besedilo.
( Note: This amendment applies throughout the text.
Če bo sprejet, bo treba omembo pristojnega organa prejemnika po potrebi po vsem besedilu nadomestiti z agencijo ali ocenjevalnim pristojnim organom.)
If adopted, reference to "receiving competent authority" is to be replaced by reference to "Agency" or "evaluating competent authority", as appropriate, throughout the text.)
Agencija (ECHA) bi morala opraviti prvotno validacijo vseh vlog.
The ECHA should conduct the initial validation of all applications .
Člen 15 – odstavek 2 – pododstavek 3 a (novo)
Article 15 – paragraph 2 – subparagraph 3 a (new)
Za skupino pripravkov, ki bodo odobreni z okvirno formulacijo, je dopustna ena sama vloga za pridobitev dovoljenja.
A single application for authorisation may be made by the applicant for a group of products intended to be authorised under a frame formulation.
V besedilu je treba izrecno navesti, da se v primerih, ko želi vlagatelj pridobiti dovoljenje za isto okvirno formulacijo, vloži ena sama vloga, s katero se zajamejo vsi pripravki, ki bodo sodili v ta okvir.
The text should explicitly specify that in case the applicant would like to have an authorisation granted for a frame formulation, then one single application is to be made to cover all products intended to be part of the frame.
Besedilo te pojasnitve doslej ni vsebovalo.
Such a clarification does not currently appear in the text.
Člen 15 – odstavek 5 – pododstavek 2 a (novo)
Article 15 – paragraph 5 –subparagraph 2 a (new)
Napad škodljivih organizmov je treba preprečiti z ustreznimi odvračilnimi ukrepi, da se ti organizmi izkoreninijo ali odženejo.
Infestation with harmful organisms shall be avoided by suitable measures of deterrence to banish or repel these organisms.
Poleg tega je treba sprejeti druge varnostne ukrepe, na primer ustrezno skladiščenje blaga, upoštevanje higienskih standardov in takojšnje odstranjevanje odpadkov.
In addition, other precautionary steps have to be taken, such as proper warehousing of goods, compliance with hygiene standards and immediate disposal of waste.
Samo če ti ukrepi niso učinkoviti, je treba sprejeti nadaljnje ukrepe.
Only if these measures show no effect shall further steps be taken.
Biocidni pripravki, ki predstavljajo majhno tveganje za ljudi, živali in okolje, se vedno uporabijo pred drugimi.
Biocidal products that pose low risks for humans, animals and the environment sh all always be used in preference to others.
Biocidni pripravki, ki bi ubili ali uničili živali, ki so sposobne čutiti bolečino in stisko, ali jim škodovali, se uporabijo samo v skrajni sili.
Biocidal products that are intended to harm, kill or destroy animals that are capable of experiencing pain and distress sh all only be applied as a last resort.
Člen 15 bi bilo treba razširiti z novim odstavkom 1, da se vključijo določbe o trajnostni uporabi biocidov.
Article 15 should be extended by a new Paragraph 1 to include regulations on the sustainable use of biocides.
Člen 15 – odstavek 5 – pododstavek 2 b (novo)
Article 15 – paragraph 5 – subparagraph 2 b (new)
Z okvirno direktivo za ukrepanje Unije se vzpostavijo in izvajajo obvezni ukrepi, s katerimi bi dosegli trajnostno profesionalno uporabo biocidnih pripravkov, vključujejo pa uvedbo nacionalnih akcijskih načrtov, celostno zatiranje škodljivcev, ukrepe za zmanjševanje tveganja ter spodbujanje alternativnih možnosti.
Mandatory measures shall be established and implemented with a f ramework d irective for Union action in order to achieve the sustainable professional use of biocid al products including the introduction of National Action Plans, integrated pest management, risk reduction measures and the promotion of alternatives.
Komisija do …* poda predlog Evropskemu parlamentu in Svetu.
By ... * , the Commission shall submit a proposal to the European Parliament and the Council.
* Vstaviti datum dve leti po sprejetju te uredbe.
* Please insert date two years after adoption of this Regulation.
Člen 16 – odstavek 1 – točka b – točka iii
Article 16 – paragraph 1 – point b – point iii
(iii) nima sam po sebi ali njegovi ostanki nesprejemljivih neposrednih ali posrednih učinkov na zdravje človeka ali živali;
(iii) it has no unacceptable effects itself or as a result of its residues, directly or indirectly , on human or animal health;
(iii) sam po sebi ali njegovi ostanki nimajo takojšnjega ali zapoznelega škodljivega učinka na podtalnico ali zdravje ljudi, vključno z ranljivimi skupinami, ali zdravje živali, neposredno ali prek pitne vode (ob upoštevanju snovi, nastalih pri obdelavi vode), hrane, krme ali zraka ali posledic na delovnem mestu ali preko drugih neposrednih učinkov, ob upoštevanju ugotovljenih kumulativnih in sinergijskih učinkov, kadar so na voljo znanstvene metode za ocenjevanje takšnih učinkov, ki jih priznava agencija;
(iii) it has no immediate or delayed harmful effect on groundwater or on human health itself or as a result of its residues, including that of vulnerable groups , or animal health , directly or through drinking water (taking into account substances resulting from water treatment), food, feed or air, or consequences in the workplace or through other indirect effects, taking into account known cumulative and synergistic effects where the scientific methods accepted by the Agency to assess such effects are available ;
Kadar gre za zdravje ljudi, je nesprejemljivo govoriti o „nesprejemljivih“ učinkih.
It is unacceptable to speak of "unacceptable" effects when speaking about human health.
Pri dovoljenjih za fitofarmacevtska sredstva je bil izraz nesprejemljivo uporabljen samo za učinke na okolje.
In the context of the authorisation of plant protection products, the term "unacceptable" was only used in the context of environmental effects.
Tukaj bi bilo treba uporabiti ubeseditev iz uredbe o fitofarmacevtskih sredstvih, še toliko bolj, ker vključuje kumulativne in sinergijske učinke.
The wording from the PPP regulation should be used here, all the more that it also includes cumulative and synergistic effects.
Člen 16 – odstavek 1 – točka b – točka iv – alinea 2
Article 16 – paragraph 1 – point b –point iv – indent 2
– onesnaženje površinskih voda (vključno s somornico in morsko vodo), podtalnice in pitne vode, zraka ter tal;
- contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil;
– onesnaženje površinskih voda (vključno s somornico in morsko vodo), podtalnice in pitne vode, zraka ter tal ob upoštevanju lokacij, oddaljenih od kraja uporabe snovi zaradi prenosa v okolju na velike razdalje ;
- contamination of surface waters (including estuarial and seawater), groundwater and drinking water, air and soil , taking into account locations distant from its use following long-range environmental transportation ;
Uskladitev z ubeseditvijo uredbe o fitofarmacevtskih sredstvih.
To be in line with the wording adopted for PPP.
(c) je v skladu z zahtevami iz Prilog II in III mogoče določiti vrsto , količino in tehnično enakovrednost aktivnih snovi v biocidnem pripravku, in kadar je to primerno, vse toksikološko ali ekotoksikološko pomembne nečistote in neaktivne snovi ter ostanke toksikološkega in okoljskega pomena, ki so posledica dovoljene uporabe;
(c) the nature , the quantity and the technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant impurities and non-active substances, and its residues of toxicological or environmental significance, which result from uses to be authorised, can be determined according to the relevant requirements in Annexes II and III;
(c) v skladu z zahtevami iz prilog II in III je treba določiti kemijsko identiteto , količino in tehnično enakovrednost aktivnih snovi v biocidnem pripravku in, kadar je to primerno, vse toksikološko ali ekotoksikološko pomembne nečistote in neaktivne snovi ter metabolite in ostanke toksikološkega ali okoljskega pomena, ki so posledica dovoljene uporabe;
(c) the chemical identity , the quantity and the technical equivalence of active substances in the biocidal product and, where appropriate, any toxicologically or ecotoxicologically significant impurities and non-active substances, and its metabolites and residues of toxicological or environmental significance, which result from uses to be authorised, should be determined according to the relevant requirements in Annexes II and III;
Člen 16 – odstavek 1 – točka d a (novo)
Article 16 - paragraph 1 - point d a (new)
(da) je bilo pri uporabi nanomaterialov v tem izdelku posebej ocenjeno tveganje za okolje in zdravje.
(da) where nanomaterials are used in that product , the risk to the environment and to health has been assessed separately.
Nanomateriali imajo drugačne lastnosti kot enake snovi, ki niso v nanoobliki.
Nanomaterials have different characteristics to the same substances in a non-nanomaterial form.
Nevarnost biocidov z nanomateriali je treba zato še posebno dobro preveriti.
The risks posed by biocides with nanomaterials must therefore be investigated separately.
Člen 16 – odstavek 2 – točka (c a) (novo)
Article 16 – paragraph 2 – point c a (new)
(ca) kumulativni in sinergijski učinki.
( ca) cumulative or synergistic effects.
Za zagotovitev doslednega varovanja zdravja ljudi in okolja.
Ensures a consistent protection of the environment and human health.
Poleg tega je treba upoštevati varstvo ranljivih skupin – kot je predpisano z Uredbo (ES) 1107/2009 o fitofarmacevtskih sredstvih – in kombinacijo učinkov.
In addition, the protection of vulnerable groups – like it is prescribed according to Regulation (EC) 1107/2009 concerning provisions on plant protection products - and combination effects should be taken into consideration.
Namen predloga spremembe je preprečitev nepotrebnih poskusov na vretenčarjih.
Avoidance of unnecessary tests on vertebrates.
Gre za prilagoditev določbam glede koncentracijskih območij za poročilo o kemijski varnosti.
Adaptation to the rules on concentration limits for a chemical safety report.
Člen 16 – odstavek 2 b (novo)
Article 16 – paragraph 2 b (new)
Ocena, koliko biocidni pripravek izpolnjuje zastavljena merila iz točk (b) in (c) odstavka 1, ne sme upoštevati snovi iz biocidnega pripravka, če je koncentracija te snovi v pripravku nižja od:
The evaluation of the compliance of the biocidal product with the criteria set out in points (b) and (c) of paragraph 1 shall not take into account a substance contained in the biocidal product if it is present in a preparation at a concentration lower than any of the following:
(a) ustreznih koncentracij iz člena 3(3) Direktive 1999/45/ES,
(a) the applicable concentrations laid down in Article 3(3) of Directive 1999/45/EC;
(b) najvišje dovoljene koncentracije iz Priloge I Direktive 67/548/EGS;
(b) the concentration limit values laid down 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 laid down 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 laid down in Part B of Annex III to Directive 1999/45/EC;
(e) mejna koncentracije iz sporazumno določenih vrednosti v popisu razvrstitev in oznak, vzpostavljenem v skladu z naslovom V Uredbe (ES) št. 1272/2008;
(e) the concentration limit values laid down in an agreed entry in the classification and labelling inventory established under Title V of Regulation (EC) No 1272/2008;
(f) 0,1 % masnega deleža (w/w), če snov izpolnjuje merila iz Priloge XIII Uredbe (ES) št. 1907/2006.
(f) 0.1% weight by weight (w/w), if the substance meets the criteria in Annex XIII to Regulation (EC) No 1907/2006.
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 avoid unnecessary animal testing by providing a clearer definition of the procedures for comparing existing information, while complying with the requirements of REACH with regard to the Chemical Safety Report thresholds.
Dovoljenje za dajanje biocidnega pripravka z manjšim tveganjem v promet je skladno z zahtevami iz točk (b), (c) in (d) odstavka 1.
An authorisation to place a low-risk biocidal product on the market shall be subject to compliance with the requirements of points (b), (c) and (d) of paragraph 1.
Dovoljenje za dajanje biocidnega pripravka z manjšim tveganjem v promet se lahko izda samo, če se oceni, da gre za aktivne snovi z manjšim tveganjem, ki so vključene v Prilogo I (ali ločeno prilogo) v skladu s členoma 4 in 5 .
An authorisation to place a low-risk biocidal product on the market can be granted only if the active substances are evaluated as low-risk active substances and included in Annex I (or a separate annex) in accordance with Article s 4 and 5 .
Dovoljenje je skladno z zahtevami iz točk (a), (b), (c) in (d) odstavka 1.
T he authorisation shall be subject to compliance with the requirements of points (a), (b), (c) and (d) of paragraph 1.
Predlog Komisije ne zagotavlja nobenega ocenjevanja aktivnih snovi z manjšim tveganjem na ravni EU.
The Commission's proposal does not guarantee any kind of evaluation on EU-level of low risk active substances.
Da bi bil nek pripravek priznan kot pripravek z manjšim tveganjem, je treba njegove aktivne snovi oceniti vsaj na ravni EU in jih vključiti v Prilogo I.
Therefore, the active substances of a low risk product should as a very minimum be evaluated on an EU-level and be included on annex I in order for the product to be recognized as a low-risk product.
Člen 16 – odstavek 5 – točka b a (novo)
Article 16 – paragraph 5 – point b a (new)
(ba) ima lastnosti povzročiteljev endokrinih motenj.
( ba) considered to have endocrine - disrupting properties ;
Te snovi pomenijo tveganje za zdravje, zato ne bi smele pristati v rokah splošne javnosti.
Because of the health hazards of these substances, they should not be allowed in the hands of the general public
Člen 16 – odstavek 5 – točka b b (novo)
Article 16 – paragraph 5 – point b b (new)
(bb) ima razvojne nevrotoksične ali imunotoksične učinke.
( bb ) developmental neurotoxic or immunotoxic effects.