natgillin/translations-raw huggingface dataset:
V skladu z uredbo o fitofarmacevtskih sredstvih je treba državam članicam dovoliti, da prilagodijo uporabo biocidov (člen 58(2)(d)) in kategorije uporabnikov (člen 58(2)(k)).
In line with the PPP regulation, Member States should also be allowed to adjust the uses of the biocides (Article 58(2)(d)) and the categories of users (Article 58(2)(k)).
Člen 29 – odstavek 1 – pododstavek 1 – točka c
Article 29 – paragraph 1 – subparagraph 1 – point c
(c) se ustrezne okoliščine uporabe, zlasti podnebje ali obdobje razmnoževanja ciljne vrste, znatno razlikujejo od okoliščin v državi članici, v kateri je bila opravljena prvotna ocena, ali državi članici, v kateri je bilo izdano prvotno nacionalno dovoljenje, in bi zato nespremenjeno nacionalno dovoljenje lahko pomenilo nesprejemljivo tveganje za človeka ali okolje .
(c) the relevant circumstances of use, in particular the climate or the breeding period of the target species, differ significantly from those in the Member State where the initial evaluation was carried out or the Member State where the initial national authorisation was issued, and an unchanged national authorisation may therefore present unacceptable risks to humans or to the environment .
(c) se ustrezne okoliščine uporabe, zlasti podnebje ali obdobje razmnoževanja ciljne vrste, znatno razlikujejo od okoliščin v državi članici, v kateri je bila opravljena prvotna ocena, ali državi članici, v kateri je bilo izdano prvotno nacionalno dovoljenje.
(c) the relevant circumstances of use, in particular the climate or the breeding period of the target species, differ significantly from those in the Member State where the initial evaluation was carried out or the Member State where the initial national authorisation was issued.
Državam članicam bi bilo treba dovoliti prilagoditev glede na lokalne okoliščine, kadar podnebje ali obdobje za razmnoževanje bistveno odstopa.
Member States should be allowed to adjust to local circumstances whenever the climate or the breeding period differs significantly.
To je celo strožje kot pri uredbi o fitofarmacevtskih sredstvih, ki dopušča nacionalne prilagoditve brez kakršnih koli pogojev (glej člen 36(3) te uredbe).
This is even more strict than the PPP regulation, which allows for national adjustments without any conditions (see Article 36(3) of the PPP regulation).
Člen 29 – odstavek 1 – pododstavek 1 – točka (c a) (novo)
Article 29 – paragraph 1 – subparagraph 1 – point c a (new)
(ca) nespremenjeno nacionalno dovoljenje lahko pomeni škodljive učinke za zdravje ljudi ali nesprejemljive vplive na okolje.
( ca) an unchanged national authorisation may present harmful effects on human health or unacceptable effects on the environment.
V uredbi o fitofarmacevtskih sredstvih ni pogojev za prilagoditev dovoljenj glede na lokalne okoliščine.
In the PPP regulation, there are no conditions for the adjustment of authorisations to local circumstances.
Države članice morajo imeti splošno možnost prilagoditve za primere, ko menijo, da bi nespremenjeno nacionalno dovoljenje škodilo zdravju ljudi ali bi imelo nesprejemljiv vpliv na okolje.
As such, it should be possible for Member States to adjust in general in case they consider that an unchanged national authorisation would present harmful effects on human health or unacceptable effects on the environment.
Ob upoštevanju prava Unije je mogoče uvesti ustrezne pogoje v skladu z zahtevami iz člena 15 ter druge ukrepe za zmanjšanje tveganja, ki izhajajo iz posebnih pogojev uporabe.
Subject to Union law, appropriate conditions may be imposed with respect to the requirements referred to in Article 15 and other risk - mitigation measures deriving from specific conditions of use.
Dodatni ukrepi za zmanjšanje tveganja za ljudi in okolje v zvezi z uporabo biocidov glede na posebne okoliščine v državi članici.
Additional measures to reduce the risk to humans and the environment with regard to the use of biocides, in the light of specific circumstances in a Member State.
Komisija sprejme odločitev o predlagani prilagoditvi pogojev za nacionalno dovoljenje lokalnim okoliščinam v skladu s postopkom iz člena 72(3).
The Commission shall adopt a decision on the proposed adjustment of the conditions of the national authorisation to local circumstances in accordance with the procedure referred to in Article 72(3).
Pristojni organ zadevne države članice nemudoma sprejme vse ustrezne ukrepe, da bo v skladu z navedeno odločitvijo.
The competent authority of the concerned Member State shall without delay adopt all appropriate measures to comply with that decision.
Komisija po posvetovanju s predlagateljem sprejme odločitev o predlagani prilagoditvi pogojev za nacionalno dovoljenje lokalnim okoliščinam v skladu s postopkom iz člena 72(3).
The Commission shall , after consultation with the applicant, adopt a decision on the proposed adjustment of the conditions of the national authorisation to local circumstances in accordance with the procedure referred to in Article 72(3).
Člen 29 – odstavek 2 a (novo)
Article 29 – paragraph 2 a (new)
(2a) Komisija pripravi predlog sklepa v treh mesecih od prejetja obvestila.
(2a) Within three months of receiving the notification, the Commission shall make a proposal for a decision.
Trije meseci so primerno časovno obdobje, da lahko Komisija izdela predlog sklepa za utemeljitev priznanja ali nepriznanja dovoljenja.
Three months is an adequate period of time for the Commission to make a proposal for a decision setting out the grounds for recognising or not recognising authorisations.
Člen 31 – naslov
Article 31 – title
Odstopanje v zvezi z nekaterimi vrstami pripravkov
Derogation regarding certain product-types
Odstopanje v zvezi z nekaterimi aktivnimi snovmi ali vrstami pripravkov
Derogation regarding certain active substances or product-types
(Povezano s predlogom spremembe za člen 31.)
((Linked to the amendment of Article 31.) )
Državam članicam je treba dovoliti, da zavrnejo medsebojno priznavanje za snovi, ki spadajo pod merila za izključitev, in za možne snovi za zamenjavo.
Member States should be allowed to refuse mutual recognition for substances that fall under the exclusion criteria and for substances that are candidates for substitution.
Ne glede na člena 25 in 28 lahko pristojni organi držav članic zavrnejo medsebojno priznavanje nacionalnih dovoljenj, izdanih za pripravke vrst 15, 17 in 23 Priloge V, če se take zavrnitve lahko upravičijo z zaščito zdravja ljudi, živali ali rastlin, varstvom nacionalnega bogastva umetniške, zgodovinske ali arheološke vrednosti ali varstvom industrijske in poslovne lastnine.
By way of derogation from Articles 25 and 28 , competent authorities of Member States may refuse mutual recognition of national authorisations granted for product types 15, 17 and 23 of Annex V provided that such a refusal can be justified on grounds of the protection of health of humans, animals or plants, the protection of national treasures possessing artistic, historic or archaeological value, or the protection of industrial and commercial property.
Pristojni organi držav članic nemudoma obvestijo drug drugega in Komisijo o vseh odločitvah, sprejetih v zvezi s tem, ter navedejo razloge zanje.
Competent authorities of Member States shall without delay inform each other and the Commission of any decision taken in this respect and shall indicate the reasons thereof.
Ne glede na člene 25 –29 lahko pristojni organi držav članic zavrnejo medsebojno priznavanje nacionalnih dovoljenj, izdanih za aktivne snovi iz členov 5 in 9 ter za pripravke vrst 15, 17 in 23 Priloge V, če se take zavrnitve lahko upravičijo z zaščito zdravja ljudi, zlasti ranljivih skupin, z zaščito zdravja živali ali rastlin, varstvom okolja, nacionalnega bogastva umetniške, zgodovinske ali arheološke vrednosti ali varstvom industrijske in poslovne lastnine.
By way of derogation from Articles 25 - 29 , competent authorities of Member States may refuse mutual recognition of national authorisations granted for active substances referred to in Article s 5 and 9 and for product types 15, 17 and 23 of Annex V provided that such a refusal can be justified on grounds of the protection of health of humans, particularly of vulnerable groups, the protection of the health of animals or plants, the protection of environment , national treasures possessing artistic, historic or archaeological value, or the protection of industrial and commercial property.
Člen 33 – odstavek 1
Article 33 – paragraph 1
Dovoljenje Skupnosti se lahko izda za naslednje kategorije biocidnih pripravkov:
The Community authorisation may be granted to the following categories of biocidal products:
Dovoljenje Unije se lahko izda za vse kategorije biocidnih pripravkov.
The Union authorisation may be granted to any category of biocidal products.
(a) biocidne pripravke, ki vsebujejo eno ali več novih aktivnih snovi;
(a) biocidal products containing one or more new active substances;
(b) biocidne pripravke z manjšim tveganjem.
(b) low-risk biocidal products.
Centraliziran sistem izdaje dovoljenj bo za delovanje notranjega trga koristen, saj bo omogočal dosledno ocenjevanje in usklajeno izvajanje zahtev v vseh državah članicah, z njim pa se bodo lahko tudi širili primeri najboljše prakse in enaki standardi za zaščito potrošnikov po vsej Evropi.
A centralised authorisation system has clear benefits for the functioning of the internal market by ensuring consistent assessments and a harmonised implementation of the requirements in all Member States , driving best practices and same standards of consumer protection across Europe .
Zato je treba postopek izdajanja dovoljenj Skupnosti razširiti na vse kategorije izdelkov in ne le na zelo omejeno skupino pripravkov (biocidni pripravki z nizkim tveganjem in pripravki, ki vsebujejo nove aktivne snovi).
The Community authorisation procedure should therefore extend to all product categories instead of only a small minority of products (low risk biocidal products and products with new active substances).
Člen 33 – odstavek 1a (novo)
Article 33 – paragraph 1a (new)
Dovoljenje Unije se ne izda za biocidne pripravke, ki vsebujejo aktivne snovi iz členov 5 ali 9.
A Union authorisation may not be granted for biocidal products that contain active substances that fall under Article s 5 or 9.
(2) Glede na poročilo Komisije o izvajanju te uredbe iz člena 54(4) in glede na izkušnje v zvezi z dovoljenji Skupnosti lahko Komisija doda druge kategorije biocidnih pripravkov v odstavek 1 tega člena.
(2) Following the report of the Commission on the implementation of this Regulation referred to in Article 54(4) and in light of the experience gained with the Community authorisations, the Commission may add other categories of biocidal products in paragraph 1 of this Article.
Ti ukrepi, oblikovani za spreminjanje nebistvenih elementov te uredbe, tako da jo dopolnijo, 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 according to the regulatory procedure with scrutiny referred to in Article 72(4).
Izdaja dovoljenja Skupnosti bi morala biti mogoča za vse vrste pripravkov, torej tudi za pripravke, ki vsebujejo izključno obstoječe aktivne snovi.
It should be possible to obtain the Community authorisation for all types of product, i.e. including products that contain only existing active substances.
Na drugi strani bi se upravni stroški tako predlagateljev kot držav članic znatno zmanjšali.
On the one hand, administrative expenditure by both applicants and Member States would be substantially reduced.
Na drugi strani takšna razširitev ne bi preobremenila sistema, ker je vključitev aktivnih snovi v Prilogo I vezana na program preverjanja.
On the other, extending the system in this way would not overburden it because the inclusion of active substances in Annex I is linked to the review programme.
Biocidni pripravki s podobnimi pogoji uporabe
Biocidal products with similar conditions of use
V skladu s točko (ba) člena 33(1) se pripravek šteje za biocidni pripravek s podobnimi pogoji uporabe, če so izpolnjena vsa naslednja merila:
In accordance with point (ba) of Article 33(1), a product shall be considered a biocidal product with similar use conditions if all of the following criteria are met:
(a) glede na navodila za uporabo se po vsej Uniji uporablja pri podobnih pogojih;
( a ) it has similar conditions of use across the Union , according to use instructions;
Komisija opredeli ali prilagodi število držav članic iz točke (b) z delegiranimi akti v skladu s členom 71 a in pod pogoji iz členov 71(b) in 71(c).
T he Commission shallt , by means of delegated acts in accordance with Article 71 a and subject to the conditions of Articles 71 b and 71 c, define or adapt the number of Member States referred to in point (b).
Števila držav članic ni mogoče zmanjšati za več kot dve vsaki dve leti.
The number of Member States shall not be reduced by more than two every two years.
Merila temeljijo na ciljno usmerjeni in skladni uporabi teh vrst pripravkov v celotni EU (število držav članic še ni določeno) ter njihovem pozitivnem prispevku k zaščiti varnosti ljudi in živali.
The criteria are based on the targeted and consistent application and use of those types of products across the EU (number of Member States to be specified), as well as their positive contribution to human and animal safety protection.
V prilogi VI so določena načela za ocenjevanje dokumentacije za biocidne pripravke za zagotavljanje usklajene visoke ravni varovanja ljudi in okolja.
Annex VI lays down the principles for the evaluation of dossiers for biocidal products to ensure a harmonised high level of protection for humans and the environment.
To vključuje natančne ocene tveganja za izdelke med njihovo uporabo.
This involves detailed risk assessment of products during their use.
Člen 35 – odstavek 3 – pododstavek 1
Article 35 – paragraph 3 – subparagraph 1
(3) V devetih mesecih od prejema zaključkov ocene agencija pripravi in predloži Komisiji mnenje o dovoljenju za biocidni pripravek.
(3) Within nine months from the receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the authorisation of the biocidal product.
(3) V treh mesecih od prejema zaključkov ocene agencija pripravi in predloži Komisiji mnenje o dovoljenju za biocidni pripravek.
(3) Within three months from the receipt of the conclusions of the evaluation, the Agency shall prepare and submit to the Commission an opinion on the authorisation of the biocidal product.
Obdobje devetih mesecev, ki ga ima agencija na voljo za pripravo in predložitev mnenja, je bistveno predolgo, saj se mnenje oblikuje na podlagi obstoječe ocene, ki jo je pripravil ocenjevalni organ.
Nine months is much too long a time to allow for the Agency to prepare and submit an opinion, given that opinions are prepared on the basis of existing evaluations carried out by the evaluating authority.
Za to nalogo bi bilo ustreznejše obdobje treh mesecev.
Three months would be a more suitable period.
Člen 35 – odstavek 4 – pododstavek 2
Article 35 - paragraph 4 - subparagraph 2
Komisija lahko na zahtevo države članice odloči, da dovoljenje Skupnosti za biocidni pripravek vrste 15, 17 ali 23 Priloge V ne velja na ozemlju navedene države članice, če se taka zahteva lahko upraviči z zaščito zdravja ljudi, živali ali rastlin, varstvom nacionalnega bogastva umetniške, zgodovinske ali arheološke vrednosti ali varstvom industrijske in poslovne lastnine.
The Commission may, on the request of a Member State , decide that the Community authorisation shall not apply in the territory of that Member State for a biocidal product of the product-types 15, 17 or 23 of Annex V provided that such a request can be justified on grounds of the protection of health of humans, animals or plants, the protection of national treasures possessing artistic, historic or archaeological value, or the protection of industrial and commercial property.
Država članica obvesti Komisijo, če omeji ali prepove dovoljenje Unije za biocidni pripravek vrste 15, 17 ali 23 Priloge V na ozemlju te države članice .
The Member State shall notify the Commission where it restrict s or prohibit s the Union authorisation for a biocidal product of the product-types 15, 17 or 23 of Annex V in the territory of that Member State .
Omejite ali prepoved mora biti utemeljena na podlagi varstva:
Such restriction or prohibition must be justified on grounds of the protection of :
(a) zdravja ljudi, zlasti ranljivih skupin, ali
(a) human health, particularly that of vulnerable groups ,
(b) okolja, zlasti občutljivih ekosistemov,
(b) the environment, particularly vulnerable ecosystems ,
(e) nacionalnega bogastva umetniške, zgodovinske ali arheološke vrednosti ali
(e) national treasures possessing artistic, historic or archaeological value, or
(f) industrijske in poslovne lastnine.
(f) industrial and commercial property.
Člen 35 – odstavek 4 – pododstavek 3
Article 35 - paragraph 4 - subparagraph 3
Komisija lahko na zahtevo države članice odloči, da je treba nekatere pogoje za dovoljenje Skupnosti prilagoditi različnim lokalnim okoliščinam v navedeni državi članici v skladu s členom 29.
The Commission may, on the request of a Member State , decide that certain conditions of the Community authorisation should be adjusted to the different local circumstances in that Member State in accordance with Article 29.
Država članica obvestijo Komisijo , če se odloči, da je treba dovoljenje Unije prilagoditi različnim lokalnim okoliščinam v navedeni državi članici v skladu s členom 29
A Member State shall inform the Commission if it decid es that the Union authorisation should be adjusted to the different local circumstances in that Member State in accordance with Article 29.
Imetnik dovoljenja ali njegov zastopnik vloži vlogo za obnovitev dovoljenja Skupnosti agenciji najmanj 18 mesecev pred iztekom dovoljenja.
The authorisation holder or his representative shall submit an application for renewal of a Community authorisation to the Agency at least 18 months before the expiry date of the authorisation.
Imetnik dovoljenja ali njegov zastopnik vloži vlogo za obnovitev dovoljenja Unije agenciji najmanj 12 mesecev pred iztekom dovoljenja.
The authorisation holder or his representative shall submit an application for renewal of a Union authorisation to the Agency at least 12 months before the expiry date of the authorisation.
Če ni novih podatkov za oceno, je 18 mesecev predolgo obdobje za obnovitev dovoljenja za pripravek.
Unless there is new data to evaluate, 18 months is not necessary to renew an authorisation of a product.
12-mesečno obdobje je ustreznejše.
12 months would be a more appropriate time frame.
Člen 37 – odstavek 2 – pododstavek 1
Article 37 – paragraph 2 - subparagraph 1
Če ocenjevalni pristojni organ, ki je opravil prvotno oceno vloge za dovoljenje Skupnosti odloči, da popolna ocena vloge ni potrebna, v dvanajstih mesecih po validaciji pripravi in predloži agenciji priporočilo za obnovitev dovoljenja.
If the evaluating competent authority that carried out the initial evaluation of the application for Community authorisation decides that a full evaluation of the application is not necessary, it shall, within twelve months after the validation, prepare and submit to the Agency a recommendation on the renewal of the authorisation.
Če ocenjevalni pristojni organ, ki je opravil prvotno oceno vloge za dovoljenje Unije odloči, da popolna ocena vloge ni potrebna, v šestih mesecih po validaciji pripravi in predloži agenciji priporočilo za obnovitev dovoljenja.
If the evaluating competent authority that carried out the initial evaluation of the application for Union authorisation decides that a full evaluation of the application is not necessary, it shall, within six months after the validation, prepare and submit to the Agency a recommendation on the renewal of the authorisation.
In Article 12.2 for renewal of inclusion of active substance in Annex I, when full evaluation is not necessary it is required that the evaluating authority issues a recommendation for renewal in 6 months not 12.
In Article 12.2 for renewal of inclusion of active substance in Annex I, when full evaluation is not necessary it is required that the evaluating authority issues a recommendation for renewal in 6 months not 12.
(a) nova spoznanja ali podatki o učinkih aktivne snovi ali biocidnega pripravka na človeka ali okolje;
(a) new knowledge or information on the effects of the active substance or biocidal product for humans or the environment;
(a) nova spoznanja ali podatki o učinkih aktivne snovi ali biocidnega pripravka na človeka ali okolje , zlasti učinke na ranljive skupine;
(a) new knowledge or information on the effects of the active substance or biocidal product for humans or the environment , especially effects on vulnerable groups ;
Člen 38 – odstavek 1 – točka (c a) (novo)
Article 38 – paragraph 1 – point c a (new)
(ca) spremembe v izvoru ali sestavi aktivne snovi.
(ca) changes in the source or composition of the active substance.
Treba je sporočiti spremembo vira aktivne sestavine, ki se uporablja v biocidnih pripravkih, saj bi lahko vplivala na varnost pripravka.
A change in the source of an active substance used in a biocidal product needs to be reported because it could affect the product’s safety.
Člen 39 - odstavek 1 - točka a
Article 39 - paragraph 1 - point a
(a) zahteve iz člena 16 niso izpolnjene ;
(a) the requirements referred to in Article 16 are not satisfied ;
(a) če niso izpolnjene zahteve iz člena 16 ali standardi Unije za varstvo zdravja ljudi in okolja, določeni zlasti v Direktivi 2008/56/ES Evropskega parlamenta in Sveta z dne 17. junija 2008 o določitvi okvira za ukrepe Skupnosti na področju politike morskega okolja (Okvirna direktiva o morski strategiji) 1 , Direktivi 2006/118/ES Evropskega parlamenta in Sveta z dne 12. decembra 2006 o varstvu podzemne vode pred onesnaževanjem in poslabšanjem 2 , Direktivi Sveta 96/61/ES z dne 24. septembra 1996 o celovitem preprečevanju in nadzorovanju onesnaževanja 3 ;
(a) where there is failure to comply with the requirements referred to in Article 16 or Union standards for the protection of human health and the environment, particularly laid down in Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) 1 , Directive 2006/118/EC of the European Parliament and of the Council of 12 December 2006 on the protection of groundwater against pollution and deterioration 2 , Directive 2000/60/EC, Directive 98/83/EC and Council Directive 96/61/EC of 24 September 1996 concerning integrated pollution prevention and control 3 ;
Člen 39 – odstavek 1 – točka d a (novo)
Article 39 – paragraph 1 – point d a (new)
(da) obstajajo znaki, da cilji iz členov 4(1)(a)(iv), 4(1)(b)(i) ter 7(2) in (3) Direktive 2000/60/ES morda ne bodo doseženi.
(da) 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/ may not be achieved.
Podobno predlogu spremembe 39.
Analogous to the rapporteur's Amendment 39.
Poleg revizije vključitve aktivne snovi v Prilogo I mora biti znak (z vidika praktičnih meritev), da so cilji iz okvirne direktive o vodah ogroženi, osnova za preklic ali spremembo izdaje dovoljenja za biocidni pripravek.
In addition to revision of the inclusion of an active substance in Annex I, an indication (from practical measurements) that the aims of the Water Framework Directive are jeopardised must also be grounds for cancelling or amending the authorisation of a biocidal product.
Člen 42 – naslov
Article 42 – title
Podrobni postopki za odpoved in spremembe
Detailed procedures on cancellation and amendments