natgillin/translations-raw huggingface dataset:
Such comments shall be communicated to the Authority within 2 months, which shall collate and forward those comments, including its own, to the Commission.
Take pripombe se Agenciji sporočijo v dveh mesecih, Agencija pa jih zbere in vključno s svojimi pošlje Komisiji.
Upon request from any interested party, the Authority shall make the renewal assessment report available, excluding any information for which confidential treatment has been requested and is justified pursuant to Article 14 of Directive 91/414/EEC.
Agencija na zahtevo katere koli zainteresirane strani zagotovi dostop do poročila o oceni podaljšanja, izjema pa so vse informacije, za katere je bilo zahtevano zaupno obravnavanje, ki je utemeljeno v skladu s členom 14 Direktive 91/414/EGS.
The Authority shall make the supplementary summary dossier available to the public, with the exception of parts of it for which confidential treatment has been requested and is justified pursuant to Article 14 of Directive 91/414/EEC.
Agencija zagotovi dostop javnosti do povzetka dopolnilne dokumentacije, izjema pa so vsi njegovi deli, za katere je bilo zahtevano zaupno obravnavanje, ki je utemeljeno v skladu s členom 14 Direktive 91/414/EGS.
Evaluation of the renewal assessment report
Ocenjevanje poročila o oceni podaljšanja
The Commission shall, without delay, examine the renewal assessment report and the comments received in accordance with Article 15(1).
Komisija nemudoma preuči poročilo o oceni podaljšanja in pripombe, prejete v skladu s členom 15(1).
The Commission may consult the Authority asking it for a conclusion on the entire risk assessment or on specific points thereof.
Komisija se lahko posvetuje z Agencijo, tako da jo zaprosi za sklepno ugotovitev o celotni oceni tveganja ali za njene posamezne točke.
Such consultation may include a request to organise a consultation of experts.
Tako posvetovanje lahko vključuje zahtevo za organizacijo posvetovanja strokovnjakov.
The Authority shall use the guidance documents available at the time of the entry into force of this Regulation.
Agencija uporablja smernice, ki so na voljo ob začetku veljavnosti te uredbe.
The Authority shall deliver its conclusion at the latest 6 months after receipt of the request.
Agencija predloži sklepno ugotovitev najpozneje šest mesecev po prejemu zahteve.
Where paragraph 3 applies, that period shall be extended by the periods referred to in the first and the second subparagraph of that paragraph.
Če se uporablja odstavek 3, se navedeno obdobje podaljša za obdobja iz prvega in drugega pododstavka navedenega odstavka.
Where the Authority considers that additional information or data from the applicant is necessary to comply with a request made by the Commission pursuant to paragraph 2, it shall in consultation with the rapporteur Member State, set a period of maximum 1 month for the applicant to supply it.
Če Agencija meni, da so za uskladitev z zahtevo Komisije v skladu z odstavkom 2 potrebne dodatne informacije ali podatki vložnika, ob posvetovanju z državo članico poročevalko določi obdobje največ enega meseca, v katerem mora vložnik predložiti te informacije in podatke.
It shall at the same time inform the Commission and the Member States.
Hkrati obvesti Komisijo in države članice.
The applicant shall communicate the requested information to the Authority, the rapporteur Member State and the co-rapporteur Member State.
Vložnik predloži zahtevane informacije Agenciji, državi članici poročevalki in državi članici soporočevalki.
The rapporteur Member State shall, within 2 months of receipt, evaluate the information received and send its evaluation to the Authority.
Država članica poročevalka v dveh mesecih po prejemu oceni prejete informacije in to oceno pošlje Agenciji.
Review report and presentation of draft acts
Poročilo o pregledu in predložitev osnutkov aktov
The Commission shall draft a review report, hereinafter ‘the review report’, taking into account the renewal assessment report by the rapporteur Member State, the comments referred to in Article 15(1) and, where applicable, the conclusion of the Authority.
Komisija sestavi poročilo o pregledu (v nadaljnjem besedilu: poročilo o pregledu) ob upoštevanju poročila o oceni podaljšanja, ki ga je pripravila država članica poročevalka, pripomb iz člena 15(1) in sklepne ugotovitve Agencije, kadar je to primerno.
The applicant shall be given the possibility to submit comments on the draft review report within a period set by the Commission.
Vložniku se zagotovi možnost, da predloži pripombe o osnutku poročila o pregledu v obdobju, ki ga določi Komisija.
The Commission shall present to the Committee referred to in Article 19(1) of Directive 91/414/EEC the draft review report within 6 months of receipt of the comments referred to in Article 15(1) or, where the Commission has consulted it in accordance with Article 16(2), of receipt of the conclusion of the Authority.
Komisija Odboru iz člena 19(1) Direktive 91/414/EGS predloži osnutek poročila o pregledu v šestih mesecih po prejemu pripomb iz člena 15(1) ali po prejemu sklepne ugotovitve Agencije, če se je Komisija z njo posvetovala v skladu s členom 16(2).
On the basis of the review report and taking into account any comments submitted by the applicant within the period set by the Commission pursuant to the second subparagraph of paragraph 1, the Commission shall submit to the Committee:
Komisija na podlagi poročila o pregledu in ob upoštevanju vseh vložnikovih predloženih pripomb v obdobju, ki ga je določila Komisija v skladu z drugim pododstavkom odstavka 1, Odboru predloži:
a draft act renewing the inclusion of the active substance concerned in Annex I to Directive 91/414/EEC, setting out, where appropriate, the conditions and restrictions, including the period for such inclusion; or
osnutek akta o podaljšanju vključitve zadevne aktivne snovi v Prilogo I k Direktivi 91/414/EGS, ki, kadar je to primerno, določa pogoje in omejitve, vključno z obdobjem za tako vključitev, ali
a draft act removing the active substance from Annex I to Directive 91/414/EEC and providing for its non-inclusion and the withdrawal of the authorisations of plant-protection products containing that active substance.
osnutek akta o črtanju aktivne snovi iz Priloge I k Direktivi 91/414/EGS in zagotovitvi nevključitve navedene aktivne snovi in preklica registracije fitofarmacevtskih sredstev, ki jo vsebujejo.
The draft acts referred to in paragraph 2 shall be adopted in accordance with the procedure referred to in Article 19(2) of Directive 91/414/EEC.
Osnutka akta iz odstavka 2 se sprejmeta v skladu s postopkom iz člena 19(2) Direktive 91/414/EGS.
The Commission shall make the review report available to the public, with the exception of parts of it for which confidential treatment has been requested and is justified pursuant to Article 14 of Directive 91/414/EEC.
Komisija zagotovi dostop javnosti do poročila o pregledu, izjema pa so vsi njegovi deli, za katere je bilo zahtevano zaupno obravnavanje, ki je utemeljeno v skladu s členom 14 Direktive 91/414/EGS.
Member States may recover the costs associated with any work they carry out within the scope of this Regulation, by means of fees or charges.
Države članice lahko izterjajo stroške za delo v okviru področja uporabe te uredbe s pristojbinami ali taksami.
Member States shall ensure that the fees or charges referred to in paragraph 1:
Države članice zagotovijo, da so pristojbine ali takse iz odstavka 1:
are established in a transparent manner; and
določene na pregleden način in
correspond to the actual total cost of the work involved except if it is in public interest to lower the fees or charges.
skladne z dejanskimi skupnimi stroški opravljenega dela, razen če je zmanjšanje pristojbin ali takse v javnem interesu.
The fees or charges may include a scale of fixed charges based on average costs for the work referred to in paragraph 1.
Pristojbine ali takse lahko vključujejo lestvico fiksnih taks, ki temeljijo na povprečnih stroških za delo iz odstavka 1.
Other charges, levies or fees
Druge takse, dajatve ali pristojbine
Article 19 is without prejudice to Member States’ rights to maintain or introduce, in accordance with the Treaty, charges, levies or fees with regard to the authorisation, placing on the market, use and control of active substances and plant protection products other than the fee provided for in Article 19.
Člen 19 ne posega v pravice držav članic, da v skladu s Pogodbo poleg pristojbine iz člena 19 ohranijo ali uvedejo tudi druge takse, dajatve ali pristojbine za registracijo, dajanje v promet, uporabo in nadzor aktivnih snovi ter fitofarmacevtskih sredstev.
List of active substances referred to in Article 1 and their rapporteur Member States (RMS), co-rapporteur Member States (Co-RMS) and of the final dates for submission of dossiers
Seznam aktivnih snovi iz člena 1 in njihovih držav članic poročevalk („DČP“) in držav članic soporočevalk („DČS“) ter končni roki za predložitev dokumentacije
New RMS
Nova DČP
Co-RMS
DČS
Deadline for submission of dossier
Rok za predložitev dokumentacije
29 February 2012
februar 2012
31 May 2012
maj 2012
31 August 2012
avgust 2012
Format for application, as provided for in Article 5(1)
Oblika zahtevka, kakor je določen v členu 5(1)
The application shall be in writing, signed by the applicant, and sent by registered mail to the rapporteur Member State listed in column B of Annex I and to the co-rapporteur Member State listed in column C of Annex I.
Pisni zahtevek s podpisom vložnika je treba s priporočeno pošto poslati državi članici poročevalki iz stolpca B v Prilogi I in državi članici soporočevalki iz stolpca C v Prilogi I.
A copy of the application without the updating statement shall be sent to the European Commission, DG Health and Consumers, unit E3, 1049 Brussels, Belgium
Kopija zahtevka brez izjave o posodobitvi se pošlje Evropski komisiji na naslov: European Commission, DG Health and Consumers, Unit E3, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË
and to the Authority, European Food Safety Authority, Largo N. Palli 5/A, 43121 Parma, Italy
, in Agenciji na naslov: European Food Safety Authority, Largo N. Palli 5/A, 43121 Parma, ITALIJA
The application shall be submitted in accordance with the following model.
Zahtevek se predloži v skladu z naslednjim obrazcem.
Information concerning the applicant
Podatki o vložniku
Name and address of the applicant including the name of the natural person responsible for the application and further engagements resulting from this Regulation:
Ime in naslov vložnika, vključno z imenom fizične osebe, odgovorne za zahtevek ter druge obveznosti, ki izhajajo iz te uredbe:
Information to facilitate identification
Podatki za lažjo identifikacijo aktivne snovi
Common name (proposed or ISO-accepted) specifying, where relevant, any variants thereof such as salts, esters or amines produced by the manufacturer.
Splošno ime snovi (predlagano ali sprejeto po ISO) z navedbo, kadar je primerno, vseh njenih variant, kot so soli, estri ali amini, ki jih proizvaja proizvajalec.
Chemical name (IUPAC and CAS nomenclature).
Kemijsko ime (po nomenklaturi IUPAC in CAS).
CAS, CIPAC and EEC numbers (if available).
Številke CAS, CIPAC in EEC (če so na voljo).
Empirical and structural formula, molecular mass.
Empirična in strukturna formula, molekulska masa.
Specification of purity of the active substance in g/kg which should be whenever possible identical or already accepted as equivalent to the one included in Annex I to Directive 91/414/EEC.
Opis čistosti aktivne snovi v g/kg, ki mora biti po možnosti enaka ali že sprejeta kot enaka tisti iz Priloge I k Direktivi 91/414/EGS.
Classification and labelling of the active substance in accordance with the provisions of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures [1] (health and environment effects).
Razvrstitev in označitev aktivne snovi v skladu z določbami Uredbe (ES) št. 1272/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o razvrščanju, označevanju in pakiranju snovi ter zmesi [1] (učinki na zdravje in okolje).
An updating statement, as provided for in Article 5(2), shall be attached as an Annex to the application.
Izjava o posodobitvi, kakor je določena v členu 5(2), se zahtevku priloži kot priloga.
The applicant confirms that the above information submitted on … (date) is correct.
Vložnik potrjuje točnost zgoraj navedenih podatkov, predloženih dne … (datum).
Signature (of the person competent to act for the applicant referred to under 1.1)
Podpis (pristojnega zastopnika vložnika iz točke 1.1).
Commission Regulation (EU) No 1142/2010
Uredba Komisije (EU) št. 1142/2010
amending Regulation (EC) No 1266/2007 as regards the period of application of the transitional measures concerning the conditions for exempting certain animals from the exit ban provided for in Council Directive 2000/75/EC
o spremembi Uredbe (ES) št. 1266/2007 glede obdobja uporabe prehodnih ukrepov glede pogojev za izvzetje nekaterih živali iz prepovedi izstopa iz Direktive Sveta 2000/75/ES
Commission Regulation (EC) No 1266/2007 of 26 October 2007 on implementing rules for Council Directive 2000/75/EC as regards the control, monitoring, surveillance and restrictions on movements of certain animals of susceptible species in relation to bluetongue [2] lays down rules for the control, monitoring, surveillance and restrictions on movements of animals, in relation to bluetongue, in and from the restricted zones.
Uredba Komisije (ES) št. 1266/2007 z dne 26. oktobra 2007 o pravilih za izvajanje Direktive Sveta 2000/75/ES v zvezi z nadzorom, spremljanjem in omejitvami premikov nekaterih živali, ki so dovzetne za bolezen modrikastega jezika [2], določa pravila za nadzor, spremljanje in omejitve premikov živali na območja z omejitvami v zvezi z boleznijo modrikastega jezika in z njih.
Article 8 of Regulation (EC) No 1266/2007 lays down conditions for exemption from the exit ban provided for in Directive 2000/75/EC.
Člen 8 Uredbe (ES) št. 1266/2007 določa pogoje za izvzetje iz prepovedi izstopa iz Direktive 2000/75/ES.
Article 8(1) of that Regulation provides that movements of animals, their semen, ova and embryos, from a holding or semen collection or storage centre located in a restricted zone to another holding or semen collection or storage centre are to be exempted from that exit ban provided that they comply with the conditions set out in Annex III to that Regulation or with any other appropriate animal health guarantees based on a positive outcome of a risk assessment of measures against the spread of the bluetongue virus and protection against attacks by vectors, required by the competent authority of the place of origin and approved by the competent authority of the place of destination, prior to the movement of such animals.
Člen 8(1) navedene uredbe določa, da se premiki živali, njihovega semena, jajčnih celic in zarodkov s kmetijskega gospodarstva ali iz centra za zbiranje ali skladiščenje semena, ki je na območju z omejitvami, na drugo kmetijsko gospodarstvo ali v center za zbiranje in skladiščenje semena izvzamejo iz prepovedi izstopa, če izpolnjujejo pogoje iz Priloge III k navedeni uredbi ali katera koli druga ustrezna jamstva za zdravstveno varstvo živali na podlagi pozitivnega rezultata ocene tveganja ukrepov proti širjenju virusa bolezni modrikastega jezika in zaščite pred napadi vektorjev, ki jih zahteva pristojni organ kraja izvora in odobri pristojni organ namembnega kraja pred premiki takih živali.
Article 9(a) of Regulation (EC) No 1266/2007 provides that, until 31 December 2010, and by way of derogation from the conditions set out in Annex III to that Regulation, Member States of destination may require that the movement of certain animals which are covered by the exemption, provided for in Article 8(1) thereof, be subjected to additional conditions, on the basis of a risk assessment taking into account the entomological and epidemiological conditions in which animals are being introduced.
Člen 9(a) Uredbe (ES) št. 1266/2007 določa, da lahko namembne države članice do 31. decembra 2010 in z odstopanjem od pogojev iz Priloge III k navedeni uredbi zahtevajo, da za premike nekaterih živali, za katere velja izvzetje iz člena 8(1) navedene uredbe, veljajo dodatni pogoji, določeni na podlagi ocene tveganja entomoloških in epidemioloških razmer, v katere se vnesejo živali.
Those additional conditions specify that the animals must be less than 90 days old, they must have been kept since birth in vector protected confinement and they must have been subject to certain tests referred to in Annex III to that Regulation.
Navedeni dodatni pogoji določajo, da morajo biti živali stare manj kot 90 dni, da so morale biti od rojstva zaprte v prostorih, zaščitenih pred vektorji, in da so opravile nekatere teste iz Priloge III k navedeni uredbi.
Fifteen Member States and Norway have notified the Commission that they have applied that transitional measure.
Petnajst držav članic in Norveška je Komisijo obvestilo, da so uporabile navedeni prehodni ukrep.
The outcomes of the risk assessments that were carried out, which are publicly available on the Commission’s website, show that the introduction of bluetongue in those Member States and in Norway as a result of animal movements from restricted zones could have a major negative impact.
Rezultati ocen tveganj, ki so bile izvedene in so javno dostopne na spletni strani Komisije, kažejo, da bi lahko imel vnos bolezni modrikastega jezika v navedene države članice in na Norveško zaradi premikov živali z območja z omejitvami negativne posledice.
The overall disease situation as regards bluetongue has improved considerably since 2008.
Splošno stanje bolezni modrikastega jezika se je od leta 2008 znatno izboljšalo.
However the virus is still present in parts of the Union.
Vendar je virus še vedno prisoten v nekaterih delih Unije.
For the sake of harmonized implementation, Member States have requested for specific criteria for the ‘vector proof establishment’ which is an important requirement for a number of the conditions set out in Annex III of Regulation (EC) No 1266/2007 and aims at the protection of animals against attacks by vectors.
Države članice so zaradi usklajene uporabe zaprosile za specifična merila za „objekte, zaščitene pred vektorji“, kar je pomembna zahteva za številne pogoje iz Priloge III k Uredbi (ES) št. 1266/2007 in je namenjena zaščiti živali pred napadi vektorjev.
Currently, the World Organization for Animal Health (OIE) is working on a definition of a vector-protected establishment or facility.
Mednarodna organizacija za zdravje živali (OIE) trenutno pripravlja opredelitev objektov ali obratov, zaščitenih pred vektorji.
The outcome of this work shall serve as input for the Commission to define criteria for the vector proof establishment as referred to in Annex III of the Regulation.
Rezultat tega dela Komisiji služi kot informacija, da bo lahko opredelila merila za objekte, zaščitene pred vektorji, navedene v Prilogi III k Uredbi.
Pending the development of the criteria for a vector proof establishment, the period of application of the transitional measures provided for in Article 9(a) of Regulation (EC) No 1266/2007 should be prolonged for another six months.
Dokler se ne razvijejo merila za objekte, zaščitene pred vektorji, je treba obdobje uporabe prehodnih ukrepov iz člena 9a Uredbe (ES) št. 1266/2007 podaljšati še za šest mesecev.
In the introductory phrase of Article 9a(1) of Regulation (EC) No 1266/2007, the date ‘31 December 2010’ is replaced by ‘30 June 2011’.
V uvodnem stavku člena 9a(1) Uredbe (ES) št. 1266/2007 se datum „31. decembra 2010“ nadomesti s „30. junija 2011“.
Commission Regulation (EU) No 1143/2010
Uredba Komisije (EU) št. 1143/2010
amending Regulation (EC) No 1251/2008 as regards the period of application of the transitional provisions for certain ornamental aquatic animals intended for closed ornamental facilities
o spremembi Uredbe (ES) št. 1251/2008 glede obdobja uporabe prehodnih določb za nekatere okrasne vodne živali, namenjene za zaprte okrasne objekte
Commission Regulation (EC) No 1251/2008 of 12 December 2008 implementing Council Directive 2006/88/EC as regards conditions and certification requirements for the placing on the market and the import into the Community of aquaculture animals and products thereof and laying down a list of vector species [2] lays down the animal health conditions and certification requirements for imports into the Union of ornamental aquatic animals intended for closed ornamental facilities.
Uredba Komisije (ES) št. 1251/2008 z dne 12. decembra 2008 o izvajanju Direktive Sveta 2006/88/ES glede pogojev in zahtev v zvezi z izdajanjem spričeval za dajanje živali in proizvodov iz ribogojstva na trg in za njihov uvoz v Skupnost ter o določitvi seznama vektorskih vrst [2] določa pogoje v zvezi z zdravstvenim varstvom živali in izdajanjem spričeval za uvoz okrasnih vodnih živali, namenjenih za zaprte okrasne objekte, v Unijo.
Article 11 of Regulation (EC) No 1251/2008 provides that ornamental fish of species susceptible to one or more of the diseases listed in Part II of Annex IV to Directive 2006/88/EC and intended for closed ornamental facilities are only to be imported into the Union from third countries, territories, zones or compartments listed in Annex III to that Regulation.
Člen 11 Uredbe (ES) št. 1251/2008 določa, da se okrasne vrste rib, ki so dovzetne za eno ali več bolezni iz dela II Priloge IV k Direktivi 2006/88/ES in so namenjene za zaprte okrasne objekte, v Unijo uvozijo le iz tretjih držav, z ozemelj, območij ali iz kompartmentov, navedenih v Prilogi III k navedeni uredbi.
Epizootic ulcerative syndrome (EUS) is listed in Part II of Annex IV to Directive 2006/88/EC as an exotic disease of certain susceptible species of fish.
Epizootski ulcerativni sindrom (EUS) je v delu II Priloge IV k Direktivi 2006/88/ES naveden kot eksotična bolezen nekaterih dovzetnih vrst rib.
Article 20(5) of Regulation (EC) No 1251/2008 provides that for a transitional period until 31 December 2010, Member States may authorise the import of ornamental aquatic animals of species susceptible to EUS intended solely for closed ornamental facilities from third countries or territories that are members of the World Organisation for Animal Health (OIE).
Člen 20(5) Uredbe (ES) št. 1251/2008 določa, da lahko države članice za prehodno obdobje do 31. decembra 2010 odobrijo uvoz okrasnih vodnih živali tistih vrst, ki so dovzetne za EUS in so namenjene izključno za zaprte okrasne objekte, iz tretjih držav ali z ozemelj, ki so člani Svetovne organizacije za zdravje živali (OIE).
Part II.2 of the model animal health certificate applicable to ornamental aquatic animals intended for closed facilities set out in Part B of Annex IV to Regulation (EC) No 1251/2008 sets out certain import requirements related to EUS.
Del II.2 vzorca veterinarskega spričevala, ki se uporablja za okrasne vodne živali, namenjene za zaprte okrasne objekte, iz dela B Priloge IV k Uredbi (ES) št. 1251/2008 določa nekatere uvozne zahteve, ki so povezane z EUS.
The second sub-paragraph of Article 20(5) of that Regulation provides that these requirements shall not apply during the transitional period referred to above.
Drugi pododstavek člena 20(5) navedene uredbe določa, da se te zahteve ne uporabljajo med zgoraj navedenim prehodnim obdobjem.
Further studies are needed at present to assess more precisely the risks associated with the import into the Union of such ornamental aquatic animals.
Trenutno so potrebne nadaljnje študije, da se natančneje ocenijo tveganja, ki so povezana z uvozom takšnih okrasnih vodnih živali v Unijo.
In order not to disrupt trade in those animals, it is appropriate to prolong until 31 December 2012 the period of application of the transitional measures currently laid down in Article 20(5) of Regulation (EC) No 1251/2008.
Za zagotovitev neprekinjene trgovine z navedenimi živalmi je primerno, da se obdobje uporabe prehodnih ukrepov, kot je trenutno določeno v členu 20(5) Uredbe (ES) št. 1251/2008, podaljša do 31. decembra 2012.