natgillin/translations-raw huggingface dataset:
concerning the authorisation of a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) as feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all other avian species (excluding laying birds) and weaned piglets (holder of the authorisation BASF SE)
o odobrenju pripravka 6-fitaze proizvedenog od Aspergillus niger (DSM 25770) kao dodatka hrani za piliće za tov, kokoši nesilice, svinje za tov, krmače, manje značajne vrste svinja za tov ili za rasplod, pure za tov, pure uzgajane za rasplod, ostale ptičje vrste (osim ptica nesilica) te odbijenu prasad (nositelj odobrenja BASF SE)
In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of 6-phytase, produced by Aspergillus niger (DSM 25770).
U skladu s člankom 7.
That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
Uredbe (EZ) br. 1831/2003 podnesen je zahtjev za odobrenje pripravka 6-fitaze proizvedenog od Aspergillus niger (DSM 25770).
That application concerns the authorisation of the preparation of 6-phytase produced by Aspergillus niger (DSM 25770) as a feed additive for chickens for fattening, chickens reared for laying, pigs for fattening, sows, minor porcine species for fattening or for reproduction, turkeys for fattening, turkeys reared for breeding, all avian species for fattening or growing or reared for laying and weaned piglets to be classified in the additive category ‘zootechnical additives’.
Uz navedeni zahtjev priloženi su podaci i dokumenti propisani člankom 7. stavkom 3.
The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 September 2017 that, under the proposed conditions of use, the preparation of 6-phytase produced by Aspergillus niger (DSM 25770) does not have an adverse effect on animal health, human health or the environment, and that it improves the zootechnical performance and/or phosphorus utilisation in the target species.
Uredbe (EZ) br. 1831/2003.
The Authority does not consider that there is a need for specific requirements of post-market monitoring.
Zahtjev se odnosi na odobrenje pripravka 6-fitaze proizvedenog od Aspergillus niger (DSM 25770) kao dodatka hrani za piliće za tov, kokoši nesilice, svinje za tov, krmače, manje značajne vrste svinja za tov ili za rasplod, pure za tov, pure uzgajane za rasplod, sve ptičje vrste za tov ili uzgoj ili koje se uzgajaju za nesenje i odbijenu prasad te njegovo razvrstavanje u kategoriju dodataka „zootehnički dodaci”.
It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
Europska agencija za sigurnost hrane („Agencija”) u svojem je mišljenju od 28. rujna 2017. zaključila da pod predloženim uvjetima uporabe pripravak 6-fitaze proizveden od Aspergillus niger (DSM 25770) nema štetan učinak na zdravlje životinja, zdravlje ljudi ili na okoliš te da se njime poboljšavaju zootehnička obilježja i/ili iskorištavanje fosfora kod ciljnih vrsta.
The assessment of the preparation of 6-phytase produced by Aspergillus niger (DSM 25770) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Agencija smatra da ne postoji potreba za posebnim zahtjevima za praćenje nakon stavljanja na tržište.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Ocjena pripravka 6-fitaze proizvedenog od Aspergillus niger (DSM 25770) pokazuje da su ispunjeni uvjeti za odobrenje propisani člankom 5.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Pripravak naveden u Prilogu, koji pripada kategoriji dodataka hrani „zootehnički dodaci” i funkcionalnoj skupini „tvari za poticanje probavljivosti”, odobrava se kao dodatak hrani za životinje pod uvjetima utvrđenima u tom Prilogu.
Done at Brussels, 7 March 2018.
Članak 2.
OJ L 268, 18.10.2003, p. 29.
Sastavljeno u Bruxellesu 7. ožujka 2018.
EFSA Journal 2017; 15(11)5024.
Za Komisiju
Name of the holder of authorisation
EFSA Journal 2017.; 15(11)5024.
Species or category of animal
Ime nositelja odobrenja
End of period of authorisation
Najmanja dopuštena količina
6-phytase
Jedinice aktivnosti/kg potpune krmne smjese s udjelom vlage od 12 %
Additive composition:
Funkcionalna skupina: tvari za poticanje probavljivosti
Preparation of 6-phytase, produced by Aspergillus niger (DSM 25770) with a minimum content of:
6-fitaza
Solid form: 5000 FTU/g
Sastav dodatka:
Liquid form: 5000 FTU/g
Pripravak 6-fitaze proizveden od Aspergillus niger (DSM 25770) s najmanjom dopuštenom količinom od:
Characterisation of the active substance:
Kruto stanje: 5000 FTU/g
6-phytase produced by Aspergillus. niger (DSM 25770)
Tekuće stanje: 5000 FTU/g
Analytical method:
Karakteristike aktivne tvari:
For the quantification of phytase activity in the feed additive:
6-fitaza proizvedena od Aspergillus. niger (DSM 25770)
colorimetric method based on the enzymatic reaction of phytase on the phytate
Analitička metoda:
For the quantification of phytase activity in premixtures:
Za kvantifikaciju aktivnosti fitaze u dodatku hrani za životinje:
colorimetric method based on the enzymatic reaction of phytase on the phytate — VDLUFA 27.1.3
kolorimetrijska metoda koja se temelji na enzimskoj reakciji fitaze na fitat
For the quantification of phytase activity in feedingstuffs:
Za kvantifikaciju aktivnosti fitaze u premiksima:
colorimetric method based on the enzymatic reaction of phytase on the phytate — EN ISO 30024
kolorimetrijska metoda koja se temelji na enzimskoj reakciji fitaze na fitat – VDLUFA 27.1.3
Pigs for fattening
Za kvantifikaciju aktivnosti fitaze u hrani za životinje:
Sows
kolorimetrijska metoda koja se temelji na enzimskoj reakciji fitaze na fitat – EN ISO 30024
Minor porcine species for fattening or for reproduction
Svinje za tov
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
Krmače
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use.
Manje značajne vrste svinja za tov ili za rasplod
Where those risks cannot be eliminated or reduced to a minimum by such procedures and measures, the additive and premixtures shall be used with personal protective equipment, including breathing protection.
U uputama za uporabu dodatka hrani za životinje i premiksa potrebno je navesti uvjete skladištenja i stabilnost pri toplinskoj obradi.
For use in weaned piglets up to 35 kg.
Za korisnike dodatka i premiksa subjekti koji posluju s hranom za životinje utvrđuju operativne postupke i organizacijske mjere za uklanjanje mogućih opasnosti koje proizlaze iz njihove uporabe.
Weaned piglets
Ako se opasnosti s pomoću tih postupaka i mjera ne mogu otkloniti ili smanjiti na najmanju moguću mjeru, pri uporabi dodatka i premiksa potrebno je nositi odgovarajuću osobnu zaštitnu opremu, uključujući zaštitu za dišne organe.
Chickens for fattening
Za korištenje u odbijene prasadi do 35 kg.
Chickens reared for laying
Odbijena prasad
Turkeys for fattening
Pilići za tov
Turkeys reared for breeding
Pilići uzgajani za nesenje
All other avian species (excluding laying birds)
Purani za tov
1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from sodium phytate at pH 5,5 and 37 °C
Purani uzgajane za rasplod
Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports
Ostale ptičje vrste (osim ptica nesilica)
Commission Implementing Regulation (EU) 2018/339
Provedbena uredba Komisije (EU) 2018/339
amending and derogating from Regulation (EC) No 2535/2001 as regards the import licences for dairy products originating in Iceland
o izmjeni i odstupanju od Uredbe (EZ) br. 2535/2001 u pogledu uvoznih dozvola za mliječne proizvode podrijetlom iz Islanda
Having regard to Regulation (EU) No 1308/2013 of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007, and in particular Article 187 thereof,
uzimajući u obzir Uredbu (EU) br. 1308/2013 Europskog parlamenta i Vijeća od 17. prosinca 2013. o uspostavljanju zajedničke organizacije tržišta poljoprivrednih proizvoda i stavljanju izvan snage uredbi Vijeća (EEZ) br. 922/72, (EEZ) br. 234/79, (EZ) br. 1037/2001 i (EZ) br. 1234/2007, a posebno njezin članak 187.,
Annex V to the Agreement in the form of an Exchange of Letters between the European Union and Iceland concerning additional trade preferences in agricultural products undertaken on the basis of Article 19 of the Agreement on the European Economic Area, approved by Council Decision (EU) 2017/1913 provides for an increase in the annual duty free tariff quotas and for the introduction of a new quota for cheeses.
Prilogom V. Sporazumu u obliku razmjene pisama između Europske unije i Islanda o dodatnim trgovinskim povlasticama za poljoprivredne proizvode provedenom na temelju članka 19.
The application period precedes the end of the approval procedure for applicants to be authorised to import under the quotas as from 1 July 2018.
Stoga bi, odstupajući od članka 14. stavka 1. točke (b) te uredbe, trebalo odrediti novo razdoblje za podnošenje zahtjeva, i to od 1. do 10. travnja 2018.
In order for applicants, not yet listed on an approval list, to participate in the quota allocation for the period 1 May to 31 December 2018, derogation from Article 10 of Regulation (EC) No 2535/2001 should be provided for.
Uredbu (EZ) br. 2535/2001 trebalo bi u skladu s tim izmijeniti.
The period for lodging import licence applications for the first half year of 2018, as provided for in Article 14(1)(a) of Regulation (EC) No 2535/2001, has expired.
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Odbora za zajedničku organizaciju poljoprivrednih tržišta,
By way of derogation from Article 14(1)(b) of that Regulation provision should therefore be made for a new license application period from 1 to 10 April 2018.
DONIJELA JE OVU UREDBU:
Regulation (EC) No 2535/2001 should therefore be amended accordingly.
Članak 1.
The measures provided for in this Regulation are in accordance with the opinion of the Committee for the Common Organisation of the Agricultural Markets,
Izmjena Uredbe (EZ) br. 2535/2001
HAS ADOPTED THIS REGULATION:
Uredba (EZ) br. 2535/2001 mijenja se kako slijedi:
Article 1
u članku 5. točka (i) zamjenjuje se sljedećim:
Amendment of Regulation (EC) No 2535/2001
kvote predviđene u Prilogu V. Sporazumu između Europske unije i Islanda o dodatnim trgovinskim povlasticama za poljoprivredne proizvode odobrenom Odlukom Vijeća (EU) 2017/1913 ( ‚Sporazum s Islandom’)
Regulation (EC) No 2535/2001 is amended as follows:
točka I.I. Priloga I. Uredbi (EZ) br. 2535/2001 zamjenjuje se tekstom u Prilogu ovoj Uredbi.
In Article 5, point (i) is replaced by the following:
Članak 2.
the quotas provided for in Annex V to the Agreement between the European Union and Iceland concerning additional trade preferences in agricultural products, approved by Council Decision (EU) 2017/1913 ( ‘the Agreement with Iceland‘)
Odstupanje od Uredbe (EZ) br. 2535/2001
Point I.I of Annex I to Regulation (EC) No 2535/2001 is replaced by the text in the Annex to this Regulation.
Odstupajući od članka 6. drugog stavka Uredbe (EZ) br. 2535/2001, za količine predviđene u točki I.I. Priloga I. toj uredbi razdoblje od 6 mjeseci od 1. srpnja do 31. prosinca 2018. zamjenjuje se razdobljem od 1. svibnja do 31. prosinca 2018.
Article 2
Odstupajući od članka 10. stavka 1. drugog podstavka Uredbe (EZ) br. 2535/2001, podnošenje zahtjeva za dodjelu kvota za razdoblje iz stavka 1. ovog članka dopušteno je ne samo uvoznicima s popisa odobrenih uvoznika nego i podnositeljima koji su valjan zahtjev za odobrenje podnijeli prije 1. travnja 2018. u skladu s člankom 8. te uredbe.
Derogation from Regulation (EC) No 2535/2001
Odstupajući od članka 14. stavka 1. točke (b) Uredbe (EZ) br. 2535/2001, za razdoblje od 1. svibnja do 31. prosinca 2018. zahtjevi za uvozne dozvole podnose se od 1. do 10. travnja 2018. za količine predviđene u točki I.I. Priloga I. toj uredbi kako je izmijenjena ovom Uredbom.
By way of derogation from the second paragraph Article 6 of Regulation (EC) No 2535/2001, for the quantities set out in Point I.I of Annex I to that Regulation, the six-month period from 1 July to 31 December 2018 shall be replaced by the period from 1 May to 31 December 2018.
Zahtjevi iz stavka 3. odnose se na količine od najmanje 5 tona, a najviše na dostupnu količinu.
By way of derogation from the second subparagraph of Article 10(1) of Regulation (EC) No 2535/2001, in addition to importers included on a list, applicants who submitted a valid request for approval before 1 April 2018 in accordance with Article 8 of that Regulation shall also be authorised to apply for licenses for the quotas and for the period referred to in paragraph 1 of this Article.
Zahtjevi se ne mogu podnositi za razdoblje od 1. srpnja do 31. prosinca 2018.
By way of derogation from Article 14(1)(b) of Regulation (EC) No 2535/2001, for the period from 1 May to 31 December 2018 applications for import licences shall be submitted from 1 to 10 April 2018 for quantities set out in Point I.I of Annex I to that Regulation as amended by this Regulation.
Uvozne dozvole odobrene na zahtjeve podnesene u skladu sa stavkom 3. vrijede do 31. prosinca 2018.
The applications referred to in paragraph 3 shall relate to not less than 5 tonnes and not more than the available quantity.
Članak 3.
No applications shall be submitted for the period from 1 July to 31 December 2018.
Stupanje na snagu i primjena
Import licences issued for applications submitted in accordance with paragraph 3 shall be valid until 31 December 2018.
Ova Uredba stupa na snagu trećeg dana od dana objave u Službenom listu Europske unije.
Entry into force and application
Primjenjuje se od 1. travnja 2018.
This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.
Sastavljeno u Bruxellesu 7. ožujka 2018.
It shall apply from 1 April 2018.
Predsjednik
Done at Brussels, 7 March 2018.
SL L 347, 20.12.2013., str. 671.
For the Commission
Odluka Vijeća (EU) 2017/1913 od 9. listopada 2017. o sklapanju Sporazuma u obliku razmjene pisama između Europske unije i Islanda o dodatnim trgovinskim povlasticama za poljoprivredne proizvode (SL L 274, 24.10.2017., str. 57.).
The President
Uredba Komisije (EZ) br. 2535/2001 od 14. prosinca 2001. o utvrđivanju detaljnih pravila za primjenu Uredbe Vijeća (EZ) br. 1255/1999 u pogledu uvoznih režima za mlijeko i mliječne proizvode i o otvaranju carinskih kvota (SL L 341, 22.12.2001., str. 29.).
OJ L 347, 20.12.2013, p. 671.
Odluka Vijeća (EU) 2017/1913 od 9. listopada 2017. o sklapanju Sporazuma u obliku razmjene pisama između Europske unije i Islanda o dodatnim trgovinskim povlasticama za poljoprivredne proizvode (SL L 274, 24.10.2017., str. 57.).”;
Council Decision (EU) 2017/1913 of 9 October 2017 on the conclusion of the Agreement in the form of an Exchange of Letters between the European Union and Iceland concerning additional trade preferences in agricultural products (OJ L 274, 24.10.2017, p. 57).
PRILOG
Commission Regulation (EC) No 2535/2001 of 14 December 2001 laying down detailed rules for applying Council Regulation (EC) No 1255/1999 as regards the import arrangements for milk and milk products and opening tariff quotas (OJ L 341, 22.12.2001, p. 29).
„I.I.
Council Decision (EU) 2017/1913 of 9 October 2017 on the conclusion of the Agreement in the form of an Exchange of Letters between the European Union and Iceland concerning additional trade preferences in agricultural products (OJ L 274, 24.10.2017, p. 57).’
Carinske kvote u skladu s Prilogom V. Sporazumu s Islandom odobrenom Odlukom (EU) 2017/1913
ANNEX
Godišnja kvota od 1. siječnja do 31. prosinca
‘I.I
(Količina u tonama)
Tariff quotas under Annex V to the Agreement with Iceland approved by Decision (EU) 2017/1913
Primjenjiva carina: izuzeće
Annual quota from 1 January to 31 December
Broj kvote
(Quantity in tonnes)
Naziv
Applicable duty: exemption
Prirodni maslac
Quota number
‚Skyr’
Description
Sirevi
Natural butter
Oznaka KN
‘Skyr’
isključujući ‚Skyr’ obuhvaćen tarifnim podbrojem KN 04061050
Cheeses
Količina za razdoblje svibanj – prosinac 2018.
CN code
Godišnja količina u 2019.
Excluding ‘Skyr’ of CN subheading 04061050
Količina za razdoblje siječanj – lipanj
Quantity for May – December 2018
Količina za razdoblje srpanj – prosinac
Annual quantity in 2019
Godišnja količina u 2020.
Quantity for January – June
Godišnja količina od 2021. nadalje
Quantity for July — December
Neovisno o pravilima za tumačenje kombinirane nomenklature, mora se smatrati da naziv proizvodâ ima samo indikativno značenje, a povlašteni režimi u kontekstu ovog Priloga određuju se oznakama KN.
Annual quantity in 2020
U slučaju kada su navedene oznake ex KN, primjenjivost povlaštenih režima određuje se na temelju kombinacije oznake KN i odgovarajućeg naziva.
Annual quantity from 2021 and following
Oznaka KN podliježe izmjeni ovisno o potvrdi razvrstavanja proizvoda.”
Notwithstanding the rules for the interpretation of the Combined Nomenclature, the wording for the description of the products is to be considered as having no more than an indicative value, the preferential arrangements being determined, within the context of this Annex, by the coverage of the CN codes.
Količine novih kvota počinju se primjenjivati 1. svibnja 2018.
Where ex CN codes are referred to, the applicability of the preferential arrangements is determined to the basis of the CN code and the corresponding description taken jointly.
Stoga bi, odstupajući od članka 6.
CN code subject to modification, pending confirmation of classification of the product.’
Uredbe Komisije (EZ) br. 2535/2001, trebalo utvrditi novo razdoblje od 1. svibnja do 31. prosinca 2018. umjesto razdoblja od 1. srpnja do 31. prosinca 2018. te utvrditi količine za to novo razdoblje u točki I.I. Priloga I. toj uredbi kako je izmijenjena ovom Uredbom.
The new quota quantities will apply from 1 May 2018.
Razdoblje primjene prethodi završetku postupka odobrenja podnositeljima da od 1. srpnja 2018. uvoze u okviru kvota.
Consequently, by way of derogation from Article 6 of Commission Regulation (EC) No 2535/2001, a new period from 1 May to 31 December 2018 should be established replacing the period from 1 July to 31 December 2018 and for the quantities to be set for that new period in Point I.I of Annex I to that Regulation as amended by this Regulation.
Kako bi podnositelji koji još nisu uvršteni u popis odobrenih uvoznika mogli sudjelovati u dodjeli kvota za razdoblje od 1. svibnja do 31. prosinca 2018., trebalo bi utvrditi odstupanje od članka 10.
of 14 November 2017
оd 14. studenoga 2017.
Having regard to Directive 2014/59/EU of the European Parliament and of the Council of 15 May 2014 on establishing a framework for the recovery and resolution of credit institutions and investment firms, and in particular Article 74(4) thereof,
uzimajući u obzir Direktivu 2014/59/EU Europskog parlamenta i Vijeća od 15. svibnja 2014. o uspostavi okvira za oporavak i sanaciju kreditnih institucija i investicijskih društava, a posebno njezin članak 74. stavak 4.,
It is appropriate to have rules establishing a methodology for carrying out valuations aimed at determining whether there is any difference between the actual treatment of shareholders and creditors in respect of which resolution action or actions have been effected, and the amount that those shareholders and creditors would have received had the institution or entity as referred to in points (b), (c) or (d) of Article 1(1) of Directive 2014/59/EU (‘entity’) been subject to normal insolvency proceedings at the date on which the decision to resolve that entity was adopted according to Article 82 of Directive 2014/59/EU.
Primjereno je donijeti pravila kojima se utvrđuje metodologija za provedbu vrednovanja kojemu je cilj utvrditi postoji li razlika između konkretnog postupanja s dioničarima i vjerovnicima u odnosu na koje je izvršena mjera sanacije ili više takvih mjera i iznosa koji bi ti dioničari i vjerovnici primili da se na instituciju ili subjekt iz članka 1. stavka 1. točaka (b), (c) ili (d) Direktive („subjekt”) primijenio redovni postupak u slučaju insolventnosti na datum na koji je donesena odluka o sanaciji tog subjekta u skladu s člankom 82.
Any difference in treatment resulting in greater losses in resolution for particular shareholders and creditors should entitle those shareholders and creditors to compensation from the resolution financing arrangements, pursuant to point (e) of Article 101(1) of Directive 2014/59/EU.
Direktive 2014/59/EU.
The ex post valuation is to be carried out by the required independent person meeting the conditions set out in Article 38 of Commission Delegated Regulation (EU) 2016/1075 (‘valuer’), as soon as possible after the resolution action or actions have been effected, even though its completion could take some time.
U slučaju razlike u postupanju zbog koje su neki dioničari ili vjerovnici pretrpjeli veće gubitke u sanaciji ti dioničari i vjerovnici imaju pravo na odštetu koja se isplaćuje iz aranžmana financiranja sanacije na temelju članka 101. stavka 1. točke (e) Direktive 2014/59/EU.
That valuation should be based on available information relevant to the date when the decision to resolve an entity is adopted, in order to adequately reflect specific circumstances, such as distressed market conditions, existing at that resolution decision date.
Ex post vrednovanje provodi neovisna osoba koja ispunjava uvjete utvrđene člankom 38.
Information obtained after the resolution decision date should only be used where it could reasonably have been known at that date.
Delegirane uredbe Komisije (EU) 2016/1075 („procjenitelj”) što je prije moguće nakon izvršenja mjere odnosno mjera sanacije, iako možda bude potrebno određeno vrijeme za dovršetak vrednovanja.
In order to ensure that a comprehensive and credible valuation is carried out, the valuer should have access to any appropriate legal documentation, including to a list of all claims and contingent claims against the entity, classified according to their priority under normal insolvency proceedings.
To bi se vrednovanje trebalo temeljiti na dostupnim informacijama relevantnima za datum donošenja odluke o sanaciji subjekta kako bi se njime primjereno uzele u obzir konkretne okolnosti, primjerice postojanje otežanih tržišnih uvjeta na datum odluke o sanaciji.
The valuer should be allowed to enter into arrangements to obtain specialist advice or expertise as required by the circumstances.
Informacije dobivene nakon datuma odluke o sanaciji trebale bi se upotrebljavati samo ako je razumno pretpostaviti da su te informacije mogle biti poznate na taj datum.
For purposes of determining the treatment that shareholders and creditors would have received had the entity been put under normal insolvency proceedings, the valuer should determine the expected timing and amount of net cash flows that each shareholder and creditor would have received from the insolvency proceedings without assuming any State aid, discounted at the relevant discount rate or rates.
Kako bi se osigurala provedba sveobuhvatnog i vjerodostojnog vrednovanja, procjenitelj bi trebao imati pristup svoj odgovarajućoj pravnoj dokumentaciji, uključujući popis svih tražbina i potencijalnih tražbina prema subjektu, klasificiranih prema prioritetu u okviru redovnog postupka u slučaju insolventnosti.