natgillin/translations-raw huggingface dataset:
Since the introduction of the random genotyping requirement set out point 8.2 of Part II of Chapter A of Annex III to Regulation (EC) No 999/2001, the original objectives of mapping scrapie susceptible sheep genotypes and identifying resistant sheep genotypes per country have been achieved.
Prilogom III. poglavljem A dijelom II. utvrđena su pravila praćenja bolesti kod ovaca i koza, a Prilogom III. poglavljem A dijelom II. točkom 8.2. utvrđeno je da su sve države članice dužne odrediti genotip bjelančevine priona za kodone 136, 141, 154 i 171 na minimalnom uzorku ovaca reprezentativnom za čitavu populaciju ovaca te države članice, od najmanje 600 životinja za države članice s populacijom odraslih ovaca od više od 750000 životinja i od najmanje 100 životinja za druge države članice.
However, random genotyping of sheep remains useful in Member States which, in accordance with Article 6a of Regulation (EC) No 999/2001 and Chapter C of Annex VII thereto, carry out a breeding programme to select for resistance to TSEs in their ovine populations, and whose breeding programme aims at having an impact on the genetic profile of their overall ovine population.
Od uvođenja zahtjeva za nasumičnu genotipizaciju utvrđenog poglavljem A dijelom II. točkom 8.2.
For those Member States, genotyping randomly a fraction of their entire ovine population allows them to assess whether the breeding programme in place has the desired impact, which is to increase the frequency of the ARR allele while reducing the prevalence of those alleles which have been shown to contribute to susceptibility to TSEs.
Priloga III.
Chapter C of Annex VII to Regulation (EC) No 999/2001 sets out the minimum requirements for breeding programmes for resistance to TSEs in ovine animals in the Member States, and point 1 of Part 1 of that Chapter provides that the breeding programme is to concentrate on flocks of high genetic merit.
Uredbi (EZ) br. 999/2001, izvorni su ciljevi mapiranja genotipova ovaca prijemljivih na grebež i utvrđivanja otpornih genotipova ovaca po zemlji postignuti.
The second paragraph of point 1 permits those Member States where a breeding programme is in place to decide to allow sampling and genotyping of breeding rams only, in flocks not participating in the breeding programme.
Međutim, nasumična genotipizacija ovaca i dalje je korisna u državama članicama koje, u skladu s člankom 6.a Uredbe (EZ) br. 999/2001 i njezinim Prilogom VII. poglavljem C, u svojim populacijama ovaca provode programe uzgoja za selekciju ovaca otpornih na TSE i gdje taj program uzgoja ima za cilj učinak na genetski profil njihove čitave populacije ovaca.
That provision is used where the breeding programme of a Member State aims at having an impact on the genetic profile of the overall ovine population.
Za te države članice nasumična genotipizacija dijela njihove čitave populacije ovaca omogućuje im da procijene ima li program uzgoja koji provode željeni učinak, a to je povećanje učestalosti alela ARR uz istodobno smanjenje prevalencije onih alela za koje se pokazalo da doprinose prijemljivosti na TSE.
Therefore, the random genotyping requirement set out in point 8.2 of Part II of Chapter A of Annex III to Regulation (EC) No 999/2001 should be limited to those Member States carrying out a breeding programme and which allow the sampling and genotyping of breeding rams in flocks not participating in the breeding programme.
Poglavljem C Priloga VII.
The Opinion of the Scientific Panel on Biological Hazards (BIOHAZ) on the Breeding programme for TSE resistance in sheep of 13 July 2006 [2], of the European Food Safety Authority (‘the EFSA Opinion’), considered that the current requirement laid down in point 8.2 of Part II of Chapter A of Annex III to Regulation (EC) No 999/2001 to randomly genotype 100 or 600 ovine animals per year, depending on the sheep population size of the Member State, seems inadequate to monitor the impact of a breeding programme on the overall ovine population of a Member State given the small sample size required.
Uredbi (EZ) br. 999/2001 utvrđeni su minimalni zahtjevi za uzgojni program za postizanje otpornosti ovaca na TSE u državama članicama, a u dijelu 1. točki 1. tog poglavlja utvrđeno je da se uzgojni program mora usredotočiti na stada visoke genetske vrijednosti.
The EFSA Opinion recommended increasing the sampling size and noted that, assuming that the prevalence of the genotype targeted by the monitoring is 50 %, 1560 animals would need to be tested each year to detect a change of 5 % in the genotype prevalence with a level of confidence of 95 %.
U točki 1. drugom stavku utvrđeno je da države članice koje imaju uzgojni program mogu odlučiti da u stadima koja nisu obuhvaćena uzgojnim programom dopuste uzorkovanje i genotipizaciju samo rasplodnih ovnova.
Since a change of 5 % in the genotype prevalence at the level of the entire ovine population is unlikely to occur within a year, it is appropriate to carry out such random genotyping once every 3 years.
Ta se odredba primjenjuje ako uzgojni program države članice za cilj ima učinak na genetski profil čitave populacije ovaca.
The EFSA Opinion also recommended collecting epidemiological relevant data, such as the region, flock type and sex of the animal, for a posteriori adjustment and the monitoring of a proper sampling design.
Stoga bi zahtjev za nasumičnu genotipizaciju iz poglavlja A dijela II. točke 8.2.
It is therefore appropriate to give Member States the possibility to determine the exact sampling size and frequency of their representative sampling and genotyping of their national sheep population, taking into account epidemiological data collected during previous sampling campaigns, provided that the sampling design allows at a minimum to detect a change of 5 % in genotype prevalence over a 3-year period, with a level of confidence of 95 %.
Priloga III.
The random genotyping requirement set out in point 8.2 of Part II of Chapter A of Annex III to Regulation (EC) No 999/2001 should therefore be deleted and replaced by a requirement set out in Part 1 of Chapter C of Annex VII to that Regulation laying down that Member States carrying out a breeding programme for ovine animals, and allowing the sampling and genotyping of breeding rams in flocks not participating in the breeding programme, should genotype a random sample of ovine animals, representative of the ovine population of the Member State, either of at least 1560 animals once every 3 years, or of a sample size and at a frequency determined by the Member State based on criteria defined in the previous recital.
Uredbi (EZ) br. 999/2001 trebao biti ograničen na one države članice koje imaju uzgojni program i koje dopuštaju uzorkovanje i genotipizaciju rasplodnih ovnova u stadima koja nisu obuhvaćena uzgojnim programom.
Annexes III and VII to Regulation (EC) No 999/2001 should therefore be amended accordingly.
Prema Mišljenju Znanstvenog odbora za biološke opasnosti (Odbor BIOHAZ) Europske agencije za sigurnost hrane o uzgojnom programu za postizanje otpornosti ovaca na TSE od 13. srpnja 2006.
Since the random genotyping is organised per calendar year, this amendment should become applicable on 1 January 2018.
[2] (Mišljenje EFSA-e), postojeći zahtjev iz poglavlja A dijela II. točke 8.2.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Priloga III.
HAS ADOPTED THIS REGULATION:
Uredbi (EZ) br. 999/2001 za nasumičnu genotipizaciju na uzorku veličine 100 ili 600 ovaca godišnje, ovisno o veličini populacije ovaca u državi članici, čini se nedovoljnim za praćenje utjecaja uzgojnog programa na čitavu populaciju ovaca u državi članici s obzirom na malenu zahtijevanu veličinu uzorka.
Article 1
U Mišljenju EFSA-e preporučuje se povećanje veličine uzorka i napominje da bi, pod pretpostavkom da je prevalencija genotipa koji je predmet praćenja 50 %, svake godine trebalo testirati 1560 životinja da bi se otkrila promjena od 5 % u prevalenciji genotipa uz razinu pouzdanosti od 95 %.
Annexes III and VII to Regulation (EC) No 999/2001 are amended in accordance with the Annex to this Regulation.
Budući da nije vjerojatno da će se promjena od 5 % u prevalenciji genotipa na razini čitave populacije ovaca dogoditi unutar jedne godine, prikladno je provesti takvu nasumičnu genotipizaciju jednom svake tri godine.
Article 2
U Mišljenju EFSA-e preporučuje se i prikupljanje epidemioloških relevantnih podataka kao što su regija, vrsta stada i spol životinje u cilju naknadne prilagodbe i praćenja ispravnog plana uzorkovanja.
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Stoga je primjereno državama članicama dati mogućnost da same odrede točnu veličinu uzorka i učestalost njihova reprezentativnog uzorkovanja i genotipizacije njihove nacionalne populacije ovaca, uzimajući u obzir epidemiološke podatke prikupljene tijekom prethodnih programa uzorkovanja, uz uvjet da plan uzorkovanja omogućuje otkrivanje promjene u prevalenciji genotipa od najmanje 5 % u razdoblju od tri godine, uz razinu pouzdanosti od 95 %.
It shall apply from 1 January 2018.
Zahtjev za nasumičnu genotipizaciju iz poglavlja A dijela II. točke 8.2.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Priloga III.
Done at Brussels, 24 May 2017.
Uredbi (EZ) br. 999/2001 stoga bi trebalo izbrisati i zamijeniti zahtjevom iz poglavlja C dijela 1.
For the Commission
Priloga VII. toj uredbi kojim je utvrđeno da bi države članice koje imaju uzgojni program za ovce i koje dopuštaju uzorkovanje i genotipizaciju rasplodnih ovnova u stadima koja nisu obuhvaćena uzgojnim programom trebale provoditi genotipizaciju na nasumično odabranom uzorku ovaca reprezentativnom za populaciju ovaca te države članice i to ili na uzorku od barem 1560 životinja jednom svake tri godine ili na uzorku veličine koju odredi država članica i s učestalošću koju odredi država članica na temelju kriterija iz prethodne uvodne izjave.
The President
Priloge III. i VII.
OJ L 147, 31.5.2001, p. 1.
Uredbi (EZ) br. 999/2001 trebalo bi stoga na odgovarajući način izmijeniti.
EFSA Journal (2006) 382, 1-46.
Kako se nasumična genotipizacija organizira po kalendarskim godinama, ova bi izmjena trebala stupiti na snagu 1. siječnja 2018.
ANNEX
Mjere predviđene ovom Uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
Annexes III and VII to Regulation (EC) No 999/2001 are amended as follows:
DONIJELA JE OVU UREDBU:
Annex III is amended as follows:
Članak 1.
in Chapter A, in Part II, point 8 is replaced by the following:
Prilozi III. i VII.
Genotyping
Uredbi (EZ) br. 999/2001 mijenjaju se u skladu s Prilogom ovoj Uredbi.
The prion protein genotype for the codons 136, 154 and 171 shall be determined for each positive TSE case in sheep.
Članak 2.
TSE cases found in sheep of genotypes which encode alanine on both alleles at codon 136, arginine on both alleles at codon 154 and arginine on both alleles at codon 171 shall immediately be reported to the Commission.
Ova Uredba stupa na snagu dvadesetog dana od dana objave u Službenom listu Europske unije.
Where the positive TSE case is an atypical scrapie case the prion protein genotype for the codon 141 shall also be determined.’;
Ova se Uredba primjenjuje od 1. siječnja 2018.
in Chapter B, in Part I(A), point 8 is replaced by the following:
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
The genotype, and, where possible, the breed, of each ovine animal found positive to TSE and sampled in accordance with Chapter A, Part II, point 8.’;
Sastavljeno u Bruxellesu 24. svibnja 2017.
in Annex VII, in Chapter C, in Part 1, the following point 8 is added:
Za Komisiju
Where the Member State allows, in accordance with the second paragraph of point 1, the sampling and genotyping of breeding rams in flocks not participating in the breeding programme, the prion protein genotype for the codons 136, 141, 154 and 171 shall be determined for a minimum sample representative of the entire ovine population of the Member State, either:
Predsjednik
once every 3 years with a minimum sample of at least 1560 ovine animals; or
SL L 147, 31.5.2001., str. 1.
at a frequency and with a sample size determined by the Member State based on compliance with the following criteria:
EFSA Journal (2006.) 382, 1-46.
the sampling design takes into account relevant epidemiological data collected during previous surveys, including data concerning the prion protein genotype of sheep for the codons 136, 141, 154 and 171 by breed, region, age, sex and flock type;
PRILOG
the sampling design allows at a minimum to detect a change of 5 % in genotype prevalence over a 3-year period, with a 80 % power and 95 % confidence level.’
Prilozi III. i VII.
In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094).
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 3-fitaze proizvedenog od Komagataella pastoris (CECT 13094).
The application concerns the authorisation of a preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) as a feed additive for chickens for fattening and laying hens 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 19 October 2016 [2] that, under the proposed conditions of use, 3-phytase produced by Komagataella pastoris (CECT 13094) does not have an adverse effect on animal health, human health or the environment.
Uredbe (EZ) br. 1831/2003.
The Authority has also concluded that the additive has a potential to be efficacious in improving the availability of phytate phosphorus of the diets for the target species.
Zahtjev se odnosi na odobrenje pripravka 3-fitaze proizvedenog od Komagataella pastoris (CECT 13094) kao dodatka hrani za piliće za tov i kokoši nesilice te njegovo razvrstavanje u kategoriju dodataka „zootehnički dodaci”.
The Authority does not consider that there is a need for specific requirements of post-market monitoring.
Europska agencija za sigurnost hrane (dalje u tekstu „Agencija”) u svojem je mišljenju od 19. listopada 2016.
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.
[2] zaključila da 3-fitaza proizvedena od Komagataella pastoris (CECT 13094) u predloženim uvjetima uporabe nema nepovoljan učinak na zdravlje životinja, zdravlje ljudi ni na okoliš.
The assessment of the 3-phytase shows that the conditions for authorisation of 3-phytase produced by Komagataella pastoris (CECT 13094), as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Agencija je zaključila i da bi dodatak mogao djelovati na povećanje dostupnosti fitinskog fosfora u prehrani za ciljne vrste.
Accordingly, the use of that preparation should be authorised as specified in the Annex to this Regulation.
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,
Isto tako, potvrdila je izvješće o metodi analize dodatka hrani za životinje koje je dostavio referentni laboratorij osnovan Uredbom (EZ) br. 1831/2003.
HAS ADOPTED THIS REGULATION:
Procjena 3-fitaze pokazala je da su ispunjeni uvjeti za odobrenje 3-fitaze proizvedene od Komagataella pastoris (CECT 13094) predviđeni člankom 5.
Article 1
Uredbe (EZ) br. 1831/2003.
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘digestibility enhancers’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
U skladu s tim trebalo bi odobriti uporabu tog pripravka kako je navedeno u Prilogu ovoj Uredbi.
Done at Brussels, 24 May 2017.
Pripravak naveden u Prilogu, koji pripada kategoriji dodataka hrani za životinje „zootehnički dodaci” i funkcionalnoj skupini „tvari za poticanje probavljivosti”, odobrava se kao dodatak hrani za životinje u skladu s uvjetima utvrđenima u tom prilogu.
OJ L 268, 18.10.2003, p. 29.
Ova je Uredba u cijelosti obvezujuća i izravno se primjenjuje u svim državama članicama.
EFSA Journal 2016;14(11):4622.
Sastavljeno u Bruxellesu 24. svibnja 2017.
Identification number of the additive
Predsjednik
Name of the holder of authorisation
SL L 268, 18.10.2003., str. 29.
Additive
EFSA Journal 2016.;14(11):4622.
Composition, chemical formula, description, analytical method
PRILOG
Species or category of animal
Identifikacijski broj dodatka hrani za životinje
Maximum age
Ime nositelja odobrenja
Minimum content
Dodatak hrani za životinje
Maximum content
Sastav, kemijska formula, opis, analitička metoda
Other provisions
Vrsta ili kategorija životinje
End of period of authorisation
Najviša dob
Units of activity/kg of complete feedingstuff with a moisture content of 12 %
Najmanja dopuštena količina
Category of zootechnical additives.
Najveća dopuštena količina
Functional group: digestibility enhancers
Ostale odredbe
hytase
Datum isteka valjanosti odobrenja
Additive composition
Kategorija zootehničkih dodataka hrani za životinje.
Preparation of 3-phytase produced by Komagataella pastoris (CECT 13094) having a minimum activity of: 1000 FTU [1]/ml
Funkcionalna skupina: tvari za poticanje probavljivosti
Liquid form
itaza
Characterisation of the active substance
Sastav dodatka
hytase (EC 3.1.3.8) produced by Komagataella pastoris (CECT 13094)
Pripravak 3-fitaze proizveden od Komagataella pastoris (CECT 13094) s najmanjom aktivnošću od: 1000 FTU [1]/ml
Analytical method [2]For the quantification of 3-phytase activity in the feed additive:
Tekući oblik
colorimetric method based on the enzymatic reaction of phytase on the phytate
Karakteristike aktivne tvari
For the quantification of 3-phytase activity in feedingstuffs:
itaza (EC 3.1.3.8) proizvedena od Komagataella pastoris (CECT 13094)
colorimetric method based on the enzymatic reaction of phytase on the phytate — EN ISO 30024
Analitička metoda [2]Za kvantifikaciju aktivnosti 3-fitaze u dodatku hrani za životinje:
Chickens for fattening
kolorimetrijska metoda koja se temelji na enzimskoj reakciji fitaze na fitat.
In the directions for use of the additive and premixtures, the storage conditions and stability to heat treatment shall be indicated.
kolorimetrijska metoda koja se temelji na enzimskoj reakciji fitaze na fitat – EN ISO 30024.
Recommended maximum dose for chickens for fattening and laying hens: 1000 FTU/kg complete feed.
Pilići za tov
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from its use.
U uputama za uporabu dodatka hrani za životinje i premiksa potrebno je navesti uvjete skladištenja i stabilnost pri toplinskoj obradi.
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.
Najveća preporučena količina za piliće za tov i kokoši nesilice: 1000 FTU/kg potpune krmne smjese.
14 June 2027
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.
Laying hens
Ako se opasnosti s pomoću tih postupaka i mjera ne mogu otkloniti ili svesti na najmanju moguću mjeru, pri uporabi dodatka hrani za životinje i premiksa potrebno je nositi odgovarajuću osobnu zaštitnu opremu, uključujući zaštitu za dišne organe.
1 FTU is the amount of enzyme which liberates 1 micromole of inorganic phosphate per minute from a sodium phytate substrate at pH 5,5 and 37 °C.
14. lipnja 2027.
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
Kokoši nesilice
The use of preparation of 6-phytase, produced by Trichoderma reesei (ATCC SD-6528) in liquid form, was authorised for 10 years for all poultry and all porcine species (other than suckling piglets) by Commission Implementing Regulation (EU) 2016/899 [2].
Upotreba pripravka 6-fitaze proizvedenog od Trichoderma reesei (ATCC SD-6528) u tekućem obliku odobrena je na deset godina za sve vrste peradi i sve vrste svinja (osim prasadi) Provedbenom uredbom Komisije (EU) 2016/899 [2].
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 Trichoderma reesei (ATCC SD-6528) in solid form.
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 Trichoderma reesei (ATCC SD-6528) u krutom obliku.
That application concerns the authorisation of the preparation of 6-phytase produced by Trichoderma reesei (ATCC SD-6528) in solid form as a feed additive for poultry and porcine species 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 20 October 2016 [3] that, under the proposed conditions of use, the preparation of 6-phytase produced by Trichoderma reesei (ATCC SD-6528) in solid form does not have an adverse effect on animal health, human health or the environment, and that it improves the availability of phytate phosphorus 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 Trichoderma reesei (ATCC SD-6528) u krutom obliku kao dodatka hrani za perad i svinje 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 (dalje u tekstu: „Agencija”) zaključila je u mišljenju od 20. listopada 2016.
The assessment of the preparation of 6-phytase produced by Trichoderma reesei (ATCC SD-6528) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
[3] da u predloženim uvjetima uporabe pripravak 6-fitaze proizveden od Trichoderma reesei (ATCC SD-6528) u krutom obliku nema nepovoljan učinak na zdravlje životinja, zdravlje ljudi ili na okoliš te da može poboljšati dostupnost fitinskog fosfora u prehrani za ciljne vrste.
HAS ADOPTED THIS REGULATION:
Procjena pripravka pripravka 6-fitaze proizvedenog od Trichoderma reesei pokazala je da su ispunjeni uvjeti za odobrenje pripravka 6-fitaze proizvedenog od Trichoderma reesei (ATCC SD-6528) predviđeni člankom 5.
Commission Implementing Regulation (EU) 2016/899 of 8 June 2016 concerning the authorisation of a 6-phytase produced by Trichoderma reesei (ATCC SD-6528) as a feed additive for all poultry species and all porcine species (other than suckling piglets) (holder of authorisation Danisco (UK) Ltd) (OJ L 152, 9.6.2016, p. 15).
Sastavljeno u Bruxellesu 24. svibnja 2017.
EFSA Journal 2016; 14(11):4625.
Za Komisiju
Identification number of the additive
SL L 268, 18.10.2003., str. 29.