natgillin/translations-raw huggingface dataset:
concerning the authorisation of a preparation of endo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM 28088) as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species other than laying birds, turkeys for fattening, turkeys reared for breeding, weaned piglets, pigs for fattening and minor porcine species (holder of authorisation Elanco GmbH)
o odobrenju pripravka endo-1,4-beta-mananaze proizvedenog od Pediococcus pentosaceus (DSM 28088) kao dodatka hrani za piliće za tov, piliće uzgajane za nesenje i manje značajne vrste peradi osim ptica nesilica, pure za tov, pure uzgajane za rasplod, odbijenu prasad, svinje za tov i manje značajne vrste svinja (nositelj odobrenja Elanco GmbH)
In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of endo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM 28088).
U skladu s člankom 7. Uredbe (EZ) br. 1831/2003 podnesen je zahtjev za odobrenje pripravka endo-1,4-beta-mananaze proizvedenog od Pediococcus pentosaceus (DSM 28088).
That application concerns the authorisation of a preparation of endo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM 28088) as a feed additive for chickens for fattening, chickens reared for laying and minor poultry species other than laying birds; turkeys for fattening, turkeys reared for breeding, weaned piglets, pigs for fattening and minor porcine species to be classified in the additive category ‘zootechnical additives’.
Zahtjev se odnosi na odobrenje pripravka endo-1,4-beta-mananaze proizvedenog od Pediococcus pentosaceus (DSM 28088) kao dodatka hrani za piliće za tov, piliće uzgajane za nesenje i manje značajne vrste peradi osim ptica nesilica, pure za tov, pure uzgajane za rasplod, odbijenu prasad, svinje za tov i manje značajne vrste svinja te njegovo razvrstavanje u kategoriju dodataka „zootehnički dodaci”.
The European Food Safety Authority (‘the Authority’) concluded in its opinions of 7 December 2016 and 17 April 2018 that, under the proposed conditions of use, the preparation of endo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM 28088) does not have an adverse effect on animal health, human health or the environment.
Europska agencija za sigurnost hrane („Agencija”) u svojim je mišljenjima od 7. prosinca 2016. i 17. travnja 2018. zaključila da pripravak endo-1,4-beta-mananaze proizveden od Pediococcus pentosaceus (DSM 28088) u predloženim uvjetima uporabe nema štetan učinak na zdravlje životinja, zdravlje ljudi ili na okoliš.
The Authority also concluded that the additive is considered efficacious for chickens for fattening, turkeys for fattening and weaned piglets, pigs for fattening and minor porcine species.
Agencija je zaključila i da se taj dodatak smatra učinkovitim za piliće za tov, pure za tov, odbijenu prasad, svinje za tov i manje značajne vrste svinja.
The Authority considered that these conclusions can be extended to chickens reared for laying and turkeys reared for breeding and that they can be extrapolated to minor poultry species for fattening or reared for breeding or reared for laying.
Agencija je zaključila da se ti zaključci mogu proširiti i na piliće uzgajane za nesenje i pure uzgajane za rasplod te primijeniti na manje značajne vrste peradi za tov ili peradi uzgajane za rasplod ili za nesenje.
The assessment of the preparation of endo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM 28088) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Procjena pripravka od endo-1,4-beta-mananaze proizvedenog od Pediococcus pentosaceus (DSM 28088) pokazala je da su ispunjeni uvjeti za odobrenje predviđeni člankom 5. 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 the Annex.
Pripravak naveden u Prilogu, koji pripada kategoriji dodataka „zootehnički dodaci” i funkcionalnoj skupini „tvari za poticanje probavljivosti”, odobrava se kao dodatak hrani za životinje podložno uvjetima utvrđenima u Prilogu.
EFSA Journal 2017;15(1):4677.
EFSA Journal 2017.;15(1):4677.
EFSA Journal 2018;16(5):5270.
EFSA Journal 2018.;16(5):5270.
Identi-fication number of the additive
Identifikacijski broj dodatka
Endo-1,4-beta-mannanase
Endo-1,4-beta-mananaza
Preparation of endo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM 28088) having a minimum activity of:
Pripravak endo-1,4-beta-mananaze proizveden od Paenibacillus lentus (DSM 28088) s najmanjom aktivnošću od:
1,6 × 108 U/g solid form;
1,6 × 108 U/g u krutom obliku;
5,9 × 108 U/g liquid form.
5,9 × 108 U/g u tekućem obliku.
endo-1,4-beta-mannanase produced by Paenibacillus lentus (DSM 28088)
endo-1,4-beta-mananaza proizvedena od Paenibacillus lentus (DSM 28088)
Analytical methods
Analitička metoda
For the quantification of endo-1,4-beta-mannanase in the feed additive, premixtures and feedingstuffs:
Za kvantifikaciju endo-1,4-beta-mananaze u dodatku hrani za životinje, premiksima i hrani za životinje:
colorimetric methods based on enzymatic hydrolysis and the reaction of reducing sugars (mannose equivalent) with 3,5-dinitrosalicylic acid (DNS)
kolorimetrijska metoda koja se temelji na enzimskoj hidrolizi i reakciji reducirajućih šećera (ekvivalent manaze) s 3,5-dinitrosalicilnom kiselinom (DNS).
Minor poultry species other than laying birds
Manje značajne vrste peradi osim ptica nesilica
In the directions for use of the additive and premixtures, the storage conditions and stability heat treatment shall be indicated.
U uputama za uporabu dodatka hrani za životinje i premiksâ potrebno je navesti uvjete skladištenja i stabilnost pri toplinskoj obradi.
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks to their use.
Za korisnike dodatka i premiksâ subjekti koji posluju s hranom za životinje utvrđuju operativne postupke i organizacijske mjere za uklanjanje mogućih rizika koji proizlaze iz njihove uporabe.
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 skin and breathing protections.
Ako se tim postupcima i mjerama rizici ne mogu ukloniti ili smanjiti na najmanju moguću mjeru, pri uporabi dodatka i premiksâ potrebno je nositi odgovarajuću osobnu zaštitnu opremu, uključujući zaštitu za kožu i dišne organe.
Turkeys reared for breeding
Pure uzgajane za rasplod
Minor porcine species for fattening
Manje značajne vrste svinja za tov
1 U is the amount of enzyme which liberates 0,72 micrograms of reducing sugars (mannose equivalents) from a mannan-containing substrate (locust bean gum) per minute at pH 7,0 and 40 °C.
1 U količina je enzima koja oslobađa 0,72 mikrograma reducirajućih šećera (ekvivalenti manaze) iz supstrata koji sadržava manazu (karuba guma) po minuti pri pH 7,0 i 40 °C.
Commission Implementing Regulation (EU) 2018/1566
Provedbena uredba Komisije (EU) 2018/1566
concerning the authorisation of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) as a feed additive for weaned piglets and minor porcine species (weaned) and amending Regulation (EC) No 1453/2004 (holder of authorisation Andrès Pintaluba S.A.)
o odobrenju pripravka endo-1,3(4)-beta-glukanaze i endo-1,4-beta-ksilanaze proizvedenih od Aspergillus niger (NRRL 25541) i alfa-amilaze proizvedene od Aspergillus niger (ATCC66222) kao dodatka hrani za odbijenu prasad i manje značajne vrste svinja (odbijene) i o izmjeni Uredbe (EZ) br. 1453/2004 (nositelj odobrenja Andrès Pintaluba S.A.)
Article 10 of that Regulation provides for the re-evaluation of additives authorised pursuant to Council Directive 70/524/EEC.
Člankom 10. te uredbe propisuje se ponovna procjena dodataka odobrenih u skladu s Direktivom Vijeća 70/524/EEZ.
The preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) was authorised in accordance with Directive 70/524/EEC without a time limit as a feed additive for weaned piglets by Commission Regulation (EC) No 1453/2004.
Pripravak endo-1,3(4)-beta-glukanaze i endo-1,4-beta-ksilanaze proizvedenih od Aspergillus niger (NRRL 25541) i alfa-amilaze proizvedene od Aspergillus niger (ATCC66222) odobren je, u skladu s Direktivom 70/524/EEZ, bez vremenskog ograničenja kao dodatak hrani za odbijenu prasad Uredbom Komisije (EZ) br. 1453/2004.
In accordance with Article 10(2) of Regulation (EC) No 1831/2003 in conjunction with Article 7 of that Regulation, an application was submitted for the re-evaluation of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) as a feed additive for weaned piglets and minor porcine species (weaned).
U skladu s člankom 10. stavkom 2. Uredbe (EZ) br. 1831/2003 u vezi s člankom 7. te uredbe podnesen je zahtjev za ponovnu procjenu pripravka endo-1,3(4)-beta-glukanaze i endo-1,4-beta-ksilanaze proizvedenih od Aspergillus niger (NRRL 25541) i alfa-amilaze proizvedene od Aspergillus niger (ATCC66222) kao dodatka hrani za odbijenu prasad i manje značajne vrste svinja (odbijene).
The European Food Safety Authority (‘the Authority’) concluded in its opinions of 8 October 2013, 16 May 2017 and 17 April 2018 that, under the proposed conditions of use, of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) does not have an adverse effect on animal health, human health or the environment.
Europska agencija za sigurnost hrane („Agencija”) u svojim je mišljenjima od 8. listopada 2013., 16. svibnja 2017. i 17. travnja 2018. zaključila da u predloženim uvjetima uporabe pripravak endo-1,3(4)-beta-glukanaze i endo-1,4-beta-ksilanaze proizvedenih od Aspergillus niger (NRRL 25541) i alfa-amilaze proizvedene od Aspergillus niger (ATCC66222) nema negativan učinak na zdravlje životinja, zdravlje ljudi ili na okoliš.
The Authority also concluded that the use of that preparation has the potential to improve the final body weight and the feed to gain ratio in weaned piglets and that conclusion can be can be extrapolated to minor porcine species (weaned).
Osim toga, Agencija je zaključila da se upotrebom tog preparata može poboljšati konačna tjelesna masa te omjer utroška hrane i prirasta tjelesne mase kod odbijene prasadi te da se isti zaključak može primijeniti i na manje značajne vrste svinja (odbijene).
The assessment of the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Ocjena pripravka endo-1,3(4)-beta-glukanaze i endo-1,4-beta-ksilanaze proizvedenih od Aspergillus niger (NRRL 25541) i alfa-amilaze proizvedene od Aspergillus niger (ATCC66222) pokazuje da su ispunjeni uvjeti za njegovo odobrenje propisani člankom 5. Uredbe (EZ) br. 1831/2003.
As a consequence of granting the authorisation for the preparation Regulation (EC) No 1453/2004 should be amended accordingly.
S obzirom na izdavanje odobrenja za pripravak trebalo bi na odgovarajući način izmijeniti Uredbu (EZ) br. 1453/2004.
Since there are no safety concerns requiring the immediate application of the modifications to the conditions of authorisation, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
Budući da ne postoje sigurnosni razlozi zbog kojih bi izmjene uvjeta izdavanja odobrenja bilo potrebno odmah primjenjivati, primjereno je zainteresiranim stranama omogućiti prijelazno razdoblje kako bi se pripremile za ispunjavanje novih zahtjeva koji proizlaze iz odobrenja.
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 the Annex.
Pripravak naveden u Prilogu, koji pripada kategoriji dodataka „zootehnički dodaci” i funkcionalnoj skupini „tvari za poticanje probavljivosti”, odobrava se kao dodatak hrani za životinje podložno uvjetima utvrđenima u tom prilogu.
In Annex II to Regulation (EC) No 1453/2004 entry E 1612 on the preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase and alpha-amylase is deleted.
U Prilogu II. Uredbi (EZ) br. 1453/2004 briše se unos E 1612 za pripravak endo-1,3(4)-beta-glukanaze i endo-1,4-beta-ksilanaze i alfa-amilaze.
The preparation specified in the Annex, and feed containing that preparation, which are produced and labelled before 8 May 2019 in accordance with the rules applicable before 8 November 2018 may continue to be placed on the market and used until the existing stocks are exhausted.
Pripravak naveden u Prilogu i hrana za životinje koja sadržava taj pripravak, a koji su proizvedeni i označeni prije 8. svibnja 2019. u skladu s pravilima primjenjivima prije 8. studenoga 2018., mogu se nastaviti stavljati na tržište i upotrebljavati dok se ne potroše postojeće zalihe.
EFSA Journal 2013; 11(10):3430.
EFSA Journal 2013.; 11(10):3430.
EFSA Journal 2017; 15(6):4856.
EFSA Journal 2017.; 15(6):4856.
EFSA Journal 2018; 1(5):5271.
EFSA Journal 2018.; 1(5):5271.
Preparation of endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222) having respectively a minimum activity of.
Pripravak endo-1,3(4)-beta-glukanaze i endo-1,4-beta-ksilanaze proizvedenih od Aspergillus niger (NRRL 25541) i alfa-amilaze proizvedene od Aspergillus niger (ATCC66222) s minimalnom aktivnošću od:
Endo-1,3(4)-beta-glucanase 900 U/g;
endo-1,3(4)-beta-glukanaza 900 U/g,
Endo-1,4-beta-xylanase 1000 U/g;
endo-1,4-beta-ksilanaza 1000 U/g,
Alpha-amylase 3000 U/g
alfa-amilaza 3000 U/g.
endo-1,3(4)-beta-glucanase and endo-1,4-beta-xylanase produced by Aspergillus niger (NRRL 25541) and alpha-amylase produced by Aspergillus niger (ATCC66222
Endo-1,3(4)-beta-glukanaza i endo-1,4-beta-ksilanaza proizvedene od Aspergillus niger (NRRL 25541) i alfa-amilaza proizvedena od Aspergillus niger (ATCC66222)
Determination in the feed additive of:
Određivanje u dodatku hrani za životinje:
endo-1,3(4)-beta glucanase: colorimetric method based on the enzymatic reaction of glucanase on barley betaglucan substrate in the presence of 3,5-dinitrosalicylic acid (DNS) at pH 4,0 and 30 °C;
endo-1,3(4)-beta-glukanaze: kolorimetrijska metoda koja se temelji na enzimskoj reakciji glukanaze na supstratu betaglukana ječma u prisutnosti 3,5-dinitrosalicilne kiseline (DNS) pri pH 4,0 i 30 °C,
endo-1,4-β-xylanase in the feed additive: colorimetric method based on the enzymatic reaction of xylanase on rye arabinoxylan substrate in the presence of DNS at pH 4,0 and 30 °C;
endo-1,4-β-ksilanaze: kolorimetrijska metoda koja se temelji na enzimskoj reakciji ksilanaze na supstratu arabinoksilana raži u prisutnosti DNS-a pri pH 4,0 i 30 °C,
alpha-amylase: colorimetric method based on the enzymatic reaction of amylase on wheat starch substrate in the presence of DNS at pH 5,0 and 30 °C.
alfa-amilaze: kolorimetrijska metoda koja se temelji na enzimskoj reakciji amilaze na supstratu pšeničnog škroba u prisutnosti DNS-a pri pH 5,0 i 30 °C.
Determination of the active substances in premixtures and feedingstuffs:
Određivanje aktivnih tvari u premiksima i hrani za životinje:
Colorimetric method measuring depolymerised soluble fragments released by action of glucanase on azo-barley-glucan;
kolorimetrijska metoda kojom se mjere depolimerizirani topivi fragmenti oslobođeni djelovanjem glukanaze na azoječmeni glukan,
Colorimetric method measuring depolymerised soluble fragments released by action of endo-1,4-β-xylanase on azo-xylan;
kolorimetrijska metoda kojom se mjere depolimerizirani topivi fragmenti oslobođeni djelovanjem endo-1,4-β-ksilanaze na azoksilan,
Colorimetric method measuring depolymerised soluble fragments released by action of amylase on p-nitrophenylmaltoheptaoside.
kolorimetrijska metoda kojom se mjere depolimerizirani topivi fragmenti oslobođeni djelovanjem amilaze na p-nitrofenilmaltoheptaozid.
Minor porcine species
Manje značajne vrste svinja
(weaned)
(odbijene)
endo-1,3(4)-beta-glucanase
Endo-1,3(4)-beta-glukanaza
beta-xylanase
Beta-ksilanaza
alpha-amylase
Alfa-amilaza
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 skin, eyes and breathing protections.
Ako se tim postupcima i mjerama rizici ne mogu ukloniti ili smanjiti na najmanju moguću mjeru, pri uporabi dodatka i premiksâ potrebno je nositi odgovarajuću osobnu zaštitnu opremu, uključujući zaštitu za kožu, oči i dišne organe.
For use in weaned piglets until approximately 35 kg.
Za uporabu kod odbijene prasadi do približno 35 kg.
1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from barley beta-glucan per minute at pH 4,0 and 30 °C.
1 U je količina enzima koja oslobađa 1 mikromol reducirajućih šećera (ekvivalenta glukoze) iz betaglukana ječma po minuti pri pH 4,0 i 30 °C.
1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from rye arabinoxylan per minute at pH 4,0 and 30 °C.
1 U je količina enzima koja oslobađa 1 mikromol reducirajućih šećera (ekvivalenta glukoze) iz arabinoksilana raži po minuti pri pH 4,0 i 30 °C.
1 U is the amount of enzyme which liberates 1 micromole of reducing sugars (glucose equivalents) from wheat starch per minute at pH 5,0 and 30 °C.
1 U je količina enzima koja oslobađa 1 mikromol reducirajućih šećera (ekvivalenta glukoze) iz pšeničnog škroba po minuti pri pH 5,0 i 30 °C.
1500 U
1500 U
Commission Implementing Regulation (EU) 2018/1567
Provedbena uredba Komisije (EU) 2018/1567
correcting Implementing Regulation (EU) 2018/249 concerning the authorisation of taurine, beta-alanine, L-alanine, L-arginine, L-aspartic acid, L-histidine, D,L-isoleucine, L-leucine, L-phenylalanine, L-proline, D,L-serine, L-tyrosine, L-methionine, L-valine, L-cysteine, glycine, monosodium glutamate and L-glutamic acid as feed additives for all animal species and L-cysteine hydrochloride monohydrate for all species except cats and dogs
o ispravku Provedbene uredbe (EU) 2018/249 o odobrenju taurina, beta-alanina, L-alanina, L-arginina, L-asparaginske kiseline, L-histidina, D,L-izoleucina, L-leucina, L-fenilalanina, L-prolina, D,L-serina, L-tirozina, L-metionina, L-valina, L-cisteina, glicina, mononatrijeva glutamata i L-glutaminske kiseline kao dodataka hrani za sve životinjske vrste te L-cistein hidroklorid monohidrata za sve vrste osim mačaka i pasa
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, and in particular Article 9(2) thereof,
uzimajući u obzir Uredbu (EZ) br. 1831/2003 Europskog parlamenta i Vijeća od 22. rujna 2003. o dodacima hrani za životinje, a posebno njezin članak 9. stavak 2,
Commission Implementing Regulation (EU) 2018/249 authorises certain feed additives as flavourings, including glycine, L-cysteine and L-cysteine hydrochloride monohydrate.
Provedbenom uredbom Komisije (EU) 2018/249 odobravaju se određeni dodaci hrani za životinje kao arome, uključujući glicin, L-cistein i L-cistein hidroklorid monohidrat.
An error appears in the Annex to Implementing Regulation (EU) 2018/249 in the entry for glycine where, in the column ‘Other provisions’, it is stated that the label of this additive is to indicate that recommended maximum content of the active substance of complete feedingstuff, with a moisture content of 12 % for other categories and species, is 25 g/kg.
U Prilogu Provedbenoj uredbi (EU) 2018/249 pojavljuje se pogreška u unosu za glicin gdje je u stupcu „Ostale odredbe” navedeno da je na oznaci tog dodatka potrebno navesti da najveća preporučena količina aktivne tvari u potpunoj krmnoj smjesi s udjelom vlage od 12 % za druge kategorije i vrste iznosi 25 g/kg.
In accordance with the opinion of the European Food Safety Authority issued for the authorisation of this feed additive, the correct amount is 25 mg/kg.
U skladu s mišljenjem Europske agencije za sigurnost hrane, koje je izdano za odobrenje tog dodatka hrani za životinje, ispravni je iznos 25 mg/kg.
Errors appear in the Annex to Implementing Regulation (EU) 2018/249, in the entries for L-cysteine and L-cysteine hydrochloride monohydrate regarding the manufacturing process of the active substance.
U Prilogu Provedbenoj uredbi (EU) 2018/249 pojavljuju se pogreške u unosima za L-cistein i L-cistein hidroklorid monohidrat u pogledu proizvodnog postupka aktivne tvari.
In particular, while it is indicated in the column ‘Composition, chemical formula, description analytical method’ that the active substance is produced by chemical synthesis or protein hydrolysis.
Konkretno, u stupcu „Sastav, kemijska formula, opis, analitička metoda” navedeno je da se aktivna tvar proizvodi kemijskom sintezom ili hidrolizom bjelančevina.
In this part, it is omitted to indicate that the protein hydrolysis is made with animal or vegetal proteins, so the use of human hair that could be used as a source for hydrolysis to produce this specific additive is not allowed.
U tom je dijelu izostavljeno da se hidroliza bjelančevina provodi s životinjskim ili biljnim bjelančevinama te stoga u proizvodnji tog dodatka nije dopuštena upotreba ljudske kose, koja bi se mogla upotrijebiti kao izvor za hidrolizu.
The erroneous provisions have given rise to confusion for the feed business operators as regards the actual provisions for placing on the market of the additives concerned.
Neispravne odredbe uzrokovale su nejasnoće subjektima u poslovanju s hranom za životinje u pogledu stvarnih odredbi o stavljanju predmetnih dodataka na tržište.
That situation has created legal uncertainty as to the applicable regulatory framework.
Ta je situacija dovela do pravne nesigurnosti u pogledu primjenjivog regulatornog okvira.
Those errors have therefore resulted in some market disturbance linked to the questioned authorisation to place on the market and use of glycine, L-cysteine and L-cysteine hydrochloride monohydrate.
Navedene pogreške stoga su dovele do određenih poremećaja na tržištu povezanih s nedoumicama u pogledu odobrenja za stavljanje na tržište i uporabu glicina, L-cisteina i L-cistein hidroklorid monohidrata.
The corrections to Implementing Regulation (EU) 2018/249 should therefore apply retroactively on the day of entry into force of that Implementing Regulation, in order to restore legal certainty in relation to the regulatory status of the additives subject to the errors, to avoid any detrimental consequences for the operators concerned and consequently, to bring stability back to the market.
Ispravci Provedbene uredbe (EU) 2018/249 trebali bi se stoga primijeniti retroaktivno od dana stupanja na snagu te provedbene uredbe, kako bi se ponovo uspostavila pravna sigurnost s obzirom na regulatorni status dodataka u pogledu kojih je došlo do pogreške, izbjegle štetne posljedice za predmetne subjekte i na taj način ponovno uspostavila stabilnost na tržištu.
The Annex to Implementing Regulation (EU) 2018/249 is corrected in accordance with Annex to this Regulation.
Prilog Provedbenoj uredbi (EU) 2018/249 ispravlja se u skladu s Prilogom ovoj Uredbi.
It shall apply from 15 March 2018.
Primjenjuje se od 15. ožujka 2018.