natgillin/translations-raw huggingface dataset:
This Directive allows imports of animals intended for breeding, breeding animals at the end of their reproductive life, or meat therefrom, from third countries, which can afford guarantees at least equivalent to those laid down in that Directive, which have been established for the purpose of giving effect to Chapter V of Council Directive 96/23/EC [7] describing the measures to be taken in the event of infringement.
Tom se direktivom dopušta uvoz rasplodnih životinja i rasplodnih životinja koje su na kraju reproduktivnog života i mesa takvih životinja iz trećih zemalja ako se daju jamstva koja su najmanje istovjetna jamstvima propisanima u toj direktivi, koja su bila određena za potrebe primjene poglavlja V. Direktive Vijeća 96/23/EZ [7] s opisom mjera koje treba poduzeti u slučaju kršenja.
Directive 96/23/EC lays down measures for monitoring the presence of certain substances and groups of residues in live animals and animal products.
Direktivom 96/23/EZ utvrđuju se mjere za praćenje prisutnosti određenih tvari i skupina rezidua u živim životinjama i proizvodima životinjskog podrijetla.
It provides that imports of animals for slaughter and of products of animal origin intended for human consumption are only to be authorised from third countries whose monitoring plan has been approved by the Commission.
Njome se predviđa da se uvoz životinja za klanje i proizvoda životinjskog podrijetla namijenjenih prehrani ljudi može odobriti samo za one treće zemlje čiji je plan praćenja odobrila Komisija.
Domestic solipeds are usually not raised solely for the production of meat and are only sent for slaughter at the end of their productive life.
Domaći kopitari obično se ne uzgajaju isključivo za proizvodnju mesa te ih se šalje na klanje tek na kraju njihova proizvodnog života.
In the Union, animals of the equidae family are considered to be food-producing animals, unless they are irreversibly excluded from slaughter for human consumption in accordance with Directive 2001/82/EC of the European Parliament and of the Council [8].
Životinje iz porodice kopitara u Uniji se smatraju životinjama koje se upotrebljavaju za proizvodnju hrane, osim ako su nepovratno isključene iz klanja za prehranu ljudi u skladu s Direktivom 2001/82/EZ Europskog parlamenta i Vijeća [8].
Following audit missions in certain third countries, where deficiencies had been detected, and in order to ensure compliance with the provisions of Directive 96/22/EC, it is necessary to reinforce the guarantees on imports of fresh meat of equidae intended for human consumption, meat preparations as well as meat products and treated stomachs, bladders and intestines produced therefrom as regards the monitoring of substances and groups of residues and substances referred to in Annex I to Directive 96/23/EC.
Nakon revizija na terenu u određenim trećim zemljama u kojima su otkrivene nepravilnosti te kako bi se osigurala usklađenost s odredbama Direktive 96/22/EZ, potrebno je ojačati jamstva za uvoz svježeg mesa kopitara namijenjenog prehrani ljudi, mesnih pripravaka te mesnih proizvoda i obrađenih želudaca, mjehura i crijeva proizvedenih od njih u pogledu praćenja tvari i skupina rezidua i tvari iz Priloga I. Direktivi 96/23/EZ.
Therefore, the health certificate for meat preparations, the health certificate for meat products and treated commodities and the EQU certificate should be amended so that they provide the necessary guarantees that the commodities covered by them, when they are produced from or contain meat of domestic solipeds, were produced from meat which meets the requirements set out for the imports of fresh meat of domestic solipeds.
Stoga bi zdravstveni certifikat za mesne pripravke, zdravstveni certifikat za mesne proizvode i obrađene proizvode i certifikat EQU trebalo izmijeniti tako da se njima daju potrebna jamstva da su proizvodi koji su njima obuhvaćeni, kada su proizvedeni od mesa domaćih kopitara ili ga sadržavaju, proizvedeni od mesa koje ispunjava zahtjeve utvrđene za uvoz svježeg mesa domaćih kopitara.
Decisions 2000/572/EC and 2007/777/EC and Regulation (EU) No 206/2010 should therefore be amended accordingly.
Odluke 2000/572/EZ i 2007/777/EZ te Uredbu (EU) br. 206/2010 trebalo bi stoga na odgovarajući način izmijeniti.
To avoid any disruption of trade, imports into the Union of consignments of commodities accompanied by the health certificate for meat preparations, the health certificate for meat products and treated commodities and the EQU certificate issued in accordance with Decisions 2000/572/EC and 2007/777/EC and Regulation (EU) No 206/2010 before the amendments made by this Regulation should continue to be authorised for a transitional period.
Kako bi se izbjegli poremećaji u trgovini, uvoz u Uniju pošiljaka proizvoda popraćenih zdravstvenim certifikatom za mesne pripravke, zdravstvenim certifikatom za mesne proizvode i obrađene proizvode i certifikatom EQU, koji su izdani u skladu s odlukama 2000/572/EZ i 2007/777/EZ i Uredbom (EU) br. 206/2010 prije izmjena uvedenih ovom uredbom, trebalo bi nastaviti odobravati tijekom prijelaznog razdoblja.
The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
Mjere predviđene ovom uredbom u skladu su s mišljenjem Stalnog odbora za bilje, životinje, hranu i hranu za životinje,
Amendment to Decision 2000/572/EC
Izmjena Odluke 2000/572/EZ
Annex II to Decision 2000/572/EC is amended in accordance with Annex I to this Regulation.
Prilog II. Odluci 2000/572/EZ mijenja se u skladu s Prilogom I. ovoj uredbi.
Annex III to Decision 2007/777/EC is amended in accordance with Annex II to this Regulation.
Prilog III. Odluci 2007/777/EZ mijenja se u skladu s Prilogom II. ovoj uredbi.
Amendment to Regulation (EU) No 206/2010
Izmjena Uredbe (EU) br. 206/2010
Part 2 of Annex II to Regulation (EU) No 206/2010 is amended in accordance with Annex III to this Regulation.
Dio 2. Priloga II. Uredbi (EU) br. 206/2010 mijenja se u skladu s Prilogom III. ovoj uredbi.
For a transitional period until 31 March 2017, consignments of meat preparations accompanied by a health certificate for meat preparations issued in accordance with the model set out in Annex II to Decision 2000/572/EC before the amendments made by this Regulation, shall continue to be authorised for importation into the Union provided that the certificate was issued no later than 28 February 2017.
Tijekom prijelaznog razdoblja do 31. ožujka 2017. pošiljke mesnih pripravaka popraćene zdravstvenim certifikatom za mesne pripravke izdanim u skladu s obrascem navedenim u Prilogu II. Odluci 2000/572/EZ prije izmjena uvedenih ovom uredbom nastavljaju se odobravati za uvoz u Uniju, uz uvjet da je certifikat izdan najkasnije 28. veljače 2017.
For a transitional period until 31 March 2017, consignments of meat products and treated stomachs, bladders and intestines, accompanied by a health certificate for meat products and treated commodities issued in accordance with the model set out in Annex III to Decision 2007/777/EC before the amendments made by this Regulation, shall continue to be authorised for importation into the Union provided that the certificate was issued no later than 28 February 2017.
Tijekom prijelaznog razdoblja do 31. ožujka 2017. pošiljke mesnih proizvoda i obrađenih želudaca, mjehura i crijeva popraćene zdravstvenim certifikatom za mesne proizvode i obrađene proizvode izdanim u skladu s obrascem navedenim u Prilogu III. Odluci 2007/777/EZ prije izmjena uvedenih ovom uredbom nastavljaju se odobravati za uvoz u Uniju, uz uvjet da je certifikat izdan najkasnije 28. veljače 2017.
For a transitional period until 31 March 2017, consignments of fresh meat of equidae intended for human consumption, accompanied by an EQU certificate issued in accordance with the model set out in Part 2 of Annex II to Regulation (EU) No 206/2010 before the amendments made by this Regulation, shall continue to be authorised for importation into the Union provided that the certificate was issued no later than 28 February 2017.
Tijekom prijelaznog razdoblja do 31. ožujka 2017. pošiljke svježeg mesa kopitara namijenjenog prehrani ljudi popraćene certifikatom EQU izdanim u skladu s obrascem iz dijela 2. Priloga II. Uredbi (EU) br. 206/2010 prije izmjena uvedenih ovom uredbom nastavljaju se odobravati za uvoz u Uniju, uz uvjet da je certifikat izdan najkasnije 28. veljače 2017.
Done at Brussels, 17 October 2016.
Sastavljeno u Bruxellesu 17. listopada 2016.
Council Directive 96/22/EC of 29 April 1996 concerning the prohibition on the use in stockfarming of certain substances having a hormonal or thyrostatic action and of ß-agonists, and repealing Directives 81/602/EEC, 88/146/EEC and 88/299/EEC (OJ L 125, 23.5.1996, p. 3).
Direktiva Vijeća 96/22/EZ od 29. travnja 1996. o zabrani primjene određenih tvari hormonskog ili tireostatskog učinka i beta-agonista na farmskim životinjama i o stavljanju izvan snage direktiva 81/602/EEZ, 88/146/EEZ i 88/299/EEZ (SL L 125, 23.5.1996., str. 3.).
Council Directive 96/23/EC of 29 April 1996 on measures to monitor certain substances and residues thereof in live animals and animal products and repealing Directives 85/358/EEC and 86/469/EEC and Decisions 89/187/EEC and 91/664/EEC (OJ L 125, 23.5.1996, p. 10).
Direktiva Vijeća 96/23/EZ od 29. travnja 1996. o mjerama za praćenje određenih tvari i njihovih rezidua u živim životinjama i proizvodima životinjskog podrijetla i o stavljanju izvan snage direktiva 85/358/EEZ i 86/469/EEZ i odluka 89/187/EEZ i 91/664/EEZ (SL L 125, 23.5.1996., str. 10.).
In Annex II to Decision 2000/572/EC, in the model animal and public health certificate for meat preparations intended for consignment to the European Union from third countries, the following point II.1.10 is added to the public health attestation in Part II:
U Prilogu II. Odluci 2000/572/EZ u obrascu certifikata o zdravlju životinja i javnom zdravlju za mesne pripravke namijenjene otpremi u Europsku uniju iz trećih zemalja, sljedeća točka II.1.10. dodaje se Potvrdi o javnom zdravlju u dijelu II.:
if containing material from domestic solipeds, the fresh meat used in the preparation of the meat preparations:
ako sadržava materijal od domaćih kopitara, svježe meso upotrijebljeno za pripremu mesnih pripravaka:
either (2)
ili (2)
[was obtained from domestic solipeds which immediately prior to slaughter had been kept for at least six months or since birth, if slaughtered at an age of less than six months, or since importation as food producing equidae from a Member State of the European Union, if imported less than six months prior to slaughter, in a third country:
[dobiveno je od domaćih kopitara koji su neposredno prije klanja bili držani najmanje šest mjeseci ili od rođenja, ako su zaklani u dobi od manje od šest mjeseci, ili od uvoza kao kopitari za proizvodnju hrane iz države članice Europske unije, ako su uvezeni manje od šest mjeseci prije klanja, u trećoj zemlji:
in which the administration to domestic solipeds:
u kojoj je primjena na domaćim kopitarima:
of thyrostatic substances, stilbenes, stilbene derivatives, their salts and esters, oestradiol 17β and its ester-like derivatives is prohibited;
i. tireostatika, stilbena, derivata stilbena, njihovih soli i estera, estradiola 17β i njegovih esteru srodnih derivata zabranjena;
of other substances having oestrogenic, androgenic or gestagenic action and of beta-agonists is only allowed for:
ostalih tvari koje imaju estrogeni, androgeni ili gestageni učinak i beta-agonista dopuštena samo za:
therapeutic treatment as defined in Article 1(2)(b) of Directive 96/22/EC, where applied in conformity with Article 4(2) of that Directive, or
terapijsku primjenu kako je definirano u članku 1. stavku 2. točki (b) Direktive 96/22/EZ, kada se primjenjuje u skladu s člankom 4. stavkom 2. te direktive, ili
zootechnical treatment as defined in Article 1(2)(c) of Directive 96/22/EC, where applied in conformity with Article 5 of that Directive; and
zootehničku primjenu kako je definirano u članku 1. stavku 2. točki (c) Direktive 96/22/EZ, kada se primjenjuje u skladu s člankom 5. te direktive; i
which has had, at least during the six months prior to slaughter of the animals, a plan for the monitoring of the groups of residues and substances referred to in Annex I to Directive 96/23/EC which covers equidae born in and imported into the third country and was approved in accordance with the fourth subparagraph of Article 29(1) of Directive 96/23/EC;]]
koja je najmanje tijekom šest mjeseci koji prethode klanju životinja imala plan praćenja skupina rezidua i tvari iz Priloga I. Direktivi 96/23/EZ, koji obuhvaća kopitare rođene u trećoj zemlji i uvezene u treću zemlju i koji je odobren u skladu s člankom 29. stavkom 1. četvrtim podstavkom Direktive 96/23/EZ;]]
and/or (2)
i/ili (2)
[was imported from a Member State of the European Union.]]’
[uvezeno je iz države članice Europske unije.]]”
In Annex III to Decision 2007/777/EC, in the model animal health and public health certificate for certain meat products and treated stomachs, bladders and intestines intended for consignment to the European Union from third countries, the following point II. 2.10. is added to the Public health attestation in Part II:
U Prilogu III. Odluci 2007/777/EZ u obrascu certifikata o zdravlju životinja i javnom zdravlju za određene mesne proizvode i obrađene želuce, mjehure i crijeva namijenjene otpremi u Europsku uniju iz trećih zemalja, sljedeća točka II.2.10. dodaje se Potvrdi o javnom zdravlju u dijelu II.:
if containing material from domestic equine animals, the fresh meat, stomachs, bladders or intestines used in the preparation of the meat products and/or treated stomachs, bladders and intestines
ako sadržava materijal od domaćih kopitara, svježe meso, želuce, mjehure ili crijeva upotrijebljene u pripremi mesnih proizvoda i/ili obrađenih želuca, mjehura i crijeva
( 2) either
( 2) ili
[was/were obtained from domestic equine animals which immediately prior to slaughter had been kept for at least six months or since birth if slaughtered at an age of less than six months, or since importation as food producing equidae from a Member State of the European Union, if imported less than six months prior to slaughter, in a third country:
[dobiven je/dobiveni su od domaćih kopitara koji su neposredno prije klanja bili držani najmanje šest mjeseci ili od rođenja, ako su zaklani u dobi od manje od šest mjeseci, ili od uvoza kao kopitari za proizvodnju hrane iz države članice Europske unije, ako su uvezeni manje od šest mjeseci prije klanja, u trećoj zemlji:
in which the administration to domestic equine animals:
u kojoj je primjena na domaćim kopitarima:
which has had, at least during the six months prior to slaughter of the animals, a plan for the monitoring of the groups of residues and substances referred to in Annex I to Directive 96/23/EC which covers equidae born in and imported into the third country and was approved in accordance with the fourth subparagraph of Article 29(1) of Directive 96/23/EC.]
koja je najmanje tijekom šest mjeseci koji prethode klanju životinja imala plan praćenja skupina rezidua i tvari iz Priloga I. Direktivi 96/23/EZ, koji obuhvaća kopitare rođene u trećoj zemlji i uvezene u treću zemlju i koji je odobren u skladu s člankom 29. stavkom 1. četvrtim podstavkom Direktive 96/23/EZ.]
( 2) and/or
( 2) i/ili
[was/were imported from a Member State of the European Union.]’
[uvezen je/uvezeni su iz države članice Europske unije.]”
In Part 2 of Annex II to Regulation (EU) No 206/2010, in the model veterinary certificate ‘EQU’ for fresh meat, excluding minced meat, of domestic solipeds (Equus caballus, Equus asinus and their cross-breeds), point II.1.7. of the Public Health Attestation in Part II is replaced by the following:
U dijelu 2. Priloga II. Uredbi (EU) br. 206/2010 u obrascu veterinarskog certifikata „EQU” za svježe meso, isključujući mljeveno meso, domaćih kopitara (Equus caballus, Equus asinus i njihovih križanaca), točka II.1.7. Potvrde o javnom zdravlju u dijelu II. zamjenjuje se sljedećim:
the meat was obtained from domestic solipeds which immediately prior to slaughter had been kept for at least six months or since birth, if slaughtered at an age of less than six months, or since importation as food producing equidae from a Member State of the European Union, if imported less than six months prior to slaughter, in a third country:
meso je dobiveno od domaćih kopitara koji su neposredno prije klanja bili držani najmanje šest mjeseci ili od rođenja, ako su zaklani u dobi od manje od šest mjeseci, ili od uvoza kao kopitari za proizvodnju hrane iz države članice Europske unije, ako su uvezeni manje od šest mjeseci prije klanja, u trećoj zemlji:
therapeutic treatment, as defined in Article 1(2)(b) of Directive 96/22/EC, where applied in conformity with Article 4(2) of that Directive, or
terapijsku primjenu kako je definirano u članku 1. stavku 2. točki (b) Direktive 96/22/EZ, kada se primjenjuje u skladu s člankom 4. stavkom 2. te direktive, ili
zootechnical treatment, as defined in Article 1(2)(c) of Directive 96/22/EC, where applied in conformity with Article 5 of that Directive; and
zootehničku primjenu kako je definirano u članku 1. stavku 2. točki (c) Direktive 96/22/EZ, kada se primjenjuje u skladu s člankom 5. te direktive; i
which has had, at least during the six months prior to slaughter of the animals, a plan for the monitoring of the groups of residues and substances referred to in Annex I to Directive 96/23/EC which covers equidae born in and imported into the third country and was approved in accordance with the fourth subparagraph of Article 29(1) of Directive 96/23/EC;’
koja je najmanje tijekom šest mjeseci koji prethode klanju životinja imala plan praćenja skupina rezidua i tvari iz Priloga I. Direktivi 96/23/EZ, koji obuhvaća kopitare rođene u trećoj zemlji i uvezene u treću zemlju i koji je odobren u skladu s člankom 29. stavkom 1. četvrtim podstavkom Direktive 96/23/EZ;”
Commission Implementing Regulation (EU) 2016/1833
Provedbena uredba Komisije (EU) 2016/1833
concerning the authorisation of a preparation of kidney bean lectins (Phaseolus vulgaris lectins) as a feed additive for suckling piglets (holder of authorisation Biolek Sp. z o.o.)
o odobrenju pripravka lektina iz običnog graha (lektini Phaseolus vulgaris) kao dodatka hrani za prasad (nositelj odobrenja Biolek Sp. z.o.o.)
In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of a preparation of kidney bean lectins (Phaseolus vulgaris lectins).
U skladu s člankom 7. Uredbe (EZ) br. 1831/2003 podnesen je zahtjev za odobrenje pripravka lektina iz običnog graha (lektini Phaseolus vulgaris).
That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003.
Uz navedeni zahtjev priloženi su pojedinosti i dokumenti propisani člankom 7. stavkom 3. Uredbe (EZ) br. 1831/2003.
That application concerns the authorisation of a preparation of kidney bean lectins (Phaseolus vulgaris lectins) as a feed additive for suckling piglets to be classified in the additive category ‘zootechnical additives’.
Zahtjev se odnosi na odobrenje pripravka lektina iz običnog graha (lektini Phaseolus vulgaris) kao dodatka hrani za prasad i njegovo razvrstavanje u kategoriju dodataka „zootehnički dodaci”.
The European Food Safety Authority (‘the Authority’) concluded in its opinions of 29 October 2014 [2] and 22 October 2015 [3] that, under the proposed conditions of use, the preparation of kidney bean lectins (Phaseolus vulgaris lectins) 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 29. listopada 2014. [2] i 22. listopada 2015.
It further concluded that the additive should be considered as a respiratory sensitizer and there is a potential hazard by inhalation exposure.
zaključila da pripravci lektina iz običnog graha (lektini Phaseolus vulgaris) u predloženim uvjetima uporabe nemaju negativan učinak na zdravlje životinja, zdravlje ljudi i okoliš.
The Authority has also concluded that it can have some potential to improve the performance of the piglets during the post-weaning period.
Nadalje, zaključila je da bi trebalo smatrati da dodatak uzrokuje preosjetljivost dišnog sustava te da postoji potencijalna opasnost od izloženosti udisanjem.
The Authority does not consider that there is a need for specific requirements of post-market monitoring.
Agencija je zaključila i da bi dodatak mogao poboljšati proizvodna svojstva prasadi u razdoblju nakon odbijanja od sise. Agencija smatra da ne postoji potreba za posebnim zahtjevima za praćenje nakon stavljanja na tržište.
The assessment of the preparation of kidney bean lectins (Phaseolus vulgaris lectins) shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Procjenom pripravka lektina iz običnog graha (lektini Phaseolus vulgaris) pokazuje se da su ispunjeni uvjeti za odobrenje predviđeni u članku 5. Uredbe (EZ) br. 1831/2003.
The preparation specified in the Annex, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, is authorised as an additive in animal nutrition, subject to the conditions laid down in that Annex.
Pripravak naveden u Prilogu, koji pripada kategoriji dodataka „zootehnički dodaci” i funkcionalnoj skupini „ostali zootehnički dodaci”, odobrava se kao dodatak hrani za životinje podložno uvjetima utvrđenima u Prilogu.
EFSA Journal 2015;13(1):3903.
EFSA Journal 2015.; 13(1):3903.
EFSA Journal 2015;13(11):4276.
EFSA Journal 2015.; 13(11):4276.
Units of activity animal/day
Jedinice aktivnosti životinja/dan
Functional group: other zootechnical additives (performance enhancer in weaned piglets)
Funkcionalna skupina: ostali zootehnički dodaci (poboljšivač proizvodnih svojstava odbijene prasadi)
Kidney bean lectins
Lektini iz običnog graha
Preparation of kidney bean lectins (Phaseolus vulgaris lectins), having a minimum of activity: 1280 HAU/g [1]Characterisation of the active substance
Pripravak lektina iz običnog graha (lektini Phaseolus vulgaris) s najmanjom aktivnošću od: 1280 HAU/g [1]Karakteristike aktivne tvari
Mixture of phytohaemagglutinin (PHA) isoforms: PHA-E4, PHA-E3L, PHA-E2L2, PHA-EL3, PHA-L4
Mješavina izooblika fitohemaglutinina (PHA): PHA-E4, PHA-E3L, PHA-E2L2, PHA-EL3, PHA-L4
Analytical methods [2]For the quantification of the kidney bean lectin in the additive:
Analitičke metode [2]Za kvantifikaciju količine lektina iz običnog graha u dodatku:
Haemagglutination assay
hemaglutinacijski test
The additive shall be fed only via a complementary feed to suckling piglets from 10th to 14th day of age with the maximum dose of:
Dodatak se prasadi staroj 10 do 14 dana daje samo preko dopunske krmne smjese u najvećoj dopuštenoj količini od:
220 HAU/suckling piglet/day for 3 days or
220 HAU po prasetu po danu tijekom 3 dana ili
660 HAU/suckling piglet (in one day).
660 HAU po prasetu (u jednom danu).
On the label of the additive, the instructions for use via complementary feed shall be indicated.
Na oznaci dodatka obvezno je navesti upute za upotrebu u dopunskoj krmnoj smjesi.
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.
Za korisnike dodatka i premiksa subjekti u poslovanju s hranom za životinje dužni su utvrditi operativne postupke i organizacijske mjere za uklanjanje mogućih opasnosti koje proizlaze iz njihove upotrebe.
7 November 2026
7. studenoga 2026.
1 HAU (Haemagglutination Activity Units) is the amount of material (1 mg/ml) in the last dilution giving 50 % agglutination (clumping) of the red blood cells.
HAU (jedinica hemaglutinacijske aktivnosti) količina je materijala (1mg/ml) koja u posljednjem razrjeđivanju uzrokuje 50 % aglutinacije (sljepljivanje) crvenih krvnih zrnaca.