natgillin/translations-raw huggingface dataset:
Khao Hom Mali Thung Kula Rong-Hai is the rice produced in the Thung Kula Rong-Hai area, extending across five provinces of north-east Thailand.
„Khao Hom Mali Thung Kula Rong-Hai“ je riž, ki se prideluje na območju Thung Kula Rong-Hai. To se razprostira čez pet provinc na severovzhodu Tajske.
It is grown from Khao Dawk Mali (KDML 105) and RD 15 varieties and is a light-sensitive paddy rice.
Vzgaja se iz sort Khao Dawk Mali (KDML 105) in RD 15 ter je na svetlobo občutljiv neoluščen riž.
It can be brown or white (milled rice).
Lahko je rjavi ali beli (brušeni riž).
Physical characteristics
Fizikalne lastnosti
Rice hull: straw yellow colour.
Ovojnica riževih zrn: slamnato rumene barve.
Long, slim, transparent and shiny.
Dolga, tanka, prosojna in svetleča.
Silky smooth.
Svilnato gladka.
Good smell like pandanus leaf.
Lepo diši po listih pandanusa.
Brown rice
Rjavi riž
White rice
Beli riž
Length (mm)
Dolžina (mm)
Shape (Length/Width)
Oblika (dolžina/širina)
Yellowish brown
rumenkasto rjava
Moisture content
Vlažnost
Mixture of other rice varieties
Mešanica zrn drugih sort
Amylose (%)
Amiloza (%)
Alkaline test
Preskus bazičnosti
Chemical characteristics (mean value (± 5 %))
Kemične lastnosti (srednja vrednost (± 5 %))
Protein (%)
Beljakovine (%)
Vitamin B1 (mg/100g)
Vitamin B1 (mg/100 g)
Vitamin B2 (mg/100g)
Vitamin B2 (mg/100 g)
Vitamin B3 (mg/100g)
Vitamin B3 (mg/100 g)
Cooking characteristics (mean values)
Značilnosti pri kuhanju (povprečne vrednosti)
Cooking time
Čas kuhanja
Rice:water ratio for cooking
Razmerje med rižem in vodo za kuhanje
Aroma and flavour
Aroma in okus
The cooked rice smells liked pandanus leaf and tastes velvety, spongy and slightly sweet.
Kuhan riž diši po listih pandanusa ter ima blag, mehek in rahlo sladek okus.
It has a slight hint of the added condiments when cooked with other ingredients.
Če so mu primešane dodatne sestavine, ima rahel okus po dodanih začimbah.
Newly harvested KDML 105 and RD 15 rice grains have a creamy smooth texture when boiled.
Skuhana sveže požeta riževa zrna sort KDML 105 in RD 15 imajo gladko kremasto zgradbo.
The rice seeds used to produce Khao Hom Mali Thung Kula Rong-Hai have to be grown in Thung Kula Rong-Hai.
Riževa semena, ki se uporabijo za pridelavo riža „Khao Hom Mali Thung Kula Rong-Hai“, morajo biti vzgojena na območju Thung Kula Rong-Hai.
The seeds must be Khao Dawk Mali 105 (KDML 105) and Kor Khor or RD 15 breeds obtained from the Rice Department or rice-grain producers, i.e. farmers’ organisations or private organisations certified by the Rice Department based on the standards for rice grain production.
Semena morajo biti sort Khao Dawk Mali 105 (KDML 105) in Kor Khor ali RD 15, pridobiti pa jih je treba pri Oddelku za riž ali pridelovalcih riževih zrn, to je organizacijah kmetov ali zasebnih organizacijah, ki jih je Oddelek za riž potrdil na podlagi standardov za pridelavo riževih zrn.
The whole of the production cycle must take place in the defined geographical area to ensure that it is conducted entirely under the geomorphological conditions specific to that area.
Celoten proizvodni cikel mora potekati na opredeljenem geografskem območju, da se zagotovi, da je izveden popolnoma v skladu z geomorfološkimi razmerami, značilnimi za navedeno območje.
Needless to say, given the growing conditions the entire biological cycle up to harvesting is carried out in the same place, i.e. where the rice was originally sown.
Samoumevno je, da zaradi rastnih pogojev celoten biološki cikel do žetve poteka na istem mestu, to je tam, kjer je bil riž na začetku posejan.
Harvesting is governed by special rules which cover the dates, phonological stages and grain moisture to guarantee the hygiene and safety of the product and complete traceability of the rice to the region of origin and even, in many cases, to the original farmer.
Žetev določajo posebna pravila glede datumov, fenofaz in vlažnosti zrn, s katerimi se zagotavljata higiena in varnost proizvoda ter popolna sledljivost riža do regije porekla, v številnih primerih pa prav do kmeta.
The processing shall take place in Roi Et, Surin, Sisaket, Mahasarakham, and Yasothon Provinces, which are the five provinces of the Thung Kula Rong-Hai area.
Predelava mora potekati v petih provincah območja Thung Kula Rong-Hai, tj. v provincah Roi Et, Surin, Sisaket, Mahasarakham in Yasothon.
The packaging shall take place in Roi Et, Surin, Sisaket, Mahasarakham, and Yasothon Provinces, which are the five provinces of the Thung Kula Rong-Hai area.
Pakiranje mora potekati petih v provincah območja Thung Kula Rong-Hai, tj. v provincah Roi Et, Surin, Sisaket, Mahasarakham in Yasothon.
This is to give consumers an effective guarantee of the origin, the quality of the rice and in order to ensure the retention of 2-acetyl-1-pyrroline (0,1-0,2 micrograms at the growing field), unique to Khao Hom Mali grown within the identified geographical area.
Tako se potrošnikom dejansko zajamčita poreklo in kakovost riža ter v njem zagotovi vsebnost 2-acetil-1-pirolina (0,1–0,2 mikrograma na njivi), ki je edinstvena snov v sorti Khao Hom Mali, ki se goji na navedenem geografskem območju.
The repackaging is not allowed in order to minimise possible dilution in concentration, which would undermine its distinctive aroma and to prevent any possible contamination or alteration of the product.
Da se čim bolj omeji možno zmanjšanje koncentracije, kar bi razdišalo proizvod, ki ima zelo značilen vonj, in preprečita kakršna koli kontaminacija ali sprememba proizvoda, prepakiranje ni dovoljeno.
Packages must be labelled with the weight, the date of packing, the name of the mill or the name of the cooperative.
Na embalaži morajo biti označeni teža, datum pakiranja, naziv rižarne ali naziv zadruge.
Each package must bear the words ‘
Na vsaki embalaži mora biti navedeno „
’ and/or ‘Khao Hom Mali Thung Kula Rong-Hai’.
“ in/ali „Khao Hom Mali Thung Kula Rong-Hai“.
The Thai GI logo plus the EU logo (after European registration) are also mandatory.
Obvezna sta tudi logotip tajske geografske označbe in logotip EU (po evropski registraciji).
The geographical area where all the operations take place (sowing, cultivation, harvesting, milling, packaging and labelling) is Roi-et, Mahasarakam, Surin, Yasothon and Srisaket.
Geografsko območje, na katerem potekajo vse dejavnosti (sejanje, obdelovanje, žetev, brušenje, pakiranje in označevanje), zajema province Roi-et, Mahasarakam, Surin, Yasothon in Srisaket.
Due to the specific weather and soil conditions required the cultivation area lies in:
Zaradi zahtevanih posebnih vremenskih in talnih razmer območje pridelave leži v:
Roi Et province consisting of 986807 rai (6,25 rai = 1 hectare) of land in tambons within the Thung Kula Rong-Hai Plain in Kaset Wisai, Suwannabhumi, Pratumrat and Phonsai districts and Nong Hee subdistrict.
provinci Roi Et, ki jo sestavlja 986807 raijev (6,25 raija = 1 hektar) zemlje v okrajih (tambonih) v nižini Thung Kula Rong-Hai v okrožjih Kaset Wisai, Suwannabhumi, Pratumrat in Phonsai ter podokrožju Nong Hee,
Surin province consisting of 575993 rai of land in tambons within the Thung Kula Rong-Hai Plain in Ta Tum and Chumpol Buri districts.
provinci Surin, ki jo sestavlja 575993 raijev zemlje v okrajih (tambonih) v nižini Thung Kula Rong-Hai v okrožjih Ta Tum in Chumpol Buri,
Sisaket province consisting of 287000 rai of land in tambons within the Thung Kula Rong-Hai Plain in Rasi Salai district and Silalat subdistrict.
provinci Sisaket, ki jo sestavlja 287000 raijev zemlje v okrajih (tambonih) v nižini Thung Kula Rong-Hai v okrožju Rasi Salai in podokrožju Silalat,
Maharasakham province consisting of 193890 rai of land in tambons within the Thung Kula Rong-Hai Plain in Phayakaphum Pisai district.
provinci Maharasakham, ki jo sestavlja 193890 raijev zemlje v okrajih (tambonih) v nižini Thung Kula Rong-Hai v okrožju Phayakaphum Pisai,
Yasothon province consisting of 64000 rai of land in tambons within the Thung Kula Rong-Hai Plain in Maha Chanachai and Kor Wang districts.
provinci Yasothon, ki jo sestavlja 64000 raijev zemlje v okrajih (tambonih) v nižini Thung Kula Rong-Hai v okrožjih Maha Chaichana in Kor Wang.
The Thung Kula Rong-Hai Plain is a large plain in north-east Thailand, extending across five provinces, namely Roi Et, Mahasarakam, Surin, Yasothon and Srisaket.
Thung Kula Rong-Hai je velika nižina na severovzhodu Tajske, ki se razprostira čez pet provinc: Roi Et, Mahasarakam, Surin, Yasothon in Srisaket.
It covers a total of 2107690 rai and was formerly named Thung Mah Long or Thung Pu Pa Lan.
Skupno pokriva 2107690 raijev. V preteklosti se je imenovala Thung Mah Long ali Thung Pu Pa Lan.
Natural and human factors play an integral role in production and, in particular, cultivation of Khao Hom Mali Thung Kula Rong-Hai rice.
Naravni in človeški dejavniki imajo pri pridelavi riža „Khao Hom Mali Thung Kula Rong-Hai“ ter zlasti pri njegovi obdelavi ključno vlogo.
Human knowledge also plays a key role in production of this rice, from selecting quality seeds to following suitable cultivation methods, constructing bunds and segmenting the paddy field into sections to retain sufficient water for the rice to grow.
Pri pridelavi tega riža ima pomembno vlogo tudi znanje: od znanja o izbiri kakovostnih semen do nadaljnjih ustreznih metod obdelave, izdelave nasipov in razdeljevanja riževih polj na dele, tako da se za rast riža ohranja dovolj vode.
Water is drained from the fields about 10 days before harvest, when the mature rice is cut and dried for 2 or 3 days to reduce moisture.
Voda se s polj odvede približno 10 dni pred žetvijo, ko se zrel riž poreže in dva ali tri dneve suši, da se zmanjša vsebnost vlage.
These are the natural factors and local knowledge which determine the quality of Khao Hom Mali Thung Kula Rong-Hai.
Kakovost riža „Khao Hom Mali Thung Kula Rong-Hai“ določajo naravni dejavniki in lokalno znanje.
Khao Hom Mali Thung Kula Rong-Hai refers to paddy, brown and milled rice processed from the light-sensitive rice varieties Khao Dawk Mali 105 and Kor Khor or RD 15, grown in the rainy season in Thailand in the Thung Kula Rong-Hai area and exuding a natural aroma.
„Khao Hom Mali Thung Kula Rong-Hai“ je ime, ki se nanaša na neoluščeni, rjavi in brušeni riž, predelan iz sort Khao Dawk Mali 105 in Kor Khor ali RD 15, občutljivih na svetlobo, ki v deževni dobi rastejo na območju Thung Kula Rong-Hai na Tajskem in izločajo naravno aromo.
The only rice eligible is the abovementioned variety from the defined geographical area, since only these conditions produce rice with low amylose content (14-16 %) and with an amylopectin content of 86-84 %.
Edini upravičeni riž je zgoraj navedena sorta z opredeljenega geografskega območja, saj se le v teh razmerah pridela riž z zelo nizko vsebnostjo amiloze (14–16 %) in z vsebnostjo amilopektina 84 do 86 %.
This allows the rice to absorb a low proportion of the water in which it is cooked and release flavours.
To mu omogoča, da vpije majhen delež vode, v kateri se kuha, in sprosti okuse.
These outstanding characteristics are possible only under the unique geomorphological conditions in the north-eastern part of Thailand (nature of the soil, quality of the water used, number of hours of sunshine, narrow range of temperatures, cool dry weather in the harvesting season, etc.).
Te izjemne lastnosti so mogoče le v edinstvenih geomorfoloških razmerah v severovzhodnem delu Tajske (narava tal, kakovost uporabljene vode, število ur osončenosti, majhne temperaturne razlike, mrzlo in suho vreme v času žetve itd.).
‘Thung Kula Rong-Hai’ is derived from the legendary ‘Kula merchants’.
Ime „Thung Kula Rong-Hai“ izvira iz legendarnega trgovskega plemena Kula.
According to the legend, because of the dry weather in the dry season, a group of native people called Kula who were merchants journeyed across this large plain to sell their wares.
Legenda pravi, da naj bi skupina ljudi iz trgovskega ljudstva po imenu Kula zaradi suhega vremena med sušno dobo potovala po tej veliki nižini in prodajala svoje blago.
They travelled until they were exhausted, but were still unable to reach the other side.
Potovala je, dokler niso bili ljudje povsem izčrpani, a še vedno niso dosegli druge strani.
They then felt like crying (‘Rong-Hai’ in Thai), hence the name ‘Thung Kula Rong-Hai’ (‘plain of the crying Kula’).
Šlo jim je na jok („Rong-Hai“ v tajščini), in od tu tudi ime „Thung Kula Rong-Hai“ („nižina jokajočega Kule“).
Cultivation of Hom Mali rice in Thung Kula Rong-Hai began after the government improved the Hom Mali rice variety and certified it in 1959 naming it ‘Khao Dawk Mali 105’.
Obdelovanje riža Hom Mali v nižini Thung Kula Rong-Hai se je začelo, ko je vlada izboljšala sorto Hom Mali, jo leta 1959 certificirala in poimenovala „Khao Dawk Mali 105“.
Cultivation became more widespread in 1979 when the rice seeds exchange project called for planting glutinous rice in the Thung Kula Rong-Hai area.
Obdelovanje se je bolj razširilo leta 1979, ko se je s projektom za izmenjavo riževih semen pozivalo k sajenju lepkega riža na območju Thung Kula Rong-Hai.
Farmers were advised to change the new rice seeds every three years to maintain seed purity.
Kmetom se je svetovalo, naj vsaka tri leta posadijo nova riževa semena, da bi tako ohranili njihovo čistost.
Because the paddy depended on rain water, cultivation could be carried out only once a year.
Ker je bil neoluščeni riž odvisen od deževnice, je bilo obdelovanje mogoče samo enkrat na leto.
Harvesting takes place in the cold season when the weather is cold and dry (after the end of the rainy season).
Žetev se izvede v hladni dobi, ko je hladno in suho (po koncu deževne dobe).
According to local knowledge, a flooded paddy field needs to be drained about 10 to 15 days before harvesting to obtain rice of good physical quality, with long, slim, clear and sturdy grains.
Lokalno znanje uči, da je treba vodo s poplavljenih riževih polj odvesti 10 do 15 dni pred žetvijo, da riž dobi dobro fizikalno kakovost ter dolga, tanka, čista in čvrsta zrna.
The cooked rice should be soft and fragrant.
Kuhan riž mora biti mehek in dišeč.
This practice, coupled with good agricultural practice (GAP), gives Khao Hom Mali Thung Kula Rong-Hai its unique quality, distinctive from Hom Mali rice grown in other areas and recognised by traders and consumers both in the producing country itself and internationally.
Ta navada in dobra kmetijska praksa dajeta rižu „Khao Hom Mali Thung Kula Rong-Hai“ edinstveno kakovost, ki jo cenijo domači in tuji trgovci in potrošniki in po kateri se razlikuje od riža Hom Mali, ki raste na drugih območjih.
The slightly saline soil in northern Thailand, the coolness and dryness of the area, the specific rice varieties (KDML 105 and RD 15) used, the climate and the soil nutrients cause the paddy to become stressed and to produce the aromatic substance 2-acetyl-1-pyrroline (2AP), the same substance which produces the fragrance in pandanus leaves.
Zaradi blago slanih tal na severnem Tajskem, hladnih in suhih razmer na območju, posebnih uporabljenih sort riža (KDML 105 in RD 15), podnebja in hranilnih snovi v tleh postane neoluščeno zrno napeto in začne proizvajati aromatično snov 2-acetil-1-pirolin (2AP), ki daje prijeten vonj tudi listom pandanusa.
This is the miracle gift from the nature on Khao Hom Mali Thung Kula Rong Hai.
To je čarobno darilo, ki ga narava daje rižu „Khao Hom Mali Thung Kula Rong Hai“.
(Article 5(7) of Regulation (EC) No 510/2006).
(Člen 5(7) Uredbe (ES) št. 510/2006.)
Replaced by Regulation (EU) No 1151/2012 of the European Parliament and of the Council of 21 November 2012 on quality schemes for agricultural products and foodstuffs (OJ L 343, 14.12.2012, p. 1).
Nadomeščena z Uredbo (EU) št. 1151/2012 Evropskega parlamenta in Sveta z dne 21. novembra 2012 o shemah kakovosti kmetijskih proizvodov in živil (UL L 343, 14.12.2012, str. 1).
Commission Implementing Regulation (EU) No 121/2013
Izvedbena uredba Komisije (EU) št. 121/2013
Commission Regulation (EU) No 122/2013
Uredba Komisije (EU) št. 122/2013
amending Regulation (EC) No 1950/2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae
o spremembi Uredbe (ES) št. 1950/2006 o določitvi seznama snovi, bistvenih za zdravljenje konjev, v skladu z Direktivo 2001/82/ES Evropskega parlamenta in Sveta o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini
Commission Regulation (EC) No 1950/2006 [2] established a list of substances essential for the treatment of equidae which, by way of derogation from Article 11 of Directive 2001/82/EC, may be administered to equidae intended for slaughter for human consumption subject to a withdrawal period of not less than six months.
V Uredbi Komisije (ES) št. 1950/2006 [2] je določen seznam snovi, bistvenih za zdravljenje enoprstih kopitarjev, ki se z odstopanjem od člena 11 Direktive 2001/82/ES lahko dajejo enoprstim kopitarjem za zakol, namenjenim za prehrano ljudi, za katere velja rok za preklic najmanj šest mesecev.
Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin [3] amended Article 10(3) of Directive 2001/82/EC in order to include in the list of substances referred to in that Article substances which bring added clinical benefit compared to other treatment options available for equidae, hereinafter ‘substances bringing added clinical benefit’, in addition to essential substances.
Z Uredbo (ES) št. 470/2009 Evropskega parlamenta in Sveta z dne 6. maja 2009 o določitvi postopkov Skupnosti za določitev mejnih vrednosti ostankov farmakološko aktivnih snovi v živilih živalskega izvora [3] je bil spremenjen člen 10(3) Direktive 2001/82/ES, da bi se na seznam snovi iz navedenega člena poleg bistvenih snovi vključile snovi, ki predstavljajo dodano klinično korist v primerjavi z drugimi možnostmi zdravljenja enoprstih kopitarjev (v nadaljevanju: snovi, ki predstavljajo dodano klinično korist).
A substance should only be included in the list as a ‘substance bringing added clinical benefit’ where it provides a clinically relevant advantage based on improved efficacy or safety or a major contribution to treatment.
Snov bi bilo treba na ta seznam vključiti samo kot „snov, ki predstavlja dodano klinično korist“, kadar ima klinično pomembno prednost zaradi izboljšane učinkovitosti ali varnosti ali pomembno prispeva k zdravljenju.
This may be the result, inter alia, of different modes of actions, different pharmacokinetic or pharmacodynamic profiles, different lengths of treatment or different routes of administration.
To je lahko med drugim rezultat različnih načinov delovanja, različnih farmakokinetskih ali farmakodinamičnih profilov, različnih trajanj zdravljenja ali različnih poti uporabe.
Substances listed in the Annex to Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin [4] should not appear on the list of essential substances and substances bringing added clinical benefit.
Snovi, navedene v Prilogi k Uredbi Komisije (EU) št. 37/2010 z dne 22. decembra 2009 o farmakološko aktivnih snoveh in njihovi razvrstitvi glede mejnih vrednosti ostankov v živilih živalskega izvora [4], ne bi smele biti na seznamu bistvenih snovi in snovi, ki predstavljajo dodano klinično korist.
Therefore, it is necessary to amend the list in the Annex to Regulation (EC) No 1950/2006 to remove from that list any substances listed in Regulation (EU) No 37/2010.
Zato je primerno, da se seznam iz Priloge k Uredbi (ES) št. 1950/2006 spremeni tako, da se z njega odstranijo vse snovi, navedene v Uredbi (EU) št. 37/2010.
It is also appropriate to remove from the list in the Annex to Regulation (EC) No 1950/2006 several substances identified as alternatives to the substances listed, which are not available for the treatment of horses because they are not listed as ‘essential substances’ or ‘substances bringing added clinical benefit’ under Regulation (EC) No 1950/2006 nor listed in the Annex to Regulation (EU) No 37/2010.
Primerno je tudi, da se s seznama v Prilogi k Uredbi (ES) št. 1950/2006 odstrani več snovi, opredeljenih kot alternative navedenim snovem, ki jih ni mogoče uporabiti za zdravljenje konjev, ker niso navedene kot „bistvene snovi“ ali „snovi, ki predstavljajo dodano klinično korist“ v skladu z Uredbo (ES) št. 1950/2006 in niso na seznamu v Prilogi k Uredbi (EU) št. 37/2010.
Due to changes in Union legislation since the adoption of Regulation (EC) No 1950/2006, the references in that Regulation to the relevant legislation on control mechanisms for equidae and on maximum residue limits should be updated.
Zaradi sprememb zakonodaje Unije od sprejetja Uredbe (ES) št. 1950/2006 bi bilo treba v navedeni uredbi posodobiti sklice na ustrezno zakonodajo o nadzornih mehanizmih za enoprste kopitarje in o mejnih vrednostih ostankov.
The amended list set out in the Annex to this Regulation has been subject to a scientific evaluation carried out by the Committee for Veterinary Medicinal Products of the European Medicines Agency established by Regulation (EC) No 726/2004 of the European Parliament and of the Council [5].
Odbor za zdravila za uporabo v veterinarski medicini Evropske agencije za zdravila, ustanovljen z Uredbo (ES) št. 726/2004 Evropskega parlamenta in Sveta [5], je opravil znanstveno vrednotenje spremenjenega seznama iz Priloge k tej uredbi.
Regulation (EC) No 1950/2006 should be amended accordingly.
Uredbo (ES) št. 1950/2006 bi bilo zato treba ustrezno spremeniti.
Regulation (EC) No 1950/2006 is amended as follows:
Uredba (ES) št. 1950/2006 se spremeni:
the title of Regulation (EC) No 1950/2006 is replaced by the following:
naslov Uredbe (ES) št. 1950/2006 se nadomesti z naslednjim:
‘Commission Regulation (EC) No 1950/2006 of 13 December 2006 establishing, in accordance with Directive 2001/82/EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products, a list of substances essential for the treatment of equidae and of substances bringing added clinical benefit’;
„Uredba Komisije (ES) št. 1950/2006 z dne 13. decembra 2006 o določitvi seznama snovi, bistvenih za zdravljenje enoprstih kopitarjev, in snovi, ki predstavljajo dodano klinično korist, v skladu z Direktivo 2001/82/ES Evropskega parlamenta in Sveta o zakoniku Skupnosti o zdravilih za uporabo v veterinarski medicini“;
The list of substances essential for the treatment of equidae, hereinafter “essential substances”, as well as of substances which bring added clinical benefit compared to other treatment options available for equidae, hereinafter “substances bringing added clinical benefit”, applicable by way of derogation from Article 11 of Directive 2001/82/EC, is set out in the Annex to this Regulation.’;
V Prilogi k tej uredbi je seznam bistvenih snovi za zdravljenje enoprstih kopitarjev (v nadaljevanju: bistvene snovi) in snovi, ki predstavljajo dodano klinično korist v primerjavi z drugimi možnostmi zdravljenja enoprstih kopitarjev (v nadaljevanju: snovi, ki predstavljajo dodano klinično korist), ki se uporablja z odstopanjem od člena 11 Direktive 2001/82/ES.“;
in Article 2, the second subparagraph is replaced by the following:
v členu 2 se drugi pododstavek nadomesti z naslednjim: