natgillin/translations-raw huggingface dataset:
The European Food Safety Authority (‘the Authority’) concluded in its opinions of 11 September 2013 [4], 10 April 2014 [5], 9 September 2014 [6], 29 January 2015 [7], 10 September 2015 [8], 1 December 2015 [9], 25 January 2017 [10] and of 25 January 2017 [11] that, under the proposed conditions of use, L-tryptophan produced by Escherichia coli KCCM 11132P, Escherichia coli DSM 25084, Escherichia coli FERM BP-11200, Escherichia coli FERM BP-11354, Escherichia coli CGMCC 7.59 and Escherichia coli CGMCC 3667 does not have an adverse effect on animal health, human health or the environment, and that it is considered an efficacious source of the essential amino acid tryptophan for animal nutrition; the applicant for L-tryptophan produced by Escherichia coli DSM 25084 provided evidence that, after a change of the manufacturing process, the endotoxin level of the additive was reduced to an acceptable level; for the supplemental L- tryptophan to be fully efficacious in ruminants, it should be protected against degradation in the rumen.
Evropska agencija za varnost hrane (v nadaljnjem besedilu: Agencija) je v svojih mnenjih z dne 11. septembra 2013 [4], 10. aprila 2014 [5], 9. septembra 2014 [6], 29. januarja 2015 [7], 10. septembra 2015 [8], 1. decembra 2015 [9], 25. januarja 2017 [10] in 25. januarja 2017 [11] navedla, da L-triptofan, ki ga proizvajajo Escherichia coli KCCM 11132P, Escherichia coli DSM 25084, Escherichia coli FERM BP-11200, Escherichia coli FERM BP-11354, Escherichia coli CGMCC 7.59 in Escherichia coli CGMCC 3667, pod predlaganimi pogoji uporabe nima škodljivega učinka na zdravje živali in ljudi ali na okolje ter da se šteje za učinkovit vir esencialne aminokisline triptofan v prehrani živali; vlagatelj zahteve za izdajo dovoljenja za L-triptofan, ki ga proizvaja Escherichia coli DSM 25084, je predložil dokaz, da je bila raven endotoksinov v dodatku po spremembi postopka proizvodnje zmanjšana na sprejemljivo raven; da bi bil dodani L-triptofan lahko v celoti učinkovit pri prežvekovalcih, bi ga bilo treba zaščititi pred razgradnjo v vampu.
The assessment of L-tryptophan shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied.
Ocena L-triptofana je pokazala, da so pogoji za dovoljenje iz člena 5 Uredbe (ES) št. 1831/2003 izpolnjeni.
Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation for L-tryptophan, it is appropriate to allow a transitional period for interested parties to prepare themselves to meet the new requirements resulting from the authorisation.
Ker ni varnostnih razlogov, zaradi katerih bi morali takoj začeti veljati spremenjeni pogoji za izdajo dovoljenja za L-triptofan, je primerno zagotoviti prehodno obdobje, da se lahko zainteresirane strani pripravijo na izpolnjevanje novih zahtev zaradi izdaje dovoljenja.
The substance specified in the Annex authorised by Commission Directive 88/485/EEC and premixtures containing it may be placed on the market until 12 December 2017 in accordance with the rules applicable before 12 June 2017 and used until the existing stocks are exhausted.
Snov iz Priloge, za katero je izdano dovoljenje z Direktivo Komisije 88/485/EGS, in premiksi, ki jo vsebujejo, se lahko dajejo na trg do 12. decembra 2017 v skladu s pravili, ki se uporabljajo pred 12. junijem 2017 in uporabljajo do porabe obstoječih zalog.
Feed materials and compound feed containing the substance referred to in paragraph 1 which are produced and labelled before 12 June 2018 in accordance with the rules applicable before 12 June 2017 may be placed on the market and used until the existing stocks are exhausted if they are intended for food producing animals.
Posamična krmila in krmne mešanice, ki vsebujejo snov iz odstavka 1, proizvedeni in označeni pred 12. junijem 2018 v skladu s pravili, ki se uporabljajo pred 12. junijem 2017, se lahko dajejo na trg in uporabljajo do porabe obstoječih zalog, če so namenjeni živalim za proizvodnjo hrane.
Feed materials and compound feed containing the substances referred to in paragraph 1 which are produced and labelled before 12 June 2019 in accordance with the rules applicable before 12 June 2017 may be placed on the market and used until the existing stocks are exhausted if they are intended for non-food producing animals.
Posamična krmila in krmne mešanice, ki vsebujejo snovi iz odstavka 1, proizvedeni in označeni pred 12. junijem 2019 v skladu s pravili, ki se uporabljajo pred 12. junijem 2017, se lahko dajejo na trg in uporabljajo do porabe obstoječih zalog, če so namenjeni živalim, ki niso namenjene proizvodnji hrane.
Council Directive 82/471/EEC of 30 June 1982 concerning certain products used in animal nutrition (OJ L 213, 21.7.1982, p. 8).
Direktiva Sveta 82/471/EGS z dne 30. junija 1982 o nekaterih proizvodih, ki se uporabljajo v prehrani živali (UL L 213, 21.7.1982, str. 8).
Commission Directive 88/485/EEC of 26 July 1988 amending the Annex to Council Directive 82/471/EEC concerning certain products used in animal nutrition (OJ L 239, 30.8.1988, p. 36).
Direktiva Komisije 88/485/EGS z dne 26. julija 1988 o spremembi Priloge k Direktivi Sveta 82/471/EGS o nekaterih proizvodih, ki se uporabljajo v prehrani živali (UL L 239, 30.8.1988, str. 36).
ANNEX
Najvišja vsebnost
Identification number of the additive
Druge določbe
Name of the holder of authorisation
Datum poteka veljavnosti dovoljenja
Additive
mg/kg popolne krmne mešanice z vsebnostjo vlage 12 %
Composition, chemical formula, description, analytical method
Kategorija nutritivnih dodatkov.
Species or category of animal
Funkcionalna skupina: aminokisline, njihove soli in analogi
Maximum age
L-triptofan
Minimum content
Sestava dodatka
Maximum content
Prah z najmanj 98 % L-triptofana (na osnovi suhe snovi).
Other provisions
Najvišja vsebnost 10 mg/kg 1,1′-etiliden-bis-L-triptofana (EBT).
mg/kg of complete feed with a moisture content of 12 %
L-triptofan, pridobljen s fermentacijo z Escherichia coli KCCM 11132P ali
Category of nutritional additives.
Escherichia coli DSM 25084 ali
Functional group: amino acids, their salts and analogues
Escherichia coli FERM BP-11200 ali
L-tryptophan
Escherichia coli FERM BP-11354 ali
Additive composition
Escherichia coli CGMCC 7.59 ali
Powder with a minimum of 98 % L-tryptophan (on a dry matter basis).
Kemijska formula: C11H12N2O2
Maximum content of 10 mg/kg 1,1′-ethylidene-bis-L-tryptophan (EBT)
Št.
Characterisation of the active substance
CAS: 73-22-3
L-tryptophan produced by fermentation with Escherichia coli KCCM 11132P or
Analizna metoda [1]Za določanje L-triptofana v krmnem dodatku:
Escherichia coli DSM 25084 or
„monografija o L-triptofanu“ iz Food Chemical Codex.
Escherichia coli FERM BP-11200 or
Za določanje triptofana v krmnem dodatku in premiksih:
Escherichia coli FERM BP-11354 or
Tekočinska kromatografija visoke ločljivosti v povezavi s fluorescenčno detekcijo (HPLC-FD) – EN ISO 13904-2016
Escherichia coli CGMCC 7.59 or
Za določanje triptofana v krmnem dodatku, premiksih, krmnih mešanicah in posamičnih krmilih:
Chemical formula: C11H12N2O2
Tekočinska kromatografija visoke ločljivosti (HPLC) v povezavi s fluorescenčno detekcijo, Uredba Komisije (ES) št. 152/2009 (UL L 54, 26.2.2009, str.
CAS No: 73-22-3
1) (Priloga III, G).
Analytical methods [1]For the identification of L-tryptophan in the feed additive:
vse vrste
Food Chemical Codex ‘L-tryptophan monograph’.
L-triptofan se lahko daje na trg in uporablja kot dodatek v pripravku.
For the determination of tryptophan in the feed additive and premixtures:
Nosilci dejavnosti poslovanja s krmo zaradi morebitnih tveganj pri vdihavanju, stiku s kožo ali stiku z očmi za uporabnike dodatka in premiksov določijo postopke varnega ravnanja in organizacijske ukrepe.
High performance liquid chromatography coupled to fluorescence detection (HPLC-FD) — EN ISO 13904-2016
Kadar navedenih tveganj s takimi postopki in ukrepi ni mogoče odpraviti ali čim bolj zmanjšati, se dodatek in premiksi uporabljajo z osebno zaščitno opremo, vključno z zaščito za dihala, zaščitnimi očali in rokavicami.
For the determination of tryptophan in the feed additive, premixtures, compound feed and feed materials:
Vsebnost endotoksinov v dodatku in njihov potencial prašnosti zagotavljata največjo možno izpostavljenost endotoksinom, ki znaša 1600 IU endotoksinov/m3 zraka [2].
High Performance Liquid Chromatography (HPLC) coupled with fluorescence detection, Commission Regulation (EC) No 152/2009 (OJ L 54, 26.2.2009, p.
Za prežvekovalce je L-triptofan zaščiten pred razgradnjo v vampu.
1) (Annex III, G)
Navedbe na oznaki dodatka:
All species
Vsebnost vlage.
L-tryptophan may be placed on the market and used as an additive consisting of a preparation.
12. junijem 2027
For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks by inhalation, dermal contact or eyes contact.
Podrobnosti o analiznih metodah so na voljo na naslovu referenčnega laboratorija: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports.
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, safety glasses and gloves.
Izpostavljenost, izračunana na podlagi ravni endotoksinov in potenciala prašnosti dodatka v skladu z metodo, ki jo uporablja EFSA (EFSA Journal 2017;15(3):4705); analizna metoda: evropska farmakopeja 2.6.14.
amending Annex III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council as regards the use of butane (E 943a), isobutane (E 943b) and propane (E 944) in colour preparations
o spremembi Priloge III k Uredbi (ES) št. 1333/2008 Evropskega parlamenta in Sveta glede uporabe butana (E 943a), izobutana (E 943b) in propana (E 944) v pripravkih barvila
An application for authorisation of the use of butane (E 943a), isobutane (E 943b) and propane (E 944) as propellants in colour preparations of group II and group III, as defined in Part C of Annex II to Regulation (EC) No 1333/2008, was submitted on 26 January 2016.
Zahtevek za odobritev uporabe butana (E 943a), izobutana (E 943b) in propana (E 944) kot potisnih plinov v pripravkih barvil iz skupine II in skupine III, kot je določeno v delu C Priloge II k Uredbi (ES) št. 1333/2008, je bil predložen 26. januarja 2016.
Butane, isobutane and propane used as propellants can produce the necessary pressure to expel colour preparations from a spray in order to obtain an appropriate homogenous coverage of colours on foods.
Butan, izobutan in propan, uporabljeni kot potisni plini, lahko ustvarijo potreben pritisk za potis pripravkov barvil iz razpršila, da se dobi primerna enakomerna pokritost z barvili na živilih.
The Scientific Committee for Food evaluated safety of propane, butane and isobutane as extraction solvents in 1991 and found such use acceptable subject to a residue limit in food of 1 mg/kg per substance [3].
Znanstveni odbor za hrano je leta 1991 ocenil varnost propana, butana in izobutana kot ekstrakcijskih topil in ugotovil, da je bila taka uporaba sprejemljiva ob upoštevanju mejne vrednosti ostankov v živilih 1 mg/kg za vsako snov [3].
In 1999 the Scientific Committee for Food expressed its opinion on propane, butane and isobutane as propellant gases for vegetable oil-based aerosol cooking sprays and water-based emulsion cooking sprays [4] concluding that in the view of the low residue level of propellant gases the use for baking and frying has no toxicological concerns.
Znanstveni odbor za hrano je leta 1999 podal mnenje o propanu, butanu in izobutanu kot potisnih plinih za aerosolne razpršilce za kuhanje na osnovi rastlinskega olja in emulzijske razpršilce za kuhanje na vodni osnovi [4], v katerem je ugotovil, da zaradi nizke ravni ostankov potisnih plinov uporaba za pečenje in cvrtje s toksikološkega vidika nista zaskrbljujoči.
Analytical data provided by the applicant confirmed that one hour after spraying various foods, the residues of butane (E 943a), isobutane (E 943b) and propane (E 944) are below the limit of 1 mg/kg.
Analitski podatki, ki jih je zagotovil vložnik, so potrdili, da so ostanki butana (E 943a), izobutana (E 943b) in propana (E 944) eno uro po razpršitvi različnih živil pod mejno vrednostjo 1 mg/kg.
Pursuant to Article 3(2) of Regulation (EC) No 1331/2008, the Commission is to seek the opinion of the European Food Safety Authority (‘the Authority’) in order to update the Union list of food additives set out in Annex III to Regulation (EC) No 1333/2008, except where that update is not liable to have an effect on human health.
V skladu s členom 3(2) Uredbe (ES) št. 1331/2008 mora Komisija za posodobitev seznama Unije aditivov za živila iz Priloge III k Uredbi (ES) št. 1333/2008 zaprositi za mnenje Evropsko agencijo za varnost hrane (v nadaljnjem besedilu: Agencija), razen če navedena posodobitev ne bo imela učinka na zdravje ljudi.
Since the authorisation of use of butane (E 943a), isobutane (E 943b) and propane (E 944) as propellants in colour preparations constitutes an update of that list which is not liable to have an effect on human health, it is not necessary to seek the opinion of the Authority.
Ker odobritev uporabe butana (E 943a), izobutana (E 943b) in propana (E 944) kot potisnih plinov v pripravkih barvil pomeni posodobitev navedenega seznama, ki ne bo imela učinka na zdravje ljudi, Agencije ni treba zaprositi za mnenje.
Therefore, it is appropriate to authorise the use of butane (E 943a), isobutane (E 943b) and propane (E 944) as propellants in colour preparations of groups II and III, as defined in Part C of Annex II to Regulation (EC) No 1333/2008.
Zato je primerno odobriti uporabo butana (E 943a), izobutana (E 943b) in propana (E 944) kot potisnih plinov v pripravkih barvil iz skupine II in skupine III, kot je določeno v delu C Priloge II k Uredbi (ES) št. 1333/2008.
Due to risk of ignition and the time needed to decrease the levels of propellants under the limit of 1 mg/kg it is appropriate to grant the authorisation for professional use only to ensure that the standardised industrial protocols are respected and the time between spraying and consumption is sufficient to comply with the acceptable residue limit.
Zaradi tveganja vžiga in časa, potrebnega za zmanjšanje ravni potisnih plinov pod mejo 1 mg/kg, je ustrezno odobriti samo poklicno uporabo za zagotovitev, da se spoštujejo standardizirani industrijski protokoli in da čas med razprševanjem in zaužitjem zadostuje za izpolnitev sprejemljive mejne vrednosti ostankov.
Therefore, Annex III to Regulation (EC) No 1333/2008 should be amended accordingly.
Prilogo III k Uredbi (ES) št. 1333/2008 bi bilo zato treba ustrezno spremeniti.
Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (OJ L 354, 31.12.2008, p. 1).
Uredba (ES) št. 1331/2008 Evropskega parlamenta in Sveta z dne 16. decembra 2008 o vzpostavitvi skupnega postopka odobritve za aditive za živila, encime za živila in arome za živila (UL L 354, 31.12.2008, str. 1).
Reports of the Scientific Committee for Food, Twenty-ninth series, 1992.
Poročila Znanstvenega odbora za hrano, devetindvajseta serija, 1992.
Opinion on propane, butane and iso-butane as propellant gases for vegetable oil-based aerosol cooking sprays and water-based emulsion cooking sprays.
Mnenje o propanu, butanu in izobutanu kot potisnih plinih za aerosolne razpršilce za kuhanje na osnovi rastlinskega olja in emulzijske razpršilce za kuhanje na vodni osnovi.
Scientific Committee on Food, 29.3.1999.
Znanstveni odbor za hrano, 29.3.1999.
In Part 2 of Annex III to Regulation (EC) No 1333/2008, the following entries are inserted after the entry for E 903:
V delu 2 Priloge III k Uredbi (EU) št. 1333/2008 se za vnosom za E 903 vstavijo naslednji vnosi:
1 mg/kg in final food
1 mg/kg v končnem živilu
Colour preparations of group II and group III as defined in Part C of Annex II (for professional use only)
pripravki barvil iz skupine II in skupine III, kot je določeno v delu C Priloge II (samo za poklicno uporabo)
Colour preparations of group II and group III as defined in Part C of Annex II (for professional use only)’
pripravki barvil iz skupine II in skupine III, kot je določeno v delu C Priloge II (samo za poklicno uporabo)“
Commission Implementing Regulation (EU) 2017/875
Izvedbena uredba Komisije (EU) 2017/875
laying down rules on the use of a maximum residue limit established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species and a maximum residue limit established for a pharmacologically active substance in one or more species for other species, in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council
o določitvi pravil o uporabi mejne vrednosti ostanka, določene za posamezno farmakološko aktivno snov v posameznem živilu, za drugo živilo, pridobljeno iz iste vrste, in o uporabi mejne vrednosti ostanka, določene za posamezno farmakološko aktivno snov v eni ali več vrstah, za druge vrste, v skladu z Uredbo (ES) št. 470/2009 Evropskega parlamenta in Sveta
Having regard to 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, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and the Council [1], and in particular Article 13(2)(b) thereof,
ob upoštevanju Uredbe (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 in razveljavitvi Uredbe Sveta (EGS) št. 2377/90 in spremembi Direktive 2001/82/ES Evropskega parlamenta in Sveta ter Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta [1] ter zlasti člena 13(2)(b) Uredbe,
Those opinions consist of a scientific risk assessment and risk management considerations.
Navedena mnenja vključujejo znanstveno oceno tveganja in obravnavajo obvladovanje tveganja.
When carrying out scientific risk assessments and drawing up risk management recommendations, EMA is required to consider using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species or MRLs established in one or more species for other species in extrapolation, in order to increase the availability of authorised veterinary medicinal products for conditions affecting food producing animals.
Pri izvajanju znanstvenih ocen tveganja in pripravi priporočil za obvladovanje tveganja mora Agencija proučiti uporabo MRL, določenih za posamezno farmakološko aktivno snov v posameznem živilu, za drugo živilo, pridobljeno iz iste vrste, ali MRL, določenih za eno ali več vrst, za druge vrste z ekstrapolacijo, da se poveča razpoložljivost odobrenih zdravil za uporabo v veterinarski medicini za bolezni, ki prizadenejo živali za proizvodnjo živil.
Extrapolation of MRLs involves the process by which residue levels in tissues or food commodities of a food producing species for which MRLs exist are used to estimate residue levels and establish MRLs in a tissue or a food commodity of another species or another tissue or food commodity of the same species for which no, or no complete, conventional residue data is available.
Ekstrapolacija MRL pomeni postopek, pri katerem se vrednosti ostankov v živilih ali tkivih iz vrst za proizvodnjo živil, za katere obstajajo MRL, uporabijo za oceno vrednosti ostankov in določitev MRL v posameznem živilu ali tkivu iz druge vrste ali drugem živilu ali tkivu iz iste vrste, za katero niso na voljo popolni konvencionalni podatki ali noben konvencionalen podatek o ostankih.
For proper application of Regulation (EC) No 470/2009 principles and minimum criteria for extrapolation should be established.
Za pravilno uporabo Uredbe (EU) št. 470/2009 bi bilo treba določiti načela in minimalna merila za ekstrapolacijo.
This Regulation establishes principles and minimum criteria for using MRLs established for a pharmacologically active substance in a particular foodstuff for another foodstuff derived from the same species and MRLs established in one or more species for other species (‘extrapolation’).
Ta uredba določa načela in minimalna merila za uporabo MRL, določenih za posamezno farmakološko aktivno snov v posameznem živilu, za drugo živilo, pridobljeno iz iste vrste, in MRL, določenih za ene ali več vrst, za druge vrste („ekstrapolacija“).
‘reference species/food commodity/tissue’ means a species/food commodity/tissue in which MRLs based on appropriate and complete data has been established;
„referenčna vrsta/živilo/tkivo“ pomeni vrsto/živilo/tkivo, za katero so bile določene MRL, ki temeljijo na ustreznih in popolnih podatkih;
‘concerned species/food commodity/tissue’ means a species/food commodity/tissue for which extrapolation is considered;
„zadevna vrsta/živilo/tkivo“ pomeni vrsto/živilo/tkivo, za katero se preuči možnost ekstrapolacije;
‘major species’ means cattle, sheep for meat, pigs, chicken including eggs, and Salmonidae;
„glavna vrsta“ pomeni govedo, ovce za meso, prašiče, piščance, vključno z jajci, in salmonide;
‘minor species’ means any species other than major species;
„manj pomembna vrsta“ pomeni katero koli vrsto, ki ni glavna vrsta;
‘related species’ means species belonging to the same category of food producing species of ruminants, monogastrics, mammals, birds or fish;
„sorodna vrsta“ pomeni vrsto, ki spada v isto kategorijo vrst za proizvodnjo živil, ki zajemajo prežvekovalce, monogastrične živali, sesalce, ptice ali ribe;
‘unrelated species’ means species belonging to different categories of food producing species.
„nesorodna vrsta“ pomeni vrsto, ki spada v drugo kategorijo vrst za proizvodnjo živil.
Principles for extrapolation
Načela za ekstrapolacijo
The EMA shall consider the extrapolation of MRLs where there is MRL or ‘No MRL required’ status established for the pharmacologically active substance and one of the following circumstances applies to the concerned species:
Agencija preuči možnost ekstrapolacije MRL, kadar je za farmakološko aktivno snov določena MRL ali status „MRL se ne zahteva“ in za zadevno vrsto velja ena od naslednjih okoliščin:
It is related to a major reference species for which MRLs have been established or a ‘No MRL required’ status exists for the concerned tissue/food commodity;
sorodna je glavni referenčni vrsti, za katero so bile določene MRL, ali pa ima zadevno tkivo/živilo status „MRL se ne zahteva“;
It is related to a minor reference species for which MRLs have been established or a ‘No MRL required’ status exists for the concerned tissue/food commodity;
sorodna je manj pomembni referenčni vrsti, za katero so bile določene MRL, ali pa ima zadevno tkivo/živilo status „MRL se ne zahteva“;
It is unrelated to the reference species for which MRLs have been established or a ‘No MRL required’ status exists for the concerned tissue/food commodity;
ni sorodna referenčni vrsti, za katero so bile določene MRL, ali pa ima zadevno tkivo/živilo status „MRL se ne zahteva“;
MRL has been established for the concerned species but not for the concerned tissue/food commodity.
MRL je bila določena za zadevno vrsto, ne pa za zadevno tkivo/živilo.
Minimum criteria for extrapolation
Minimalna merila za ekstrapolacijo
The EMA may undertake extrapolation only when all of the following conditions are fulfilled:
Agencija lahko izvede ekstrapolacijo samo, če so izpolnjeni vsi naslednji pogoji:
a full set of residue data for the reference species is available to the EMA;
Agenciji je na voljo popoln sklop podatkov o ostankih za referenčno vrsto;
the degree to which the pharmacologically active substance is metabolised in the reference species is established;
določena je stopnja metabolizma farmakološko aktivne snovi pri referenčni vrsti;