FREE SHIPPING over $40
OVER 9000 FIVE-STAR REVIEWS
5% OFF ALL SUBSCRIPTIONS
100% HAPPINESS GUARANTEE
Analyze Diet
0
Home / Equine Research Bank / EFSA J / Safety and efficacy of a feed additive consisting of a tinct...
EFSA journal. European Food Safety Authority2024; 22(4); e8731; doi: 10.2903/j.efsa.2024.8731

Safety and efficacy of a feed additive consisting of a tincture derived from the dried fruit of Schisandra chinensis (Turcz.) Baill. (omicha tincture) for poultry, horses, dogs and cats (FEFANA asbl).

Abstract: Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the dried fruit of (Turcz.) Baill. (omicha tincture), when used as a sensory additive in feed for horses, cats, dogs, and in feed and in water for drinking for poultry. The product is a water/ethanol (55:45 v/v) solution, with a dry matter content of not more than 4% (w/w) and a content of 0.01%-0.15% (w/w) for the sum of schisandrin and deoxyschisandrin. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that omicha tincture is safe at the following concentrations in complete feed: 16 mg/kg for turkeys for fattening, 12 mg/kg for chickens for fattening and other poultry for fattening or reared for laying/reproduction, 18 mg/kg for laying hens and other laying/reproductive birds, 56 mg/kg for dogs and 47 mg/kg for horses and cats. The additive is considered safe for consumers when used up to the highest safe level in feed for poultry species and horses. Omicha tincture should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. The use of omicha tincture as a flavour in feed for poultry species and horses was not considered to be a risk to the environment. Since it was recognised that the fruit of can influence sensory properties of feedingstuffs, no further demonstration of efficacy was considered necessary for the tincture under assessment.
© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.
Get Full Text
Publication Date: 2024-04-10 PubMed ID: 38601870PubMed Central: PMC11004902DOI: 10.2903/j.efsa.2024.8731Google Scholar: Lookup
The Equine Research Bank provides access to a large database of publicly available scientific literature. Inclusion in the Research Bank does not imply endorsement of study methods or findings by Mad Barn.
LinkedInCopy
  • Journal Article

Summary

This research summary has been generated with artificial intelligence and may contain errors and omissions. Refer to the original study to confirm details provided. Submit correction.

This research article is about the safety and efficiency of a tincture from the dried fruit of Schisandra chinensis, known as omicha tincture, as an additive in feed for poultry, horses, dogs, and cats. The European Food Safety Authority (EFSA) found omicha tincture to be safe and effective when used under specific concentrations.

Introduction and Methods

  • The research was conducted upon a request from the European Commission.
  • The focus was on the safety and efficacy of a tincture from the dried fruit of Schisandra chinensis, referred to as omicha tincture, when used as a sensory additive in feed and water for poultry, horses, dogs, and cats.
  • The omicha tincture is a water/ethanol (55:45 v/v) solution, containing 0.01%-0.15% (w/w) of schisandrin and deoxyschisandrin and a maximum of 4% (w/w) dry matter.

Findings

  • The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that omicha tincture is safe at specific concentrations in complete feed: 16 mg/kg for fattening turkeys, 12 mg/kg for fattening chickens and other poultry being reared for laying/reproduction, 18 mg/kg for laying hens and other laying/reproductive birds, 56 mg/kg for dogs, and 47 mg/kg for horses and cats.
  • Omicha tincture was found to be safe for consumers when used up to the highest safe feeding level for poultry and horses.
  • The additive is considered an irritant to skin and eyes, and can cause dermal and respiratory sensitivity.
  • No environmental risks were associated with the use of omicha tincture as a flavour in feed for poultry and horses.

Conclusion

  • The fruit of Schisandra chinensis can influence sensory properties of feedingstuffs.
  • No further demonstration of efficacy was considered necessary for the tincture under assessment since its influence on the sensory properties was recognized.

Cite This Article

APA
Bampidis V, Azimonti G, Bastos ML, Christensen H, Durjava M, Kouba M, López-Alonso M, Puente SL, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Villa RE, Woutersen R, Brantom P, Chesson A, Schlatter J, Westendorf J, Dirven Y, Manini P, Dusemund B. (2024). Safety and efficacy of a feed additive consisting of a tincture derived from the dried fruit of Schisandra chinensis (Turcz.) Baill. (omicha tincture) for poultry, horses, dogs and cats (FEFANA asbl). EFSA J, 22(4), e8731. https://doi.org/10.2903/j.efsa.2024.8731

Publication

EFSA journal. European Food Safety Authority
ISSN: 1831-4732
NlmUniqueID: 101642076
Country: United States
Language: English
Volume: 22
Issue: 4
Pages: e8731
PII: e8731

Researcher Affiliations

Bampidis, Vasileios
    Azimonti, Giovanna
      Bastos, Maria de Lourdes
        Christensen, Henrik
          Durjava, Mojca
            Kouba, Maryline
              López-Alonso, Marta
                Puente, Secundino López
                  Marcon, Francesca
                    Mayo, Baltasar
                      Pechová, Alena
                        Petkova, Mariana
                          Ramos, Fernando
                            Villa, Roberto Edoardo
                              Woutersen, Ruud
                                Brantom, Paul
                                  Chesson, Andrew
                                    Schlatter, Josef
                                      Westendorf, Johannes
                                        Dirven, Yvette
                                          Manini, Paola
                                            Dusemund, Birgit

                                              Conflict of Interest Statement

                                              If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu.

                                              References

                                              This article includes 44 references
                                              1. Court MH, Greenblatt DJ. Molecular basis for deficient acetaminophen glucuronidation in cats. An interspecies comparison of enzyme kinetics in liver Microsomes.. Biochemical Pharmacology 53, 1041–1047.
                                                doi: 10.1016/s0006-2952(97)00072-5pubmed: 9174118google scholar: lookup
                                              2. Cramer GM, Ford RA, Hall RL. Estimation of toxic hazard–a decision tree approach.. Food and Cosmetics Toxicology 16, 255–276.
                                                doi: 10.1016/s0015-6264(76)80522-6pubmed: 357272google scholar: lookup
                                              3. EFSA CEF Panel. Scientific opinion on Flavouring group evaluation 12, revision 4 (FGE.12Rev4): Primary saturated or unsaturated alicyclic alcohols, aldehydes, acids and esters from chemical groups 1 and 7.. EFSA Journal 11(10), 3391.
                                                doi: 10.2903/j.efsa.2013.3391google scholar: lookup
                                              4. EFSA CEF Panel. Scientific opinion on Flavouring group evaluation 72, revision 1 (FGE.72Rev1): Consideration of aliphatic, branched‐chain saturated and unsaturated alcohols, aldehydes, acids, and related esters evaluated by the JECFA (61st meeting) structurally related to branched‐ and straight‐chain unsaturated carboxylic acids, esters of these and straight‐chain aliphatic saturated alcohols evaluated by EFSA in FGE.05Rev2.. EFSA Journal 11(10), 3392.
                                                doi: 10.2903/j.efsa.2013.3392google scholar: lookup
                                              5. EFSA FEEDAP Panel. Guidance for the preparation of dossiers for sensory additives.. EFSA Journal 10(1), 2534.
                                                doi: 10.2903/j.efsa.2012.2534google scholar: lookup
                                              6. EFSA FEEDAP Panel. Scientific opinion on the safety and efficacy of aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols and esters with esters containing tertiary alcohols ethers (chemical group 6) when used as flavourings for all animal species.. EFSA Journal 10(11), 2966.
                                                doi: 10.2903/j.efsa.2012.2966google scholar: lookup
                                              7. EFSA FEEDAP Panel. Scientific opinion on the safety and efficacy of aliphatic and alicyclic ethers (chemical group 16) when used as flavourings for all animal species.. EFSA Journal 10(11), 2967.
                                                doi: 10.2903/j.efsa.2012.2967google scholar: lookup
                                              8. EFSA FEEDAP Panel. Scientific opinion on the safety and efficacy of aromatic ethers including anisole derivatives (chemical group 26) when used as feed additives for all animal species.. EFSA Journal 10(5), 2678.
                                                doi: 10.2903/j.efsa.2012.2678google scholar: lookup
                                              9. EFSA FEEDAP Panel. Scientific opinion on the safety and efficacy of aliphatic and aromatic hydrocarbons (chemical group 31) when used as flavourings for all animal species.. EFSA Journal 13(3), 4053.
                                                doi: 10.2903/j.efsa.2015.4053google scholar: lookup
                                              10. EFSA FEEDAP Panel. Scientific opinion on the safety and efficacy of secondary alicyclic saturated and unsaturated alcohols, ketones, ketals and esters with ketals containing alicyclic alcohols or ketones and esters containing secondary alicyclic alcohols from chemical group 8 when used as flavourings for all animal species.. EFSA Journal 14(6), 4475.
                                                doi: 10.2903/j.efsa.2016.4475google scholar: lookup
                                              11. EFSA FEEDAP Panel. Scientific opinion on the safety and efficacy of aliphatic and aromatic hydrocarbons (chemical group 31) when used as flavourings for all animal species and categories.. EFSA Journal 14(1), 4339.
                                                doi: 10.2903/j.efsa.2016.4339google scholar: lookup
                                              12. EFSA FEEDAP Panel, Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López‐Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Innocenti ML. Guidance on the identity, characterisation and conditions of use of feed additives.. EFSA Journal 15(10), 5023.
                                                doi: 10.2903/j.efsa.2017.5023google scholar: lookup
                                              13. EFSA FEEDAP Panel, Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López‐Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Martino L. Guidance on the assessment of the safety of feed additives for the target species.. EFSA Journal 15(10), 5021.
                                                doi: 10.2903/j.efsa.2017.5021google scholar: lookup
                                              14. EFSA FEEDAP Panel, Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López‐Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Innocenti ML. Guidance on the assessment of the safety of feed additives for the consumer.. EFSA Journal 15(10), 5022.
                                                doi: 10.2903/j.efsa.2017.5022google scholar: lookup
                                              15. EFSA FEEDAP Panel, Rychen G, Aquilina G, Azimonti G, Bampidis V, Bastos ML, Bories G, Chesson A, Cocconcelli PS, Flachowsky G, Gropp J, Kolar B, Kouba M, López‐Alonso M, López Puente S, Mantovani A, Mayo B, Ramos F, Saarela M, Martino L. Guidance on the assessment of the efficacy of feed additives.. EFSA Journal 16(5), 5274.
                                                doi: 10.2903/j.efsa.2018.5274google scholar: lookup
                                              16. EFSA FEEDAP Panel, Bampidis V, Bastos ML, Christensen H, Dusemund B, Kouba M, Kos Durjava M, López‐Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Brock T, Knecht J, Azimonti G. Guidance on the assessment of the safety of feed additives for the environment.. EFSA Journal 17(4), 5648.
                                                doi: 10.2903/j.efsa.2019.5648google scholar: lookup
                                              17. EFSA FEEDAP Panel, Bampidis V, Azimonti G, Bastos ML, Christensen H, Kouba M, Fašmon Durjava M, López‐Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Brantom P, Chesson A, Dusemund B. Scientific opinion on the safety and efficacy of feed additives consisting of expressed lemon oil and its fractions from Citrus limon (L.) Osbeck and of lime oil from Citrus aurantiifolia (Christm.) Swingle for use in all animal species.. EFSA Journal 19(4), 6548.
                                                doi: 10.2903/j.efsa.2021.6548google scholar: lookup
                                              18. EFSA FEEDAP Panel, Bampidis V, Azimonti G, Bastos ML, Christensen H, Durjava M, Dusemund B, Kouba M, López‐Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Villa RE, Woutersen R, Brantom P, Chesson A, Galobart J. Guidance on the assessment of the safety of feed additives for the users.. EFSA Journal 21(12), e8469.
                                                doi: 10.2903/j.efsa.2023.8469pmc: PMC10698700pubmed: 38075627google scholar: lookup
                                              19. EFSA SC. Guidance on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements, on request of EFSA.. EFSA Journal 7(9), 1249.
                                                doi: 10.2093/j.efsa.2009.1249google scholar: lookup
                                              20. EFSA SC, More SJ, Hardy A, Bampidis V, Benford D, Bennekou SH, Bragard C, Boesten J, Halldorsson TI, Hernandez‐Jerez AF, Jeger MJ, Knutsen HK, Koutsoumanis KP, Naegeli H, Noteborn H, Ockleford C, Ricci A, Rychen G, Schlatter JR, Hogstrand C. Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals.. EFSA Journal 17(3), 5634.
                                                doi: 10.2903/j.efsa.2019.5634google scholar: lookup
                                              21. EFSA SC, More S, Bampidis V, Benford D, Boesten J, Bragard C, Halldorsson T, Hernandez‐Jerez A, Hougaard‐Bennekou S, Koutsoumanis K, Naegeli H, Nielsen SS, Schrenk D, Silano V, Turck D, Younes M, Aquilina G, Crebelli R, Gürtler R, Schlatter J. Statement on the genotoxicity assessment of chemical mixtures.. EFSA Journal 17(1), 5519.
                                                doi: 10.2903/j.efsa.2019.5519google scholar: lookup
                                              22. EFSA SC, More SJ, Bampidis V, Benford D, Bragard C, Halldorsson TI, Hernandez‐Jerez AF, Hougaard BS, Koutsoumanis KP, Machera K, Naegeli H, Nielsen SS, Schlatter JR, Schrenk D, Silano V, Turck D, Younes M, Gundert‐Remy U, Kass GEN, Wallace HM. Guidance on the use of the threshold of toxicological concern approach in food safety assessment.. EFSA Journal 17(6), 5708.
                                                doi: 10.2903/j.efsa.2019.5708google scholar: lookup
                                              23. Giridharan VV, Thandavarayan RA, Bhilwade HN, Ko KM, Watanabe K, Konishi T. Schisandrin B, attenuates cisplatin‐induced oxidative stress, genotoxicity and neurotoxicity through modulating NF‐κB pathway in mice.. Free Radical Research 46(1), 50–60.
                                                doi: 10.3109/10715762.2011.638291pubmed: 22059853google scholar: lookup
                                              24. Hou W, Gao W, Wang D, Liu Q, Zheng S, Wang Y. The protecting effect of deoxyschisandrin and schisandrin B on HaCaT cells against UVB‐induced damage.. PLoS ONE 10, e0127177.
                                                pmc: PMC4433126pubmed: 25978330
                                              25. Ikeya Y, Mitsuhashi H, Sasaki H, Matsuzaki Y, Matsuzaki T, Hosoya E. Studies on the metabolism of Gomisin a (TJN‐101). II.: Structure determination of biliary and urinary metabolites in rat.. Chemical and Pharmaceutical Bulletin 38, 136–141.
                                                doi: 10.1248/cpb.38.136pubmed: 2337937google scholar: lookup
                                              26. Iwata H, Tezuka Y, Kadota S, Hiratsuka A, Watabe T. Identification and characterization of potent CYP3A4 inhibitors in Schisandra fruit extract.. Drug Metabolism and Disposition 32, 1351–1358.
                                                doi: 10.1124/dmd.104.000646pubmed: 15342469google scholar: lookup
                                              27. Ko RK, Chen N, Leong PK, Ma CW. Pharmacological profile of dibenzocyclooctadiene lignans and other active ingredients in Schisandrae Fructus.. In Schisandra chinensis (pp. 97–138). World Scientific.
                                                doi: 10.1142/9789814635936_0004google scholar: lookup
                                              28. Kopustinskiene DM, Bernatoniene J. Antioxidant effects of Schisandra chinensis fruits and their active constituents.. Antioxidants 10, 620.
                                                doi: 10.3390/antiox10040620pmc: PMC8073495pubmed: 33919588google scholar: lookup
                                              29. Lautz LS, Jeddi MZ, Girolami F, Nebbia C, Dorne JLCM. Metabolism and pharmacokinetics of pharmaceuticals in cats (Felix sylvestris catus) and implications for the risk assessment of feed additives and contaminants.. Toxicology Letters 338, 114–127.
                                                doi: 10.1016/j.toxlet.2020.11.014pubmed: 33253781google scholar: lookup
                                              30. Li CL, Cheng YY, Hsieh CH, Tsai TH. Pharmacokinetics of Schizandrin and its pharmaceutical products assessed using a validated LC–MS/MS method.. Molecules 23, 173.
                                                doi: 10.3390/molecules23010173pmc: PMC6017025pubmed: 29342955google scholar: lookup
                                              31. Li LM, Yang J. Effect of Schisandra chinensis (Turcz) Schisandraceae seed extracts and cisplatin on cytotoxicity, genotoxicity and wound healing in MCF‐7 cells.. Tropical Journal of Pharmaceutical Research 16, 2843.
                                                doi: 10.4314/tjpr.v16i12.7google scholar: lookup
                                              32. Munro IC, Ford RA, Kennepohl E, Sprenger JG. Correlation of structural class with no‐observed‐effect levels: A proposal for establishing a threshold of concern.. Food and Chemical Toxicology 34, 829–867.
                                                doi: 10.1016/s0278-6915(96)00049-xpubmed: 8972878google scholar: lookup
                                              33. Morimoto I, Watanabe F, Osawa T, Okitsu T. Mutagenicity screening of crude drugs with Bacillus subtilis rec‐assay and Salmonella/microsome reversion assay.. Mutation Research 97, 81–102.
                                                pubmed: 6804865
                                              34. Nowak A, Zakłos‐Szyda M, Błasiak J, Nowak A, Zhang Z, Zhang B. Potential of Schisandra chinensis (Turcz.) Baill. in human health and nutrition: A review of current knowledge and therapeutic perspectives.. Nutrients 11(2), 333.
                                                doi: 10.3390/nᄂ0333pmc: PMC6412213pubmed: 30720717google scholar: lookup
                                              35. Ono H, Matsuzaki Y, Wakui Y, Takeda S, Ikeya Y, Amagaya S, Maruno M. Determination of schizandrin in human plasma by gas chromatography‐mass spectrometry.. Journal of Chromatography B: Biomedical Sciences and Applications 674(2), 293–297.
                                                doi: 10.1016/0378-4347(95)00298-7google scholar: lookup
                                              36. PhEur (European Pharmacopoeia). Schisandra chinensis fructus.. European Pharmacopoeia 11th ed. Monograph 07/2016:2428.
                                              37. PhEur Commentary, Bracher F, Heisig P, Langguth P, Mutschler E, Rücker G, Schirmeister T, Scriba GKE, Stahl‐Biskup E, Troschütz R. Arzneibuch‐Kommentar: Wissenschaftliche Erlauterungen zum Arzneibuch (Commentary to the European Pharmacopeia).. Wissenschaftliche Verlagsgesellschaft .
                                              38. Van den Berg M, Birnbaum LS, Denison M, De Vito M, Farland W, Feeley M, Fiedler H, Hakansson H, Hanberg A, Haws L, Rose M, Safe S, Schrenk D, Tohyama C, Tritscher A, Tuomisto J, Tysklin M, Walker N, Peterson RE. The 2005 World Health Organization reevaluation of human and mammalian toxic equivalency factors for dioxins and dioxin‐like compounds.. Toxicological Sciences 93, 223–241.
                                                doi: 10.1093/toxsci/kfl055pmc: PMC2290740pubmed: 16829543google scholar: lookup
                                              39. Wan CK, Tse AK, Yu ZL, Zhu GY, Wang H, Fong DWF. Inhibition of cytochrome P450 3A4 activity by schisandrol a and gomisin a isolated from Fructus Schisandrae chinensis, Phytomedicine.. Phytomedicine 17(8–9), 702–705.
                                                doi: 10.1016/j.phymed.2009.12.005pubmed: 20089387google scholar: lookup
                                              40. Wang Z, You L, Cheng Y, Hu K, Wang Z, Cheng Y, Yang J, Yang Y, Wang G. Investigation of pharmacokinetics, tissue distribution and excretion of schisandrin B in rats by HPLC–MS/MS.. Biomedical Chromatography 2018(32), e4069.
                                                doi: 10.1002/bmc.4069google scholar: lookup
                                              41. WHO (World Health Organization). Fructus Schisandrae.. WHO monographs on selected medicinal plants Vol. 3, pp. 296–313.
                                              42. Xu H, Gan J, Liu X, Wu R, Jin Y, Li M, Yuan B. Gender‐dependent pharmacokinetics of lignans in rats after single and multiple oral administration of Schisandra chinensis extract.. Journal of Ethnopharmacology 147(1), 224–231.
                                                doi: 10.1016/j.jep.2013.03.008pubmed: 23501155google scholar: lookup
                                              43. Yan‐Yan C, Mu‐Zou W. Aspects of schizandrin metabolism in vitro and in vivo.. European Journal of Drug Metabolism and Pharmacokinetics 18(2), 155–160.
                                                doi: 10.1007/BF03188790pubmed: 8243498google scholar: lookup
                                              44. Zhu H, Zhang X, Guan J, Cui B, Zhao L, Zhao X. Pharmacokinetics and tissue distribution study of schisandrin B in rats by ultra‐fast liquid chromatography with tandem mass spectrometry.. Journal of Pharmaceutical and Biomedical Analysis 78–79, 136–140.
                                                doi: 10.1016/j.jpba.2013.01.041google scholar: lookup

                                              Citations

                                              This article has been cited 0 times.
                                              Subscribe to our newsletter
                                              Join 99,344 horse owners like you who receive our email updates on horse health and nutrition.