Analyze Diet
EFSA journal. European Food Safety Authority2025; 23(4); e9357; doi: 10.2903/j.efsa.2025.9357

Safety and efficacy of a feed additive consisting of an essential oil derived from the leaves of Pogostemon cablin Benth. (patchouli oil) for use in all animal species (FEFANA asbl).

Abstract: Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of patchouli oil from the leaves of Benth. (patchouli oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is safe up to the maximum use level in complete feed of 7.5 mg/kg for chickens for fattening, laying hens, turkeys for fattening, pigs for fattening, horses, salmonids, shrimps, rabbits, dogs, cats and ornamental fish, 24 mg/kg for piglets, 35 mg/kg for sows, 34 mg/kg for dairy cows, 60 mg/kg for veal calves (milk replacer) and 53 mg/kg for cattle for fattening, sheep and goats. These conclusions were extrapolated to other physiologically related minor species. For any other species, the additive is safe at 7.5 mg/kg complete feed. The FEEDAP Panel considered that the use level in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumers were identified following the use of patchouli oil up to the highest proposed use level in feed. Regarding user safety, the essential oil under assessment should be considered as irritant to skin and eyes, and respiratory sensitiser. The use of the additive in animal feed under the proposed conditions is not expected to pose a risk to the environment. Since the leaves of and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.
Publication Date: 2025-04-17 PubMed ID: 40248049PubMed Central: PMC12004087DOI: 10.2903/j.efsa.2025.9357Google 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.
  • 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.

Overview

  • This research assesses the safety and efficacy of patchouli oil, an essential oil derived from the leaves of Pogostemon cablin Benth., when used as a sensory additive in feed and drinking water for all animal species.
  • The study concludes safe usage levels for various animal species and addresses potential risks to consumers, users, and the environment.

Background and Purpose

  • The European Food Safety Authority (EFSA) Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was requested by the European Commission to evaluate patchouli oil.
  • Patchouli oil is derived from the leaves of Pogostemon cablin Benth., also known as patchouli.
  • The main objective was to determine if patchouli oil is safe and effective when used as a sensory additive in animal feed and water for all species.

Safety Assessment

  • FEEDAP Panel established maximum safe levels of patchouli oil in complete feed for different animal species:
    • 7.5 mg/kg for chickens for fattening, laying hens, turkeys for fattening, pigs for fattening, horses, salmonids, shrimps, rabbits, dogs, cats, and ornamental fish.
    • 24 mg/kg for piglets.
    • 35 mg/kg for sows.
    • 34 mg/kg for dairy cows.
    • 60 mg/kg for veal calves (milk replacer).
    • 53 mg/kg for cattle for fattening, sheep, and goats.
  • These safety limits were extrapolated to minor species physiologically related to the main species.
  • For any other species without specific data, a safe level of 7.5 mg/kg complete feed was suggested.
  • Use in drinking water is considered safe if the total daily intake from water and feed does not exceed the safe daily intake from feed alone.

Consumer Safety

  • No safety concerns were identified for consumers when animals are fed patchouli oil at the proposed maximum use levels.
  • This implies no harmful residues or adverse effects from consumption of animal products derived from treated animals.

User Safety

  • Patchouli oil is considered an irritant to the skin and eyes.
  • It is also identified as a respiratory sensitiser, potentially causing allergic respiratory reactions upon inhalation.
  • Appropriate handling measures should be taken by users to minimize exposure risks.

Environmental Safety

  • The use of patchouli oil as a feed additive is not expected to pose a risk to the environment under proposed conditions.
  • The panel assessed factors such as environmental persistence, bioaccumulation, and toxicity.

Efficacy

  • Patchouli oil and its preparations are recognized to flavor food.
  • Because the flavoring function in feed is essentially the same as in food, no additional demonstration of efficacy as a sensory additive was necessary.

Summary

  • Patchouli oil is deemed safe for use at specified concentrations in feed and water for many animal species.
  • It poses no consumer or environmental risks under these conditions.
  • Users handling the oil should be aware of its irritant and sensitising properties.
  • The flavoring effect is accepted without extensive efficacy testing due to its established use in food.

Cite This Article

APA
Villa RE, Azimonti G, Bonos E, Christensen H, Durjava M, Dusemund B, Gehring R, Glandorf B, Kouba M, López-Alonso M, Marcon F, Nebbia C, Pechová A, Prieto-Maradona M, Röhe I, Theodoridou K, de Lourdes Bastos M, Brantom P, Chesson A, Schlatter J, Westendorf J, Manini P. (2025). Safety and efficacy of a feed additive consisting of an essential oil derived from the leaves of Pogostemon cablin Benth. (patchouli oil) for use in all animal species (FEFANA asbl). EFSA J, 23(4), e9357. https://doi.org/10.2903/j.efsa.2025.9357

Publication

ISSN: 1831-4732
NlmUniqueID: 101642076
Country: United States
Language: English
Volume: 23
Issue: 4
Pages: e9357
PII: e9357

Researcher Affiliations

Villa, Roberto Edoardo
    Azimonti, Giovanna
      Bonos, Eleftherios
        Christensen, Henrik
          Durjava, Mojca
            Dusemund, Birgit
              Gehring, Ronette
                Glandorf, Boet
                  Kouba, Maryline
                    López-Alonso, Marta
                      Marcon, Francesca
                        Nebbia, Carlo
                          Pechová, Alena
                            Prieto-Maradona, Miguel
                              Röhe, Ilen
                                Theodoridou, Katerina
                                  de Lourdes Bastos, Maria
                                    Brantom, Paul
                                      Chesson, Andrew
                                        Schlatter, Josef
                                          Westendorf, Johannes
                                            Manini, Paola

                                              References

                                              This article includes 38 references
                                              1. Burdock GA. Fenaroli's handbook of flavor ingredients. CRC Press. Taylor & Francis Group 6th ed.
                                                doi: 10.1201/9781439847503google scholar: lookup
                                              2. Chen H, Li Y, Wu X, Li C, Li Q, Qin Z, Yi Y, Chen J, Lai X, Su Z. LC‐MS/MS determination of pogostone in rat plasma and its application in pharmacokinetic studies. Biomedical Chromatography 27, 1092–1099.
                                                doi: 10.1002/bmc.2897pubmed: 23505096google scholar: lookup
                                              3. Chen Z, Song Y, Che J, Liu X, Ning Y, Shan C, Hou Y, Liu Y, Miao X, Cheng Y. Validation of a sensitive gas chromatographic‐mass spectrometric method for the simultaneous determination of β‐elemene and β‐elemenal in human plasma. Journal of Chromatography. B, Analytical Technologies in the Biomedical and Life Sciences 877(4), 408–414.
                                                doi: 10.1016/j.jchromb.2008.12.038pubmed: 19124285google scholar: lookup
                                              4. 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
                                              5. 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
                                              6. EFSA (European Food Safety Authority). Compendium of botanicals reported to contain naturally occurring substances of possible concern for human health when used in food and food supplements. EFSA Journal 10(5), 2663.
                                                doi: 10.2903/j.efsa.2012.2663google scholar: lookup
                                              7. EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids). Guidance on the data required for the risk assessment of flavourings. EFSA Journal 8(6), 1623.
                                                doi: 10.2093/j.efsa.2010.1623google scholar: lookup
                                              8. EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids). Scientific Opinion on flavouring group evaluation 25, revision 2 (FGE.25Rev2): Aliphatic hydrocarbons from chemical group 31. EFSA Journal 9(6), 2177.
                                                doi: 10.2903/j.efsa.2011.2177google scholar: lookup
                                              9. EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids). Scientific opinion on flavouring group evaluation 82, revision 1 (FGE.82Rev1): Consideration of epoxides evaluated by the JECFA (65th meeting). EFSA Journal 12(6), 3708.
                                                doi: 10.2903/j.efsa.2014.3708google scholar: lookup
                                              10. EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids). Scientific Opinion on flavouring group evaluation 78, revision 2 (FGE.78Rev2): Consideration of aliphatic and alicyclic and aromatic hydrocarbons evaluated by JECFA (63rd meeting) structurally related to aliphatic hydrocarbons evaluated by EFSA in FGE.25Rev3. EFSA Journal 13(4), 4067.
                                                doi: 10.2903/j.efsa.2015.4067google scholar: lookup
                                              11. EFSA CEF Panel (EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids). Scientific Opinion on Flavouring group evaluation 25, revision 3 (FGE.25Rev3): Aliphatic hydrocarbons from chemical group 31. EFSA Journal 13(4), 4069.
                                                doi: 10.2903/j.efsa.2015.4069google scholar: lookup
                                              12. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed). 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
                                              13. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed). 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.2015.4053pmc: PMC11883103pubmed: 40061604google scholar: lookup
                                              14. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed). 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.2016.4339pmc: PMC11883103pubmed: 40061604google scholar: lookup
                                              15. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 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.2017.5023pmc: PMC7010039pubmed: 32625313google scholar: lookup
                                              16. 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 2017b;15(10):5021.
                                                doi: 10.2903/j.efsa.2017.5021pmc: PMC7009839pubmed: 32625311google scholar: lookup
                                              17. 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 2017c;15(10):5022.
                                                doi: 10.2903/j.efsa.2017.5022google scholar: lookup
                                              18. 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 2018;16(5):5274.
                                                doi: 10.2903/j.efsa.2018.5274pmc: PMC7009555pubmed: 32625911google scholar: lookup
                                              19. EFSA FEEDAP Panel, Bampidis V, Bastos M, 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, de Knecht J, Azimonti G. Guidance on the assessment of the safety of feed additives for the environment. EFSA Journal 2019;17(4):5648.
                                                doi: 10.2903/j.efsa.2019.5648pmc: PMC7009194pubmed: 32626279google scholar: lookup
                                              20. 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 2023;21(12):e8469.
                                                pmc: PMC10698700pubmed: 38075627
                                              21. EFSA Scientific Committee. Guidance on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements, on request of EFSA. EFSA Journal 2009;7(9):1249.
                                                doi: 10.2093/j.efsa.2009.1249google scholar: lookup
                                              22. EFSA FEEDAP Panel, Bampidis V, Azimonti G, Bastos ML, Christensen H, Durjava M, Kouba 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. Safety and efficacy of a feed additive consisting of an essential oil obtained from the wood of Steud. (cedarwood Texas oil) for use in all animal species (FEFANA asbl). EFSA Journal 2024;22(5):8799.
                                                doi: 10.2903/j.efsa.2024.8799pmc: PMC11096998pubmed: 38756350google scholar: lookup
                                              23. EFSA Scientific Committee, 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 2019a;17(3):5634.
                                                doi: 10.2903/j.efsa.2019.5634pmc: PMC7009070pubmed: 32626259google scholar: lookup
                                              24. EFSA Scientific Committee, 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 2019b;17(1):5519.
                                                doi: 10.2903/j.efsa.2019.5519pmc: PMC7009058pubmed: 32626066google scholar: lookup
                                              25. EFSA Scientific Committee, 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 2019c;17(6):5708.
                                                doi: 10.2903/j.efsa.2019.5708pmc: PMC7009090pubmed: 32626331google scholar: lookup
                                              26. FAO. Black tiger shrimp – Penaeus monodon. Aquaculture Feed and Fertilizer Resources Information System (AFFRIS) 2025.
                                              27. Fukushima S, Cohen SM, Eisenbrand G, Gooderham NJ, Guengerich FP, Hecht SS, Rietjens IMCM, Rosol TJ, Davidsen JM, Harman CL, Lu V, Taylor SV. FEMA GRAS assessment of natural flavor complexes: Lavender, guaiac coriander‐derived and related flavoring ingredients. Food and Chemical Toxicology 2020;145:111584.
                                                doi: 10.1016/j.fct.2020.111584pubmed: 32682832google scholar: lookup
                                              28. Hosseini Aghuzbeni SH, Hajirezaee S, Matinfar A, Khara H, Ghobadi M. A preliminary study on polyculture of western white shrimp () with mullet (): An assessment of water quality, growth parameters, feed intake efficiency and survival. Journal of Applied Animal Research 2017;45(1):247–251.
                                              29. Lautz LS, Jeddi MZ, Girolami F, Nebbia C, Dorne JLCM. Metabolism and pharmacokinetics of pharmaceuticals in cats () and implications for the risk assessment of feed additives and contaminants. Toxicology Letters 2021;338:114–127.
                                                doi: 10.1016/j.toxlet.2020.11.014pubmed: 33253781google scholar: lookup
                                              30. Lee C, Lee KJ. Dietary protein requirement of Pacific white shrimp in three different growth stages. Fisheries and Aquatic Science 21, 30.
                                                doi: 10.1186/s41240-018-0105-0google scholar: lookup
                                              31. Li Y, Su Z, Lin S, Li C, Zhao Y, Gao X, Lai Y, Wu X, Wu H, Cai Z. Characterisation of the metabolism of pogostone in vitro and in vivo using liquid chromatography with mass spectrometry. Phytochemical Analysis 25, 97–105.
                                                doi: 10.1002/pca.2471pubmed: 24605365google scholar: lookup
                                              32. Liwska K. Oral (dietary) reproduction/developmental toxicity screening test in the rat (OECD 421) (patchouli oil) [Unpublished study report, study no. 4112905]. Harlan Laboratories Ltd .
                                              33. Liwska K. Twenty‐eight day repeated dose oral (dietary) toxicity study in the rat (patchouli oil) [Unpublished study report, study no. 41102453]. Harlan Laboratories Ltd .
                                              34. 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
                                              35. TNAU. TNAU Agritech portal. Fisheries. Shrimps Culture. 2009.
                                              36. Toyes-Vargas E, de la Calderón-Barca AM, Duran-Encinas Y, Palacios E, Civera-Cerecedo R. Marine co‐product meals as a substitute of fishmeal in diets for white shrimp improve growth, feed intake and muscle HUFA composition. Aquaculture Research 48, 3782–3800.
                                                doi: 10.1111/are.13205google scholar: lookup
                                              37. van Beek TA, Joulain D. The essential oil of patchouli, : A review. Flavour and Fragrance Journal 33, 6–51.
                                                doi: 10.1002/ffj.3418google scholar: lookup
                                              38. Wang K, Li Z, Chen Y, Su C. The pharmacokinetics of a novel anti‐tumor agent, beta‐elemene, in Sprague‐Dawley rats. Biopharmaceutics & Drug Disposition 26, 301–307.
                                                doi: 10.1002/bdd.463pubmed: 16041842google scholar: lookup

                                              Citations

                                              This article has been cited 0 times.