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EFSA journal. European Food Safety Authority2023; 21(10); e08348; doi: 10.2903/j.efsa.2023.8348

Safety and efficacy of feed additives consisting of essential oils from the fruit and stems of Foeniculum vulgare Mill. ssp. vulgare: Bitter fennel oil for use in all animal species and sweet fennel oil for use in 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 essential oils from fruit and stems of Mill. (bitter fennel oil and sweet fennel oil), when used as sensory additives (flavourings). For long-living and reproductive animals, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered of low concern the use of bitter fennel oil (with a content of estragole up to 6.1%) at the proposed use level in complete feed: 0.6 mg/kg for laying hens and rabbits, 1.0 mg/kg for sows and dairy cows, 1.5 mg/kg for sheep/goats, horses and cats, 1.9 mg/kg for dogs and 7.1 mg/kg for ornamental fish. For short-living animals (animals for fattening), the Panel had no safety concern when bitter fennel oil is used at the proposed use level in complete feed of 18.2 mg/kg for chickens for fattening, 24.3 mg/kg for turkeys for fattening and 25 mg/kg for piglets, pigs for fattening, veal calves, cattle for fattening, sheep/goats, horses, rabbits and salmon. These conclusions were extrapolated to other physiologically related species. The use of sweet fennel oil (with a content of estragole up to 5.0%) was considered of low concern at the proposed use level in complete feed of 2.3 mg/kg for dogs and 1.9 mg/kg cats. The use of bitter fennel oil in animal feed is expected to be of no concern for consumers and the environment. The additives under assessment should be considered as irritants to skin and eyes, and as dermal and respiratory sensitisers. Due to the high concentration of estragole (> 1%), fennel oils are classified as suspected of causing genetic defects and of causing cancer and should be handled accordingly. Since the fruit of Mill. ssp. and its preparations are recognised to flavour food, no further demonstration of efficacy was necessary.
Publication Date: 2023-10-30 PubMed ID: 37908453PubMed Central: PMC10613937DOI: 10.2903/j.efsa.2023.8348Google Scholar: Lookup
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  • 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 discusses the safety and efficacy of using essential oils from the fruit and stems of Foeniculum vulgare species as flavoring additives in animal feeds for different species. The research concluded their use is generally of low concern for animals, consumers, and the environment, but should be handled with caution due to potential risks.

Study Purpose and Context

  • The purpose of the study was to understand the safety and efficacy of essential oils derived from the fruit and stems of Foeniculum vulgare (bitter fennel oil and sweet fennel oil), when used as flavor additives in feed for various animal species.
  • The context for the study is the feed industry’s need for flavouring additives in feed for animals, and the potential biological and environmental effects of these additives.

Approach and Findings

  • The study used the Panel on Additives and Products or Substances in Animal Feed (FEEDAP) to analyze the proposed levels of bitter and sweet fennel oil in animal feed.
  • The study was conducted for a wide range of animal classifications: long-living and reproductive animals, and short-living animals.
  • After the analysis, the panel found that the use of the fennel oils is considered to be of low concern for both categories of animals when used at the proposed levels.
  • It was also stated that the use of these oils in animal feeds does not create a safety concern for consumers of the animal products, nor have a negative impact on the environment.

Risks and Recommendations

  • Despite the low level of concern associated with the additives’ use in animal feeds, the study pointed out that these additives could be skin and eye irritants, as well as dermal and respiratory sensitizers.
  • The oils are also recognized as potential carriers of genetic defects and cancer, given the high concentration of estragole they contain. Therefore, it was recommended that they should be handled with care.
  • Given that the extracts from the fruit of Foeniculum vulgare and its preparations are acknowledged as food flavor enhancers, the research did not find the need for further demonstration of efficacy.

Cite This Article

APA
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, Villa RE, Woutersen R, Brantom P, Chesson A, Schlatter J, Westendorf J, Dirven Y, Manini P, Pizzo F, Dusemund B. (2023). Safety and efficacy of feed additives consisting of essential oils from the fruit and stems of Foeniculum vulgare Mill. ssp. vulgare: Bitter fennel oil for use in all animal species and sweet fennel oil for use in dogs and cats (FEFANA asbl). EFSA J, 21(10), e08348. https://doi.org/10.2903/j.efsa.2023.8348

Publication

ISSN: 1831-4732
NlmUniqueID: 101642076
Country: United States
Language: English
Volume: 21
Issue: 10
Pages: e08348
PII: e08348

Researcher Affiliations

Bampidis, Vasileios
    Azimonti, Giovanna
      Bastos, Maria de Lourdes
        Christensen, Henrik
          Durjava, Mojca
            Kouba, Maryline
              López-Alonso, Marta
                López Puente, Secundino
                  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
                                            Pizzo, Fabiola
                                              Dusemund, Birgit

                                                References

                                                This article includes 60 references
                                                1. Anthony A, Caldwell J, Hutt AJ, Smith RL. Metabolism of estragole in rat and mouse and influence of dose size on excretion of the proximate carcinogen 1′‐hydroxyestragole. Food and Chemical Toxicology 25, 799–806.
                                                  doi: 10.1016/0278-6915(87)90257-2pubmed: 3121480google scholar: lookup
                                                2. Api AM, Belsito D, Botelho D, Bruze M, Burton GA Jr, Buschmann J, Dagli ML, Date M, Dekant W, Deodhar C, Francis M, Fryer AD, Jones L, Joshi K, La Cava S, Lapczynski A, Liebler DC, O'Brien D, Patel A, Penning TM, Ritacco G, Romine J, Sadekar N, Salvito D, Schultz TW, Sipes IG, Sullivan G, Thakkar Y, Tokura Y, Tsang S. RIFM fragrance ingredient safety assessment, Fenchone, CAS Registry Number 1195‐79‐5. Food and Chemical Toxicology 112, S209–S217.
                                                  doi: 10.1016/j.fct.2018.08.052pubmed: 30048645google scholar: lookup
                                                3. Burdock GA. Fenaroli's handbook of flavor ingredients. 6th Edition. CRC Press. Taylor & Francis Group. Boca Raton, FL, pp. 692–694.
                                                  doi: 10.1201/9781439847503google 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. EC (European Commission). Opinion of the Scientific Committee on Food on Estragole (1‐allyl‐4‐methoxybenzene) 2001. 2001. 583 SCF/CS/FLAV/FLAVOUR/6 ADD 2 Final.
                                                7. EFSA (European Food Safety Authority). Opinion of the Scientific Committee on a request from EFSA related to a harmonised approach for risk assessment of substances which are both genotoxic and carcinogenic. EFSA Journal 2005;3(10):282, 31 pp.
                                                  doi: 10.2903/j.efsa.2005.282google scholar: lookup
                                                8. EFSA (European Food Safety Authority). Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Materials in Contact with Food on a request from Commission on Flavouring Group Evaluation 69, (FGE.69) Aromatic substituted secondary alcohols, ketones and related esters. EFSA Journal 2008;869, 35 pp.
                                                  doi: 10.2903/j.efsa.2008.896google scholar: lookup
                                                9. 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 2012;10(5):2663, 60 pp.
                                                  doi: 10.2903/j.efsa.2012.2663google scholar: lookup
                                                10. 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 to be used in or on foods. EFSA Journal 2010;8(6):1623, 38 pp.
                                                  doi: 10.2093/j.efsa.2010.1623google 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 2 (FGE.25Rev2): Aliphatic hydrocarbons from chemical group 31. EFSA Journal 2011;9(6):2177, 126 pp.
                                                  doi: 10.2903/j.efsa.2011.2177google scholar: lookup
                                                12. 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 2015;13(4):4069, 116 pp.
                                                  doi: 10.2903/j.efsa.2015.4069google scholar: lookup
                                                13. 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 2015;13(4):4067, 72 pp.
                                                  doi: 10.2903/j.efsa.2015.4067google scholar: lookup
                                                14. EFSA FAF Panel (EFSA Panel on Food Additives and Flavourings), Younes M, Aquilina G, Castle L, Engel K‐H, Fowler P, Frutos Fernandez MJ, Fürst P, Gürtler R, Gundert‐Remy U, Husøy T, Moldeus P, Oskarsson A, Shah R, Waalkens‐Berendsen I, Wölfle D, Benigni R, Bolognesi C, Chipman K, Cordelli E, Degen G, Marzin D, Svendsen C, Carfì M, Kovalkovicova N, Martino C, Vianello G, Mennes W. Scientific Opinion on Flavouring Group Evaluation 208 Revision 3 (FGE.208Rev3): consideration of genotoxicity data on alicyclic aldehydes with a,b‐unsaturation in ring/ side‐chain and precursors from chemical subgroup 2.2 of FGE.19. EFSA Journal 2019;17(1):5569, 50 pp.
                                                  doi: 10.2903/j.efsa.2019.5569pmc: PMC7009078pubmed: 32626109google scholar: lookup
                                                15. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed). Statement on the use of feed additives authorised/applied for use in feed when supplied via water. EFSA Journal 2010;8(12):1956, 9 pp.
                                                  doi: 10.2903/j.efsa.2010.1956google scholar: lookup
                                                16. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed). Scientific Opinion on the safety and efficacy of allylhydroxybenzenes (chemical group 18) when used as flavourings for all animal species. EFSA Journal 2011;9(12):2440, 14 pp.
                                                  doi: 10.2903/j.efsa.2011.2440google scholar: lookup
                                                17. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed). Scientific Opinion on the safety and efficacy of branched‐chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched‐chain alcohols and acetals containing branched‐chain aldehydes (chemical group 2) when used as flavourings for all animal species. EFSA Journal 2012;10(10):2927, 26 pp.
                                                  doi: 10.2903/j.efsa.2012.2927google scholar: lookup
                                                18. 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 2012;10(11):2966, 25 pp.
                                                  doi: 10.2903/j.efsa.2012.2966google scholar: lookup
                                                19. 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 alicyclic ethers (chemical group 16) when used as flavourings for all animal species. EFSA Journal 2012;10(11):2967, 17 pp.
                                                  doi: 10.2903/j.efsa.2012.2967google scholar: lookup
                                                20. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed). Scientific Opinion on the safety and efficacy of benzyl alcohols, aldehydes, acids, esters and acetals (chemical group 23) when used as flavourings for all animal species. EFSA Journal 2012;10(7):2785, 30 pp.
                                                  doi: 10.2903/j.efsa.2012.2785google scholar: lookup
                                                21. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed). Scientific Opinion on the safety and efficacy of phenol derivatives containing ring‐alkyl, ring‐alkoxy and side‐chains with an oxygenated functional group (chemical group 25) when used as flavourings for all species. EFSA Journal 2012;10(2):2573, 19 pp.
                                                  doi: 10.2903/j.efsa.2012.2573google scholar: lookup
                                                22. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed). Guidance for the preparation of dossiers for sensory additives. EFSA Journal 2012;10(1):2534, 26 pp.
                                                  doi: 10.2903/j.efsa.2012.2534google scholar: lookup
                                                23. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed). Guidance on studies concerning the safety of use of the additive for users/workers. EFSA Journal 2012;10(1):2539, 5 pp.
                                                  doi: 10.2903/j.efsa.2012.2539google scholar: lookup
                                                24. 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 2015;13(3):4053, 22 pp.
                                                  doi: 10.2903/j.efsa.2015.4053google scholar: lookup
                                                25. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed). 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 2016;14(6):4475, 26 pp.
                                                  doi: 10.2903/j.efsa.2016.4475google scholar: lookup
                                                26. 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 2016;14(1):4339, 17 pp.
                                                  doi: 10.2903/j.efsa.2016.4339google scholar: lookup
                                                27. 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, Villa RE, Wallace RJ, Wester P, Anguita M, Galobart J, Innocenti ML. Guidance on the identity, characterisation and conditions of use of feed additives. EFSA Journal 2017;15(10):5023, 12 pp.
                                                  doi: 10.2903/j.efsa.2017.5023pmc: PMC7010039pubmed: 32625313google scholar: lookup
                                                28. 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, Villa RE, Wallace RJ, Wester P, Anguita M, Galobart J, Innocenti ML, Martino L. Guidance on the assessment of the safety of feed additives for the target species. EFSA Journal 2017;15(10):5021, 19 pp.
                                                  doi: 10.2903/j.efsa.2017.5021pmc: PMC7009839pubmed: 32625311google scholar: lookup
                                                29. 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, Villa RE, Wallace RJ, Wester P, Anguita M, Dujardin B, Galobart J, Innocenti ML. Guidance on the assessment of the safety of feed additives for the consumer. EFSA Journal 2017;15(10):5022, 17 pp.
                                                  doi: 10.2903/j.efsa.2017.5022google scholar: lookup
                                                30. 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, Villa RE, Wallace RJ, Wester P, Anguita M, Galobart J, Innocenti ML, Martino L. Guidance on the assessment of the efficacy of feed additives. EFSA Journal 2018;16(5):5274, 25 pp.
                                                  doi: 10.2903/j.efsa.2018.5274pmc: PMC7009555pubmed: 32625911google scholar: lookup
                                                31. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 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, Kolar B, Beelen P, Padovani L, Tarrés‐Call J, Vettori MV, Azimonti G. Guidance on the assessment of the safety of feed additives for the environment. EFSA Journal 2019;17(4):5648, 78 pp.
                                                  doi: 10.2903/j.efsa.2019.5648google scholar: lookup
                                                32. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 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, Westendorf J, Galobart J, Manini P, Pizzo F, 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 2021;19(4):6548, 55 pp.
                                                  doi: 10.2903/j.efsa.2021.6548pmc: PMC8085978pubmed: 33968248google scholar: lookup
                                                33. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed). General approach to assess the safety for the target species of botanical preparations which contain compounds that are genotoxic and/or carcinogenic. .
                                                34. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), Bampidis V, Azimonti G, Bastos ML, Christensen H, Fašmon 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, Westendorf J, Manini P, Pizzo F, Dusemund B. Scientific Opinion on the safety and efficacy of a feed additive consisting of an extract of olibanum from Boswellia serrata Roxb. ex Colebr. for use in dogs and horses (FEFANA asbl). EFSA Journal 2022;20(3):7158, 24 pp.
                                                  doi: 10.2903/j.efsa.2022.7158pmc: PMC8900119pubmed: 35281639google scholar: lookup
                                                35. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), 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, Schlatter J, Schrenk D, Westendorf J, Manini P, Pizzo F, Dusemund B. Scientific Opinion on the safety and efficacy of a feed additive consisting of an essential oil from the leaves of Laurus nobilis L. (laurel leaf oil) for all animal species (FEFANA asbl). EFSA Journal 2023;21(3):7875, 28 pp.
                                                  doi: 10.2903/j.efsa.2023.7875pmc: PMC9996239pubmed: 36908566google scholar: lookup
                                                36. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed), Bampidis V, Azimonti G, Bastos ML, Christensen H, Dusemund B, Durjava M, 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, Dierick N, Martelli G, Westendorf J, Ortuño Casanova J, Dirven Y, Firmino JP, Manini P. Safety of 41 flavouring compounds providing an Herbal flavour and belonging to different chemical groups for use as feed additives in all animal species (FEFANA asbl). EFSA Journal 2023;21(X):8340, 25 pp.
                                                  doi: 10.2903/j.efsa.2023.8340pmc: PMC10599282pubmed: 37886609google scholar: lookup
                                                37. 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, 19 pp.
                                                  doi: 10.2093/j.efsa.2009.1249google scholar: lookup
                                                38. 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, Silano V, Nielsen SS, Schrenk D, Solecki R, Turck D, Younes M, Benfenati E, Castle L, Cedergreen N, Laskowski R, Leblanc JC, Kortenkamp A, Ragas A, Posthuma L, Svendsen C, Testai E, Dujardin B, GEN Kass, Manini P, Zare Jeddi M, Dorne J‐LCM, Hogstrand C. Guidance on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals. EFSA Journal 2019;17(3):5634, 77 pp.
                                                  doi: 10.2903/j.efsa.2019.5634pmc: PMC7009070pubmed: 32626259google scholar: lookup
                                                39. 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, Hirsch‐Ernst KI, Mosesso P, Nielsen E, Solecki R, Carfì M, Martino C, Maurici D, Parra Morte J, Schlatter J. Statement on the genotoxicity assessment of chemical mixtures. EFSA Journal 2019;17(1):5519, 11 pp.
                                                  doi: 10.2903/j.efsa.2019.5519pmc: PMC7009058pubmed: 32626066google scholar: lookup
                                                40. 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, Kleiner J, Rossi AM, Serafimova R, Reilly L, Wallace HM. Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment. EFSA Journal 2019;17(6):5708, 17 pp.
                                                  doi: 10.2903/j.efsa.2019.5708pmc: PMC7009090pubmed: 32626331google scholar: lookup
                                                41. EMA (European Medicines Agency). Public statement on the use of herbal medicinal products containing estragole. 2005. EMEA/HMPC/137212/2005.
                                                42. EMA (European Medicines Agency). Community herbal monograph on Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung, fructus. 2007. EMEA/HMPC/263293/2007.
                                                43. EMA (European Medicines Agency). Opinion of the Committee on Herbal Medicinal Products (HMPC) on a Community herbal monograph on Foeniculum vulgare Miller subsp. vulgare var. dulce (Miller) Thellung, fructus. 2007. EMEA/HMPC/280074/2007, EMEA/HMPC/M/H/0012.
                                                44. EMA (European Medicines Agency). Assessment report on Foeniculum vulgare Miller. 2008. EMEA/HMPC/137426/2006.
                                                45. EMA (European Medicines Agency). Public statement on the use of herbal medicinal products containing estragole. 2021. EMA/HMPC/137212/2005 Rev 1.
                                                46. Ishidate M Jr, Sofuni T, Yoshikawa K, Hayashi M, Nohmi T, Sawada M, Matsuoka A. Primary mutagenicity screening of food additives currently used in Japan. Food and Chemical Toxicology 22, 623–636.
                                                  doi: 10.1016/0278-6915(84)90271-0pubmed: 6381265google scholar: lookup
                                                47. 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
                                                48. Levorato S, Dominici L, Fatigoni C, Zadra C, Pagiotti R, Moretti M, Villarini M. In vitro toxicity evaluation of estragole‐containing preparations derived from Foeniculum vulgare Mill. (fennel) on HepG2 cells. Food and Chemical Toxicology 111, 616–622.
                                                  doi: 10.1016/j.fct.2017.12.014pubmed: 29233689google scholar: lookup
                                                49. Mahmoud I, Alkofahi A, Abdelaziz A. Mutagenic and toxic activities of several spices and some Jordanian medicinal plants. International Journal of Pharmacognosy 30, 81–85.
                                                  doi: 10.3109/13880209209053961google scholar: lookup
                                                50. Morimoto I, Watanabe F, Osawa T, Okitsu T, Kada T. Mutagenicity screening of crude drugs with Bacillus subtilis rec‐assay and Salmonella/microsome reversion assay. Mutation Research/Environmental Mutagenesis and Related Subjects 97, 81–102.
                                                  doi: 10.1016/0165-1161(82)90007-3pubmed: 6804865google scholar: lookup
                                                51. 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
                                                52. NTP (National Toxicology Program). NTP Technical Report on the Toxicology and carcinogenesis studies of methyleugenol (CAS NO. 93‐15‐2) in F344/N rats and B6C3F1 mice (gavage study). NTP, Technical Report Series 491, 1–420.
                                                  pubmed: 12563349
                                                53. PhEur (European Pharmacopoeia). “Fennel, sweet” (Foeniculi dulcis fructus). European Pharmacopoeia 11th Edition. Monograph 04/2011:0825.
                                                54. PhEur (European Pharmacopoeia). “Fennel, bitter” (Foeniculi amari fructus). European Pharmacopoeia 11th Edition. Monograph 04/2013:0824.
                                                55. PhEur (European Pharmacopoeia). “Bitter‐fennel fruit oil” (Foeniculi amari fructus aetheroleum). European Pharmacopoeia 11th Edition. Monograph 01/2008:1826.
                                                56. PhEur (European Pharmacopoeia). “Bitter‐fennel berb oil” (Foeniculi amari herbae aetheroleum). European Pharmacopoeia 11th Edition. Monograph 07/2009:2380.
                                                57. Sangster SA, Caldwell AJ, Hutt A, Anthony A, Smith RL. The metabolic disposition of [methoxy‐14C]‐labelled trans‐anethole, estragole and p‐propylanisole in human volunteers. Xenobiotica 17, 1223–1232.
                                                  doi: 10.3109/00498258709167414pubmed: 3424869google scholar: lookup
                                                58. Suparmi S, Ginting AJ, Mariyam S, Wesseling S, Rietjens IMCM. Levels onogof methyleugenol and eugenol in instant herbal beverages available on the Indonesian market and related risk assessment. Food and Chemical Toxicology 125, 467–478.
                                                  doi: 10.1016/j.fct.2019.02.001pubmed: 30721739google scholar: lookup
                                                59. Yamamoto H, Mizutani T, Nomura H. [Studies on the mutagenicity of crude drug extracts. I]. Yakugaku Zasshi 102, 596–601.
                                                  doi: 10.1248/yakushi1947.102.6_596pubmed: 6757409google scholar: lookup
                                                60. Zangouras A, Caldwell J, Hutt AJ, Smith RL. Dose‐dependent conversion of estragole in the rat and mouse to the carcinogenic metabolite 1′‐hydroxyestragole. Biochemical Pharmacology 30, 1383–1386.
                                                  doi: 10.1016/0006-2952(81)90329-4pubmed: 7271835google scholar: lookup

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