FREE SHIPPING over $40
OVER 10000 FIVE-STAR REVIEWS
5% OFF ALL SUBSCRIPTIONS
100% HAPPINESS GUARANTEE
Analyze Diet
0
EFSA journal. European Food Safety Authority2022; 20(10); e07433; doi: 10.2903/j.efsa.2022.7433

Safety and efficacy of a feed additive consisting of glyceryl polyethyleneglycol ricinoleate (PEG castor oil) for 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 glyceryl polyethyleneglycol ricinoleate (PEG castor oil) as technological feed additive for all animal species. PEG castor oil is safe at a maximum concentration in complete feed of 90 mg/kg for chickens for fattening and other minor growing poultry; 134 mg/kg for laying hens and other laying/breeding birds kept for egg production/reproduction; 121 mg/kg for turkeys for fattening; 162 mg/kg for piglets and other minor growing ; 194 mg/kg for pigs for fattening; 236 mg/kg for sows other minor reproductive ; 231 mg/kg for dairy cows and other dairy ruminants (other than sheep/goats); 142 mg/kg in rabbits and 377 mg/kg in veal calves; 356 mg/kg for cattle for fattening and other growing ruminants, sheep, goat, horses and cats; 427 mg/kg for dogs; 407 mg/kg for salmonids and other fin fish; and 1,584 mg/kg for ornamental fish. For other growing species and non-food producing animals, the additive is considered safe at 90 mg/kg complete feed. The use of PEG castor oil as feed additive for all animal species would be of no concern for the consumer. The FEEDAP Panel considered inhalation exposure of the user to the additive unlikely. PEG castor oil is not considered a skin sensitiser. The panel was not in the position to conclude on the potential of the additive to be a skin or eye irritant. The additive is a readily biodegradable substance and is not expected to pose a risk for the environment. The lack of sufficient data does not allow the FEEDAP Panel to conclude on the efficacy of PEG castor oil as an emulsifier in feedingstuffs.
© 2022 Wiley‐VCH Verlag GmbH & Co. KgaA on behalf of the European Food Safety Authority.
Get Full Text
Publication Date: 2022-10-28 PubMed ID: 36320457PubMed Central: PMC9615474DOI: 10.2903/j.efsa.2022.7433Google 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.

The research article discusses the safety and efficacy of a feed additive known as glyceryl polyethyleneglycol ricinoleate or PEG castor oil for animals of various species, as assessed by the European Food Safety Authority (EFSA). The study reports that the additive is safe at specific concentrations in complete feed for different animal species and is unlikely to create risks for consumers or the environment. However, sufficient data to assess its efficacy as an emulsifier in feedingstuffs is lacking.

About the Research

  • This research was prompted by a request from the European Commission to the EFSA to provide a scientific opinion on the safety and use rights of glyceryl polyethyleneglycol ricinoleate, also known as PEG castor oil, as a technological feed additive for all animal species.
  • The decision was based on maximum concentrations in complete feed for various animals such as chickens, laying hens, turkeys, piglets, pigs, sows, dairy cows, rabbits, veal calves, cats, dogs, fish, and non-food producing animals.

Safety of PEG Castor Oil

  • The study concluded that PEG castor oil is safe for all animals when used at the recommended concentrations in their feed. The concentrations vary by species, with the highest permitted level being 1,584 mg/kg for ornamental fish.
  • For non-food producing and growing animals, the additive is safe at a concentration of 90 mg/kg in the total feed.
  • The use of PEG castor oil as a feed additive is deemed to pose no risk for consumers.
  • The researchers further noted that while inhalation exposure to the additive by the user is considered unlikely, they could not definitively conclude on the potential of the additive to cause skin or eye irritation due to lack of data.

Environmental Impact and Efficacy of PEG Castor Oil

  • PEG castor oil was found to be a readily biodegradable substance and thus is not expected to pose a risk to the environment.
  • However, the plan was not able to conclude on the effectiveness of PEG castor oil as an emulsifier in animal feed due to insufficient data.

Conclusion

  • The research provides important insights into the safety and potential impact of using PEG castor oil as a feed additive for various animals. However, further studies are required to definitively establish its efficacy as an emulsifier and assess its potential to irritate the skin or eyes.

Cite This Article

APA
Bampidis V, Azimonti G, Bastos ML, Christensen H, Dusemund B, 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, Aquilina G, Bories G, Gropp J, Nebbia C, Innocenti M. (2022). Safety and efficacy of a feed additive consisting of glyceryl polyethyleneglycol ricinoleate (PEG castor oil) for all animal species (FEFANA asbl). EFSA J, 20(10), e07433. https://doi.org/10.2903/j.efsa.2022.7433

Publication

EFSA journal. European Food Safety Authority
ISSN: 1831-4732
NlmUniqueID: 101642076
Country: United States
Language: English
Volume: 20
Issue: 10
Pages: e07433
PII: e07433

Researcher Affiliations

Bampidis, Vasileios
    Azimonti, Giovanna
      Bastos, Maria de Lourdes
        Christensen, Henrik
          Dusemund, Birgit
            Fašmon Durjava, Mojca
              Kouba, Maryline
                López-Alonso, Marta
                  López Puente, Secundino
                    Marcon, Francesca
                      Mayo, Baltasar
                        Pechová, Alena
                          Petkova, Mariana
                            Ramos, Fernando
                              Sanz, Yolanda
                                Villa, Roberto Edoardo
                                  Woutersen, Ruud
                                    Aquilina, Gabriele
                                      Bories, Georges
                                        Gropp, Jürgen
                                          Nebbia, Carlo
                                            Innocenti, Matteo

                                              References

                                              This article includes 27 references
                                              1. Al-Ali AAA, Nielsen RB, Steffansen B, Holm R, Nielsen CU. Nonionic surfactants modulate the transport activity of ATP-binding cassette (ABC) transporters and solute carriers (SLC): Relevance to oral drug absorption.. Int J Pharm 2019 Jul 20;566:410-433.
                                                pubmed: 31125713doi: 10.1016/j.ijpharm.2019.05.033google scholar: lookup
                                              2. Au WW, Anwar W, Paolini M, Ramanujam S, Cantelli-Forti G. Mechanism of clastogenic and co-clastogenic activity of cremophore with benzene in mice.. Carcinogenesis 1991 Jan;12(1):53-7.
                                                pubmed: 1988182doi: 10.1093/carcin/12.1.53google scholar: lookup
                                              3. Blazak WF, Meier JR, Stewart BE, Blachman DC, Deahl JT. Activity of 1,1,1- and 1,1,3-trichloroacetones in a chromosomal aberration assay in CHO cells and the micronucleus and spermhead abnormality assays in mice.. Mutat Res 1988 Dec;206(4):431-8.
                                                pubmed: 3205262doi: 10.1016/0165-1218(88)90050-xgoogle scholar: lookup
                                              4. Borzelleca JF, Hayes JR, Condie LW, Egle JL Jr. Acute and subchronic toxicity of 2,4-dichlorophenol in CD-1 mice.. Fundam Appl Toxicol 1985 Jun;5(3):478-86.
                                                pubmed: 4007306doi: 10.1016/0272-0590(85)90095-8google scholar: lookup
                                              5. Cosmetic Ingredient Review. Final report on the safety assessment of PEG‐ 30, −33, −35, −36, and −40 castor oil and PEG‐30 and ‐40 hydrogenated castor oil. International Journal of Toxicology 16, 269–306.
                                              6. nECHA (European Chemicals Agency)n. Guidance on the application of the CLP criteria. Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures. .
                                              7. EFSA ANS Panel (EFSA Panel on Food Additives and Nutrient Sources added to Food), Mortensen A, Aguilar F, Crebelli R, Di Domenico A, Dusemund B, Frutos MJ, Galtier P, Gott D, Gundert‐Remy U, Leblanc J‐C, Lindtner O, Moldeus P, Mosesso P, Parent‐Massin D, Oskarsson A, Stankovic I, Waalkens‐Berendsen I, Woutersen RA, Wright M, Younes M, Boon P, Chrysafidis D, Gürtler R, Tobback P, Rincon AM, Tard A, Lambrè C. Scientific Opinion on re‐evaluation of polyglycerolpolyricinoleate (E 476) as a food additive. EFSA Journal 2017;15(3):4743, 54 pp.
                                                doi: 10.2903/j.efsa.2017.4743google scholar: lookup
                                              8. 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
                                              9. EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed). Scientific Opinion on the safety and efficacy of polyoxyethylene (20) sorbitan monooleate as a feed additive for all animal species. EFSA Journal 2016;14(3):4443, 18 pp.
                                                doi: 10.2903/j.efsa.2016.4443google scholar: lookup
                                              10. 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 J 2017 Oct;15(10):e05022.
                                                doi: 10.2903/j.efsa.2017.5022pmc: PMC7009902pubmed: 32625312google scholar: lookup
                                              11. 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 J 2017 Oct;15(10):e05023.
                                                doi: 10.2903/j.efsa.2017.5023pmc: PMC7010039pubmed: 32625313google scholar: lookup
                                              12. 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 J 2017 Oct;15(10):e05021.
                                                doi: 10.2903/j.efsa.2017.5021pmc: PMC7009839pubmed: 32625311google scholar: lookup
                                              13. 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 J 2018 May;16(5):e05274.
                                                doi: 10.2903/j.efsa.2018.5274pmc: PMC7009555pubmed: 32625911google scholar: lookup
                                              14. 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, Kolar B, van 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 J 2019 Apr;17(4):e05648.
                                                doi: 10.2903/j.efsa.2019.5648pmc: PMC7009194pubmed: 32626279google scholar: lookup
                                              15. nEMA (European Medicines Agency)n. Polyoxyl castor oil. Polyoxyl hydrogenated castor oil. Summary report. .
                                              16. Goto E, Shimazaki J, Monden Y, Takano Y, Yagi Y, Shimmura S, Tsubota K. Low-concentration homogenized castor oil eye drops for noninflamed obstructive meibomian gland dysfunction.. Ophthalmology 2002 Nov;109(11):2030-5.
                                                pubmed: 12414410doi: 10.1016/s0161-6420(02)01262-9google scholar: lookup
                                              17. Hanke U, May K, Rozehnal V, Nagel S, Siegmund W, Weitschies W. Commonly used nonionic surfactants interact differently with the human efflux transporters ABCB1 (p-glycoprotein) and ABCC2 (MRP2).. Eur J Pharm Biopharm 2010 Oct;76(2):260-8.
                                                pubmed: 20600890doi: 10.1016/j.ejpb.2010.06.008google scholar: lookup
                                              18. Howes D, Wilson R, James CT. The fate of ingested glyceran esters of condensed castor oil fatty acids [polyglycerol polyricinoleate (PGPR)] in the rat.. Food Chem Toxicol 1998 Sep-Oct;36(9-10):719-38.
                                                pubmed: 9737418doi: 10.1016/s0278-6915(98)00055-6google scholar: lookup
                                              19. JECFA (Joint FAO/WHO Expert Committee on Food Additives). Castor oil. WHO food additive series 14, 469.
                                              20. Kortselius MJ. Mutagenicity of BCNU and related chloroethylnitrosoureas in Drosophila.. Mutat Res 1978 Jul;57(3):297-305.
                                                pubmed: 353550doi: 10.1016/0027-5107(78)90214-2google scholar: lookup
                                              21. Krogdahl A. Digestion and absorption of lipids in poultry.. J Nutr 1985 May;115(5):675-85.
                                                pubmed: 3889239doi: 10.1093/jn/115.5.675google scholar: lookup
                                              22. Machemer L, Lorke D. Mutagenicity studies with praziquantel, a new anthelmintic drug, in mammalian systems.. Arch Toxicol 1978 Jan 25;39(3):187-97.
                                                pubmed: 580366doi: 10.1007/bf00368227google scholar: lookup
                                              23. OECD (Organisation for Economic Co‐operation and Development). OECD guidelines for the testing of chemicals. Revised introduction to the OECD guidelines for testing of chemicals, section 3. .
                                                doi: 10.1787/9789264030213-engoogle scholar: lookup
                                              24. Tachon P, Descotes J, Laschi-Loquerie A, Guillot JP, Evreux JC. Assessment of the allergenic potential of althesin and its constituents.. Br J Anaesth 1983 Aug;55(8):715-7.
                                                pubmed: 6882610doi: 10.1093/bja/55.8.715google scholar: lookup
                                              25. Tocher DR. Metabolism and functions of lipids and fatty acids in teleost fish. Reviews in Fisheries Science 11, 107–184.
                                              26. Villeneuve DC, Chu I, Secours VE, Coté MG, Plaa GL, Valli VE. Results of a 90-day toxicity study on 1,2,3- and 1,1,2-trichloropropane administered via the drinking water.. Sci Total Environ 1985 Dec;47:421-6.
                                                pubmed: 4089609doi: 10.1016/0048-9697(85)90346-8google scholar: lookup
                                              27. Xiao L, Yi T, Chen M, Lam CW, Zhou H. A new mechanism for increasing the oral bioavailability of scutellarin with Cremophor EL: Activation of MRP3 with concurrent inhibition of MRP2 and BCRP.. Eur J Pharm Sci 2016 Oct 10;93:456-67.
                                                pubmed: 27586020doi: 10.1016/j.ejps.2016.08.054google scholar: lookup

                                              Citations

                                              This article has been cited 2 times.
                                              1. Zhang Y, Lin X, Qian Y, Qin M, Zhang S, Wang L, Luo Y. Preparation and Characterization of Efficient and Safe Rotenone Solid Nanodispersion by Self-Emulsifying Technique. Nanomaterials (Basel) 2025 Jul 8;15(14).
                                                doi: 10.3390/nano15141056pubmed: 40711175google scholar: lookup
                                              2. Lindner S, Ricci F, Sandmeier M, Holm R, Michalowski CB, Washburn N, Sun D, Di Pretoro G, Bernkop-Schnürch A. Optimizing hydrophilic drug incorporation into SEDDS using dry reverse micelles: a comparative study of preparation methods. Drug Deliv Transl Res 2025 Aug;15(8):2904-2923.
                                                doi: 10.1007/s13346-024-01787-4pubmed: 39821869google scholar: lookup
                                              Subscribe to our newsletter
                                              Join 99,727 horse owners like you who receive our email updates on horse health and nutrition.