Safety and efficacy of polyoxyethylene (20) sorbitan monooleate as a feed additive for all animal species


Panel on Additives and Products or Substances used in Animal Feed
EFSA Journal
EFSA Journal 2016;14(3):4443 [3 pp.].
Panel Members
Gabriele Aquilina, Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.

The Panel wishes to thank the members of the Working Group on Technological Additives, including Anne-Katrine Lundebye, Carlo Nebbia and Derek Renshaw, for the preparatory work on this scientific output.

Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
9 March 2016
Published in the EFSA Journal
22 March 2016
Last Updated
25 January 2017. This version replaces the previous one/s.
European Food Safety Authority (EFSA), Parma, Italy
The full opinion will be published in accordance with article 8(6) of Regulation (EC) No 1831/2003 once the decision on confidentiality, in line with article 18(2) of the Regulation, will be received from the European Commission.

The additive is a mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides. It contains a minimum of 65% of oxyethylene groups, equivalent to not less than 96.5% of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis and less than 3% water. The following concentrations of polyoxyethylene (20) sorbitan monooleate per kg complete feedingstuffs are considered safe: 1,260 mg for salmonids, 1,100 mg for cattle for fattening, 830 mg for pigs for fattening and sows, 750 mg for turkeys for fattening, 720 mg for dairy cows, 500 mg for piglets, 420 mg for chickens for fattening and laying hens, 1,320 mg for dogs and 1,100 mg for cats; and 5,000 mg/kg milk replacer are considered safe for calves. The use of polyoxyethylene (20) sorbitan monooleate as feed additive for all animal species at the maximum concentration proposed of 5,000 mg/kg complete feedingstuffs would not raise concerns for the consumer. Polyoxyethylene (20) sorbitan monooleate is non-irritant to skin and eyes, and is not a skin sensitiser. There is evidence that dermal or oral exposure to the additive can exacerbate the symptoms in individuals who are already sensitised. Users are unlikely to be exposed to the additive by inhalation. The lack of data and the inherent uncertainties do not allow concluding on the safety for the environment. Polyoxyethylene (20) sorbitan monooleate is a recognised emulsifier used in food and it is expected to have the same effect when applied to feed. From the practical examples provided, polyoxyethylene (20) sorbitan monooleate appears to be effective in aiding and maintaining the homogeneous distribution of feed materials and/or additives in feedingstuffs.

polyoxyethylene (20) sorbitan monooleate, safety, efficacy, technological additive, emulsifier, target species
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