Sorbitan monolaurate - 1c493

In the current application authorisation is sought under article 10(2) for Sorbitan monolaurate under the category/ functional group 1(c) "technological additives"/"emulsifiers" according to the classification system of Annex I of Regulation (EC) No 1831/2003. Specifically, the authorisation is sought for the use of the feed additive for all animal species and categories.

Sorbitan monolaurate is an yellow-to-amber oily liquid, consisting of a minimum of 95 % of a mixture of partial esters of sorbitol, sorbitan and isosorbide with edible commercial lauric acid; the later comprises mainly lauric acid (ca. 40-60 %), myristic acid (ca. 14-25 %) and palmitic acid (ca. 7-15 %). The Applicant states that the specific purity criteria set in the Commission Directive 2008/84/EC for the food additive are applicable for the feed additive.

Sorbitan monolaurate is intended to be added to other feed additives (mainly antioxidants) in order to assist their uniform distribution when added to other feed ingredients. No recommended minimum or maximum concentration levels were proposed by the Applicant. However, the typical maximum inclusion level is equivalent to 5 g of the feed additive /kg complete feedingstuffs. 

For the characterisation of Sorbitan monolaurate in the feed additive the Applicant submitted the internationally recognised FAO JECFA monographs dedicated for Sorbitan monolaurate, based on the determination of - saponification-, - acid-, - hydroxyl- values; and - the assay of polyols and fatty acids, as recommended by Commission Directive 2008/84/EC. 

Even though no performance characteristics were provided, the EURL recommends for official control the methods described in the above mentioned FAO JECFA monographs to characterise Sorbitan monolaurate in the feed additive.

For the characterisation of fatty acids in the feed additive the gas chromatography (GC) method described in the European Pharmacopoeia monographs (Eur. Ph. 6.0, 1040 and 20422) may be applied. 

The accurate determination of Sorbitan monolaurate in premixtures and feedingstuffs is not achievable experimentally. Therefore the EURL is not able to evaluate nor recommend any method for official control to determine Sorbitan monolaurate in premixtures and feedingstuffs.

Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by article 10 (Commission Regulation (EC) 
No 378/2005) is not considered necessary.

Recommended Method

as of:

- Commission Implementing Regulation (EU) 2021/344

For the characterisation of sorbitan monolaurate in the feed additive: 

 FAO JECFA Monograph ‘Sorbitan Monolaurate’