Sesamin

Trade grades run from 10 and 20 percent sesame lignan concentrates, which are oily or waxy materials carrying sesamin, sesamolin and residual sesame oil, through 50 percent purified powder to 90, 95 and 98 percent crystalline material. The 98 percent grade is the reference item for supplement capsules. A key distinction on the certificate is whether the assay covers sesamin alone or the sum of sesamin and episesamin, since a product declaring 98 percent total lignans may hold well under that as sesamin proper.

Powder grades are milled to pass 80 mesh, with micronised material offered where dissolution rate matters. Oil-dispersion grades supply the lignan pre-dissolved in sesame or medium chain triglyceride oil at 5 to 20 percent for direct softgel filling. Water-dispersible grades exist as cyclodextrin inclusion complexes or as spray-dried emulsions on a modified starch carrier, both of which trade at a much lower nominal assay because of the carrier load.

In the United States sesamin is marketed as a dietary ingredient under the Dietary Supplement Health and Education Act. Sesame oil and sesame seed are conventional foods, but a purified lignan concentrate is a different article, so firms rely on documented pre-1994 marketing history or on a new dietary ingredient notification. There is no food additive regulation covering purified sesamin, and it is not GRAS-listed, so addition to conventional foods requires the user to make and document its own determination. Sesame is a major food allergen in the United States and must be declared on the label of any product containing sesame-derived material.

In the European Union sesamin has no E number, being a nutritional ingredient rather than an additive. A purified sesame lignan preparation is likely to require novel food authorisation unless significant consumption in the Union before May 1997 can be demonstrated, since the history of consumption of sesame oil does not automatically extend to a concentrated isolate. Sesame seed and products thereof are a listed allergen and must appear in the ingredient declaration. Any health claim made must be authorised under the EU nutrition and health claims framework. No Codex commodity standard or JECFA specification applies to the isolated lignan, though the Codex standard for named vegetable oils covers the sesame oil from which it derives.