Beta-Carotene and Lutein Eye Nutrition Capsules

Three carotenoids sit in this capsule and they are not interchangeable. Beta-carotene, CAS 7235-40-7, C40H56, MW 536.9, is a provitamin A carotenoid and food colour E 160a; it is supplied either as a 10% cold-water-soluble beadlet or a 30% suspension in sunflower oil, from Blakeslea trispora fermentation for a natural declaration or from chemical synthesis where cost governs. Lutein, CAS 127-40-2, C40H56O2, MW 568.9, colour E 161b, and zeaxanthin, CAS 144-68-3, same formula and mass, are xanthophylls co-isolated from Tagetes erecta L. flower oleoresin. The marigold route matters commercially: hexane extraction gives an oleoresin of lutein esters, and saponification then strips the fatty acids to leave free lutein, which is what the 5%, 10% and 20% beadlet grades declare. Unsaponified 20% ester oleoresin is a different article with a different assay basis and we quote it separately. The claim position is the single most useful thing a formulator can know about this SKU, and it is counter-intuitive. Neither lutein nor zeaxanthin holds an authorised EU health claim - the Article 13(1) submissions on vision were refused, and a later Article 13(5) dossier on vision under bright light went the same way. Any vision wording therefore has to be carried by a nutrient that does hold one, which under Reg. (EU) 432/2012 means vitamin A, riboflavin or zinc, each with "contributes to the maintenance of normal vision". That is why the reference build sets zinc at 10 mg, riboflavin at 1.4 mg and vitamin A at 800 micrograms RE, all at 100% of the EU nutrient reference value, so the label has a lawful basis rather than resting on the carotenoids alone. Beta-carotene also needs deliberate dosing. The UK Expert Group on Vitamins and Minerals set a safe upper level of 7 mg a day for supplemental beta-carotene in the general non-smoking population, derived from a 20 mg/day LOAEL with an uncertainty factor of three, and smokers and the asbestos-exposed are advised to avoid supplemental beta-carotene entirely. The reference build sits at 4.8 mg, about 8,000 IU of vitamin A activity, well inside that. Shell and matrix choices drive the origin declaration: a two-piece HPMC or pullulan capsule keeps the SKU vegan, a softgel means bovine gelatin and is neither vegan nor vegetarian, and while our base beadlet matrix is modified food starch and fish-gelatin free, gelatin/sucrose matrix grades do exist in the market and we declare the matrix on every specification we issue.