Vitamin premix overages: why the label claim is never the batch formula
Every vitamin premix is dosed above its label claim. How much above is a decision with cost, stability and compliance riding on it — and it belongs in writing before production.
Two phytosterol powders at 95% total sterols can have quite different compositions, and in the markets where sterols are regulated as a novel food, composition is what the authorisation is written against.
Commercial phytosterols come mainly from two feedstocks: tall oil, a by-product of wood pulp processing, and vegetable oil deodoriser distillate, usually soy or rapeseed. The feedstock determines the sterol profile and also determines what you can say about the material — a soy-derived sterol carries an allergen consideration that a tall oil sterol does not, and a wood-derived one is not a food-crop material at all.
Stanols are the saturated form, produced by hydrogenating sterols. They behave similarly in most applications but are analytically distinct and are regulated separately in several jurisdictions. A specification should state the sterol-to-stanol split rather than reporting a combined figure.
Free sterols are crystalline, high-melting and essentially insoluble in both fat and water, which makes them difficult to incorporate into anything. Esterifying with fatty acids produces a fat-soluble material used in spreads and dairy. The ester is heavier per unit of sterol, so a 100% sterol ester contains roughly 60% actual sterol — another case where the headline percentage needs converting before quotes are comparable.
Phytosterols are authorised novel foods in the EU with conditions attached, including specified compositional criteria and mandatory labelling on finished products. Other markets treat them differently again. Confirm that the specific material and its intended use fall inside the authorisation in your destination market before you get as far as negotiating a price — the compositional detail is what that determination turns on.
Every vitamin premix is dosed above its label claim. How much above is a decision with cost, stability and compliance riding on it — and it belongs in writing before production.
Magnesium oxide and magnesium bisglycinate are priced per kilo of compound but formulated per milligram of elemental mineral. Confusing the two is the most expensive arithmetic error in mineral sourcing.
The same amino acid reaches the market by three different manufacturing routes. They differ in isomer purity, allergen risk and which certifications they can carry.