Chromium forms for supplement manufacturing

How the chromium forms compare

Of the chromium forms used in EU food supplements, this page covers chromium picolinate, the chromium raw material SoleChem supplies. It contains 12.4 % chromium by mass, anhydrous basis. About 804 µg of powder carries 100 µg of chromium. No single form is the best form of chromium for every product: the choice depends on label claim, format, dispersion and regulatory listing.

Annex II of Directive 2002/46/EC also lists other chromium compounds, including chromium(III) chloride and chromium(III) sulphate. This page gives no data for them. Compare them using each material’s specification sheet.

Chromium is declared in micrograms, so the active is a tiny fraction of any capsule fill or tablet mass. Fill volume is rarely the constraint. Content uniformity is. Most manufacturers first dilute chromium picolinate on a carrier as a premix, then add the premix to the main blend and confirm the result by assay.

Common carriers include dicalcium phosphate and calcium carbonate, or the filler already used in the product. A mineral carrier adds its own element to the formula. Check whether that amount affects the nutrient amounts declared on the label.

Chromium picolinate is a coloured powder. Well dispersed at microgram levels, it is unlikely to show in a light-coloured blend. Poor mixing can show as specks in white tablets, which is a useful visual check during development.

Choosing a form of chromium

The decision points below apply to chromium picolinate and to any other listed form you compare it with.

• Label claim per serving. Work from the powder factor, not from the rounded percentage. To declare 25 µg of chromium per serving you need about 201 µg of chromium picolinate. To declare 50 µg you need about 402 µg, before any overage. The elemental content calculator does this arithmetic for other claims.
• Rounding. Dividing by 12.4 % gives slightly higher figures than the 804 µg factor, because the percentage is rounded. For batch records, use the factor derived from the molar mass, 418.31 g/mol.
• Overage. Set any overage from your own stability data and assay variability. The overage calculator applies it to the powder quantity.
• Format. In capsules and tablets the premix carries most of the work. In gummies, drinks and effervescent products, dispersion in the matrix matters more. Test the finished format, not the raw material alone.
• Solubility. For clear liquids or fully dissolving powders, confirm the solubility figure on the specification sheet before choosing the form.
• Taste. At microgram inclusion the chromium form is rarely the deciding taste factor. The carrier and the other actives usually dominate.
• Cost. The chromium source is a small share of cost per serving because so little is used. Premix preparation, mixing validation and assay often cost more than the raw material itself.
• Regulatory listing. The form must appear in Annex II of Directive 2002/46/EC, and the finished product must meet the national rules of each target market.

SoleChem sends the specification sheet and certificate of analysis with its quote. Use the quote form to state the form and grade you need.

EU regulatory status

Annex I of Directive 2002/46/EC lists chromium among the minerals that may be used in food supplements. Annex II lists the chemical forms that may be used to manufacture them. Chromium picolinate appears in Annex II. Only forms listed there may be used as the source of chromium in a food supplement.

Article 8 of the Directive requires the amount of each vitamin and mineral to be declared per recommended daily portion, using the units in Annex I. For chromium that unit is the microgram, expressed as the element, not as the salt. The labelling guide covers the other mandatory particulars under Regulation (EU) No 1169/2011.

The Directive provides for harmonised EU maximum and minimum amounts, but these have not yet been set for chromium. Member states apply their own rules, and these differ. Some set national maximum amounts, and some require the placing on the market to be notified to the competent authority. The competent authority of each member state publishes its rules. See maximum levels of vitamins and minerals by EU country for how these national systems work.

Adding chromium to ordinary foods falls under Regulation (EC) No 1925/2006, which has its own list of permitted forms. Check that list separately if the material is intended for fortified foods rather than food supplements. The guide to permitted vitamin and mineral forms explains how the two annexes relate.

Any health claim on a chromium product must be authorised under Regulation (EC) No 1924/2006 and used in accordance with the conditions of use held in the EU Register of nutrition and health claims. The health-claims guide explains the conditions of use.