Biotin (Vitamin B7)

Biotin grades and forms

Biotin for EU food supplements means D-biotin, the only biotin form listed in Annex II of Directive 2002/46/EC. Manufacturers therefore do not choose between chemical forms. They choose between pure D-biotin powder and diluted grades, and that choice settles most questions about the “best form of biotin” for a formulation.

• Pure D-biotin. A white powder with the highest biotin content per gram. It suits premix manufacturers and plants that run validated dilution steps in-house.
• Triturations (diluted biotin). D-biotin dispersed on a carrier, such as dicalcium phosphate or maltodextrin, at a declared content. They are easier to weigh and blend evenly at microgram label claims.
• Water-dispersible grades. Diluted grades designed to disperse in liquids, used in drink powders and liquid formats.

Four points usually decide the grade: the size of the label claim, the blending equipment, the product format and whether the carrier fits the intended ingredient list. The specification sheet states the assay, the carrier and the physical properties of each grade. SoleChem sends the specification sheet and the certificate of analysis with its quote; ask for the grade you need in the quote form.

EU regulatory status

Biotin appears in Annex I of Directive 2002/46/EC among the vitamins that may be used in food supplements. Annex II lists D-biotin as the permitted form. Only substances listed in Annex II may be used as a source of biotin, so check the current consolidated text before you specify any other form.

For foods other than supplements, D-biotin is also listed in Annex II of Regulation (EC) No 1925/2006. See the guide to permitted vitamin and mineral forms for how the two lists relate.

The amount of biotin on a supplement label is declared in the unit set by Annex I of the Directive, which is micrograms. The percentage of the nutrient reference value follows Annex XIII of Regulation (EU) No 1169/2011. The labelling guide covers the full declaration.

No harmonised EU maximum level for biotin in food supplements is in force. Member states set their own limits, and these differ; see maximum levels by EU country. For authorised claim wording, consult the EU Register of nutrition and health claims and the site’s health-claims guide.

If a trituration carrier is a food additive, its use must comply with Regulation (EC) No 1333/2008. A carrier that is itself a nutrient source, such as a calcium phosphate, may also count towards the mineral content of the product.

Formulation notes

Biotin is declared in micrograms, so it forms a tiny fraction of a capsule fill or tablet mass. Content uniformity is the main technical risk. Use a trituration or a vitamin premix, apply geometric dilution and validate blending time with uniformity testing on each batch.

The weight to add follows from the declared biotin content on the certificate of analysis:

mass of material per serving = label claim ÷ declared biotin content (as a fraction)

As an illustration, a trituration declared at 1.0 % biotin would need 5 mg per serving for a 50 µg claim and 50 mg for a 500 µg claim. Always use the value on the certificate of analysis for the batch you receive. Add any overage on top of this figure; the overage calculator does that step.

Biotin is generally regarded as one of the more stable B vitamins in dry blends. Avoid strong oxidising agents and extremes of pH in the same mix. Set the overage from your own stability data in the final pack.

Notes by format:

• Capsules and tablets: a trituration on a compressible or free-flowing carrier blends well with other vitamins and minerals. Pure biotin is best added through a premix.
• Powders and drinks: biotin is only very slightly soluble in water, so water-dispersible grades give a more even result in liquids.
• Gummies: add biotin as a diluted grade late in the process, and confirm distribution across the batch.

At microgram inclusion levels, biotin has no practical effect on the taste of a product. Biotin often sits alongside other B vitamins such as cyanocobalamin and folic acid in a single premix. See the vitamins category for the other vitamins that can share a premix.