Ergothioneine (Oral Grade)

Who this page is for

Oral and cosmetic ergothioneine requirements

This page is for ergothioneine intended for nutraceutical manufacture; topical formulation enquiries belong with our cosmetic ergothioneine entry. The two catalogue entries refer to the same named substance, but the intended use and the purchase requirements must be stated separately.

PubChem describes ergothioneine as a sulfur-containing derivative of L-histidine. For an oral-use enquiry, specify whether you require L-ergothioneine and identify the chemical form on your purchase specification.

A shared CAS number does not show that a cosmetic material meets a food-use specification. Ask for the composition and identity evidence for the material proposed for ingestion, rather than accepting a cosmetic ingredient name as the full description.

In particular, distinguish the ergothioneine ingredient itself from a preparation containing carriers or other ingredients when defining the composition to be quoted.

What to specify for oral-use ergothioneine

An oral-use acceptance specification needs more detail than a single ergothioneine percentage. EFSA's 2016 assessment of a particular synthetic L-ergothioneine ingredient lists identity, optical rotation, chemical purity, loss on drying, impurities, residual solvents, metals and microbiological parameters.

Those categories provide useful questions for a buyer, but the assessed ingredient and its limits are not a specification for our supply. Ask which method identifies the L-form and how the assay and related-substance results are reported for the proposed material.

Keep the assay method and its acceptance limit together when comparing offers, because the assessment reports chemical-purity criteria separately for different analytical techniques. For the contamination panel, specify the individual metals and the organisms or count limits relevant to your oral product and destination.

Request the actual numerical results or stated detection limits alongside the specification limits, so the batch can be reviewed against your acceptance criteria. If a proposed specification contains a combined test such as total metals, ask what it covers before treating it as evidence for each individual element.

Food-use scope and formulation questions

The European Union's 2017 decision on L-ergothioneine covers a defined ingredient specification and food-supplement uses with stated conditions. Annex II sets different maximum levels for the general population and children older than three years; Article 1 excludes specified groups, and Article 2 sets the ingredient name for labelling.

It should therefore be read for the particular ingredient, population and product category, rather than as permission for any ergothioneine material in any food. Before ordering for an oral product, identify the destination market, intended age group, product category and proposed daily amount for your regulatory review.

Include the ingredient's source and production process in that review; a decision or assessment of one described material does not establish the status of every other source. For a capsule, tablet or drink project, send the intended format and any composition restrictions with the enquiry so the proposed raw material can be assessed for that application.

For a blend or diluted preparation, state the ergothioneine content you require and ask for the complete carrier composition before comparing quantities. Review the currently applicable local requirements for the proposed material and use before commercial manufacture.

Qualifying an ergothioneine batch

For ergothioneine bulk sourcing, ask for the proposed food-use specification and the documents that relate to the material you would receive. A COA should let your team distinguish the specification limit, the analytical method and the measured batch result for each acceptance test.

Under the US dietary-supplement component rules, reliance on a supplier COA requires supplier qualification and confirmation of the reliability of the reported tests. The identity-testing requirement for a dietary ingredient is separate, subject to the exemption procedure described in those rules.

Ask your quality team which ergothioneine checks it will perform and which supporting supplier records it will accept before the order is agreed. For packaging and storage, request conditions and an expiry or retest period supported for the specific ingredient proposed in the quotation.

Published stability data in the EFSA assessment concern the assessed synthetic ingredient and do not establish a shelf life for a different source or a finished oral formulation. Include the packaging size and any handling requirements in your request, and ask us to confirm the available specification and matching documents for your proposed purchase.

Product identity

INCI name

CAS and formula (verified against PubChem)

Molecular formula and weight describe the substance identified by that CAS number. Confirmation that a specific batch matches this identity comes from the specification sheet and COA.

Specification

Specification: confirmed per inquiry against your target parameters.

Specification, COA, TDS and SDS

Ask for the specification sheet, COA, TDS and SDS of the item and form you are evaluating through Request Technical Documents, and we will confirm which are available.

Certificates: Ask us to confirm whether product-specific certificates are available, their issuer, scope and validity. Certificate copies are not published on this site.

Supply terms

Common specifications are listed for reference. If you need a different specification, send us your target parameters and we will match them from the manufacturers we buy from.

Buying notes

For ergothioneine bulk inquiries for nutraceutical use, send us your target specification, quantity and destination.

Related ingredients