SRC-01
European Commission
Article 4 consultation — Lion’s Mane fruiting-body extract powder
Not novel conclusion for the described fruiting-body extract powder
RULE / SOURCE VERSIONPublished 28 February 2025Open primary source ↗
EU + POLAND EVIDENCE PROFILE
Lion’s Mane supplement compliance
A fungal ingredient where fruiting body and mycelium are not interchangeable in the EU Novel Food analysis.
STATUSPART CHANGES OUTCOME
JURISDICTIONEuropean Union · Poland
RULE VERSIONSV-ING-HER-2026.09
LAST CHECKED2026-09-12
01
IDENTITY BEFORE STATUS
Name, part and form
- Name
- Lion’s Mane
- Synonyms
- Lion's mane · Hericium erinaceus · hedgehog mushroom · yamabushitake
- Botanical / chemical identity
- Hericium erinaceus
- Plant part
- Fruiting body versus vegetative mycelium — keep them separate.
- Reviewed form
- Fruiting-body extract powder and dehydrated mycelium powder.
02
CLAIMS
What the profile supports
NO AUTHORISED CLAIM ASSERTED
- Treat cognition, focus, memory, nerve and immunity wording as claims requiring separate verification.
- Do not use a fruiting-body identity to support a mycelium product, or vice versa.
This profile makes no product-ready EU health-claim conclusion for Hericium erinaceus.
03
RESTRICTIONS
Conditions that can change the answer
- 01
Record whether the ingredient is fruiting body, mycelium or a mixture before any status search.
- 02
Match extraction method and concentration to the 2025 fruiting-body consultation; its conclusion is not a category-wide approval.
- 03
For dehydrated mycelium powder, the cited Article 4 outcome is Novel Food and requires an authorisation pathway check.
04
POLISH NOTES
National regulatory layer
The same identity split should appear in Polish specifications, labels and supplier documents; a common name alone is not enough.
Check the current Union list and Polish market context at the time of the product decision.
05
PRIMARY SOURCES
Evidence ledger
SRC-02
European Commission
Article 4 consultation — Hericium erinaceus dehydrated mycelium
Novel Food conclusion for dehydrated mycelium powder
RULE / SOURCE VERSIONPublished 29 October 2019Open primary source ↗
SRC-03
European Commission
EU Novel Food consultation index
Current published Article 4 outcomes
RULE / SOURCE VERSIONLive index, checked 12 September 2026Open primary source ↗
PRODUCT-LEVEL CHECK
Check your product ↗