EU + POLAND EVIDENCE PROFILE

Berberine supplement compliance

An alkaloid identity that cannot be reviewed safely without its botanical source, salt or derivative, assay and daily exposure.

STATUSIDENTITY + SAFETY REVIEW
JURISDICTIONEuropean Union · Poland
RULE VERSIONSV-ING-BER-2026.09
LAST CHECKED2026-09-12
01

IDENTITY BEFORE STATUS

Name, part and form

Name
Berberine
Synonyms
Berberine hydrochloride · berberine HCl · dihydroberberine (distinct derivative)
Botanical / chemical identity
Source-dependent — often declared from Berberis species; the exact species must be evidenced.
Plant part
Source-dependent; root and bark declarations occur and must be tied to the named species.
Reviewed form
Berberine and berberine hydrochloride screening; dihydroberberine is treated as a distinct substance.
02

CLAIMS

What the profile supports

NO AUTHORISED CLAIM ASSERTED
  • Screen metabolic, glucose, cholesterol and weight-control wording as health claims rather than ingredient description.
  • Keep dihydroberberine evidence separate from berberine or berberine hydrochloride evidence.

This snapshot does not identify a product-ready authorised EU health claim for berberine. Proposed wording requires a current register and botanical-claims review.

03

RESTRICTIONS

Conditions that can change the answer

  1. 01

    Capture botanical species, plant part, salt or derivative, assay, extraction or purification process and recommended daily intake.

  2. 02

    An application or a terminated Novel Food procedure is not an authorisation and does not establish the status of every berberine form.

  3. 03

    Review target population, medicine-interaction wording and the complete formula before a Polish market decision.

04

POLISH NOTES

National regulatory layer

Check the current GIS ingredient guidance and the product notification context; notification does not certify safety or compliance.

Do not transplant limits or conclusions from a different botanical source, derivative or combination product.

05

PRIMARY SOURCES

Evidence ledger

SRC-01
European Commission

Decisions terminating Novel Food procedures

Specific berberine hydrochloride and silymarin mixture; not a generic berberine conclusion

RULE / SOURCE VERSIONIncludes Commission Decision C(2025) 2494Open primary source ↗
SRC-02
European Commission

Dihydroberberine Novel Food application summary

Distinct hydrogenated derivative; an application is not market authorisation

RULE / SOURCE VERSIONApplication NF 2023/18134Open primary source ↗
SRC-03
Polish GIS

Current ingredient-composition materials

Polish ingredient review context and current resolutions

RULE / SOURCE VERSIONLive GIS compilation, checked 12 September 2026Open primary source ↗
SRC-04
European Commission

EU Register of nutrition and health claims

Proposed marketing wording

RULE / SOURCE VERSIONLive register, checked 12 September 2026Open primary source ↗

Apply the evidence to your wording.

Check your product ↗