EU + POLAND EVIDENCE PROFILE

Creatine supplement compliance

A clear example of why the chemical form must precede the verdict: monohydrate and two alternative salts have different EU Novel Food conclusions.

STATUSFORM CHANGES OUTCOME
JURISDICTIONEuropean Union · Poland
RULE VERSIONSV-ING-CRE-2026.09
LAST CHECKED2026-09-12
SOURCE FRESHNESSPOINT-IN-TIME SOURCE CHECKNO LIVE MONITORING
LAST VERIFIED2026-09-12SV-ING-CRE-2026.09
PRIMARY AUTHORITY REFERENCEEuropean Commission · Article 4 consultation — micronised creatine monohydratePublished 20 August 2025 ↗
TRANSLATION BOUNDARYORIGINAL AUTHORITY TEXT CONTROLSPage summaries and working translations are context, not decision sources.

This profile records the cited evidence at the stated date. Re-check the authority source before a final formula, claim, artwork or market-access decision.

01

IDENTITY BEFORE STATUS

Name, part and form

Name
Creatine
Synonyms
Creatine monohydrate · micronised creatine monohydrate · creatine malate · creatine alpha-ketoglutarate
Botanical / chemical identity
Not applicable — nitrogen-containing organic compound.
Plant part
Not applicable.
Reviewed form
Creatine monohydrate, micronised monohydrate, creatine malate and creatine alpha-ketoglutarate.
02

CLAIMS

What the profile supports

AUTHORISED CLAIM WITH CONDITIONS
  • Increased physical performance in successive bursts of short-term, high-intensity exercise.

The claim requires a daily intake of 3 g creatine, accompanying consumer information and food intended for adults performing high-intensity exercise. A separate claim exists for resistance training in adults over 55 with its own conditions.

RELATED HEALTH CLAIMReview the authorised creatine high-intensity performance claim→
03

RESTRICTIONS

Conditions that can change the answer

  1. 01

    Do not map the monohydrate conclusion to malate, alpha-ketoglutarate or another creatine form.

  2. 02

    For a claim, verify 3 g daily intake, target population, accompanying wording and the exact current register entry.

  3. 03

    Micronisation did not change the status in the cited consultation, but a materially different process or composition still needs its own comparison.

ENF

ENFORCEMENT OBSERVED · MT / GR

Observed enforcement activity

Separate event evidence, checked 3 October 2026. This does not refresh the earlier legal-status or claim-condition check. Original authority text takes precedence over summaries and translations.

GR · DISTRIBUTION PROHIBITION

National Organisation for Medicines (EOF) · 113393

CM3 CAPS; CM3 POWDER 250G PINK GRAPEFRUIT

Authority-stated reason: unauthorised Novel Food creatine malate.

Distribution prohibition for named products. Lot numbers, best-before dates and EANs are not specified in the decision; Malta's scope is not transplanted.

Original source (el) ↗
GR · DISTRIBUTION PROHIBITION

National Organisation for Medicines (EOF) · 115544

Redweiler 480g Red Punch; Redweiler 480g Orange; Redweiler 480g Cola; TCM 120 MEGA caps

Authority-stated reason: unauthorised Novel Food creatine malate.

Distribution prohibition for named products. Lot numbers, best-before dates and EANs are not specified in the decision; Malta's scope is not transplanted.

Original source (el) ↗
MT · CONSUMER WARNING

Food Safety and Security Authority · PR261551en

Redweiler 480g Red Punch; Redweiler 480g Orange; Redweiler 480g Cola

Authority-stated reason: unauthorised Novel Food creatine malate.

All lots and all best-before dates of the named products. Consumer warning.

Original source (en) ↗

SV-ENF-CRE-2026.10.03 · RASFF: linkage reported by the authorities; no direct notification record or ID verified. Point-in-time registry, not live monitoring. A form match still needs product, material, market and notice-scope confirmation.

EXACT FORM → ENFORCEMENTCheck whether your exact creatine form is affected→
04

POLISH NOTES

National regulatory layer

Confirm the exact chemical name in the ingredient list and keep claim conditions consistent across the Polish label, website and advertising.

Novel Food status and health-claim permission are separate checks; one does not resolve the other.

05

PRIMARY SOURCES

Evidence ledger

SRC-01
European Commission

Article 4 consultation — micronised creatine monohydrate

Not Novel Food conclusion for the specified micronised monohydrate

RULE / SOURCE VERSIONPublished 20 August 2025Open primary source ↗
SRC-02
European Commission

Article 4 consultation — creatine malate and alpha-ketoglutarate

Novel in foods conclusion for the two specified forms

RULE / SOURCE VERSIONPublished 17 February 2022Open primary source ↗
SRC-03
EUR-Lex

Regulation (EU) No 432/2012

Authorised creatine claims and conditions

RULE / SOURCE VERSIONConsolidated text, 20 August 2025Open primary source ↗

Apply the evidence to your wording.

Check your product ↗