EU + POLAND CLAIM PROFILE

Limicol combination and LDL cholesterol health claim

An authorised disease-risk-reduction claim whose use remains restricted to the named applicant during the protected-data period. Authorisation alone does not establish that another operator may use it.

REGISTER STATUSAuthorisedConditions still apply
AUTHORISED WORDING
A combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, procyanidolic oligomers from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate reduces blood LDL-cholesterol concentrations. High LDL-cholesterol is a risk factor in the development of coronary heart disease.
Limicol® specified combinationReduction of blood LDL-cholesterol concentrations
HEALTH CLAIM ENTITLEMENTLICENCE REQUIRED

Authorised claim — restricted use: you have not established entitlement.

Beneficiary
Laboratoire Lescuyer
Protected until
2028-04-10
General use from
2028-04-11
Licence evidence
MISSING
STATUSAUTHORISED
SUBSTANCELimicol® specified combination
RULE VERSIONSV-HC-LIMICOL-2026.09
LAST CHECKED2026-09-19
USE RIGHTLICENCE REQUIRED
01

CONDITIONS OF USE

Authorised does not mean unconditional

  1. 01

    Use is restricted to Laboratoire Lescuyer for five years from 10 April 2023, unless another applicant obtains an authorisation without relying on the protected data or has the beneficiary’s agreement.

  2. 02

    The food supplement must provide 600 mg artichoke leaf dry extract containing 30–36 mg caffeoylquinic acids and 500 mg red yeast rice containing 2 mg monacolin K.

  3. 03

    It must also provide 10 mg sugar-cane derived policosanols, 20 mg French maritime pine bark extract containing 18 mg procyanidolic oligomers and 30 mg garlic dry extract containing 0.25 mg allicin.

  4. 04

    The daily amount must also provide 30 mg alpha-tocopherol equivalents, 5 mg riboflavin and 9 mg inositol hexanicotinate, divided into three daily doses consumed with the major meals.

  5. 05

    The authorisation of the claim does not authorise the ingredients, finished product or market placement; restrictions applying to monacolins and the complete presentation require separate review.

02

COMMON MARKETING VARIANTS

Where wording begins to drift

These are Suppvera’s illustrative review examples, not entries copied from the EU Register. A variant is assessed in its full consumer-facing context.

AUTHORISED · RESTRICTED USE
A combination of artichoke leaf dry extract standardised in caffeoylquinic acids, monacolin K in red yeast rice, sugar-cane derived policosanols, procyanidolic oligomers from French maritime pine bark, garlic dry extract standardised in allicin, d-α-tocopheryl hydrogen succinate, riboflavin and inositol hexanicotinate reduces blood LDL-cholesterol concentrations. High LDL-cholesterol is a risk factor in the development of coronary heart disease.

Official wording. Composition, dose, presentation and operator entitlement remain separate gates.

WORDING + ENTITLEMENT REVIEW
The authorised Limicol combination helps reduce LDL cholesterol.

A shortened disease-risk claim needs meaning, mandatory context, exact composition and entitlement review.

EVIDENCE CONTEXT NEEDED
Clinically studied cholesterol support.

The wording no longer states the authorised relationship and may imply a broader evidence package than the protected authorisation supports.

03

RISK EXAMPLES

Language that changes the promise

ENTITLEMENT NOT ESTABLISHED
Our botanical blend uses the authorised Limicol claim.

A third party cannot infer a right of use merely because the claim appears as authorised in the Register.

TREATMENT CLAIM
Treats high cholesterol naturally.

This changes a risk-factor relationship into treatment wording.

DIFFERENT PRODUCT + EFFECT
Any red yeast rice supplement lowers LDL cholesterol.

The authorisation concerns a precisely specified multi-component combination and does not extend to every red yeast rice product.

04

POLISH MARKET LAYER

Meaning must survive localisation

Verify the current Polish wording and every disease-risk statement required around the claim; a translation does not remove the applicant restriction.

Do not convert the protected claim into a general claim for red yeast rice or a single botanical ingredient.

05

EVIDENCE

Rule and source ledger

EU REGISTER CLAIM ID(S)Q-2012-00968
SCIENTIFIC REFERENCES IN LEGAL LISTEFSA Journal 2013;11(7):3327
SRC-01
European Commission

EU Register of nutrition and health claims

Claim status, conditions, restrictions and linked legal acts

RULE / SOURCE VERSIONLive register, checked 12 September 2026Open primary source ↗
SRC-02
EUR-Lex

Regulation (EU) No 432/2012

Authorised Article 13 wording, conditions and scientific-reference IDs

RULE / SOURCE VERSIONConsolidated text, 20 August 2025Open primary source ↗
SRC-03
EUR-Lex

Regulation (EC) No 1924/2006

General claims rules, Article 10 information and Article 12 prohibitions

RULE / SOURCE VERSIONConsolidated text, 13 December 2014Open primary source ↗
SRC-04
European Commission

Guidelines for implementing Article 10

How specific health-claim conditions and mandatory information operate

RULE / SOURCE VERSIONImplementing Decision 2013/63/EUOpen primary source ↗
SRC-05
European Union

Commission Regulation (EU) 2023/648

Applicant restriction, protected-data period, authorised wording and exact conditions of use

RULE / SOURCE VERSIONOfficial Journal L 81, authorised 10 April 2023Open primary source ↗

Check what you plan to publish.

Check entitlement for this claim