Claims audit in food: Compliance and Regulation

Regulation of claims in food: compliance and requirements

Regulatory Framework of Claims in Food

The requirements for health communication on food products are defined by Regulation 1924/2006/EC, which mandates the prior evaluation and authorization of health claims before market placement.

Regulation 432/2012/EC introduced a list of 222 authorized health claims for food products since June 14, 2012. Some so-called generic claims have subsequently been validated by the European Commission.

Since December 14, 2012, only claims authorized by European legislation can be used, provided that their conditions of use are respected. Claims pending evaluation (Pending List), primarily concerning botanical substances, remain tolerated as long as the European Commission has not made a decision on their evaluation.

Claims not submitted to EFSA are prohibited. For a finished product containing multiple active ingredients, a specific claims dossier is required.

Claims Audit: Compliance of Regulatory Mentions

Conditions of Use of Claims

The labeling and communication of food products must strictly adhere to the conditions of use defined for each authorized claim.

Analyzed Example: Weight Loss Infusion

– The evaluation is based on a table of tolerated claims for the plants contained in the product.

– When the conditions of use are met, the claim is marked in green in the audit.

Verification of authorized claims on product ingredients

Each ingredient with a health claim must comply with:

– A conforming label

– A sufficient quantity to validate the claimed effect

– Use in accordance with the doses specified in the regulation

Analyzed Example: Green Tea (Camellia sinensis)

✅ Validated claims: “Helps combat excess weight”, “Helps in the context of a slimming diet”

❌ Non-compliance: Insufficient quantity in some formulations

Conclusion

Securing Claims Before Market Placement

Nutritional and health claims are strictly regulated by European legislation.

• It is imperative to use only authorized claims and to respect their conditions of use.

• For botanical substances, verification of the Pending List is necessary before their communication.

• A preliminary audit of claims allows anticipating non-compliance risks and avoiding reclassification as a medicine.

Compliant labeling and regulatory communication ensure a risk-free market placement.