Labeling Audit of Dietary Supplements: Compliance and Regulation
Le 10 January 2025
Labeling Audit of Dietary Supplements: A Key Regulatory Challenge
The labeling of dietary supplements is a crucial element to ensure the compliance of products sold in Europe. It must adhere to strict standards established by Regulation (EU) No 1169/2011, particularly regarding readability, mandatory information, and translation for consumers.
The image below illustrates a labeling audit conducted on a probiotic dietary supplement, highlighting several essential control points:
- Readability of mandatory information (minimum font size, compliance with Articles 13 and 15 of the INCO regulation).
- Translation and accessibility of information in the language of the country of commercialization.
- Compliance of health claims with European regulations.
Non-compliant labeling can lead to sanctions, product withdrawal, or mandatory adjustments to meet current requirements.
Key points analyzed during the audit
Readability and font size
European regulations require a minimum font size of 1.2 mm to ensure the essential information is easily readable. For packaging smaller than 80 cm², a font size of 0.9 mm is permitted.
Mandatory Information
The label must include the following mandatory mentions:
- Detailed composition, including ingredients and additives.
- Conditions of use (recommended daily dose, usage precautions).
- Identification of the manufacturer and the batch number for traceability.
Verification of nutritional and health claims
The claims highlighted on the packaging must comply with Regulation (EC) No 1924/2006, which prohibits misleading or scientifically unjustified statements.
Conclusion
Ensuring Labeling Compliance to Avoid Sanctions
The labeling of dietary supplements must be accurate, legible, and compliant with European regulations. A thorough audit helps prevent errors, ensure transparency for consumers, and anticipate inspections by authorities.
- Verify readability and font size to ensure the accessibility of information.
- Ensure all mandatory mentions are present and understandable.
- Analyze health claims to avoid any reclassification of the product as a medicine.
A compliant label is a guarantee of safety and quality, essential for the commercial success of a dietary supplement on the European market.
Mastering the regulation of your dietary supplements
Why is it important to conduct a labeling audit for a dietary supplement?
A labeling audit ensures that a dietary supplement’s packaging meets European regulatory requirements, particularly in terms of readability, mandatory information, and compliance with health claims. Non-compliant labeling can lead to sanctions, product recalls, or importation blocks.
What are the most common errors found during a labeling audit?
The most frequent errors include non-compliant font size, missing mandatory mentions (ingredients, recommended daily dose, usage precautions, batch number), or nutritional and health claims that do not comply with Regulation (EC) No 1924/2006.
How often should a labeling audit be conducted to maintain compliance?
It is recommended to perform a labeling audit whenever a new product is launched, when regulations are updated, or when formulations are revised. Active regulatory monitoring and regular checks help anticipate potential non-compliance issues and avoid sanctions.