Dietary supplements : safety and Annex III for herbal preparations
A dietary supplement is "a product intended to supplement a normal diet, which is a concentrated source of nutrients or other substances with a nutritional or physiological effect, alone or in combination." To launch a dietary supplement on the market, it is necessary to compile a technical dossier including, if necessary, a safety dossier in accordance with Annex III of the Decree of 24 June 2014 for herbal preparations and, in all cases, a risk analysis (safety margins for the various target populations, etc.) of all its constituents, documenting the safety of the product for the consumer.
General regulatory framework for food supplements
Food supplements are regulated at European and national level, at the crossroads between food and medicine :
- Directive 2002/46/EC of the European Parliament establishes the basis for the regulation of food supplements within the European Union.
- In France, they are governed by the Consumer Code and the Public Health Code.
- The competent authority is the Directorate-General for Food (DGAL), with support from ANSES for risk assessments.
Why is it important to assess the safety of my products ?
Compliance with regulatory obligations (France & EU). The decree of 24 June 2014 requires a safety assessment for plants listed in Annex III, i.e. those authorised with conditions (dose limits, precautions or subject to restrictions on use (children, pregnant women, etc.).
Justification of the doses used. It allows you to define the maximum daily doses based on scientific data and justify the safety of the dose present in your product, as well as avoid overdoses or side effects.
Assessment for sensitive populations. The authorities require the manufacturer to validate the safety of the product for at-risk populations or, failing that, to clearly advise against its use (mandatory statement on the label). This point is often checked in the event of notification or inspection.
Assistance with compliance in the event of an inspection. This facilitates the registration and marketing of the product and is often required by distribution platforms and certain export countries. In the event of an inspection by the authorities, it shows that safety has been assessed in advance.
Strengthen the scientific credibility of your product. It is a tool for transparency for your professional customers or distributors. It enhances the brand through a rigorous and serious approach.
How can BSI support you in your safety assessment ?
BSI carries out risk analysis of your food supplements, including the definition of maximum daily doses and justification for use in sensitive populations (infants, children, pregnant women, etc.).
We can also prepare the safety dossier for the plant preparations used in your food supplements in accordance with Annex III of the Decree of 24 June 2014.
