As of January 5, 2026, France has updated List A and List B of the French Pharmacopoeia (Pharmacopée française), introducing new medicinal plants and specific plant parts. This update is relevant for nutraceutical operators, as classification within the Pharmacopoeia classification can have indirect consequences on regulatory and safety assessment of botanicals in France, including those used in foods and food supplements.

The French Pharmacopoeia

In France, plants listed in the Pharmacopée française are recognized under the Code de la santé publique as medicinal plants. As plants used for therapeutic purposes, their manufacture and marketing are subject to pharmaceutical law and, where applicable, pharmacy-reserved distribution, unless specific statutory derogations apply.

The medicinal status, defined by Pharmacopoeia, must be distinguished from food use.
The same botanical species may be permitted in supplements depending on the plant part, preparation method, and dosage. Inclusion in the Pharmacopoeia is not among the eligibility criteria for use in food; rather, compliance for food and nutraceuticals must be assessed under Décret n°2006-352 and the Arrêté du 24 juin 2014.

2026 French Pharmacopeia updates in List B:  significance for food and nutraceuticals

The January 2026 update of the French Pharmacopoeia expanded List B to include several Prunus species due to the presence of cyanogenic glycosides, which may release hydrogen cyanide:

• Prunus armeniaca (bitter seeds).
• Prunus mandshurica (bitter seeds).
• Prunus sibirica (bitter seeds).
• Prunus persica (seeds).
• Prunus davidiana (seeds).

List B includes plants where potential adverse effects are considered to outweigh expected therapeutic benefits. While the classification of plants and plant parts in List B results in a prohibition of use as medicinal products, it does not establish an automatic and explicit legal ban of use as botanicals in food and food supplements.

However, this classification heightens regulatory concern, representing a strong negative safety signal also for food and nutraceutical use.

Compliance and Safety Assessment in Nutraceuticals

In the nutraceutical context, compliance must be assessed under the applicable food legislation on a case-by-case basis, taking into account:

• Exact botanical identity and specific plant part used.
• Preparation method, composition, and level of active constituents.
• Proposed conditions of use and dosage.

Moreover, under the EU nutraceutical regulatory framework, foods and food supplements must not be attributed properties of preventing, treating or curing human disease. Such claims are prohibited not only in labelling, but also in presentation, advertising and, more generally, in any commercial communication directed to consumers.

Escalation of scrutiny in food and nutraceuticals

The inclusion of a plant or plant part in List B, particularly where linked to identified hazardous substances, is likely to trigger reinforced safety controls by the French health authorities. This may affect the feasibility of using such botanicals in food supplements on the French market, even if lawfully marketed in other EU Member States under the principle of mutual recognition.

Botanicals: strategic recommendations for FBOs

The lack of EU-wide harmonization regarding botanicals creates a complex landscape for Food Business Operators (FBOs). While the mutual recognition principle may be available, national regulations across the EU vary widely, including:

• Discrepant Frameworks: Member States with “Positive Lists” versus those with “Negative Lists”, or even those with no lists at all.
• Safety & Labeling: specific labeling requirements and mandatory health warnings that differ by jurisdiction.
• Functional Limits: differences in permitted claims and markers to be monitored or substance not allowed.

Given the increasing regulatory challenge on plant preparations, FBOs must ensure compliance before entering the French market. Indeed, a thorough check of botanical compliance and specific market access conditions in France is highly recommended, to mitigate the risk of product withdrawal.

Complife supports operators in the nutraceutical sector through testing services and strategic regulatory consultancy, ensuring full compliance of nutraceutical products.

SOURCES:

• Pharmacopée – Liste des plantes médicinales utilisées traditionnellement – ANSM
• Liste B des plantes médicinales utilisées traditionnellement
• Full text of the 11th edition of the French Pharmacopoeia
• Article D4211-12 – Code de la santé publique – Légifrance
• Article R5112-2 – Code de la santé publique – Légifrance
• Décret n° 2008-839 du 22 août 2008 – Légifrance
• Arrêté du 24 juin 2014 – Légifrance
• Decree No. 2006-352