EU: D-mannose Potential to be Re-evaluated as a Medicinal Product

   A recent legal dispute involving Casella-med GmbH & Co., MCM Klosterfrau, and the Social Competition Association could have significant implications for the legal classification of D-mannose. 

   The dispute centers two products marketed by Casella-med: Femannose (which contains D-mannose and cranberry) and Femmanose N (which contains only D-mannose): the Social Competition Association (VSW) challenged the classification of these products as medical devices before the Regional Court of Cologne, arguing that they should instead be classified as medicinal products.

   The case escalated to the European Court of Justice (ECJ) to determine whether D-mannose, as an active ingredient, could be classified as having a “pharmacological effect” under the terms of Directive 2001/83/EC (directive that rules the medicinal products and their ingredients in the European Union). The ECJ ruled that if there is uncertainty about the correct classification of a product that may fall under the definition of a medicinal product, priority should be given to Directive 2001/83 (medicinal product). 

   This ruling could have significant implications for the legal status of D-mannose as: 

        – It suggests that D-mannose may be re-evaluated for classification as a medicinal product;

        – The ruling may prompt Member States to reconsider the status of D-mannose in Food Supplements, due to its potential pharmacological effects.

   Companies involved in marketing products containing active ingredients like D-mannose should carefully assess the implications of this decision on their product classifications and claims.

Spain: New Guidance for Mutual Recognition

   Last month, the Spanish authorities published a guide outlining the notification procedure for the application of mutual recognition.

  The updated guide now includes the option to use the Mutual Recognition document available on the European Commission’s website. This is particularly useful when the Member State where the product is already being sold does not have a notification procedure in place. 

   In the previous version, proof was required in the form of a country notification certificate or receipt—this included in-store country receipts—to demonstrate that the product was legally marketed in another Member State. 

   As a reminder, the Mutual Recognition process allows food supplements containing ingredients or substances that are not on a positive list or are in higher doses than those authorized for commercialization.

European Commission Future Actions for Vegetarian/Vegan Foods and Nutrition/Health Claims

   A report published by the European Court of Auditors in November 2024 called for an urgent review of EU food labelling. 

   This recommendation arose due to inconsistencies in national labelling schemes, including the various symbols used to represent vegetarian and vegan options, which could confuse consumers.

   The European Commission (EC) acknowledged the concerns raised in the report. However, it did not propose any new EU-wide front-of-pack nutrition labelling; instead, it noted that several Member States continue to support voluntary national schemes.

        – Vegetarian & Vegan Foods: the EC highlighted its authority to establish EU-wide rules, suggesting that this could be included in the agenda for the upcoming mandate.

        – Nutrition & Health Claims: the EC accepted the recommendation to address pending actions, particularly concerning botanical claims, with a target implementation date of 2027. However, it remains uncertain whether any action will be taken on (the long-delayed) nutrient profiles, which would set limits on sugar, salt, and fat content for products that make health claims.

This is a developing narrative; we will update it as new information emerges.