European consultation: Have your say on mutual recognition

By Nikki Hancocks

- Last updated on GMT

artJazz | Getty
artJazz | Getty

Related tags Regulation

Nutraceutical players are invited to give their thoughts on the implementation of of the mutual recognition regulation as part of a new consultation run by the European Commission (EC).

The principle of mutual recognition aims to ensure Member States (MS) do not prohibit the sale of goods in their territory if they are lawfully marketed in another EU country. This is crucial for businesses operating across borders.

But its implementation has been heavily criticized by experts in the food and supplements industry, with many saying there's a lack of trust between different MS so they regularly hold the importance of local guidelines and opinions above that of the single market, and the process is backed by a flawed problem-solving network in SOLVIT​.

The newly launched EC consultation​, open until the end of September, aims to evaluate the implementation of the Regulation based on five criteria: effectiveness, efficiency, coherence, relevance, and EU added value.
Companies are invited to provide feedback on how effectively the mutual recognition principle is working, highlight any regulatory challenges faced in different Member States, suggest improvements to streamline processes and reduce administrative burdens, and ensure the regulations remain relevant and coherent with market needs.

“I think it's very important for the food supplement and broader nutrition industry to be heard on this piece of EU law,” European regulatory expert and Hylobates Consulting MD Luca Bucchini told NutraIngredients. “The Commission asks if it is still relevant, and anyone in the industry with some regulatory expertise would reply that it is extremely relevant and the issue is that the Member States have managed to avoid using mutual recognition with ruses, that courts have been shy, that Member States have built new barriers and the Commission has been very hesitant to pursue Member States that do not implement mutual recognition correctly.”

He noted every MS applies it with varying levels of stringency, with Spain being one of the most compliant while Germany has “systematically used medicinal law to deprive mutual recognition of its efficacy, which is one of the major failures of the EU internal market for food supplements”.

Providing its input to the EC’s consultation, Food Supplements Europe (FSE) noted that a number of MS persistently do not accept food supplements that are lawfully placed elsewhere in Europe, “with arguments that are more based on protection of the local economy than on protection of human health”.

It noted that because of the notification obligation for supplements, local authorities can challenge food supplements before they are placed on the market which is often a lengthy process ending with no formal decision, and therefore no placement on the market.

“Requests for further information, challenges of the legality of the product and discussions on product composition or properties delay the placing on the market of the product and often end without a formal decision, which prevents companies to follow the procedure...

“It would be good if…there were a clear procedure for discussion between companies and Member States with deadlines and the obligation on Member State authorities to provide justifiable grounds for the refusal of Mutual Recognition,” it said.

It noted MS often use non-legislative measures, such as opinions and guidelines, as a basis for refusing mutual recognition - measures which often are not notified in The Technical Regulation Information System (TRIS) - however, companies usually do not have the willingness to challenge this before the Court.

FSE stated: “To make the Regulation more effective, the Commission and the SOLVIT centres should be given more authority to judge on the acceptability of the justification of authorities refusing a product on their market and making opinions binding in that respect.”

EHPM (the European Federation of Associations of Health Product Manufacturers) has also given its feedback to the EC, informing that several cases have been reported where MR has not been implemented which share a number of common elements. Namely, companies have to convince the national authorities of the concerned Member States that the regulation applies, which it states is "indicative of the level of trust of one Member States towards another".

It added: "In most cases when national authorities issue administrative decisions the argument on product safety is not sufficiently substantiated. On the contrary, Member States have vested local preferences which they do not abandon and have little relevance to product safety or to a well functioning single market.

As a further example of lack of trust between authorities, EHPM noted there are often issues with food supplements containing botanicals: "The advisory board for botanicals ask a lot of information to prove the non-toxicity of a food supplement that is already legally commercialised in another member states." 

Simon Jurkiw, Vice Chair of the European Specialist Sports Nutrition Alliance (ESSNA), the European trade body for sports foods, noted challenges with MR tend to arise when Member States impose restrictions citing public health, "which are often not backed by a scientific risk assessment and appropriate evidence, as envisaged in EU case law".

He said: "As it stands, businesses often depend on the willingness of Member State authorities to issue a statement showing that their product meets the technical and regulatory criteria as laid down in their national laws. This can lead to long discussions that may result in increased administrative burden on businesses and overall disruptions for businesses and consumers alike."

Claudia Mucciardi, Vice Chair of the alliance, added: "Enhanced cross-border cooperation is crucial for effective implementation of the MR principle. The current evaluation of the Regulation is a valuable opportunity for the sports nutrition industry to address their challenges and ensure the MR Regulation supports the efficient marketing of their products across Member States.”

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