First EC Opinion on Mutual Recognition. Success story for the free movement in the EU Food Supplement market

DISCLAIMER: All opinions in this column reflect the views of the author(s), not of EURACTIV Media network.

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Magdalini Selanikli is the EHPM Vice Chair, Dir. of Regulatory Affairs and Quality Assurance Southeast Europe ISO PLUS SA

Mutual Recognition works to safeguard the internal market from local impediments to trade! This is what the first European Commission Opinion on the application of the principle of mutual Recognition and the requirements of Regulation (EU) 2019/515 regarding food supplements came to prove in late September last year.

Doing business in the European Union can be a puzzle; there are twenty-seven (27) regulatory regimes on Food Supplements in the European Union, all under the umbrella implementation of the Food Supplements’ Directive 2002/46/EC. Moreover, these regulatory regimes commonly divert from one another due to national implementing technical rules and local preferences of food supplements’ regulation.

This is not only the case for food supplements. Over time, several other sectors like transport, fertilizers, qualification certificates face the same hurdles. However, with the enforcement of Regulation (EU) 515/2019, trade barriers can be lifted, safeguarding the free movement of goods within the EU, ‘making the life of business and citizens easier”.

The opportunity for business under the Mutual Recognition Regulation

As a Vice-Chair of the EHPM, representing the Greek Association of Food Supplements, and as the Regulatory and Quality lead for Southeast Europe in ISO PLUS, I led the submission of the first case of Mutual Recognition on Food Supplements to SOLVIT. This procedure is part of the novel toolbox of the Regulation on Mutual Recognition (EU) 515/2019. The case was based on Bulgaria’s refusal to accept the notification and circulation of one of our Solgar food supplements, lawfully marketed in other EU member states for several years now.

The mutual recognition principle and the relevant of Regulation (EU) 515/2019, which was adopted to facilitate the application of the principle, has as a scope ‘to ensure market access for goods that are not, or are only partly subject to EU harmonization legislation’. The principle and the Regulation apply in the case also that the good in question does not fully comply with the technical rules of the other member state, with the only exception being a substantiated health or safety concern. In each particular case of application, what is essential to demonstrate is the product’s suitability with the European framework law in place and its lawful marketing in one of the EU member states.

Mutual Recognition is a solid ally for businesses across the EU. It could also boost healthy competition between companies and ensure higher quality and innovative products to consumers across the EU, positively impacting consumer choice.

How does it work?

For food supplements, in most EU member states, the first step to ensuring lawful circulation is notifying the product to the relevant competent authority based on a regulated procedure. After notification, a product can be placed on the market, except if the national authorities refuse the notification on the grounds of national technical rules. In the great majority of cases, the refusal procedure is not based on a comprehensive safety assessment in a case-by-case evaluation and the relevant notification to the European Commission under Article 11 of the Mutual Recognition Regulation, as EU law requires it. On this occasion, the economic operator has three options to choose from; drop the business plan of market expansion, use the Mutual Recognition amicable tools or resort to the local Courts.

In our case, we opted for Mutual Recognition, referring the problem to SOLVIT as a first step. The SOLVIT center guided us on the requirements of the procedure and approached the Bulgarian authorities on the compatibility of their decision. After that, however, the EC Opinion was necessary to confirm that the Regulation applied in the case under consideration and that it was the Bulgarian Authorities, which should “take the necessary measures to ensure the proper application of the principle of mutual recognition and Regulation (EU) 2019/515, having regard to the concerns identified in this opinion”1.

How does the Opinion impact the Food Supplements’ sector?

The EU has one of the most comprehensive legal frameworks globally to guarantee product safety, quality, and efficacy in food and food supplements. The Food Supplements Directive in 2002 established the legal framework for the approximation of national laws on food supplements. Before that, national laws differed significantly, with food supplements manufactured and marketed under different standards across EU member states.

Though explicit in many fields, several fields of Food Supplements’ regulatory framework like maximum levels of vitamins and minerals, positive lists of botanical extracts etc., remained non-harmonized and, as a result, under national competence. The Mutual Recognition procedure can bridge this gap in European legislation and allow reliable national practices to prevail in favour of the internal market.

As in other areas of law, bridging the gap between national and European legislation on food supplements is a matter of perceptions and giving up national sovereignty. Problems with free movement come up due to the lack of understanding of the role of food supplements and member states’ resistance to change perceptions and subsequently laws.

This change barely has to do with product safety. Instead, it is a matter of accepting modern science and traditional use of nutrients and herbs and recognizing the role of food supplements in reducing nutritional deficiencies, addressing some of the risk factors of certain diseases and helping EU citizens remain healthy longer.

Stimulating growth and innovation providing healthy and nutritious products which contribute to the betterment of health are a few of the goals of the food supplements industry. But, what is the value of an innovative product which cannot enter all 27 markets? Moreover, how will the targets of the Farm-to-form Strategy be accelerated to develop sustainable food systems when businesses still fight for the very basic; trading with the same standards and the same legal obligations in EU 27.

Perpetuating non-compliance or ‘selective’ compliance with EU law has brought the European Union to a state of making uncomfortable concessions. From barriers to trade in food supplements to technical barriers in other sectors, the EU has to safeguard its fundamental freedoms in the best way possible. The new Mutual Recognition Regulation addresses those local bottlenecks by employing the active participation of SOLIVT centres in the resolution of cases, by increasing the obligations of member states on transparency of decisions (notification of the decision in ICSMS) and by foreseeing a timely (45 day) intervention of the European Commission and issuing of a relevant opinion.

To meet the challenge of increasing competitiveness, the EU needs to ensure that, similarly to businesses, Member States are building a culture of compliance with EU laws, especially on the free movements of goods.

What action will follow the European Commission Opinion also matters and will help appreciate the potential of the EU as a source of opportunity for business and consumers.

[1] C(2021) 6950 final, Brussels, 30.9.2021

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