For businesses, having technical barriers to trade lifted across the EU means goods and services can once again move freely throughout the Single Market. For consumers, it means they can access a wider selection of products. For both of them, it is something more than that. It is restoring a freedom offered by the EU, however it remains hindered by local bottlenecks.
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, a procedure which 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, which has been lawfully marketed in other EU member states for several years now.
The mutual recognition principle and the subsequent Regulation, 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 harmonisation 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.
“It is an everyday reality for businesses with commercial activities across the EU that they may have registered a food supplement in one member state and the competent authorities of another member state refuse the product notification”
It is an everyday reality for businesses with commercial activities across the EU that they may have registered a food supplement in one Member State and the competent authorities of another member state refuse the product notification and, subsequently, market access, based on differing national laws on food supplements.
Ironically enough, if a consumer is lucky, they can just cross the border and buy the product from a shop or a pharmacy in the place with the most favourable regime. If not, then the consumer is deprived of choice and left with a limited product selection thanks to local laws. Finally, a business cannot do business, nor expand its workforce orcommercial activities with the same line of products across EU27.
According to the Commission's Opinion (C(2021) 6950), "The Bulgarian authorities did not apply correctly the principle of mutual recognition.” Instead of denying the notification of the product, the Bulgarian authorities should have requested information from our business on whether the goods are being sold in another Member State.
The Commission's Opinion reiterated the direct applicability of the mutual recognition principle. It confirmed the necessity of thorough examination of national decisions in non-harmonised fields of law before the national decision creates a restriction that could hinder the free movement of the good in question.
The big question remains, though. Will the recent European Commission Opinion manage to change perceptions and, as a result, enhance the application of the mutual recognition principle?
In food and food supplements, the EU has one of the most comprehensive legal frameworks globally to guarantee product safety, quality and efficacy. 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-harmonised 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.
“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”
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 recognising 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.
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.
The leverage of the European Commission's Opinion is therefore not negligible; it was a moment in history for food supplements. What action comes next is what matters the next day and will help appreciate the potential of the EU as a source of opportunity for business and consumers.
This article reflects the views of the author and not the views of The Parliament Magazine or of the Dods Group