Towards A More Harmonised EU Regulatory Framework On Food SupplementsPosted: January 11, 2021 | |
Last week I received a call from an entrepreneur who wanted to know what requirements he had to bear in mind when distributing food supplements from Finland to other EU Member States. I told him about the language requirements for mandatory food information. I also informed him that the allowed level of vitamins and minerals could differ from Member State to Member State. Furthermore, in some countries a so-called notification system for market access has been put in place, whereas in others, no such system applies. Finally, I informed him that there is no harmonised approach on prohibited substances in the EU either. In fact, he was quite surprised to learn about all this, as he thought food supplements to be subject to the principle of free circulation of goods in the internal market. Is not that correct? Yes, it is. However, as follows from the above, a number of exceptions apply to this principle. This blogpost explains what is being done to achieve more harmonisation in the food supplements market.
Food supplements: what are they in fact and what happens in practice?
According to the Food Supplements Directive, food supplements are meant to supplement the normal diet. They are concentrated sources of nutrients or other substances having a nutritional or physiological effect that are mostly sold in the form of pills or powders. While nutrients are vitamins and/or minerals, such other substances are, for example, amino acids, glucosamine or certain substances contained in herbs or plants. What we see in practice, is that more and more consumers use food supplements not only to supplement their diet, but for a targeted health effect. Increasing concentration or improving sport achievements are two examples thereof. Another trend is that a broad number of food supplements is nowadays offered for sale online. As many of them come with striking health claims, it is not always sufficiently clear for consumers what they are actually buying. In these COVID-times, many supplements claimed for example to boost the immune system without meeting the specific requirements for such claim. This may create a dangerous situation if and when dangerous substances are involved.
Food supplements: a boosting market but not without risks
The market of food supplements in the Netherlands alone was valued in 2019 by Neprofarm at € 143 million. In that same year, the Netherlands pharmacovigilance centre Lareb received 165 notifications of adverse reactions regarding food supplements. Even worse, the Netherlands Intoxications Information Centre NVIC reported 891 cases of intoxications through the use of food supplements in 2019. These adverse effects or intoxications may result in stomach complaints, headaches or dizziness, but also in more severe conditions such as hart complaints or even cerebral haemorrhage. It follows from inspection results of the Dutch Food Safety Authority NVWA that only 45 % of the food business operators comply with all applicable food safety requirements. Due to the lack of regulatory harmonisation in this field and the open norm laid down in the General Food Law Regulation (article 14 thereof states “food shall not be placed on the market if it is unsafe”), this makes effective enforcement of food safety for food supplement a complex task.
Dutch initiatives aimed at more EU harmonization for food supplements
In an ideal world, dangerous substances are prohibited on an EU-wide basis. Currently, an initiative is ongoing to add substances to the list of unsafe substances under the Fortification Directive. Furthermore, in February 2020, an initiative was launched by the enforcement authorities of 18 Member States including those of the Netherlands, to draft a joint list of prohibited substances for food supplements. Since both initiatives are not expected to materialize overnight, the Dutch Health Minister has decided, in cooperation with the Dutch Food Safety Authority and the Dutch Medicines Evaluation Board CBG amongst others, to draft a national list of unsafe substances. This list will be based on risk evaluations pertaining thereto and the aim is to give this list a statutory basis, by integrating it in the Dutch Commodities Act (“Warenwet”). Furthermore, the Dutch Food Safety Authority has designed a targeted approach of sales of food supplements via the internet. Based on the Dutch polder tradition, this approach is consensus-based, aiming to agree with online marketplaces that they remove from their offerings any food supplements containing prohibited substances. Also, the Dutch Health Minister oversees that the communications to consumers on food supplements by a number of channels, such as the Netherlands Nutrition Centre (“Voedingscentrum”), the Health Inspectorate IGJ and the National Institute for Public Health RIVM, provides proper risk information. Finally, the Health Minister considers introducing a system of prior notification and some level of safety evaluation into the Netherlands as well.
Are these initiatives a good thing or a bad thing?
In order to enhance consumer safety, the above initiatives are certainly a good thing. For food business operators however, they may entail further obstacles to the free circulation of goods in the internal market. Based on the new Official Controls Regulation, enforcement authorities are allowed to do “mystery shopping”, i.e. ordering food supplements without identifying themselves. Once the Dutch national list of dangerous substances will have a statutory basis, the Dutch Food Safety Authority could do online test purchases with EU food business operators that may not be aware of such list. If their products are not in line therewith, they are subject to enforcement measures. As to the intended introduction of the notification requirement of food supplements in the Dutch market, this will certainly make market access less smooth.
On the other hand, in a number of EU countries, such as Belgium and France, a system of prior notification for food supplements is already in place. In practice, we see this can operate as a “safety seal”, meaning that supplements that were allowed on those markets, potentially earn more easily market access in other Member States as well. Furthermore, a new tool is available to food business operators since the new Regulation on mutual recognition became applicable in April 2020. Article 4 thereof offers the possibility to draw up a voluntary declaration to demonstrate to the competent authorities of other Member States that a food product is lawfully marketed, for instance in the Netherlands. The competent authorities in the Member State of destination can only oppose the further marketing thereof based on legitimate public interest, for instance public health. I expect this to be as useful tool for the further circulation of food supplements in the internal market.
Finally, I expect the Dutch national list of unsafe and hence prohibited substances for food supplements also to provide some more clarity in this field, provided that it will also be easily accessible to food business operators abroad. When these food business operators indeed duly inform themselves, this list could facilitate the successful EU-wide launch of food supplements, with less unclarity pre-launch and less surprises after launch. Which is supposed to be a good thing.
The information shared in this blogpost stems from a letter of the Dutch Health Minister to the Dutch House of representatives dated 14 December 2020, which can be viewed here (in Dutch only).