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The dietary supplement industry is booming in the Netherlands. By 2022, nearly half of the Dutch population reported using supplements and 1.6 billion euros was spent on them. But there are concerns about the safety of these products. Bureau of Risk Assessment & Research (BuRO) now recommends the introduction of a notification system.
In recent years, the Ministry of Health, Welfare and Sport (VWS) has engaged BuRO's help several times to assess certain supplements. Often these were supplements that posed a serious health risk. In response to these earlier requests about the safety of certain supplements, BuRO now provides an overarching opinion on the safety of supplements in general. The conclusion: the Dutch Food and Consumer Product Safety Authority (NVWA) has too little insight into the composition and so it is time for a notification system.
In addition to the requirements for food, food supplements must comply with specific European and national regulations, as laid down in various legislations. For minerals and vitamins, the permitted chemical forms are laid down in Directive 2002/46. Reference values for these nutrients can be found in Annex XIII, Part A, point 2 of Regulation 1169/2011. European legislation has been implemented in the Netherlands through the Commodities Act Decree on Food Supplements, the Commodities Act Decree on Herbal Preparations and the Commodities Act Regulation on Exemption of Food Supplements. The latter sets limits for the daily dosage of vitamins A, B6 and D in supplements. But when it comes to other vitamins and minerals, it is up to companies to substantiate and prove the safety of the dosage used. For herbal preparations, no quality requirements (besides a list of banned substances) have been described at all.
This lack of requirements can create health risks. BuRO describes that the use of supplements can be risky due to the nature of the substances themselves, added ingredients or interactions with other substances, such as medications. Because there is no duty to notify supplements in the Netherlands, the NVWA has very limited insight into how much and which substances supplements contain. This makes enforcement difficult. BuRO now recommends introducing a notification system where consumers can also view the data and make an informed choice.
Through Article 10 of Directive 2002/46, member states may require manufacturers and sellers to notify the control authority before placing new food supplements on the market. Belgium is one of the member states that has made use of this possibility. When companies want to market supplements in Belgium, they must first register them through FOODSUP. Here they provide information on use, ingredients and labeling. By providing not only the various ingredients, but also the exact quantities and details about, for example, the plant parts used for herbal preparations, the Belgian government has insight into what exactly is contained in the supplements. It can then decide whether the product is allowed or not. It is still unclear whether the Dutch system will be just as extensive, or whether only a notification without further explanation will be required. In addition, it is not yet known whether there will be costs associated with the notification procedure.
The feasibility of a notification system for food supplements in the Netherlands has been under consideration for some time. An in-depth study of the added value and practical feasibility, including the role of self-regulation, was planned for 2021. Examples include the assessment of health claims by the KOAG/KAG and the Dutch Nutritional Supplements Top Sport Assurance System (NZVT) that focuses on screening nutritional supplements for banned substances in sport. To the best of our knowledge, the results of this investigation have not yet been published.
The Ministry of VWS itself has not yet responded to BuRO's advice, but Gerard Bakker, the Inspector General of the NVWA has at least endorsed it. Introducing a notification system would require additional capacity on the part of the NVWA. The NVWA and the Ministry of Health, Welfare and Sport will discuss this. In addition, the Dutch legislation on food supplements will also have to be amended in order to implement a notification system.
Would you like more information on food supplement legislation? Contact us at info@precongroup.com, NL +31 (0)30 65 66 010 or BE +32 (0)11 26 99 07.
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