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Potential new regulation could introduce prior notification for food supplements in the Netherlands

Article-Potential new regulation could introduce prior notification for food supplements in the Netherlands

© iStock/Charday Penn shopper-examining-supplement-label-iStock-Charday Penn-1068340648.png
The Netherlands Food and Consumer Product Safety Authority (NVWA) has advised the country’s Ministry of Public Health, Wellbeing, and Sports to implement a notification system for food supplements.

Such a system would bring the Netherlands in line with most other EU member states, but it could also introduce new challenges for the sector.

The advice was issued by the NVWA Risk Evaluation & Research Bureau (BuRO). In a 51-page report, BuRO outlined the health risks of food supplements, offering suggestions to better ensure their safety.

Life sciences lawyer Karin Verzijden, of Amsterdam-based law firm Axon, explained the four different categories in the proposed notification system: food supplements containing vitamins and minerals; single herbal preparations; compound food supplements; and food supplements that are actually novel foods or (herbal) medicines.

Verzijden told Vitafoods Insights: “If such a system is implemented, the data requirements for the last category are expected to be more extensive than for the first category, since the risk factor increases with each category.”

Food supplements have received more scrutiny in recent years by the NVWA, following increased attention to side effects. The Dutch newspaper Het Parool reported on the trend in December 2023, when it found that Lareb, the Dutch reporting and knowledge centre for side effects of medicines, vaccines, and health products, received between 110 and 150 notifications of side effects related to supplement use.

And according to 2016 research from NVWA, more than 60% of libido-enhancing, weight loss-inducing, and pre-workout supplements contain one or more regulated pharmacological substances – with some of them containing amounts that are sufficient to cause negative health effects.

“BuRO cannot provide a detailed substantiation of the health risks of all dietary supplements because the data are not available for this and the group of 'dietary supplements' is too diverse,” said Verzijden.

It is also not possible to calculate in advance what effect on consumer health will be when the safety of food supplements is better ensured. However, it is apparent from the many reported cases that serious health effects can occur from the use of dietary supplements.”

While the advice is a step towards the establishment of a notification system, according to Verzijden, it is difficult to predict if and when this would be implemented.

She said: “[The notification system] will require additional manpower and resources to implement and apply such system, and it is well known that NVWA is short of each. So, implementation of such system is by no means a given, let alone that a timeline could be applied to it.”

EU rules and practices

Although EU rules on food supplements have become increasingly harmonised in recent years – starting with the Food Supplements Directive of 2002, which resulted in more similar national legislation – the Netherlands remains one of the few EU member states without a prior notification system for food supplements. But it is not the only country in the region considering or implementing new rules or legislation in this area.

Two years ago, Romania introduced a new food supplements law which tightened the rules on marketing, labelling, and communication. This included a mandatory notification system, with the nature of the notification depending on the origin of the product – particularly whether it has already been notified in another EU state – and the composition of the product.

Lessons from Belgium

Belgium is another member state with a strict mandatory notification system. The country requires the (electronic or physical) submission of a notification dossier, containing detailed information about the ingredients of food supplements and enriched foods; a full nutritional analysis; details on the presence of active substances and their non-toxicity; and labelling.

Aude Mahy, lawyer at the Brussels-based legal firm Daldewolf, told Vitafoods Insights that the long-standing Belgian notification system, established in 1992, has its own challenges.

She said: In Belgium, the system is often perceived as being burdensome, while not offering the operators with the guarantee that the product is compliant.”

According to Mahy, a major challenge is that the line between prior notification and prior authorisation is often unclear, leading to confusion among manufacturers.

“[T]he administration to which the food supplement must be notified (FPS Public Health) does not have the authority to control food business operators or decide whether a food product should not be placed on the market,” she said.

“This authority falls under the jurisdiction of the Federal Agency for the Safety of the Food Chain… [W]hen manufacturers have been granted a notification number, they reasonably assume their product complies with the applicable legal requirements, especially if the notification number was issued after addressing comments from FPS Public Health. They are therefore often surprised to face additional challenges from the Federal Agency for the Safety of the Food Chain.”

Supplement consumption is on the rise in the Netherlands

A 2022 study from the Dutch national statistical bureau Statistics Netherlands (CBS) showed that there has been a significant growth in the number of people using supplements in the country.

Nearly 60% of adults used a supplement in the period 2019-21 – up 10 percentage points compared with the period 2012-16. Women are much more likely than men to use supplements (69 vs 44%), and most adults that use supplements do so on their own initiative. Just 19% of those taking supplements have been advised to do so by a medical specialist.

Popular supplements include vitamins B12, D, C, and multivitamins, magnesium, omega-3, calcium, and folic acid. However, herbal supplements that have been marked as high-risk by the RIVM earlier this year, including Tabernanthe iboga and Huperzia serrate, are not among those in widespread use.