Food supplements on the Dutch market
Category: Food and commodities practice
Food supplements on the Dutch market
Dutch food rules are quite a challenge. In this blog I pay attention to specific rules for food and specific rules for food supplements. Both sets of rules may be material when you introduce your food product in the Netherlands.
European Directive 2002/46/EC on the approximation of the laws of the Member States relating to food supplements, sets out the basic framework for ‘food supplements’, which are described as: ‘foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients [vitamins or minerals] or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.’
A product will classify as a ‘food’ if it meets the following definition: ‘any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans.’ Be sure about the qualification of your product, that is important.
Claims made for food supplements
If the intention is to sell a product in the Netherlands as a food supplement, makes no health claims with regard to the working of the product and does not supply the product with any similarities to traditional medicines, he maximizes his chance that the product won’t be seen as such. In the end, the recognizing is up to the authorities, but so far there have not been examples of situations where CBD oils that are sold without any medical claims have been recognized as a medicine in accordance with the Dutch Medicines Act. Also be aware of novel food rules in the Netherlands.
European Court on food supplements
In the Hecht-Pharma judgment (ECJ, 15 January 2009, Case C-140/07), the European Court of Justice ruled that all the characteristics of a product must be taken into account when classifying a product as a medicinal product. The following criteria, taken together, are particularly important in this context:
The composition of the product. This concerns, for example, products which, according to their composition, are foods or not.
The pharmacological properties of the product as established by current scientific knowledge. It appears from case law that it is required that scientific research has sufficiently demonstrated that there is a pharmacological effect worth mentioning. For example, the effect must be greater than that of an ordinary cigarette (ECLI:NL:GHSGR:2012:BW8660 (e-cigarette)).
The way in which the product is used or can be used. The question here is whether the product is known as a stimulant vs. as a medicine (ECLI:NL:GHSGR:2012:BW8660 (e-cigarette)).
The extent of the distribution of the product.
The consumer’s familiarity with the product.
The risks that the use of the product can entail for health. Application of the Medicines Act must not lead to obstacles to the free movement of goods which are disproportionate to the objective of protecting public health pursued (Commission v. Germany, C-319/05 (e-cigarette)).
Presentation of a food supplement
However, a product may also be classified as a medicinal product in the Netherlands along the line of the presentation criterion. The European Court of Justice has also laid down criteria for this. If the average consumer concludes from the presentation of a product that the product will prevent, treat or cure illness, this is a medicine by presentation (see ECJ, 30 November 1983, case C-227/82 (Van Bennekom)). The European Court of Justice wants to protect consumers against quackery. Presentation also concerns the labelling of your food product; more about that here.
Dutch food rules and food supplement rules
It is clear that the producer and seller of a product holds quite some influence over whether or not a product is recognized as a medicine, especially through the presentation criterium, which is – in case law – the more prominent criterium. Since there are rules for food products as well as food supplements it is advisable to adhere to the regulatory compliance rules regarding both foods and food supplements to stay on the safe side. Also check out the basics of Dutch food law.
To be sure about your product, don’t hesitate to contact Mark van Weeren.