+390677209020 | +39 0267380552 info@direnzo.biz | sedemilano@direnzo.biz


The regulatory history of food supplements

According to the definition of Legislative Decree 169/2004, food supplements are “foodstuffs intended to complete ordinary diet and constituting a concentrated source of nutrients, such as minerals and vitamins, or other substances with a nutritional or physiological effect including, but not limited to, amino acids, essential fatty acids, fibre and herbal extracts, with either one or more ingredients in their composition, in pre-dosed forms”.

The European Food Safety Agency (EFSA) stresses that food supplements can contain “a wide range of nutrients and other ingredients”, including vitamins, minerals, amino acids, essential fatty acids, fibre and various plants and herbal extracts.

In the European Union, food supplements fall into the wider category of foods, and therefore they follow all European regulations on this subject (such as the so called “hygiene package”), but are also regulated by a dedicated directive. The European directive has been implemented by every Member State into local norms, thus making the food supplement market not fully harmonised. While there are harmonised rules for some ingredients, such as vitamins and minerals, for other ingredients and nutrients there are only national norms.

Such norms aim at protecting consumers against any risks related to the consumption of these products: a list of substances which are known or suspected to have adverse effects on health is integral part of these rules as well as any consequent restrictions on their use in food supplements.

The regulations on food supplements

As all norms on safety, the regulatory framework regarding food supplements evolved hand in hand with the consolidation of knowledge and information about the ingredients and the effects they can have on our body. It should be reminded that supplements are food products presenting some peculiarities regarding their forms of presentation, their consumption units and their pre-set daily supply.

At the beginning of their regulatory history, they were in fact part of the category of “food intended for particular nutritional uses”, that is foods intended for infants and young children and dietetic products.

Then, Directive 2002/46/EC, implemented in Italy by Legislative Decree 21 May 2004, no. 169, introduced specific rules for the category of food supplements, deleting any reference to “dietetic products” from their definition. Consequently, foods for particular nutritional uses were subject to changes over the years. The first Directive 77/94/EEC was then replaced by Directive 89/398/EEC, included into Directive 2009/39/EC, following several amendments.

In 2016, this directive was repealed by regulation (EU) 609/2013 on food for specific groups, the so called FSG. The regulation limited the previous classification (9 specific categories of products for particular nutritional uses: 3 for foods intended for infants and 6 for dietetic products) to 3 type of products: food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control. Therefore, over time, the different role of food supplements was acknowledged. In fact, directive 2002/46/EC provides for that they should complete ordinary diet.

To be defined as food supplements, products had to present nutritional features, i.e. pre-defined supply of vitamins and minerals, so that they could be regulated as foods. This “theorem” posed the problem of products containing other ingredients, such as those containing herbal extracts, that cannot be considered as “nutrients”.

Being neither food supplements, nor medicines, a different classification was attempted for these products as herbals, but in the end nothing came out of it. However, there were several attempts to regulate the admitted plants, not only at national level, but also in Europe, as shown by the BELFRIT project.

The issue of the food supplement “indications” had also remained open, as an actual effect can be only claimed by products classified as drugs. The use of claims, that is specific nutritional and health indications, solved the problem. It is in fact possible to apply to the EFSA for the approval of indications to be reported on foodstuffs, including food supplements.

Food supplement market continues to flourish and it has apparently found its natural setting in the online sales. The regulatory history of these products is destined to evolve in order to harmonise local norms throughout the Community to ensure higher safety of these products. Technological and cultural progress in this sector will be certainly followed by interesting novelties in the legal sphere, for the protection and benefit of consumers.

Written by: Maria Pia Felici

Foto di Bruno /Germany da Pixabay