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Dra. Magda Rafecas

professor of Nutrition and Bromatology, University of Barcelona


Directive 2002/46/EC stipulates that food supplements are food products whose purpose is to “complement” the normal diet and that comprise concentrated sources of nutrients or other substances (let’s call these bioactive substances). These products have nutritional or physiologic effects –either alone or combined– and are sold as capsules, pills, bottles of liquid, powders or in other forms, and are to be taken in small, pre-measured doses.

This definition may cause some consumers to confuse food supplements with medicines; however, since they are legally described as foodstuffs containing concentrated sources of nutrients, they are legally considered to be foods. Nonetheless, given the way they are packaged, labeled and sold, they clearly seem more related to the pharmaceutical sector than to the food sector.

The aforementioned Directive defines “nutrients” as vitamins and minerals. Which automatically leads us to ask: “What about other nutrients or bioactive substances, like fatty acids or dietary fiber?”. The answer is that although these other substances can be included in the design and formulation of food supplements, their chemical structure and dosing are not legally defined in Directive 2002/46/EC or in Guidelines 1952/2006 or 1170/2009, all of which only refer to vitamins and minerals, and to their chemical forms that can be added either to foods (to create functional foods) or to food supplements. Nutritional recommendations are normally applied for these substances and for substances on the Dietetic Products, Nutrition and Allergies (NDA) panel of the European Food Safety Authority (EFSA).

Thus, for marketing of food supplements, Europe has a main directive and guidelines that outline the chemical forms of vitamins and minerals that can legally be added. For example, according to these guidelines the nutrient vitamin C can be added as L-ascorbic acid, L-ascorbic acid sodium salt (also called sodium L-ascorbate), or L-ascorbyl-6-palmitate, each of which affects the bioavailability of this nutrient to the organism, and therefore, determines how the organism will obtain maximum benefits from the nutrient.

Another aspect to consider is how food supplements are sold, especially how they are labeled. In this area the European Union published Directive 2008/100/EC, which explains the concept of recommended daily allowance (RDA) and corresponding definitions, outlines the vitamins and minerals that can be legally declared in commercial products, and lists the RDA for each of these nutrients. The Directive also establishes, “as a rule”, that vitamins and minerals present in “significant amounts” (equivalent to at least 15% of the RDA) can be declared. Thus, if folic acid, whose RDA (as of 2008) is 200 ?g/day, is to be added to a product, it can be declared starting from 30 ?g. However, despite this seemingly clear framework, comparing real nutritional needs to RDAs can be problematic. Let us not forget that the latter are simply tools for the labeling and sales of foodstuffs and food supplements: they enable consumers to compare different products to determine how much of a given vitamin or mineral each product would provide them, so that they can meet their own nutritional requirements.

As I mentioned above, this legal framework, despite offering a convenient way to identify which product offers the most of a given vitamin or mineral, and to compare different products, is sometimes inconsistent with the actual nutritional needs of certain demographic groups. Let me illustrate this discrepancy by continuing with the example of folic acid: it is well known that folic acid deficiency in a pregnant woman can cause defects in her baby’s brain and spine, and therefore, that pregnant women should consume at least 400 ?g /day of folic acid three months before conception. However, this quantity clearly does not coincide with the RDA for folic acid, which is only half this amount. So what should we do? Well, there are various proposals. One possibility is to use a formulation of 400 ?g of folic acid per tablet, which would represent 200% of the RDA, and therefore, conflict with Directive 2002/46/EC, which explicitly states that the RDA should not be exceeded. Another idea is to recommend that two 200 ?g tablets be taken. Thus, comparing certain nutritional recommendations with legal guidelines for the labeling and sales of food supplements is not trivial.

Lastly, we should not forget that Directive 2002/46/EC clearly prohibits that the label, packaging or advertising for food supplements contain any claims that the nutrient in question can prevent, treat or cure a particular disease. Furthermore, it states that the product should not be used as a substitute for a balanced diet, but only as a complimentary addition.

As we have seen, formulation of food supplements is clearly a challenge for our industry; we must perform the complex task of meeting real nutritional needs without violating the European legal framework.

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