Even though the regulatory landscape surrounding food and food supplements is theoretically shaped at the EU level, there are many areas that are still far from harmonized. For example, maximum intake amounts of vitamins and minerals are still not regulated throughout the EU. Some Member States have filled this void by coming up with their own maximum intake levels while the European Food Safety Authority (EFSA) deliberated about setting up recommendations.

And thus, for the last 10 years, EFSA has been evaluating and updating the values for 14 vitamins and 13 minerals as well as for macronutrients such as proteins and carbohydrates. EFSA’s last scientific opinion concerning dietary reference values (DRVs) was published in August, setting the DRVs for sodium and chloride, which concludes the authority’s updates for the DVRs of 34 nutrients.

Understanding Terms & Process
DRV is an umbrella term for science-based reference values for the daily intake of nutrients among healthy populations, including population reference intakes (PRIs), average requirements (ARs), adequate intakes (AIs), and reference intakes (RIs) for macronutrients. These values indicate the amount of a nutrient that must be consumed on a regular basis to maintain health in an otherwise healthy individual (or population).

Based on this scientific opinion, EFSA experts concluded that 2.0 grams of sodium per day is both safe and adequate for the adult population. The same value applies to pregnant and lactating women. When it comes to children, the safe sodium intake was adjusted for their respective energy requirements and growth factors.

Meanwhile, the dietary reference value for chloride for adults (as well as for children from 11 years of age) was set at 3.1 grams per day. This value is also safe for pregnant and lactating women. The EFSA panel considered that sodium chloride is the main source of chloride in European diets.

For comparison, the German Institute for Risk Assessment (BfR) recommends that no additional sodium or chloride should be taken up except for that which is taken up with food anyway, (i.e., the BfR recommendation is 0 mg both for sodium and natrium. France, on the other hand, gives no recommendation and merely states “quantum satis.”

The ranges are similarly divergent for other nutrients. France states a maximum uptake amount for vitamin A of 800 mcg, while EFSA’s recommendation for the maximum daily amount is 3,000 mcg and Germany’s (not yet legally binding) recommendation is 200 mcg. Niacin ranges from 10 mg/day (EFSA) to 54 mg/day (Italy).

The DRV Finder
Apart from EFSA’s DRV opinions published in the EFSA Journal, EFSA also launched a simple tool last year—the DRV Finder. This interactive tool provides a quick and easy search of EFSA’s DRVs by population group or nutrient. It contains DRVs for water, fats, carbohydrates, dietary fiber, protein, and energy, as well as for vitamins and minerals. This finder allows nutritionists and other health professionals to make quick and easy calculations using EFSA’s dietary reference values. It can be found online at https://bit.ly/2NfVtIq.

However, this does not mean that food business operators should interpret these values as legally binding. As EFSA states in its disclaimer: “DRVs should not be viewed as recommendations for individuals. Rather, DRVs are scientific references for professionals, who use them when setting nutrient goals for populations or recommendations for individuals. DRVs are also used by policy makers to inform the setting of reference values in food labeling. The development of nutrition goals, recommendations or labeling reference values is outside EFSA’s remit.”

In other words, these values are intended to serve as a basis for legislators to set up legally binding upper intake levels. The many different values as set up by EU Member States currently are in fact more binding than EFSA’s recommendations.

Conclusions
The conclusions to be drawn from this are, while there are still no reliable upper limits for vitamins and minerals that are valid for the whole of the EU, the assessments by EFSA constitute an important step toward realizing these values. It remains to be seen what results, if any, will come from this on an EU level.

In the meantime, food business operators wishing to market their vitamin/mineral products in more than one EU market are well advised to research the local maximum limits and/or to adhere to the recommended daily allowances as set out in Directive 90/496/EEC on nutrition labeling for foodstuffs. In any case, it might be a good idea to confirm these values with the help of experienced consultancies such as analyze & realize GmbH. 

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Joerg Gruenwald
analyze & realize ag

Dr. Joerg Gruenwald is co-founder of analyze & realize GmbH, a specialized business consulting company and CRO in the fields of nutraceuticals, dietary supplements, herbals and functional food, and author of the PDR for Herbal Medicines. He can be reached at analyze & realize GmbH, Waldseeweg 6, 13467 Berlin, Germany; +49-30-40008100; E-mail: jgruenwald@a-r.com;
Website: www.analyze-realize.com.