EFSA’s latest guidance on dietary supplements for consumers, suppliers and producers

09 Aug 2024 --- The European Food Safety Authority (EFSA) shares its most up-to-date advice on EU regulations for over-the-counter tablets, capsules, powders and liquids containing vitamins, minerals, amino acids, enzymes, herbal extracts and other dietary supplements.

"EFSAs' role is to provide independent scientific advice to EU Risk Managers — the European Commission (EC) and member states. EFSA scientific advice helps to inform help inform public health policies and recommendations across Europe. It is the role of policy makers in the EU and its member states to issue recommendations on nutrient intake to consumers," an EFSA spokesperson tells Nutrition Insight.

“Some supplements provide essential nutrients and vitamins you might be missing in your diet, and they’re safe to use thanks to strict European and national safety regulations,” the EFSA states.

Ariane Titz, a nutrition scientist at EFSA, adds: “EU countries run the market for food supplements nationally. When they have concerns about any of them, we are called on to do a safety assessment.”

According to the authority, vitamin D, echinacea, fish oil and calcium are some of the most commonly used supplements in the EU. Botanicals from plants, algae, fungi and lichens have also become widely available in the EU as food supplements. These include ginseng, ginkgo, garlic and St. John’s Wort.

This year, EFSA updated the guidance documents used by supplement suppliers when seeking market authorization and by risk assessors during the evaluation process. The update seeks to take into account two new areas of guidance (new forms of micronutrients and quantification of relative bioavailability) and the latest science and recent experience in the evaluation of applications.

When to consider supplementation
EFSA advises that supplements are to be consumed to add nutrients and vitamins that may not be sufficient in the average diet or to reduce risk factors for some diseases.

Certain population groups are at greater risk of certain nutrient deficiencies.The general public may use dietary supplementation to maintain general health, mental health, sports-related performance and provide immune system support.

The authority asserts that “certain population groups are at greater risk of certain nutrient deficiencies and may benefit from food supplements, such as women who are pregnant or may become pregnant, infants, people with insufficient exposure to the sun, or vegans, for example.”

“Food supplements shouldn’t be seen as a substitute for a balanced healthy diet. In fact, most people don’t need food supplements as their diets provide them with all the nutrients they need, except for vitamin D if your sun exposure is limited.”

Ensuring safety
The food safety body reminds that the human body only needs a certain amount of every nutrient, with higher amounts sometimes being unnecessary or dangerous.

Many food supplements currently on the EU market have been available to European consumers for a long time and are, therefore, considered tried and tested.

However, EFSA notes that there are still concerns about the safety and quality of some supplements. It warns of the risk of chemical and microbiological contamination. EFSA calls on producers and suppliers to ensure that the concentration of bioactive agents in supplements are within safe limits.

“EFSA provides scientific opinions on the safety of a substance if it is intended for use in a food supplement and does not have a history of safe use in the EU before 1997 or if a Member State requests an evaluation.”

In the EU, dietary supplements are regulated as a type of food.EU supplement regulation
In the EU, dietary supplements are regulated as a type of food, so the food safety authority oversees the safety regulations concerning such ingredients and products. “Harmonized legislation regulates the vitamins and minerals, and the substances used as their sources, which can be used in manufacturing food supplements.”

“For ingredients other than vitamins and minerals, the EC has established harmonized rules to protect consumers against potential health risks and maintains a list of substances which are known or suspected to have adverse effects on health and the use of which is therefore controlled.”

This year, EFSA’s nutritionists are updating the authority’s guidance on the scientific principles and data required to assess the safety and relative bioavailability of new substances proposed as sources of micronutrients for use in food supplements, fortified foods and foods for specific groups (for infants and young children, for medical purposes, and total diet replacements for weight control).

The guidance draft was made available to the public and EFSA collected feedback from nutrition experts and scientists with relevant knowledge.

The EC requested the guidance to cover two new areas. One is new forms of micronutrients, including micronutrient metabolites and new molecules having vitamin activity, many of which are novel foods.

The other is the quantification of the relative bioavailability of the micronutrient from a new source to derive a conversion factor for labeling purposes.

By Milana Nikolova

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