Understanding ingredient regulations in Europe

The EU General Food Law Regulation (EC) No 178/2002 puts the onus of the responsibility for the safety of food supplements on the business operator placing the product on the market.??

As a food supplement manufacturer in Europe, we’ve had our fair share of trying to understand all the various laws governing food supplements,??

We believe that knowledge is free and is meant to be shared and so in this article, we will explain what the main regulations on food supplements within the European Union are and how companies can make sure they are applied.?

What are food supplements??

In 2002, in Directive 2002/46/EC, the European parliament defined ‘food supplements’ as those foodstuffs which are meant to supplement the normal diet. They added that food supplements “are concentrated sources of nutrients or other substances with a nutritional or physiological effect”. The directive went on to further describe that these supplements may be?

• consumed alone or in combination,??
• marketed in dose form (capsules, pastilles, tablets, pills, 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.??

What nutrients are allowed to be used in the manufacture of supplements??

Directive 2002/46/EC includes only vitamins and minerals under the category of nutrients.??

Annex I and Annex II of the directive list the forms of the vitamins and minerals approved for use in food supplements?

What about nutrients not on the list??

The Directive states that vitamins and minerals that are not on the list may be used in food supplements if:?

1. the substance was already in use in one or more commercial food supplements as of June 2002; and/or if?
2. the EFSA has not given an unfavourable opinion in respect of the use of that substance, or its use in that form.?

Since the first legal act in 2002, the EFSA constantly updates the “approved nutrients” lists. Food supplement businesses are therefore advised to regularly check Annex I and Annex II of Directive 2002/46/EC for any additions or deletions to the lists of approved nutrients.?

What nutrients are not allowed to be used in food supplements in the EU??

Only those nutrients, and their forms mentioned above, are permitted for use in food supplements.??

Items that are on the “prohibited” list may not be used or requested for use. As of the date of publishing this article, there are 6 substances that are prohibited for use in food supplements. Please refer to Part A of Annex III of Regulation (EC) No 1925/2006 of the European Parliament for this list.?

Part B of this list provides information on substances that may be used under certain conditions (referred to as “restricted” substances).?

Are there any directives with respect to the nutrition claims??

According to Regulation (EC) No 1924/2006, a 'Nutrition claim' refers to any claim which states, suggests or implies that a food has particular beneficial nutritional properties. An ingredient may be considered nutritious due to the energy it provides or the nutrients contained in it (Nutrition claims).??

There are very specific rules to nutrition claims such as ‘low fat’, ‘sugar-free’ or ‘natural’, for example. Please refer to the Annex of the Regulation for information on nutrition claims permitted for use with food supplements.?

It is to be noted that claims that could mislead consumers are prohibited on the EU market.?

Are there any directives with respect to the health claims about specific nutrients??

As we do in all of our blog posts, newsletters and LinkedIn articles about nutrients, it is advised to refer to the EU Register of nutrition and health claims made on foods. This register lists all of the EFSA-authorised and non-authorised health claims with respect to the vitamins and minerals stated above.??

It is to be noted that these health claims are only applicable to human health.?

Is the amount of a nutrient that a food supplement can contain regulated??

Yes, where possible, the EFSA establishes the tolerable upper intake levels (ULs) for different population groups. The ULs represent the highest dosage of a nutrient that is considered safe for one’s health upon long-term daily use.? As a food supplement manufacturer, we strongly advise our customers to stay within the recommended limits.??

You can find the data by nutrients or target populations using the DRV finder tool.?

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Would you like to know about EU directives regarding plant substances, novel ingredients and food additives in food supplements? Do you also have questions about whether a food supplement containing EFSA-approved ingredients and additives also be sold for children? Then read our full-length blog post on this topic which can answer these questions and more in detail.??

Alternately, contact us!?