EU Supplement Regulation News

You are about to finalise a label for a European launch, and a colleague forwards a headline about a “new EU supplement rule.” Before you reopen the artwork, ask what kind of news it is. It might be a change to the law, a scientific guidance update, or a discussion that has not produced a proposal. Each has very different consequences for your product.

This post does not report a single announcement. It explains the legal structure that headlines refer to, lists the open items the official sources currently describe, and gives you a routine for checking changes yourself.

The framework behind every headline

In the EU, food supplements are regulated as foods [2]. Under the General Food Law Regulation (EC) No 178/2002, food supplements are considered foodstuffs, and responsibility for their safety lies with the food business operator placing the product on the market [2]. That matters more than any single headline: if you place the product on the market, the safety responsibility is yours.

The reference EU legislation in the area of food supplements is Directive 2002/46/EC [2]. It establishes harmonised lists of the vitamins and minerals used in the manufacture of food supplements, and it sets the labelling requirements for these products [2]. Its stated objective is to protect consumers against potential health risks and to ensure they are not given misleading information [1].

Several other texts apply alongside it:

Regulation (EC) No 1925/2006 covers the addition of vitamins, minerals and certain other substances to foods [3].
Regulation (EC) No 1924/2006 sets the rules on nutrition and health claims [4].
Regulation (EC) No 1333/2008 governs which food additives can be used [2].
Regulation (EC) No 2015/2283 covers novel foods [2].

When a headline names one of these texts, you already know which part of your product file it touches: composition, claims, additives or novelty status.

Vitamins and minerals: the lists, and the missing maximums

Annex I to Directive 2002/46/EC is a harmonised list of vitamins and minerals that may be added for nutritional purposes in food supplements, and Annex II lists the permitted sources from which they may be manufactured [1]. The Annex II list has been amended to include additional substances by Commission Regulation (EU) 2017/1203, Commission Regulation (EU) 2015/414, Commission Regulation (EU) No 119/2014, Commission Regulation (EU) No 1161/2011, Commission Regulation (EC) No 1170/2009 and Commission Directive 2006/37/EC [1].

The trade of products containing vitamins and minerals not listed in Annex II has been prohibited from the 1st of August 2005 [1]. If a headline announces a “newly permitted” nutrient form, look for an amending act like those above. Until you find one, assume your source form must already be on the list.

The most common source of confusion is maximum and minimum amounts. Directive 2002/46/EC envisages setting them through the Standing Committee on Plants, Animals, Food and Feed (PAFF Committee) procedure [1]. The Commission has consulted extensively with EU countries and stakeholders, but its page states that no proposal has yet been presented because of the complex nature of the issue and the divergent views expressed [1]. If you read that harmonised maximums are “coming,” treat it as a discussion rather than a rule. Check the Commission page before you reformulate for a limit that does not yet exist.

EU countries may also, for monitoring purposes, request notification to their competent authority of a food supplement being placed on the market in their territory [1]. Before launching in a new country, confirm with that country’s competent authority whether a notification is expected.

Botanicals and other substances: where restrictions appear

Headlines affecting herbal products usually concern substances other than vitamins and minerals. For these, the European Commission has established harmonised rules to protect consumers against potential health risks and maintains a list of substances known or suspected to have adverse effects on health, the use of which is therefore controlled [2].

Annex III of Regulation (EC) No 1925/2006 is a list of substances other than vitamins or minerals whose use in foods is prohibited, restricted or under Community scrutiny [3]. Two examples show how the list moves:

Commission Regulation (EU) 2015/403 placed Ephedra herb and its preparations in Part A of Annex III and Yohimbe bark and its preparations in Part C [3].
Commission Regulation (EU) 2019/650 later placed Yohimbe bark and its preparations in Part A of Annex III [3].

A botanical can therefore move between parts of the list over time. If your formulation contains a botanical, keep the species name and plant part in your file so you can check it against each amendment.

The route to a restriction is also visible in advance. The Commission, on its own initiative or at the request of a Member State, may initiate the procedure under Article 8 of Regulation (EC) No 1925/2006 to prohibit, restrict or put under Union scrutiny a substance other than vitamins or minerals [3]. The conditions for using that procedure are found in Commission Implementing Regulation (EU) No 307/2012 [3]. Two substances show the procedure in practice:

Green tea catechins. The risks were outlined in a scientific opinion on green tea extracts by the National Food Institute of the Technical University of Denmark, and in a safety assessment on levels of EGCG in green tea extracts by the Norwegian Institute of Public Health [3]. The Commission requested an EFSA scientific opinion under Article 8(2), and EFSA has adopted an opinion on the safety of green tea catechins [3].
Alpha-lipoic acid. The Commission initiated the Article 8 procedure on the basis of a request by a Member State because of the potential risk to health associated with intake of this substance [3]. The safety concerns were outlined by the Danish National Food Institute (DTU) and by the Belgian Superior Health Council [3].

If a substance in your product shows up in a national risk assessment or a Member State request, you are watching the early stage of this procedure. That is the moment to review your formulation, rather than waiting for a final act.

Novel foods, additives and EFSA’s role

EFSA provides scientific opinions to support the evaluations carried out by the European Commission [2]. When an EFSA opinion appears in the news, read it as scientific input to those evaluations and check whether the Commission has acted on it [2].

Several EFSA pathways matter for supplement brands:

If a substance intended for food supplements has no history of safe use in the EU before 1997, EFSA is requested to provide a scientific opinion on its safety under Regulation (EC) No 2015/2283 on novel foods [2].
A novel food is a foodstuff or ingredient that was not used for human consumption to a significant degree within the EU before 15 May 1997 [2].
Only food additives specifically authorised for use in this food category under Regulation (EC) No 1333/2008 can be added to food supplements [2]. This includes coating agents for tablets and sweeteners [2].

One active item shows how guidance evolves. In February 2024, EFSA nutrition experts were updating its 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 and other food categories [2]. The update addresses new forms of micronutrients, many of which are novel foods, and the quantification of relative bioavailability to derive a conversion factor for labelling purposes [2]. If you plan to use a new micronutrient form, read the current guidance before you commission any data.

Claims: the rule that hits your label first

Regulation (EC) No 1924/2006 started to apply on 1 July 2007 [4]. It is the legal framework for food business operators who want to highlight beneficial effects of their products on the label or in advertising [4]. It applies to nutrition claims and to health claims [4]. Its objective is to ensure that any claim made on a food’s labelling, presentation or advertising in the EU is clear, accurate and based on scientific evidence [4]. Food bearing claims that could mislead consumers are prohibited on the EU market [4].

A public EU Register of Nutrition and Health Claims lists all permitted nutrition claims and all authorised and non-authorised health claims [4]. For substances claimed to have an effect on the nutritional or health status of consumers, EFSA carries out an assessment in line with the same regulation [2]. The Commission completed its evaluation of the regulation on 20 May 2020 [4]. Before you adopt any claim wording from an article or a competitor, look it up in the register.

A routine for reading supplement regulation news

Use this checklist whenever a headline lands in your inbox:

Name the instrument. Is it a directive, a regulation, a guidance document or a scientific opinion? Remember that EFSA’s opinions support the evaluations carried out by the Commission [2].
Find the text it amends. Amendments to the vitamin and mineral lists or to Annex III are published as their own acts [1][3]. If no act is named, treat the headline as unconfirmed.
Match it to your file. Compare the substance, the species and plant part, the additive or the claim against your formulation and label.
Check the national layer. Confirm with the competent authority in each target market whether a notification is expected [1].
Record the decision. Note the date, the source you checked and what you changed. Responsibility for safety stays with you as the operator placing the product on the market [2].

Care Europe provides EU and UK regulatory consulting and coordinates testing for brands. For any specific product, consult a qualified EU regulatory expert, because requirements vary by market and by ingredient.

Sources

[1] Food supplements (food.ec.europa.eu, accessed 2026-11-09)
[2] Food supplements | EFSA (efsa.europa.eu, accessed 2026-11-09)
[3] Addition of vitamins and minerals (food.ec.europa.eu, accessed 2026-11-09)
[4] Nutrition and Health Claims (food.ec.europa.eu, accessed 2026-11-09)

Written by Nour Abochama, Quality & Regulatory Advisor, Care Europe | VP Operations, Qalitex. Learn more about our team

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EU Supplement Regulation News: What Is Changing and What Is Not