The Working Group "Food Supplements" of the European Heads of Food Safety Agencies (HoA WG FS) identifies substances that, in the opinion of all members should not be used or should only be used with restrictions in food (food supplements) due to their potential risk to human health.

The working group submitted its first report to the Heads of Food Safety Agencies (HoA) in spring 2024.

Information on the working group "Food supplements"

In 2019 HoA decided to set up a working group to develop a common concept for handling and classification of "other substances with a nutritional or physiological effect" (hereinafter referred to as “other substances”) used in or as food supplements. This was defined in the working group's Terms of Reference (ToR).

Members of the HoA WG FS present in Berlin at the 9th hybrid meeting in May 2023 Source: BVL

The first meeting of the HoA Working Group "Food Supplements" (HoA WG FS) took place in 2020. The working group had met until 2022 under Irish-German mutual chairmanship, followed by the chairmanship of Germany and the co-chairmanship of the Netherlands.

In addition to members from 24 Member States of the European Union (EU), representatives from Norway and Switzerland are also members of the working group. The working group therefore covers the majority of the Member States of the EU and the European Economic Area (EEA). The members are recruited from risk management and risk assessment. For Germany, these are the Federal Office of Consumer Protection and Food Safety (BVL) and the Federal Institute for Risk Assessment (BfR). Countries in which risk assessment is not carried out by an authority are represented by the relevant university institutions, for example. The European Commission (EU COM) and the European Food Safety Authority (EFSA) participate as guests.

Since its founding until the completion of the first report, the working group has met twelve times in total, of which one meeting took place in person.

Background information on existing legal regulations

The use of "other substances" than vitamins and minerals with a nutritional or physiological effect in foods and thus also in food supplements is only partially harmonized in the EU. Only the "other substances" listed in Annex III of Regulation (EC) No. 1925/2006 on fortified foods (Fortified Food Regulation) or in Regulation (EU) 2017/2470 on authorized novel foods (Union List of authorized Novel Foods, or only Union List) are subject to harmonized regulations within the EU.

Below, information on the regulations of "other substances" can be found:

EU Legislation

Food supplements are foodstuffs, therefore all regulations applicable to foodstuffs and in particular Regulation (EC) No 178/2002 (General Food Law Regulation) apply. According to this legislation, food has to be safe, which is the responsibility of the food business operator (FBO).

According to the Directive 2002/46/EC (Food Supplements Directive), food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination. These substances comprise e. g. vitamins, minerals, amino acids, fibres, bacteria, fungi, plant extracts or other substances with a nutritional or physiological effect. The Ordinance on Food Supplements (NemV, German) transposes this directive into German law.

These other substances are defined in Article 2 (2) of Regulation (EC) No 1925/2006 (Fortified Food Regulation) as “substances other than vitamins and minerals with a nutritional or physiological effect”.

The permitted vitamins and minerals to be used in food supplements are defined in Annex I and II of Directive 2002/46/EC. For the use in foods, other than food supplements, the permitted vitamin and mineral substances are defined in Annex II of Regulation (EC) No 1925/2006.

According to Recital 8 of the Food Supplements Directive, specific rules for "other substances" with a nutritional or physiological effect used as ingredients in food supplements are to be laid down "at a later stage". The EU COM stated in a report in 2008 that the Community legal instruments already provide a sufficient legal basis for the regulation of "other substances" and therefore no additional instruments need to be created.

Further specific provisions for the regulation of "other substances", which may pose a risk to consumers, are outlined in Article 8 of Regulation (EC) No 1925/2006. For this case, Article 8 provides a procedure for imposing restrictions on substances that are forbidden or under review.

On its own initiative or on the basis of information provided by Member States of the European Union and the European Economic Area (hereinafter referred to as EU/EEA MS), the EU COM may initiate the ‘Article 8 procedure’ based on recent scientific evidence in order to include a certain substance on a list to prohibit (Annex III Part A) or restrict (Annex III Part B). If sufficient scientific information is not available, a substance may be put under community scrutiny to be reviewed within four years (Annex III Part C). So far, however, only few substances have been included in Annex III of the Fortified Food Regulation.

Additionally, Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods (Novel Food Regulation) is applicable when it comes to the use of „other substances“ in food supplements.

Novel Food is defined as food that had not been used for human consumption to a significant degree in the EU before 15th of May 1997 and is falling under at least one of the ten categories mentioned in the regulation (e. g. foods consisting of, isolated from or produced from plants or their parts). The obligation to verify whether food intended to be placed on the EU market is ‘novel’ or ‘not novel’, lies with the FBO.

It must be determined whether it is ‘novel’, ‘not NFS’ or ‘not novel’. If food businesses are not sure whether food to be placed on the market in the Union falls within the scope of the Novel Food Regulation, they consult the Member State in which they intend to place the novel food on the market first.

Any food which meets the definition of ‘novel’ falls under the scope of the Novel Food Regulation and needs a pre-market approval at EU level. Food supplements containing for instance a plant extract which is regarded ‘novel’ may not enter the market until the ingredient has been authorized by the EU COM.

The purpose of the legislation is to ensure that new foods that have not yet been consumed in the EU are just as safe as foods with a history of consumption in the EU. The Commission Implementing Regulation (EU) 2017/2470 (Union List of authorized Novel Foods) establishes a list of all the authorized Novel Foods in the EU, including their conditions of use, labelling requirements and their specifications. This Regulation is amended following each new authorization.

Besides this, there is also the Novel Food Status-Catalogue (NFSC) of the EU COM. It contains information agreed between the Member States on the status of some substances as novel foods. The information in the NFSC is neither conclusive nor legally binding. Not all substances that fall within the scope of the Novel Food Regulation are listed in the NFSC. The status of listed substances can also be changed, if new information becomes available.

Substances that are added to food for technological purposes, e.g. for colouring or to extend the shelf life, are subject to the provisions of Regulation (EC) No. 1333/2008 (Food Additive Regulation) and Regulation (EU) No. 231/2012 (Food Additive Specification Regulation). For substances with flavouring properties, the provisions of Regulation (EC) No. 1334/2008 (Food Flavourings Regulation) apply.

These regulations define the specifications (synonyms, definition and purity) and any restrictions linked with their use (maximal quantities and specific food categories to which these substances may be added). As a rule, the addition for technological purposes is either 'quantum satis' or in precisely specified small quantities.

Some of these substances can also be added for nutritional or physiological purposes. In this case, they are usually added in larger quantities.

National Regulations

For "other substances" with a nutritional or physiological effect which are not or not yet restricted at EU level specific national laws can be applied in EU/EEA MS ensuring a high level of consumer protection.

Currently, some EU/EEA MS and Switzerland have developed national policies or guidelines to authorize, prohibit or restrict the use of certain "other substances" than vitamins and minerals in food and/or food supplements.

In Germany, Austria and Switzerland, the "Lists of Substances” of the Federal Government and the Federal States" are used as a non-legally binding guidance for the classification of substances.

Many of these national legal instruments are not legally binding or based traditionally on 'expert opinions' only, and not on proper scientific risk assessments. However, these are required for transposition into harmonised law. This means that the national legal instruments do not meet the requirements for direct transposition into European law.

Mutual recognition

Legal requirements for products that are not or not fully harmonized in EU are subject to the free movement of goods in accordance with Article 28 et seq. of the Treaty on the Functioning of the European Union (TFEU; see in particular Article 34) and thus the principle of mutual recognition applies. The mutual recognition principle ensures market access for goods that are not or only partly subject to EU harmonization legislation. EU/EEA MS may not prohibit the sale of goods on their territory that do not fall under Union harmonization legislation but which have been lawfully marketed in another EU/EEA MS. This even applies if the good does not comply with the technical rules of the other country. However, there may be exceptions to this principle whenever public safety, health protection or the environment are concerned. Directive 2001/83/EC of the European Parliament and of the Council applies where a product, taking into account all its characteristics, may fall within the definition of ‘medicinal product’ as laid down in Article 1(2) of that Directive. In that respect, in the case a EU/EEA MS classifies a product as a medicinal product in accordance with Directive 2001/83/EC, it may restrict placing on the market of that product in accordance with Union law.

Regulation (EU) 2019/515 applies to goods or aspects of goods that are not exhaustively covered by Union harmonization rules. The subject of the ordinance is, in particular, to describe the formal procedures of the mutual recognition.

In general, products can be placed on the market of EU/EEA MS without a proper risk assessment or pre-market assessment by competent authorities. However, the fact that a product is on the market does not necessarily mean that it is legal. In the case of products containing substances of concern, the competent food control authority can only take action and prohibit the sale on the basis of concerns about public safety, health protection or the environment. With harmonisation of the rules for the regulation of substances and articles containing these "other substances", the need for mutual recognition of these substances would no longer be necessary.

Resulting consequences for food business operators and authorities

For "other substances" with a nutritional or physiological effect, only general food law and provisions under the general food law are applicable throughout the EU, such as the Fortified Food Regulation, Novel Food Regulation, etc. For most "other substances" no additional specific regulations (e. g. maximum levels) are in place on EU and national level.

The general requirement that all foods must be safe also applies to food supplements (Article 14 of Regulation (EC) No 178/2002) and is the primary responsibility of the FBO to be ensured. According to Article 17 of Regulation (EC) No 178/2002, FBO at all stages of production, processing and distribution within the businesses under their control shall ensure that foods satisfy the requirements of food law which are relevant to their activities and shall verify that such requirements are met. They must therefore take appropriate measures and carry out controls to meet this requirement. This case-by-case assessment is often challenging and time-consuming. If the data situation is uncertain, the distributor must acquire this data. If the authorities suspect that a food is not safe, they may carry out or arrange risk assessments to evaluate the potential risk of individual products for consumers.

According to legislation non-authorized Novel Foods shall not be placed on the EU market. The responsibility lies with the FBO.

Due to the not fully harmonized pharmaceutical legislation in the EU, products containing "other substances" may also be classified as medicinal products in some EU/EEA MS, but not in others. This means that these substances may or may not be used in food supplements in different EU/EEA MS, respectively, depending on their categorisation in that Member State. This poses major challenges for both FBO and food control authorities, particularly in the context of mutual recognition.

Regulation (EU) 2023/915 (Contaminant Regulation) already sets maximum levels for some toxic substances originating from plants (e.g. hydrocyanic acid). However, in order to set further maximum levels within the framework of this regulation, monitoring data for the respective substances in foods are needed, which are often not present and difficult to collect. For this reason, among others, only a few substances the HoA WG FS has dealt with would be suitable for inclusion in this regulation.

The EU MS, together with the EU COM, have already issued EU-wide harmonized regulations for the use of some "other substances".

However, from the perspective of the HoA WG FS, there is still a great need to find common ways of dealing with or regulating of these "other substances".

Legal basis

• Regulation (EC) No 178/2002 (General Food Law Regulation)
• Regulation (EC) No. 1925/2006 (Fortified Food Regulation)
• Directive 2002/46/EC (Food Supplements Directive)
• Ordinance on Food Supplements (NemV, German)
• Regulation (EU) 2015/2283 (Novel Food Regulation)
• Commission Implementing Regulation (EU) 2017/2470 (Union List of authorized Novel Foods)
• Report from the commission to the council and the European Parliament on the use of substances other than vitamins and minerals in food supplements
• Novel Food Status-Catalogue (NFSC) of the EU COM
• Regulation (EC) No. 1333/2008 (Food Additive Regulation)
• Regulation (EU) No. 231/2012 (Food Additive Specification Regulation)
• Regulation (EC) No. 1334/2008 (Food Flavourings Regulation)
• Treaty on the Functioning of the European Union (TFEU)
• Directive 2001/83/EC (Medicinal products Directive)
• Regulation (EU) 2019/515
• Regulation (EU) 2023/915 (Contaminant Regulation)
• Implementing Regulation (EU) No 307/2012

Approach of the working group "Food supplements"

The HoA WG FS took a two-stage approach to its work assignment:

Risk-Assessment

The members of the HoA WG FS collected existing risk assessments of plants, plant parts or substances. To evaluate these documents, a checklist was developed to categorise the information collected and to identify any need for additions. The available risk assessments were reviewed in a sub-working group and evaluated using this checklist. This sub-working group examined whether a procedure in accordance with Article 8 of the Fortified Food Regulation and thus inclusion in Annex III of this Regulation was justified for individual substances. The results of the sub-working group were discussed in the HoA WG FS which also contemplated on how to proceed and which risk management measures could be derived.

Risk-Management

The members of the HoA WG FS have checked whether the use of certain plants and plant parts is already subject to legal restrictions in the EU or in the countries of individual members of the working group. For these substances, it was reviewed whether risk assessments already exist and whether there are indications that they could fall under the scope of the Novel Food Regulation. The HoA WG FS has developed a multi-stage work programme for this purpose in order to enable proper processing of the substances with regard to

a) their assumed status as novel foods and
b) the information already available.

Those substances that had been categorized “assumed not novel” or “assumed not novel exclusively in food supplements” (in short "assumed not NFS") were analysed in more detail by the HoA WG FS. The status of these and all other substances that are “assumed to be novel” is to be confirmed by the European Commission's Working Group on Novel Foods (CAFAB WG NF). The further processing of the substances then confirmed as novel is to be carried out by the CAFAB WG NF.

A common list of so-called "other substances" that should not be used in food supplements, or only to a limited extent, was drawn up step by step. From this list, substances were identified for a procedure in accordance with Article 8 of the Fortified Food Regulation, which are suitable to be included in Annex III, Parts A, B or C of this Regulation. A prerequisite for this is however a respective current scientific risk assessment.

To enable substances to undergo a "procedure under Article 8" of the Fortified Food Regulation, they must fulfil various criteria. The criteria are set out in Implementing Regulation (EU) No 307/2012: The substances must actually be used in food. In addition, their intake must exceed values of a normal diet. Furthermore, there must be evidence (usually risk assessments) that there is a possible risk associated with the consumption of these substances.

The working group has so far collected risk assessments, information on assumed novel food status, existing RASFF notifications (notifications in the European Rapid Alert System), fulfilment of the requirements under Implementing Regulation (EU) No. 307/2012 and other information for 117 substances. Based on these criteria, these substances were categorised and prioritised accordingly.

The first report of the Working Group "Food Supplements"

The working group has completed a report in which 117 substances have been categorised and already partially prioritised with regard to the above-mentioned information:

Cover page of the first HoA WG FS report, February 2024 Source: BVL

Six of these substances have already been legally regulated in the meantime or are currently in the process of being assessed or regulated by the European authorities.

Twelve substances are proposed in the report for a procedure under Article 8 of the Fortified Food Regulation. If EU COM follows this proposal, it will mandate EFSA to evaluate these substances. On the basis of EFSA's opinion, the EU Commission can decide on further steps, e.g. restricting or banning the use of these substances. This could be done by including them in Annex III of the Fortified Food Regulation.

The available information for 34 other substances was not sufficient to propose their regulation at the time the report was prepared. For 65 other substances, such a regulation is not possible, as they are assumed to be novel substances and may not be used in food anyway. In its report, the working group proposes that the status of these substances should be confirmed by the CAFAB WG NF and that they should then be considered for inclusion in the NFSC.

Finally, the HoA WG FS proposes in this report that the HoA's mandate to the working group should be extended and expanded to include new tasks.