How to Sell Compliant Food Supplements in the EU and UK

Placing Food Supplements on the Market in the European Union (EU) and the UK with Legal Certainty

Food supplements are regulated as food products in the European Union and are subject to general food legislation. At EU level, there are horizontal and vertical regulations applicable to food supplements, but nearly every member state also has its own national legislation.

Food law is complex, and the aim of this legislation is to ensure public health is not compromised, that products sold within the union are safe, effective and their presentation to the public is not misleading.

Businesses are expected to comply with all aspects governing the sale and marketing of food supplements, in such way that human health is at the forefront of any product development and the information provided with every product enables the public to make a well-informed decision prior to purchase.

So how can you navigate this complex landscape to ensure your food supplement is marketed in compliance with the law?

What are Food Supplements?

It's always important that every product concept starts with the definition of the specific category and the same should be considered before you decide to sell food supplements. This will enable appropriate selection of raw materials, combinations and quantities of nutrients and informative and compliant messages in all marketing materials.

Directive 2002/46/EC defines food supplements as foods which are intended to supplement the normal diet and which consist of:

• concentrations of nutrients (vitamins or minerals) and/or
• other substances with a nutritional or physiological effect, and
• are placed on the market in dosed form (e.g. as capsules, pastilles, tablets, powders, liquids or similar) for ingestion in measured small quantities.

Food is defined as any substance or product that is intended or can be expected to be ingested by humans, whether raw or processed.

A grey line already exists in determining appropriate formats for food supplements, in relation to the expectation of ingestion, and it is important to take into consideration the scientific facts that digestion begins in the mouth.

Although some typical food formats like jellies or gummies are becoming more popular, the dosage forms of food supplements are rather atypical for food, often as 'pharma forms' They are by no means intended to alleviate, cure or prevent medical complaints or illnesses. In principle, only medicinal products may have these properties. This fact must be taken into consideration when advertising food supplements in a legally compliant manner.

A Step-by-Step How To Navigate EU Law

What are the applicable EU regulations?

The classification of food supplements as food implies that all applicable food regulations must be considered, along with specific rules pertaining to food supplements. This includes regulations related to safety, labeling, and marketing practices. Manufacturers must ensure that their products do not contain harmful substances which could include physical or chemical contaminants, or food ingredients which are banned on safety grounds Additionally, the labeling must accurately reflect the contents of the supplement, including the active ingredients, dosage instructions, and any potential allergens.

Furthermore, claims made about the health benefits of food supplements must be substantiated by scientific evidence to avoid misleading consumers. This necessitates a careful review process to ensure that all claims comply with regulations set forth by food authorities.

In many regions, food supplements are also subject to specific notification requirements before they can be marketed. This may involve submitting detailed information about the product's formulation, manufacturing processes, labels and technical information about ingredients.

Moreover, the classification as food rather than a pharmaceutical product means that food supplements are typically not subject to the same rigurous pre-market approval processes as medications. However, this does not exempt manufacturers from the responsibility of ensuring that their products are safe and effective for consumer use.

An exploration of the websites of national food safety authorities offers an initial glimpse into how this subject is addressed in various member states (the EU can be referenced at: Competent Organisation List; for the UK, visit: Homepage | Food Standards Agency).

Both European and national associations also provide relevant information on this matter.

In general, it is essential to adhere to the following regulations:

• Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers (FIC).
• The national transpositions implementing regulations and in particular, the European Food Supplements Directive (Directive 2002/46/EC).
• Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on Nutrition and Health Claims made on foods - alongside the list of permitted health claims (Regulation 432/2012).

Anyone who has already dealt with food law knows that this fact is already very complex and difficult to understand. However, there is another hurdle to overcome: The EU directive 2002/46/EC on food supplements has been extended at national level to include very different requirements. For example, some countries set precise specifications as to which plants and plant parts may or may not be used in a food supplement. And there are also completely different requirements from country to country with regard to maximum quantities of certain substances (e.g. for vitamins and minerals) which we will explore further below.

What Nutrients and Other Food Ingredients May be Included?

For this specific product categorisation, it is implied that the nutrients and other substances used must fulfill the purpose of quantitatively and qualitatively supplementing the diet.

The qualitative aspect for example, can be considered to be fulfilled if authorised vitamin and mineral sources are used. The quantitative aspect can be taken into account by using a significant amount of such nutrients (e.g. 15 % of the established Nutrient Reference Values).

The "other substances with a nutritional or physiological effect" are partly regulated by the list of prohibited substances in the Food Fortification Regulation (1925/2006), but are otherwise much more difficult to assess, as the broad definition of food according to Regulation (EC) No. 178/2002 is restricted here by the reference to the effect. Due to the lack of a legal definition, a restriction can only be made by derivation. On the one hand, the substances must be foodstuffs, as they must not have an effect reserved for medicinal products (pharmacological, metabolic or immunological). Secondly, they must be "safe" and must have a measurable effect on the human organism (in the form of an effect on the organism's degradation, build-up or remodeling processes or normal bodily functions). Ineffective or harmful substances are therefore excluded.

The purpose of supplementing the normal diet also excludes the supply of macro-nutrients (fat, proteins, carbohydrates), although, some food supplements are developed in formats where energy and macro-nutrients are present in significant amounts.

In general, only "safe" substances may be used in foods and food supplements, which often raises the question of how "safe" my substance is in both a physiological and legal sense.

An authorised list of vitamin and mineral compounds are regulated by Directive 2002/46/EC and its respective national implementation but plant substances or preparations, on the other hand, often present Food Business Operators with challenges.

Some EU member states have established various lists that permit the use of botanicals in supplements and they may be included for use with no restriction or with some restrictions in terms of maximum dose or contaminants that should be controlled. Usually those countries, alongside positive lists, may also have expanded negative lists of banned botanical substances.

Similarly, some EU member states have established positive lists of 'other nutrients' such as amino acids, specific strains of probiotics or enzymes. The EU lacks harmonisation regarding 'other nutrients' and their use in food supplements must take into account national aspects.

Another crucial element in the formulation of a food supplement is the auxiliary ingredients that stabilise the product or provide unique characteristics.

Those are additives and only those authorised under the primary EU law governing food additives, Regulation (EC) No 1333/2008, may be used. Some are authorised at quantum satis while others come with maximum amounts that may be added per daily consumption, possibly additional warning messages, and a delimitation between solid and liquid food supplements is also considered.

Additionally, vertical EU legislation applies to ingredients which provide flavour, as they must adhere to Regulation (EC) No 1334/2008 of the European Parliament and of the Council of 16 December 2008 on flavourings and certain food ingredients with flavouring properties for use in and on foods.

New substances consistently receive authorisations after comprehensive risk assessments, either as new additives or new sources of nutrients (novel foods), and the European Commission will amend the legislation to include the new additions.

What Dosages or Reference Quantities are Possible?

The legally compliant dosage of an ingredient often depends on its safety as assessed by the European Food Safety Authority, also known as EFSA. These assessments are recommendations that have been incorporated into national legislation by some European Union member states. Other countries have created their own list of Upper Tolerable Limits based on a national assessment. For example, maximum recommended levels for vitamins and minerals have been set in Belgium and Poland under their own legislation and principles, while Spain and Portugal are guided by the EFSA recommendations.

The requirements here are very inconsistent across the EU; it is possible that the EU Commission will issue a regulation on maximum amounts of vitamins and minerals in the near future. Until such regulation comes into force, this is another aspect where each country must be considered for possible special requirements.

Although food supplements benefit from free movement of goods in the EU, as the principle of mutual recognition is a cornerstone of the Union and its trade system, products can be challenged and removed on a national level based on safety arguments, where the national authority has determined that products may raise safety risks for the population.

EU-wide regulated maximum levels will initially pose major challenges for some distributors of food supplements. With the support of Regulatory Specialists like ourselves, you can stay up to date with the latest developments and ensure that your products are reviewed and, if necessary, revised in time. This will allow companies to prepare for changes and potentially benefit from a transition period implemented by the EU commission as well.

Plant-based ingredients are not conclusively regulated at European level, which is why safety and dosage often cause difficulties. The dose in such cases shall be established based on available scientific data to ensure safety and nutritional or physiological benefits, but also national legislation must be consulted in many EU member states such as Malta, Belgium, Italy or others which have botanical positive / negative lists.

In addition, another complex subject surrounding botanical ingredients is their medicinal status. Some plants are recognised as medicinal above specific doses, either by virtue of well-established use or traditional use, and the position of health authorities in each country should be considered in order to avoid rulings that your food supplement is actually an unregistered medicine.

Aspects Regarding Nutrition and Health Claims Made on Food and What Other Regulations Apply for the Provision of Food Information on the Label

In terms of food labelling, the provisions of general food law such as the Food Information Regulation (Regulation (EC) No. 1169/2011) must be observed. In addition, there are national regulations based on Directive 2002/46/EC for supplements and other possible rules in regards to certain ingredients (e.g. a law on vitamins A, B6 and D in the Netherlands). Furthermore, it is essential to ensure compliance with labeling requirements that mandate clear and accurate information regarding the composition, nutritional content, and allergen information of food products.

Moreover, manufacturers and distributors should stay informed about any updates or amendments to existing legislation, as food laws can evolve based on new scientific findings, public health concerns, or changes in consumer preferences.

Promoting products with nutrition and health assertions is governed by the NHC Regulation (Regulation (EC) No. 1924/2006) alongside Regulation (EC) No. 432/2012.

A significant number of Health Claims and Nutrition Claims are authorised for use under certain conditions. These claims are mostly authorised for vitamins and minerals, with a small number associated to 'other nutrients' such as barley fibres or beta-glucans, carbohydrates, fructose etc.

In similar fashion to the authorisation of use or dosage management for botanicals, making claims for such ingredients is also a grey area.

Since 2010, both consumers and the industry have been anticipating a conclusive evaluation of the so-called botanicals by the EFSA, which would allow for the lawful advertisement of herbal components. This prolonged wait for clarity has created challenges for businesses seeking to market their products effectively while remaining compliant with the established regulations. The uncertainty surrounding the approval of health claims for botanicals has led many companies to adopt a cautious approach, often limiting their marketing strategies to generic statements about health benefits rather than specific claims that could enhance consumer appeal.

Launching Food Supplements into the UK - Does EU Legislation Still Apply?

The short answer is "NO". Upon EU exit, also known as the event called Brexit, the United Kingdom has left behind the obligation to adhere to any past, present or future EU legislation. However, at the point of departure, all relevant EU food law was and has been transferred into UK statutory law, meaning that on day 1 of Brexit, there was no divergence between the UK and EU.

All aspects mentioned above are still relevant steps when looking to sell compliant food supplements in the UK.

However, since then, the UK has taken a few steps in terms of different risk assessment principles, creating standalone authorisation procedures for regulated foods such as new additives, novel foods, flavourings etc. New procedure of authorisation of nutrition and health claims. As a result of these changes, businesses looking to market supplements in the UK must navigate a distinct regulatory landscape that differs from that of the EU. The UK Food Standards Agency (FSA) and the Department for Environment, Food & Rural Affairs (DEFRA) now oversee the safety and compliance of food, including supplements, which requires companies to be proactive in understanding and adhering to the new regulations.

One significant shift has been the introduction of the UK Nutrition and Health Claims Register (NHCR), which serves as the primary reference for claims related to nutrition and health. Companies must ensure that any claims made on their products are not only scientifically substantiated but also compliant with the specific criteria laid out by UK regulations. This includes ensuring that any health claims are clear, not misleading, and appropriately supported by evidence.

Furthermore, the new risk assessment principles established by the UK government mean that businesses may encounter different thresholds for safety and efficacy evaluations compared to the EU. This could impact the approval process for novel foods, necessitating a thorough understanding of the updated requirements for authorisation.

Importantly, companies must also consider the implications of labeling and marketing their products in the UK. The rules governing product labeling have been updated, and businesses must ensure that their labels comply with UK-specific requirements, including language, nutritional information, and any necessary warnings, disclaimers, and most importantly, the mandatory presence of the Food Business Operator in the UK (mandatory UK address on product labels).

In conclusion, while the foundational principles of food law remain similar post-Brexit, the divergence in regulatory frameworks necessitates that businesses remain vigilant and adaptable. Understanding the specific requirements of the UK market is crucial for ensuring compliance and successfully navigating the evolving landscape of food supplement regulation. As the UK continues to develop its own regulatory standards, companies must stay informed about any changes that may arise and be prepared to adjust their practices accordingly. This proactive approach will not only help in maintaining compliance but also in building consumer trust in a competitive market.

As of the end of 2024, some of the main points where this divergence is observed are:

1. **Difference of Additive Authorisation and Risk Assessment**: The regulatory approaches to food additives, particularly steviol glycosides and titanium dioxide, vary significantly between regions. The status of titanium dioxide has shifted, with the EU banning its use in food due to emerging studies linking it to potential health risks.
2. **Difference in Novel Food Authorisation and the CBD Situation**: The regulatory landscape surrounding Novel Foods, especially concerning cannabidiol (CBD), illustrates significant divergence.
3. **Divergence in Restrictions of Green Tea Extracts**: The regulation of green tea extracts has also shown notable differences. The EU has established limits on the concentration of certain compounds, such as epigallocatechin gallate (EGCG), due to potential adverse effects linked to excessive consumption.

Closing Words

Overall, it should be noted that the regulatory framework for food supplements in the EU is very inconsistent. Some things are regulated by EU requirements, but many things are also recommended or regulated at national level - depending on the market in which the products are to be marketed, this results in new challenges. It should also be noted that many products have to be adapted due to national court rulings, warnings from competitors or assessments by consumer associations.

In addition, the UK is now a third country and a seamless transition of a food supplement from UK to the EU may be a thing of the past.

When companies struggle to navigate the regulatory maze, its important to partner up with regulatory experts who can support your business reach the market in a fast and compliant manner.