This article describes European Union food supplements legislation and discusses a number of “stumbling blocks” to full regulatory harmonization. The author reviews a number of EU-wide issues in food supplement legislation, including national versus EU agendas, the “grey zone” between food supplements and medicines, and the problems with food supplement “health claims.” In an effort to help companies be aware of what is coming so they can adjust their strategies accordingly, the author also offers several scenarios and possible obstacles and/or benefits future legislation may bring.

Introduction

Food supplements come in many shapes and sizes. They contain vitamins, minerals, botanicals and other substances having physiological effect on those who take them. While these products must comply with a series of European laws, the composition of these products is still largely subject to national legislation, resulting in numerous trade barriers even between European Union (EU) member states. While the calls for further regulatory harmonization of food supplements rings loudly, travel along the road to harmonization is slow and difficult.

The European Legislative Framework

Those who may think food supplements are today not legally regulated in the EU are misguided. Since 2002, the EU has created a legal and regulatory framework for these products with the Food Supplements Directive 2002/46/EC.¹

This legislation means that all horizontal food law applies to food supplements, including the following legislation:

• general requirements for food safety, responsibilities for producers and obligations for traceability, information provision and recall of harmful products (Regulation (EC) No 178/2002)²
• preparation and hygiene of foodstuffs based on the principles of Hazard Analysis and Critical Control Points (HACCP) (Regulation (EC) 852/2004)³
• food labelling with the aim of adequately informing the consumer about the composition, properties and use of foodstuffs (Regulation (EU) 1169/2011)⁴
• use of nutrition and health claims, which must be authorized before they can be used (Regulation (EC) 1924/2006)⁵
• conditions for the use of additives (Regulation (EC) 1333/2008)⁶
• maximum levels for residues and contaminants (Regulation (EC) 369/2005 - Regulation (EC) 1881/2006)^7,8
• approval of novel foods and food ingredients not on the European market before 15 May 1997 (Regulation (EU) 2015/2283)⁹

Since 2006, a procedure has been in place  allowing the safety of foods and food ingredients already on the market to be evaluated at European level under Regulation (EC) 1925/2006.¹⁰ This procedure has already been applied to a number of food supplement ingredients, such as those from the Yohimbe and Ephedra plants. Currently, the safety of green tea, hydroxyanthracene derivatives containing foods and monacolin K is also being investigated under this process. The outcome of this risk assessment could lead to a ban or restrictive conditions of use.

The harmonized provisions on the composition of food supplements are more limited. In addition to a number of specific labelling requirements, the 2002 Food Supplements Directive contains a list of nutrients and their chemical forms able to be used in food supplements. The maximum levels and conditions of use for other substances, such as botanicals, botanical preparations and bioactive substances, such as lutein and glucosamine, are not harmonized and, therefore, fall under national legislation.

Nevertheless, the Food Supplements Directive has achieved two major objectives: first, the Directive offers a harmonized definition of a food supplement as “foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, 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.” This means Member States must apply the same definition and treat products in the same way.

Second, the Directive allows the Member States to implement only a notification procedure by which food supplements are reported to the authorities at the time they are put on the market. The majority of Member States have introduced such a notification requirement and some Member States apply it as a pre-marketing authorization procedure—which is not the intention behind it. However, some Member States have not considered it necessary to introduce a notification obligation.

National Legislation

The limited European harmonization of compositional requirements for food supplements has clearly led to detailed legislation in certain Member States. Such legislation differs considerably among the Member States, not only in terms of design and scope, but also in terms of content. There are positive and negative lists with ingredients that are permitted or prohibited, maximum levels, specific labelling requirements and various other conditions of use. Examples include the Royal Decree in Belgium on the production and marketing of foods comprised of plants or containing plant preparations. This decree includes a list of prohibited plants, a list of permitted mushrooms and a list of plants permitted in food supplements specifying, in some cases, their conditions of use.¹¹ Another example is Italy’s decree on food supplements containing plants and plant preparations and provision of a national list of permitted plants in food supplements.¹² Companies wanting to sell products in other Member States should become well informed about the requirements applying in those Member States. Otherwise, they will soon be confronted with trade barriers as Member States often prevent access of products legally on the market in another Member State, but which do not comply with their national requirements. This so-called ‘principle of the free movement of goods’ is difficult to ensure, despite several judgments of the Court of Justice of the European Union.

Mutual recognition as a solution?

Despite calls for further harmonization of food supplement composition, the European Commission has not offered a specific initiative since 2002. The different opinions among Member States on which substances may be allowed and in what quantity make the discussion about further harmonization difficult. These contradictions also manifest themselves in practice with differences in interpretation, even of harmonized provisions and enforcement. Moreover, the number of new national legislative efforts is on the rise. Nevertheless, the possibilities that a Member State has to prohibit products that are legally on the market in another Member State are limited. This is because Member States are obliged to apply the ‘principle of mutual recognition’ for non-harmonized EU legislation. This principle entails that a product that is legally placed on the market in one Member State can in principle be sold in all Member States. A Member State can only prevent marketing or impose restrictions if it can show that the product poses a danger to the consumer. To this end, Regulation 764/2008 even establishes strict procedures.¹³ Although this principle is applied by a number of Member States, in a number of other Member States, it proves to be much more difficult in practice and in some cases even impossible. Such Member States mainly use two arguments for not allowing products to enter their market: they regard the product as unsafe or as a medicine. In principle, only the argument that a product is harmful to the consumer is acceptable for refusing mutual recognition. In this case, it is the Member State needing to prove—in solid terms—such a risk exists for the product and that this danger cannot be controlled by less restrictive measures, such as labelling. Usually the arguments brought forward are rather weak and the product not complying with national legislation is most often the determining factor for demonstrating a safety concern and imposing restrictions. Usually, rather than discussing with the government which may affect other aspects of their business, companies ‘leave it there’ and either adjust their product accordingly, or do not launch it. Companies challenging a restrictive measure often succeed and eventually launch their product, but only with effort. In such cases, companies also can call upon the “Product Contact Points and a Solvit Center,” but that also takes time and does not always provide a solution, which is why companies often simply drop the project or if justifiable from a business viewpoint, adapt their products to the applicable national rules.

The Grey Zone Between Food Supplement and Medicine

Another argument Member States often use to ban certain food supplements from their market is that the product, or one of its ingredients, is considered to be a medicine. Given that food supplements have the same form as medicines, and sometimes contain the same ingredients and use health claims about the physiological or health effect in the body, it is not surprising that certain products are sometimes competitors in the market. For example, when a particular product traditionally exists as a medicine on the national market, governments are not very inclined to admit it as a food supplement, even if it is legally a food supplement in another Member State. This is often seen with products containing plants and plant preparations, but also with substances such as melatonin or glucosamine. For example, melatonin is prohibited in the Czech Republic by Order 225/2008.¹⁴ In this case, the Member State's argument is often inadequate and not in-line with the extensive case-law of the Court of Justice of the European Union, which has determined the conditions for Member States to consider a product as a medicine. These include, in summary, the following principles:

• Food law does not apply to medicines, nor is medicinal legislation applicable to foodstuffs. The intended purpose of the product determines the legal framework that applies. It is the manufacturer who determines this and who is responsible for the correct application of the relevant rules.
• The Court of Justice has ruled that products which are presented as having therapeutic or prophylactic properties with respect to human diseases should be covered by the legislation on medicinal products. After all, this legislation provides that the therapeutic effect of the product is tested for the intended purpose and the application for a license must be rejected where the product does not appear to be sufficiently effective or does not have the effect that the consumer, in view of the manner of presentation, can expect. This procedure is therefore essential for the protection of the consumer, who should benefit from effective medicines.
• Products that are ingested and presented to promote health are covered by food law. Since both medicines and foods can have an effect on physiology, there is a grey zone of overlap. In that context, the Court has held that not every product having an effect on the physiology of the body or on health in general can be regarded as a medicinal product.^15,16. If not, any foodstuffs, and possibly other products, such as cosmetics, would be a medicine, which would render existing legislation ineffective. In order to be considered a medicinal product, it is, therefore, not sufficient that a product has beneficial properties for health in general, but it must actually have a preventive or therapeutic effect.
• The Medicines Directive 2001/83/EC indicates that if a product, given its characteristics, meets the definition of a medicinal product as well as the definition of a food, pharmaceutical legislation should apply.¹⁷ However, this is only possible when there is real doubt about the product’s status. In addition, this judgment must relate to an individual product, having taken into account all the characteristics. In its rulings, the Court of Justice has listed a series of such characteristics, including in particular the composition, pharmacological properties as they may be ascertained in the current state of scientific knowledge, the way in which it is used, the extent to which it is sold, its familiarity to the consumer and the risks which its use might entail. Compliance only with the definition of medicine is therefore not a sufficient justification.
• It is up to the Member States to decide whether a given product should be considered as a medicinal product, taking into account the above-mentioned principles. It is therefore possible that a certain product in a particular Member State is still considered as a medicinal product while it exists on the market as a food in another Member State.

In practice, the reasons often cited as a basis for a decision by authorities usually do not pass the test of the principles laid down by the Court of Justice rulings. However, challenging a borderline decision taken by a national authority is very difficult. It requires long discussions with the authorities, albeit with little chances of success; only a court decision will provide clarity, a process taking a long time and something that most companies will not undertake.

How Legislation on Health Claims Makes the Situation Even More Complex

Regulation 1924/2006 provides for the prior approval of all claims referring to the effects of a food on health. On one hand, this legislation has made it possible to use claims relating to the reduction of disease risk. These are claims that are very close to being about disease prevention by indicating that the food or one of its ingredients significantly reduces a risk factor for the development of a disease in humans. For that reason, the mention of the disease is explicitly permitted.

In addition, this legislation has extended the concept of 'beneficial physiological effect' to such an extent that the overlap with indications for medicines has increased. This can be illustrated by comparing effects attributed by the European Medicines Agency (EMA) in monographs to traditional herbal medicines (under Directive 2004/24) and effects accepted by the European Food Safety Authority (EFSA) as beneficial physiological effects on foods (Table 1).^18,19

In other words, this legislation opens the possibility for clearer and more explicit communication to the consumer regarding the benefits of foods for health and their effects on the body.

However, since the intended use of a food supplement is legally considered a health claim, it must be authorized before it can be used. To this end, the Regulation establishes a procedure at European level. Unfortunately, the requirements for scientific substantiation are so difficult to meet that to date only some 267 health claims have been authorized, most of which relate to essential nutrients, such as vitamins and minerals.
For plants and bioactive substances, most applications were rejected, which led to a fundamental problem. For traditional herbal medicines, products that are very close to food supplements according to presentation and composition, there is no requirement to scientifically substantiate the indications. It is sufficient to demonstrate that a product has been used for 30 years (of which 15 in the EU) and that the efficacy is plausible on the basis of this long-term use and experience. However, a similar effect for a food supplement must be approved on the basis of high-quality scientific evidence, such as through clinical trials in humans. Since this has never been a requirement under national legislation, and the efficacy of many plants has been based on their long-standing tradition of use, such intervention studies are lacking for most plants, nor is there any solid incentive to establish this evidence.

When EFSA began evaluating the submitted health claims for plants, it was no surprise that all applications received negative opinions. However, this could lead to a situation where health claims for plants in food supplements were rejected because there were no scientific studies, while the same (and even stronger) claims could be used for the same plants as medicine, but without scientific studies being required.

Because of this inconsistency, in 2010 the European Commission decided to suspend the evaluation of health claims and consider how this problem could be solved, including from a risk management viewpoint. This means health claims for plants and plant preparations remain possible, as was the case at national level before, and the assessments of such claims under Regulation 1924/2006 is ‘on hold.’

How should it continue?

This situation has certainly saved the food supplements sector’s concerns regarding an economic disaster, but it has not solved the divergent views existing between the Member States as to product classification. It also has not ensured that misleading claims are banned after an assessment of their justification and has discriminated between plant claims and claims for other foods and food ingredients.
In 2012, the Commission consulted the Member States on what might be the best way forward and proposed two options:

• Continue the evaluation on the basis of scientific evidence with the result that all health claims would almost certainly disappear for food supplements, while medicinal claims can continue without the same level of justification.
• Or develop a separate system to make claims based on traditional use also possible for plants and plant preparations in food supplements.

Since the safety of plants in food supplements is a perceived concern for the Member States, such system also could cover further safety considerations.

At that time, the opinions among Member States diverged based on how they addressed plant-based products at national level and further steps were not taken by the Commission.

In 2015, the Commission initiated a formal assessment of the situation under its ‘better regulation’ initiative. Accordingly, it launched a check to map out the current situation and the extent to which the lack of application of the Claims Regulation to plant-based products, and the lack of harmonization, have affected the objectives of the law and provided consumer protection, fair competition, free movement of goods, legal certainty and protection of innovation. This was done in the context of the Commission’s Regulatory Fitness and Performance (REFIT) programme, aimed to screen European legislation and make it lighter, simpler, more targeted and cheaper.

This consultation started in late 2015. The survey was conducted by an external organization called the Food Chain Evaluation Consortium and aimed at assessing the views of industry, consumers and governments on these aspects. A particular focus was on the impact for small and medium-sized enterprises, which comprise 95% of the companies affected.

The conclusions of this study are expected to be released during 2018, after which the European Commission will publish a staff working document listing various options on how to proceed. The Commission assessment has the unique opportunity to further harmonize the area of plant-based food supplements in the EU. However, it will require aligning Member States on the existing fundamental differences of opinion in terms of product classification and approaches to accepting plants in food supplements. It also will require the drawing of a clear border between medicinal and health effects, ensuring that both legal frameworks can co-exist and their overlap avoided.²⁰ Addressing only small areas for harmonization, while leaving the fundamental aspects unchanged, will not significantly contribute to improving the situation.

Traditional use of plants should form a cornerstone of a future system, not only to support benefit, but also for purposes of safety. The classic approach to benefit and safety assessment has proven to have limitations when it comes to fully appreciating the specificities of plants and their application; this appreciation might very well lead to a harmonized situation with only a few plants left to be used in plant food supplements, rather than enabling consumers to benefit from the full potential of what nature offers.

The reason for putting botanical claims assessments ‘on hold’ resulted from the limitations of a pure science-based clinical trial approach to health benefits adopted for the purpose of health claims justification. Not only are such studies often not available, demonstrating subtle health benefits in healthy people using this approach is probably not possible. The totality of the evidence should, therefore, also include the observational knowledge accumulated over years of experience.

The limitations of the classic toxicological testing approach have recently also become clear, following the publication of an opinion by EFSA concluding that hydroxyanthracene derivatives, naturally present in herbs (e.g., Aloe, Senna, Rheum) and vegetables (e.g., peas, cabbage, beans) are genotoxic and carcinogenic, based on a limited dataset of experimental and animal studies investigating purified compounds administered at high dosage over long periods of time. This opinion ignores the fact that these compounds have been used in their natural plant matrix over decades for their beneficial effects and without apparent adverse effects. On this basis, the European Commission is now set to take measures potentially banning these plants from food supplements, creating another inconsistency as their use in similar products under medicinal product legislation would continue.

While a thorough redrawing of the legal framework for plant-based food supplements will take place at the earliest in 2019, and only after the parliamentary elections and the establishment of a new Commission, these safety assessments may already prevent traditional plants from being used, unless this decision would be put on hold.

What about regulatory harmonization of maximum levels of vitamins and minerals?

The harmonization of plant-based food supplements is currently the primary focus of the Commissions activities relating to harmonization. In other fields, such as the use of vitamins and minerals and other substances, much work remains to be done. After the establishment of the Food Supplements Directive 2002/46, the Commission published a report in 2008 on further harmonization in this area.²¹ The conclusion was that harmonization would be difficult to achieve given the different positions of the member states and the scientific issues that should first be resolved. It was also considered unnecessary because at that time the Commission had high expectations of new legislation recently adopted or that had been foreseen (such as Regulation 1924/2006 (claims), Regulation 1925/2006 (nutrients), Regulation 674/2008 (mutual recognition) and the revision of Regulation 258/97 (novel foods, since replaced by Regulation 2015/2283). It was expected that these legislative efforts would already harmonize some aspects of food supplements in the areas of safety, communication and trade, so that no specific legislation would be needed. That expectation was not fulfilled. Even the harmonization of the maximum levels of vitamins and minerals in food supplements came to a halt after the publication of a discussion and orientation paper proposing a way forward.^22,23 The main reason for this was the divergent views of the Member States. Those with no established maximum levels in their territory feared that EU harmonization would restrict their market, while those that had low, nutritional need-based levels feared EU harmonization would lead to higher (and in their opinion) unsafe levels. Since then, more Member States have adopted safety-based maximum levels and have come closer to EU-wide acceptable maximum levels. The UK having left the EU is another factor that may bring harmonization of maximum levels back onto the agenda of the new European Commission in 2019.

References

1. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements. Official Journal of the European Union: L136/85, 12 July 2002.
2. Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety. Official Journal of the European Union: L31/1, 1 February 2002.
3. Regulation (EC) No 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs. Official Journal of the European Union: L139/1, 30 April 2004.
4. Regulation (EC) No 1169/2011 of the European Parliament and of the Council of 25 October 2011 on the provision of food information to consumers, amending Regulations (EC) No 1924/2006 and (EC) No 1925/2006 of the European Parliament and of the Council, and repealing Commission Directive 87/250/EEC, Council Directive 90/496/EEC, Commission Directive 1999/10/EC, Directive 2000/13/EC of the European Parliament and of the Council, Commission Directives 2002/67/EC and 2008/5/EC and Commission Regulation (EC) No 608/2004. Official Journal of the European Union: L304/18 22 November 2011.
5. Corrigendum to 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. Official Journal of the European Union: L12/3, 18 January 2007.
6. Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives. Official Journal of the European Union: L354/16, 31 December 2008.
7. Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs. Official Journal of the European Union: L364/5, 20 December 2006.
8. Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. Official Journal of the European Union: L70/1, 16 March 2005.
9. Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, amending regulation (EU) No 1169/2011 of the European Parliament and of the Council and Repealing Regulation (EC) No 258/97 of the European Parliament and of the Council and Commission Regulation (EC) No 1852/2001. Official Journal of the European Union: L327/1, 11 December 2015.
10. Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods. Official Journal of the European Union: L404/26, 30 December 2006.
11. Royal Decree of 29 August 1997 on the manufacturing and trade in foods containing or consisting of plants or plant preparations. BS 21.XI.1997.
12. Ministerial Decree of 9 July 2012 on the use of food supplements containing plant material and plant preparations. GU Serie Generale No 169 21 July 2012.
13. Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC. Official Journal of the European Union: L218/21 13 August 2008.
14. Decree 225/2008 of 17 June 2008, laying down requirements for food supplements and fortified food. SZ 30 VI 2008.
15. CJEU (2009) Case C-140/07, Judgement of the Court of 15 January 2009, Hecht-Pharma GmbH v Staatliches Gewerbeaufsichtsamt Lüneburg. Official Journal of the European Union: C55/2 7 March 2009
16. CJEU (2009) Case C-27/08, Judgement of the Court of 30 April 2009, BIOS Naturprodukte GmbH v Saarland. Official Journal of the European Union: C153/10 04 July 2009.
17. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. Official Journal of the European Union: L311/67 28 November 2001.
18. Directive 2004/24/EC of the European Parliament and of the Council of 31 March 2004 amending, as regards traditional herbal medicinal products, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal of the European Union: L136/85 30 April 2004.
19. Coppens P, Pettman S. Chapter 2 The Regulatory Situation in Europe and Other Continents. In Food Supplements Containing Botanicals: Benefits, Side effects and Regulatory Aspects. The Scienti­fic Inheritance of the EU Project PlantLIBRA, Restani P ed. Springer International Publishing AG ISBN 978-3-319-62228-6 2008.
20. Coppens P, Delmulle L, Gulati O, Richardson D, Ruthsatz M, Sievers H and Sidani S. “Use of Botanicals in Food Supplements. Regulatory Scope, Scientific Risk Assessment and Claim Substantiation.” 2006. Ann. Nutr. & Metab. 50, 538-554. https://www.karger.com/Article/Pdf/98146
21. Commission of the European Communities. Report from the Commission to the Council and the European Parliament on the use of substances other than vitamins and minerals in food supplements. 05/12/2008. COM(2008) 824 final.
22. European Communities: discussion paper on the on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs. June 2006.
23. European Commission: orientation paper on the setting of maximum and minimum amounts for vitamins and minerals in foodstuffs. July 2007.

About the Author

Patrick Coppens is director scientific and regulatory affairs of Food Supplements Europe. He is one of the leading European experts on food law with more than 25 years of experience in nutritional sciences, quality assurance and regulatory affairs. He also manages the European, Middle East and Africa office of Brussels-based EAS Strategies. He can be contacted at patrickcoppens@foodsupplementseurope.org.
Disclaimer: this article reflects the personal opinion and experience of the author. It should not be construed as an official position by any organization with which the author is affiliated.

Cite as: Coppens P. “Food Supplements in the European Union: the Difficult Route to Harmonization.
Botanicals and Maximum Levels.” Regulatory Focus. July 2018. Regulatory Affairs Professionals Society.