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Posted 10 July 2018 | By Patrick Coppens
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.
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.
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:
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.
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.
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.
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:
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.
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.’
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:
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.
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.
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 email@example.com.
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.
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