Regulatory framework for food supplements in Europe and the new Mutual Recognition Regulation
On April 19th, 2020, the new Mutual Recognition Regulation 2019/515 (1) will apply. Mutual recognition is a principle derived from the case-law of the Court of Justice of the European Union by which member states may not prohibit the sale on their territory of goods which are lawfully marketed in another member state, even where those goods have been produced in accordance with different technical rules. This new Regulation is a revision of current Regulation 764/2008 (2) and has the objective to strengthen the existence of a single market inside the EU (3), given the de facto lack of application of the mutual recognition principle. Food supplements are amongst the goods most affected from this lack of application and are hence one of the potential fields in which the new Regulation will have a greater impact.
Directive 2002/46/EC (4), still in force, was the first approach to a common regulatory framework in Europe on food supplements. It poses a partial harmonization on the rules applicable to the placing of food supplements on the market. However, it leaves some loose ends for future regulations or national transpositions. These non-harmonised areas include the maximum level of vitamins and minerals to be added to food supplements, other substances allowed to be used besides vitamins and minerals, and the obligation for product registration at national level.
Similarly, nutritional and health claims that may be made on foods in Europe are established in Regulation 1924/2006 (5) and Regulation 432/2012 (6). Although the legal relevance of Regulations is higher than that of Directives, some member states have independently legislated on this respect as well.
There is the hope that this new Mutual Recognition Regulation will make it easier for economic operators to commercialize food supplements across the EU, as applicable legislations are currently full of discrepancies between EU and national regulations, and between national regulations from different European member states.
Differences in permitted vs. not permitted ingredients
Active ingredients allowed in food supplements in Europe, as well as their permitted chemical forms, are set out in Directive 2002/46/EC. Nevertheless, this document only deals with vitamins and minerals. Other actives such as probiotics, prebiotics, plant extracts, etc., are not mentioned in this Directive and their regulation is thus left to each country national ruling (7).
In order to regulate these other actives in a coordinated manner, Belgium, France and Italy jointly compiled the “BELFRIT list”, an inventory of plants eligible for use in food supplements. All three countries have included this list in their respective national legislations.
However, not all countries have regulated these other actives. Until as recently as 2018, only vitamins and minerals were allowed in food supplements in Spain. In 2018 new local regulation Royal Decree 130/2018 (8) was passed allowing for the use of other substances for the first time. It indeed regulated the use of ingredients like amino acids, omega-3s and coenzyme Q10, however, all probiotics (excluding S. cerevisiae) and most prebiotics are technically not allowed in food supplements in the country. In order to commercialize these products in Spain, the industry has made extensive use of the mutual recognition principle (mostly with success, in this particular case).
Food additives that may be used in the formulation of supplements have a more established European legislation, and an exhaustive positive list of additives for foodstuffs appears in Regulation 1333/2008. However, the use of additives is not exempt from national particularities, as some countries impose specific rules on them. That is the case of France, which banned titanium dioxide, a common whitener, from its use as an additive in any foodstuff in the country for one year initially, starting in 2020.
Differences in maximum limits in permitted ingredients
This is, arguably together with the discrepancies on health claims policies, the most controversial point. Directive 2002/46/EC sets a provision for the future setting of upper limits for vitamins and minerals in food supplements. The European Food Safety Authority (EFSA) took a step forward in this direction, with a scientific report on Tolerable Upper Intake Levels (UL) for vitamins and minerals. However, this document is a recommendation that has not yet been adopted by the European Commission and therefore compliance is not mandatory for member states. In this scenario, approximately half of European countries have adhered to EFSA’s recommended limits, while the other half have set their own limits based on national scientific assessments, with striking differences, not only with EFSA limits but also between one another (Image).
For example, based on EFSA´s scientific opinion, Vitamin A UL for adults is 3000 μg/day while in Italy it is 1,200 μg/day, in France is 800 μg/day and Germany recommends a maximum of 200 μg/day. These differences are similar for certain minerals: Italy sets iron levels to 30 mg for adults, France limits to 14 mg, being Germany again more restrictive with their recommendation of 6 mg, whereas EFSA’s scientific panel hasn’t even set a limit for iron.
In the case of Germany and Poland, published maximum levels are just a recommendation. However, in other countries like France and Italy these limits are legally binding.
This situation has led to cases like Noria Distribution SARL v France (9) in the Court of Justice of the European Union in which Noria Distribution, a French company, was prosecuted in France for selling products exceeding the maximum daily doses established in French legislation. One of the Court conclusions was that, even if national authorities are competent for setting upper limits of vitamins and minerals, they shall also ensure the free movement of goods within the Union. Furthermore, the Court also indicated that these levels should be established in compliance with the principles provided in Directive 2002/46/EC, requiring a risk assessment based on generally accepted scientific data and not just national reports. Something illustrative on the poor visibility and application of the still current Mutual Recognition Regulation is that, even though the free movement of goods was the crux of the matter, no reference was made to Regulation 764/2008 in the judgement of the Court.
Differences in health claims
Claims are the subject of probably the fiercest battles between the industry and the authorities, as only health claims previously authorised by the European Commission may be used. On one hand, authorities (lawfully) are not willing to permit any claim which may be misleading or related to the prevention or treatment of diseases. On the other hand, claims are practically the only resource for industry to give information about the intended use for the supplement, i.e. normal function of immune system, for most multivitamins.
Consequently, the scientific requirements for the substantiation of a health claim are so hard that up to date, out of 2,338 applications from industry, only 261 are approved and 2,077 rejected.
There is a special situation with regards to botanicals, as most claims are “on hold”. When EFSA began their evaluation, none were compliant with the scientific requirements, so they were all rejected. Meanwhile, for the same botanicals with the same scientific evidences, similar health claims (or even stronger) are being made on plant-based medicines. EFSA decided to halt the assessment and leave these claims in a kind of limbo, being possible to use them until the evaluation is resumed and a verdict is issued.
Italian authorities, on this sense, decided to regulate the situation with the publication of a list of authorized claims for botanicals. In fact, Italy has a history of legislating on the use of claims not authorized in other member states. For instance, the use of the very words probiotic or prebiotic is considered an unauthorized health claim potentially misleading for consumers in most European countries. However, Italian authorities permit not only the use of those terms but also specific health claims related to these ingredients.
Differences in warnings
Regulation 432/2012, where health claims are listed, also includes mandatory warnings for some substances, that must be added to the labelling of any foodstuff containing those substances. However, again, some member states have added additional warnings for certain ingredients.
Warnings for monacolin K in Italy are mandatory for pregnant women, while in EU Regulation no warning is included for this ingredient (at least yet). The same situation exists in Spain, where specific warnings have been set in the above mentioned new Royal Decree 130/2018. For instance, supplements containing beta-glucans are exempt from warnings according to EU Regulation, however they must hold a special advice regarding consumption together with medicines and other supplements containing fiber in Spain.
On ingredients not regulated by the EU, plants for instance, warnings have been added in some countries, which also may differ from one to another. Italy has recently set a warning restricting curcumin’s use in persons with altered hepatic or biliary function, being the only country holding a warning for curcumin.
Differences in market-placing procedures
Directive 2002/46/EC left the enforceability for product registration to national authorities, for monitoring purposes, providing no harmonized procedure to be followed for such registration.
Some countries such as France, Italy, Portugal, Belgium and Spain have set up notification systems by which companies must inform the authorities about their intention to place a food supplement on the market within their jurisdiction. This notification obligation also applies when the product is being legally marketed in a different EU country (i.e. when mutual recognition is being used).
In other territories like the UK (throughout its entire permanence in the EU) and Sweden, there is no need or system to notify the authorities about the intention to market a new food supplement.
Where they exist, notification systems have slight differences, price being one of them. Whereas some member states (e.g. France, Germany, Portugal) do not charge notification fees, others like Belgium and Italy charge around €200 per product. In Spain this price depends on where the notifying company is based, ranging from no fees in certain regions, to up to €200 in other autonomous communities. However, if the notifier is based within the EU but outside the Spanish territory, fees climb up to almost €1,000 per product, which can make a difference given the large product portfolio many food supplements companies have.
How new Regulation aims to solve these differences
The Regulation introduces several new mechanisms to promote the free movement of goods, therefore making it easier for companies to sell their products across the entire Europe.
It aims at easing administrative procedures by introducing the Mutual Recognition Declaration, a voluntary self-declaration of current lawful marketing of products in a different EU country. The law also elaborates on the procedure by which a Member State can evaluate whether goods are being legally marketed in another Member State and establishes that the economic operator involved shall maintain its right to market the goods in question in that country throughout the duration of the process. It also establishes a problem-solving procedure, SOLVIT (10), which consists on a non-judicial mechanism to resolve conflicts between individuals or businesses and member states.
Nonetheless, and for obvious reasons, the new Regulation also allows member states to allege safety concerns to (at least, temporarily) prevent the commercialization of new products in their jurisdiction based on public health or safety concerns. Given that the limits and restrictions that national authorities have put in place are based on their own risk assessments, and despite other provisions of the Regulation and the European case-law, member states might still effectively enforce their own rulings.
There is therefore room for hope that the new Mutual Recognition Regulation will help in the free movement of goods and in the legislative harmonization in Europe. However, only time and experience will tell if it does so with food supplements.