The safety of food supplements is currently a hot topic in the European Union. A list of 117 substances has recently been gathered by The Working Group “Food Supplements” of Heads of Food Safety Agencies to identify potential health risks. The working group has provided some initial insights to the risks related to these substances to tackle the health-related aspects associated with food supplement ingredients for consumer protection.
In general, food supplements often contain vitamins and minerals, which are regulated on EU level. However, there is a wide range of so-called other substances, which are not subject to this type of harmonised legislation.
Some substances could be considered novel foods, for which harmonised legislation exists. Authorised novel foods can be used in accordance with the legislation, whereas non-authorised novel foods require authorisation prior to use in food.
This concise blog post explores the legal conformity of other substances used in food supplements within the EU and Nordic countries.
The list of substances for future harmonisation?
In a report concerning the 117 substances on the list, the working group proposed that around a dozen of the substances should be prioritised due to their potential health risks especially in a concentrated form such as in food supplements. The recommendations in the report serve as support for the European Commission.
Next, the European Food Safety Authority (EFSA) will most likely evaluate the prioritised substances from a health perspective. Finally, it is up to the European Commission to decide whether the substances require any regulatory measures. One possibility is that these substances could be banned or restricted in Regulation (EC) No 1925/2006.
The list of substances to be prioritised contains some quite common food supplement ingredients, such as tryptophan and piperine. Moreover, melatonin, which is considered medicinal in several member states, is included; however, the topic is very complex due to the potential medicinal status. Hence, the working group suggests that further assessment concerning melatonin is put on hold. Some examples on current practices concerning melatonin in food supplements in the Nordics are presented further in the text.
National approaches to substances in food supplements
Although a common framework for the regulation of food supplements exists within the EU, national variations persist regarding which substances are permitted or prohibited in the product category of food supplements. These differences can present challenges for food companies seeking to market food supplements across the EU, and, furthermore, compromise the free movement of goods.
While the EU provides a positive list of vitamins and minerals that can be added to food supplements, there is no such harmonised list for other substances, such as botanicals, amino acids, or other bioactive compounds. Member states have the authority to establish their own lists of substances that can or cannot be included in food supplements, as well as their own maximum and minimum limits for vitamins and minerals. National lists exist in e.g. Denmark, Norway, Germany, and several other member states, but not across the whole EU. The presence of such lists can simplify the regulatory process in the countries where they are applied – however, it can also be restrictive, particularly if a substance is widely accepted in other member states or whether one country restricts the quantity of vitamins and minerals whereas others don’t.
Companies must ensure that their products comply with not only the legislative requirements on EU level, but also the potential national restrictions. In many cases no explicit list exists, but instead the potential medicinal status of a substance needs to be assessed before using it in a non-medicinal product. Oftentimes, the evaluation is further based on quantitative and qualitative aspects. This, on the other hand, means that the status of a substance could be both dose-dependent and dependent on the manufacturing process and presentation.
The classification as medicine can drastically change the regulatory requirements, including the need for clinical data, marketing authorisation, and other stringent controls typical of pharmaceuticals.
Orion & Medfiles: 15 years of cooperation in food supplements
Medfiles has been involved in various stages of Orion’s food supplement lifecycle. Medfiles assists Orion in the evaluation of new products and the preparation of labelling for each supplement. In addition, Medfiles experts are responsible for maintaining the supplements on the market and have contributed to the development of shelf-life monitoring and risk assessment for food supplements.
“We have received a thorough and professional service from Medfiles. Medfiles has shown excellent expertise and service spirit, even in complex matters. They have provided us with answers quickly and have been very helpful in moving things forward,” says Niklas Ståhle from Orion.
Compliance of food supplement ingredients in the Nordics
If the company intends to sell food supplements on the Nordic market, one might be surprised by the national differences across this relatively small area. For instance, whether maximum and minimum limits exist for the addition of vitamins and minerals to food supplements depends on the target market.
There are also evident differences in how substances are classified – let’s have a look at melatonin mentioned earlier, a substance widely available on the food supplement market in, for instance, Finland. It’s marketed as contributing to the reduction of time taken to fall asleep as well as through the alleviation of subjective feelings of jet lag in accordance with the list of permitted health claims in the EU. Although being included on the Finnish medicinal list, this particular substance is one of those for which a dose-dependent approach applies.
Sweden has adopted quite the opposite approach. On the Swedish market, melatonin is classified as medicine at all doses, which means that consumers cannot order food supplements containing melatonin from overseas either. In Norway, on the other hand, melatonin is included on the list of certain “other substances” allowed to be used in food supplements at a certain dose, but the dose differs from that in Finland.
It is, therefore, of such great importance to know the ways of the target markets – and we know that it can be a challenge to keep up with all the requirements. Although, this can easily be managed through consulting regulatory experts.
Medfiles – an expert in the regulation of food supplements
Careful planning and staying ahead when it comes to regulatory compliance and changes within the field of food supplements is important for business continuity. While the EU aims for regulatory harmonisation, national differences continue to play a significant role. They may restrict the products’ potential on some markets and help them flourish on others. A harmonised approach, on the other hand, would facilitate the free movement of goods and save companies some valuable time.
Medfiles’ food regulatory experts have strong competence in the regulatory requirements in both Finland and Sweden, but through the partner network also in the other Nordic countries Norway and Denmark. We keep a close eye on the changes and on-going discussions in the EU. The easiest way for companies to provide safe and compliant products and to avoid potential interventions by the authorities or other parties is to come prepared.
If you’re planning to expand into new markets such as the Nordics and are unsure about the local legislation – don’t hesitate to reach out to our expert team!
Author: Mia Gothóni
Team leader, Labelling // Regulatory Affairs Expert, Food
Mia joined Medfiles in 2018, and since then has led and worked with a broad range of projects and different product categories. Mia’s core expertise is in food supplements and food labelling; however, with her linguistic skills (she is bilingual in Finnish and Swedish), she can handle regulatory projects effectively and in a client-oriented manner also in the other Nordic countries.
Mia has a M.Sc. degree in food sciences (nutrition) with minor studies in psychology and communications. Her previous studies in business administration and management provide insight into the needs of Medfiles’ valued clients, not only from a regulatory point of view, but in terms of practical issues, tight schedules, budgets and goals. Together with her team, she helps clients reach new markets, launch products compliant with the applicable legislation and create package labels that serve both the client and the consumer.
Author: Maija Salmenhaara
Regulatory Affairs Expert, Food and feed
Maija has worked at Medfiles from 2019. Her expertise covers regulatory affairs in food and feed, and she has strong competence in regulations concerning food composition and safety, food labelling, nutrition and health claims, novel food ingredients, food supplements and fortified foods.
She is also very experienced with work related to animal feed composition, labelling and marketing claims, with a balanced set of skills in project management, client service and writing reports.
Maija has a M.Sc. degree in food sciences (nutrition) from 2007. Before Medfiles, Maija has worked both in governmental agencies and the private sector, focusing on nutrition research, risk assessment and market research.
