New directives to protect consumers
The regulation of „other substances” with nutritional or physiological effects in food supplements is currently not fully harmonised in the European Union. Although common directives for such substances exist, for example for novel foods as defined in Annex III of Regulation (EC) No 1925/2006 or in Regulation (EU) No 2470/2017, the lack of a harmonised approach to risk management remains a challenge. This may cause obstacles to the free movement of goods and a high level of consumer protection within the EU.
To address this, the Heads of the European Food Safety Authorities (HoA) have set up the Working Group on Dietary Supplements (HoA WG FS), which brings together 26 participating experts. The aim of the WG is to draw up a list of substances that should either be completely banned or restricted to a certain extent in food supplements.
The WG has so far collected risk assessments for 117 different substances, as well as data on the status of novel foods and other relevant factors. Of these, 13 substances have been identified that may pose a particular risk to consumers with the increased intake of food supplements required for the average daily diet. The HoA recommends the inclusion of these substances in Annex III to Regulation (EC) No 1925/2006 under the ‘Article 8 procedure’.
The working group also recommended that potential novel food substances should be submitted to the EU Commission in order of priority, for example on the basis of national lists and RASFF reports. It is worth noting that these recommendations are not intended to replace the decisions of the EU Commission’s working groups, but are intended only to support them and to facilitate their legislative processes.
This new approach could represent a significant step forward in terms of transparency in the food supplements market and consumer safety, while continuing to support the creation of a harmonised regulatory environment in the European Union.
Why do we need a single framework?
The safe use of food supplements is receiving increasing attention from both EU regulators and businesses. In the EU, food supplements are food and are therefore covered by general food legislation, such as Regulation (EC) 178/2002. These make it the responsibility of food operators to ensure that their products are safe.
The composition of food supplements: what does the EU regulate?
Food supplements are concentrated sources of nutrients (vitamins and minerals) or other substances with a nutritional or physiological effect. The main parts of the regulation that apply to them are:
– A list of authorised vitamins and minerals, as set out in the Annexes to Directive 2002/46/EC.
– The regulation of „other substances”, such as plant extracts, amino acids or bacterial cultures, which is dealt with in a specific article of Regulation (EC) 1925/2006.
It is worth noting that there are currently no uniform maximum intake levels for vitamins and minerals in the EU. The European Commission (EU COM) is working on a model to ensure that safe levels are set.
"Other substances" and legislative challenges
The regulation of „other substances” (ingredients that are not vitamins or minerals but have a nutritional or physiological effect) raises a number of issues. The EU currently addresses safety concerns related to these substances under Article 8 of Regulation 1925/2006:
– Substances can be banned, restricted or placed on a watch list, which is reviewed every four years.
– Ingredients in the „Novel Food” category, which were not present on the European market before 1997, are subject to a separate authorisation process under Regulation (EU) 2015/2283.
Currently, only a few substances are listed as banned or restricted, such as berberine, Garcinia cambogia and alpha-lipoic acid. The authorisation process for new substances is time-consuming and challenging for industry players.
Why is harmonisation important?
The lack of harmonised legislation in the EU makes it difficult to place food supplements on the market and can hinder the free movement of goods.
The European Commission is therefore working to:
- set safe maximum intake levels.
- place ‘other substances’ within a single legal framework.
- make the authorisation process for novel foods faster and more transparent.
What does this mean for industry players?
For companies that produce and market food supplements, it is crucial that they know and comply with the regulations. Regulatory compliance not only increases consumer safety, but also helps them to enter new markets. Companies that proactively follow regulatory changes can gain a significant competitive advantage in the EU market.
The pursuit of harmonisation is not only an administrative relief, but can also offer a long-term perspective for the sustainable development of the food supplements market.
