The year had barely started when the European Parliament adopted a resolution calling for more harmonization of food supplements; in particular, establishing a negative list of botanicals that should not be used in food supplements and resuming the work on the botanical claims which are currently on hold and can still be used under national legislation.
The year is closing with a similar recommendation from the European Court of Auditors.
A superficial reading of such events may suggest that food supplements are not sufficiently regulated. In reality, the opposite is true.
In 2002, the Food Supplements Directive created a solid legal framework for food supplements under food law. As such, the entire corpus of food law applies to food supplements.
As the 2020 REFIT assessment of botanical claims concluded, EU general food safety rules, existing national regulations and the Fortified Foods Regulation’s Article 8 procedure adequately addresses the safety of foods containing plants and their preparations.
A call for more regulations
So, where does this perception and call for more regulations come from? One factor lies in the fact that compositional aspects of food supplements are regulated nationally in different ways and that mutual recognition is not always accepted.
This renders the assessment of compliance by Member States complex, prompting them to call for further harmonization.
Another factor lies in the fact that a number of uncontrolled products circulate in the EU, mainly via e-commerce, creating frustration which the Member States also hope to solve via harmonized and stricter regulation.
Seeking harmonization
When the Commission evaluated the need for further harmonization in 2008, it concluded that such an undertaking was not feasible due to scientific and methodological difficulties that would need to be overcome.
It was also deemed not to be necessary since much legislation was being put in place at that time that would further harmonize rules, in particular on claims, Article 8, novel foods and mutual recognition.
The fact that the Commission has undertaken several initiatives over the following 15 years shows how complex further harmonization will be, mainly because of the divergent situations in the Member States.
One key instrument the Commission has used to address safety concerns is the Article 8 procedure.
The European Food Safety Authority (EFSA) is expected to publish the outcome on three substances (berberine, sweet and bitter fennel and hydroxy citric acid) in the second quarter of 2025.
Based on these opinions, the Commission will need to decide if, and what, measures are required. Mid this year, the Heads of the National Food Safety Agencies published a report identifying a further 12 substances as a priority for risk assessment by EFSA.
This process will likely start in 2025. It is crucial for companies to submit data when EFSA launches calls for data on these substances.
Given that several November 2024 judgments by the Court of Justice of the EU declared a 2021 decision to prohibit Aloe and its preparations containing hydroxyanthracene derivatives pursuant to the Article 8 procedure unlawful, the Commission must carefully consider its options because the ruling shows that the approach for blank prohibitions of food supplement ingredients, which is currently also foreseen for alpha-lipoic acid, needs refining.
Also, the approach that EFSA takes towards the safety assessment of botanicals shows room for nuance.
One domain that will soon be harmonized is the maximum levels of vitamins and minerals in food and food supplements.
This work has been ongoing for over two years, also illustrating how difficult it is to reach agreement across the Member States on approaches that have been in place for decades at the national level, not least because any change is bound to have economic consequences.
It is therefore sincerely hoped that the harmonized levels will solely be based on the safety requirements that are specified by law and confirmed by the Court of Justice of the European Union (CJEU), rather than on the lowest common denominator that the Member States would accept.
This would not give justice to the seriousness with which companies have formulated product composition based on guidance that has been in place for 20 years.
Relabeling and SME-friendly legislation
If in 2025 maximum levels are established and initiatives are taken on botanicals, the vast majority of the food supplements on European markets today would face massive reformulation and relabeling.
Having seen the intention of the new Commission to reduce administrative burden and focus on the competitiveness of the EU industry, particularly for small and medium-sized businesses which constitute the vast majority of companies in the food supplements sector, we look forward to seeing these principles also applied to new legislation.
We trust that legislation will be guided by necessity and proportionality and that the impact and SME-friendliness of each new measure is assessed and considered before decisions are taken.
The regulatory framework was particularly dynamic in 2024 and is bound to be even more so in 2025. Food Supplements Europe will remain at the forefront, supporting its membership and working towards a regulatory environment fit for both industry and consumers.