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More than 90 experts gathered at this year’s Fresenius Conference in Mainz to discuss current market trends, scientific findings and regulatory developments.
1. Botanicals in the spotlight of legislation and regulation
The use of plants and plant extracts in food supplements remains a legally complex issue. There are no harmonised regulations across Europe for many so-called 'other substances', and Germany has no binding positive or negative lists. Consequently, the marketability, safety and novel food status of these substances must be assessed on a case-by-case basis. Distinguishing them from medicinal products is also crucial. Representatives from the official food control authorities emphasised that a substance must have a nutrition- or physiology-specific effect. If it also has a pharmacological effect, however, the product may be classified as a medicinal product. While the dietary supplement industry prioritises clear labelling for consumers, regulatory authorities focus on the analytical traceability and comparability of products. Substances responsible for the effect must be named and quantified (Section 4(3) of the NemV). If these are unknown, information on extraction solvents and the drug-to-extract ratio (DEV) is important. Meaningful product specifications are therefore essential for quality assurance. The food control authorities also consider suitable and validated analytical methods to be key in verifying the declared levels, particularly when specific constituents such as catechins, flavonoids or polyphenols are highlighted. This means that businesses must analyse and document the identity, composition, relevant constituents and purity in a traceable manner. Specifications and certificates of analysis should be available to submit to the supervisory authority at any time upon request.
2. Beauty Claims vs. Health Claims: Advertising requirements
What constitutes a beauty claim and what constitutes a health claim under the Health Claims Regulation when it comes to skin, hair or nails? On 9 October 2025, the Federal Court of Justice (BGH) ruled on collagen drink ampoules, providing greater clarity regarding beauty-related advertising claims (BGH judgment of 9 October 2025 – I ZR 135/24). The BGH classified three of the six contested advertising statements as 'beauty claims' and three as 'health claims'. The decisive factor is how the average consumer understands the statement in its overall context. Beauty claims describe exclusively aesthetic effects, such as 'beautiful skin' or 'shiny hair'. While they do not fall under the Health Claims Regulation, they must not be misleading. However, if links to bodily functions or health are implied, this constitutes a health claim, to which the requirements of Regulation (EC) No 1924/2006 apply. Statements regarding bioavailability must also be considered on a case-by-case basis. Describing how an ingredient is absorbed does not constitute a health claim in itself. However, if it is linked to a specific bodily function or promises a health benefit, it may be regarded as such.
3. Current priorities in food control
Market trends, social media, and products with unclear intended uses present new challenges for food control. One example of a current market trend is shilajit. Traditionally used in Ayurveda, this natural product has increasingly become popular thanks to social media. Investigations by the CVUA Stuttgart revealed significant irregularities. Frequent inadmissible health-related advertising claims were made regarding energy balance, the immune system and testosterone levels. Furthermore, the advertised mineral content was mostly below one per cent of the nutrient reference values in accordance with Regulation (EU) No 1169/2011. The samples also contained foreign substances such as MOSH/MOAH, 5-hydroxymethylfurfural and chlormequat. Three samples had been adulterated. Another challenge arises from products that are originally marketed as laboratory chemicals or research substances (such as methylene blue or lithium), but which are increasingly likely to be consumed by the public. Classification under food law is not determined solely by the label and packaging; rather, the product must be considered in its overall context. Social media, influencers, online communities and user reviews can also influence the consumption of such products.
4. New Reference Values for Vitamins and Their Practical Implications
The new calculation factors for vitamin E and folate affect formulation, analysis, and nutrition labelling. These are based on the updated GDCh conversion tables from November 2025 and the ALS statement on labelling folic acid and folates. This gives rise to new practical questions, particularly with regard to the calculation and declaration of these two vitamins. For instance, the ALS statement suggests that folate content should typically be calculated as dietary folate equivalent (DFE). The reference value of 200 µg specified in Annex XIII of Regulation (EU) No 1169/2011 also refers to this. However, the declaration continues to be made under the name 'folic acid'. In the case of vitamin E, the focus is on distinguishing between different tocopherol isomers. According to the EFSA assessment, only certain forms of alpha-tocopherol possess vitamin E activity. The updated calculation factors may therefore lead to changes in vitamin E levels. For manufacturers, this may necessitate adjustments to raw material usage, formulations, and production costs. Analytical testing also presents challenges as standard methods cannot always distinguish between the different isomers. Furthermore, different calculation approaches within the EU may result in inconsistent labelling.
5. MOSH/MOAH: regulatory requirements
Saturated mineral oil hydrocarbons (MOSH) and aromatic mineral oil hydrocarbons (MOAH) can enter food through packaging, lubricants, additives, or during transport and processing. While the EFSA did not consider the current dietary exposure to MOSH to be a cause for concern in 2023, it does consider MOAH to be a cause for concern due to their potential genotoxic and carcinogenic effects. The draft regulations, adopted in May 2026, set maximum levels for MOAH in the Contaminants Regulation (Regulation (EU) 2023/915), and provide for the monitoring of MOSH and MOAH. In addition, uniform guidelines for sampling and analysis are planned. The regulations are scheduled to come into force on 1 January 2027. For certain food categories, the maximum levels will not apply until between 2028 and 2030. Food supplements are expressly included. Where the maximum levels set out in Regulation (EU) 2023/915 are exceeded, a case-by-case assessment is required. In addition to establishing the toxicological relevance, this assessment must clarify whether there is a health risk. This may result in measures such as suspension, withdrawal or recall. Therefore, it is becoming increasingly important for manufacturers to control potential sources of contamination and analyse their products for MOSH and MOAH levels on a risk-based basis. They must also carry out a thorough assessment of any abnormal findings.
6. Contaminants and residues: Analysis and risk assessment
Food supplements present specific challenges in terms of analytical testing. The use of a wide variety of raw materials, global supply chains, complex formulations and concentrated extracts can introduce contaminants or complicate measurements. The responsibility for product safety lies with the distributor. Test plans for food supplements should therefore be risk-based. The origin, processing and daily dose of the raw materials determine which risks are relevant and which tests are required. Supplier data, certificates and batch-specific certificates of analysis are important for this purpose. Relevant substance groups include MOSH/MOAH, pesticides, pyrrolizidine alkaloids, tropane alkaloids, perfluoroalkyl substances (PFAS), heavy metals and polycyclic aromatic hydrocarbons (PAHs). The example of MOSH/MOAH illustrates just how important it is to choose the correct method. The standard LC-GC-FID method can be affected by naturally occurring substances and overlapping signals. This can lead to false positives or elevated detection limits. Where signal assignment is unclear, two-dimensional analysis can aid qualitative confirmation. An extended method also enables more precise quantification. The decisive factor is the concentration that can be relied upon after the separation of interfering components. The details matter with 3-MCPD and glycidyl esters too. introduces new requirements, including those relating to compound foodstuffs. Manufacturers must check which substances are covered by the laboratory value and whether it refers to the entire product or just the fat content. The measured value, maximum level and limit of quantification must all be based on the same reference point.
YOUR PLUS: For decades, AGROLAB LUFA GmbH in Kiel has been supporting leading food supplement manufacturers by providing expert advice on appropriate testing ranges, accredited analytical methods, and the competent evaluation of results. As a reliable partner, we monitor market trends and share our assessment of potential new risks with our customers.
Author: Anika Wolf, dietary supplement expert, AGROLAB LUFA GmbH
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