A recent report from the Heads of Food Safety Agencies in Europe raises concerns about 13 ingredients in food supplements, including curcumin, Hypericum perforatum, Actaea species and Withania somnifera. This article puts this report into context using comments made by the European Federation of Health Products Manufacturers.
What is HoA?
The Heads of Food Safety Agencies (HoA) represents public authorities in Europe responsible for food safety risk management. The HoA helps different authorities work together to monitor compliance with food laws. They also share ideas and experiences to improve, speed up and harmonize enforcement. Representatives of the European Commission’s Directorate-General for Health and Food Safety (DG SANTE) and the European Food Safety Authority (EFSA) also participate in the biennial meetings. The HoA Working Group on Food Supplements was established to create a common approach to the management and assessment of ingredients or nutrients that could pose a risk to public health when used in food supplements.
In the EU, the monitoring of ingredients with functional effects in food is harmonized only for those listed in EU regulations for fortified foods [1] and novel foods [2]. To extend consumer protection, this Working Group discusses which “other substances” should be restricted. The HoA recommends adding these risky ingredients to the fortified foods regulation.
Recently, this Working Group published a report with a list of substances that should not be used or only be restricted in food because of their potential risk to human health. [3]
Summary of the HoA report
The Working Group report addresses the legislation and assessment of substances with nutritional or physiological effects in food supplements across the EU. It lists 117 substances that should be banned or restricted in food supplements to protect public health. Of these, the following 13 were identified as priorities due to potential health risks, given the likelihood that normal intakes of these substances in supplements are exceeded.
- Coumarin in plant preparations;
- Curcumin in Curcuma preparations;
- Hypericum perforatum;
- Melaleuca essential oils;
- melatonin;
- piperin;
- p-synefin in Citrus preparations;
- tryptophan;
- Actaea rhizome;
- Lepidium meyenii;
- Ocimum tenuiflorum;
- Tribulus terrestris;
- Withania somnifera.
What are the industry’s concerns?
The European Federation of Health Products Manufacturers (EHPM) highlights that food supplements are subject to a range of strict EU rules under EU food law that ensure a high level of safety and quality and protect consumers. The EHPM believes that the food supplements industry needs to collect data to address concerns about the safety of food supplements. Existing national reporting systems are valuable tools to further ensure the safety of food supplements in the EU. The EHPM supports its members by providing tools and resources to further improve safety and quality, by advocating for regulatory compliance and best practice. Specifically in relation to the report, the EHPM is concerned about:
- Potentially misleading use of the Article 8 procedure of Regulation 1925/2006. Article 8 provides that the EC may prohibit, restrict or control ingredients. This article should be applied when a safety risk arises and not for arbitrary classification. The HoA approach could lead to misleading use of this procedure for classification purposes, which could set a worrying legal precedent.
- Exceeding the powers of food safety authorities. This approach risks exceeding the powers of food safety authorities and infringing on the risk management responsibilities reserved for the EC and the Member States. Food safety authorities are responsible for carrying out risk assessments, not risk management. The latter falls under the remit of the EC, after a risk assessment has been carried out by EFSA or the safety authorities of the Member States. If food safety authorities have direct influence on risk management decisions, this could undermine the regulatory process and infringe on the legal responsibilities of competent authorities.
- Disproportionate approach based on hazard rather than proven risk. The methodology advocated is worrying. In fact, banning substances based on potential hazard rather than proven risk is not in line with the regulations. This could result in disproportionate risk assessment and management measures. There is a crucial difference between ‘hazard’ (potential for harm) and ‘risk’ (likelihood of harm). Banning substances solely on their hazard profile without clear evidence of actual risk (i.e. exposure levels that lead to harm) is disproportionate and could unfairly disadvantage industry. A risk-based approach rather than a hazard-based approach should be adopted. This means that substances should only be restricted if there is clear evidence of risk under realistic conditions of use, supported by robust data.
- Safety data collection and post-market surveillance. The EHPM will mobilize its members to collect safety data, including real-world post-market surveillance data, which are crucial in demonstrating the true safety profile of the substances concerned. Firms are encouraged to compile comprehensive safety dossiers, including all adverse event reports and exposure data, to provide a factual basis for discussions on safety and regulatory decisions.
Food supplements are regulated by a comprehensive regulatory framework that ensures their safety and quality. Food supplements on the EU market must meet strict quality and safety standards set by various regulations, including the EU Food Supplements Directive (2002/46/EC) and the General Food Law Regulation (EC No 178/2002). These regulations ensure that supplements are safe for consumption and meet specific quality criteria. Manufacturers must use ingredients that are safe and correctly labelled and adhere to good manufacturing practices (GMP) to maintain product integrity and quality. The regulatory framework for food supplements in the EU is designed to ensure that products are effective, safe and accurately labelled. This includes rigorous pre-marketing safety evaluation, adherence to established safety limits and ongoing monitoring of products in the marketplace to ensure product safety. Regulations also require that supplement claims are supported by scientific evidence to ensure that consumers are not misled about the benefits of these products.
The EHPM supports its members by providing resources and tools to help improve the safety and quality of food supplements (e.g. Quality Guide) [4].
The aim of the industry organizations is to ensure that the regulation of food supplements remains fair, evidence-based and appropriately balanced between safety and consumer choice.
[1] https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02006R1925-20210408
[2] https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:02015R2283-20210327
[3] https://www.bvl.bund.de/SharedDocs/Downloads/01_Lebensmittel/Internationales/Report_HoA_WG_FS-de.pdf?__blob=publicationFile&v=8
[4] https://ehpm.org/ehpm-standards/
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