The regulatory landscape for food supplements in the European Union is undergoing significant changes, prompting companies to reassess their product offerings, packaging, and compliance strategies. While some measures are still under consultation, key adjustments are already influencing how supplements are produced and marketed.
Ingredients Under Regulatory Scrutiny
Several supplement ingredients are facing increased scrutiny, with formal safety reviews underway for substances like berberine and hydroxycitric acid (HCA). The European Food Safety Authority (EFSA) has initiated a public consultation to assess their regulatory status. Additionally, concerns are rising about Monacolin K from red yeast rice, with a ban proposed, and new restrictions for Mineral Oil Aromatic Hydrocarbons (MOAH) and Mineral Oil Saturated Hydrocarbons (MOSH) are being implemented. Other ingredients like ashwagandha, CBD, and caffeine are also under examination, although formal assessments have yet to commence.
In positive news, β-NMN (nicotinamide mononucleotide) has received a favorable safety opinion, advancing its path toward EU approval.
Novel Foods
The EU regularly updates its Novel Food Catalogue to reflect regulatory changes based on consumption history before May 1997. CBD has faced a tumultuous year, leading to multiple rejections for novel food applications. Conversely, pomegranate extract and whey protein concentrate with alpha-lactalbumin have been classified as non-novel, allowing them to remain on the market.
Health Claim Updates
This year, only oat-beta glucans received a positive health claim opinion from EFSA, demonstrating its ability to reduce post-meal glucose spikes. Meanwhile, negative opinions were issued for claims related to creatine and Echinacea angustifolia.
QPS List Updates
The Qualified Presumption of Safety (QPS) list by EFSA evaluates microbes for safety and is updated roughly every six months. These updates streamline the safety assessment process for approved microorganisms.
New Legislative Developments
MPLs for Vitamins and Minerals
The European Commission has initiated consultations for setting Maximum Permissible Levels (MPLs) for vitamins and minerals in supplements, with scientific evidence being solicited until the final legal act is expected in early 2028.
Packaging and Waste Regulations
New regulations concerning packaging, particularly regarding PFAS (per- and polyfluoroalkyl substances), will be enforced starting August 12, prohibiting food-contact packaging that exceeds certain PFAS thresholds. Concerns have been raised about the time frame for implementing these changes in the food supplement industry.
UK-EU Sanitary and Phytosanitary Agreement (SPS)
A new SPS agreement between the UK and EU aims to synchronize agricultural, food safety, and environmental standards, expected to come into effect in mid-2027. This alignment will impact ingredient suppliers, manufacturers, and retailers by updating various regulatory requirements.
These developments underscore the dynamic nature of the regulatory environment affecting the food supplement industry in the EU and UK, necessitating companies to remain agile and informed.
