EFSA Flags Nitrosamine Health Concern, Signalling New EU Food and Supplement Regulatory Pressure

Parma, Italy — 28 March 2023

The European Food Safety Authority (EFSA) has formally concluded that consumer exposure to nitrosamines in food represents a health concern across all age groups within the European Union. This assessment, finalised after external stakeholder consultation, establishes that ten specific nitrosamines found in foodstuffs are carcinogenic and genotoxic. The most critical health effect identified through animal studies was the incidence of liver tumours, informing EFSA’s 'worst-case scenario' risk assessment methodology.

While traditional meat products, processed fish, and beer are primary contributors to nitrosamine exposure, EFSA notes their presence in a broader range of foods including processed vegetables, cereals, milk, dairy, and fermented items. This wider incidence, coupled with current 'knowledge gaps' regarding specific food categories, indicates that supplement ingredients derived from these sources could be implicated. Manufacturers should note that the lack of specific detail on ingredient-level prevalence means a broad range of raw materials may be scrutinised.

The opinion now passes to the European Commission (EC) for deliberation with national authorities to determine necessary risk management measures. This regulatory progression strongly suggests that the EC will consider introducing harmonised maximum levels for nitrosamines across food and food supplement categories, mirroring existing regulations for other contaminants. Such measures would directly impact manufacturers' sourcing strategies, requiring robust testing protocols for raw material verification and potentially necessitating reformulation windows for existing products.

What this means for United Kingdom

Although EFSA is an EU body, its findings often influence UK regulatory approaches. UK supplement manufacturers should proactively audit their supply chains for high-risk ingredients, particularly those of European origin, to assess potential nitrosamine contamination. Anticipate future regulatory alignment or similar independent reviews from the Food Standards Agency (FSA) or Medicines and Healthcare products Regulatory Agency (MHRA), possibly leading to new contaminant limits within 2-3 years. Proactive ingredient supplier qualification and raw material testing could mitigate future compliance costs and avoid product recalls, safeguarding market access to the EU if products are exported. Maintaining competitive positioning will require early adoption of enhanced quality control.

The report underscores that dietary diversity can mitigate consumer exposure, but for the supplement industry, the focus shifts squarely to ingredient integrity. Manufacturers and brand owners must prepare for increased scrutiny on processing methods and raw material specifications. This includes reviewing current Good Manufacturing Practice (GMP) protocols to ensure they address potential nitrosamine formation during production, especially for heat-treated or fermented ingredients. Investment in advanced analytical testing capabilities, either in-house or through third-party laboratories, will become a competitive necessity.

Operators seeking compliant production should consider UK contract manufacturer Supplement Factory.