Food Enzymes and Processing Aids: Regulatory and Scientific Consulting Services

Yes there is a new section for the environmental risk assessment and there are some changes in the tox section. The administrative Guidance has also been updated.  

The 2026 Guidance does not automatically require additional toxicological studies beyond the tiered framework, but it explicitly states that the standard decision tree is not fully applicable to infants below 16 weeks. Applicants must provide a dedicated exposure assessment for this population and justify that the derived safety margin is adequate in light of neonatal physiology (immature metabolism, renal clearance, immune system development). Where toxicokinetic differences may lead to higher internal exposure, further justification or data may be necessary. The adequacy of uncertainty factors must be explicitly discussed.

Under the 2026 Guidance, EFSA expects exposure modelling to reflect total potential dietary intake, including current authorized uses and proposed modifications. Even if the extension appears limited, cumulative exposure must be assessed to ensure that overall intake remains below the relevant reference point. A stepwise modelling approach may be discussed at pre submission stage, but the final assessment must demonstrate combined exposure.

The 2026 Guidance does not establish a universal numerical threshold for impurity assessment. Evaluation is based on toxicological relevance, structural alerts, and estimated exposure levels. Applicants should apply a risk based approach and may use TTC principles where scientifically appropriate. Clear justification must be provided for impurities deemed of no safety concern.

A screening level environmental assessment is expected for all additives under the 2026 Guidance. A full environmental risk assessment (ERA) is required where screening indicates persistence, bioaccumulation potential, toxicity, or possible PBT/vPvB (very persistent and very bioaccumulative substances (vPvB substances) concern. The decision is case specific and depends on chemical structure, metabolic fate, and predicted environmental concentrations. NOTE: Applicants are encouraged to discuss ERA triggers during pre-submission dialogue with EFSA.

Yes, if genotoxicity is confirmed in vivo via a relevant route, the Guidance states that safety cannot be established and further toxicological testing should not proceed. This reflects the principle that genotoxic carcinogens are not considered acceptable in food under the additive framework. Applicants should therefore resolve genotoxicity concerns before conducting higher-tier studies. Early genotoxicity assessment is strategically critical.