EU Reassesses the Safety of Shellac as a Food Additive

The European Food Safety Authority (EFSA) officially announced on August 1, 2024 that its Panel on Food Additives and Flavorings (FAF) has conducted a comprehensive and in-depth reassessment of the safety of shellac (E 904) as a food additive.

EFSA elaborated on the findings of the FAF Panel, noting that the Panel had established a provisional Acceptable Daily Intake (ADI) standard of 4 mg of shellac per kg of body weight (E 904), which applies specifically to waxy shellac produced by physical decolorization. This ADI value is set on the basis of a non-toxic dose class (NOAEL) of 400 mg/kg body weight, and a 100 times uncertainty factor is carefully applied to ensure a margin of safety.

For wax-free shellac (E 904) produced by chemical bleaching, the FAF Group stressed that further up-to-date data on the type and content of organochlorine impurities needed to be collected in order to finalize their ADI values. At the same time, the FAF group also made it clear that waxy shellac as a food additive, its ADI value is not applicable.

In the course of the assessment, the FAF panel noted that in the non-brand loyalty exposure assessment and maximum exposure assessment scenarios for specific age groups, some individuals slightly exceeded the 95th percentile of the ADI. However, the Panel considers that this slight overshoot does not pose a safety risk, as the assessment methodology is inherently conservative and designed to ensure safety.

Based on these findings, EFSA has made a number of recommendations to the European Commission. It is suggested that different specifications should be developed for E 904 depending on the production process (chemical bleaching versus physical decolorization). In particular, it is proposed to amend the definition of food additives to explicitly include descriptions of various production processes; At the same time, the relevant information on waxy shellac should be deleted, and the acid value standard for chemical bleaching shellac should be revised to lower the maximum limit for lead and introduce limits for other potentially toxic elements. In addition, for shellac produced by chemical bleaching, maximum limits for chloroform and inorganic chlorides should also be set to ensure their safety.