EFSA FAF Panel 2022 — Heavy metals in food additive E 475 (polyglycerol esters of fatty acids)
The EFSA Panel on Food Additives and Flavourings conducted a follow-up risk assessment of polyglycerol esters of fatty acids (PEFA, E 475) to address data gaps identified in the 2017 re-evaluation. Analytical data on toxic elements in 14 commercial E 475 samples were provided by an interested business operator and assessed against current EU specification limits. The Panel concluded that the maximum limits for all four toxic elements (arsenic, lead, mercury, and cadmium) in the EU specifications should be lowered based on the actual levels achievable in commercial product, and that the proposed lowest technologically achievable levels for Hg, Cd, and As do not raise safety concerns at the calculated exposure levels, though the MOE for arsenic was insufficient at the lower end.
Key numbers
- Analytical data from 14 commercial E 475 samples by ICP-MS
- Lead: 4 of 14 samples reported at 0.29 mg/kg (LOQ 0.05 mg/kg); remaining 10 below LOQ (ranging 0.01–0.05 mg/kg)
- Mercury: all 14 samples below LOQ (LOQs ranged 0.005–0.01 mg/kg)
- Cadmium: all 14 samples below LOQ (LOQs ranged 0.005–0.02 mg/kg)
- Arsenic: all 14 samples below LOQ (LOQs ranged 0.02–0.1 mg/kg)
- Current EU specification limits: As ≤3 mg/kg, Pb ≤2 mg/kg, Hg ≤1 mg/kg, Cd ≤1 mg/kg
- Lowest technologically achievable levels proposed by IBO: Pb 2 mg/kg (unchanged), Hg 0.1 mg/kg, Cd 0.2 mg/kg, As 1 mg/kg
- Panel conclusion: lower all four toxic element limits in EU specifications; Pb actual levels substantially below proposed limit even without specification change
Methods (brief)
ICP-MS analysis of commercial E 475 samples submitted by one interested business operator (EFEMA). Risk assessment comparing potential exposure from E 475 use at proposed specification limits against EFSA health-based guidance values (HBGVs) and reference points (RPs). MOE analysis for arsenic; comparison against HBGV for Pb, Hg, and Cd.
Implications
Certification: Documents that commercial food emulsifier E 475 contains trace levels of Pb, As, Cd, Hg well below current EU limits, but also establishes that lower achievable limits are appropriate. Relevant when evaluating food additives as a contamination pathway in certified products. Courses: Illustrates how EU food additive specification-setting works for toxic elements; good example of carry-over contamination from raw material inputs into emulsifiers. App: Food additive E 475 is an indirect source of toxic metals in finished products; contribution is small at current commercial levels.