EFSA FAF Panel 2022 — Heavy metals in PGPR food additive (E 476)
The EFSA Panel on Food Additives and Flavourings conducted a follow-up risk assessment of polyglycerol polyricinoleate (PGPR, E 476), an emulsifier used in chocolate, emulsified sauces, and other foods, focusing on updating EU specifications for impurities including arsenic, lead, mercury, and cadmium. In 13 commercial E 476 samples analyzed by the interested business operator (IBO), all four toxic element concentrations were below limits of quantification (LOQs). The Panel concluded that the current EU specification limits for these four elements should be lowered, as actual levels in commercial product are substantially below the existing limits. For arsenic, the margin of exposure was insufficient at the lower end of calculated values; for lead, mercury, and cadmium, proposed lowest technologically achievable levels do not raise safety concerns.
Key numbers
Food additive analyzed: Polyglycerol polyricinoleate (PGPR, E 476); used as emulsifier in chocolate and cocoa products, emulsified sauces, and proposed for edible ices. ADI: 25 mg/kg body weight/day (revised from 7.5 mg/kg bw/day in the 2017 re-evaluation). Analytical samples: n=13 commercial E 476 samples. Method: ICP-MS and ICP-OES.
Measured results (all below LOQ): As all samples <LOQ (LOQ range 0.01–0.1 mg/kg); Pb all samples <LOQ (LOQ range 0.01–0.05 mg/kg); Hg all samples <LOQ (LOQ range 0.005–0.01 mg/kg); Cd all samples <LOQ (LOQ range 0.005–0.02 mg/kg).
Current EU specification limits (Commission Regulation (EU) No 231/2012): As ≤3 mg/kg; Pb ≤2 mg/kg; Hg ≤1 mg/kg; Cd ≤1 mg/kg.
Proposed lowest technologically achievable levels (IBO proposal): Pb 0.5 mg/kg; Hg 0.1 mg/kg; Cd 0.2 mg/kg; As 1 mg/kg. These values are based on the highest measured value or LOQ, whichever is higher, multiplied by a factor of 10.
Panel conclusion: Current specification limits should be lowered to match achievable levels. For arsenic specifically, even at the proposed achievable level, the lower end of the margin of exposure range was considered insufficient, warranting attention to arsenic content in raw materials (castor oil and glycerol) used in E 476 manufacturing.
Extension of use proposed: edible ices at up to 4,000 mg/kg; emulsified sauces at up to 8,000 mg/kg. Extension would not give rise to safety concerns at these levels.
Methods (brief)
Regulatory review of data submitted by one interested business operator (IBO). EFSA performed risk assessment comparing exposure estimates (from use of E 476 at authorized and proposed levels) against health-based guidance values and reference points for As, Pb, Hg, and Cd. Dietary exposure calculated by multiplying impurity concentrations by estimated E 476 dietary exposure and compared to HBGV/RP. The finding that all 13 samples were below LOQ is the key data point; no measured concentrations reported for the food additive itself.
Limitation: Only 13 samples; data submitted by a single IBO. Actual product concentrations not reportable (all below LOQ). Speciation of arsenic (inorganic vs organic) not differentiated.
Implications
Certification: PGPR is used in chocolate production. This opinion establishes that actual heavy metal levels in commercial E 476 are far below current EU specification limits, supporting the reasonableness of supply-chain specifications for food additives. The arsenic concern at the achievable level is a supply-chain alert.
Courses: Illustrative example of how food additive specifications for heavy metals can lag behind what is technologically achievable in commercial production.
App: PGPR is a food additive ingredient in chocolate and emulsified sauces; its heavy metal contribution to the final product is negligible at commercial use levels (1,000–10,000 mg/kg in the additive equates to very small per-serving exposure given typical PGPR use levels).