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Scientific opinion on the amendment of the specifications for vegetable carbon (E 153) as a food additive

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Overview

The EFSA Panel on Food Additives and Flavourings evaluated a proposed amendment to extend the authorized use of vegetable carbon (E 153) to food supplements, based on new occurrence data for toxic elements and polycyclic aromatic hydrocarbons (PAHs). The opinion covers current EU specification limits, measured concentrations in commercial samples and applicant batches, proposed revised limits, and risk characterization. Per the evidence deposit ruling for HMI-FILL-0005, the EFSA specification limits and HBGVs are regulatory positions; concentration data from the 10 EU market samples are independent; concentration data from the 5 applicant batches are operator-submitted.

Key numbers

Current EU specification limits for E 153 (Regulation 231/2012):

  • Lead: at or below 10 mg/kg (10,000 ppb)
  • Arsenic (total): at or below 10 mg/kg (10,000 ppb)
  • Cadmium: at or below 1 mg/kg (1000 ppb)
  • Mercury: at or below 1 mg/kg (1000 ppb)
  • Benzo[a]pyrene: at or below 10 µg/kg
  • Sum of 4 PAHs: at or below 50 µg/kg

Proposed revised specification limits (accepted by EFSA for food supplements extension):

  • Lead: at or below 10 mg/kg (unchanged)
  • Arsenic (total): at or below 5 mg/kg (tightened from 10)
  • Cadmium: at or below 1 mg/kg (unchanged)
  • Mercury: at or below 1 mg/kg (unchanged)
  • Benzo[a]pyrene: at or below 5 µg/kg (tightened from 10)
  • Sum of 4 PAHs: at or below 30 µg/kg (tightened from 50)
  • Sum of 16 EPA PAHs: at or below 500 µg/kg (new limit)

Measured concentrations in 10 EU market samples (independent, Table 2 in source), mg/kg dry weight:

  • Lead: below LOQ (20-100 ppb) to 3.2 mg/kg (3200 ppb); mean approximately 860 ppb
  • Total arsenic: below LOQ to 2.1 mg/kg (2100 ppb); mean approximately 740 ppb
  • Cadmium: below LOQ (5-20 ppb) to 0.12 mg/kg (120 ppb); mean approximately 40 ppb
  • Mercury: below LOQ (2-10 ppb) to 0.03 mg/kg (30 ppb); mean below LOQ

Measured concentrations in 5 applicant batches (operator-submitted; Table 2 in source):

  • Lead: 0.21-1.4 mg/kg (210-1400 ppb)
  • Total arsenic: 0.08-1.2 mg/kg (80-1200 ppb)
  • Cadmium: below LOQ to 0.05 mg/kg (50 ppb)
  • Mercury: below LOQ

All measured values were below the current specification limits and below the proposed revised limits.

Key observation (p.8 in source): “The Panel noted that the highest aluminium level (990 mg/kg) is close to the IBO’s proposed limit of 1000 mg/kg and that the highest lead level (1.53 mg/kg) exceeds the proposed limit of 1 mg/kg.” These values are from the applicant-submitted (IBO) data context.

HBGVs applied in EFSA risk characterization (Table 7 in source):

  • Lead: BMDL01 = 0.50 µg/kg body weight per day (no safe threshold)
  • Cadmium: TWI = 2.5 µg/kg body weight per week
  • Inorganic arsenic: BMDL0.5 = 0.3 µg/kg body weight per day (no safe threshold)
  • Total mercury: TWI = 4.0 µg/kg body weight per week
  • Aluminum: TWI = 1000 µg/kg body weight per week (EFSA CONTAM Panel 2024)
  • Benzo[a]pyrene: BMDL10 = 1.4 µg/kg body weight per day

Methods

  • Toxic elements (lead, cadmium, arsenic): ICP-MS, microwave-assisted acid digestion.
  • Mercury: CV-AAS or DMA.
  • Inorganic arsenic speciation: HPLC-ICP-MS.
  • PAHs: GC-MS or HPLC-fluorescence.
  • LOQ ranges: lead 0.02-0.10 mg/kg, cadmium 0.005-0.02 mg/kg, arsenic 0.02-0.10 mg/kg, mercury 0.002-0.01 mg/kg, benzo[a]pyrene 0.1-0.5 µg/kg.

Evidence fitness

The 10 EU market samples are independently collected commercial samples and are used here for occurrence context. The 5 applicant batches are operator-submitted and are presented as such, not as independent measurements. PAH contamination is the primary safety driver for E 153; toxic metals are a secondary concern at current market concentrations.

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