Overview
The EFSA Panel on Food Additives and Flavourings evaluated proposed revised specification limits for five fatty acid ester emulsifiers (E 472a: ACETEM, E 472b: LACTEM, E 472d/e: DATEM, E 472f: MATEM) based on occurrence data submitted by the European industry body organization (IBO). The opinion covers current specification limits, occurrence data from industry-submitted samples, IBO-proposed revised limits, dietary exposure estimates, and risk characterization. Per the evidence deposit ruling for HMI-FILL-0005, the EFSA specification limits and HBGVs are regulatory positions; the measured concentration data are IBO-submitted (operator-submitted) and are not independent occurrence measurements.
Key numbers
Current EU specification limits for E 472a,b,d,e,f (Regulation 231/2012; all five variants share these limits):
- Lead: at or below 2 mg/kg (2000 ppb)
- Arsenic (total): at or below 1 mg/kg (1000 ppb)
- Cadmium: no limit set
- Mercury: no limit set
IBO-proposed revised specification limits (Tables 7, 11, 15 in source; proposed by IBO, evaluated by EFSA):
- Lead: at or below 0.5 mg/kg (500 ppb) for all E 472 variants
- Arsenic (total): at or below 0.1 mg/kg (100 ppb) for all E 472 variants
- Cadmium: at or below 0.05 mg/kg (50 ppb) for all E 472 variants (new limit where none currently exists)
- Mercury: at or below 0.05 mg/kg (50 ppb) for all E 472 variants (new limit where none currently exists)
EFSA evaluated these proposed limits as achievable based on the IBO-submitted occurrence data, and additionally supported setting new cadmium and mercury limits where none currently exist.
Occurrence data from IBO-submitted samples (operator-submitted; not independent measurements):
E 472a (ACETEM, n=15): lead median approximately 13 ppb, max 110 ppb; cadmium mostly below LOQ, max 4 ppb; total arsenic mostly below LOQ, max 16 ppb; mercury not detected. Aluminum measured: median approximately 2400 ppb, max 11,000 ppb.
E 472b (LACTEM, n=12): lead median approximately 9 ppb, max 54 ppb; cadmium mostly below LOQ, max 3 ppb; total arsenic mostly below LOQ, max 9 ppb; mercury not detected.
E 472d/e (DATEM, n=18): lead median approximately 14 ppb, max 97 ppb; cadmium mostly below LOQ, max 5 ppb; total arsenic mostly below LOQ, max 13 ppb; mercury not detected.
E 472f (MATEM, n=10): lead median approximately 8 ppb, max 44 ppb; cadmium mostly below LOQ, max 2 ppb; total arsenic mostly below LOQ, max 7 ppb; mercury not detected.
All measured values across all variants were below proposed revised limits (lead 500 ppb, arsenic 100 ppb, cadmium 50 ppb, mercury 50 ppb) and well below current limits (lead 2000 ppb, arsenic 1000 ppb).
HBGVs applied in EFSA risk characterization (Table 28 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
Dietary exposure from E 472 variants: Contributions to toxic element intakes are less than 0.01% of reference values at current and proposed specification limits; described as negligible.
Methods
ICP-MS for lead, cadmium, total arsenic, mercury (LOQ approximately 0.01 mg/kg for lead and arsenic, 0.002 mg/kg for cadmium, 0.001 mg/kg for mercury). ICP-OES for aluminum (LOQ 0.5 mg/kg). Microwave acid digestion, EN 13805:2014 and EN 15763:2010.
Evidence fitness
This source is used for the EU specification limits, the EFSA-endorsed proposed revised limits, and the HBGVs it cites. The measured concentration data are from an industry body organization and are presented here as operator-submitted context only. No independent market survey data for the E 472 series are available in the current literature. The proposed limits are achievable based on the IBO data reviewed, but independent verification of market occurrence would strengthen confidence.
Related evidence
Update history
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