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Safety evaluation of the food additive rebaudioside M produced via enzymatic conversion of purified steviol glycosides leaf extracts

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Overview

The EFSA Panel on Food Additives and Flavourings evaluated the safety of rebaudioside M (Reb M, E 960c(ii)) produced by a new enzymatic bioconversion process using a genetically modified Escherichia coli K-12 DSM 35119 strain. The opinion covers proposed EU specification limits for toxic elements, risk characterization at those limits, and an evaluation of batch data submitted by the two applicants. Per the evidence deposit ruling for this unit (HMI-FILL-0005), the EFSA specification limits and health-based guidance values (HBGVs) cited here count as regulatory sources; the batch concentration data are applicant-submitted and are not independent occurrence measurements.

Key numbers

Proposed EU specification limits for Reb M produced by this process (Table 1 in source; proposed by applicants, evaluated and accepted by EFSA):

  • Lead: at or below 1.0 mg/kg (1000 ppb)
  • Total arsenic: at or below 1.0 mg/kg (1000 ppb)
  • Cadmium: at or below 1.0 mg/kg (1000 ppb)
  • Mercury: at or below 1.0 mg/kg (1000 ppb)

These limits are identical to those for Reb M produced by other currently authorized production routes under existing E 960c(ii) specifications, and the EFSA Panel found them appropriate.

Batch data (applicant-submitted; not independent occurrence measurements):

  • Lead, total arsenic, cadmium, mercury: all below 0.1 mg/kg in all six batches (Table 3 in source).

HBGVs applied in EFSA risk characterization (Table 2 in source):

  • Lead: BMDL01 = 0.50 µg/kg body weight per day (cardiovascular and developmental neurotoxicity endpoint; no safe threshold recognized)
  • Inorganic arsenic: BMDL0.5 = 0.3 µg/kg body weight per day (lung cancer; no safe threshold recognized)
  • Cadmium: TWI = 2.5 µg/kg body weight per week (kidney tubular dysfunction)
  • Total mercury: TWI = 4.0 µg/kg body weight per week (neurotoxicity)

Risk characterization: Margin of Exposure for lead at the proposed 1.0 mg/kg limit exceeds 10,000 for mean consumers; margin of exposure for inorganic arsenic exceeds 100. Cadmium and mercury contributions to TWI are below 1% at the proposed limits.

Methods

Analytical methods for the batch measurements are not described in detail in the EFSA opinion; methods are per applicant dossier analytical documentation (ICH Q3D and food additive analytical methods). LOQ is implied at or below 0.1 mg/kg given that all measured values are reported as below 0.1 mg/kg.

Evidence fitness

This source is used for the EU specification limits it cites and the HBGVs it applies, both of which are regulatory positions. The measured batch concentrations are applicant-submitted and are not presented here as independent occurrence data. No independent market survey data for Reb M produced by this route are available in the current literature.

Update history

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