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Safety of chromium-enriched biomass of Yarrowia lipolytica as a novel food pursuant to Regulation (EU) 2015/2283

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The EFSA panel assessed dried, heat-killed yeast biomass grown with chromium chloride and proposed as a food supplement ingredient. Applicant analyses showed about 20 to 23 µg of chromium per gram, identified as trivalent chromium with no hexavalent chromium detected, and the panel concluded that intakes at the proposed use levels stay well below the tolerable daily intake for trivalent chromium.

Key numbers

  • Total chromium in five production lots: 22.4, 20.6, 22.8, 19.3 and 21.1 µg/g; specification maximum 23 µg/g (Table 1, p. 6; abstract).
  • Chromium fractions: 50.2% water-soluble, 43.9% polysaccharide-bound, 4.3% protein-bound; size-exclusion HPLC/ICP-MS of water extract and simulated digestate identified trivalent chromium, no hexavalent chromium peak (p. 6).
  • Chronic dietary exposure to trivalent chromium (from the 2014 EFSA contaminants assessment, as restated): means 0.6 to 5.9 µg/kg bw per day; 95th percentile 1.1 to 7.9 µg/kg bw per day, excluding infants and toddlers (Section 3.7.3, p. 9).
  • Chromium from the novel food at proposed use: 46 µg/day (children 3 to 9 years, 2 g/day) and 92 µg/day (4 g/day thereafter); combined with high dietary intake 9.9, 6.9 and 3.9 µg/kg bw per day, i.e. 3.3%, 2.3% and 1.3% of the tolerable daily intake (Table 5, p. 9; p. 10).
  • Tolerable daily intake for trivalent chromium: 300 µg/kg bw per day (EFSA contaminants panel 2014, NOAEL of a two-year rat study, uncertainty factor 1,000) (Section 3.10, p. 10).

Methods (brief)

Regulatory evaluation of applicant data on production, composition, stability, specifications, fractionation and speciation, combined with prior EFSA exposure and toxicity assessments.

Evidence fitness

Supports statements on the trivalent chromium tolerable daily intake used by EFSA, the reported European dietary exposure range, EFSA views on chromium essentiality, and the composition of one chromium-enriched yeast ingredient. Product data come from the applicant.

Limitations

Composition data are applicant-supplied for one product; no toxicological studies on the novel food; exposure figures are restated from an earlier EFSA assessment rather than newly measured.

Update history

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