Both the technical report and food additives monograph from JECFA’s 80th meeting have been released. The main conclusions regarding the evaluated food additives are:

  • Benzoates: mean exposure estimates for consumers of soft drinks were below the acceptable daily intake (ADI) of 0–5 mg/kg bw, expressed as benzoic acid, although 95th percentile exposures in some groups of children were in excess of this level.
  • Lipase from the fungus Fusarium heterosporum: an ADI of “not specified” was established [ADI “not specified” is used for food substances of very low toxicity that, on the basis of the available, data do not, in the opinion of the Committee, represent a hazard to human health.]
  • Magnesium stearate: the ADI of “not specified” already established for magnesium salts was confirmed to be applicable to the stearic and palmitic acid salts.
  • Maltotetraohydrolase from the bacterium Pseudomonas stuzeri: an ADI of “not specified” was established.
  • Mixed β-glucanase, cellulase and xylanase from the fungus Rasamsonia emersonii and mixed β-glucanase and xylanase from the fungus Disporotrichum dimorphosporum: an ADI “not specified” was established for both.
  • Polyvinyl alcohol (PVA)–polyethylene glycol (PEG) graft co-polymer: considered to be of low toxicity therefore an ADI “not specified” would normally be established, however there were concerns over potential levels of ethylene glycol and diethylene glycol as impurities in the co-polymer.

Two classes of contaminant (non-dioxin-like polychlorinated biphenyls, NDL-PCBs, and pyrrolizidine alkaloids, PAs) were discussed in detail. There were no suitable toxicity studies from which to derive a health-based guidance value for the PCBs, so JECFA evaluated margins of exposure (MoEs) between levels of dietary exposure in the general population and intakes shown to cause cellular changes in the liver and thyroid. The derived MoEs ranging from 4.5 to 5000 were considered “to give some assurance that dietary exposures to NDL-PCBs are unlikely to be of health concern for adults and children.” For PAs, known genotoxic carcinogens, a benchmark dose limit (BMDL10) of 182 µg/kg bw/day, based on liver cancer in female rats exposed to the PA riddelliine, was derived for use in risk assessment. Concerns were expressed for children drinking tea, and for adult high-consumers of tea and honey.

Other issues discussed at the meeting included:

  • Changes to the number of amino acids in segments used in allergen database searches to predict the sensitisation risk of genetically modified enzymes.
  • Revised guidance for experts preparing JECFA monographs evaluating food additives and contaminants in food and feed.

Joint FAO/WHO Expert Committee on Food Additives (2016).Eightieth meeting. Rome, 16–25 June 2015.

WHO Technical Report Series 995.

WHO Food Additives Series 71.


The above items were taken from the April 2016 issue of Toxicology and Regulatory News which is sent automatically to members of bibra (click here)

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