Hi Jason,
You will need to refer to local/national legislation first and also legislation in the country that your products as sold. Just a warning that the levels quoted are not absolute, opinions vary and it up to you and your organisation to decide if you wish to apply best practice and if it is practical. See the links and quotes below.
FAO/WHO RISK ASSESSMENT OF FOOD ALLERGENS PART 2: REVIEW AND ESTABLISH THRESHOLD LEVELS IN FOODS FOR THE PRIORITY ALLERGENS
CHAPTER 9 DEFINITION OF REFERENCE DOSES (RfDs)
9.2 SUMMARY AND CONCLUSIONS ON HAZARD CHARACTERIZATION
‘The group also reviewed the supporting data from the Remington et al. (2020) and Houben et al. (2020) manuscripts with a focus on reaction severity characteristics at ED01/ED05/ED10. Over 1 100 data points lent themselves to this analysis. Evidence indicated that reactions at levels of exposure up to and including the ED05 could include mild anaphylaxis, but none of the reported reactions met the World Allergy Organization (WAO) definition for severe (i.e. life-threatening or refractory) anaphylaxis (although the group acknowledged that the dataset examined does not preclude the possibility of such a severe reaction). The group also found that, on the basis of the available evidence, the characteristics of objective (externally observable) reactions were no different at ED01 and ED05, with up to 5 percent of individuals with objective symptoms to that level of exposure developing symptoms consistent with anaphylaxis. Furthermore, the expected (very low) rate of severe anaphylaxis would not be expected to differ between ED01 and ED05. The group noted that (by definition) around five times more individuals would be expected to develop any objective symptoms to ED05 than ED01 exposure, and therefore in absolute terms, five times more people would be expected to experience mild anaphylaxis to ED05 exposures as to the ED01 level. However, given the very significant analytical limitations that currently exist in relation to using ED01 rather than ED05 as RfDs, the group suggested that the ED05 form the basis of the proposed RfDs. It was noted that while fewer individuals would experience allergic symptoms to ED01 levels of exposure, the same proportion of reactors would experience anaphylaxis, and use of ED01 would not “minimise the probability of any clinically relevant objective allergic response, to a point where such further refinement meaningfully reduces health impact”, particularly where the “incidental symptoms likely to be elicited in the range of envisioned RfDs are of an acceptable severity”. In contrast, use of the ED01 would introduce considerable burdens and limitations for monitoring and potential unintended consequences on the application of PAL or other risk management strategies.’
VITAL Scientific Expert Panel 2019 Summary Recommendations – the new allergen Reference Doses for VITAL® Program Version 3.0
‘The VSEP noted a significant increase in the number of suitable data points from individuals who had undergone challenge studies for most allergens. Sufficient data were available for egg, hazelnut, lupin, milk, mustard, peanut, sesame, shrimp, soy, wheat, cashew, celery, fish and walnut and as a result ED01 doses were identified for all allergens.The VSEP considered that ED01 best meets the requirements of the Allergen Bureau, including minimising the percentage of the allergic population at risk from cross contact allergens in unlabelled products, increasing the likelihood of global acceptance of VITAL and a level of risk no greater than VITAL 2.0.’
Also see some reference in this topic Allergen validation.
Kind regards,
Tony