The fourth meeting of our Joint FAO/WHO Expert group was dedicated to developing a process for the consideration of future exemptions. The process is depicted in the diagram of the summary (Annex 3) and was tested against allergen derivatives previously granted exemptions in various countries or regions. The 10-step decision-tree process leads through the assessment of the substance or compound to be considered for exemption. It should assess the equivalence of any new derivative and its uses to any existing ingredient(s) of a similar type from similar sources, taking into account species of origin, total protein content, other critical compositional features, safety and any reported adverse reactions, and methods of manufacture.
Assessments of potential alterations in the allergenicity of the protein(s) in the derivative can be established using a weight-of-evidence approach.
Clinical evaluation, if necessary, may require an oral food challenge study. Oral food challenge study design and assessment criteria should be determined on a case-by-case basis in consultation with relevant parties.
Establishment of safety based upon this weight of evidence approach is dependent upon consideration of data quality, the outcome of the exposure assessment for all intended ingredient uses (specified for exemption) and review by Competent Authorities. When safety is established, the exemption can be justified.
