Risk Assessment Of Food Allergens Part 4 Establishing Exemptions From Mandatory Declaration For Priority Food Allergens

The Codex Committee on Food Labelling (CCFL) requested scientific advice as to whether certain foods and ingredients, such as highly refined foods and ingredients, that are derived from the list of foods known to cause hypersensitivity can be exempted from mandatory declaration. The objective of this fourth meeting was to expand on the recommendations from the first meeting concerning derivatives of food allergens and establish a framework for evaluating exemptions for food allergens. A pro forma process has been developed and tested against allergen derivatives previously granted exemptions in various countries or regions and found to be effective for consideration in future exemption decisions. The Expert Committee recommends that the process outlined in the pro forma process be used to guide any future development and evaluation of derivative exemptions. Establishment of safety based upon this weight of evidence approach is dependent upon consideration of data quality, outcome of the exposure assessment for all intended ingredient uses (specified for exemption), and review by competent authorities (as needed). When safety is established, exemption can be justified.

The Codex Committee on Food Labelling (CCFL) requested scientific advice as to whether certain foods and ingredients, such as highly refined foods and ingredients, that are derived from the list of foods known to cause hypersensitivity can be exempted from mandatory declaration. The objective of this fourth meeting was to expand on the recommendations from the first meeting concerning derivatives of food allergens and establish a framework for evaluating exemptions for food allergens. A pro forma process has been developed and tested against allergen derivatives previously granted exemptions in various countries or regions and found to be effective for consideration in future exemption decisions. The Expert Committee recommends that the process outlined in the pro forma process be used to guide any future development and evaluation of derivative exemptions. Establishment of safety based upon this weight of evidence approach is dependent upon consideration of data quality, outcome of the exposure assessment for all intended ingredient uses (specified for exemption) and review by competent authorities (as needed). When safety is established, exemption can be justified.

In Part 2 of the Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens, reference doses (RfDs) were recommended for the global priority allergens, which included: walnut (and pecan), cashew (and pistachio), almond, peanut, egg, hazelnut, wheat, fish, shrimp, milk and sesame. Still, RfDs were not recommended for a number of regional or national priority allergens as they did not meet the criteria to be global priority allergens. In an additional request, the Codex Committee on Food Labelling (CCFL) indicated interest in potential RfD derivation for the following specific food allergens: specific tree nuts (Brazil nut, macadamia nut or Queensland nut, pine nut), soy, celery, lupin, mustard, buckwheat, and oats. An overview of the available data and recommended RfDs (or reasons no RfD could be derived) are given here for these specific food allergens. These RfDs were derived following the guidelines described in Part 2 of the Ad hoc Joint FAO/WHO Expert Consultation for deriving an RfD for priority allergenic foods. Details of the available data and discussions of the Expert Committee are presented in this report.

FAO and WHO reconvened a third meeting to review and evaluate the evidence in support of precautionary allergen labelling to address unintended allergen presence in foods. The Expert Committee at the third meeting reviewed the data on the current status and uses of the precautionary allergen labelling (PAL) and unanimously agreed that current PAL systems used in many countries needed to be improved as they were neither uniform nor informative and were not consistently risk based on amount and frequency of UAP found in food products. The Expert Committee also found that current PAL approaches led to widespread PAL that diminished information and value for consumers. The Expert Committee reviewed again the principles and basis of RfD from the second meeting and reached a consensus that the RfD for each priority allergen, as described by the HBGV and safety objectives, was a valid risk assessment endpoint for determining when sporadic or unexpected UAP posed more than appreciable risk to consumers and needed to be communicated to consumers by PAL.

Lipid-based nutrient supplements (LNS) and ready-to-use therapeutic food (RUTF) are used to prevent and treat malnutrition in children. [Author] They are often produced in regions experiencing food insecurity and include edible oils obtained from oleaginous seeds or fruits that must be refined to remove undesirable substances and ensure adequate shelf-life for the product. [Author] However, the formation of the heat-induced contaminants 3-monochloropropane-1,2-diol (3-MCPD) fatty acid esters and glycidyl fatty acid esters (GEs) may occur during the refining process of edible oils. [Author] 3-MCPD and its fatty acid esters are present in many other foodstuffs and most of the total lifetime exposure is attributed to foods other than LNS/RUTF. [Author] While the only Codex standard developed for 3-MCPD is for liquid condiments containing acid hydrolyzed vegetable proteins, no Codex standards are available for GEs. [Author] This publication provides an overview of risk assessments for 3-MCPD and GEs previously performed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), European Food Safety Authority (EFSA) and other authorities, based on chronic exposure. [Author] The use of LNS/RUTF is intended to be of finite duration and confined to a specific life stage. [Author] The aim of this report was to provide an assessment to characterize the risk of less-than-lifetime exposure to 3-MCPD (including 3-MCPD fatty acid esters) and GEs via LNS/RUTF in the context of limited food availability. [Author] The thresholds identified herein for concentrations of 3-MCPD and glycidol equivalents in LNS/RUTF products are considered to represent a level of exposure that is of low concern for human health. [Author]