The labelling of food allergens in pre-packaged foods plays a key role in protecting food allergic individuals, as no preventative clinical treatment is currently available. The list of major foods and ingredients known to cause hypersensitivity was included into the Codex General Standard for the Labelling of Packaged Foods (GSLPF) in 1999. There have been many scientific developments in the understanding of food allergens and their management since the original drafting of the GSLPF. Thus, in response to the request from Codex for scientific advice, including current evidence of consumer understanding of allergens, FAO and WHO convened a series of three expert meetings to provide scientific advice on this subject. The purpose of the first meeting of the Ad hoc Joint FAO/WHO Expert Consultation on Risk Assessment of Food Allergens was to review and validate the Codex priority allergen list through risk assessment. This report focuses on the deliberations and conclusions of this meeting.

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.

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.

Food allergy is recognized as an important public health issue, requiring collaboration between multiple stakeholders, including the food industry, to be effectively addressed. Allergen management in food production aims to assure the safety of allergic consumers. This is achieved by accurate allergen labeling and ensuring that either products do not contain unintended allergens in amounts that pose an unacceptable risk to food allergy sufferers or meaningful precautionary labeling is applied. To ensure this, food allergen risk management must be integrated into general food safety management and allergen risks considered at all stages of the food manufacturing process. Recent advances in understanding of minimum eliciting doses make it possible to estimate quantitatively the risk from cross-contact. However, validation studies and the use of analytical methods to quantify levels of carry-over are subject to many potential pitfalls and benefit from a rigorous approach to design, conduct and interpretation.