Learning outcomes
Every allergen control you will ever design rests on two numbers you did not choose: the dose at which a sensitised consumer reacts, and the dose your process can be proven to deliver. This module builds the first of those numbers. It explains the immunological mechanisms that make a food hazardous to a minority of consumers, why those mechanisms demand different control strategies rather than one generic “allergen procedure”, how the world’s regulators have drawn very different lines around the same science, and how clinical challenge data becomes the reference dose that Module 2 will turn into a release limit. If you cannot explain why a peanut reference dose is 2.0 mg of protein rather than 0.2 mg, you cannot defend the action level your site is releasing product against.
- Describe the sensitisation and elicitation phases of IgE-mediated Type I hypersensitivity in mechanistic terms, including the cellular and mediator events that produce clinical signs.
- Explain why reaction severity cannot be predicted from a consumer’s history, diagnostic test results or previous reactions, and state what that means for control design.
- Differentiate IgE-mediated allergy, non-IgE immune reactions, coeliac disease and non-immune intolerance across mechanism, onset, dose-dependence and management — and select the correct manufacturing control for each.
- Apply the formal Codex definitions of allergenic food, food allergen, food allergy and coeliac disease, and the three-category classification of food allergy by immune mechanism in CXC 80-2020, with its distinct symptom timings.
- Reproduce the two-tier Codex allergen structure of CXS 1-1985 — the mandatory list at Section 4.2.1.4 and the discretionary regional or national list at Section 4.2.1.5 — with the specified names, and state the separate position of sulphite at Section 4.2.1.7.
- Compare the mandatory allergen declaration lists of Codex, the United States, the European Union and South Africa, and identify the gaps that create export non-compliance.
- Assess your site’s readiness for draft R3337 without treating it as current law.
- Derive the meaning of NOAEL, LOAEL, an eliciting dose distribution, ED01 and ED05, and explain the basis for VITAL 4.0’s move to ED05 reference doses.
- Distinguish the two published reference-dose frameworks — the Codex CXS 1-1985 precautionary allergen labelling annex, Tables A1 and A2, and VITAL 4.0 — state where they diverge, and record which one the site works to.
- Calculate an action level in ppm from a published reference dose and a stated reference amount, and explain why the same reference dose produces different action levels in different products.