Allergen Declaration Exemptions
If an ingredient contains (or is) a highly processed common allergen derivative, it may pose a reduced risk to sensitive consumers.
Several countries have established a list of ingredients exempted from allergen labelling, but South Africa does not currently have such a list. However, the Regulations Relating to the Labelling and Advertising of Foodstuffs (R. 146/2010, as amended) define a common allergen as an ingredient ‘that retains its allergenicity’ in the final product. This implies that some ingredients may be exempted from allergen declaration, should allergenicity not be retained.
In this case, a thorough, recognised, science-based risk assessment should be conducted and kept on file to support the decision not to declare the ingredient as an allergen and demonstrate that there is no risk to the consumer.
Compiling this supporting dossier can be daunting.
Below is a brief summary of the process for considering labelling exemptions, taken from the brief on Exemptions from Mandatory Food Allergen Declaration, published after a series of expert consultations conducted under the ad hoc Joint FAO/WHO Risk Assessments on Food Allergens between 2020 and 2023.
Extract from Food and Agriculture Organization of the United Nations & World Health Organization. (2024). In brief: risk assessment of food allergens: exemptions from mandatory food allergen declaration. Food and Agriculture Organization of the United Nations. https://doi.org/10.2471/B09027. License: CC BY-NC-SA 3.0 IGO
The documentation generated by this process should be kept on record to support your decision-making and reflect the outcome of the risk assessment.
If you need support in completing this process, please contact us.
Questions to ask when completing the exposure assessment (step 7)
To determine if the expected consumer exposure is a low risk, consider (a) how much of the derivative will be used in food manufacturing, (b) how much protein does the derivative contain, (c) how much of the derivative will consumers be exposed to in a single eating occasion, and (d) the reference dose of the specific allergen.
For support in completing this assessment, contact us.
A tricky example:
What about a soybean oil that has been degummed, neutralised, bleached, and deodorised – and likely does not retain any allergenicity to pose a risk to a consumer?
Even if documentation is on file demonstrating that the ingredient no longer retains its allergenicity, R.146/2010 provides specific guidance regarding the labelling of fats and oils, namely:
– The name used for an ingredient in a foodstuff in a list of ingredients on any label shall be the name used for such ingredient when independently sold as a foodstuff; and
– In relation to fats and oils, the class names shall be indicated in the list of ingredients as “vegetable”, “animal”, “fish” or “marine”; provided not only the class names are specified, but each class name is further qualified by an indication of all of its ingoing type(s) of fats and oils, in parenthesis after the class name. In the case of vegetable fats and oils, the particular part of the plant from which the fat or oil is derived shall be specified.
Therefore, in this case, the ingredient would need to be declared as vegetable oil (soya bean) in the ingredient list – but based on the supporting dossier, it may be exempt from inclusion in the allergen declaration section.
Ingredients: Wheat flour (gluten), vegetable oil (soya bean), sugar, eggs, banana, cinnamon, salt, raising agents.
Contains: Wheat, Gluten, Egg
Does this sound similar to a challenge you might be facing?
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