The guidelines for Precautionary Allergen Labelling (PAL) were adopted at the 49th Session of the Codex Alimentarius Commission (CAC49), held from July 6 to 10, 2026.
These latter were included in the Codex General Standard for the Labelling of Pre-packed Foods (CXS 1-1985).
What Is Precautionary Allergen Labelling?
Codex Alimentarius is a collection of FAO/WHO food standards and guidelines designed to protect consumers and promote fair international food trade.
Use of PAL applies to pre-packaged foods and provides a risk notification on accidental contamination of foods with a particular allergen. For instance, milk intentionally used in a recipe must be declared as an ingredient. A statement such as “may contain milk” instead addresses a residual cross-contact risk identified through a risk assessment. Sharing a facility or production line is not, by itself, sufficient to justify PAL.
Why was a new Guidance Needed?
“May contain” statements have often been used extensively and inconsistently.
This may unnecessarily restrict food choices for allergic consumers while reducing trust in warnings that appear on many products.
The guidance therefore aims to make PAL more consistent, meaningful and science based.
Application of the Risk-Based Approach
Food business operators must first implement measures to prevent or minimize cross-contact. PAL is restricted to situations in which unintended allergen presence cannot be adequately prevented or controlled. The process starts with a qualitative risk assessment and may be supplemented by a quantitative assessment. Analytical data may support the evaluation, but quantification is not automatically required.
PAL should be used when unintended allergen presence exceeds the relevant action level after appropriate mitigation. Otherwise, it should not be applied if there is less presence of such substances.
Reference Doses and Action Levels
The reference dose (RfD) is the estimated daily oral exposure level for humans which is likely to result in no adverse effects over the lifetime. Reference doses for allergic reactions are expressed in milligrams of total protein from the allergen-containing food for one occasion of consumption.
Codex values are set at 2 mg for peanut, egg, milk and sesame; 5 mg for wheat and fish; and 10 mg for buckwheat, lupin and soy.
For coeliac disease, a special RfD of 4 mg of total gluten is set for the relevant food sources such as wheat, rye and barley. This value is distinct from the 5 mg RfD established for IgE-mediated wheat allergy.
The action level is calculated by dividing the RfD by the amount of food reasonably expected to be consumed on one occasion. The exposure is compared with the RfD, whereas the estimated concentration in the product is compared with the action level.
Codex Guidance application for European Companies
Codex guidelines are voluntary and do not automatically amend EU legislation. In the EU, substances or products listed in Annex II to Regulation (EU) No 1169/2011 must be declared when used in manufacture and still present in the finished food, including relevant processing aids and derived products. Still, this framework provides an important benchmark for reviewing allergen-management procedures, consumption data, analytical strategies and labelling decisions.
Need help?
The new Codex guidance confirms the importance of a science-based approach to allergen risk. This principle is also relevant at an earlier stage of product development, when the allergenic potential of Novel Food, new food ingredient or food additive must be appropriately characterized as part of its safety assessment.
Chemsafe supports companies in the scientific and regulatory assessment of allergenic potential, from the identification of relevant data requirements to the preparation of the supporting documentation for new ingredients applications. Contact us to know more!
