The precautionary statement "may contain" indicates the possible unintended presence of an allergen that is not part of the product formulation. Its use, however, varies considerably across brands and markets. In some cases, it is supported by a documented risk assessment; in others, it is applied routinely as an additional precaution.
New guidelines adopted by the Codex Alimentarius Commission in July 2026 aim to make precautionary allergen labeling, or PAL, more consistent and science-based. The central principle is that a warning should be used only when a risk assessment shows that a residual risk remains after appropriate allergen management and mitigation measures have been implemented.
When a "may contain" statement should be used
The guidelines apply to prepackaged foods and the unintended presence of allergens resulting from cross-contact, meaning the transfer of an allergen during production, storage, transportation or handling. This can occur, for example, when different products share facilities, equipment, production areas, raw materials or handling systems.
Under the new approach, precautionary allergen labeling must not be used as a substitute for good manufacturing practices or effective allergen management. Before applying a warning, food business operators should take reasonable steps to prevent or minimize cross-contact. These may include separating raw materials, scheduling production runs, improving cleaning procedures, managing rework and internal product movement, and training employees.
The final decision should be based on a risk assessment that considers the likelihood of unintended allergen presence, its concentration, process variability and the amount of food that can reasonably be expected to be consumed on a single eating occasion.
From reference doses to action levels
One of the most significant developments is the introduction of scientifically established reference doses for a range of allergens. These values can be used to calculate an action level, meaning the concentration above which precautionary allergen labeling may be required.
An action level is not necessarily a single analytical threshold that applies equally to every food. It is calculated by relating the reference dose, expressed as an amount of protein from the allergenic food, to the amount of the product that can reasonably be consumed on a single eating occasion. The same allergen concentration may therefore lead to different conclusions for a sauce consumed in small quantities and a food typically eaten in a larger portion.
Laboratory testing remains important, but it should form part of a broader assessment system. A single result may not capture variability between batches, intermittent cross-contact or differences between sampling points along a production line. Risk assessment should therefore combine analytical results with process knowledge, allergen characteristics and realistic consumption data.
Are the Codex guidelines legally binding?
The adoption of the guidelines by Codex does not automatically create a new legal obligation for food companies. Codex standards and guidelines are voluntary and become legally enforceable only when they are incorporated into national or regional legislation.
Manufacturers are therefore not required to immediately revise all their labels solely because the Codex guidelines have been adopted. They must continue to comply with the legislation of every country in which their products are marketed, including any applicable rules, official guidance and enforcement practices.
The voluntary nature of the guidelines does not, however, make them irrelevant. Codex standards provide an international reference for food safety under World Trade Organization agreements. They may influence future legislation, support assessments of the scientific justification for national measures and be considered in international trade disputes.
Retailers, importers, certification bodies and private label operators may also begin incorporating the new criteria into their technical specifications before they are formally reflected in legislation.
What the guidelines mean for companies operating in the European Union
Within the European Union, Regulation (EU) No 1169/2011 continues to govern the provision of food information to consumers, including the declaration of allergens intentionally used in the manufacture or preparation of food and still present in the finished product.
The European Commission already states that precautionary allergen labeling may be used when there is a risk of unintended allergen presence due to cross-contact. However, such warnings must not replace good manufacturing practices and must be supported by a thorough risk assessment.
Responsibilities throughout the supply chain
Manufacturers should first confirm that any precautionary statement is supported by a documented risk assessment. This requires them to identify potential cross-contact points, verify the effectiveness of cleaning procedures and establish processes for managing formulation changes, new ingredients and modifications to facilities or production lines.
Suppliers must provide reliable information about product composition, allergens handled at their facilities and any residual cross-contact risks. Technical specifications should also include procedures for updating information whenever raw materials, production processes or sourcing locations change.
In relationships involving co-packers, brand owners and private label operators, responsibilities for conducting the assessment, approving the label and communicating changes should be clearly assigned. Although the brand owner may make the final packaging decision, it needs complete and up-to-date information from the manufacturing facility.
Distributors and importers should also verify the requirements of each destination market. A label developed according to Codex principles may provide a strong technical basis, but it does not automatically ensure regulatory compliance in every country.
Toward more reliable and consistent warnings
Overuse of "may contain" statements can unnecessarily restrict food choices for people with allergies and reduce confidence in precautionary warnings. Insufficient use, on the other hand, can expose consumers to risks that are not adequately communicated.
The new guidelines seek to balance these concerns by linking precautionary labeling to preventive controls and science-based risk assessment. The most important development therefore lies in the quality of the information and the decision-making criteria used by food companies.
