Actus des entreprises

Schoenherr: Allergen Labeling on Prepackaged Foods in Accordance with the July 2026 Revision of the Codex Alimentarius

Elena Todorova/Alexandra Minioti

In July 2026, Codex Alimentarius Commission adopted a significant revision of the General Standard for the Labeling of Prepackaged Foods, known as Standard CXS 1-1985 (published on August 31, 2026). This update addresses key sections related to the declaration of allergens and includes a completely new annex with guidelines on the use of precautionary allergen labeling. This article examines the main changes and their implications for the legal framework of the European Union and Bulgarian food legislation.

Standard CXS 1-1985 is an international regulatory standard applicable to the labeling of all prepackaged foods offered to consumers or for the purposes of mass catering. It is recognized by the World Trade Organization as the reference standard for the safety of internationally traded foods. 

The 2026 revision introduces an updated list of allergens that must be declared when intentionally added to food. The list now includes gluten-containing grains such as wheat, rye and barley; crustaceans; eggs; fish; peanuts; milk; sesame; as well as specific types of nuts such as almonds, cashews, hazelnuts, pecans, pistachios and walnuts. Each allergen must be declared by its specific name, rather than by any general terms. 

The standard distinguishes between a mandatory list of allergens in Section 4.2.1.4 and a supplementary list in Section 4.2.1.5, which may be introduced at the national or regional level based on a thorough risk assessment. The supplementary list includes buckwheat, celery, oats, lupin, mustard, soy, macadamia nuts and pine nuts. Sulfites (in wines) in concentrations of 10 milligrams per kilogram or more are subject to mandatory declaration. 

One of the most significant innovations is the annex containing guidelines for precautionary allergen labeling ("PAL"). These guidelines apply when the unintentional presence of an allergen in a food cannot be prevented or controlled through appropriate risk management practices throughout the food chain. The decision to use PAL must be based on a risk assessment and applied only when levels of unintentional presence exceed a specified action level, calculated based on the reference doses listed in the annex. The standard specifies precise reference doses for each allergen (e.g., 2 milligrams of total protein for peanuts, eggs, milk and sesame; 4 milligrams of total gluten for gluten-containing grains). PAL must begin with words equivalent to the phrase "may contain…" and be clearly and conspicuously displayed. 

These changes are of direct relevance to the European legal framework. European Union Regulation No. 1169/2011 on the provision of food information to consumers (the "Regulation") establishes the mandatory labeling requirements, including the declaration of allergens listed in Annex II. Pursuant to Article 21 of the Regulation, allergens must be highlighted in the list of ingredients using a format that clearly distinguishes them from the rest of the text. The European Union is actively participating in the Codex Alimentarius's work on precautionary allergen labeling, supporting a harmonized and risk-based approach. The European Commission is in the process of developing uniform rules for the precautionary labeling of allergens, considering the progress of work within the Codex Alimentarius. 

Under Bulgarian law, Article 17, paragraph 1 of the Foodstuff Act requires food business operators to offer foods labelled in accordance with the requirements of European Union Regulation No. 1169/2011, as well as national legislation and subordinate legislation. Information about foods offered within the territory of the Republic of Bulgaria, including that on the label, must be provided in Bulgarian. Violation of the provisions of Regulation No. 1169/2011 is subject to administrative liability, which entails fines or financial penalties. 

The revision of Standard CXS 1-1985 represents an important step toward the global harmonization of allergen labeling. It is essential for practicing lawyers, food technologists and legal counsel in Bulgaria to monitor the upcoming transposition of the precautionary labeling guidelines at the European Union level and the resulting amendments to national legislation. The new annex, which includes reference doses and action levels, could significantly alter business operators' approach to managing cross-contamination and communicating with consumers.