The Codex Committee on Food Labelling (CCFL) has approved updated international guidance establishing a formal 4 mg gluten reference dose for precautionary allergen labelling (PAL) on cereals containing gluten, an important step toward greater global consistency in the use of “may contain” statements.

The guidance, which now moves forward for final adoption by the Codex Alimentarius Commission, is designed to support science-based risk assessment approaches and reduce the overuse of precautionary allergen labels across international food markets.

Crucially, the globally recognised standard for foods labelled “gluten-free” remains unchanged at less than 20 parts per million (ppm). The 20-ppm threshold continues to serve as the international benchmark for gluten-free claims in many major markets, including the European Union, United States, Canada, Australia, New Zealand, and numerous Codex-aligned jurisdictions worldwide.

A More Science-Based Approach to Precautionary Labelling 

The updated Codex guidance specifically addresses precautionary allergen labelling – voluntary statements such as “may contain wheat” or “may contain cereals containing gluten.” Under the revised framework, manufacturers are expected to apply these warnings based on documented risk assessments rather than as routine or blanket statements. The newly adopted 4 mg reference dose is based on scientific evaluations conducted through FAO/WHO expert consultations supporting Codex work on allergen management and threshold setting. The objective is to improve consumer confidence in precautionary labelling while maintaining appropriate protections for individuals with coeliac disease and gluten-related disorders.

The approach also reinforces the distinction between precautionary labelling and regulated “gluten-free” claims. Codex standards continue to specify that foods labelled gluten-free must contain less than 20 ppm gluten, a threshold that has remained internationally accepted for more than a decade.

Implications for Global Food Trade

The development is expected to have broad implications for multinational food manufacturers, exporters, regulators, and certification bodies seeking greater alignment in allergen communication practices. Industry stakeholders have long raised concerns that inconsistent or excessive use of precautionary allergen labelling can reduce consumer trust, restrict food choice, and create barriers in international trade. The Codex update is intended to encourage more harmonised, evidence-based application of PAL across global supply chains.
Because Codex standards are widely referenced by national regulators and international trade frameworks, the guidance may also influence future policy development in multiple regions as governments continue modernising allergen management systems.

For consumers, the update reinforces that precautionary allergen statements and gluten-free claims serve different regulatory purposes. Products labelled “gluten-free” must still comply with the strict international limit of <20 ppm gluten, regardless of any accompanying advisory statements relating to cereals containing gluten.