Gluten Allergen Detection & Labeling Laws

Food (Amendment) Regulations 2025

Adopts the Codex 20 ppm threshold for 'gluten-free' claims and introduces requirements for nutrient replacement in gluten-free substitutes, effective 2026.

ISO 21415-2:2015 Wheat and wheat flour — Gluten content

Specifies a method for determining the content of wet gluten and gluten index in wheat flours by mechanical means, used primarily for industrial quality control.

Food and Drug Regulations (Allergens, Gluten Sources and Sulphites)

Requires priority allergens, gluten sources, and added sulphites to be declared by their common names on food labels.

Canada Gluten-Free Regulation

Food and Drug Regulations, Division 24 (Foods for Special Dietary Use)

Prohibits labeling food as gluten-free if it contains any gluten, with an administrative threshold of 20 ppm for cross-contamination.

ISO Gluten Content Standard

Wheat and wheat flour — Gluten content — Part 4: Determination of wet gluten by mechanical means

Provides the international standard method for mechanical determination of gluten content in wheat and wheat flour.

Argentine Food Code

Código Alimentario Argentino - Alimentos Libres de Gluten

Specifies that gluten-free products (sin TACC) must contain less than 10 mg/kg (10 ppm) of gluten to be certified for sale.

FDA Gluten in Drugs Guidance

Gluten in Drug Products and Associated Labeling Guidance for Industry

Recommends that drug manufacturers voluntarily label products as 'gluten-free' if they contain less than 20 ppm of gluten to assist celiac patients.

EMA Wheat Starch Guideline

Annex to the European Commission guideline on 'Excipients in the labelling and package leaflet of medicinal products for human use'

Mandates warnings for wheat starch used as an excipient, specifically noting it is safe for celiac patients if the gluten content is below 20 ppm.

FSAI Gluten-Free Guidance

Guidance Note 31: Gluten-free Foods

Outlines compliance requirements for food businesses using gluten-free and very low gluten labels according to the 20 ppm and 100 ppm standards.

FSSAI Gluten Regulation

Food Safety and Standards (Health Supplements and Food for Special Dietary Use) Regulations

Prescribes that 'gluten-free' products must not exceed 20 ppm and 'low gluten' must not exceed 100 ppm.

EMA Excipients Guideline

Excipients in the labelling and package leaflet of medicinal products for human use

Requires labeling for wheat starch in medicines; products with <20 ppm gluten are considered gluten-free for pharmaceutical labeling purposes.

Enhanced Food Allergen Labelling Regulations

Food and Drug Regulations (Allergens, Gluten Sources and Added Sulphites)

Requires mandatory identification of priority allergens, gluten sources, and sulphites on prepackaged food labels in plain language.

Ley Celíaca Chilena

Ley que modifica diversos cuerpos legales con el objeto de regular el etiquetado, publicidad y venta de alimentos libres de gluten

Requires mandatory gluten-free labeling and dedicated separate shelves in supermarkets for gluten-free products.

FSSAI Gluten-Free Rule

Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011

Requires foods labeled as 'gluten-free' to contain less than 20 mg/kg (20 ppm) of gluten and mandates specific label declarations regarding manufacturing facilities.

ISO Gluten Mechanical Method

Wheat and wheat flour — Gluten content — Part 2: Determination of wet gluten and gluten index by mechanical means

Provides a standardized mechanical washing method for determining wet gluten content in wheat flours, widely used in industrial and regulatory laboratories.

Gulf Gluten Labeling Standard

GSO Technical Regulation on Labeling of Prepackaged Food Stuffs

Harmonizes food labeling across GCC states, requiring the mandatory declaration of gluten-containing cereals and aligning with the 20 ppm Codex threshold.

Israel Gluten Labeling Rule

Public Health Regulations (Food) (Gluten Marking)

Regulates the labeling of gluten-free products in Israel, adopting a 20 ppm threshold and mandatory allergen highlighting in ingredient lists as per EU standards.

Codex Gluten Standard

Codex Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten

Establishes the international threshold of 20 mg/kg (ppm) for foods labeled as 'gluten-free' and 20-100 ppm for 'very low gluten' products.

CAA Art 1383

Argentine Food Code Article 1383

Strictly defines 'Sin TACC' (Gluten-Free) products as those containing less than 10 mg/kg (10 ppm) of gluten.

EMA Annex to Guideline on Excipients in Labeling

Specifies that wheat starch in medications is considered gluten-free if it contains no more than 20 micrograms of gluten per gram.

FSSAI Gluten Regulation

Food Safety and Standards (Special Dietary Foods) Regulations

Defines 'gluten-free' food as having a gluten level below 20 mg/kg and sets labeling requirements for low-gluten foods.

Law No. 10.674

Mandatory Labeling of Products Containing Gluten

Mandates that all industrialized food products must state 'CONTÉM GLÚTEN' or 'NÃO CONTÉM GLÚTEN' on their labels.

Codex ELISA Standard

Recommended Methods of Analysis and Sampling

Endorses the R5 Mendez Enzyme-Linked Immunosorbent Assay (ELISA) as the Type 1 method for gluten detection in food with a detection limit of approx 5 ppm.

CAA Allergen Labeling

Japan Food Labeling Standard for Allergens

Mandates labeling for wheat as a top-priority allergen; voluntary 'gluten-free' rice flour standards require less than 1 ppm of gluten.

EMA Excipients Annex

Questions and answers on wheat starch (containing gluten) used as an excipient in medicinal products

Requires wheat starch in medicines to be declared and allows 'gluten-free' claims for pharmaceutical products containing less than 20 ppm gluten.

MFDS South Korea Food Code

Korean Food Code (Labeling of Gluten-Free Foods)

Permits 'gluten-free' labeling only when the total gluten content in the finished product is confirmed to be 20 mg/kg (20 ppm) or less.

Crossed Grain Trademark Standard

AOECS Standard for Gluten-Free Foods

The global private standard for the 'Crossed Grain' certification symbol, requiring 20 ppm compliance and annual independent facility audits.

Argentina Sin TACC Law

Joint Resolution No. 32/2023 (Amending Article 1383 of the Argentine Food Code)

Stipulates a strict gluten-free threshold of 10 ppm (10 mg/kg) for products labeled with the 'Sin TACC' (Gluten-Free) logo.

MFDS Gluten Standard

Food Labeling Standards

Establishes a 20 ppm threshold for labeling food products as 'gluten-free' in South Korea.

CAA Gluten Labeling

Food Labeling Standards

Japan's voluntary gluten-free labeling guidelines for rice flour and other products set a 10 ppm threshold based on the ELISA method.

Commission Implementing Regulation (EU) No 828/2014

Mandates a maximum limit of 20 ppm for 'gluten-free' labels and 100 ppm for 'very low gluten' labels across all EU member states.

EU FIC Regulation

Regulation (EU) No 1169/2011 - Provision of Food Information to Consumers

Annex II mandates the clear declaration of cereals containing gluten (wheat, rye, barley, oats) in the ingredient list of prepacked foods.

Brazil Gluten Labeling Law

Lei Nº 10.674, de 16 de Maio de 2003

Mandates that all industrialized food products include either 'Contém Glúten' (Contains Gluten) or 'Não Contém Glúten' (Does Not Contain Gluten) on their labels.

FSSAI Gluten Regulation

Food Safety and Standards (Packaging and Labelling) Regulations, 2011

Sets the standard for 'Gluten-Free Food' at below 20 mg/kg (20 ppm) and mandates specific label declarations.

EMA Wheat Starch Guidance

Information for the package leaflet regarding wheat starch (containing gluten) used as an excipient

Specifies that medicinal products with wheat starch containing less than 20 ppm gluten are regarded as 'gluten-free' for labeling purposes.

Joint Resolution 32/2023 - Amendment to Article 1383 of the Argentine Food Code

Updates the definition of 'gluten-free' in the Argentine Food Code to a maximum threshold of 10 mg/kg (10 ppm).

R5 Mendez Method Standard

Methods of Analysis for Gluten in Foods

Endorses the R5 Mendez ELISA method as the Type I method for the determination of gluten in food with a detection limit of 5 ppm.

Food and Drug Regulations (Allergen Labelling)

Requires the declaration of priority food allergens, gluten sources, and added sulphites on the labels of most prepackaged products.

Health Canada's Position on Gluten-Free Claims

Prohibits gluten-free claims if gluten is intentionally added or exceeds 20 ppm due to cross-contamination.

EMA Excipients Guideline

Guideline on excipients in the label and package leaflet of medicinal products for human use

Establishes that medicines with wheat starch containing less than 20 ppm gluten are regarded as 'gluten-free' for the package leaflet.

Food (Amendment) Regulations 2025 (Regulation 250B)

Adopts the Codex threshold of 20 ppm for 'gluten-free' labels and introduces strict requirements for naturally gluten-free product claims.

Gluten Law

Ley n. 10.674, obriga a que os produtos alimentícios comercializados informem sobre a presença de glúten

Requires all industrialized food products to carry the mandatory warning 'CONTAINS GLUTEN' or 'DOES NOT CONTAIN GLUTEN'.

Japan Allergen Labeling

Food Labeling Standards based on the Food Labeling Act

Mandates labeling of wheat as an allergen if present at levels exceeding 10 ppm protein, though domestic 'gluten-free' claims are less strictly defined.

Food Labeling Standards (Gluten-Free provisions)

Sets a 20 mg/kg (20 ppm) threshold for labeling a food product as 'gluten-free'.

GB 7718-2025 National Food Safety Standard - General Standard for the Labeling of Prepackaged Foods

Upgrades allergen labeling to mandatory status for cereals containing gluten, requiring clear identification on all prepackaged food labels by 2027.

Ley Celíaca

Ley de Enfermedad Celíaca (Celiac Disease Law)

Mandates a 10 ppm threshold for gluten-free certification (Sin TACC) and requires gluten disclosure in both foods and medications.

FDA Gluten in Drugs Guidance

Gluten in Drug Products and Associated Labeling Recommendations

Recommends that drug manufacturers use the statement 'Contains no ingredient made from a gluten-containing grain' when oral drugs meet specific safety thresholds.

FDA Gluten-Free Rule

Gluten-Free Labeling of Food

Defines the term 'gluten-free' as a voluntary claim requiring the food to contain less than 20 ppm of gluten.

FSANZ Code

Standard 1.2.7 - Nutrition, health and related claims

Stipulates that a 'gluten-free' claim may only be made if the product contains no detectable gluten (effective limit of ~3-5 ppm).

Codex Gluten Standard

Standard for Foods for Special Dietary Use for Persons Intolerant to Gluten

Establishes the international reference threshold of 20 ppm for 'gluten-free' foods and identifies the R5 Mendez ELISA as the Type I method for detection.

FSSAI Gluten Standards

Food Safety and Standards (Food Products Standards and Food Additives) Regulations, Section 2.14

Defines 'gluten-free food' as containing less than 20 mg/kg of gluten, validated by AOAC or OECD methods.

AOAC Mendez Method

Gliadin as a Measure of Gluten in Rice- and Corn-Based Foods

The standard analytical method using the R5 Mendez antibody ELISA to quantify gluten in food with a detection limit typically near 3 ppm.

Argentine Celiac Law

Ley 26.588: Declárase de interés nacional la atención médica de la Enfermedad Celíaca

Declares celiac disease care of national interest, mandates gluten-free labeling, and requires health coverage for gluten-free flour and pre-mixes.

Enhanced Allergen Labelling Regulations

Food and Drug Regulations: Food Allergen, Gluten and Added Sulphite Labelling

Requires that the source of a food allergen or gluten be shown on the label of most prepackaged products in plain language.

EU Gluten-Free Regulation

Commission Implementing Regulation (EU) No 828/2014 on the requirements for the provision of information to consumers on the absence or reduced presence of gluten in food

Establishes harmonized EU rules for the terms 'gluten-free' (under 20mg/kg) and 'very low gluten' (under 100mg/kg).