The global gluten-free market has grown rapidly over the past decade, driven by increased diagnosis of celiac disease, rising awareness of gluten sensitivities, and evolving dietary preferences. However, while “gluten-free” labeling appears simple to consumers, the underlying regulatory frameworks are far from uniform. Thresholds, testing methods, permitted ingredients, and enforcement vary widely between countries — posing significant challenges for food producers, exporters, and regulatory professionals.
Understanding how key markets — including the EU, US, Australia, India, Japan, China, and South Korea — define, measure, and control gluten content is critical for ensuring compliance, maintaining consumer trust, and avoiding costly mislabeling. This article outlines the major regulatory differences and provides a clear, comparative overview for stakeholders operating in global food supply chains.
Gluten is a group of proteins found naturally in wheat, barley, rye, and other grains. It acts like a glue that holds food together, giving bread and other baked goods their chewy, elastic texture. When flour is mixed with water, gluten proteins form stretchy networks that trap air bubbles during baking, which is why bread rises and has a soft, bouncy texture. While gluten is harmless for most people, some individuals have celiac disease or gluten sensitivity, which means their bodies cannot properly process these proteins. This can cause digestive problems, inflammation, and other health issues. For people with these conditions, following a gluten-free diet by avoiding wheat, barley, rye, and products made from these grains is essential for maintaining good health.
Scientifically proven harm from gluten exists only for specific groups of people. Celiac disease is an autoimmune condition where gluten damages the small intestine, which is confirmed by extensive research and diagnosed through blood tests and biopsies. There's also non-celiac gluten sensitivity, where people experience digestive symptoms from gluten without having celiac disease, though this condition is less well understood scientifically. For people with wheat allergies, gluten-containing foods can trigger allergic reactions.
However, for the majority of the population without these conditions, there is no scientific evidence that gluten is harmful. Many studies show that whole grains containing gluten can actually be beneficial for heart health and provide important nutrients like fiber, B vitamins, and minerals. The idea that gluten is universally bad for everyone is not supported by current scientific research. People without celiac disease or gluten sensitivity who avoid gluten may miss out on the nutritional benefits of whole grains unless they carefully plan their diet.
Gluten-free means that a food or product contains no gluten proteins, which are naturally found in wheat, barley, rye, and related grains. When something is labeled as gluten-free, it has been made without these grains or has had the gluten removed through special processing. This includes foods made with alternative flours like rice flour, almond flour, or corn flour instead of wheat flour. For a product to be officially labeled "gluten-free" in most countries, it must contain less than 20 parts per million of gluten, which is considered safe even for people with celiac disease. Gluten-free foods are essential for people who have celiac disease, gluten sensitivity, or wheat allergies, as consuming gluten can make them seriously ill. Common gluten-free alternatives include rice, potatoes, quinoa, fruits, vegetables, meat, fish, and many dairy products, which are naturally free of gluten.
A complete and filterable report with global regulations on gluten— including content limits, labeling requirements, age restrictions, and country-specific rules — is available to paid users of the SGS Digicomply Global Ingredient Monitor. Feel free to explore the Global Ingredient Monitor demo and try this tool in action.
Despite widespread consumer use of the “gluten-free” label, the underlying legal definitions and enforcement mechanisms vary significantly across markets. This presents critical challenges for food manufacturers operating internationally. Below is a comparative overview of how major jurisdictions define and regulate gluten-free labeling, including threshold limits, ingredient restrictions, and testing requirements.
The EU follows the Codex Alimentarius definition of “gluten-free” — meaning the final food product must contain less than 20 mg/kg (20 ppm) of gluten.
Very Low Gluten: A separate category applies to foods containing 21–100 ppm, typically relevant for products made with specially processed wheat starch.
Oats: Permitted if specially produced to avoid cross-contamination and contain less than 20 ppm of gluten.
Enforcement: Regulated under Commission Implementing Regulation (EU) No 828/2014.
Testing: ELISA-based methods (e.g., R5 antibody test) are standard for gluten quantification.
The EU allows ingredients derived from wheat, barley, or rye (e.g., wheat starch) in gluten-free products, provided the final gluten content remains under the legal threshold.
The US Food and Drug Administration (FDA) defines gluten-free similarly — less than 20 ppm — but applies stricter restrictions on ingredients.
Ingredient Restrictions: Products must not contain any ingredient that is:
a gluten-containing grain (e.g., wheat, rye, barley);
derived from such grains and not processed to remove gluten;
processed to remove gluten unless it results in <20 ppm and is validated.
Fermented and Hydrolyzed Foods: Cannot bear a gluten-free label unless the manufacturer can demonstrate compliance before fermentation, as gluten quantification in these products is unreliable post-processing.
Oats: Permitted if purity protocols are followed and the product contains <20 ppm.
The US model emphasizes ingredient origin and process, not just final detection.
This is the strictest jurisdiction globally. Under Food Standards Code 1.2.7, a product can be labeled “gluten-free” only if it contains no detectable gluten.
Practical Limit: Since test sensitivity is around 3–5 ppm, this is the de facto limit.
Oats: Categorically prohibited, regardless of purity.
Wheat Starch: Not permitted in gluten-free products.
Precautionary Statements: “May contain traces of gluten” cannot appear on products labeled gluten-free.
There is no allowance for “very low gluten” categories. Compliance requires complete exclusion of gluten and stringent control of cross-contamination.
India aligns with Codex and sets the threshold for gluten-free labeling at 20 ppm under FSSAI Notification 2331 (2018).
Low Gluten Category Removed: The previous category (20–100 ppm) was eliminated due to concerns over consumer confusion and lack of medical consensus.
Permitted Ingredients: Only naturally gluten-free ingredients (e.g., rice, lentils, millet) are typically used. Wheat derivatives are discouraged.
Oats: Not explicitly addressed in regulation; industry practice varies, and use is discouraged without certification.
The Indian model is relatively conservative, with growing emphasis on enforcement in metropolitan markets.
Japan has no formal regulation defining gluten-free foods. However, industry follows voluntary guidance:
Non-Gluten Label: Introduced by the Ministry of Agriculture, Forestry and Fisheries (MAFF) for rice-based foods, allowing gluten content up to 1 ppm.
Industry Practice: Many manufacturers target <10 ppm in self-regulated gluten-free claims to avoid liability.
Oats and Derivatives: Rarely used in gluten-free products due to risk of contamination and lack of regulatory clarity.
Japan’s model prioritizes caution and consumer protection but lacks legal enforceability, creating inconsistency across product categories.
China currently lacks national gluten-free labeling legislation but is actively developing a standard based on Codex principles.
Draft Standard: In development under the National Health Commission (NHC) and China National Center for Food Safety Risk Assessment (CFSA).
Expected Threshold: ≤20 ppm.
Current Market Practice: Gluten-free products exist, but labeling is voluntary and unregulated, leading to consumer mistrust.
Once formalized, China is expected to implement a dual threshold (e.g., gluten-free and very low gluten), similar to the EU model.
South Korea does not have a dedicated gluten-free regulation. However, the Korean Food Code includes allergen labeling requirements that mandate declaration of gluten-containing grains.
Labeling Practice: Products may carry gluten-free labels voluntarily, with <20 ppm as the de facto industry standard.
Testing: No official test method required, but R5 ELISA is generally accepted.
Gluten-free products are mostly imported or targeted toward niche domestic consumers.
Although “gluten-free” is now a global label, its legal interpretation is anything but standardized. While Codex Alimentarius sets a baseline at 20 ppm, national regulators apply this limit in different ways — or, in some cases, adopt stricter definitions. The result is a fragmented regulatory environment in which identical products may be compliant in one country and non-compliant in another.
For manufacturers and food exporters, a one-size-fits-all approach is no longer viable. It is essential to understand local requirements, especially when working with oats, fermented ingredients, or processed wheat derivatives. Clear testing protocols, traceability documentation, and ingredient sourcing strategies must be adapted to each target market.
As gluten regulation continues to evolve, particularly in emerging regions like China and India, staying current with local policies and scientific validation methods will be key to maintaining product integrity and meeting the expectations of increasingly informed consumers.