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Gluten is a protein composite mainly found in foods processed from wheat, rye and barley.

It’s found in products as varied as pasta and ice cream, bread and beer, soups and cereals.

People who are gluten-intolerant and/or have coeliac disease (CD) suffer intestinal pain and associated complications if they eat food that is not gluten-free. While the symptoms can vary amongst individuals making the disease hard to diagnose, food manufacturers and processors that label their products “gluten-free” have a responsibility to ensure that they use this claim in a truthful manner so that they do not mislead consumers.

Definitions and Regulatory Frameworks

Variations in the definition of “gluten-free” between countries include the type of grain foods that should be permitted in a gluten-free diet, as well how much gluten should be allowed in a “gluten-free” labeled product.

The US Food and Drug Administration (FDA) set a gluten limit of less than 20 parts per million (ppm) for foods carrying a “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” label.

In Canada, gluten-free foods are those prepared under good manufacturing practices (GMP) with levels of gluten not exceeding 20 ppm as a result of cross-contamination. Similarly, the revised (2008) Codex Alimentarius standard states that gluten levels in “gluten-free” foods should not exceed 20 ppm. Codex also defines “very low gluten” foods as those containing gluten levels above 20 ppm and up to 100 ppm (Codex STAN 118-1979; Revised 2008).

In contrast to the Canadian and Codex definitions, the US FDA rule allows for the use of oats in a gluten-free diet. However, the use of oats in products that are targeting people with CD should ensure the absence of cross-contamination.

The Management Of Risk

Allergen management, including the controls associated with “gluten-free” claims, should be integral to manufacturers’ food safety management systems rather than a completely new system. What’s more, it must apply to all of the different operations taking place along the supply chain, from the sourcing of raw materials through to reformulation, manufacturing, processing and packaging.

The accurate declaration of allergens, including gluten, is the key to risk management. It is achieved through the correct labeling of the allergenic ingredients intentionally added, as part of the product recipe. Any ingredients that may be unintentionally present, at levels constituting a risk to allergic consumers, as a result of cross-contamination must also be listed. In Europe, Regulation EU No. 828/2014 aligns EU legislation with the Codex standard and clearly defines gluten-free labeling requirements.

What’s A Safe Gluten-Free Threshold?

The identification of a single gluten-safe threshold for the population suffering from CD is rather complicated, as a result of differences in gluten sensitivity amongst individuals. It seems that a combination of gender, physical activity, weight, age and other factors all play a part, although the latest clinical research (Husby et al., 2014) does show that gluten levels of 10 mg are safe for individuals suffering from CD.

Effective Allergen-Free Risk Management

With regards to allergen labeling and risk management, a useful reference tool is the FoodDrinkEurope (FDE) Allergen Management Guidance document (published in January 2013). This document offers general allergen risk management advice while also covering specific gluten-free regulations and labeling guidance.

Manufacturers should have a written allergen management plan that clearly defines their policy and its aims, plus the measures needed to deliver it. The plan must be facility-specific, regularly reviewed, and maintained to ensure continuous compliance. The plan must include all of the facilities and people involved at every stage of the product life cycle. This entails all staff (including temporary workers and contractors) committing to attending the appropriate training and to putting its lessons into action.

Allergen (including gluten) risk management should be integrated within an overall food safety management approach that’s fully supported by GMP and Hazard Analysis and Critical Control Point (HACCP) programs.

This combination can help manufacturers to develop an allergen process flow (or allergen “map”) that identifies the allergenic ingredients and foods within a facility, including the specific points where they are introduced into the process. Such an analysis can then lead to minimizing the risk of cross-contamination during production through the application of several measures. These might include segregation, traffic control (of raw materials, employees and packaging), and the control of re-work and work in progress. Other measures could involve the use of dedicated equipment and processing lines (where possible) and/or the intelligent scheduling of processing runs. Such measures should also be backed up by a validated allergen cleaning program.

How SGS Can Help

A leading provider of certification, verification, inspection and testing services to the agriculture and food industries, SGS has the expertise to help manufacturers adopt effective gluten-free risk management policies.

With a global network of laboratories and experts, SGS can help food manufacturers worldwide with self-assessment, gap analysis, certification, testing and training across several schemes. In fact, SGS is the only certification body offering a choice:

Crossed Grain Symbol Gluten-Free Product Certification

This involves a stand-alone audit against the Association of European Coeliac Societies (AOECS) Standard for Gluten-Free Foods. The Association’s Crossed Grain symbol signifies that all ingredients used in a product have 20 mg/km (ppm) or less of gluten.

Manufacturing facilities producing AOECS-certified products must undertake an audit and finished-product testing annually, using accredited laboratories.

Gluten-Free Certification Organization (GFCO)

Developed by the Gluten Intolerance Group (GIG), this gluten-free certification program asserts that finished products (and their ingredients) must contain 10 ppm or less of gluten. Additionally, they may not contain any barley-based ingredients.

The ongoing testing of products and equipment is required, along with an annual audit, and manufacturers must comply with all government regulations regarding allergens, gluten-free labeling and GMP.

Gluten-Free Certification Program (GFCP)

GFCP is a HAACP-based standard that aims to address incoming and process hazards, including undeclared gluten, as part of a manufacturer’s overall food safety management system. It has been endorsed by the leading North American celiac organizations and administered by the Allergen Control Group.

The ingredients used in GFCP-certified products must contain 20 ppm or less of gluten, and the facility must have an auditable GMP/HACCP-based food safety system or equivalent in place. It must also undergo an annual audit from a GFCP-licensed auditing company/certification body.

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For more information about the range of SGS services regarding gluten-free certification, please visit SGS Gluten Free Certification Services.

Dr Evangelia Komitopoulou
Global Customized Solutions Manager – Food Safety & Quality
t: +44 (0)7824 089985


Codex Alimentarius STAN 118-1979, Revised 2008. Codex Standard For Foods For Special Dietary Use For Persons Intolerant To Gluten. Available online.

FDE (2013) Guidance on Food Allergen Management for Food Manufacturers. Available online.

Husby, S., Olsson, C., and Ivarsson, A. (2014) Coeliac disease and Risk Management of Gluten. In: “Risk Management for Food Allergy”, edited by Madsen, C.B., Crevel, R.W.R., Mills, C. And Taylor, S.L. Elsevier.

About SGS

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 85,000 employees, SGS operates a network of over 1,800 offices and laboratories around the world.