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Gluten intolerance and coeliac disease are on the rise in the US and Europe, creating greater demand for ‘gluten-free’ products.

Raw Pasta

By 2020, ‘gluten free’ is projected to be worth USD 7.59 billion globally. Companies have a responsibility to ensure ‘gluten free’ is a truthful claim. But, what is it?

Gluten is a composite of storage proteins termed prolamins and glutelins. It is found in products made from wheat, rye and barley. For example, pasta, ice cream, bread, beer, soups and breakfast cereals.

Sufferers of gluten intolerance and coeliac disease (CD) complain of intestinal pains when consuming products that contain gluten. The problem is, no safe ‘gluten free’ threshold can be identified because everyone’s sensitivity to gluten is different. Research suggests that factors including gender, physical activity, weight and age all impact upon a sufferer’s response.

What is ‘gluten free’?

Different territories and standards may allow for varying amounts of gluten to be included in a product labeled ‘gluten free’. At the same time, literature contains different definitions of coeliac disease, gluten and gluten free and major markets offer the following guidance and regulations:

  • The US Food and Drug Administration (FDA) allows a gluten limit of less than 20 parts per million (ppm) for foods labeled “gluten-free,” “no gluten,” “free of gluten,” or “without gluten”. The FDA also allows for the use of oats, stipulating products targeting CD sufferers must ensure against cross-contamination
  • Canadian rules require good manufacturing practices (GMP) and levels of cross-contamination not exceeding 20ppm. Canada does not allow the use of regular oats in ‘gluten-free’ products
  • The Codex Alimentarius standard, devised by the Codex Alimentarius Commission and revised in 2008, states ‘gluten-free’ must not contain oats and must not exceed 20ppm. The Codex also has a definition for ‘very low gluten’ – containing above 20ppm and below 100pm. (Codex STAN 118-1979; Revised 2008)
  • In Europe, Regulation EU No. 828/2014 aligns EU legislation with the Codex standard, it also defines the requirements for labeling a product ‘gluten free’

Effective allergen-free risk management

Consumers need to be sure that ‘gluten-free’ products are truly ‘gluten free’. To reinforce their claims, manufacturers need to employ effective allergen-free risk management strategies, backed up by a recognized certification scheme.

Manufacturers must have a written allergen management plan, clearly defining their policy and aims, and it should cover the measures enforced to achieve these aims. The plan should be facility-specific and relate to all staff involved at every stage of the manufacturing process, including temporary and contract workers. It should be regularly reviewed to guarantee continuous compliance. Effective risk management for allergens requires staff to undergo and implement specific training strategies related to allergens. Allergen risk management, including the risk of gluten contamination, should be integrated into the overall food safety management system, fully supported by GMP and Hazard Analysis and Critical Control Point (HACCP) programs.

Manufacturers should develop an allergen process flow, or allergen ‘map’, identifying the allergenic ingredients and foods within a facility. This will identify where allergens can potentially enter the process, allowing isolation to minimize the possibility of cross-contamination. This will be achieved by segregation, traffic control (of raw materials, employees and packaging), and the control of re-work and work-in-progress. The allergen ‘map’ will allow the manufacturer to identify when dedicated equipment, processing lines, and intelligent scheduling of processing of runs, must be employed to reduce the risk of contamination. Any effective allergen management system is always backed-up by a validated allergen cleaning program.

This level of risk management must be employed along the complete supply chain, from raw materials to reformulation, manufacturing, processing and packaging. It is the basis of all accurate allergen declarations. Without these controls, a manufacturer cannot responsibly claim ‘gluten free’ on their products.

SGS solutions: independent gluten-free certification

SGS is the only independent certification body offering manufacturers a choice of ‘gluten-free’ certification schemes. With its global network of laboratories and specialists, it has the expertise to help manufacturers adopt effective ‘gluten-free’ risk management policies.

Crossed Grain Symbol Gluten-Free Product Certification1

Administered by the Association of European Coeliac Societies (AOECS), this scheme certifies that a product has 20 mg/km (ppm) or less of gluten. It involves a stand-alone audit against AOECS’ ‘gluten-free’ standard. Manufacturing facilities producing AOECS-certified products must be audited, with finished products being tested annually by accredited laboratories. Certified products can display AOECS’ Crossed Grain symbol, denoting ‘gluten-free’ status.

Gluten-Free Certification Organization (GFCO)

Developed by the Gluten Intolerance Group (GIG), this ‘gluten-free’ certification program2 is currently the most popular in the US. It asserts that finished products and their ingredients contain 10 ppm or less of gluten. To gain certification, the product must also avoid any barley-based ingredients.

GFCO requires ongoing testing of products and equipment, and an annual audit. Manufacturers must also comply with all government regulations regarding allergens, ‘gluten-free’ labeling and GMP.

Gluten-Free Certification Program (GFCP)

Administered by the Allergen Control Group and endorsed by North American coeliac organization, the GFCP3 is a HACCP-based standard that addresses incoming and process hazards, including undeclared gluten, as part of a manufacturer’s overall food safety management system.

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.

We offer manufacturers a range of solutions for complying with international ‘gluten-free’ standards. These include gap analysis and audit pre-assessment, certification, customized audits, testing, and training.

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For the complete range of SGS services and support visit SGS Food Safety.

For further information contact:

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

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 90,000 employees, SGS operates a network of over 2,000 offices and laboratories around the world.

1 Crossed Grain Symbol Gluten-Free Product Certification
2 Gluten-Free Certification Organization
3 Gluten-Free Certification Program