Gluten-Free: Effective Risk Management
Gluten is a protein composite mainly found in foods processed from wheat and related species including rye and barley. Typically, gluten is found in pasta and bread, as well as other industrially processed foods such as soups, sauces and condiments, cereals, beer, ice cream and snacks, for example.
Gluten ingestion can trigger an autoimmune-like systemic disorder in genetically susceptible individuals, commonly known as coeliac disease (CD), which affects the intestine and organs outside the gut. CD is a widespread public health problem that can develop at any age. The variation in age, as well as symptoms amongst individuals, makes the disease hard to diagnose. A strict gluten-free diet is currently the only effective treatment.
Existing substitutes for most gluten-containing products are either based on inherently gluten-free ingredients or ingredients that have been processed to remove gluten. According to recent market data, US sales of gluten-free products were estimated at $4.2 billion in 2012 and are predicted to reach $6.6 billion by 2017. In Canada, the gluten-free market was worth an estimated $450 million in 2012, showing an annual growth rate of 26.6% between 2008 and 2012. North America and Europe are the largest manufacturers of gluten free products, followed by Asia-Pacific and rest of the world. North America and Europe also dominate the demand for gluten free products. Gluten-free bakery and confectionery products represent 46% of global gluten-free product sales, followed by gluten-free snacks at 20% (Markets & Markets Report, 2013; Packaged Facts, 2013).
Disagreements between countries over the definition of ‘gluten-free’ have mainly involved which type of grain foods should be permitted in a ‘gluten-free’ diet, as well as the amount of gluten that should be allowed in a product labelled ‘gluten-free’. Recently, the US Food and Drug Administration (FDA) issued its final rule to define gluten-free for voluntary use in the labelling of foods. The FDA has set a gluten limit of less than 20 parts per million (ppm) for foods that carry the label ‘gluten-free’, ‘no gluten’, ‘free of gluten’, or ‘without gluten’. The FDA rule is comparable to the Canadian definition; ‘gluten-free’ foods are those which are prepared under good manufacturing practices and contain levels of gluten not exceeding 20 ppm as a result of cross-contamination. A ‘gluten-free’ claim would be considered misleading and false in cases of intentional addition of gluten sources, even at low levels (Health Canada, 2012). Along the same lines, the revised Codex Alimentarius standard adopted in 2008 indicates that gluten levels in foods labelled ‘gluten-free’ should not exceed 20 ppm. The Codex also defines ‘very low gluten’ foods as those that contain gluten above 20 and up to 100 ppm (Codex STAN 118-1979; Revised 2008). The reason for the second definition is insufficient evidence for a single threshold, as well as the observed variability in gluten sensitivity found in CD.
Differences amongst definitions exist with regards to the use of oats in a ‘gluten-free’ diet. In contrast to the Canadian and Codex definitions, the US FDA rule allows the use of oats in gluten-free diet. However, oats contamination by wheat, rye and barley is a major concern and could happen at different stages from growth and harvest, to processing, storage and serving. In all cases, the use of oats in products that are targeting people with CD should ensure the absence of cross contamination.
Gluten-Free / Allergen Risk Management
Allergen management should be an integral part of existing food safety management systems rather than a completely new system. It must take into account all different operations, from sourcing of raw materials, reformulation and manufacturing, to processing and packaging. Accurate declaration of allergens, including gluten, is key to risk management and this is achieved not only by applying the correct labelling of allergenic ingredients intentionally added as part of the product recipe, but also of allergenic ingredients that may be unintentionally present as a result of cross-contamination, at levels that would pose a risk to the allergic consumer. In Europe, Regulation EC/41/2009 aligns EU legislation with the Codex standard and clearly defines gluten-free labelling requirements.
Given that it is not always practically feasible to avoid the possibility of cross-contamination, irrespective of the Good Manufacturing Processes (GMP) followed, the risk posed by cross-contamination and residual allergens should be assessed using available information on allergen safe thresholds. 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, difficulties in establishing methodologies for the assessment and control of human dietary intake, and variations in individual energy requirements. The latter are dependent on a number of factors including gender, physical activity and weight. Clinical research to-date indicates that gluten levels of 10 mg are safe for individuals suffering from CD (Husby et al., 2014).
Allergen labelling is an important risk communication tool that also constitutes a significant part in effective allergen management approaches. Gluten risk management follows the same key principles recently summarised in the FoodDrinkEurope (FDE) Allergen Management Guidance document published in January 2013, which also covers specific gluten-free regulations and labelling guidance for industry (FDE, 2013).
Manufacturers should have a well-defined and written allergen management plan that clearly defines their allergen management policy, its aims, objectives and measures that need to be taken to deliver it. Allergen control plans need to be facility-specific and be regularly reviewed and maintained to ensure continuous compliance.
In any allergen management programme, it is important that people involved at all stages of a product’s life cycle, from development, production and commercialisation, through to distribution, are made aware of the implications of the presence of allergens and take appropriate measures to minimise the risk of allergen cross contamination. Employees at all levels need to show the same level of commitment to meet allergen management targets and be assigned clear responsibilities relevant to their specific roles. To be able to achieve this, all staff (permanent, temporary and contractors) need to go through the appropriate training programme relevant to their job roles.
Supplier-provided information should not be taken at a face value. An appropriate supplier control plan should be put in place to clearly indicate and confirm suppliers’ own understanding, commitment to and application of an effective allergen management policy, ensuring that any changes to the product/ingredient specifications are appropriately communicated. Understanding the allergenic potential of incoming materials is key in the design of an appropriate production plan.
Allergen risk management, including gluten, needs to be integrated within an overall food safety management approach and be fully supported by a system framework that includes elements of Good Manufacturing Practices (GMP) and HACCP. The development of an allergen process flow, or allergen “map” is important in order to ensure that the appropriate measures are taken to minimise the risk of cross-contamination during production. The process flow should also identify the allergenic ingredients and foods that exist on site, including the points at which they are introduced into production. Amongst the most effective means of minimising cross contamination are considered to be segregation, traffic control (raw material, employee and packaging), effective control of rework and work in progress, use of dedicated equipment and processing lines and, where possible, intelligent scheduling of processing runs, with a validated allergen cleaning program.
Effective allergen management is a shared responsibility and requires the adoption of a systematic allergen risk assessment approach by using effective allergen cross-contamination control plans and providing accurate allergen information and risk advice, including appropriate on-pack labelling.
As a leading provider of certification, verification, inspection and testing with a global reach, we are happy to discuss your gluten-free certification, training or other requirement anywhere in the world. SGS currently offers gluten-free certification against the Gluten-Free Certification Program (GFCP). The scheme has been developed and owned by the Canadian Celiac Association, North America’s leading coeliac organisation, in consultation with key industry experts, consumer groups and government stakeholders to ensure that it meets all requirements and maximises industry applications at a global level. The scheme is based on globally recognised food safety management approaches and systems and therefore adopts a preventative approach, rather than an end product testing approach.
For further information, please contact:
Dr. Evangelia Komitopoulou
Global Technical Manager – Food
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. (Last accessed: 10th December 2013).
FDA (2013) Gluten- Free Labelling of Foods. Available online. (Last accessed: 10th December 2013).
FDE (2013) Guidance on Food Allergen Management for Food Manufacturers. Available online. (Last accessed: 15th December 2013).
Health Canada (2012). Health Canada's Position on Gluten-Free Claims. Available online. (Last accessed: 10th December 2013).
Husby, S., Olsson, C., and Ivarsson, A. (2014) Celiac 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.
Markets & Markets Report (May 2013) Global Gluten Free Products Market - Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 – 2019.
Packaged Facts (2013) market Report “Gluten-Free Foods in Canada”.