Celiac.com 12/01/2017 - Celiac disease is a genetically determined disorder in which affected individuals show an intolerance to ingested gluten (Food Safety Authority of Ireland [FSAI]). It is an inheritable, life-long disease and is characterized by an inflammatory reaction to dietary gluten in the human small intestine. The special feature of the disease is a flattening of intestinal villi along with crypt hypertrophy. As a result, it leads to significant loss of absorptive surface area and resulting malabsorption of nutrients, vitamins and minerals. Untreated celiac disease may be found in the context of symptoms like: anemia, bone diseases, infertility, neurological problems, cancer and other complications due to persistent inflammation and micronutrient deficiencies. Approximately 1% of the United States population has the disease, which is similar to its frequency in the United Kingdom. Only about 10% of affected individuals have been diagnosed thus far [Kagnoff MF (2007) Celiac disease: pathogenesis of a model immunogenetic disease. J Clin Invest 117: 41–49].
At present, the only suitable treatment is strict, life-long exclusion of gluten from the patient's diet. Although a large fraction of patients who attempt to follow such a diet still exhibit signs or symptoms of active disease, there is no available supplementary therapy for such conditions [Ehren J, Morón B, Martin E, Bethune MT, Gray GM, et al. (2009) A Food-Grade Enzyme Preparation with Modest Gluten Detoxification Properties. PLoS ONE 4(7): e6313. doi:10.1371/journal.pone.0006313].
To address this problem, the food industry is developing new products for people affected by celiac disease. These new foods are very helpful in diversifying the celiac diet. More available products will increase nutrient consumption, including fiber and minerals, which are often lacking in restrictive diets.
Production of gluten free products involves the fulfillment of specific requirements. These products must be free of gluten, which is present in most components of confectionery production. Labeling of the final product is subject to the European Community Commission Regulation No 41/2009 of 20 January 2009, which sets conditions that must be fulfilled by manufacturers. The composition and labeling of foodstuffs suitable for people who are intolerant to gluten is divided into two categories of products according to the nutritional purpose: Gluten free for people intolerant to gluten, and very low gluten content [Wojtasik. A, Daniewski W., Kunachowicz H., 2010. Ocena wybranych produktów spoÅ¼ywczych w aspekcie moÅ¼liwoÅ›ci ich stosowania w diecie bezglutenowej. Bromat. Chem. Toksykol., XLIII, 2010, 3, str. 362-371].
Selected paragraphs of these labeling rules are quoted below:
- Foodstuffs for people intolerant to gluten, consisting of or containing one or more ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been especially processed to reduce gluten, shall not contain a level of gluten exceeding 100 mg/kg in the food as sold to the final consumer.
- The labeling, advertising and presentation of the products referred to in paragraph 1 shall bear the term ‘very low gluten'. They may bear the term ‘gluten-free' if the gluten content does not exceed 20 mg/kg in the food as sold to the final consumer.
- Oats contained in foodstuffs for people intolerant to gluten must have been specially produced, prepared and/or processed in a way to avoid contamination by wheat, rye, barley, or their crossbred varieties and the gluten content of such oats must not exceed 20 mg/kg.
- Foodstuffs for people intolerant to gluten, consisting of or containing one or more ingredients which substitute wheat, rye, barley, oats or their crossbred varieties shall not contain a level of gluten exceeding 20 mg/kg in the food as sold to the final consumer. The labeling, presentation and advertising of those products shall bear the term ‘gluten-free'.
- Where foodstuffs for people intolerant to gluten contain both ingredients which substitute wheat, rye, barley, oats or their crossbred varieties and ingredients made from wheat, rye, barley, oats or their crossbred varieties which have been especially processed to reduce gluten, paragraphs 1, 2, and 3 shall apply and paragraph 4 shall not apply.
- The terms ‘very low gluten' or ‘gluten-free' referred to in paragraphs 2 and 4 shall appear in proximity to the name under which the food is sold.
To achieve gluten content as described above, special conditions in work environment must be instituted. Preparation of high quality products that are safe for people affected by celiac disease, the production process must be controlled not only at the production plant. Origin, breeding, harvesting, storage and transport of ingredients must be also taken into account. The best way to ensure the customer about the safety of a given product is to implement a specially designed quality management plan from the very first step of production.
In order for products to be gluten-free or reduced in gluten when they reach the consumer, the gluten-free quality of the product must prevail at every stage of production. Cross contamination is the process by which a reduced-gluten or gluten-free product loses that status. It has come into contact with something that is not gluten-free. Cross contamination may happen during primary production, harvesting and storage of grain, during the manufacture of gluten-free or reduced gluten food in the same plant where gluten-containing food is produced. Cross contamination may also occur as a result of poor re-work, incorrect formulation, product carry-over due to use of common equipment, clean-up or sanitation, poor equipment design, human error or the presence of gluten products near exposed product lines. Potential risks, preventative measures and critical control points need to be identified in the handling of ‘gluten-free' or ‘very low gluten' products. (Deibel, Kurt, Tom Trautman, Tom DeBoom, William H. Sveum, George Dunaif, Virginia N. Scott, and Dane T. Bernard. 1997. A Comprehensive Approach to Reducing the Risk of Allergens in Food. Journal of Food Protection. Vol. 60, No. 4: 436-441)
Raw Materials Origin
To minimize risk, producers of raw ingredients have to implement appropriate control practices during crop production, harvesting and storage. Plants should originate from certified seeds which guarantees a high level of species purity. Cleaning of sowing machines is also important because seeds from the previous planting can contaminate new crops. The same rule applies to equipment used for harvesting and transportation. Storage areas should be thoroughly cleaned before filling with new crops. Every magazine should be identifiable and people responsible for crop delivery must be informed and instructed to maintain a gluten free workplace. Producers should produce representative samples for laboratory analysis to verify their product's "gluten free" status. Even on the first level of food production, which is plant growing, training and supervision of employees and producers is critical for maintaining the non gluten status of raw materials. Good training of all staff working at these first stages will help to avoid potential sources of food allergens. This type of training should increase awareness about food allergens and the consequences of unintentional consumption by allergic persons. Workers should be encouraged to report any suspected breaches of protocol to their supervisors and suggest possible improvements [Australian Food and Grocery Council, Food Industry Guide to Allergen Management and Labelling - 2007 Revised Edition].
Suppliers of raw materials are obligated to have good allergen management practices to minimize the risk of cross contact between raw materials. Suppliers should provide information identifying any products that contain allergens, the origins of allergenic materials, or those that are likely to cross contamination with allergens. Vendor audits are recommended to verify and explore potential contact with allergenic substances [Australian Food and Grocery Council, Food Industry Guide to Allergen Management and Labelling - 2007 Revised Edition].
Manufacturing plants should be designed to accommodate all aspects of the quality control and allergen management plan,. Storage of raw materials should prevent mixing allergens with non allergenic ingredients. To meet this condition, allergenic materials should be kept at separate facilities, or when this is impossible, all raw materials should be covered to avoid allergenic dust contamination. Clear and visible labeling of containers and all equipment should also be implemented. Tools and equipment used for different materials must also be kept separate [Guidance Note No. 24 Legislation on ‘Gluten-free' Foods and Avoidance of Cross-contamination during Manufacture of ‘Gluten-free' or ‘Very Low Gluten' Products Published by: Food Safety Authority of Ireland 2010, ISBN 1-904465-71-4].
To minimize the risk of unintentional contamination of products good manufacturing practices – the Good Manufacturing Practice (GMP) and Hazard Analysis and Critical Control Points (HACCP) plan must note all specific conditions. The production plan should be designed to avoid production of allergenic and non allergenic foods during the same shift. If this is impossible, non allergenic products should be produced first to avoid contamination from dust. Ingredients containing gluten should be identified by color-coded containers or stickers. Ingredients containing gluten must be added at the end of the shift after gluten free products are completed and removed. Rework containing gluten should be reused into the same products. Appropriate employee training and labeling for rework can also help to minimize the risk of cross contamination through human error. The possibility of contamination can easily be minimized by using dedicated equipment for the gluten free products. When it is impossible to have a separate building, the use of special barriers is necessary. The use of separate space and separate containers for all materials (as above) is recommended for gluten free production. In such conditions ventilation and dust flow must be well controlled. Dust flow in the plant has a potential to carry over allergens from separate spaces of facilities. [Guidance Note No. 24 Legislation on ‘Gluten-free' Foods and Avoidance of Cross-contamination during Manufacture of ‘Gluten-free' or ‘Very Low Gluten' Products Published by: Food Safety Authority of Ireland 2010, ISBN 1-904465-71-4].
Packing and labeling are also important elements in preventing cross contamination. Packing equipment may also be a source of contamination. The packaging machines and material should be checked for any allergens, e.g. foil coated with releasing agents derived from wheat flour. Appropriate labeling should be use to inform customers who are affected by coeliac disease. Correct labeling should reflect actual and real composition of the product. Labels must also fulfill legislative requirements. To facilitate recognition of gluten free products, labeling must be clear and readable. EU legislation regarding food labeling imposes an obligation to provide true and clear information about ingredients. Alerts to all allergenic ingredients, starch source (plant from witch starch originates) and gluten content are required. The manufacturer is obligated to ensure readability of the above information. Directive 2003/13/EC of 10 February 2003 posted in the Official Journal of the European Union requires that food manufacturers should place notification on labels of any of the fourteen groups of potential allergens responsible for more than 90% of allergic reactions if they have been used as food ingredients (including alcoholic drinks), regardless of the allergen content. The list of allergenic ingredients is constantly being updated. Also, the components derived from allergenic substances must be listed as potential allergens [ Czarniecka-Skubina E., Janicki A. 2009. Znakowani produktów Å¼ywnoÅ›ciowych. Informacje Å¼ywieniowe i zdrowotne. PrzemysÅ‚ SpoÅ¼ywczy, StyczeÅ„, 34-36; Commission Directive 2003/13/EC of 10 February 2003 amending Directive 96/5/EC on processed cereal-based foods and baby foods for infants and young children. Official Journal of the European Union L 41/33, 14.2.2003]
Codex Alimentarius has proposed the introduction of the following descriptions in the vicinity of the product name. If the product comes from natural raw materials that do not contain gluten, it is described as "gluten free by nature," or "product may be used in gluten-free diet" [Hoffmann M., JÄ™drzejczyk H. 2007. Å»ywnoÅ›Ä‡ bezglutenowa – legislacja i aspekty technologiczne jej produkcji. PostÄ™py Techniki Przetwórstwa SpoÅ¼ywczego, 1, 67-69]. Products low in gluten, are marked with the inscription: "very low gluten foods", "low gluten foods", or gluten-reduced foods [Wojtasik. A, Kunachowicz H., Daniewski W. 2008. Aktualne wymagania dla produktów bezglutenowych w Å›wietle ustaleÅ„ kodeksu Å¼ywnoÅ›ciowego. Bromat. Chem. Toksykol., XLI, 2008, 3, str. 229-233; Darewicz M., Jaszczak L.; „Oznakowanie produktów stosowanych w diecie osób chorych na celiakiÄ™", PrzeglÄ…d Piekarski i Cukierniczy, march, 2012.].
Employee awareness at all levels of production, beginning with plant growing to finished preparation of proper labels is necessary throughout the gluten free production chain. Everybody must be informed about the consequences of gluten consumption by coeliac patients. Staff who are employed from time to time must be also well trained. Implementation of control procedures and proper documentation will be very helpful in maintaining control. Documentation of the training of every new employee needs to be prepared and maintained. All working stuff and implemented methods must be supervised all the time [Guidance Note No. 24 Legislation on ‘Gluten-free' Foods and Avoidance of Cross-contamination during Manufacture of ‘Gluten-free' or ‘Very Low Gluten' Products Published by: Food Safety Authority of Ireland 2010, ISBN 1-904465-71-4].
By taking into account all aspects mentioned above and striving to make continuous improvements, manufactures are able to produce safe, high quality gluten free products. The human factor is one of the most important elements in this process because only human mistakes can lead to contamination and only good training and awareness at every stage of production stage can produce the best possible product. Implementation of quality management systems like HACCP or GMP assures customers of food quality and safety, while also allowing the producer to lower production costs related to potential human mistakes. However, nothing will really change the fact that all of the factors described above must be implemented in everyday production, ensuring that they are not simply ideas on the piece of paper. Implementation is the key.