Food Diagnostics - Allergens




Food and Feed Testing for Allergens

An allergen is a substance in food that causes a vigorous immune response to a perceived threat that would otherwise be harmless. It stimulates a type 1 hypersensitive reaction through immunoglobulin E response. Usually this occurs only in individuals that have a special disposition called atopy which can be hereditary or acquired. The Food and Drug Administration recognizes eight foods as commonly responsible for food allergies and they are peanuts, tree nuts, eggs, milk, shell fish, fish, wheat and their derivatives, soy and their derivatives, and sulfides.

The EU regulation specifies 14 allergens as celery, cereals containing gluten including wheat, oats, rye, barley, crustaceans, eggs, fish, lupin, milk, mollusks, mustard, tree nuts, peanuts, sesame seeds, soya beans, Sulphur dioxide and sulfites. This is stated in the Regulation (EU) No 1169/2011 of the European Parliament and of the Council of 25 October 2011. The Federal food Drug and cosmetic act requires that the label of a food product disclose the presence of an ingredient derived from on the eight allergens stated. If there is risk of a food being affected by cross contamination, the label should contain a warning of the allergen. Free from foods are special ranges of food made without allergens.

Manufacturing of such products must be based on specific and rigorous controls to ensure that the final product is below the regulatory standards. Special efforts to prevent cross contamination during manufacturing. As such cleaning of production equipment after a change of product becomes very important and a cleaning validation is needed. This is specifically emphasized in the Food Safety Modernization Act good manufacturing practice and preventive controls. Sub section 117.3 of this act spell out allergen cross contact and sub part B establishes GMP guidelines to prevent allergen cross contamination. Sub section 117.135 establishes requirements for preventive controls. Sanitation controls, testing and cleaning validation is an important requisite for all the above regulations.

To carry a risk assessment of allergens it is prudent to carry out a thorough review of the allergen status of all ingredients and their processing conditions that contribute towards the allergen status of the final product. To this end, use of the Allergen Bureau’s VITAL Program (Voluntary Incidental Trace Allergen Labelling) is useful. VITAL allows the assessment of likely sources of allergen cross contact from raw materials and the processing environment, plus an evaluation of the amount present and a review of the ability to reduce the allergenic material from all contributing sources. VITAL also provides for ongoing monitoring and verification of the risk assessment process to ensure any changes to the level of risk are acted upon without delay.


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