There are several broad classes of compliance with which food and beverage producers must deal, one of which is product labeling. Many consumer products must include an ingredient label listing product contents. Consumers use this information in many ways, especially to avoid ingredients that cause problems ranging from mild rashes to severe allergic reactions.

Labeling regulations strive to balance the risks against the costs of reporting. Since people with severe allergies can die in minutes from exposure to tiny quantities of materials like peanuts, it is critically important to them to know if the foods they eat might contain allergens.

Although symptoms can be treated, there is no known cure for allergies or for most food sensitivity. Avoidance becomes paramount. The public relies on food manufacturers to disclose on their labels the presence of even small amounts of allergens. At first blush, that might seem to be a simple matter--after all, surely the manufacturer knows whether peanuts are in the product or not.

However, determining whether an allergen could be in a product can be a challenge, since allergens may be introduced in trace amounts anywhere in the food manufacturing chain--from a subcomponent of an ingredient to cross-contamination between production lines; from a processing aid, like a pan-release lubricant used in baking muffins to, in rare cases, a contaminant that might even blow in from a cornfield across the county.

To combat this, manufacturers must have in place good controls over both ingredients and manufacturing practices. In turn, the suppliers of raw materials also must have similar controls in place, throughout the entire supply chain. A single lapse can have fatal consequences.

Surprisingly, many companies do not have these controls in place. According to a study by the FDA, some 25% of manufacturers have inadequate tracking and reporting systems and cannot reliably generate an accurate ingredient label. Specifically, federal and state inspectors found unlabelled peanut and egg proteins in 23 of 118 samples of ice cream, baked goods and candy they suspected were contaminated. Although this is a small non-random sample, it is still quite sufficient to give an allergic person cause for concern.

Formation Systems (Southborough, Mass.), as part of its overall software offering, includes a module specifically designed to create an accurate, technical statement for a product label. The Optiva International Ingredient Statement functionality generates ingredient listings by predominance and the data needed for nutritional facts and warning labels. It operates by rolling up the characteristics of raw materials to the finished product level. As products are formulated, the ingredient labels are calculated and produced automatically. When a formula is changed, or the characteristics of a raw material change, Optiva recalculates the label content, ensuring accurate allergen reporting. Additionally, as regulations change, Optiva allows for easy rule additions or updates to immediately track new requirements.

When food allergen and ingredient labeling regulations require manufacturers to design their food labels as an integral part of bulk product development, Optiva makes this a simple task.

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Formation Systems, Steve Phelan