Decernis Announces Regulatory Compliance System

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Decernis releases information system for improved global compliance with food additive and food contact requirements resulting from cooperative project.

Decernis, LLC (http://www.decernis.com)announced today the release of FDA PLUS, a regulatory compliance information system for improving the searchability and transparency of FDA regulations, actions, and toxicity data relating to food contact substances and food additives. FDA PLUS is the result of a cooperative project over the last eighteen months between Decernis and the Food and Drug Administration (FDA), and is a new component of Decernis' web-based gComply, an information system used by manufacturers, law firms, and governmental agencies to determine requirements applicable to food and industrial materials covering seventy countries.

FDA PLUS is intended to make it easier to comply to find and address agency actions and data, and to compare them with other national requirements to assist businesses in understanding what they must do in reaching a global marketplace. Determining a manufacturer's or processor's obligations with regard to requirements applicable to the safety of food additives and food contact materials in a global market is a complex task for a large company, but especially challenging for a small or medium-sized organization. Such requirements may differ in procedure and substance between countries of use. In addition, these regulations are in flux, making it difficult to keep current.

"We are delighted to have the opportunity to work with FDA on this project, and believe that the results will provide tools to make better compliance decisions and at lower cost. Our goal is to provide the information and supporting systems that a company can use throughout the enterprise to reach global markets," indicated Pat Waldo, CEO of Decernis.

FDA's Office of Food Additive Safety (FDA/OFAS) and Decernis have established a collaborative project to make available an international regulatory compliance reference system. Through this cooperation between government and industry, FDA has shared databases of critical information regarding food safety and FDA requirements. Using its multi-lingual document and data management technologies, Decernis has integrated this information together with other national requirements into a consistent system for keeping up to date with global food safety requirements.

FDA PLUS includes: Publicly disclosable information from No Objection Letters, Threshold of Regulation Decisions, details of Food Contact Notifications, and FDA toxicological data sets and literature reviews related to food contact substances and food additives.

Decernis' gComply is a web-based reference system enabling the user to search and compare requirements applicable to materials used in food and industrial manufacturing in seventy countries in North and South America, Western and Eastern Europe, Asia-Pacific, and Africa. It includes over twenty-five thousand regulations. gComply additionally provides expert capabilities that allows the user to determine requirements for substances that are chemically related to broad groups defined in a regulation. The system permits the user to work across many different languages in which the requirements appear.

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Kevin C. Kenny
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