Registrations & Approvals:
Food Additives & Packaging

In the United States, the Food and Drug Administration (FDA) regulates food ingredients and packaging materials, including food additives and contact substances.

A food additive is any substance that is expected to become a component of food, while a food contact substance is any substance intended for use in manufacturing, FDA-regulated food ingredients and food contact substances for vegetables packing, packaging, transporting or holding of food. Both are subject to premarket approval by FDA. If a food additive or food contact substance is generally recognized as safe (GRAS), as qualified by scientific experts who evaluate its safety, then companies can file a GRAS notification for that substance.

TSG’s consultants assist food and chemical companies with issues concerning food ingredients and food contact materials. Our work in this area includes advising on the regulatory status of direct and indirect food additives, submitting GRAS and

Food Contact Notifications (FCN)

, food additive petitions and threshold-of-regulation documents to the FDA, and assessing exposure and risk associated with chemicals in food.

Services include:

▲ Assessing exposure and risk associated with food ingredients, food contact substances
and impurities, contaminants and degradation products;

▲ Coordinating toxicity and migration studies;

▲ Arranging meetings, preparing presentations and providing representation at regulatory
agencies;

▲ Providing documentation of meetings and outcomes;

▲ Preparing petitions, notifications, request for opinions and providing advice regarding the
regulatory status of food packaging substances;

▲ Assisting with

Good Manufacturing Practice (GMP) compliance

for food ingredients; and

▲ Providing technical and regulatory assistance on complex issues such as the overlapping
roles of the EPA and FDA in the regulation of antimicrobial substances.
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