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, packing, packaging, transporting or holding 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
▲ 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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