Food/Color Additives and Packaging

Food and Color Additives

All new food and color additives, including antimicrobial food additives, require pre-market approval by the U.S. FDA through food additive petition (FAP) or color additive petition (CAP) unless its use is generally recognized as safe (GRAS).

Materials Needed for Review

1. Environmental impact assessment
2. Chemistry and exposure assessment
3. Toxicology data from GLP laboratories
4. Clinical data (not required)

Genetically Modified Foods

Proposed rule of the U.S. FDA require that developers submit a scientific and regulatory assessment of genetically modified food through biotechnology notification file (BNF) 120 days before marketing.

GRAS Program

A GRAS status of a substance may be established by history of common use or by scientific procedures through GRAS notification (GRN) to the U.S. FDA.

Food Contact Substances

The U.S. FDA requires reviewing a food contact notification (FCN) for any substance intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use is not intended to have a technical effect in such food.

Services

• Conducting GMP auditing and GLP auditing for facilities
• Assessing hazard analysis and critical point (HACCP)
• Preparing FAPs or CAPs for food or color additives
• Preparing BNFs for genetically modified foods
• Preparing GRNs for GRAS substances
• Preparing FCNs for food contact substances
• Assessing exposure
• Assessing environmental impact
• Submitting petitions and notifications to the U.S. FDA