21 CFR Part 170 - Food Additives

What it says

Part 170 sets out general provisions for food additives, including what a food additive is, how a petition for a new additive is filed, the use of substances that are generally recognized as safe (GRAS) by qualified experts, and the procedures for food contact substances. A substance that is added to food, or reasonably expected to become a component of food, is generally a food additive and needs FDA approval unless it is GRAS or otherwise excepted.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Before using a new ingredient, a manufacturer should confirm that it is approved for the intended use or is GRAS for that use.
• A substance may be permitted in one food at one level and not in another.
• Packaging and processing aids can be food additives if they migrate to food.

What FDA inspectors look for

• Whether ingredients and additives are permitted for the use and level in the product.
• Whether the facility can show the basis for the regulatory status of ingredients.
• Whether use stays within the conditions on the approval.

Related regulations