Our goal for writing these articles is to give you, the operator a better understanding of the current 2005 FDA Food Code. Each month we’ll continue to explore the content of the food code and how it relates to the operation of your facilities. For the next several months, we’ll be examining the source of food that may be used in a food establishment

Question

I’ve heard of the term GRAS before, what exactly does it mean?

Answer

3-202.12 Additives.* Generally Recognized as Safe (GRAS)

It is imperative for safety that food supplies come from sources that are in compliance with laws regarding chemical additives and contaminants.

Food additives are substances which, by their intended use, become components of food, either directly or indirectly. They must be strictly regulated. In excessive amounts or as a result of unapproved application, additives may be harmful to the consumer.

Unintentional contaminants or residues also find their way into the food supply. The tolerances or safe limits designated for these chemicals are determined by risk assessment evaluations based on toxicity studies and consumption estimates.

Food and Color additives must be used in compliance with a federal food, or color additive regulation, an effective food-contact notification, or a threshold of regulation exemption. Such regulations, notifications, and exemptions are generally composed of three parts: the identity of the substance, specifications including purity or physical properties, and limitations on the conditions of use. In order for a food, or color additive use to be in compliance, the use must comply with all three criteria.

Federal Food Additive regulations are found in Title 21 CFR, Parts 172-180. Color additive regulations are found in Title 21 CFR Parts 73-Subpart A, 74-Subpart A, 81 and 82. Effective food-contact notifications are listed at http://vm.cfsan.fda.gov/~dms/opafcn.html, and threshold of regulation exemptions are listed at http://www.cfsan.fda.gov/~dms/opa-torx.html.

Other substances that are added to food include those prior sanctioned for use in food by either the FDA or USDA, or those generally recognized as safe for their intended use in food. Some of these are listed in Title 21 CFR Parts 181-186, Title 9 CFR Section 424.21(b) and at 

http://www.cfsan.fda.gov/~rdb/opa-gras.html. Tolerances and exemptions from tolerance for pesticide chemical residues in or on food are found in

Title 40 CFR Part 180. Substances that are prohibited form use in human food are listed in Title 21 CFR Part 189.

3-202.12 Additives.*

FOOD may not contain unAPPROVED FOOD ADDITIVES or ADDITIVES that exceed amounts specified in 21 CFR 170-180 relating to FOOD ADDITIVES, generally recognized as safe or prior sanctioned substances that exceed amounts specified in 21 CFR 181-186, substances that exceed amounts specified in 9 CFR Subpart C Section 424.21(b) Food ingredients and sources of radiation, or pesticide residues that exceed provisions specified in 40 CFR 180 Tolerances for pesticides chemicals in food, and exceptions.

Critical Item Violation, Denoted by asterisk *

"Critical item" means a provision of this Code,  that if in noncompliance, is more likely than other violations to contribute to FOOD contamination, illness, or environmental health HAZARD.

Noncritical  Violation, Denoted by N

8-406.11 Time Frame for Correction.

(A) Except as specified in ¶ (B) of this section, the PERMIT HOLDER shall correct noncritical violations by a date and time agreed to or specified by the REGULATORY AUTHORITY but no later than 90 calendar days after the inspection.

So long for this month,

Doris Rittenmeyer, CFSP

Director – Safety Management Services

drittenmeyer@foodhandler.com