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Issue Number: Council III 024

Title

Drying Agents

Issue you would like the Conference to consider

Clarification to the 2009 US Food Code section 7-204.14 Drying Agents, Criteria, and the associated section in Annex 3 is needed to account for other regulatory procedures that can be used to clear food additives for their use in drying agents. Due to the absence of specific regulations in FDA's 21 Code of Federal Regulations (CFR) for drying agents, the FDA Food Code serves as the sole guidance for the use of drying agents in food facilities. The Food Code does not include use of Generally Recognized as Safe (GRAS) self-determinations by a panel of experts as specified in 21 CFR 170.30 or using the Food Contact Notification (FCN) process, which is included in the Federal Food Drug and Cosmetic Act (FFDCA) Section 409, and 21 CFR Parts 174.5 (d) (5). Both of these processes are appropriately used to qualify suitable components for drying agents and other chemicals associated with production and preparation of food.

Public Health Significance

Some chemicals may be poisonous or toxic if not used properly and in accordance with FDA regulations. The lack of clear and explicit guidance surrounding drying agents not only creates confusion and allows for misinterpretation. Lack of clear and explicit guidance can also lead to the improper use of chemicals and may subsequently cause public health issues such as the adulteration of food, or potentially acute and chronic health effects to both the consumer and the employees of the food facilities.

Recommended Solution: The Conference recommends...

That a letter be sent to the FDA recommending the following changes to the Food Code,

7-204.14 Drying Agents, Criteria

Drying agents used in conjunction with sanitization shall:

(A) Contain only components that are listed as one of the following:

(1) Generally recognized as safe for use in food as specified in 21 CFR 182 - Substances Generally Recognized as Safe, or 21 CFR 184 - Direct Food Substances Affirmed as Generally Recognized as Safe, P

(2) Generally recognized as safe for the intended use as specified in 21 CFR 186 - Indirect Food Substances Affirmed as Generally Recognized as Safe, P

(3) Generally recognized as safe (GRAS) as determined by independent GRAS self-determinations by a panel of experts as specified in 21 CFR 170.30, P

(4) Subject of a Food Contact Notification (FCN) that is effective in accordance with the Federal Food Drug and Cosmetic Act (FFDCA) Section 409, P

FDA publishes the effective FCN's on their website at: http://www.fda.gov/Food/FoodIngredientsPackaging/FoodContactSubstancesFCS/ucm116567.htm

(53) Approved for use as a drying agent under a prior sanction specified in 21 CFR 181 - Prior-Sanctioned Food Ingredients, P

(64) Specifically regulated as an indirect food additive for use as a drying agent as specified in 21 CFR Parts 174175-178, P or

(75) Approved for use as a drying agent under the threshold of regulation process established by 21 CFR 170.39 Threshold of regulation for substances used in food-contact articles; P and

(B) When sanitization is with chemicals, the approval required under Subparagraph (A)(3) or (A)(5) of this section or the regulation as an indirect food additive required under Subparagraph (A)(4) of this section, shall be specifically for use with chemical sanitizing solutions. P

2) Annex 3. Chapter 7- Part 204.14 Sanitizers, Criteria.

"If the chemical wash, boiler water additive, or drying agent used is not made up of components that are approved as food additives or generally recognized as safe, illness may result. This could be due to residues that may remain from the use of compounds such as unrecognized drying agents. This is why only those chemicals that are listed in the CFR or are appropriately cleared as food additives can be used.

"Chemicals that are not listed for these uses may be submitted for review by filing a Food Additive Petition, a Food Contact Notification (FCN), have GRAS clearance, or meet the Threshold of Regulation (TOR) requirements. Wash chemicals, boiler water additives, and drying agents are classified as food additives because of the possibility that they may end up in food. Therefore, they are subject to review before being used or listed in the CFR.

Submitter Information

Name Dan Dahlman
Organization Ecolab
Address 370 N Wabasha St
EUC-9
St Paul, MN 55102
Telephone 651-225-33297
Fax
Email dan.dahlman@ecolab.com
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