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Agency Response Letter GRAS Notice No. GRN 000634

Recently Published GRAS Notices and FDA Letters

See also Generally Recognized as Safe (GRAS).

CFSAN/Office of Food Additive Safety

August 8, 2016

Nga Tran, Dr.PH, MPH
Exponent, Inc.
1150 Connecticut Avenue, NW
Suite 1100
Washington, DC 20036

Re: GRAS Notice No. GRN 000634

Dear Dr. Tran:

The Food and Drug Administration (FDA) is responding to the notice, dated February 23, 2016, that you submitted on behalf of PepsiCo, Inc. (PepsiCo) in accordance with the agency’s proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on February 24, 2016, filed it on March 18, 2016, and designated it as GRAS Notice No. GRN 000634.

The subject of the notice is calcium chloride. The notice informs FDA of the view of PepsiCo that calcium chloride is GRAS, through scientific procedures, for use as an ingredient in the production of potato snacks (e.g., potato chips and sticks) to reduce the formation of acrylamide, at a maximum use level of 1%.

As part of its notice, PepsiCo includes the report of a panel of individuals (PepsiCo’s GRAS panel) that evaluated the data and information that are the basis for PepsiCo’s GRAS determination. PepsiCo considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. PepsiCo discusses the identity, manufacturing, specifications, intended uses, dietary exposure estimates, and published safety data for calcium chloride. Based on this review, PepsiCo’s GRAS panel concluded that calcium chloride produced in accordance with current good manufacturing practices (cGMP) that meets its established food grade specifications is GRAS under the conditions of its intended use.

PepsiCo describes the identity of calcium chloride (CaCl2, CAS registry number: 10043-52-4). Calcium chloride is made as a dry powder or a solution (32%).

PepsiCo describes the manufacture of calcium chloride. Calcium chloride brine is sieved and then mixed with filtered water and hydrochloric acid. The resulting solution is filtered, stored, and diluted to 32% before distribution. To produce calcium chloride powder, liquid calcium chloride is evaporated, desulphated using barium chloride, dried, and then pelletized. The dry powder is then packaged for storage and shipment. All procedures used in the manufacture of calcium chloride are consistent with cGMP for food ingredients.

PepsiCo states that calcium chloride meets Food Chemicals Codex (FCC) (9th Edition) specifications including assay (93.0 - 100.5% for the dry powder, 90 - 110% by weight in solution). Limits include lead (< 2.0 milligrams per kilogram (mg/kg)) and arsenic (< 0.03 mg/kg). PepsiCo provides analytical data from three non-consecutive batches of calcium chloride powder and solution to demonstrate conformance with the FCC specifications.

PepsiCo presents a cumulative dietary exposure to calcium from background sources of calcium (food and supplemental intake) and the intended use of calcium chloride in potato snacks. The reported estimates were generated using the 2007 - 2010 National Health and Nutrition Examination Survey two day average food consumption data. PepsiCo considers that the intended use of calcium chloride does not significantly contribute to the total cumulative calcium intake. The cumulative dietary exposure estimates to calcium for the U.S. population aged 1 year or more are 1152 mg per person per day (mg/p/d) (19 mg/kg bodyweight (bw)/d for a 60 kg individual) at the mean and 1936 mg/p/d (32 mg/kg bw/d for a 60 kg individual) at the 90th percentile. Cumulative calcium intake at the 90th percentile from the background and the intended use is below the Institute of Medicine (IOM) upper limit for calcium in all subpopulations with the exception of the older groups (males and females 51-70 years and females 71+ years). The reported estimates for the older groups are between the upper limit range of calcium exposure set forth by IOM and the European Food Safety Authority at 2000 mg/day and 2500 mg/day, respectively. PepsiCo states that this is due to the higher calcium intake from dietary supplements among the older subpopulations.

PepsiCo discusses published acute, chronic, and developmental/teratogenicity studies conducted in animals, in addition to published in vitro mutagenicity studies on calcium chloride. The results of these studies demonstrate that calcium chloride does not cause adverse effects at the levels of intended use. PepsiCo also notes that the use of calcium chloride is affirmed as GRAS under 21 CFR 184.1193 for a number of technical effects in various food categories. Based on the totality of the available data and information, PepsiCo concludes that calcium chloride is GRAS under the conditions of its intended use.

Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Section 301(ll) of the FD&C Act prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FD&C Act, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll) (1)-(4) applies. In its review of PepsiCo’s notice that calcium chloride is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing calcium chloride. Accordingly, this response should not be construed to be a statement that foods that contain calcium chloride, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).

Conclusions

Based on the information provided by PepsiCo, as well as other information available to FDA, the agency has no questions at this time regarding PepsiCo’s conclusion that calcium chloride is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of calcium chloride. As always, it is the continuing responsibility of PepsiCo to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000634, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying at www.fda.gov/grasnoticeinventory.

Sincerely,

Dennis M. Keefe, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

 
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