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  1. GRAS Notice Inventory

Agency Response Letter GRAS Notice No. GRN 000606

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See also Generally Recognized as Safe (GRAS).

CFSAN/Office of Food Additive Safety

May 27, 2016

Diane McColl, J.D.
Hyman, Phelps & McNamara, P.C.
700 Thirteenth Street, N.W. Suite 1200
Washington, D.C. 20005

Re: GRAS Notice No. GRN 000606

Dear Ms. McColl:

The Food and Drug Administration (FDA) is responding to the notice, dated October 29, 2015, that you submitted on behalf of Wacker Chemie AG (Wacker) 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 October 29, 2015, filed it on November 19, 2015, and designated it as GRAS Notice No. GRN 000606.

The subject of the notice is vinyl acetate – vinyl laurate copolymer (VAVLP). The notice informs FDA of the view of Wacker that VAVLP is GRAS, through scientific procedures, for use as a component of chewing gum base at a level up to 26% to reduce or eliminate the use of additional softeners.

As part of its notice, Wacker includes the statement of a panel of individuals (Wacker’s GRAS panel) that evaluated the data and information that are the basis for Wacker’s GRAS determination. Wacker considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. Wacker’s GRAS panel evaluated estimates of dietary exposure, method of production, and product specifications as well as published studies and an assessment of the lack of digestibility of VAVLP, supporting the safety of VAVLP. Based on this review, Wacker’s GRAS panel concluded that VAVLP that meets its established food grade specifications is GRAS under the conditions of its intended use.

Wacker provides information about the identity, composition, and method of manufacture of VAVLP. Wacker states that the full chemical name of VAVLP is dodecanoic acid, ethenyl ester, polymer with ethenyl acetate (CAS Number: 26354-30-3). At ambient temperatures, VAVLP is a light colored, odorless, tasteless solid that is insoluble in water. Wacker manufactures two varieties of VAVLP starting with different percentages of vinyl acetate and vinyl laurate. The two VALVP polymers differ primarily in their molecular weights (240,000 versus 450,000). VAVLP is produced by the polymerization of vinyl acetate with vinyl laurate. The starting vinyl acetate and vinyl laurate are of high purity (≥ 98%). After polymerization, the polymer is purified by evaporation at an elevated temperature under vacuum, and by washing with water.

Wacker provides the specifications for VAVLP. Specifications include the minimum level for VAVLP (≥99.85), residual vinyl acetate monomer (≤5 milligram per kilogram (mg/kg)), and free acetic acid (≤0.05%). Wacker states that specifications do not include limits for heavy metals, as routine analyses show that their levels are below the limit of detection of 1 mg/kg.

Wacker calculates a conservative estimated daily exposure for VAVLP by using the average U.S. daily intake of 1.72 gram (g) chewing gum/day (d) (based on data that were relied on in GRN 000374). At the 90th percentile, the intake of chewing gum would be 5.16 g/d, which was obtained by multiplying the average intake by 3. At the highest possible use level of VAVLP (17%) in the finished chewing gum, the 90th percentile chewing gum intake corresponds to 0.877 g VAVLP/person/d (0.0146 g/kg bodyweight (bw)/d assuming a body weight of 60 kg).

Wacker estimates that the maximum exposure to unpolymerized monomers and other reaction products, which would be present at a level of 0.1% in VAVLP, would occur in children aged 2 to 5 years (approximately 48 μg/kg bw/d, based on an average of 1.6 pieces of chewing gum/d and an average body weight of 17 kg).

Wacker discusses published studies on vinyl acetate and vinyl laurate, as well as published and unpublished studies on VAVLP. Wacker notes that several authoritative scientific bodies, including the Joint FAO/WHO Expert Committee on Food Additives and Health Canada, have examined published data for vinyl acetate, which show that no adverse genotoxic effects will result from exposure. In addition, a published 13 week rat study showed that up to 1000 mg/kg bw/d vinyl laurate, the highest level tested, did not have any adverse effects. Furthermore, Wacker stated that because of its physiochemical properties VAVLP would not be digested, which they confirmed with a digestibility study. Finally, Wacker reviewed a published 13 week rat study in which the rats consumed chow containing up to 5% VAVLP (3.8 or 4.6 g/kg bw/d, male or female, respectively) with no adverse effects. Thus, based on the totality of the data and information described above, Wacker has concluded that VAVLP is GRAS for its intended uses in food.

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 Wacker’s notice that VAVLP is GRAS for the intended uses, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing VAVLP. Accordingly, this response should not be construed to be a statement that foods that contain VAVLP, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).

Conclusions

Based on the information provided by Wacker, as well as other information available to FDA, the agency has no questions at this time regarding Wacker’s conclusion that VAVLP 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 VAVLP. As always, it is the continuing responsibility of Wacker 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 000606, 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