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CFSAN/Office of Food Additive Safety
December 16, 2009
Chemische Fabrik Budenheim KG
D 55257 Budenheim
Re: GRAS Notice No. GRN 000300
Dear Mr. Janssen:
The Food and Drug Administration (FDA) is responding to the notice, dated July 15, 2009, that you submitted 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 July 17, 2009, filed it on July 21, 2009, and designated it as GRAS Notice No. GRN 000300.
The subject of the notice is trisodium diphosphate. The notice informs FDA of the view of Chemische Fabrik Budenheim KG (herein after referred to as Budenheim in this letter) that trisodium diphosphate is GRAS, through scientific procedures, for use as a stabilizer, moisturizer and sequestrant in sausages (fine emulsions); fish and seafood products (excluding catfish and scallops) at levels in accordance with current good manufacturing practices (levels of addition shall not exceed 0.5 percent, as P2O5).
Budenheim describes the chemical identity and composition of trisodium diphosphate (also known as trisodium hydrogen diphosphate, trisodium pyrophosphate). Trisodium diphosphateis identified by the Chemical Abstracts Service Registry Number 14691-80-6 (anhydrous form). The empirical formula of trisodium diphosphate is Na3HP2O7, and the molecular weight of the anhydrous salt is 243.93.Trisodium diphosphate is a fine white powder, very soluble in water.
Trisodium diphosphate is manufactured by calcinating a solution of food grade caustic soda and phosphoric acid, at a ratio of approximately 1.5:1 at elevated temperatures with subsequent milling and sieving steps before filling. Budenheim notes that caustic soda is manufactured using a membrane process to avoid potential mercury contamination problems. Budenheim provides food grade specifications for trisodium diphosphate, including limits for lead, cadmium, arsenic and mercury.
The notifier states that an aqueous solution of trisodium diphosphate is chemically and metabolically indistinguishable from a 1:1 mixture of sodium acid pyrophosphate (disodium diphosphate) and tetrasodium pyrophosphate (tetrasodium diphosphate). The notifier notes that sodium acid pyrophosphate and tetrasodium pyrophosphate are already regulated as GRAS for use as sequestrants, leavening agents or other purposes. Sodium acid pyrophosphate is listed for multipurpose use under 21 CFR 182.1087, and tetrasodium pyrophosphate is listed for use as a sequestrant under 21 CFR 182.6789.The notifier discusses the available safety data on sodium and phosphate ions, since under the intended use conditions trisodium diphosphate dissociates into sodium and phosphate ions. The notifier also discussed safety data on sodium acid pyrophosphate and tetrasodium pyrophosphate, since these substances are chemically similar to trisodium diphosphate. The notifier concludes that trisodium diphosphate, produced according to good manufacturing practice, is safe under the conditions of its intended use.
Standards of Identity
In the notice, Budenheim states its intention to use trisodium diphosphate in several food categories, including foods for which standards of identity exist, located in Title 21 of the Code of Federal Regulations. We note that an ingredient that is lawfully added to food products may be used in a standardized food only if it is permitted by the applicable standard of identity.
Potential Labeling Issues
Under section 403(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA), a food is misbranded if its labeling is false or misleading in any particular.Section 403(r) of the FFDCA lays out the statutory framework for the use of labeling claims that characterize the level of a nutrient in a food or that characterize the relationship of a nutrient to a disease or health-relate condition. In describing the intended uses of trisodium diphosphate and in describing the information that Budenheim relies on to conclude that trisodium diphosphate is GRAS under the conditions of its intended use, Budenheim raises a potential issue under these labeling provisions of the FFDCA. If products that contain trisodium diphosphate bear any claims on the label or in labeling, such claims are the purview of the Office of Nutrition, Labeling, and Dietary Supplements (ONLDS) in the Center for Food Safety and Applied Nutrition. The Office of Food Additive Safety neither consulted with ONLDS on this labeling issue nor evaluated the information in your notice to determine whether it would support any claims made about trisodium diphosphate on the label or in labeling.
Use in Meat, Poultry and Egg Products
During its evaluation of GRN 000300, FDA consulted with the Risk and Innovations Management Division of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture. Under the Federal Meat Inspection Act, Poultry Products Inspection Act, and the Egg Products Inspection Act, FSIS is responsible for determining the efficacy and suitability of food ingredients in meat, poultry and egg products as well as prescribing safe conditions of use. Suitability relates to the effectiveness of the ingredient in performing the intended purpose of use and the assurance that the conditions of use will not result in an adulterated product, or one that misleads consumers.
FSIS advised that there are certain meat and poultry products that have specific standards of identity that do not permit the use of trisodium diphosphate as an ingredient. FSIS also advised that the trisodium diphosphate must be included on the ingredient label of all sausage products that it is used in.
FSIS requested that FDA advise Budenheim to seek regulatory guidance from FSIS, Labeling and Program Delivery Division, about the use of trisodium diphosphate in meat and poultry products. Budenheim should direct such an inquiry to Dr. John M. Hicks, Jr., Risk and Innovations Management Division, Office of Policy and Program Development, Food Safety and Inspection Service, via email at email@example.com.
Section 301(ll) of the FFDCA
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FFDCA to, among other things, add section 301(ll). Section 301(ll) of the FFDCA prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FFDCA, 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 Budenheim's notice that trisodium diphosphate is GRAS for use in sausages, fish and seafood products, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing trisodium diphosphate. Accordingly, this response should not be construed to be a statement that foods that contain trisodium diphosphate, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by Budenheim, as well as other information available to FDA, the agency has no questions at this time regarding Budenheim's conclusion that trisodium diphosphate 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 trisodium diphosphate. As always, it is the continuing responsibility of Budenheim 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 000300, 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 via the FDA home page at http://www.fda.gov. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the "Food" topic to the "Food Ingredients and Packaging" section to the "Generally Recognized as Safe (GRAS)" page where the GRAS Inventory is listed.
Mitchell A. Cheeseman, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
cc: Dr. John M. Hicks, Jr. DVM, MPH
Risk Management Division
Office of Policy and Program Development
Food Safety and Inspection Service
U.S. Department of Agriculture
George Washington Carver Center (GWCC)
5601 Sunnyside Avenue, Mailstop 5271
Beltsville, MD 20705-5271.