Agency Response Letter
GRAS Notice No. GRN 000219

Viggo Norn
Research and Development Director
Palsgaard A/S
Palsgaardvej 10
7130 Juelsminde
DENMARK

Re: GRAS Notice No. GRN 000219

Dear Mr. Norn:

The Food and Drug Administration (FDA) is responding to the notice, dated December 21, 2006, 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 December 28, 2006, filed it on January 3, 2007, and designated it as GRAS Notice No. GRN 000219.

The subject of the notice is ammonium phosphatide. The notice informs FDA of the view of Palsgaard A/S (Palsgaard) that ammonium phosphatide is GRAS, through scientific procedures, for use as an emulsifier in chocolate and vegetable fat coating at a level up to 0.7 percent.

Palsgaard notes that the subject of the notice is similar to monosodium phosphate derivatives of mono- and diglycerides and is manufactured under similar chemical conditions, except that ammonia is used as the neutralizing agent instead of sodium carbonate in the final manufacturing step. Monosodium phosphate derivatives of mono- and diglycerides are affirmed as GRAS in 21 CFR 184.1521 for use in dairy product analogs and soft candy as an emulsifier and emulsifier salt, a lubricant and release agent, and a surface-active agent.

Palsgaard describes generally available information about the identity and composition of ammonium phosphatide. Ammonium phosphatides consist of a mixture of mono- and diglyceride phosphatidic acid compounds that vary in fatty acid composition depending on the starting materials and manufacturing process. The final product is a yellow to light brown substance that ranges in form from a semisolid to an oil depending on the degree of saturation of the component fatty acids.

Palsgaard describes the manufacture of ammonium phosphatide and its specifications. The product is manufactured from triglycerides and glycerol that are reacted at high temperatures to produce a mixture of mono-, di-, and triglycerides. Excess glycerol is removed by deodorization. The refined mixture is then reacted with phosphorpentoxide (to form phosphoric acid esters), followed by reaction with ammonia gas (to neutralize the phosphatide). Finally, the excess ammonia is allowed to dissipate and the phosphate solids are removed by filtration. Palsgaard's specifications for its ammonium phosphatide include specifications for phosphorus content, arsenic, and heavy metals (as lead).

Palsgaard describes the intended use of ammonium phosphatide in chocolate and vegetable fat coating. Palsgaard notes that ammonium phosphatide was originally developed over 50 years ago to alter the viscosity of chocolate, and that its use remains strongly associated with this food. Palsgaard states that ammonium phosphatide has the ability to lower the plastic viscosity in chocolate when added at amounts up to 0.7 percent, noting that typical use levels range between 0.4 and 0.6 percent. Palsgaard provides an intake estimate of 107 milligrams (mg) of ammonium phosphatide per day, equivalent to 1.8 milligrams per kilogram of bodyweight per day (mg/kg bw/day) for a 60 kilogram (kg) adult. This estimate is based on per capita consumption data of chocolate and chocolate-type confectionery and a 0.7 percent use level of ammonium phosphatide.

Palsgaard provides in its notice both a summary of toxicology studies on ammonium phosphatide and the studies themselves, which include published and unpublished studies in rats, mice, guinea pigs, ferrets, and rabbits. The study types include acute, subchronic, chronic, reproductive, developmental, and metabolic studies.

Palsgaard also cites the findings of the toxicological evaluation of ammonium phosphatide by the Joint Expert Committee on Food Additives (JECFA), which is based mostly on published literature. JECFA concluded that ammonium phosphatide is of low toxicity and recommended an acceptable daily intake (ADI) of up to 30 mg/kg bw/day, but noted that the contribution from this compound to phosphate intake should be included in the ADI for phosphate.

Based on the information provided by Palsgaard, as well as other information available to FDA, the agency has no questions at this time regarding Palsgaard's conclusion that ammonium phosphatide 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 ammonium phosphatide. As always, it is the continuing responsibility of Palsgaard 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 000219 as well as a copy of the information in this notice that conforms to the information in the proposed GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying on the homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).

Sincerely,

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