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U.S. Department of Health and Human Services

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Agency Response Letter GRAS Notice No. GRN 000266

CFSAN/Office of Food Additive Safety

May 29, 2009

Mr. Viggo Norn
Palsgaard A/S
Palsgaardvej 10
7130 Juelsminde
DENMARK

Re: GRAS Notice No. GRN 000266

Dear Mr. Norn:

The Food and Drug Administration (FDA) is responding to the notice, dated November 7, 2008, 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 November 13, 2008, filed it on November 14, 2008, and designated it as GRAS Notice No. GRN 000266.

The subject of the notice is polyglycerol polyricinoleate (PGPR). The notice informs FDA of the view of Palsgaard A/S that PGPR is GRAS, through scientific procedures, for use as an emulsifier in chocolate-type products based on vegetable fats other than cocoa butter, at levels up to 0.3 percent and in accordance with good manufacturing practices.

Palsgaard A/S discusses the identity and composition of PGPR. PGPR is a water-in-oil type emulsifier that consists of polyglycerol as the hydrophilic group and interesterified ricinoleic fatty acids as the hydrophobic group. The polyglycerol is mainly present as di-, tri-, or tetra-glycerol (minimum 75 percent) with smaller amounts present as heptaglycerol or longer-chain glycerols (maximum 10 percent). The ricinoleic fatty acids are derived from castor oil, which is composed mainly of ricinoleic fatty acids (approximately 90 percent) with smaller amounts of other fatty acids, including oleic, linoleic, and stearic.

Palsgaard A/S describes the manufacturing methods for PGPR. Glycerol is heated to temperatures above 200 degrees Celsius in the presence of an alkali catalyst, generating polyglycerol units. Castor oil fatty acids are heated to temperatures above 200 degrees Celsius, generating interesterified ricinoleic fatty acid chains of varying lengths. The interesterified ricinoleic fatty acids are mixed with the polyglycerol units to form a complex mixture of polyglycerol polyricinoleate molecules of different chain lengths.

Palsgaard A/S states that food grade PGPR will meet the specifications established in the Food Chemicals Codex (sixth edition) and by the European Commission and the FAO/WHO Joint Expert Committee on Food Additives (JECFA).

Palsgaard A/S calculates the estimated intake of PGPR based on total United States manufacturers’ shipments and trade data for chocolate and chocolate-type confectionary. The notifier estimates the daily intake of PGPR would be 1.8 milligrams of PGPR per kilogram of bodyweight per day (mg/kg bw/day) for children and 0.8 mg/kg bw/day for adults.

As part of its safety evaluation of PGPR, Palsgaard A/S summarizes the results of published safety studies of PGPR as well as a published report on the status of the safety assessment of PGPR, issued under the auspices of the Nordic Working Group on Food Toxicology and Risk Assessment. The studies include a feeding study in humans, and carcinogenicity, ADME (absorption, distribution, metabolism, and excretion), and reproductive studies in rats. Palsgaard A/S cites FDA’s response letters to two prior GRAS notices for the use of PGPR as an emulsifier in food1 (GRAS Notice Nos. 000009 and 000179), in which FDA states that it had no questions at that time regarding the notifiers’ GRAS determinations.

The notifier’s safety evaluation includes a comparison of the estimated intakes (for children and adults) of PGPR from chocolate and chocolate-type confectionary to the acceptable daily intake (ADI) for PGPR of 0 – 7.5 mg/kg bw/day, as established by JECFA. Palsgaard A/S notes that the estimated intakes for children and adults are below the upper level of the ADI. Palsgaard A/S estimates that the intake of PGPR from other sources of food to be very small and without significance.

Based on the evaluation of published toxicological studies of PGPR combined with the evaluation of the estimated cumulative intake of PGPR, Palsgaard A/S concludes that PGPR is GRAS for use as an emulsifier in chocolate-type products based on vegetable fats other than cocoa butter.

Standards of Identity

In the notice, Palsgaard A/S states its intention to use PGPR 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.

Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (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 Palsgaard A/S’ notice that PGPR is GRAS for use in chocolate-type products based on vegetable fats other than cocoa butter, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing PGPR. Accordingly, this response should not be construed to be a statement that foods that contain PGPR, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).

Conclusions

Based on the information provided by Palsgaard A/S, as well as other information available to FDA, the agency has no questions at this time regarding Palsgaard A/S’ conclusion that PGPR 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 PGPR. As always, it is the continuing responsibility of Palsgaard A/S 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 0000266, 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.

Sincerely,

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


 



 

1The intended use of PGPR in GRN 000009 is as an emulsifier in chocolate; the intended use of PGPR in GRN 000179 is as an emulsifier in margarines, low fat margarines, spreads, creamers, and dairy analogs.