December 11, 2000

April Kates
American Ingredients Company
3947 Broadway
Kansas City, MO 64111

Re: GRAS Notice No. GRN 00040

Dear Ms. Kates:

The Food and Drug Administration (FDA) is responding to the notice, dated February 23, 2000, 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 February 28, 2000 and designated it as GRAS Notice No. GRN 000040.

The subject of the notice is mineral oil. The notice informs FDA of the view of American Ingredients Company that mineral oil is GRAS, through experience based on common use in food, for use as a release agent sprayed on food processing equipment resulting in a presence on food of no more than 5 parts per million (ppm). Because a substance that is used as a release agent on food processing equipment would be subject to the direct food additive regulations (see 21 CFR 178.3620(a)), FDA considers the use that you describe to be use as a direct food ingredient.

Under section 201(s) of the Federal Food, Drug, and Cosmetic Act (the FFDCA) and 21 CFR 170.30, a substance that is added to food is not subject to the requirement for premarket approval as a food additive if its safety is generally recognized among qualified experts. In the GRAS proposal, FDA proposed to establish a procedure whereby any person may notify FDA of a determination that a particular use of a substance is GRAS. Such notice to FDA is a voluntary mechanism for communication between a person who determines that a use of a substance is not subject to the statutory premarket approval requirements and FDA, the federal agency responsible for implementing those statutory provisions. A threshold question for such a notice is whether the particular use of a substance satisfies GRAS criteria.

The statutory basis for your assertion that mineral oil is GRAS for its intended use is through experience based on common use in food before 1958. Under 21 CFR 170.3(f), "common use in food" requires a substantial history of consumption for food use by a significant number of consumers. Thus, the fact that a substance was added to food before 1958 does not, in itself, demonstrate that such use is safe, unless the use before 1958 is sufficient to demonstrate to qualified experts that the addition of the substance to food is safe.

FDA has evaluated the information that you discuss in your GRAS notice as well as other data and information that are available to the agency. As discussed more fully below, your notice does not provide a sufficient basis for a determination that mineral oil is GRAS, through experience based on common use in food, under the intended conditions of use.

Data and information that you present in GRN 000040

1. Identity

Mineral oil (Chemical Abstracts Service Registry number 8012-95-1) is a mixture of aliphatic, naphthalenic, and aromatic liquid hydrocarbons that derive from petroleum. A monograph for mineral oil in the Food Chemicals Codex IV (FCC IV) describes requirements for food-grade mineral oil.

2. Use of mineral oil in food applications before 1958

You provide a copy of a paper, by R.T. Bohn et al., entitled "White Mineral Oil in the Baking Industry." This paper, which published in 1960 in the journal Cereal Science Today, makes the following points:

• An article published in 1924 in a bulletin of the American Society of Bakery Engineers, which refers to the importance of mineral oil as a lubricant for a dough divider, evidences that white mineral oil was used in the baking industry before 1958.

• An Order issued in 1949 by the British Ministry of Foods regarding the use of mineral oil as a lubricant for equipment or baking tins evidences that white mineral oil was used in food outside the U.S. before 1958.

• Regulations issued by Canada in 1954, which state that a food is not adulterated by reason only that it contains mineral oil not exceeding 3000 ppm, if good manufacturing practice requires its use, also evidence that white mineral oil was used in food outside the U.S. before 1958.

3. Regulatory status of mineral oil in the U.S. in 1960

The paper published by Bohn et al. in 1960 reports the following information about the regulatory status of mineral oil in the U.S. at that time:

• Under the 1958 Food Additives Amendment to the FFDCA, FDA granted an extension for the use of white mineral oil by food manufacturers. This "food additive extension" permitted the use of mineral oil as a dough divider oil, pan oil, and trough grease until March 5, 1961, provided that the oil is not present in the finished product in amounts exceeding 1500 ppm.

• This "food additive extension" was authorized to provide time for completion of studies and preparation of food additive petitions.

The end result of the food additive extension process was FDA's approval of mineral oil as a food additive for several uses, including use as a release agent and lubricant in bakery products at a level not to exceed 0.15 percent by weight.

4. Consumer exposure from your proposed use of mineral oil

Your notice asserts that the intended use of mineral oil would result in a level of mineral oil in food products of no more than 5 ppm. Your notice also presents the intended use of mineral oil as a broad use on food processing equipment, which could result in the presence of mineral oil at the maximum level of 5 ppm in a large variety of commonly consumed foods. However, your notice does not estimate exposure to mineral oil by consumers who would eat multiple food products that each contain 5 ppm of mineral oil.

5. Recent amendments to the food additive regulations regarding mineral oil

FDA has approved the use of mineral oil as a dust control agent for wheat, corn, soybeans, barley, rice, rye, oats and sorghum when applied at a level of no more than 0.02 percent by weight of grain (21 CFR 172.878). Recently (December 1, 1998; 63 FR 66013), FDA amended 21 CFR 172.878 to approve mineral oil for use as a dust control agent for rice when applied at an increased level (i.e., a level of no more than 0.08 percent by weight of the rice grain).

6. Information about the safety of mineral oil

A number of studies pertaining to mineral oil have been published in the scientific literature. Some of these studies show effects, such as hepatic and mesenteric microgranulomas, in Fischer 344 rats that consumed low viscosity mineral oil. These results have not been observed in other strains of rats.

FDA's evaluation of the data and information that you present in GRN 000040

Your intended use of mineral oil as a release agent sprayed on food processing equipment is related to the use of mineral oil as a release agent and lubricant in bakery products. The information that you provide about the food additive extension process, which resulted in the food additive approval of mineral oil as a release agent and lubricant in bakery products, evidences both that the agency was aware of some pre-1958 use of mineral oil and that, in 1960, it was FDA's position that this pre-1958 use of mineral oil was not sufficient to demonstrate safety. Thus, FDA had concluded that the use before 1958 did not support a general recognition of safety. Your notice provides no basis to re-evaluate the position of the agency on this point.

Because you based your GRAS determination on common use in food, we did not evaluate whether there would be a basis for GRAS status through scientific procedures. However, you should be aware that the effects in Fischer 344 rats that you describe from published studies conducted with low viscosity mineral oil have not been observed in Fischer 344 rats fed mineral oil that has a relatively high viscosity, such as a viscosity of ISO 100 (which is equal to 100 centistokes at 100 degrees Fahrenheit). You also should be aware that FDA's recent approval of an increased level of use of mineral oil as a dust control agent for rice was limited to mineral oil with a viscosity of ISO 100, thus obviating the need to resolve concerns raised by the Fischer 344 rat data. In approving this expanded use of mineral oil, FDA calculated that the increased level of use of mineral oil would result in an estimated daily intake of approximately 2 milligrams per person per day. According to FDA's calculations, this additional intake would be less than one percent of the cumulative estimated dietary intake for mineral oil from previously approved uses of mineral oil as a direct food ingredient.

Conclusions

FDA has evaluated the information in GRAS Notice No. GRN 000040, as well as other available data and information. Your notice does not provide a sufficient basis for a determination that mineral oil is GRAS, through experience based on common use in food, under the proposed conditions of use.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter, as well as a copy of the information in your notice that conforms to the information in proposed 21 CFR 170.36(c)(1), is available for public review and copying on the Office of Premarket Approval's homepage on the Internet (at http://vm.cfsan.fda.gov/~lrd/foodadd.html).

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