April 21, 2000

Mr. Michael Ryan
Marigot Ltd.
Strand Farm, Currabinny
Carrigaline, Co. Cork
IRELAND

Re: GRAS Notice No. GRN 000028

Dear Mr. Ryan:

The Food and Drug Administration (FDA) is responding to the notice, dated July 9, 1999, 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)). FDA received the notice on July 28, 1999 and designated it as GRAS Notice No. GRN 000028.

The subject of the notice is a product that you call "calcified seaweed" or "Maerl." The notice informs FDA of the view of Marigot, Limited (Marigot) that "calcified seaweed" derived from Phymatolithon calcareum or Lithothamnium corrallioides is GRAS, through scientific procedures, for use as a source of dietary calcium for food enrichment and fortification purposes. The typical level of use of "calcified seaweed" is less than 2 per cent and the maximum level of use is 4 per cent.

According to your notice, "calcified seaweed" is a naturally occurring photosynthetic product, of marine origin, that accumulates in submarine banks or deposits over time. Although its composition can vary depending on the point of harvest, season, or depth of the deposit, it typically contains 84.2 per cent calcium carbonate and 11.4 per cent magnesium carbonate. The balance is moisture (typically 0.5 to 2.0 per cent) and trace elements. Given this composition, it is the view of the Office of Premarket Approval that the term "calcified seaweed" does not adequately describe the substance that is the subject of your notice because it implies, inaccurately, that the characterizing property of the substance is "seaweed" rather than "calcium." Therefore, for the purpose of this letter, we are using the term "seaweed-derived calcium" to describe the subject of your notice. We have provided a copy of your notice to Mr. John Foret, Office of Nutritional Products, Labeling, and Dietary Supplements, Division of Compliance and Enforcement, Center for Food Safety and Applied Nutrition, HFS-156, 200 C Street S.W., Washington, DC 20204. We recommend that you contact Mr. Foret to discuss the common or usual name that would be used to identify seaweed-derived calcium in the ingredient statement of food products that contain this ingredient and would be marketed in the U.S. You can reach Mr. Foret by telephone at (202)205-5229, by telefax at (202)205-4594, or by electronic mail at JForet@cfsan.fda.gov.

In your notice, you provide a typical range for the levels of the major components of seaweed-derived calcium (i.e., calcium, 31 to 34 percent; magnesium, 2.8 to 3.3 percent; and moisture, less than 5 percent). You also provide a typical range for the levels in the final product of trace elements such as lead (less than 0.9 parts per million (ppm), iodine, boron, and selenium. In the section of your notice entitled "Specifications," you note that seaweed-derived calcium is a natural photosynthetic product of marine origin that is subject to variation, and that the typical values provided are subject to some seasonal variation.

The major component of seaweed-derived calcium, calcium carbonate, is affirmed as GRAS for use in food with no limitation other than current good manufacturing practice (21 CFR 184.1191). Seaweed-derived calcium is processed using a certified ISO 9000 procedure for food grade products. The seaweed-derived calcium is sterilized and deodorized in a heated solution of hydrogen peroxide for 90-120 minutes, depending on the rate of decomposition of the hydrogen peroxide. It is then milled and bagged under sterile conditions.

You intend to use seaweed-derived calcium as a source of calcium in food products such as biscuits, pasta, hard candy, tomato juice, soya milk, soya desserts and yoghurt, dairy yoghurt, dairy desserts, dietetic foods, and soups, at a typical level of less than 2 per cent. According to your notice, the use of "seaweed-derived calcium" is limited by its effects on palatability and texture, with an upper limit of 4 per cent.

Based on the information provided by Marigot, as well as other information available to FDA, the agency has no questions at this time regarding the conclusion of Marigot that seaweed-derived calcium is GRAS under the proposed conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of seaweed-derived calcium. As always, it is your continuing responsibility to ensure that food ingredients that you market 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, 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 World Wide Web.

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