GRAS means generally recognized as safe. It is the designation given to substances that are considered safe for direct or indirect additives to foods. For a substance to be considered GRAS it had to meet certain criteria. There are two basic ways for a substance to be designated as GRAS. The criteria for this process is given in detail in the Code of Federal Regulations Title 21, Volume 3, Parts 170.30. The Federal code is searchable from: http://www.access.gpo.gov/nara/cfr/cfr-retrieve.html#page1
Substances that were in general use as food additives prior to January 1, 1958 were give GRAS designation based on common knowledge gained through their history of use as food additives. No further safety testing was required for these substances.
Substances put into use after January 1, 1958 must be recognized as safe based on scientific procedures. These procedures should be of the same quantity and quality as would be required to obtain approval as a food additive. General recognition of safety may be based on the views of qualified experts in the food industry. The status does not have to be affirmed by the FDA.
In order for a substance to be affirmed as GRAS by the FDA the Commissioner must either through his own initiative or through petition of an interested party affirm the substance as GRAS. Before this affirmation takes place all pertinent must be put into a public file in the office of the Docket Management Branch. The Federal Register will allow a period of 60 days for comment. The Commissioner will then evaluate all the comments received. If he decides the substance is GRAS then a notice will be published in the Federal Register listing the substance as GRAS. If there is inadequate information to show the substance is safe then that finding will be published in the Federal Register.
In many instances GRAS is an industry designation not a FDA one. The procedure for having a substance affirmed as GRAS is a lengthy one that is not usually pursued by the industry. In April of 1997 there were proposed changes to this process. (http://vm.cfsan.fda.gov/~lrd/fr970417.html)
The GRAS status is designated for substances considered safe in foods. No testing is required for other routes of entry into the body other than in foods. Substances that may be safe for ingestion may not be safe for inhalation. In many industries GRAS status is considered a blanket statement of the safety of a substance even though there has been little testing in other routes of exposures.
Toxicity of a substance varies greatly on the route of administration. The fragrance industry uses GRAS status as an indication that a substance may be safely used to fragrance products. Yet GRAS status requires no safety testing of a substance's effect on the skin, the respiratory system, or on the nervous system. Dermal, olfactory, and respiratory pathways are the primary routes of exposure to fragranced products.
Science has come a long way since January 1, 1958. Substances considered safe then are no longer considered so. Yet many remain on the GRAS list. So they are still widely used in the food and fragrance industries. In the case of flavors and fragrances, individual chemicals are not listed on the label, just the word "flavors" or "fragrance".
Information compiled by Betty Bridges, RN
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Changes last made on: Sun Dec 28, 20:00:00 1997
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