GRAS list

NOTE The USDA does make an exception on the use of ammonium hydroxide for this purpose, based on its GRAS listing (21CFR 184.1139). 

Sulfites, a group of six compounds that have been on the GRAS list since 1959, include sulfur dioxide (S02), sodium sulfite (Na2S03), sodium metabisulfite (NaS205), potassium metabisulfite (KS205), sodium bisulfite (NaHS03), and... 

In the US in the 1970s when the GRAS list was being reviewed, safety data were requested on carbon black in view of the possibility that it might contain heterocyclic amines. Apparently, the cost of obtaining the data was higher than the entire annual sales of food grade carbon black so the tests were never done. Carbon black is not permitted in the US. 

According to a June 3. 1991 report in Chemical and Engineering News, an estimated 5.5 billion dollars worth of additives are currently used in the U.S. market alone. When a new additive is developed it must show "demonstrable safety in animal studies" before it can be placed on the GRAS list. Fewer than ten new chemicals have received approval by the FDA in the last twenty years. 

These considerations sparked our investigation into the possibility of producing responsive polymer gels from cellulose ether polymers. Cellulose ethers are alkyl-substituted cellulose derivatives which are on the FDA s GRAS list for use in food and pharmaceutical formulations. Since most cellulose ethers display lower critical solution temperatures (LCST), as gels they should be temperature... 

Aspartame is GRAS listed, and is accepted as a food additive in Europe and is in the FDA Inactive Ingredients Guide. It is included in non-parenteral medicines licensed in the UK, and is listed in the USP-NF, BP, JP, and EP. Aspartame is the subject of a monograph in the Food Chemicals Codex issued by the National Academy of Sciences. This document is very similar to the corresponding USP-NF monograph. 

Coloring materials and pesticides on raw agricultural products are covered by other laws. The GRAS list contains several hundred compounds, and the concept of such a list has been the subject of controversy (Hall 1975). 

The name canola was registered by the Western Canadian Oilseed Cmshers in 1978 and subsequently transferred to the Canola Council of Canada in 1980. It included those cultivars containing less than 5% emcic acid in the oil and 3 mg/g aliphatic glucosinolates in the meal. In 1986, the definition of canola was amended to B. napus and B. rapa lines with less than 2% emcic acid in the oil and less than 30 pmol/g glucosinolates in the air-dried, oil-free meal. The oil was added to the Generally Recognized as Safe (GRAS) list of food products in the United States. 

Sections 182, 184, 185—Generally Regarded as Safe (GRAS) Lists... 

Simply because an excipient is listed as Generally Recognized As Safe (GRAS) does not mean that it can be used in parenteral dosage form. The GRAS list may include materials that have been proven safe for food (oral administration) but have not been deemed safe for use in an injectable product. This makes it difficult for the formulation development scientist to choose additives during the dosage form development. 

GRAS listed. Accepted for use in Europe as a food additive. Included in the FDA Inactive Ingredients Guide (oral preparations and buccal or sublingual tablets). Included in the Canadian List of Acceptable Non-medicinal Ingredients. Included in nonparenteral medicines licensed in the UK. 

GRAS listed. Included in the Canadian List of Acceptable Non-medicinal Ingredients. 

GRAS listed. Accepted for use in human and veterinary parenteral vaccines in Europe and the USA. The limits for use in human vaccines are 0.85 mg aluminum/dose (EDA) and 1.25 mg aluminum/dose (WHO). There are no established limits for use in veterinary vaccines. Reported in the EPA TSCA Inventory. 

GRAS listed. Accepted for use in human and veterinary vaccines in Europe and the USA. The limits for use in human... 

GRAS listed. Accepted in Europe for use as a food additive. Included in the FDA Inactive Ingredients Guide (oral, tablets). 

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