Generally recognised as safe

The U.S. Food and Dmg Administration (FDA) has affirmed the status of beeswax as Generally Recognised as Safe (GRAS) (5) in Tide 21 of the Code of Federal Regulations, Section 184.1973 (21 CFR 184.1973). The major use of beeswax is in the cosmetic industry, with smaller amounts used in pharmaceuticals and candle production. 

PARABEN ESTERS Typical use concentrations 0.1 - 0.3% Low toxicity Dermatologically safe at typical use concentrations Over 70 years widespread use with an extremely low incidence rate of skin response GRAS (Generally Recognised As Safe) in the USA Stable and active over a wide pH range Stable to heat Combinations of esters exhibit increased activity Approved for cosmetic applications worldwide Low water solubility Some nonionics inactivate to varying degrees May require addition of other preservatives, eg. bactericides Incompatible with some proteins... 

Absence of carcinogenity, genotoxicity, developmental and reproductive toxicity and of chronic toxicity effects at low exposure levels are indispensable prerequisites for food additive approvals. All substances approved in the European Union or the USA or deemed generally recognised as safe (GRAS) in the USA fulfil this requirement. 

In the USA the available bulk sweeteners are listed under different provisions, like food additive, interim status, GRAS (Generally Recognised As Safe) or GRAS by self-determination or self-affirmation of the manufacturers. Intense sweeteners require food additive approval which includes a listing of the approved fields of use or may be a listing as a general purpose sweetener.32... 

The use of antioxidants in food products is governed by regulatory laws of the individual country or by internal standards. Even though many natural and synthetic compounds have antioxidant properties, only a few of them have been accepted as generally recognised as safe (GRAS) substances for use in food products by international bodies such as the Joint FAOAVHO Expert Committee on Food Additives (JECFA) and the European Community s Scientific Committee for Food (SCF). 

As enacted in 1938, the FD C Act defined a new drug as any drug that was not generally recognised as safe. Section 505 of the 1938 Act provided that an NDA must be submitted for every new drug, and authorised FDA to permit an NDA to become effective or to disapprove it, but not affirmatively to approve an NDA. If FDA took no action within 60 days after the filing of an NDA, the NDA automatically became effective and the drug could lawfully be marketed. 

GRAS (Generally Recognised as Safe) Food Ingredients Benzoic Acid and Sodium Benzoate (PB-221, PB-228), National Technical Information Service, U.S. Department of Commerce, Washington, D.C., Sept. 1972. 

The effective but volatile 2,6-di-ferf.butyl-4-methyIphenol (11) was replaced for most applications by various mononuclear (12), binuclear (13), trinuclear (14) and tet-ranuclear phenols (15, 16). Recently, synthetic DL-a-tocopherol (17) was introduced for effective melt stabilization of PO. This antioxidant may be listed among the stabilizers generally recognised as safe (GRAS). 

PLA is a non-volatile, odourless polymer and is classified as GRAS (generally recognised as safe) by the US Food and Drug Administration. 

Permitted food additives are listed in the CFR Title 21 Part 170-180, substances generally recognised as safe in Part 182-184. Because it is not so easy to find a given substance in the CFR the Food Chemical News Guide [36] is recommended. It lists all substances in alphabetical order. 

Some food and colour additives may have (generally recognised as safe) (GRAS) status, which also gives some assurance that they could be used in pharmaceutical products with minimal additional safety testing. This is especially the case if the excipient is not likely to be absorbed systemically from the formulation. 

GRAS generally recognised as safe PKOo palm kernel oil olein... 

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