Generally Recognized As Safe

Generally recognized as safe ( ' English, generally recognized as safe, GRAS) in the U.S. is an authorization name of the FDA, featuring the safety of a substance as a food additive. Such an approved substance is therefore of the limitations of a daily intake according to the Federal Food, Drug, and Cosmetic Act ( FFDCA ) exempt.

History

On January 1, 1958, the FDA published the Food Additives Amendment of 1958, a list of 700 food additives, which required no further investigations. On 31 August 1960, the assistant general counsel of the FDA, William W. Goodrich, at the annual meeting of the FFDCA with respect to the implementation date of the GRAS designation spoke on March 6, 1961. In the year 1965 1100 substances have been listed in GRAS 3, 2007, it was with GRAS -23 4429 substances.

Properties

GRASS is issued as part of a safety assessment according to estimates by qualified experts. For substances that were used prior to 1 January 1958 was either the then state of knowledge about the safety or habit than adequate. The Code of Federal Regulations, as amended from 1 April 2010 includes (CFR ) title 21 170.30 ( b ), the (GRAS ) equates the requirements for a general recognition of safety through scientific methods with the demands of a new approval of a food additive. and is based on published findings that can be backed by unpublished findings. The substance must be certain in its application determination. The applicant must demonstrate to grant GRAS as a prerequisite the scientific consensus about the safety of the substance. The FDA may prohibit the distribution of this substance and of products containing at not awarded GRAS. The properties of GRAS -approved molecules are similar to those of approved drugs.

GRAS designations

A GRAS designation exists in three forms:

• Self- Affirmed: The manufacturer of the substance has all the necessary tests will be done, including the formation of a commission to evaluate the safety.
• FDA pending: The manufacturer of the substance has all the necessary tests will be done, including the formation of a commission to assess the safety, and has applied for a GRAS approval from the FDA.
• No comment: The FDA has considered the application and any objections regarding the GRAS issue.