Generally Recognized As Safe

from Wikipedia, the free encyclopedia

Generally Recognized As Safe ( English , "generally recognized as safe" for GRAS ) in the United States an Authorization Name of the Food and Drug Administration (FDA) that the safety of a substance as a food additive features. A substance approved in this way is therefore exempt from the restrictions on daily intake under the Federal Food, Drug, and Cosmetic Act (FFDCA).

history

On January 1, 1958, the FDA published the Food Additives Amendment of 1958 , a list of 700 food additives that did not require further investigation. On August 31, 1960, the FDA's assistant general counsel , William W. Goodrich, called at the FFDCA's annual meeting on March 6, 1961 for the introduction of the GRAS designation. In 1965, GRAS-3 listed 1,100 substances; in 2007, GRAS-23 included 4,429 substances.

properties

The GRAS status is granted after assessment by qualified experts in the course of a safety assessment. In the case of substances that were used before January 1, 1958, either the level of knowledge at the time about safety or habit was considered sufficient. The Code of Federal Regulations in the version of April 1, 2010 includes (CFR) title 21 170.30 (b), which equates the requirements for a general approval of safety (GRAS) by scientific methods with the requirements for a new approval of a food additive. and is based on published knowledge that can be supported by unpublished knowledge. The substance must be safe in its intended use. As a prerequisite, the applicant for a GRAS grant must demonstrate the scientific consensus on the safety of the substance. The FDA may prohibit the distribution of this substance and any products containing it if the GRAS is not granted. The properties of GRAS -approved molecules are similar to those of approved drugs .

GRAS names

A GRAS designation exists in three forms:

  • Self-Affirmed : The manufacturer of the substance has carried out all the necessary investigations, including the formation of a safety assessment committee.
  • FDA-pending : The manufacturer of the substance has carried out all necessary investigations, including the formation of a commission to evaluate the safety, and has applied for GRAS approval from the FDA.
  • No comment : The FDA has reviewed the application and has no objections to the GRAS grant.

literature

  • US Food and Drug Administration: Everything Added to Food in the United States. Boca Raton, CK Smoley c / o CRC Press, 1993.

Web links

Individual evidence

  1. ↑ Generally Recognized as Safe (GRAS) . Fda.gov. Retrieved March 17, 2013.
  2. ↑ GRAS history . diet.com. Retrieved November 27, 2010.
  3. ↑ Address to the FFDCA Concerning GRAS . heinonline.org. Retrieved November 27, 2010.
  4. ↑ Hall, RL, and Oser, BL (1965) Recent progress in the consideration of flavor ingredients under the Food Additives Amendment. 3 GRAS Substances. Food Technology. 19 (2, Part 2): 151-197.
  5. ↑ WJ Waddel, SM Cohen, VG Feron, JS Goodman, LJ Marnett, PS Portoghese, SMCM Reitjiens, RL Smith, TB Adams, C. Lucas-Gavin, MM McGowen, MC Williams: Flavoring Substances 23 . In: Food Technology . tape 61 , no. 8 , 2007, ISSN  0015-6639 , p. 22-61 ( PDF ).
  6. ^ CRF revised statutes . accessdata.fda.gov. Retrieved November 27, 2010.
  7. ↑ Summary Table of Recommended Toxicological Testing for Additives Used in Food . Fda.gov. May 18, 2009. Retrieved September 6, 2009.
  8. ^ Federal Register Proposed Rules - 62, Federal Register 18937, April 17, 1997 - Substances Generally Recognized as Safe . cfsan.fda.gov. Archived from the original on September 16, 2008. Retrieved November 10, 2013.
  9. ↑ JL Medina-Franco, K. Martínez-Mayorga, TL Peppard, A. Del Rio: Chemoinformatic analysis of GRAS (Generally Recognized as Safe) flavor chemicals and natural products. In: PLOS ONE . Volume 7, number 11, 2012, p. E50798. doi: 10.1371 / journal.pone.0050798 . PMID 23226386 . PMC 3511266 (free full text).