Global knowledge strengthens flavor safety, says FEMA

Parallel modernization of other flavor safety evaluation programs over the past 13 years has lent added credibility to FEMA GRAS, said the authors, John Halligan and Richard Hall from the Flavor and Extract Manufacturers Association (FEMA) in a review published in the Journal of Food and Chemical Toxicology​. Assessment methods of global and regional programs such as the European Food Safety Authority (EFSA) and the FAO/WHO Joint Expert Committee on Food Additives (JECFA) have generally come into line during this time, they said, therefore making progress towards a globally accepted method for flavor safety assessment.

“These evaluation programs are consistent with those of the FEMA GRAS assessment program and have therefore led, in nearly all instances, to parallel results,” ​the authors wrote.

They added that cooperation with EFSA and JEFCA will continue to be important in the future, and said: “Even though the GRAS concept and therefore the FEMA GRAS program are uniquely American, the science behind the FEMA program is not.”​

Internet publication​

Since 1965, the FEMA expert panel has assessed some 2700 flavor ingredients and published the identity of all FEMA GRAS ingredients in Food Technology​. Although it continues to do this, the review notes that another important development since 1995 has been the rise of the internet as a widely accepted way of communicating flavor safety assessments. It now publishes information online as well as in print, while the FDA’s publication of voluntary GRAS acknowledgement letters has moved entirely online.

“Changes in publication vehicles and data gathering strategies…may be altering the perception of the general recognition requirement,” ​they said.

Although there has been no change in the publication requirement that GRAS determinations are published in open literature, online publication has become increasingly common. However, FEMA said that access to the full information that determinations are based on is often only published in print.

‘Not self-regulated’​

The review also said that FEMA GRAS is often misrepresented as a self-regulated program.

The authors wrote: “The FEMA program is not a self-regulation program. The FEMA GRAS program operates under statutory authority granted by Congress in 1958…and exists only with the oversight and participation of the Food and Drug Administration.”​

The FEMA program informs the FDA of all its GRAS determinations.

The review concluded that due to new information constantly becoming available on flavor ingredients and new methods of safety evaluation, the FEMA GRAS program should remain “dynamic and must be re-evaluated to account for new information.”​

The authors added: “The program will continue to have the opportunity to maintain its leadership position in flavor safety assessment.”​

The FEMA GRAS program started in 1960. Since the last review in 1995, FEMA has assessed and designated over 1000 flavors to be ‘FEMA GRAS’.

Source: Food and Chemical Toxicology​

Issue 47 (2009) 267–278

“Review:​Under the conditions of intended use – New developments in the FEMA GRAS program and the safety assessment of flavor ingredients”​

Authors: J.B. Hallagan, R.L. Hall