Under the conditions of intended use - New developments in the FEMA GRAS program and the safety assessment of flavor ingredients.

In 1995 we published a review describing the scientific and legal bases for the GRAS assessment program for flavor ingredients sponsored by the Flavor and Extract Manufacturers Association of the United States (FEMA) [Hallagan, J.B., Hall, R.L., 1995. FEMA GRAS - A GRAS assessment program for flavor ingredients. Regulatory Toxicology and Pharmacology 21, 422]. This review provides new information related to flavor safety assessment and regulation and is intended to complement our previous report. The FEMA GRAS assessment program is the most extensive and longest running industry-sponsored GRAS program and has established a sound record of scientific rigor and transparency. In this review, in addition to providing general information on the topics of flavor safety assessment and regulation, we explore the effects of recent developments on the four pillars of the FEMA GRAS assessment program: (1) general recognition; (2) among experts qualified by scientific training and experience to evaluate safety; (3) through scientific procedures; (4) under the conditions of intended use in food. We conclude that developments since our last review in 1995 have further strengthened the FEMA GRAS assessment program allowing it to maintain its global leadership role in the safety assessment of flavor ingredients.

[1]  Lutz Edler,et al.  Risk assessment of substances that are both genotoxic and carcinogenic: Report of an International Conference organized by EFSA and WHO with support of ILSI Europe , 2006 .

[2]  J I Goodman,et al.  Safety evaluation of natural flavour complexes. , 2003, Toxicology letters.

[3]  L. Marnett,et al.  The FEMA GRAS assessment of aromatic substituted secondary alcohols, ketones, and related esters used as flavor ingredients. , 2007, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[4]  L. Marnett,et al.  Criteria for the safety evaluation of flavoring substances. The Expert Panel of the Flavor and Extract Manufacturers Association. , 2005, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[5]  E. Boyland.  Food additives and contaminants and cancer. , 1963, Practitioner.

[6]  C. Leclercq,et al.  Assessment of dietary intake of flavouring substances within the procedure for their safety evaluation: advantages and limitations of estimates obtained by means of a per capita method. , 2005, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[7]  J. M. Hudson,et al.  Sensory evaluation : method for establishing and training a descriptive flavor analysis panel , 1990 .

[8]  William J. Waddell,et al.  Gras flavoring substances , 2000 .

[9]  Joint Fao,et al.  Toxicological evaluation of certain food additives and contaminants , 1987 .

[10]  J. Doull,et al.  GRAS evaluation of flavoring substances by the Expert Panel of FEMA. , 1991, Regulatory toxicology and pharmacology : RTP.

[11]  W Slob,et al.  Approaches to the risk assessment of genotoxic carcinogens in food: a critical appraisal. , 2006, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[12]  Sean V. Taylor,et al.  Corrigendum to: ''The FEMA GRAS assessment of a,b-unsaturated aldehydes and related substances used as flavor ingredients" [Food and Chemical Toxicology 46 (2008) 2935-2967] (DOI:10.1016/j.fct.2008.06.082) , 2009 .

[13]  Robert L. Smith,et al.  GRAS flavoring substances 25 , 2001 .

[14]  P. Brandt,et al.  Evaluation of certain food additives. Joint FAO/WHO Expert Committee on Food Additives. Fifty-ninth report of the JECFA, nitrate and nitrite , 2002 .

[15]  Josef Schlatter,et al.  Evaluation of certain food additives and contaminants. , 2013, World Health Organization technical report series.

[16]  E Kennepohl,et al.  A procedure for the safety evaluation of flavouring substances. Joint FAO/WHO Expert Committee on Food Additives. , 1999, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[17]  R. L. Hall,et al.  Regular ArticleFEMA GRAS - A GRAS Assessment Program for Flavor Ingredients , 1995 .

[18]  P. Cadby.  Estimating intakes of flavouring substances. , 1996, Food additives and contaminants.

[19]  R. L. Hall,et al.  FEMA GRAS--a GRAS assessment program for flavor ingredients. Flavor and Extract Manufacturers Association. , 1995, Regulatory toxicology and pharmacology : RTP.

[20]  R. L. Hall,et al.  Comparison of two methods to assess the intake of flavouring substances. , 1999, Food additives and contaminants.

[21]  K. Kreiss,et al.  Evaluation of Flavorings-Related Lung Disease Risk at Six Microwave Popcorn Plants , 2006, Journal of occupational and environmental medicine.

[22]  John B. Hallagan.  The safety assessment of process flavors , 2005 .

[23]  Wayne R. Curtis,et al.  Plant Cell and Tissue Culture for the Production of Food Ingredients , 1999, Springer US.

[24]  L. Marnett,et al.  The FEMA GRAS assessment of benzyl derivatives used as flavor ingredients. , 2002, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[25]  R. L. Hall,et al.  Criteria employed by the expert panel of FEMA for the GRAS evaluation of flavouring substances. , 1977, Food and cosmetics toxicology.

[26]  Philip S. Portoghese,et al.  GRAS flavoring substances 18 , 1996 .

[27]  P Shubik,et al.  Principles for the safety evaluation of flavouring substances. , 1998, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[28]  Lynn H Pottenger,et al.  Genetic toxicity assessment: employing the best science for human safety evaluation part VI: when salt and sugar and vegetables are positive, how can genotoxicity data serve to inform risk assessment? , 2007, Toxicological sciences : an official journal of the Society of Toxicology.

[29]  K. M. Reisterer,et al.  Mapping protein foulants on polysulfone membranes using microspectrophotometry : measuring adsorption spectra in reflective mode provides fast and easy determination of the extent of protein fouling on ultrafiltration membranes , 1993 .

[30]  J. Putnam,et al.  The Safety Assessment of Flavor Ingredients Derived from Plant Cell and Tissue Culture , 1999 .

[31]  L Edler,et al.  Risk assessment of substances that are both genotoxic and carcinogenic report of an International Conference organized by EFSA and WHO with support of ILSI Europe. , 2006, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[32]  I. Munro,et al.  An evaluation of the maximized survey-derived daily intake (MSDI) as a practical method to estimate intake of flavouring substances. , 2006, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[33]  I. C. Munro,et al.  Recent progress in the consideration of flavoring ingredients under the Food Additives Amendment. 15. GRAS substances. , 1990 .

[34]  J. Stofberg,et al.  The consumption ratio of flavouring materials: a mechanism for setting priorities for safety evaluation. , 1985, Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association.

[35]  M. Gibney,et al.  Comparison of stochastic modelling of the intakes of intentionally added flavouring substances with theoretical added maximum daily intakes (TAMDI) and maximized survey-derived daily intakes (MSDI) , 2002, Food additives and contaminants.

[36]  P. Cadby.  Novel estimates of the exposure to flavouring substances. , 2003, Toxicology letters.