Answer · confidence: thin
What do FEMA's 1977 and 1991 papers say about judging, and who paid?
Research question: What do the full texts of the 1977 FEMA criteria paper and the 1991 GRAS evaluation say about the evaluation criteria, the flavor chemicals reviewed, and any disclosed panel funding or conflicts of interest?
The verified facts do not include the full text of the 1977 FEMA criteria paper or the 1991 GRAS evaluation, so they cannot confirm what either document says. The available facts describe general FEMA criteria, such as a 'grandfather clause' for long-consumed compounds 9 and the principle that toxicity and risk are not synonymous, with risk defined by physical properties, toxicity, amount used and mode of use 11. They also say manufacturers must supply safety data and a report on physical, chemical, safety and metabolic properties 10. On chemicals reviewed, the facts cover a 2016 thiophene review in which 3-acetyl-2,5-dimethylthiophene was removed for missing data 14, and a 2018 affirmation of 54 Citrus-derived natural flavor complexes 5. No verified fact reports panel funding or conflicts of interest, so that part of the question is unanswered. The newest verified facts date from 2026, so they are current as of October 2026 67.
Checked 2026-10-19. Only documented and supported facts are used.
Dig deeper on this questionSources
[1] supported
The 2016 re-evaluation of GRAS flavorings was based on updated considerations of exposure, structural analogy, metabolism, pharmacokinetics and toxicology.
"Re-evaluation of GRAS status for flavorings is based on updated considerations of exposure, structural analogy, metabolism, pharmacokinetics and toxicology"Safety evaluation of substituted thiophenes used as flavoring ingredients (2016)
[2] supported
The 2018 FEMA paper evaluates natural flavor complexes using the threshold of toxicological concern (TTC) concept, along with absorption, metabolism and toxicology data for the congeneric groups.
"The safety of the NFC is evaluated using the well-established and conservative threshold of toxicological concern (TTC) concept in addition to data on absorption, metabolism and toxicology of members of the congeneric groups and the NFC under evaluation."FEMA GRAS assessment of natural flavor complexes: Citrus-derived flavoring ingredients (2018)
[3] supported
The FEMA procedure requires a complete chemical characterization of each natural flavor complex and sorting its constituents into well-defined congeneric groups.
"The procedure relies on a complete chemical characterization of each NFC intended for commerce and organization of each NFC's chemical constituents into well-defined congeneric groups."FEMA GRAS assessment of natural flavor complexes: Citrus-derived flavoring ingredients (2018)
[4] supported
The flavoring 3-acetyl-2,5-dimethylthiophene was removed from the FEMA GRAS list because the required exposure, metabolism and toxicity data were not provided.
"In the absence of these data, the compound was removed from the FEMA GRAS list."Safety evaluation of substituted thiophenes used as flavoring ingredients (2016)
[5] supported
The 54 Citrus-derived natural flavor complexes were affirmed as generally recognized as safe (GRAS) for their intended use as flavoring ingredients.
"As a result of the application of the procedure, 54 natural flavor complexes derived from botanicals of the Citrus genus were affirmed as generally recognized as safe (GRAS) under their conditions of intended use as flavoring ingredients"FEMA GRAS assessment of natural flavor complexes: Citrus-derived flavoring ingredients (2018)
[6] documented
Eighteen NFCs derived from nine plant genera were affirmed as GRAS for use as flavor ingredients.
"Eighteen (18) NFCs, derived from the Vanilla, Prunus, Betula, Acacia, Cuminum, Jasminum, Gaultheria, Polianthes and Evernia genera, were affirmed as generally recognized as safe (GRAS) under their conditions of intended use as flavor ingredients"FEMA GRAS assessment of natural flavor complexes: Vanilla extract, Bitter almond oil, Wintergreen oil and related flavoring ingredients (2026)
[7] supported
The safety evaluation excludes use of these flavor NFCs in dietary supplements or in any products other than food.
"The scope of the safety evaluation contained herein does not include added use in dietary supplements or any products other than food."FEMA GRAS assessment of natural flavor complexes: Vanilla extract, Bitter almond oil, Wintergreen oil and related flavoring ingredients (2026)
[8] supported
The FEMA expert panel reviews flavor compounds to determine whether they are generally recognized as safe under their intended use.
"An expert panel, convened to undertake a GRAS review, determines whether a compound is generally recognized as safe under the conditions of its intended use."S-1 SENOMYX INC (CIK 0001123979) 2004-03-29
[9] supported
The FEMA expert panel (FEXPAN) applied a 'grandfather clause': compounds long consumed in foods without apparent harm were treated as non-harmful at their natural concentrations.
"la « clause de grand-père » : les composés présents dans les aliments que l’homme consomme depuis toujours sans risque apparent sont tenus pour non nocifs à leurs concentrations naturelles"Generally recognized as safe
[10] supported
Manufacturers seeking GRAS review must supply safety data from the literature or from safety studies, along with a report on the compound's physical, chemical, safety, and metabolic properties.
"Under the GRAS process, manufacturers are required to obtain safety data from the scientific literature or through the conduct of safety studies"S-1 SENOMYX INC (CIK 0001123979) 2004-03-29
[11] supported
The FEXPAN criteria state that toxicity and risk are not synonymous, and risk is defined as the probability that a substance causes injury given its physical properties, toxicity, amount used, and mode of use.
"la toxicité et risque ne sont pas synonymes . Le risque est la probabilité pour qu’une substance provoque des lésions compte tenu de ses propriétés physiques, de sa toxicité, de la quantité utilisée et de son mode d’emploi"Generally recognized as safe
[12] supported
The FEMA panel was created in 1960 and was historically the first expert group to evaluate flavoring substances for GRAS status.
"a créé le Flavour EXpert PANel (FEXPAN), historiquement le premier groupe d’experts à pratiquer l’évaluation des substances"Generally recognized as safe
[13] supported
The conclusions of the FEMA expert panel on a flavor or flavor enhancer are sent directly to the FDA and published in the journal Food Technology.
"The conclusions of the expert panel regarding a flavor or flavor enhancer are provided directly to the FDA and published in the journal Food Technology"S-1 SENOMYX INC (CIK 0001123979) 2004-03-29
[14] supported
The first FDA GRAS list of flavoring substances, published in 1965, included 1,100 flavoring substances and preparations.
"La première liste de 1 100 substances et préparations aromatisantes a été publiée en 1965, dans la liste GRAS 3 publiée par la FDA"Generally recognized as safe
[15] supported
The FEMA Expert Panel's safety evaluation procedure, used for this 2020 review, was originally published in 2005 and updated in 2018.
"using the safety evaluation procedure published by the FEMA Expert Panel in 2005 and updated in 2018."FEMA GRAS assessment of natural flavor complexes: Lavender, Guaiac Coriander-derived and related flavoring ingredients (2020)
[16] supported
The FEMA Expert Panel evaluates flavoring substances by relying on the weight of evidence from all available data, including genotoxicity studies.
"The Flavor and Extract Manufacturers Association (FEMA) Expert Panel relies on the weight of evidence from all available data in the safety evaluation of flavoring substances."The safety evaluation of food flavoring substances: the role of genotoxicity studies (2020)
[17] supported
The new Japanese flavoring risk-assessment method was based on a research report whose principal investigator was Takeshi Yamazaki, and FSCJ supported that report as a Research and Survey Program.
"a new risk assessment method for flavoring substances was proposed in a research report titled “Study on the Procedure for the Risk Assessment of Flavorings in Japan”4) (Principal Research Investigator: Takeshi Yamazaki, Professor of Jissen Women’s University), supported by FSCJ as a Research and Survey Program."Guidelines for the Assessment of Flavoring Substances in Foods on Health (2016)
[18] supported
The FEMA Expert Panel considers whether genotoxicity studies followed standardized protocols, and the biological and human relevance of their results, when judging whether they raise concerns for genotoxic potential.
"The adherence of genotoxicity studies to standardized protocols and guidelines, the biological relevance of the results from those studies, and the human relevance of these studies are all important considerations in assessing whether the results raise specific concerns for genotoxic potential."The safety evaluation of food flavoring substances: the role of genotoxicity studies (2020)
[19] supported
The evaluation requires a complete chemical characterization of each natural flavor complex as intended for commerce, with its constituents organized into well-defined congeneric groups.
"The procedure relies on a complete chemical characterization of the NFC intended for commerce and organization of the chemical constituents of each NFC into well-defined congeneric groups."FEMA GRAS assessment of natural flavor complexes: Lavender, Guaiac Coriander-derived and related flavoring ingredients (2020)
[20] documented
Seven natural flavor complexes derived from clove, cinnamon leaf and West Indian bay leaf were affirmed as GRAS, and an eighth, an oleoresin of West Indian bay leaf, was affirmed based on estimated intake below the TTC of 0.15 μg/person per day for compounds with structural alerts for genotoxicity.
"seven NFCs, derived from clove, cinnamon leaf and West Indian bay leaf were affirmed as "generally recognized as safe (GRAS)" under their conditions of intended use as flavor ingredients. An eighth NFC, an oleoresin of West Indian bay leaf, was affirmed based on its estimated intake, which is below the TTC of 0.15 μg/person per day for compounds with structural alerts for genotoxicity."FEMA GRAS assessment of natural flavor complexes: Clove, cinnamon leaf and West Indian bay leaf-derived flavoring ingredients (2020)
[21] supported
The FEMA Expert Panel assesses genotoxicity data both for hazard and for the probability of risk to consumers given the actual exposure from use as flavoring substances.
"The Panel evaluates genotoxicity studies not only for evidence of genotoxicity hazard, but also for the probability of risk to the consumer in the context of exposure from their use as flavoring substances."The safety evaluation of food flavoring substances: the role of genotoxicity studies (2020)
[22] supported
The majority of flavoring substances evaluated by the FEMA Expert Panel have shown no indication of genotoxic potential.
"The majority of flavoring substances have given no indication of genotoxic potential in studies evaluated by the FEMA Expert Panel."The safety evaluation of food flavoring substances: the role of genotoxicity studies (2020)