Japan Flavour and Fragrance Materials Association’s (JFFMA) safety assessment of food-flavouring substances uniquely used in Japan that belong to the class of aliphatic primary alcohols, aldehydes, carboxylic acids, acetals and esters containing additional oxygenated functional groups

Kenji Saito, Yasuko Hasegawa-Baba, Fumiko Sekiya, Shim mo Hayashi, Yoshiharu Mirokuji, Hiroyuki Okamura, Shinpei Maruyama, Atsushi Ono, Madoka Nakajima, Masakuni Degawa, Shogo Ozawa, Makoto Shibutani, Tamio Maitani

Research output: Contribution to journalReview article

Abstract

We performed a safety evaluation using the procedure devised by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the following four flavouring substances that belong to the class of ‘aliphatic primary alcohols, aldehydes, carboxylic acids, acetals, and esters containing additional oxygenated functional groups’ and are uniquely used in Japan: butyl butyrylacetate, ethyl 2-hydroxy-4-methylpentanoate, 3-hydroxyhexanoic acid and methyl hydroxyacetate. Although no genotoxicity study data were found in the published literature, none of the four substances had chemical structural alerts predicting genotoxicity. All four substances were categorised as class I by using Cramer’s classification. The estimated daily intake of each of the four substances was determined to be 0.007–2.9 μg/person/day by using the maximised survey-derived intake method and based on the annual production data in Japan in 2001, 2005 and 2010, and was determined to be 0.250–600.0 μg/person/day by using the single-portion exposure technique and based on average-use levels in standard portion sizes of flavoured foods. Both of these estimated daily intake ranges were below the threshold of toxicological concern for class I substances, which is 1800 μg/person/day. Although no information from in vitro and in vivo toxicity studies for the four substances was available, these substances were judged to raise no safety concerns at the current levels of intake.

Original languageEnglish
Pages (from-to)1474-1484
Number of pages11
JournalFood Additives and Contaminants - Part A Chemistry, Analysis, Control, Exposure and Risk Assessment
Volume34
Issue number9
DOIs
Publication statusPublished - Sep 2 2017
Externally publishedYes

Fingerprint

Fragrances
Acetals
safety assessment
Food Safety
Flavors
flavorings
carboxylic acids
Carboxylic Acids
Aldehydes
aldehydes
Functional groups
Glycolates
average daily intake
Japan
Esters
alcohols
flavor
genotoxicity
esters
odors

Keywords

  • acetals
  • aldehydes
  • Aliphatic primary alcohols
  • and esters containing additional oxygenated functional groups
  • carboxylic acids
  • Cramer decision tree
  • food flavours
  • Joint FAO/WHO Expert Committee on Food Additives (JECFA)
  • safety
  • threshold of toxicological concern

ASJC Scopus subject areas

  • Food Science
  • Chemistry(all)
  • Toxicology
  • Public Health, Environmental and Occupational Health
  • Health, Toxicology and Mutagenesis

Cite this

Japan Flavour and Fragrance Materials Association’s (JFFMA) safety assessment of food-flavouring substances uniquely used in Japan that belong to the class of aliphatic primary alcohols, aldehydes, carboxylic acids, acetals and esters containing additional oxygenated functional groups. / Saito, Kenji; Hasegawa-Baba, Yasuko; Sekiya, Fumiko; Hayashi, Shim mo; Mirokuji, Yoshiharu; Okamura, Hiroyuki; Maruyama, Shinpei; Ono, Atsushi; Nakajima, Madoka; Degawa, Masakuni; Ozawa, Shogo; Shibutani, Makoto; Maitani, Tamio.

In: Food Additives and Contaminants - Part A Chemistry, Analysis, Control, Exposure and Risk Assessment, Vol. 34, No. 9, 02.09.2017, p. 1474-1484.

Research output: Contribution to journalReview article

Saito, Kenji ; Hasegawa-Baba, Yasuko ; Sekiya, Fumiko ; Hayashi, Shim mo ; Mirokuji, Yoshiharu ; Okamura, Hiroyuki ; Maruyama, Shinpei ; Ono, Atsushi ; Nakajima, Madoka ; Degawa, Masakuni ; Ozawa, Shogo ; Shibutani, Makoto ; Maitani, Tamio. / Japan Flavour and Fragrance Materials Association’s (JFFMA) safety assessment of food-flavouring substances uniquely used in Japan that belong to the class of aliphatic primary alcohols, aldehydes, carboxylic acids, acetals and esters containing additional oxygenated functional groups. In: Food Additives and Contaminants - Part A Chemistry, Analysis, Control, Exposure and Risk Assessment. 2017 ; Vol. 34, No. 9. pp. 1474-1484.
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abstract = "We performed a safety evaluation using the procedure devised by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the following four flavouring substances that belong to the class of ‘aliphatic primary alcohols, aldehydes, carboxylic acids, acetals, and esters containing additional oxygenated functional groups’ and are uniquely used in Japan: butyl butyrylacetate, ethyl 2-hydroxy-4-methylpentanoate, 3-hydroxyhexanoic acid and methyl hydroxyacetate. Although no genotoxicity study data were found in the published literature, none of the four substances had chemical structural alerts predicting genotoxicity. All four substances were categorised as class I by using Cramer’s classification. The estimated daily intake of each of the four substances was determined to be 0.007–2.9 μg/person/day by using the maximised survey-derived intake method and based on the annual production data in Japan in 2001, 2005 and 2010, and was determined to be 0.250–600.0 μg/person/day by using the single-portion exposure technique and based on average-use levels in standard portion sizes of flavoured foods. Both of these estimated daily intake ranges were below the threshold of toxicological concern for class I substances, which is 1800 μg/person/day. Although no information from in vitro and in vivo toxicity studies for the four substances was available, these substances were judged to raise no safety concerns at the current levels of intake.",
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AU - Saito, Kenji

AU - Hasegawa-Baba, Yasuko

AU - Sekiya, Fumiko

AU - Hayashi, Shim mo

AU - Mirokuji, Yoshiharu

AU - Okamura, Hiroyuki

AU - Maruyama, Shinpei

AU - Ono, Atsushi

AU - Nakajima, Madoka

AU - Degawa, Masakuni

AU - Ozawa, Shogo

AU - Shibutani, Makoto

AU - Maitani, Tamio

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N2 - We performed a safety evaluation using the procedure devised by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the following four flavouring substances that belong to the class of ‘aliphatic primary alcohols, aldehydes, carboxylic acids, acetals, and esters containing additional oxygenated functional groups’ and are uniquely used in Japan: butyl butyrylacetate, ethyl 2-hydroxy-4-methylpentanoate, 3-hydroxyhexanoic acid and methyl hydroxyacetate. Although no genotoxicity study data were found in the published literature, none of the four substances had chemical structural alerts predicting genotoxicity. All four substances were categorised as class I by using Cramer’s classification. The estimated daily intake of each of the four substances was determined to be 0.007–2.9 μg/person/day by using the maximised survey-derived intake method and based on the annual production data in Japan in 2001, 2005 and 2010, and was determined to be 0.250–600.0 μg/person/day by using the single-portion exposure technique and based on average-use levels in standard portion sizes of flavoured foods. Both of these estimated daily intake ranges were below the threshold of toxicological concern for class I substances, which is 1800 μg/person/day. Although no information from in vitro and in vivo toxicity studies for the four substances was available, these substances were judged to raise no safety concerns at the current levels of intake.

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KW - aldehydes

KW - Aliphatic primary alcohols

KW - and esters containing additional oxygenated functional groups

KW - carboxylic acids

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KW - Joint FAO/WHO Expert Committee on Food Additives (JECFA)

KW - safety

KW - threshold of toxicological concern

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