Scientific Opinion on Flavouring Group Evaluation 72, Revision 1 (FGE.72Rev1): Consideration of aliphatic, branched‐chain saturated and unsaturated alcohols, aldehydes, acids, and related esters evaluated by the JECFA (61st meeting) structurally related to branched‐ and straight‐chain unsaturated carboxylic acids, esters of these and straight‐chain aliphatic saturated alcohols evaluated by EFSA in FGE.05Rev2

Flavourings,

doi:10.2903/j.efsa.2013.3392

Cited by 7 publications

(9 citation statements)

References 37 publications

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“…The EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) has considered all 43 compounds, but could proceed with the assessment of only 17 compounds (EFSA, 2009a,b;EFSA CEF Panel, 2010a, 2013a, because of genotoxicity alerts based on the presence of a, b-unsaturated aldehydes and their precursors for the remaining 26 substances. The EFSA CEF Panel has requested additional data (EFSA CEF Panel, 2014a,b) and the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) will also not proceed with an assessment of these compounds until the issue of genotoxicity has been resolved.…”

Section: Additional Informationmentioning

confidence: 99%

“…The current assessment concerns 17 compounds, namely geraniol [02.012], 3,7,11-trimethyldodeca-2,6,10-trien- (EFSA, 2009a,b;EFSA CEF Panel, 2010a, 2013a. All are currently listed in the European Union database of flavouring substances 5 and in the European Union Register of Feed Additives, and thus authorised for use in food and feed in the European Union (EU).…”

Section: Additional Informationmentioning

confidence: 99%

“…The safety for the consumer of the 17 compounds used as food flavours has been already assessed by JECFA (WHO, 1999(WHO, , 2004(WHO, , 2005 and EFSA (EFSA, 2008, EFSA CEF Panel, 2013a. All compounds are currently authorised in the EU as food flavourings without limitations.…”

Section: Safety For the Consumermentioning

confidence: 99%

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Safety and efficacy of α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters belonging to chemical group 3 when used as flavourings for all animal species

2016

EFS2

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Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 43 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as feed flavourings for all animal species and categories. They are currently authorised as flavours in food. This opinion concerns 17 compounds from this group. The FEEDAP Panel established the following conclusions: geraniol [02.012] and citral [05.020] are safe for all target species at the proposed maximum use level of 25 mg/kg feed; farnesol [02.029], (Z)‐nerol [02.058], geranyl acetate [09.011], geranyl butyrate [09.048], geranyl formate [09.076], geranyl propionate [09.128], neryl propionate [09.169], neryl formate [09.212], neryl acetate [09.213], neryl isobutyrate [09.424] and geranyl isobutyrate [09.431] are safe at the maximum proposed use level of 5 mg/kg feed for all target species; 2‐methyl‐2‐pentenoic acid [08.055], (2E)‐methylcrotonic acid [08.064], ethyl (E,Z)‐deca‐2,4‐dienoate [09.260] and prenyl acetate [09.692] are safe at the proposed normal use levels of 1 mg/kg complete feed for all animal species. No safety concern would arise for the consumer from the use of these compounds up to the highest safe level in feeds. Hazards for skin and eye contact and respiratory exposure are recognised for the majority of the compounds under application. Most are classified as irritating to the respiratory system. The concentrations considered safe for the target species are unlikely to have detrimental effects on the terrestrial and fresh water environments. As all of the compounds under assessment are used in food as flavourings and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

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Section: Additional Informationmentioning

confidence: 99%

Section: Additional Informationmentioning

confidence: 99%

See 1 more Smart Citation

Safety and efficacy of α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters belonging to chemical group 3 when used as flavourings for all animal species

2016

EFS2

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“…Human exposure in the EU to the individual compounds ranges from 0.32 to 3,700 lg/person per day (EFSA, 2008a(EFSA, , 2009EFSA CEF Panel, 2010a,b,c, 2011, 2013a. Human exposure in the EU to the individual compounds ranges from 0.32 to 3,700 lg/person per day (EFSA, 2008a(EFSA, , 2009EFSA CEF Panel, 2010a,b,c, 2011, 2013a.…”

Section: Safety For the Target Speciesmentioning

confidence: 99%

Safety and efficacy of non‐conjugated and accumulated unsaturated straight‐chain and branched‐chain, aliphatic primary alcohols, aldehydes, acids, acetals and esters belonging to chemical group 4 when used as flavourings for all animal species

2016

EFS2

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Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of 24 compounds belonging to chemical group 4 (non-conjugated and accumulated unsaturated straight-chain and branched-chain, aliphatic primary alcohols, aldehydes, acids, acetals and esters). This opinion concerns 23 compounds from this group. They are currently authorised as flavours in food. The FEEDAP Panel established the following conclusions: hex-3(cis)-en-1-ol [02.056], (Z)-non-6-en-1-ol [02.093], oct-3-en-1-ol [02.094], non-6(cis)-enal [05.059], hex-3(cis)-enal [05.075], (Z)-hept-4-enal [05.085], hex-3(cis)-enyl acetate [09.197], hex-3(cis)-enyl formate [09.240], hex-3enyl butyrate [09.270], hex-3-enyl hexanoate [09.271] and hex-3(cis)-enyl isobutyrate [09.563] are safe at the proposed maximum use level of 5 mg/kg complete feed for all target species; citronellol [02.011], (-)-3,7-dimethyl-6-octen-1-ol [02.229], citronellal [05.021], 2,6-dimethylhept-5-enal [05.074], citronellic acid [08.036], citronellyl acetate [09.012], citronellyl butyrate [09.049], citronellyl formate [09.078] and citronellyl propionate [09.129] are safe at the maximum use level of 5 mg/kg for all species, except cats for which the proposed normal use level of 1 mg/kg is considered safe; undec-10enal [05.035], 1-ethoxy-1-(3-hexenyloxy)ethane [06.081] and hex-3-enyl isovalerate [09.505] are safe at the normal use levels of 1 mg/kg for all species. No safety concern would arise for the consumer from the use of these compounds up to the highest safe level in feeds. Hazards for skin and eye contact, and respiratory exposure are recognised for the majority of the compounds under application. Most are classified as irritating to the respiratory system. The use of the majority of the compounds in animal feed at the maximum safe level is considered safe for the environment. As all the compounds under assessment are used in food as flavourings, and their function in feed is essentially the same as in food, no further demonstration of efficacy is necessary.

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“…This conclusion can also be applied to the substances santalyl acetate .034] and santalyl phenylacetate for which 2,6-dimethyl-2,5,7-octatriene-1-ol acetate ] is representative. Therefore, these substances can also be evaluated through the Procedure in this FGE.73Rev2 ] is evaluated through the Procedure in FGE.72Rev1 (EFSA CEF Panel, 2013b)). No genotoxicity data are available for any of the remaining 16 JECFA evaluated substances.…”

Section: Efsa Considerationsmentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 73, Revision 2 (FGE.73Rev2): Consideration of alicyclic primary alcohols, aldehydes, acids and related esters evaluated by JECFA (59th meeting) structurally related to primary saturated or unsaturated alicyclic alcohols, aldehydes, acids and esters evaluated by EFSA in FGE.12Rev3 (2012)

Flavourings¹

2013

EFS2

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The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to consider evaluations of flavouring substances assessed since 2000 by the Joint FAO/WHO Expert Committee on Food Additives (the JECFA), and to decide whether further evaluation is necessary, as laid down in Commission Regulation (EC) No 1565/2000. The present consideration concerns a group of 17 alicyclic primary alcohols, aldehydes, acids and related esters and one phenethyl ester evaluated by the JECFA at the 59 th meeting in 2002. This revision is made due to consideration of two additional substances, santalyl acetate .034] and santalyl phenylacetate , cleared for genotoxicity concern in FGE.207. The substances were evaluated through a stepwise approach that integrates information on structureactivity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel agrees with the application of the Procedure as performed by the JECFA for all 18 substances 02.141, 05.098, 05.104, 05.112, 05.119, 05.123, 08.034, 08.060, 08.067, 09.028, 09.034, 09.289, 09.488, 09.534, 09.536, 09.615 and 09.712], considered in this FGE and agrees with the JECFA conclusion, "No safety concern at estimated levels of intake as flavouring substances" based on the FGE.73Rev1). These substances have been evaluated in FGE.207 due to structural concern for genotoxicity, and have been cleared from this concern and thus may be evaluated through the Procedure.The present consideration therefore concerns 17 alicyclic primary alcohols, aldehydes, acids and related esters and one phenethyl alcohol evaluated by the JECFA (59 th meeting) and will be considered in relation to the European Food Safety Authority (EFSA) evaluation of 10 primary saturated or unsaturated alicyclic alcohols, aldehydes and esters evaluated in the Flavouring Group Evaluation 12, Revision 3 (FGE.12Rev3).The Panel agrees with the application of the Procedure as performed by the JECFA for the 18 substances considered in this FGE.For all 18 substances evaluated through the Procedure use levels are needed to calculate the modified Theoretical Added Maximum Daily Intake (mTAMDI) in order to identify those flavouring substances that need more refined exposure assessment and to finalise the evaluation.In order to determine whether the conclusion for the 18 JECFA evaluated substances can be applied to the materials of commerce, it is necessary to consider the available specifications. Adequate specifications including complete purity criteria and identity tests are available for all 18 JECFA evaluated substances.

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Cited by 7 publications

References 37 publications

Safety and efficacy of α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters belonging to chemical group 3 when used as flavourings for all animal species

Safety and efficacy of α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters belonging to chemical group 3 when used as flavourings for all animal species

Safety and efficacy of non‐conjugated and accumulated unsaturated straight‐chain and branched‐chain, aliphatic primary alcohols, aldehydes, acids, acetals and esters belonging to chemical group 4 when used as flavourings for all animal species

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