Scientific Opinion on Flavouring Group Evaluation 47, Revision 1 (FGE.47Rev1): Bi‐ and tricyclic secondary alcohols, ketones and related esters from chemical group 8

Flavourings,

doi:10.2903/j.efsa.2012.2637

Cited by 6 publications

(3 citation statements)

References 26 publications

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“…The approach followed by the FEEDAP Panel to assess the safety and the efficacy of citronella oils from C. nardus is in line with the principles laid down in Regulation (EC) No 429/2008 12 and the relevant guidance documents: Guidance on safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements (EFSA Scientific Committee, 2009), Compendium of botanicals that have been reported to contain toxic, addictive, psychotropic or other substances of concern (EFSA, 2012), Guidance for the preparation of dossiers for sensory additives (EFSA FEEDAP Panel, 2012a), Guidance on the identity, characterisation and conditions of use of feed additives (EFSA FEEDAP Panel, 2017a), Guidance on the safety of feed additives for the target species (EFSA FEEDAP Panel, 2017b), Guidance on the assessment of the safety of feed additives for the consumer (EFSA FEEDAP Panel, 2017c), Guidance on the assessment of the safety of feed additives for the environment (EFSA FEEDAP Panel, 2019), Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2018), Guidance on the assessment of the safety of feed additives for the users (EFSA FEEDAP Panel, 2023a), Guidance document on harmonised methodologies for human health, animal health and ecological risk assessment of combined exposure to multiple chemicals (EFSA Scientific Committee, 2019a), Statement on the genotoxicity assessment of chemical mixtures (EFSA Scientific Committee, 2019b), Guidance on the use of the Threshold of Toxicological Concern approach in food safety assessment (EFSA Scientific Committee, 2019c) and General approach to assess the safety for the target species of botanical preparations which contain compounds that are genotoxic and/or carcinogenic (EFSA FEEDAP Panel, 2021a). 13…”

Section: Methodologiesmentioning

confidence: 90%

Safety and efficacy of a feed additive consisting of an essential oil derived from the leaves of Cymbopogon nardus (L.) Rendle (citronella oil) for use in all animal species (FEFANA asbl)

Bampidis,

Azimonti,

Bastos

et al. 2024

EFS2

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Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of citronella oil obtained from the leaves of Cymbopogon nardus (L.) Rendle, when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that citronella oil from C. nardus is of low concern for long‐living and reproductive animals at the use levels in complete feed of 3.5 mg/kg for laying hens and rabbits, 6 mg/kg for sows and dairy cows, 9.5 mg/kg for sheep/goats and horses, 2.0 mg/kg for cats and 10 mg/kg for dogs. For short‐living animals (species for fattening), the additive was considered of no concern at concentrations of 18 mg/kg in chickens for fattening, 24 mg/kg in turkeys for fattening, 20 mg/kg for piglets, pigs for fattening, veal calves (milk replacer), cattle for fattening, sheep/goats for meat production, horses for meat production and rabbits for meat production, and 30 mg/kg for salmonids. The conclusions were extrapolated to physiologically related minor species. For any other species, the additive is considered of low concern at 2.0 mg/kg complete feed. The use of citronella oil in animal feed is expected to be of no concern for the consumers and for the environment. The essential oil under assessment should be considered as irritant to skin and eyes and as a dermal sensitiser. When handling the essential oil, exposure of unprotected users to methyleugenol may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the leaves of C. nardus and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

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Section: Methodologiesmentioning

confidence: 90%

Safety and efficacy of a feed additive consisting of an essential oil derived from the leaves of Cymbopogon nardus (L.) Rendle (citronella oil) for use in all animal species (FEFANA asbl)

Bampidis,

Azimonti,

Bastos

et al. 2024

EFS2

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“…For the remaining 18 JECFA evaluated bicyclic secondary alcohols, ketones and related esters 02.038,02.059,02.100,02.101,07.089,07.153,07.159,09.017,09.082,09.131,09.153,09.176,09.218,09.269,09.319,09.456 and 09.457] the Panel agrees with the JECFA conclusion: "No safety concern at estimated levels of intake as flavouring substances" based on the MSDI approach. Application of the Procedure to Bicyclic Secondary Alcohols, Ketones and Related Esters by EFSA in FGE.47Rev1 (EFSA CEF Panel, 2012…”

mentioning

confidence: 99%

“…No in vitro / in vivo genotoxicity data are available for the candidate substances in FGE.47Rev1(EFSA CEF Panel, 2012).…”

mentioning

confidence: 99%

Scientific Opinion on Flavouring Group Evaluation 87, Revision 2 (FGE.87Rev2): Consideration of bicyclic secondary alcohols, ketones and related esters evaluated by JECFA (63rd meeting) structurally related to bicyclic secondary alcohols, ketones and rela

Flavourings¹

2014

EFSA Journal

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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 19 bicyclic secondary alcohols, ketones and related esters evaluated by the JECFA at the 63 rd meeting in 2004. This revision of FGE.87 is made due to inclusion of two additional substances Nookatone .089] and 4,4a,5,6-tetrahydro-7-methylnapthalen-2(3H)-one ] cleared for genotoxicity concern in FGE.213 Rev1. The substances were evaluated through a stepwise approach that integrates information on structure-activity 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 substances considered in this FGE and for 18 substances the Panel agrees with the JECFA conclusion, "No safety concern at estimated levels of intake as flavouring substances" based on the MSDI approach. For one substance .136], a production volume for Europe is not available, which precludes the finalisation of the evaluation by EFSA of this substance. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered for the substances evaluated through the Procedure and for all 19 substances, the information is adequate. This consideration deals with 19 bicyclic secondary alcohols, ketones and related esters, which are in the Register and which were evaluated by the JECFA at its 63 rd meeting.The revision is made due to consideration of two additional substances nootkatone and 4,4a,5,6-tetrahydro-7-methylnapthalen-2(3H)-one [FL-no: 07.089 and 07.136] compared to the previous version. These two substances are α,β-unsaturated alicyclic ketones which have been considered with respect to genotoxicity in FGE.213Rev1, and the Panel concluded that the data available ruled out the concern for genotoxicity and thus concluded that the two substances can be evaluated through the Procedure in this FGE.87Rev2.The Panel concluded that all 19 substances are structurally related to the group of bicyclic secondary alcohols, ketones and related evaluated by EFSA in the Flavouring Group Evaluation 47 (FGE.47Rev1).The Panel agrees with the application of the Procedure as performed by the JECFA for the 19 bicyclic secondary alcohols, ketones and related esters. It was concluded at step A3 of the Procedure that 18 substances do not pose a safety concern when used as flavouring substances at estimated levels of intake, based on the MSDI approach. For one substance ], the evaluation through the Procedure could not be finalised because of absence of an EU production volume.For all 19 substances evaluated through the Proce...

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Safety and efficacy of a feed additive consisting of an essential oil from the leaves of Agathosma betulina (P.J. Bergius) Pillans (buchu leaf oil) for use in all animal species (FEFANA asbl)

Bampidis¹,

Azimonti²,

Bastos³

et al. 2022

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 an essential oil from the leaves of Agathosma betulina (P.J. Bergius) Pillans (buchu leaf oil), when used as a sensory additive (flavouring) in feed and water for drinking for all animal species. The FEEDAP Panel concluded that the essential oil under assessment is safe up to the maximum proposed use levels in complete feed of 0.1 mg/kg for chickens for fattening, 0.15 mg/kg for laying hens, turkeys for fattening and rabbits, 0.20 mg/kg for piglets, 0.25 mg/kg for pigs for fattening, 0.30 mg/kg for sows and dairy cows, 0.45 mg/kg for cattle for fattening, sheep, goats and horses, 0.5 for veal calves (milk replacer), fish, ornamental fish and dogs. For cats, the calculated maximum safe level in feed is 0.2 mg/kg complete feed. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumer safety were identified following the use of the additive up to the highest safe levels in feed. The essential oil under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The use of the additive in animal feed under the proposed conditions was not expected to pose a risk for the environment. Buchu leaf oil was recognised to flavour food. Since its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

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Scientific Opinion on Flavouring Group Evaluation 47, Revision 1 (FGE.47Rev1): Bi‐ and tricyclic secondary alcohols, ketones and related esters from chemical group 8

Cited by 6 publications

References 26 publications

Safety and efficacy of a feed additive consisting of an essential oil derived from the leaves of Cymbopogon nardus (L.) Rendle (citronella oil) for use in all animal species (FEFANA asbl)

Safety and efficacy of a feed additive consisting of an essential oil derived from the leaves of Cymbopogon nardus (L.) Rendle (citronella oil) for use in all animal species (FEFANA asbl)

Scientific Opinion on Flavouring Group Evaluation 87, Revision 2 (FGE.87Rev2): Consideration of bicyclic secondary alcohols, ketones and related esters evaluated by JECFA (63rd meeting) structurally related to bicyclic secondary alcohols, ketones and rela

Safety and efficacy of a feed additive consisting of an essential oil from the leaves of Agathosma betulina (P.J. Bergius) Pillans (buchu leaf oil) for use in all animal species (FEFANA asbl)

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