Scientific Opinion on the safety and efficacy of primary aliphatic saturated or unsaturated alcohols/aldehydes/acids/acetals/esters with a second primary, secondary or tertiary oxygenated functional group including aliphatic lactones (chemical group 9)

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Article
EFSA Journal 2012;10(10):2928 [24 pp.].
doi
10.2903/j.efsa.2012.2928
EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)
Panel Members
Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Gerhard Flachowsky, Josep Gasa-Gasó, Mikolaj Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallac and Johannes Westendorf
Acknowledgement

The Panel wishes to thank the members of the Working Group on Feed Flavourings, including Georges Bories, Paul Brantom, Andrew Chesson, Joop de Knecht, Jürgen Gropp, Anne-Katrine Lundebye Haldorsen, and Guido Rychen, for the preparatory work on this scientific opinion.

Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
European Commission
Question Number
EFSA-Q-2010-01177
Adopted
17 Ottobre 2012
Published
26 Ottobre 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (520.4 KB)520.4 KB
Abstract

Chemical group 9 consists of primary aliphatic saturated or unsaturated alcohols/aldehydes/acids/acetals/esters with a second primary, secondary or tertiary oxygenated functional group including aliphatic lactones, of which 30 are currently authorised for use as flavours in food. The FEEDAP Panel was unable to perform an assessment of 2-oxopropanal because of issues related to the purity of the compound. The FEEDAP Panel concludes that lactic acid, succinic acid, fumaric acid, 4-oxovaleric acid, ethyl lactate, butyl lactate, butyl-O-butyryllactate, hex-3-enyl lactate, hexyl lactate, ethyl acetoacetate, ethyl 4-oxovalerate, diethylsuccinate and diethyl malonate are considered to be safe for all animal species at the use levels proposed when used as feed flavourings; octano-1,4-lactone, nonano-1,4-lactone, decano-1,4-lactone and undecano-1,4-lactone are safe at 20 mg/kg complete feed; butyro-1,4-lactone, pentano-1,4-lactone, hexano-1,4-lactone, heptano-1,4-lactone, octano-1,5-lactone, nonano-1,5-lactone, decano-1,5-lactone and undecano-1,5-lactone at 5 mg/kg complete feed; dodecano-1,4-lactone, dodecano-1,5-lactone, tetradecano-1,5-lactone, and pentadecano-1,15-lactone at a maximum of 1.5 mg/kg complete feed for cattle, salmonids and non food producing animals and of 1 mg/kg complete feed for pigs and poultry. No safety concern was identified for the consumer from the use of compounds belonging to CG 9 up to the highest safe level in feedingstuffs for all animal species. All compounds should be considered as irritants to skin, eyes and respiratory tract, and as skin sensitizers. The compounds do not pose a risk to the environment when used at concentrations considered safe for the target species. Since all compounds are used in food as flavourings, no further demonstration of efficacy is necessary.

Summary

Following a request from the European Commission, the 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 30 compounds (primary aliphatic saturated or unsaturated alcohols/aldehydes/ acids/acetals/esters with a second primary, secondary or tertiary oxygenated functional group including aliphatic lactones belonging to chemical group 9) when used as flavourings for all animal species. All 30 compounds are currently authorised for use as flavours in food and have all been detected in plant materials, in fruits or in processed foods. However the reports of their distribution vary greatly.

The FEEDAP Panel was unable to perform an assessment of 2-oxopropanal because of issues related to the purity of the compound.

The FEEDAP Panel concludes that lactic acid, succinic acid, fumaric acid, 4-oxovaleric acid, ethyl lactate, butyl lactate, butyl-O-butyryllactate, hex-3-enyl lactate, hexyl lactate, ethyl acetoacetate, ethyl 4-oxovalerate, diethylsuccinate and diethyl malonate are considered to be safe for all animal species at the use levels proposed when used as feed flavourings; octano-1,4-lactone, nonano-1,4-lactone, decano-1,4-lactone and undecano-1,4-lactone, and are safe at 20 mg/kg complete feed (with a margin of safety ranging from 1 to 3.5); butyro-1,4-lactone, pentano-1,4-lactone, hexano-1,4-lactone, heptano-1,4-lactone, octano-1,5-lactone, nonano-1,5-lactone, decano-1,5-lactone and undecano-1,5-lactone at 5 mg/kg complete feed (with a margin of safety ranging from 4 to 14); dodecano-1,4-lactone, dodecano-1,5-lactone, tetradecano-1,5-lactone, and pentadecano-1,15-lactone at a maximum of 1.5 mg/kg complete feed for cattle, salmonids and non food producing animals and of 1 mg/kg complete feed for pigs and poultry. The absence of a margin of safety would not allow the simultaneous administration in feed and water for drinking of these substances.

No safety concern would arise for the consumer from the use of compounds belonging to CG 9 up to the highest safe level in feedingstuffs for all animal species.

The FEEDAP Panel considers it prudent to treat all compounds under assessment as irritants to skin, eyes and respiratory tract, and as skin sensitizers.

The compounds considered to be safe for the target species are extensively metabolised by the target species and excreted as innocuous metabolites and carbon dioxide. Therefore no environmental risk assessment is considered necessary.

Since all 29 compounds 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.

Keywords
Sensory additives, flavourings, primary aliphatic saturated or unsaturated alcohols/aldehydes/acids/acetals/esters with a second primary, secondary or tertiary oxygenated functional group including aliphatic lactones, chemical group 9, 2-oxopropanal
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Number of Pages
24