Search EFSA Journal
Refine your search
Type
All article types
Special Issue Item
Journal Editorial
Scientific opinions of Scientific/Scientific Panel
Opinion of the Scientific Committee/Scientific Panel
Statement of the Scientific Committee/Scientific Panel
Guidance of the Scientific Committee/Scientific Panel
Other scientific outputs of EFSA
Statement of EFSA
Guidance of EFSA
Conclusion on pesticides
Reasoned opinion on pesticide
Scientific report of EFSA
Technical Report
Subject
All subjects
Animal health & welfare
Biological hazards
Biological monitoring
Contaminants
Dietary & chemical monitoring
Emerging risks
Feed
Food Ingredients and Packaging
GMO
Nutrition
Pesticides
Plant health
Assessment and methodological support
Scientific Committee
Scientific cooperation
Article ID
Digital Object ID
Sort by:
Publication date
Relevance

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) when used as flavourings for all animal species

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 Acknowledgment 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. Contact FEEDAP@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2010-01177 Adopted: 17 October 2012 Published: 26 October 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
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.

© European Food Safety Authority, 2012

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