Scientific Opinion on the safety and efficacy of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes (chemical group 2) when used as

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Article
EFSA Journal 2012;10(10):2927 [26 pp.].
doi
10.2903/j.efsa.2012.2927
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 Wallace 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-2010-00701
Adopted
17 Ottobre 2012
Published
26 Ottobre 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (548.71 KB)548.71 KB
Abstract

Chemical group 2 consists of branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes, of which 34 are currently authorised for use as flavours in food. The use of 2-methylpropionic acid, isopentyl acetate, 3-methylbutyl butyrate and 2-methylbutyl acetate is safe at the proposed use level of 25 mg/kg complete feed for cattle, salmonids and non food producing animals and at 5 mg/kg complete feed for pigs and poultry. 2-Methylpropan-1-ol, isopentanol, 2-ethylhexan-1-ol, 2-methylpropanal, 3-methylbutanal, 2-methylbutyraldehyde, 3-methylbutyric acid, 2-methylvaleric acid, 2-ethylbutyric acid, 2-methylbutyric acid, 2-methylheptanoic acid, 4-methyloctanoic acid, isobutyl acetate, isobutyl butyrate, 3-methylbutyl propionate, 3-methylbutyl formate, glyceryl tributyrate, isobutyl isobutyrate, isopentyl isobutyrate, isobutyl isovalerate, isopentyl 2-methylbutyrate, 2-methylbutyl isovalerate and 2-methylbutyl butyrate are safe at the proposed use level of 5 mg/kg complete feed for all animal species. 3,7-Dimethyloctan-1-ol, 2-methylundecanal, 4-methylnonanoic acid, 3-methylbutyl hexanoate, 3-methylbutyl dodecanoate, 3-methylbutyl octanoate and 3-methylbutyl 3-methylbutyrate are safe at a maximum of 1.5 mg/kg complete feed for cattle, salmonids and non food-producing animals and of 1.0 mg/kg complete feed for pigs and poultry. No safety concern was identified for the consumer from the use of these compounds 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 sensitisers. 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 34 compounds (branched-chain primary aliphatic alcohols/aldehydes/acids, acetals and esters with esters containing branched-chain alcohols and acetals containing branched-chain aldehydes belonging to chemical group 2) when used as flavourings for all animal species. All 34 compounds are currently authorised for use as flavours in food and are found in plant materials, in fruits or in processed foods. However the reports of their distribution vary greatly.

The FEEDAP Panel concludes that 2-methylpropionic acid, isopentyl acetate, 3-methylbutyl butyrate and 2-methylbutyl acetate are safe at the proposed use level of 25 mg/kg complete feed for cattle, salmonids and non food producing animals (with no margin of safety) and at 5 mg/kg complete feed for pigs and poultry (with a margin of safety between 1.6 and 3.4); 2-methylpropan-1-ol, isopentanol, 2-ethylhexan-1-ol, 2-methylpropanal, 3-methylbutanal, 2-methylbutyraldehyde, 3-methylbutyric acid, 2-methylvaleric acid, 2-ethylbutyric acid, 2-methylbutyric acid, 2-methylheptanoic acid, 4-methyloctanoic acid, isobutyl acetate, isobutyl butyrate, 3-methylbutyl propionate, 3-methylbutyl formate, glyceryl tributyrate, isobutyl isobutyrate, isopentyl isobutyrate, isobutyl isovalerate, isopentyl 2-methylbutyrate, 2-methylbutyl isovalerate and 2-methylbutyl butyrate at the proposed use level of 5 mg/kg complete feed for all animal species (with a margin of safety between 1.6 and 6); 3,7-dimethyloctan-1-ol, 2-methylundecanal, 4-methylnonanoic acid, 3-methylbutyl hexanoate, 3-methylbutyl dodecanoate, 3-methylbutyl octanoate and 3-methylbutyl 3-methylbutyrate at a maximum of 1.5 mg/kg complete feed for cattle, salmonids and non food-producing animals and of 1.0 mg/kg complete feed for pigs and poultry.

No safety concern would arise for the consumer from the use of compounds belonging to CG 2 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 34 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, branched-chain primary aliphatic alcohols/aldehydes/acids, acetal and esters, chemical group 2, 2-methylpropan-1-ol, isopentanol, 3,7-dimethyloctan-1-ol, 2-ethylhexan-1-ol, 2-methylpropanal, 3-methylbutanal
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Number of Pages
26