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Scientific Opinion on the safety and efficacy of aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols and esters with esters containing tertiary alcohols ethers (chemical group 6) when used as flavourings for all animal species

EFSA Journal 2012;10(11):2966 [24 pp.]. doi:10.2903/j.efsa.2012.2966
  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. 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-2010-00873 Adopted: 13 November 2012 Published: 29 November 2012 Last updated: 15 January 2013. This version replaces the previous one/s. Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

Chemical group 6 consists of aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols and esters with esters containing tertiary alcohols ethers, of which 13 are currently authorised for use as flavours in food. The high use level proposed by the applicant for linalool (25 mg/kg complete feed) is safe for salmonids, veal calves, cattle for fattening and pets (excluding cats) without a margin of safety with the exception of dogs (SF = 1.4). The safe use level for pigs and dairy cows is 20, for piglets 12 and for poultry 10 mg/kg complete feed. The high use level of 5 mg/kg complete feed for linalyl acetate, linalyl butyrate, linalyl formate, linalyl propionate, linalyl isobutyrate, terpineol, α-terpineol and terpineol acetate and 4-terpinenol is safe for all species with a margin of safety of 1.2 to 12. For nerolidol, 2-methyl-1-phenylpropan-2-ol and 2-(4-methylphenyl)propan-2-ol, the maximum safe concentration is 1 mg/kg complete feed for pigs and poultry and 1.5 mg/kg complete feed for all other species. The absence of a margin of safety would not allow the simultaneous administration in feed and water for drinking of the following compounds: linalool, nerolidol, 2-methyl-1-phenylpropan-2-ol and 2-(4methylphenyl)propan-2-ol. No safety concern would arise for the consumer from the use of compounds belonging to CG 6 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. All compounds of CG 6 are predicted to be safe to the soil compartment when used at levels safe to the target species. Using predictions based on chemical structure, 2-methyl-1-phenylpropan-2-ol and 2-(4-methylphenyl)propan-2-ol were estimated to be safe to aquatic compartments. In the absence of experimental data, safety to aquatic compartments could not be established for linalyl butyrate, linalyl isobutyrate, terpineol acetate, 4-terpinenol, linalyl formate and linalyl propionate. Since all 13 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 13 compounds (aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols and esters with esters containing tertiary alcohols and ethers, belonging to chemical group 6) when used as flavourings for all animal species. All 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 high use level proposed by the applicant for linalool (25 mg/kg complete feed) is safe for salmonids, veal calves, cattle for fattening and pets (excluding cats) without a margin of safety but for dogs (SF = 1.4). The safe use level for pigs and dairy cows is 20, for piglets 12 and for poultry 10 mg/kg complete feed. The high use level of 5 mg/kg complete feed for linalyl acetate, linalyl butyrate, linalyl formate, linalyl propionate, linalyl isobutyrate, terpineol, α-terpineol, terpineol acetate and 4-terpinenol is safe for all species with a margin of safety of 1.2 to 12. For nerolidol, 2-methyl-1-phenylpropan-2-ol and 2-(4-methylphenyl)propan-2-ol, the maximum safe concentration is 1 mg/kg complete feed for pigs and poultry and 1.5 mg/kg complete feed for all other species.

The absence of a margin of safety would not allow the simultaneous administration in feed and water for drinking of the following compounds: linalool, nerolidol, 2-methyl-1-phenylpropan-2-ol and 2-(4methylphenyl)propan-2-ol. If more than one representative of this flavouring group is used in flavouring premixtures the maximum levels should be reduced proportionally.

No safety concern would arise for the consumer from the use of compounds belonging to CG 6 up to the highest safe level in feedingstuffs for all animal species.

The FEEDAP Panel notes that use of feed flavourings has the potential of altering the organoleptic quality of animal products (e.g. milk, eggs).

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

Linalool, terpineol, alpha-terpineol, nerolidol and linalyl acetate are considered safe for the environment based on their abundance in plant materials present in European countries. All compounds belonging to CG 6 are predicted to be safe to the soil compartment when used in animal feeds at levels considered safe to the target species. Using very limited experimental data and predictions based on chemical structure, 2-methyl-1-phenylpropan-2-ol and 2-(4-methylphenyl)propan-2-ol were estimated to be safe also to aquatic compartments. However, in the absence of experimental data, safety to aquatic compartments could not be established for linalyl butyrate, linalyl isobutyrate, terpineol acetate, 4-terpinenol, linalyl formate and linalyl propionate.

Since all 13 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, aliphatic, alicyclic and aromatic saturated and unsaturated tertiary alcohols and esters with esters containing tertiary alcohols ethers, chemical group 6, linalool, alpha-terpineol, nerolidol, 2-methyl-1-phenylpropan-2-ol,