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Scientific Opinion on the safety and efficacy of aliphatic and alicyclic ethers (chemical group 16) when used as flavourings for all animal species

EFSA Journal 2012;10(11):2967 [17 pp.]. doi:10.2903/j.efsa.2012.2967
  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 and Anne-Katrine Lundebye Haldorsen, 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-2010-00989 Adopted: 13 November 2012 Published: 30 November 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

Chemical group 16 consists of aliphatic and alicyclic ethers, of which four are currently authorised for use as flavours in food. The FEEDAP Panel was unable to perform an assessment of 1,5,5,9-tetramethyl-13-oxatricyclo[8.3.0.0.(4.9)]tridecane and theaspirane because of issues related to the purity of the compounds. The FEEDAP Panel concludes that: i)1,8-cineole is safe at the high use level proposed by the applicant (5 mg/kg complete feed) for all animal species with a margin of safety of 5.6 to 28.2; ii)2-(2-methylprop-1-enyl)-4-methyltetrahydropyran (Class II) is safe at a maximum of 0.3 mg/kg complete feed for cattle, salmonids and non food producing animals and of 0.5 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. The total dose from all sources should not exceed that recommended when given in feed alone. No safety concern would arise for the consumer from the use of compounds belonging to CG 16 up to the highest safe level in feedingstuffs for all animal species. The FEEDAP Panel considers it prudent to treat both compounds under assessment as irritants to skin, eyes and respiratory tract, and as skin sensitisers. The FEEDAP Panel considers that the concentrations of the compounds belonging to CG 16 in the environment are not expected to exceed levels of concern when used in animal feeds at the levels considered to be safe to the target species. Since these 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.

© 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 four compounds (aliphatic and alicyclic ethers belonging to chemical group 16) 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, or in processed foods, however the reports of their distribution vary greatly.

The FEEDAP Panel was unable to perform an assessment of 1,5,5,9-tetramethyl-13-oxatricyclo[8.3.0.0.(4.9)]tridecane and theaspirane because of issues related to the purity of the compounds.

The FEEDAP Panel concludes that:

  • 1,8-cineole is safe at the high use level proposed by the applicant (5 mg/kg complete feed) for all animal species with a margin of safety of 5.6 to 28.2
  • 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran (Class II) is safe at a maximum of 0.3 mg/kg complete feed for cattle, salmonids and non food producing animals and of 0.5 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.

The total dose from all sources should not exceed that recommended when given in feed alone.

No safety concern would arise for the consumer from the use of compounds belonging to CG 16 up to the highest safe level in feedingstuffs for all animal species.

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

The FEEDAP Panel considers that the concentrations of the compounds belonging to CG 16 in the environment are not expected to exceed levels of concern when used in animal feeds at the levels considered to be safe to the target species.

Since these 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 and alicyclic ethers, chemical group 16, 1,8-cineole, 2-(2-methylprop-1-enyl)-4-methyltetrahydropyran, 1,5,5,9-tetramethyl-13-oxatricyclo[8.3.0.0.(4.9)]tridecane, theaspirane