Safety and efficacy of saturated and unsaturated aliphatic secondary alcohols, ketones and esters with esters containing secondary alcohols belonging to chemical group 5 when used as flavourings for all animal species

sensory additives, saturated and unsaturated aliphatic secondary alcohols, ketones and esters with esters containing secondary alcohols, chemical group 5, safety
First published in the EFSA Journal
10 November 2015
Adopted
20 October 2015
Last Updated
22 April 2016. This version replaces the previous one/s.
Type
Scientific Opinion

Abstract

This opinion considers the safety and efficacy of 17 compounds belonging to chemical group 5 when used as feed flavourings for all animal species. Isopropanol and isopropyl tetradecanoate are safe at a maximum dose level of 25 mg and 5 mg/kg feed, respectively, based on comparable levels of exposure of humans and animals to isopropanol. From toxicological data, heptan-2-one and pentan-2-one are safe at the proposed maximum dose level (5 mg/kg) for all species except piglets (4 mg/kg), chickens for fattening and laying hens (3 mg/kg) and cats (2 mg/kg). Since no acceptable toxicological data are available for the remaining compounds, the threshold of toxicological concern approach was used to calculate maximum safe concentrations in feed. For octan-2-ol, pentan-2-ol, octan-3-ol and butan-2-one the safe level is 1.5 mg/kg feed for cattle, salmonids and non-food-producing animals and 1 mg/kg feed for pigs and poultry. For 6-methylhept-5-en-2-one, undecan-2-one, octan-2-one, nonan-2-one, octan-3-one, 6-methylhepta-3,5-dien-2-one, tridecan-2-one, nonan-3-one and decan-2-one, the corresponding values are 0.5 mg/kg (cattle, salmonids and non-food-producing animals) and 0.3 mg/kg (pigs and poultry). Mammals, birds and fish share a similar capacity to metabolise secondary alcohols, ketones and esters to innocuous substances. Consequently, no safety concern would arise for consumers from the use of these compounds as proposed in feeds. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers all the compounds under assessment as irritants to skin, eyes and respiratory tract, and as skin sensitisers. Use of the compounds in animal feed at the maximum safe level is considered safe for the environment, except for nonan-3-one in sea cages, where only 0.047 mg/kg is safe. Since all of the compounds are used in food as flavourings and their function in feed is essentially the same as that in food no demonstration of efficacy is necessary.

Panel members at the time of adoption

Gabriele Aquilina, Vasileios Bampidis, Maria de Lourdes Bastos, Georges Bories, Andrew Chesson, Pier Sandro Cocconcelli, Gerhard Flachowsky, Jürgen Gropp, Boris Kolar, Maryline Kouba, Secundino López Puente, Marta López-Alonso, Alberto Mantovani, Baltasar Mayo, Fernando Ramos, Guido Rychen, Maria Saarela, Roberto Edoardo Villa, Robert John Wallace and Pieter Wester.
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap@efsa.europa.eu
doi
10.2903/j.efsa.2015.4268
EFSA Journal 2015;13(11):4268
Question Number
On request from
European Commission