Safety and efficacy of secondary aliphatic saturated or unsaturated alcohols, ketones, ketals and esters with a second secondary or tertiary oxygenated functional group belonging to chemical group 10 when used as flavourings for all animal species

Lingua Undefined

Published on: Fri, 18 Nov 2016 12:15:15 +0100

Following a request from the European Commission, the EFSA 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 11 compounds belonging to chemical group 10. They are currently authorised as flavours in food. The FEEDAP Panel concludes that: diacetyl [07.052] is safe at the proposed maximum use level of 25 mg/kg complete feed for all target species, except piglets, chickens for fattening, laying hens and cats, for which the proposed normal use level of 5 mg/kg is safe; 3-hydroxybutan-2-one [07.051], 3-methylcyclo-pentan-1,2-dione [07.056], 3-ethylcyclopentan-1,2-dione [07.057], pentan-2,3-dione [07.060], 3,4-dimethylcyclopentan-1,2-dione [07.075], 3,5-dimethyl cyclopentan-1,2-dione [07.076], hexan-3,4-dione [07.077] and sec-butan-3-onyl acetate [09.186] are safe at the proposed maximum dose level of 5 mg/kg for all target species; 2,6,6-trimethylcyclohex-2-en-1,4-dione [07.109] and 3-methylnona-2,4-dione [07.184] are safe only at concentrations below the proposed use levels (0.5 mg/kg for cattle, salmonids and non-food producing animals, and 0.3 mg/kg for pigs and poultry). No safety concern would arise for the consumer from the use of these compounds up to the highest proposed level in feeds. Hazards for skin and eye contact and respiratory exposure are recognised for the majority of the compounds under application. Most are classified as irritating to the respiratory system. For 3-hydroxybutan-2-one [07.051], diacetyl [07.052], pentan-2,3-dione [07.060], hexan-3,4-dione [07.077], 2,6,6-trimethylcyclohex-2-en-1,4-dione [07.109], 3-methylnona-2,4-dione [07.184] and sec-butan-3-onyl acetate [09.186], the maximum proposed use levels are considered safe for the environment. For cyclopentanediones (3-methylcyclopentan-1,2-dione [07.056], 3-ethylcyclopentan-1.2-dione [07.057], 3,4 dimethylcyclopentan-1,2-dione [07.075] and 3,5-dimethylcyclopentan-1,2-dione [07.076]) usage at levels up to 0.5 mg/kg feed is unlikely to have an adverse effect on the terrestrial or freshwater environments. Because all the compounds under assessment 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.