Safety and efficacy of non‐conjugated and accumulated unsaturated straight‐chain and branched‐chain, aliphatic primary alcohols, aldehydes, acids, acetals and esters belonging to chemical group 4 when used as flavourings for all animal species

Abstract

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 24 compounds belonging to chemical group 4 (non-conjugated and accumulated unsaturated straight-chain and branched-chain, aliphatic primary alcohols, aldehydes, acids, acetals and esters). This opinion concerns 23 compounds from this group. They are currently authorised as flavours in food. The FEEDAP Panel established the following conclusions: hex-3(cis)-en-1-ol [02.056], (Z)-non-6-en-1-ol [02.093], oct-3-en-1-ol [02.094], non-6(cis)-enal [05.059], hex-3(cis)-enal [05.075], (Z)-hept-4-enal [05.085], hex-3(cis)-enyl acetate [09.197], hex-3(cis)-enyl formate [09.240], hex-3enyl butyrate [09.270], hex-3-enyl hexanoate [09.271] and hex-3(cis)-enyl isobutyrate [09.563] are safe at the proposed maximum use level of 5 mg/kg complete feed for all target species; citronellol [02.011], (-)-3,7-dimethyl-6-octen-1-ol [02.229], citronellal [05.021], 2,6-dimethylhept-5-enal [05.074], citronellic acid [08.036], citronellyl acetate [09.012], citronellyl butyrate [09.049], citronellyl formate [09.078] and citronellyl propionate [09.129] are safe at the maximum use level of 5 mg/kg for all species, except cats for which the proposed normal use level of 1 mg/kg is considered safe; undec-10enal [05.035], 1-ethoxy-1-(3-hexenyloxy)ethane [06.081] and hex-3-enyl isovalerate [09.505] are safe at the normal use levels of 1 mg/kg for all species. No safety concern would arise for the consumer from the use of these compounds up to the highest safe 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. The use of the majority of the compounds in animal feed at the maximum safe level is considered safe for the environment. As all the compounds under assessment are used in food as flavourings, and their function in feed is essentially the same as in food, no further demonstration of efficacy is necessary.

Safety and efficacy of a feed additive consisting of an essential oil derived from the leaves of Cymbopogon nardus (L.) Rendle (citronella oil) for use in all animal species (FEFANA asbl)

“…The FEEDAP Panel notes that 45 of them 30 accounting together for 16.2% of the GC area are aliphatic mono‐ or sesquiterpenes structurally related to flavourings already assessed in CGs 3, 5, 6, 8, 10, 26, 31 and 32 for which a similar metabolic and toxicological profile is expected. Because of their lipophilic nature, they are expected to be rapidly absorbed from the gastro‐intestinal tract, oxidised to polar oxygenated metabolites, conjugated and excreted (EFSA CEF Panel, 2014 ; EFSA FEEDAP Panel, 2012b , 2012d , 2015b , 2016b , 2016c , 2016d ).…”

“…Toxicological data of subchronic studies, from which NOAEL values could be derived, were available for several compounds in CG 1 (EFSA FEEDAP Panel, 2013 ), for the representative compound citral [05.020] in CG 3 (EFSA FEEDAP Panel, 2016a ), for citronellol [02.011] and 2,6‐dimethylhept‐5‐enal [05.074] in CG 4 (EFSA FEEDAP Panel, 2016b ), 6‐methylhept‐5‐en‐2‐one [07.015] in CG 5 (EFSA FEEDAP Panel, 2021b ), terpineol [02.230] 40 and linalool [02.013] in CG 6 (EFSA FEEDAP Panel, 2021b ), d,l ‐isobornyl acetate [09.218] in CG 8 (EFSA FEEDAP Panel, 2016c ), methyl isoeugenol [04.013] in CG 26 (EFSA FEEDAP Panel, 2012d ), and for the representative compounds for sub‐assessment groups of CG 31, myrcene [01.008], d‐limonene [01.045] and β‐caryophyllene (EFSA FEEDAP Panel, 2015b , 2016d ), and β‐caryophyllene epoxide [16.043] for CG 32 (EFSA CEF Panel, 2014 ). For d‐ carvone [01.146], not present in the essential oil but structurally related to some components, the applicant referred to a BMDL 10 of 60 mg/kg bw per day (EFSA FEEDAP Panel, 2016c ; EFSA Scientific Committee, 2014 ).…”

“…The five major constituents of citronella oil from C. nardus (citronellal, geraniol, citronellol, limonene and ( E )‐methyl isoeugenol and additional 31 components (see Table 4 )) accounting together for about 75.5% of the composition of the oil, have been evaluated by EFSA as sensory additives for animal feed. They are present at high concentrations in plants native to Europe and are expected to be extensively metabolised by the target species (EFSA FEEDAP Panel, 2016a , 2016b , 2015a ). Therefore, no risk to the environment is expected for these compounds from the use of citronella oil in animal feed.…”

Safety and efficacy of a feed additive consisting of an essential oil obtained from the fruit of Coriandrum sativum L. (coriander oil) (FEFANA asbl)

“…Toxicological data of sub‐chronic studies, from which NOAEL values could be derived, were available for several compounds in CG 1 (EFSA FEEDAP Panel, 2013 ), citral [05.020] in CG 3 (EFSA FEEDAP Panel, 2016a ), citronellol [02.011] and citronellyl derivatives in CG 4 (EFSA FEEDAP Panel, 2016b ), 6‐methylhept‐5‐en‐2‐one [07.015] in CG 5 (EFSA FEEDAP Panel, 2021a ), terpineol [02.230] 28 and linalool [02.013] in CG 6 (EFSA FEEDAP Panel, 2012a ), 1,8‐cineole [03.001] in CG 16 (EFSA FEEDAP Panel, 2021b ), methyl salicylate in CG 23 (EFSA FEEDAP Panel, 2012d ), myrcene [01.008], limonene [01.045], p‐cymene [01.002] and β‐caryophyllene [01.007] in CG 31 (EFSA CEF Panel, 2015a , b ; EFSA FEEDAP Panel, 2015b , 2016d ) and β‐caryophyllene oxide in CG 32 (EFSA CEF Panel, 2014 ). For benzaldehyde [05.013] in CG 23, the FEEDAP Panel concluded that the maximum proposed concentration of 25 mg/kg complete feed is safe (EFSA FEEDAP Panel, 2012d ).…”

Safety and efficacy of feed additives consisting of expressed sweet orange peel oil and its fractions from Citrus sinensis (L.) Osbeck for use in all animal species (FEFANA asbl)

“…Toxicological data of subchronic studies, from which NOAELs could be derived, were available for octyl acetate [09.007] in CG 1 (EFSA FEEDAP Panel, 2013 ), citral [05.020] in CG 3 (EFSA FEEDAP Panel, 2016a ), citronellol [02.011] in CG 4 (EFSA FEEDAP Panel, 2016b ), terpineol 32 [02.230] and linalool [02.013] in CG 6 (EFSA FEEDAP Panel, 2012a ), l‐carvone [07.147] in CG 8 (EFSA FEEDAP Panel, 2016c ), myrcene [01.008], d‐limonene [01.045], p ‐cymene [01.002] and β‐caryophyllene [01.007] in CG 31 (EFSA FEEDAP Panel, 2015 , 2016d ).…”