Safety and efficacy of 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters) when used as flavourings for all animal species and categories

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 26 compounds belonging to chemical group 3 (α,β‐unsaturated straight‐chain and branched‐chain aliphatic primary alcohols, aldehydes, acids and esters). They are all currently authorised as flavours in food. The FEEDAP Panel was unable to perform the assessment of non‐2(cis)‐en‐1‐ol [02.112] in the absence of data on its purity. The FEEDAP Panel concludes that hex‐2‐en‐1‐ol [02.020], pent‐2‐en‐1‐ol [02.050], 2‐dodecenal [05.037], nona‐2,4‐dienal [05.071], trans‐2‐nonenal [05.072], hex‐2(trans)‐enal [05.073], 2,4‐decadienal [05.081], hepta‐2,4‐dienal [05.084], deca‐2(trans),4(trans)‐dienal [05.140], dodec‐2(trans)‐enal [05.144], hept‐2(trans)‐enal [05.150], non‐2‐enal [05.171], undec‐2(trans)‐enal [05.184], trans‐2‐octenal [05.190], trans‐2‐decenal [05.191], tr‐2, tr‐4‐nonadienal [05.194], tr‐2, tr‐4‐undecadienal [05.196], hex‐2(trans)‐enyl acetate [09.394] and hex‐2‐enyl butyrate [09.396] are safe at the proposed maximum use level of 5 mg/kg feed for all animal species; nona‐2,6‐dien‐1‐ol [02.049], trans‐2, cis‐6‐nonadien‐1‐ol [02.231], nona‐2(trans),6(cis)‐dienal [05.058], nona‐2(trans),6(trans)‐dienal [05.172], allyl heptanoate [09.097] and allyl hexanoate [09.244] are safe at the proposed normal use levels of 1 mg/kg complete feed for all animal species. No safety concern would arise for the consumer from the use of these compounds up to the highest safe levels in feed. In the absence of studies to assess the safety for the user, the FEEDAP Panel cannot conclude on the safety for the users when handling the additives. No environmental risk is foreseen for these compounds at the concentrations considered safe for the target species. Since the 25 compounds are used in food as flavourings and their function is essentially the same as that in food, no further demonstration of efficacy is necessary.

Safety and efficacy of a feed additive consisting of an essential oil from the fruit of Cuminum cyminum L. (cumin oil) for use in all animal species (FEFANA asbl)

“…Toxicological data for sub‐chronic studies, from which NOAEL values could be derived, were available for trans ‐2‐nonenal [05.072] and deca‐2( trans ),4( trans )‐dienal [05.140] in CG 3 (EFSA FEEDAP Panel, 2019a ), terpineol 30 [02.230] and linalool [02.013] in CG 6 (EFSA FEEDAP Panel, 2012a ), 1,8‐cineole in CG 16 (EFSA FEEDAP Panel, 2012b , 2021a ), and for the representative compounds for sub‐assessment groups of CG 31, myrcene [01.008], d‐limonene [01.045], p‐cymene [01.002] and β‐caryophyllene [01.007] (EFSA FEEDAP Panel, 2015 , 2016a ) and β‐caryophyllene epoxide [16.043] in CG 32 (EFSA CEF Panel, 2014 ). For cuminaldehyde [05.022] and 4‐isopropylbenzyl alcohol [02.039] in CG 23 the FEEDAP Panel concluded that the maximum proposed concentration of 5 mg/kg complete feed is safe, based on their structural and metabolic relationship with benzoic acid, which was considered safe up to 125 mg/kg complete feed (EFSA FEEDAP Panel, 2012c ).…”

Safety of 37 feed additives consisting of flavouring compounds belonging to different chemical groups for use in all animal species (FEFANA asbl)

“…In previous opinions of the FEEDAP Panel (EFSA FEEDAP Panel, 2012a , b , c , 2013 , 2016a , b , 2019a , b , 2020a , b ), the 37 additives under assessment were fully characterised, with the exception of ethyl oleate [09.192], and evaluated for their safety and efficacy as flavouring substances. Ethyl oleate was excluded from further assessment.…”

“…For 26 compounds belonging to CGs 03, 05, 08, 21 and 31, no studies to assess the safety for the user were submitted for previous assessments. Therefore, the FEEDAP Panel could not conclude on the safety for the users when handling the additive at that time (EFSA FEEDAP Panel, 2016b , 2019a , b , 2020a , b ).…”

“…Regarding the safety for the user, in its previous assessments, for 26 compounds, namely nona‐2,6‐dien‐1‐ol [02.049], pent‐2‐en‐1‐ol [02.050], trans‐2,cis‐6 nonadien‐1‐ol [02.231], 2‐dodecenal [05.037], nona‐2(trans),6(cis)‐dienal [05.058], nona‐2,4‐dienal [05.071], trans‐2‐nonenal [05.072], 2,4‐decadienal [05.081], hepta‐2,4‐dienal [05.084], deca‐2(trans),4(trans)‐dienal [05.140], dodec‐2(trans)‐enal [05.144], hept‐2(trans)‐enal [05.150], non‐2‐enal [05.171], nona‐2(trans),6(trans)‐dienal [05.172], undec‐2(trans)‐enal [05.184], trans‐2‐octenal [05.190], trans‐2‐decenal [05.191], trans‐2, tr‐4‐nonadienal [05.194], trans‐2, tr‐4‐undecadienal [05.196], hex‐2(trans)‐enyl acetate [09.394], hex‐2‐enyl butyrate [09.396], isopulegol [02.067], oct‐1‐en‐3‐one [07.081], benzophenone [07.032], myrcene [01.008] and β‐ocimene [01.018], in the absence of studies to assess the safety for the user, the FEEDAP Panel could not conclude on the safety for the users when handling the additives (EFSA FEEDAP Panel, 2016b , 2019a , b , 2020a , b ).…”

“…In the previous assessment, the PEC soil calculated for 3‐methyl‐2‐cyclopenten‐1‐one [07.112] at the application rate of 0.5 mg/kg, following the provision of the former guidance on environmental risk assessment (EFSA, 2008 ) was 11 µg/kg, above the threshold of 10 µg/kg. The applicant provided calculations according to the guidance on the environmental risk assessment (EFSA FEEDAP Panel, 2019a , b ), which showed that at the levels in feed considered safe for the target animals (up to 0.5 mg/kg), the PEC soil would be below the threshold of 10 µg/kg. This would exclude the need for further assessment for the terrestrial compartment.…”