Safety and efficacy of a feed additive consisting of expressed mandarin oil from the fruit peels of Citrus reticulata Blanco for use in all animal species (FEFANA asbl)

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 expressed mandarin oil from the fruit peels of Citrus reticulata Blanco, when used as a sensory additive (flavouring) in feed and water for drinking for all animal species. The FEEDAP Panel concluded that the essential oil under assessment is safe up to the maximum proposed use levels in complete feed of 15 mg/kg for poultry, 33 mg/kg for pigs, 30 mg/kg for ruminants, 40 mg/kg for horse, and 15 mg/kg for salmon and rabbit. The presence of perillaldehyde was identified as a source of potential concern. However, in target species fed citrus by‐products as part of daily feed the use of the expressed mandarin oil in feed was not expected to increase the exposure to perillaldehyde to a relevant extent (< 4%). For companion animals and ornamental fish not normally exposed to citrus by‐products, no conclusion can be drawn. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumer safety were identified following the use of the additive up to the maximum proposed use level in feed. The essential oil under assessment should be considered as irritant to skin, eyes and the respiratory tract, and as a skin sensitiser. The use of the additive in animal feed under the proposed conditions of use was not expected to pose a risk for the environment. Expressed mandarin oil was recognised to flavour food. Since its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Effect of Dietary Pomelo Peel Powder on Growth Performance, Diarrhea, Immune Function, Antioxidant Function, Ileum Morphology, and Colonic Microflora of Weaned Piglets

“…Supplementation of PPP containing 1.56 mg/g flavonoids increased average daily gain of piglets, and decreased diarrhea rate. This result was consistent with previous studies reporting the addition of citrus flavonoids reduced the occurrence of zoonotic diseases and has a significant effect on improving animal performance [ 21 , 22 ].…”

Risk Assessment of Combined Exposure to Multiple Chemicals at the European Food Safety Authority: Principles, Guidance Documents, Applications and Future Challenges

“…From these generic case studies, the EFSA Panel on Feed and Contaminants (FEEDAP Panel) applied the approach to a number of risk assessments of multiple substances in essential oils and other preparations (e.g., extracts, oleoresins and tinctures) for use in animal species, including oregano oil [ 79 , 81 ], cardamom oil from Elettaria cardamomum (L.) Maton [ 82 ], ginger preparations [ 83 ], turmeric preparations [ 84 ], expressed lemon oil and its fractions from Citrus limon (L.) Osbeck and of lime oil from Citrus aurantiifolia (Christm.) Swingle [ 85 ], petitgrain bigarade oil from the leaves of Citrus × aurantium L. [ 86 ], expressed mandarin oil from the fruit peels of C. reticulata Blanco [ 87 ], expressed sweet orange peel oil and its fractions from Citrus sinensis (L.) Osbeck [ 88 ], bitter orange extract from the whole fruit of Citrus × aurantium L. [ 89 ], lemon extract from Citrus limon (L.) Osbeck [ 90 ], litsea berry oil from the fruits of Litsea cubeba (Lour.) Pers.…”

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)

“…perillaldehyde, p ‐mentha‐1,8(10)‐dien‐9‐ol, α‐sinensal and β‐sinensal, and polymethoxylated flavones (PMF), based on the evidence provided by the applicant in the form of several literature searches, 25 and Quantitative Structure–Activity Relationship (QSAR) analysis for substances raising potential genotoxicity concern. 26 A more extensive safety evaluation of PMF is available in the EFSA opinion on expressed mandarin oil (EFSA FEEDAP Panel, 2021b ).…”

“…Absorption, distribution, metabolism and excretion (ADME) data in experimental animals and humans available in the literature were provided by the applicant (Nielsen et al., 2000 ; Murakami et al., 2002 ; Breinholt et al., 2003 ; Koga et al., 2011 ; Manthey et al., 2011 ; Hung et al., 2018 ). 27 They were reviewed by the FEEDAP Panel in the opinion on expressed mandarin oil (EFSA FEEDAP Panel, 2021b ). Briefly, the ADME studies of PMF shows that the compounds are absorbed and transformed to phase I and phase II metabolites, that are excreted both in urine and faeces.…”

“…Genotoxicity data on PMF available in the literature were provided by the applicant (Delaney et al., 2002 ; Nakajima et al., 2020 ). 27 They were reviewed by the FEEDAP Panel in the EFSA opinion on expressed mandarin oil (EFSA FEEDAP Panel, 2021b ). Briefly, a mixture of PMF (containing nobiletin 32.5%, tangeretin 14.0% and heptamethoxyflavone 25% and other components 29 ) was not mutagenic in an Ames test and in an in vitro mutagenicity assay using L5178Y tk +/− mouse lymphoma cells (Delaney et al., 2002 ).…”