Safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory additive for all animal species

sensory additives, flavouring compounds, dry extract, Melissa officinalis L., Safety, efficacy
First published in the EFSA Journal
19 February 2020
Adopted
28 January 2020
Type
Scientific Opinion

Legal notice: Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by the European Commission. The full output has been shared with the European Commission, EU Member States and the applicant. The blackening will be subject to review once the decision on the confidentiality requests is adopted by the European Commission.

Abstract

Following a request from the European Commission, the 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 a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory feed additive for all animal species. The aqueous ethanol extract is specified to contain ≥ 10% of hydroxycinnamic acid derivatives including ≥ 3% of rosmarinic acid. Considering the contradictory data from the Ames tests and uncertainty about the qualitative and quantitative presence of flavonoids and other compounds in the extract from M. officinalis L. leaves, the FEEDAP Panel could not conclude on the genotoxicity of the additive under assessment. Although the identified components of the extract do not raise concerns for the safety of target species, the analysis of the extract is incomplete. In the absence of adequate analytical and safety data, the FEEDAP Panel is unable to conclude on the safety of the additive for the target species. The use of M. officinalis L. leaf dried extract in animal feed at the proposed use level does not raise significantly the exposure levels of the consumer for compounds derived from this plant. However, in the absence of adequate data on genotoxicity, the Panel cannot conclude on the safety for the consumer. In the absence of specific studies, the FEEDAP Panel cannot conclude on the safety of the additive for the user. M. officinalis L. is a native species to Europe and its use in animal nutrition is not expected to pose a risk for the environment. Since M. officinalis L. and its extracts are recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary for the extract.

Substances
p-coumaric acid
Cas: 7400-08-0
Iupac: 4-hydroxycinnamic acid
Rosmarinic acid
Cas: 20283-92-5
Iupac: (R)-α-[[3-(3,4-dihydroxyphenyl)-1-oxo-2E-propenyl]oxy]-3,4-dihydroxy-benzenepropanoic acid
Chlorogenic acid
Cas: 327-97-9
Iupac: 5-O-(3,4-dihydroxycinnamoyl)-L-quinic acid
Caffeic acid
Cas: 331-39-5
Inchi: InChI=1S/C9H8O4/c10-7-3-1-6(5-8(7)11)2-4-9(12)13/h1-5,10-11H,(H,12,13)/b4-2+
Iupac: 3-(3,4-dihydroxyphenyl)prop-2-enoic acid

Panel members at the time of adoption

Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Maryline Kouba, Mojca Kos Durjava, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Panel on Additives and Products or Substances used in Animal Feed
Contact
feedap [at] efsa.europa.eu
doi
10.2903/j.efsa.2020.6016
EFSA Journal 2020;18(2):6016
Question Number
On request from
European Commission