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Lemon extract - 2b139a-ex

total polyphenols

Details

Publication date
16 December 2020 (Last updated on: 18 December 2020)

Description

In the current application authorisation is sought under Article 10(2) for Lemon extract under the category/functional group 2(b) 'Sensory additives' / 'flavouring compounds' according to the classification system of Annex I of Regulation (EC) No 1831/2003. Specifically, authorisation is sought for the use of the feed additive for all animal species. 

The feed additive is a dark orange-to-yellow liquid extract obtained from the peel and the seeds of the Citrus limon (L.) Burm. (CoE 139). Lemon extract is to be used through premixtures or directly into feedingstuffs and water at proposed maximum levels of 1000 mg /kg feedingstuffs and 0.25 ml / l water. According to the Applicant, the phytochemical markers proposed for the characterisation of the feed additive (Lemon extract) are total polyphenols and eriocitrin. Lemon extract is a natural product and thus the total polyphenols content varies from harvest to harvest, ranging generally from 1 to 4 % (w/w). 

For the quantification of the total polyphenols in the feed additive (Lemon extract) the Applicant proposed a colourimetric method described in the European Pharmacopoeia monograph 2.8.14. Upon request of the EURL, the Applicant provided experimental data for the analysis of the total polyphenols content in two different batches of Lemon extract. 

Based on the acceptable performance characteristics presented the EURL recommends for official control the colourimetric method described in the European Pharmacopoeia 2.8.14 monograph for the quantification of the total polyphenols content in the feed additive

For an additional identification/characterisation of the feed additive, the EURL considers a method based on high performance liquid chromatography with spectrophotometric detection (HPLC-UV) suitable for the determination of eriocitrin in the feed additive.

The Applicant did not provide experimental data or analytical methods for the determination of Lemon extract in premixtures and feedingstuffs, as the unambiguous determination of the feed additive added to the matrices is not achievable experimentally. Therefore, the EURL cannot evaluate nor recommend any method for official control for the determination of Lemon extract in premixtures and feedingstuffs

Further testing or validation of the methods to be performed through the consortium of National Reference Laboratories as specified by Article 10 (Commission Regulation (EC) No 378/2005, as last amended by Regulation (EU) 2015/1761) is not considered necessary.

Recommended Method

as of:

Commission Implementing Regulation (EU) 2022/537 

For the quantification of the phytochemical marker (total polyphenols) in the feed additive:

spectrophotometry at 760 nm expressing the total polyphenols content as pyrogallol equivalent (European Pharmacopoeia monograph 2.8.14)

Files

  • 18 DECEMBER 2020
revised_finrep_fad-2010-0130_lemon_extract.pdf