Essential oil from Origanum vulgare L., subsp. hirtum, (Link) letsw. Var. Vulkan (DOS 00001) - 2b317eo

In the current application authorisation is sought under article 4(1) for natural essential oil from Origanum vulgare L., ssp. hirtum var. Vulkan (DOS 00001) 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 and categories. 

The Applicant defined the product as "natural essential oil from Origanum vulgare L. ssp. hirtum var. Vulkan (DOS 00001)", containing the following main constituents: Carvacrol (60 – 65 %); para-Cymene (5 – 10 %); gamma-Terpinene (4 – 9 %); beta-Caryophyllene (2.0 – 5.0%); Thymol (1.0 – 3.5 %); Linalool (less than 5.0%); alpha-Terpinene and Terpinen-4-ol (less than 2.0 % each). The Applicant suggested using Carvacrol as the phytochemical marker. The feed additive is to be used in feedingstuffs with no proposed minimum or maximum concentration levels. However, recommended inclusion levels of the feed additive are ranging from 15 to 150 mg /kg complete feedingstuffs.

For the characterisation of the feed additive, the Applicant submitted a gas chromatography coupled with flame ionisation and masspectrometric detection (GC-FID/MS) method - derived from the ISO 11024 and the European Pharmacopoeia monograph 8.0, 2.2.28 - to identify and quantify the main constituents. The Applicant reported a relative standard deviation for intermediate precision (RSDip), ranging from 0.8 to 6.1% when quantifying Carvacrol and Thymol in the pure essential oil. Based on the experimental evidence provided the EURL recommends the GC-FID/MS method for official control to identify the major constituents and quantify the phytochemical marker (Carvacrol), in the feed additive. 

For the quantification of Oregano essential oil in premixtures the Applicant submitted a method based on volumetric analysis after water-steam distillation - derived from the ISO 6571 standard and European Pharmacopeia monograph 8.0, 2.8.12. The Applicant applied this method for the analysis of the essential oil in three different types of premixtures containing the essential oil on silica and fatty plant oil carriers and reported satisfactory recovery rates (Rrec) ranging from 89.7 to 90.9% for the volatile oil content. As for the feed additive, the EURL suggests applying the GC-FID/MS for the identification of the obtained essential oil. Based on the experimental evidence available the EURL considers these methods suitable for determination of Oregano essential oil in the premixtures investigated. 

The accurate quantification of added essential oil from Origanum vulgare L. ssp. hirtum var. Vulkan (DOS 00001) in feedingstuffs is not achievable experimentally. Therefore, the EURL cannot evaluate nor recommend any method for official control to quantify Origanum vulgare L. ssp. hirtum var. Vulkan (DOS 00001) in 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) is not considered necessary.

Recommended Method

as of:

- Commission Implementing Regulation (EU) 2021/658

For the identification of the major constituents and for the quantification of the phytochemical marker (carvacrol) in the feed additive: 

- gas chromatography coupled to mass spectrometry and flame ionisation detection (GC-MS and GC-FID)

For the determination of Oregano essential oil in premixtures:

 water-steam distillation combined with gas chromatography coupled to mass spectrometry and flame ionisation detection (GC-MS and GC-FID)