Preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol - 4d20

In the current application an authorisation is sought under Article 4(1) for a currently authorised preparation of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol (Biomin® DC-P) under the category/ functional group (4 d) "zootechnical additives"/"other zootechnical additives", according to the classification system of Annex I of Regulation (EC) No 1831/2003. Specifically, the authorisation is sought for the use of the feed additive for all poultry species. The feed additive is an off-white powder composed of a mixture of the following active substances: 12 to 16 % (w/w) of carvacrol, 0.1 to 0.3 % (w/w) of thymol, 0.3 to 0.6 % (w/w) of D-carvone, 1.0 to 3.5 % (w/w) of methyl salicylate and 3.0 to 5.5 % (w/w) of L-menthol. In addition, Biomin® DC-P contains hydrogenated vegetable oil and silica as carriers. 

The feed additive is intended to be incorporated through premixtures or directly into feedingstuffs at a recommended Biomin® DC-P content ranging from 65 to 105 mg/kg feedingstuffs.

For the quantification of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol in the feed additive the Applicant submitted a single-laboratory validated and further verified multi-analyte method based on gas chromatography coupled to flame ionisation detection (GC-FID). 

Based on the experimental evidence available the EURL recommends for the official control the GC-FID method for the quantification of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol in the feed additive. 

Additionally, the Applicant submitted a single-laboratory validated and further verified multi-analyte method based on gas chromatography coupled to mass spectrometry (GC-MS) for the quantification of carvacrol, thymol, D-carvone, methyl salicylate and L-menthol in premixtures and feedingstuffs. The EURL considers the GC-MS method proposed by the Applicant fit-for-purpose for the quantification of the total content of each active substances, namely carvacrol, thymol, D-carvone, methyl salicylate and L-menthol, in premixtures and feedingstuffs at the content levels investigated in the frame of the validation and verification studies. 

However, as the accurate determination of the Biomin® DC-P content added to premixtures and feedingstuffs is not achievable experimentally, the EURL cannot evaluate or recommend any method for official control to determine Biomin® DC-P 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 Methods

as of:

-Commission Implementing Regulation (EU) 2023/650

For the quantification of the active substances:

Gas chromatography coupled with flame ionisation detection (GC-FID)