Botanically defined flavourings group BDG 01 – Lamiales

In the current grouped application an authorisation is sought under Articles 4(1) and 10(2) for king of bitter extract (wb), thyme leaved gratiola tincture, devils claw extract (wb), devils claw tincture, lavender oil, lavender tincture, spike lavender oil, melissa oil, balm leaves extract (sb), mentha arvensis/cornmint oil, pennyroyal oil, spearmint oil, peppermint oil, peppermint tincture, basil oil, basil tincture, olive extract (sb), marjoram oil, oregano oil, oregano tincture, patchouli oil, rosemary oil, rosemary oleoresin, rosemary extract (sb), rosemary tincture, spanish sage oil, sage oil, sage tincture, clary sage oil, savory summer oil, savory summer tincture, pau d’arco tincture, thymus origanum oil, thyme oil, thyme oleoresin, thyme extract (sb), thyme tincture, lilac chastetree tincture, spanish marjoram oil and wild thyme tincture from botanically defined flavourings group 01 (BDG 01), under the category/functional group 2(b) 'sensory additives'/flavouring compounds', according to Annex I of Regulation (EC) No 1831/2003. The authorisation is sought for all animal species.
The applications for the feed additives included in the original dossier, namely thyme leaved gratiola tincture, spike lavender oil, melissa oil, pennyroyal oil, basil oil, savory summer oil and spanish marjoram oil have been withdrawn after the original submission and therefore, these additives will not be evaluated by the EURL in the frame of the current dossier.
Furthermore, following the priorities expressed in the EFSA request, in this report the EURL focuses exclusively on the evaluation of the suitability of analytical methods for official control of seven from the remaining feed additives, namely spanish sage oil, peppermint oil, thymus origanum oil, patchouli oil, clary sage oil, lavender oil and sage oil.
For the determination of the phytochemical markers: 1,8-cineole and camphor in spanish sage oil; menthol and menthone in peppermint oil; carvacrol and thymol in thymus origanum oil; patchouli alcohol in patchouli oil; linalyl acetate and linalool in clary sage oil and in lavender oil; and camphor, alpha-thujone and beta-thujone in sage oil, the Applicant proposed different gas chromatography coupled with flame ionisation detection (GC-FID) methods based on the following international standards: ISO 3526, ISO 856, ISO 14717, ISO 3757, ISO 3515, ISO 9909 and the European Pharmacopoeia monograph 1850.
Based on the experimental evidences provided, the EURL recommends for official control the proposed GC-FID methods for the determination of the phytochemical markers: 1,8-cineole and camphor in spanish sage oil; menthol and menthone in peppermint oil; carvacrol and thymol in thymus origanum oil; patchouli alcohol in patchouli oil; linalyl acetate and linalool in clary sage oil and in lavender oil; and camphor, alpha-thujone and beta-thujone in sage oil. The accurate determination of the feed additives added to premixtures and compound feed is not achievable experimentally. Furthermore, the Applicant did not provide any experimental data to determine the feed additives in water. Therefore, the EURL cannot evaluate or recommend any method for official control to determine the feed additives in premixtures, compound feed and water.
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.