Botanically defined flavourings group BDG 18 – Coniferales, Ginkgoales

In the present grouped application an authorisation is sought under Articles 4 and 10 for juniper oil, juniper berry extract (wb), juniper tincture, cedarwood texas oil, pine oil, pine tincture, pine oil white, pine needle oil, ginkgo extract (wb) and ginkgo tincture from botanically defined flavourings group 18 (BDG 18), 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.
However, after withdrawal of juniper berry extract (wb), pine oil and pine needle oil from this grouped application, the EURL focused on the evaluation of the remaining seven feed additives.
The feed additives are intended to be incorporated into compound feed or water for drinking directly or through flavouring premixtures. Depending on the product and species the Applicant proposed maximum inclusion levels ranging from 15 to 750 mg/kg compound feed.
For the determination of the phytochemical markers in the following products: pin-2(3)-ene in juniper oil, cis-thujopsene in cedarwood Texas oil and pin-2(3)-ene and pin-2(10)-ene in the feed pine oil white the Applicant proposed the methods of gas chromatography coupled with flame ionisation detection (GC-FID) (based on ISO 8897, ISO 4725 and ISO 11020 standards, respectively) and provided experimental evidences of the applicability of the methods. Based on the available data, the EURL recommends for official control the proposed GC-FID methods for the determination of the phytochemical markers (pin-2(3)-ene, cis-thujopsene and pin-2(10)-ene) in the corresponding products (juniper oil, cis-thujopsene and cedarwood Texas oil).
For the characterisation of pine tincture and ginkgo tincture, the Applicant proposed the spectrophotometric method based on the European Pharmacopoeia monograph (01/2008:20814) for the determination of total polyphenols in the products and the methods of high performance thin-layer chromatography (HPTLC) for the determination of total phenolic acids and total flavonoids in pine tincture and ginkgo tincture, respectively. In addition, experimental evidences were provided demonstrating the applicability of the methods. Based on the available data, the EURL recommends for official control the proposed spectrophotometric and HPTLC methods for the characterisation of pine tincture and ginkgo tincture.
For the determination of the phytochemical marker total flavone glycosides in ginkgo tincture the Applicant proposed the methods of high performance liquid chromatography with spectrophotometric detection (HPLC-UV) based on the European Pharmacopoeia monograph (01/2011:1828) and provided experimental evidences of the applicability of the method. Based on the available data, the EURL recommends for official control the proposed HPLC-UV method for the determination of the phytochemical marker total flavone glycosides in ginkgo tincture.
For the determination of the phytochemical marker total flavone glycosides in ginkgo extract the Applicant proposed the HPLC-UV methods of the US Pharmacopoeia monograph 35-NF30 (powdered ginkgo extract) and of the European Pharmacopoeia monograph (04/2008:1827) providing experimental evidences of the applicability of the methods. Based on the available data, the EURL recommends for official control the proposed HPLC-UV methods for the determination of the phytochemical marker total flavone glycosides in ginkgo extract.
For the determination of the phytochemical marker tannins in juniper tincture the Applicant proposed the spectrophotometric method of the European Pharmacopoeia monograph (01/2008:20814) and provided experimental evidences of the applicability of the method. Based on the available data, the EURL recommends for official control the proposed spectrophotometric method of the European Pharmacopoeia monograph (01/2008:20814) for the determination of the phytochemical marker tannins in juniper tincture.
The Applicant did not provide any methods or data for the determination of the feed additives from this botanically defined group in premixtures, compound feed and water as the accurate determination of these products in the mentioned matrices is not achievable experimentally. Therefore, the EURL cannot evaluate or recommend any method for official control for the determination of the feed additives of this botanically defined group 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.