Consortium Information on EIHA joint application 0 .1 overall - PowerPoint PPT Presentation

Novel Food Consortium Information on EIHA joint application 0

.1 overall strategy 1

.1 Our position Novel Food (art.10 / EIHA Consortium) Natural occurring level Traditional food (art. 4 / EIHA Secretariat) 2

Why a novel .1 Secure your market food application and stay legal • To achieve a legal and planning security for your company in the European hemp industry and its CBD market • NF registration will o will stop legal risk , will save cost for legal advice o allow considerable profit margins in the B2C sector o lead to a priceless image gain • The European Community (EU) has 510 million residents , Europe has a total of 740 million residents, most of Europe shows good income levels (next to China Europe is the largest market for consumer goods in the world) • Full exploitation of the market potential , including the correct and permitted marketing of CBD as food and food supplement • Value enhancement for your brand! 3

.1 Why joining us Share knowledge and costs • Common challenge = common reply • EIHA official EFSA Stakeholde r • Stronger together (political message) • Safe products for consumers • for a fair burden sharing , based on the economic performance of the participating companies We will ensure that • free rider effects by entities that are not willing to contribute are avoided • the worldwide turnover of international brands and/or globally operating companies as a basis for the assessment of the special contribution are considered As this o is in the industrial policy interest of the members of EIHA and o is the appropriate in relation to already mentioned benefits 4

.1 FSA approach February 2020 à pragmatic approach 70 mg CDB max daily intake (EFSA 10 mg, EIHA 100 mg) • (based on Epidolex study) Obligation to undergo a valid NF application by 31/03/2021 • FSA did not recognise natural occurring level • What EIHA proposes… NF App based on study for CBD isolate and Full Spectrum Extracts • Meet the deadline • Provide Regular Members with proof of ongoing NF app • 5

.1 How does it work? EIHA Consortium will secure various product formulations to cover every possible CBD related product • Specifications with max levels or ranges • ChemSafe will lead the tox studies • on CBD as well as THC (to increase the actual thresholds) • 5 years protection (property of the studies) à economic advantage 6

.1 How does it work? EIHA e.V. 100% shareowner EIHA Projects GmbH EIHA Board r managed by e p o r t i n Contracts g t o CEO (LR+DK) EIHA RM as EIHA Novel contractual partners Food Task Force 7

.2 the GmbH 8

.2 How does it work? Foundation & administrative requirement for RM: Foundation of EIHA projects GmbH , a 100% subsidiary of EIHA • the GmbH acquires all rights according to the NF Regulation • and manages these Members become contractual partners of the GmbH • the GmbH transfers the rights of Art. 26 NF-reg to the members • and contractual partners transfer is only made for members' and contractors' own • brands in order to avoid free-rider effects 9

.3 products formulation 10

.3 Product formulations

.3 Timeline COSTS 2020 2021 2022 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 01 02 03 04 05 06 07 08 09 10 11 12 Project Initiation (contract signature, etc.) THC Tox Study (90-day study as for OECD 408) 380.000,00 € * THC Clinical Study (Tolerability study on humans) * 200 subject 736.000,00 € 1.174.000,00 € 400 subject Stability Studies - shelf life (est. 10.000 € /product) Accelerated * Long term (if needed) 40.000,00 € * Analytical Study on CBD products (CoA + 5 batches analysis) 190.000,00 € * Biblio CBD Isolate Dossier - FSA submission 18.000,00 € * CBD extract - Tox Study Package (TOX + GENTOX + REPRO) 1.600.000,00 € * CBD Dossier preparation (4) - EFSA submission 70.000,00 € 11.500,00 € Notes: 1) All testing phases invoiced directly to the 14.000,00 € consortium Chemsafe Monitoring 2) Chemsafe work will be invoiced directly to the 6.000,00 € consortium 3) Still waiting for confirmation from lab about the payment 32.000,00 € installments TOTAL COST 3.097.500,00 € TOTAL COST 3.535.500,00 € 12

.3 Individual fees Consortium Consortium Fee Consortium Fee Consortium Fee Number of Consortium Turnover Partner Fee 2020 2021 2022 Members Partner Fee* TOTAL (40%) (40%) (20%) < 1 Mio 101 15.000,00 € 1.515.000,00 € 6.000,00 € 6.000,00 € 3.000,00 € 1-3 Mio 15 25.000,00 € 375.000,00 € 10.000,00 € 10.000,00 € 5.000,00 € 3-6 Mio 7 35.000,00 € 245.000,00 € 14.000,00 € 14.000,00 € 7.000,00 € 6-10 Mio 2 55.000,00 € 110.000,00 € 22.000,00 € 22.000,00 € 11.000,00 € 10-20 Mio 2 90.000,00 € 180.000,00 € 36.000,00 € 36.000,00 € 18.000,00 € > 20 Mio 2 140.000,00 € 280.000,00 € 56.000,00 € 56.000,00 € 28.000,00 € Total 2.705.000,00 € * based on averaged turnover of the last three years 13

.4 Resolution on the principles of the special contribution structure for the Novel Food Joint Application by EIHA e.V. 14

.4 Resolution on the admission of new members to EIHA e.V. 15

Thank you 16