32
This presenta,on will address legal status of hemp seed deriva,ves and hemp cannabinoids from the perspec,ve of interna,onal law. Some local na,onal specifics may and we suggest you contact your na,onal officials for details.

Legal Status of Cannabinoids in end-user products on EU market

Embed Size (px)

DESCRIPTION

A presentation by Boris Banas of Hemp Seed Oil Europe ltd. and CBDepot.eu about the legal status of cannabinoids in end-user products on the EU market

Citation preview

Page 1: Legal Status of Cannabinoids in end-user products on EU market

Thispresenta,onwilladdresslegalstatusofhempseedderiva,vesandhempcannabinoidsfromtheperspec,veofinterna,onallaw.Somelocalna,onalspecificsmayandwesuggestyoucontactyourna,onalofficialsfordetails.

Page 2: Legal Status of Cannabinoids in end-user products on EU market

Let’sbeginwithali?lemathema,cs101.Everybodyinthisroomisfamiliarwithpercent,representedbyabrownsquareona10x10board.1%equalsto10000partspermillion.

2

Page 3: Legal Status of Cannabinoids in end-user products on EU market

Nowlet’smovedownonedecimalpoint.Weareshowinga“magical”0.2percentvalue.

3

Page 4: Legal Status of Cannabinoids in end-user products on EU market

Let’smovedownonedecimalpointagain.0.01percent,oroneoftenthousand,isnotreallyasignificantvalueinourdiscussion.

4

Page 5: Legal Status of Cannabinoids in end-user products on EU market

Nowlet’sjumptwodecimalpointsandwearrivetoapart-per-million.Youmayimagineitastwoburnt-outpixelsonaFullHDscreenwhichhasroughly2millionpixels.

5

Page 6: Legal Status of Cannabinoids in end-user products on EU market

Wehavefinallyarrivedto100parts-per-billionor100microgramsperkilogramor0.10ppm.Youmayimagineitasoneburnt-outpixelonfiveFull-HDscreenscombined.

6

Page 7: Legal Status of Cannabinoids in end-user products on EU market

7

Page 8: Legal Status of Cannabinoids in end-user products on EU market

8

Page 9: Legal Status of Cannabinoids in end-user products on EU market

ThistablegivesabriefoverviewofvariousEUlimitsforcontaminantsintwotypesofhempfoods:oilanddryproducts.NotesomecontaminantssuchasDioxinsaretestedonppblevel.

9

Page 10: Legal Status of Cannabinoids in end-user products on EU market

Andthisisalistofpes,cideshempseedshouldbetestedfor,withcorrespondinglimitsinmg/kg.

10

Page 11: Legal Status of Cannabinoids in end-user products on EU market

11

Page 12: Legal Status of Cannabinoids in end-user products on EU market

12

Page 13: Legal Status of Cannabinoids in end-user products on EU market

13

Page 14: Legal Status of Cannabinoids in end-user products on EU market

14

Page 15: Legal Status of Cannabinoids in end-user products on EU market

LowestObservedEffectLevel"(LOEL)and“AcceptableDailyIntake”(ADI)arecommonlyappliedwhendevelopingstandardsintendedtopreventundesiredsideeffectsfromchemicals.LOEListhelowestdatapointatwhichtherewasanobservedeffect.Wemaycallitplaceboeffect.SucheffectsofTHCaredescribedintheliteratureastemporary,mildtomoderatepsychomotororcogni,veeffects.ThetermAcceptableDailyIntake(ADI)isusedtodescribesafedailyintakeofasubstancethatmaybedeliberatelyaddedtofoodoranunavoidablecontaminant.Itiscalculatedbymul,plyingtheLOELbyanuncertaintyfactor.Thistablegivesabriefcomparisononpoliciesorscien,ficopinionsonTHCADI.WestartwithGermanpolicyfromyear2000,thenpresentEFSA’sopinionsin2011and2015.Pleasenotedecreaseofsafetyfactorfrom100to30.EIHAproposesthatahumancanallowtakingtwoLOELdosesofTHCperdaysincepoten,aleffectsofTHChaveadura,onfor6hours.EIHAalsoproposessafetyfactorloweredto20resul,nginADIroundedto240microgramsperday.PleaseseeforcomparisonEFSA’sopiniononopiumalkaloidsinpoppyseed.WithLOELverysimilartothatofTHC,ADIismany,meshigherbecauseoflowsafetyfactor.IsTHCreallythatmuchmorepoten,allyharmfulthanMorphine?

15

Page 16: Legal Status of Cannabinoids in end-user products on EU market

Byusingconsump,ondataofvariouskindsoffoods,suchasfatsandoils,highvolumeproteinorcarbohydrate-basedfoods,lowvolumefoodsandvarietyofdrinks,presentedvaluesforfinalproductsarebeingproposed.Asyoucansee,adailyintakeofhemps,llleavesuswithamarginof3.96microgramsofTHCfromADIof240mcgperday.

16

Page 17: Legal Status of Cannabinoids in end-user products on EU market

HereweshowfinalproposedvaluesforingredientstradedonaB2Bmarket.Wealsoshowexis,ngguidancevaluesorlimitsinsomeEUcountriesoroutsideofEurope.

17

Page 18: Legal Status of Cannabinoids in end-user products on EU market

18

Page 19: Legal Status of Cannabinoids in end-user products on EU market

DifferentSchedulesdescribepoten,alofabuseandmedicinaluse.

19

Page 20: Legal Status of Cannabinoids in end-user products on EU market

“Cannabisplant”meansanyplantofthegenusCannabis.Legalindustrialcul,varsusuallycontainlessthen0.2%ofTHC(0.3%inCanada).UpperthirdpartofCannabisplantisusedfortes,ngcannabinoidprofileforassessmentofdrugtypevsfibertype.THC,CannabinolandCannabidiolaretakenintoaccountwithresultoftheformulahigherorlowerthan1.

“Cannabis”meansthefloweringorfrui,ngtopsofthecannabisplant(excludingtheseedsandleaves)fromwhichtheresinhasnotbeenextracted,bywhatevernametheymaybedesignated.

20

Page 21: Legal Status of Cannabinoids in end-user products on EU market

“Produc3on”meansthesepara,onof…cannabisandcannabisresinfromtheplantsfromwhichtheyareobtained.

21

Page 22: Legal Status of Cannabinoids in end-user products on EU market

“Manufacture”meansallprocesses,otherthanproduc,on,bywhichdrugsmaybeobtainedandincludesrefiningaswellasthetransforma,onofdrugsintootherdrugs.

“Extracts”and“Tinctures”of“Cannabis”aredefinedasScheduleInarco,cdrugs.“CBD-OIL”=CannabisextractunderUNOSingleConven3on.Whenperformingsuchac,vi,eseverybodyshouldbewellawareofthena,onallegisla,onsinacountrywherethisishappening.Sinceextrac,onalsoincreasesTHCcontent,theuseofcannabisextractand,ncturesonB2Cmarketisillegalorextremelygrey.OurCBDisola,onfacilityinPraguehasagovernmentlicenseforextrac,onandwearenotallowedtoselltheextract,notevenonB2Bmarket,onlytoen,,eswiththelicensetohandlenarco,candpsychotropicsubstances.

22

Page 23: Legal Status of Cannabinoids in end-user products on EU market

Pleasenotethat95%puritylevelisthedis,nguishingpointbetweenextractsandchemicalsubstances.Whateversubstanceisisolatedfromanyherbalsourceoverthislevel,canbecalleda“chemical”withitsformulaandCASdatabasenumber.Fromperspec,veoflegisla,onitdoesnotma?erifitisofherbalorsynthe,corigin.

23

Page 24: Legal Status of Cannabinoids in end-user products on EU market

24

Page 25: Legal Status of Cannabinoids in end-user products on EU market

25

Page 26: Legal Status of Cannabinoids in end-user products on EU market

ByTHCcri,calwemeanthis.Doyouwantyourfoodproducttoappearonthislist?SeethatproductsarebeingpulledfromshelvesforTHClevelaround1ppm.

26

Page 27: Legal Status of Cannabinoids in end-user products on EU market

27

Page 28: Legal Status of Cannabinoids in end-user products on EU market

Isthisreallytheproperwayofsafeandresponsiblemarke,ngofcannabisextracts?

28

Page 29: Legal Status of Cannabinoids in end-user products on EU market

29

Page 30: Legal Status of Cannabinoids in end-user products on EU market

30

Page 31: Legal Status of Cannabinoids in end-user products on EU market

31

Page 32: Legal Status of Cannabinoids in end-user products on EU market