Upload
paradigm-shift
View
326
Download
1
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
Thispresenta,onwilladdresslegalstatusofhempseedderiva,vesandhempcannabinoidsfromtheperspec,veofinterna,onallaw.Somelocalna,onalspecificsmayandwesuggestyoucontactyourna,onalofficialsfordetails.
Let’sbeginwithali?lemathema,cs101.Everybodyinthisroomisfamiliarwithpercent,representedbyabrownsquareona10x10board.1%equalsto10000partspermillion.
2
Nowlet’smovedownonedecimalpoint.Weareshowinga“magical”0.2percentvalue.
3
Let’smovedownonedecimalpointagain.0.01percent,oroneoftenthousand,isnotreallyasignificantvalueinourdiscussion.
4
Nowlet’sjumptwodecimalpointsandwearrivetoapart-per-million.Youmayimagineitastwoburnt-outpixelsonaFullHDscreenwhichhasroughly2millionpixels.
5
Wehavefinallyarrivedto100parts-per-billionor100microgramsperkilogramor0.10ppm.Youmayimagineitasoneburnt-outpixelonfiveFull-HDscreenscombined.
6
7
8
ThistablegivesabriefoverviewofvariousEUlimitsforcontaminantsintwotypesofhempfoods:oilanddryproducts.NotesomecontaminantssuchasDioxinsaretestedonppblevel.
9
Andthisisalistofpes,cideshempseedshouldbetestedfor,withcorrespondinglimitsinmg/kg.
10
11
12
13
14
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
Byusingconsump,ondataofvariouskindsoffoods,suchasfatsandoils,highvolumeproteinorcarbohydrate-basedfoods,lowvolumefoodsandvarietyofdrinks,presentedvaluesforfinalproductsarebeingproposed.Asyoucansee,adailyintakeofhemps,llleavesuswithamarginof3.96microgramsofTHCfromADIof240mcgperday.
16
HereweshowfinalproposedvaluesforingredientstradedonaB2Bmarket.Wealsoshowexis,ngguidancevaluesorlimitsinsomeEUcountriesoroutsideofEurope.
17
18
DifferentSchedulesdescribepoten,alofabuseandmedicinaluse.
19
“Cannabisplant”meansanyplantofthegenusCannabis.Legalindustrialcul,varsusuallycontainlessthen0.2%ofTHC(0.3%inCanada).UpperthirdpartofCannabisplantisusedfortes,ngcannabinoidprofileforassessmentofdrugtypevsfibertype.THC,CannabinolandCannabidiolaretakenintoaccountwithresultoftheformulahigherorlowerthan1.
“Cannabis”meansthefloweringorfrui,ngtopsofthecannabisplant(excludingtheseedsandleaves)fromwhichtheresinhasnotbeenextracted,bywhatevernametheymaybedesignated.
20
“Produc3on”meansthesepara,onof…cannabisandcannabisresinfromtheplantsfromwhichtheyareobtained.
21
“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
Pleasenotethat95%puritylevelisthedis,nguishingpointbetweenextractsandchemicalsubstances.Whateversubstanceisisolatedfromanyherbalsourceoverthislevel,canbecalleda“chemical”withitsformulaandCASdatabasenumber.Fromperspec,veoflegisla,onitdoesnotma?erifitisofherbalorsynthe,corigin.
23
24
25
ByTHCcri,calwemeanthis.Doyouwantyourfoodproducttoappearonthislist?SeethatproductsarebeingpulledfromshelvesforTHClevelaround1ppm.
26
27
Isthisreallytheproperwayofsafeandresponsiblemarke,ngofcannabisextracts?
28
29
30
31