Hemp Derivatives in Cosmetics in EU - - Brief Overview EIHA General Meeting Cologne, June 4, 2019 How to Interperete Cosing

Hemp derivatives in cosmetics in EU - - brief overview EIHA General Meeting Cologne, June 4, 2019 How to interperete CosIng

• CosIng is a only guidance tool for cosmetics professionals • it is updated very often based on inputs from cosmetic experts • There may always be inconsistencies and confusions • The only legally binding documets with respect to cosmetic ingredients are Commission Regulations / Directives / Decisions • The latest Commission Decision (EU) 2019/701 published on April 5 does include 22 hemp-related ingredients. • We will see them on the next slide

www.eiha.org Entry Common Ingredient Name In CosIng INCI Name Description Cas# EC# Functions Restriction (EU/701/2019) (EU/701/2019) CosIng? II/306 (EC) No 1223/2009. Application Date: 11/07/2013 (the date fixed by the Directive as from which Member States shall ensure that cosmetic products which fail to comply with the modifications are not placed on the CANNABIS AND CANNABIS RESIN; 8063-14-7 / - / - - - Y - market) CANNABIS SATIVA EXT. 89958-21-4 289-644-3 Withdrawal Date: - (the date fixed by the Directive as from which Member States shall ensure that cosmetic products which fail to comply with the modification are not sold or disposed of to the final consumer) II/ 306 ANTIOXIDANT Cannabidiol (CBD) as such, irrespective of its source, is not listed in the Schedules of the 1961 Single CANNABIDIOL - DERIVED FROM EXTRACT Cannabidiol - derived from extract or tincture or resin of ANTISEBORRHOEIC 4403 CANNABIDIOL Y 13956-29-1 - Convention on Narcotic Drugs. However, it shall be prohibited from use in cosmetic products (II/306), if it is OR TINCTURE OR RESIN OF CANNABIS Cannabis SKIN CONDITIONING prepared as an extract or tincture or resin of Cannabis in accordance with the Single Convention. Please SKIN PROTECTING note that national legislations on controlled substances may also apply. ANTIOXIDANT Cannabidiol (CBD) as such, irrespective of its source, is not listed in the Schedules of the 1961 Single CANNABIDIOL - SYNTHETICALLY ANTISEBORRHOEIC Convention on Narcotic Drugs. However, it shall be prohibited from use in cosmetic products (II/306), if it is 4403 CANNABIDIOL CANNABIDIOL - Synthetically Produced Y 13956-29-1 - PRODUCED SKIN CONDITIONING prepared as an extract or tincture or resin of Cannabis in accordance with the Single Convention. Please SKIN PROTECTING note that national legislations on controlled substances may also apply. Cannabis Sativa Callus Culture Lysate Extract is the extract of CANNABIS SATIVA CALLUS CANNABIS SATIVA CALLUS CULTURE HAIR CONDITIONING 4404 a suspension of the lysed cells derived from the callus of Y - - - CULTURE LYSATE EXTRACT LYSATE EXTRACT SKIN CONDITIONING Cannabis sativa, Cannabaceae, grown in culture. II/306 CANNABIS SATIVA FLOWER Cannabis Sativa Flower Extract is the extract of the flowers of EMOLLIENT 4405 CANNABIS SATIVA FLOWER EXTRACT Y - - Narcotics, natural and synthetic: All substances listed in Tables I and II of the single Convention on narcotic EXTRACT Cannabis sativa, Cannabaceae. SKIN CONDITIONING drugs signed in New York on 30 March 1961 ANTIOXIDANT CANNABIS SATIVA II/306 CANNABIS SATIVA FLOWER/LEAF/STEM Cannabis Sativa Flower/Leaf/Stem Extract is the extract of ANTISEBORRHOEIC 4406 FLOWER/LEAF/STEM Y - - Narcotics, natural and synthetic: All substances listed in Tables I and II of the single Convention on narcotic EXTRACT the flowers, leaves and stems of Cannabis sativa SKIN CONDITIONING EXTRACT drugs signed in New York on 30 March 1961 SKIN PROTECTING CANNABIS SATIVA SEED Cannabis Sativa Seed Extract is the extract of the seeds of 4407 CANNABIS SATIVA SEED EXTRACT Y 89958-21-4 289-644-3 EMOLLIENT - EXTRACT Cannabis sativa L., Cannabaceae Cannabis Sativa Seed Oil is the fixed oil expressed from the EMOLLIENT 4408 CANNABIS SATIVA SEED OIL CANNABIS SATIVA SEED OIL Y 89958-21-4 289-644-3 - seeds of Cannabis sativa L., Cannabaceae SKIN CONDITIONING Cannabis Sativa Seed Oil Glycereth-8 Esters is the product CANNABIS SATIVA SEED OIL CANNABIS SATIVA SEED OIL GLYCERETH-8 EMOLLIENT 4409 obtained by the transesterification of Glycereth-8 and Y - - - GLYCERETH-8 ESTERS ESTERS EMULSION STABILISING Cannabis Sativa Seed Oil EMOLLIENT Cannabis Sativa Seed Oil Peg-8 Esters is a complex mixture CANNABIS SATIVA SEED OIL EMULSIFYING 4410 CANNABIS SATIVA SEED OIL PEG-8 ESTERS produced by the transesterification of PEG-8 and Cannabis Y - - - PEG-8 ESTERS SKIN CONDITIONING Sativa Seed Oil SURFACTANT CANNABIS SATIVA 4411 CANNABIS SATIVA SEED/STEM OIL N - SEED/STEM OIL

Cannabis Sativa Seedcake is the residue from the expression ABRASIVE 4412 CANNABIS SATIVA SEEDCAKE CANNABIS SATIVA SEEDCAKE Y - - - of oil from the seeds of Cannabis sativa, Cannabaceae. SKIN CONDITIONING

Cannabis Sativa Seedcake powder is the residue from the CANNABIS SATIVA SEEDCAKE 4413 CANNABIS SATIVA SEEDCAKE POWDER expression of oil from the seeds of Cannabis sativa L., Y 89958-21-4 289-644-3 ABRASIVE - POWDER Cannabaceae CANNABIS SATIVA STEM Cannabis Sativa Stem Powder is the powder obtained from 4414 CANNABIS SATIVA STEM POWDER Y 89958-21-4 289-644-3 SKIN CONDITIONING - POWDER the dried, ground stems of Cannabis sativa L., Cannabaceae CETYLDIMETHYLAMONE CETYLDIMETHYLAMONE HYDROLYZED 5071 - N - - - - HYDROLYZED HEMPSEEDATE HEMPSEEDATE EMOLLIENT Decyl Hempseedate is the ester of Decyl Alcohol and the 7024 DECYL HEMPSEEDATE DECYL HEMPSEEDATE Y - - EMULSION STABILISING - fatty acids derived from Cannabis Sativa Seed Oil SKIN CONDITIONING HYDROGENATED HEMP SEED Hydrogenated Hemp Seed Oil is the end product of the EMOLLIENT 10866 HYDROGENATED HEMP SEED OIL Y - - - OIL controlled hydrogenation of Cannabis Sativa Seed Oil SKIN CONDITIONING

Hydrolyzed Cannabis Sativa Seed Extract is the hydrolysate HYDROLYZED CANNABIS HYDROLYZED CANNABIS SATIVA SEED HAIR CONDITIONING 11076 of Cannabis Sativa Seed Extract derived by acid, enzyme or Y - - - SATIVA SEED EXTRACT EXTRACT SKIN CONDITIONING other method of hydrolysis, Cannabaceae.

Hydrolyzed Hemp Seed Extract is the hydrolysate of an HYDROLYZED HEMP SEED HAIR CONDITIONING 11192 HYDROLYZED HEMP SEED EXTRACT extract of Cannabis Sativa Seed dervied by acid, enzyme or Y - - - EXTRACT SKIN CONDITIONING other method of hydrolysis HYDROLYZED HEMP SEED 11193 HYDROLYZED HEMP SEED PROTEIN - N - - - - PROTEIN HYDROLYZED HEMP SEED HYDROLYZED HEMP SEED PROTEIN 11194 PROTEIN HYDROXYPRO- - N - - - - HYDROXYPRO- PYLTRIMONIUM CHLORIDE PYLTRIMONIUM CHLORIDE

Poly(Dimer Hempseed Oil) is the polymer formed by the FILM FORMING 18900 POLY(DIMER HEMPSEED OIL) POLY(DIMER HEMPSEED OIL) dimerization of Cannabis Sativa Seed Oil via a Diels-Alder Y - - SKIN CONDITIONING - reaction VISCOSITY CONTROLLING

Potassium salt of the fatty acids of the seeds of Cannabis 19902 POTASSIUM HEMPSEEDATE POTASSIUM HEMPSEEDATE Y 68424-21-5 270-281-4 SURFACTANT sativa, Cannabaceae SODIUM 23152 SODIUM HEMPSEEDAMPHOACETATE - N - - - - HEMPSEEDAMPHOACETATE Cannabis Sativa Seed Water is the aqueous solution of the HAIR CONDITIONING - - CANNABIS SATIVA SEED WATER steam distillate obtained from the seeds of Cannabis sativa, Y 89958-21-4 289-644-3 - SKIN CONDITIONING Cannabaceae. Cannabis Sativa Leaf/Stem Water is the aqueous solution of HAIR CONDITIONING - - CANNABIS SATIVA LEAF/STEM WATER the steam distillate obtained from the leaves and stems of Y 89958-21-4 289-644-3 II/306 SKIN CONDITIONING Cannabis sativa, Cannabaceae. How to interperet CosIng

• As you can see, there are five EU Enrties not even listed in CosIng: • 4411 CANNABIS SATIVA SEED/STEM OIL • 5071 CETYLDIMETHYLAMONE HYDROLYZED HEMPSEEDATE • 11193 HYDROLYZED HEMP SEED PROTEIN 11194 HYDROLYZED HEMP SEED PROTEIN HYDROXYPRO PYLTRIMONIUM CHLORIDE • 23152 SODIUM HEMPSEEDAMPHOACETATE

• Then again we can see that two items from CosIng do not yet have an EU Entry • CANNABIS SATIVA SEED WATER • CANNABIS SATIVA LEAF/STEM WATER

www.eiha.org How to interperet CosIng

• CANNABIS AND CANNABIS RESIN; CANNABIS SATIVA EXT. are banned from cosmetics, as they fulfill definition of Schedule I narcotic drug as per US Single Convention (1961) • The remark Restriction II/306 refers to all such narcotic substances. • The reason there are two listing on Cannabidiol in CosIng (EU Entry 4403) is because “natural cosmetic” certification schemes do not allow synthesized ingredients and certifiers need to see a distinction between these two • Otherwise we have to consider both Cannabidiols as legally equivalent

www.eiha.org How WHO language is misused

„Cannabidiol is not specifically listed in the schedules of the UN International Drug Conventions. However, if prepared as an extract or tincture of cannabis it is controlled in Schedule I of the 1961 Single Convention on Narcotic Drugs.” - Proceedings of the 40th ECDD, July 2018

...preparations considered to be pure cannabidiol (CBD) should not be scheduled within the International Drug Control Conventions by adding a footnote to the entry for cannabis and cannabis resin in Schedule I of the Single Convention on Narcotic Drugs (1961) to read “Preparations containing predominantly cannabidiol and not more than 0,2 percent of delta-9- tetrahydrocannabidiol (THC) are not under international control”.

- Proceedings of the 40th ECDD, July 2018

http://eiha.org/media/2014/08/18-12-04_EIHA_contribution_41th_ECDD.pdf

www.eiha.org How WHO language is misused

European Commission, DG for Internal Market, Industry, Entrepreneurship and SMEs Unit D4 – Health Technology and Cosmetics, Working Group meeting on 18th of February 2019

• „We acknowledge the importance of these [WHO] recommendations; however, we consider that they currently have no legal value. When these recommendations are voted and adopted at UN level, resulting in the amendment of Schedule I, we can have a more clear legal basis for potential regulatory measures. „

• In addition, for clarity purposes we would like to propose having two entries for Cannabidiol. One entry stating: “Cannabidiol - synthetically produced” where no prohibition will be indicated and a second entry stating “Cannabidiol – plant-derived” where the prohibition 306 of Annex II will be added. In both entries, a disclaimer will be added to read:

“Cannabidiol (CBD) as such, irrespective of its source, is not listed in the Schedules of the 1961 Single Convention on Narcotic Drugs. However, it shall be prohibited from use in cosmetic products (II/306), if it is prepared as an extract or tincture or resin of Cannabis in accordance with the Convention. Please note that national legislations on controlled substances may also apply.” THIS OPINION HAS NO LEGAL POWER www.eiha.org How WHO language is misused

BY THESE STANDARDS

ISOLATED CANNABIDIOL

IS A NARCOTIC DRUG.

www.eiha.org Meanwhile – entries in CosIng

Cosmetics - CosIng 04/06/2019 11:51 Cosmetics - CosIng 04/06/2019 11:51

Ingredient: CANNABIDIOL - DERIVED FROM EXTRACT OR TINCTURE OR RESIN OF CANNABIS Ingredient: CANNABIDIOL - SYNTHETICALLY PRODUCED

INCI Name CANNABIDIOL - DERIVED FROM EXTRACT OR TINCTURE OR RESIN OF CANNABIS INCI Name CANNABIDIOL - SYNTHETICALLY PRODUCED Description Cannabidiol - derived from extract or tincture or resin of Cannabis Description CANNABIDIOL - Synthetically Produced INN Name INN Name Ph. Eur. Name Ph. Eur. Name CAS # 13956-29-1 CAS # 13956-29-1 EC # EC # Chemical/IUPAC 1,3-Benzenediol, 2-[(1R,6R)-3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl- Chemical/IUPAC 1,3-Benzenediol, 2-[(1R,6R)-3-methyl-6-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl- Name Name Cosmetic Restriction II/306 Cosmetic Restriction Cannabidiol (CBD) as such, irrespective of its source, is not listed in the Schedules of the 1961 Single Convention on Narcotic Cannabidiol (CBD) as such, irrespective of its source, is not listed in the Schedules of the 1961 Single Convention on Narcotic Drugs. However, it shall be prohibited from use in cosmetic products (II/306), if it is prepared as an extract or tincture or resin of Drugs. However, it shall be prohibited from use in cosmetic products (II/306), if it is prepared as an extract or tincture or resin of Cannabis in accordance with the Single Convention. Please note that national legislations on controlled substances may also apply. Cannabis in accordance with the Single Convention. Please note that national legislations on controlled substances may also apply. Other Restriction(s) Other Restriction(s) Functions ANTIOXIDANT Functions ANTIOXIDANT ANTISEBORRHOEIC ANTISEBORRHOEIC SKIN CONDITIONING SKIN CONDITIONING SKIN PROTECTING SKIN PROTECTING SCCS opinions SCCS opinions Identified Identified INGREDIENTS or INGREDIENTS or substances e.g. substances e.g.

TWO ENTRIES FOR CANNABIDIOL

www.eiha.org Meanwhile – Commission Decision (EU) 2019/701

ONE ENTRY FOR CANNABIDIOL Stance of Czech auhtorities

National Institute of Public Health keeps looking at both Cannabidiols

as leaglly equivalent as long as the isolate has been manufactured

legally in all stages of production.

At least this is what was told during a seminar last week.

www.eiha.org Always consult you Risk Assessor

• Any cosmetic product needs to undergo an official risk assessment by an authorized person BEFORE it is placed on the market. • These persons have an authorization from EU Commission.. • Risk assessors are always partially responsible for their assessment reports. • A legal practice and precedents show that if there is any damage caused by the “responsible person” nominated on the product label, an assessor may be liable to 10% of the damages. • Do not forget to notify your product on CPNP portal no later than two years after first placing on the product. www.eiha.org What about THC in cosmetics?

• General safety rule to consider with hemp-based cosmetics is ZERO tolerance for THC. • This means THC MUST NOT BE QUANTIFIED by analytical methods in the final formulaiton. • As we know LODs/LOQs vary depending on analytical methods. • A robust method such as GC-MS or LC-MS/MS should be applied. • For example, when Czech authorities want to check THC level in a cosmetic product, they send samples to the lab of Czech Customs Directorate. Their LOQ is 5 ppm. Another lab considered by Czech National Institute of Publich Health has a LOQ for total THC at 1 ppm (0.95 ppm THC / 0.26 ppm THC-A).