The European Industrial Hemp Association (EIHA) is the only international organization which gathers and represents the interest of hemp manufacturing and processing companies in Europe.
EIHA welcomes the fact that Commission Decision (EU) 2019/701 published on April 5 does includes 22 hemp- related ingredients. This list also includes Cannabidiol as item 4403, without differentiation between synthetic and plant derived substance.
In the light of the latest decisions proposed by the Working Group on Cosmetic Products on Cannabis sativa L., EIHA would like to reiterate its position on this issue. Given that the latest changes have been dictated by an alignment exercise between the UN Single Convention on Narcotic Drugs and EU regulations, it seems appropriate to underline the inaccuracy of this harmonisation, as industrial hemp is clearly excluded from the scope of the UN Single Convention.
Summary
Industrial hemp (expressis verbis seeds and leaves) and any products or ingredients derived from industrial hemp are excluded from the scope of the Single Convention.
At EU community level, the cannabis plant (Cannabis sativa L.) is considered as an agricultural product and as an "industrial plant" both for cultivation and seed production according to Regulation (EU) 1308/2013, and may be grown legally as long as their THC content does not exceed (actual) 0,2%.
Similar regulations can be found in the national legislations.
Following the recent changes in the CosIng Catalogue, EIHA would like to propose a new wording for Cannabidiol and 3 new INCI entries. The new wording takes into account the basic legality of hemp for industrial use under the existing international treaties, but also the rules of the European Union and the Member States concerning the precise classification of hemp for industrial use.
In order to ensure that consumers can purchase a safe product at any time (Art. 3 of Regulation EC/1223/2009), a guideline for the content of THC in cosmetic products should not exceed 20 μg THC/g.
EIHA's proposal for the COSING entry is as follows:
Pure Cannabidiol (CBD) as such, irrespective of its source, is not listed in the Schedules of the Single Convention on Narcotic Drugs (1961), so it is not a controlled substance. However, it shall be prohibited from use in cosmetic products, if it is isolated from an extract or tincture or resin of Cannabis Sativa L. different from industrial hemp.
For clarification purposes EIHA request the following categories to be added as new INCI entries in the CosIng Catalogue:
• CANNABIS SATIVA LEAF EXTRACT
• CANNABIS SATIVA LEAF/STEM EXTRACT
• CANNABIS SATIVA ROOT EXTRACT
Industrial hemp and the UN Single Convention of 1961
Considering as a fundamental principle the hierarchy of laws, at international level, European Member States (as signatory countries) have to comply with the 1961 Single Convention on Narcotic Drugs (the so-called New York Convention), as amended by the 1972 Protocol.
Starting from the preamble, it is clearly stated that the Convention aims at protecting the health and welfare of mankind. Hence, the parties (countries) recognized that drugs are indispensable for the relief of pain and suffering of people while at the same time the parties committed to fight the addiction to and the abuse of narcotic drugs. Despite this, a clear distinction between narcotic cannabis (with high THC levels) and industrial cannabis (with low THC level) needs to be made as industrial hemp simply cannot be used for narcotic purposes and is therefore not included in the intention and the scope of the Single Convention.
Both the 1961 and 1971 Conventions (the latter on Psychotropics) allow for the use of narcotic drugs and psychotropic substances for the manufacture of substances or products not covered by these Conventions (see article 2, paragraph 9 of the 1961 Convention, and article 4 (b) of the 1971 Convention). The Parties must, however, ensure that the narcotic drugs/psychotropic substances used in these processes will finally be in such a condition that they will in practice not be abused or the original drug or substance recovered.
Reading the preamble in combination with article 1 § 1b of the Convention, the distinction is clear: seeds and leaves (when not accompanied by the flowering or fruiting tops, the latter being defined as "cannabis" only) are excluded from the scope of the Convention, because they are not considered a drug.
Article 4 of the Single Convention (which is on general obligations for the parties) only refers to medical and scientific purposes for all activities with drugs. As a consequence, industrial hemp and its derived products are not considered drugs due to their low content of THC.
Furthermore, the Convention states in Art. 28, paragraph 2 that: "This Convention shall not apply to the cultivation of the cannabis plant exclusively for industrial purposes (fibre and seed) or horticultural purposes”. The official Commentary of 3 August 1962 on the UN Single Convention concludes on page 312 that “[T]he cannabis plant is grown for its fibre, its seeds, for drugs (cannabis and cannabis resin) and for its leaves.", and "... the leaves are not "drugs"" The commentary follows that [this] “control régime applies only to the cultivation of the cannabis plant for the production of cannabis and cannabis resin”. And even more importantly that “cultivation for any other purpose, and not only for the purposes mentioned in paragraph 2, is consequently exempted from the control régime provided for in article 23”.
The exclusion of the cannabis plant for industrial and horticultural uses from the intention and the legislation of the Convention itself authorizes therefore the cultivation and use of this specified type of cannabis plant, industrial hemp, and its derivatives for uses that differ from those related to drugs manufacturing.
As leaves from industrial hemp cannot be used to produce narcotic drugs they therefore cannot be included in the intention and meaning of article 28 § 3.
When the DG Growth states that “Ingredients that are derived from seeds or leaves of Cannabis, for example Cannabis sativa seed oil/extract/powder/etc. should not be prohibited, as they are exempt based on Article 1 (b)” it should be added that “ingredients that are derived from other parts of Cannabis and destined for non- medical and non-scientific purposes should not be prohibited either, as they are exempt based on Articles 2 (9) and 28 (2).
In the conclusions of the DG Growth document, the assumptions that “Cannabidiol [...] 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” totally disregards and forgets a major criteria of the Single Convention: the “purpose” of cultivation and use.
As long as cosmetic products do not fall under the competency of Member States’ medicine and pharmaceutical regulations, there is no obligation whatsoever to prohibit their production, manufacture and use. States would simply be required to submit basic statistical information to the INCB for monitoring purposes (as per Article 2(9)b).
The EU taking such steps would mean the creation of a new layer of sui generis regulations (unrelated to the Single Convention, disregarding the interpretation of the Secretary-General’s the Commentary, and undermining the WHO’s recent scientific assessment of CBD and its recommendation that it should not fall under the scope of the Single Convention). This is likely to enshrine stricter and stronger measures of controls than those of most signatories of the Single Convention, undermining an agricultural sector already subject to an important set of rulings. Worst, this seems to go in the exact opposite direction of the global trend, where countries from China to the United States of America are reforming their hemp laws towards simplification, to support a constantly growing hemp market.
Industrial hemp and the European Union
At EU level, the TFEU (Treaty on the Functioning of the European Union), in annex I, lists the agricultural products for which the provisions of the Treaty itself are applied, among them under chapter 57.01 the “True hemp (Cannabis sativa), raw or processed but not spun; tow and waste of true hemp (including pulled or garneted rags or ropes)".
At community level, the cannabis plant (Cannabis sativa L.) is considered as an agricultural product and as an "industrial plant" both for cultivation and seed production according to Regulation (EU) 1308/2013.
The Regulation (EU) 1307/2013 (see articles 32.6, 35.3 and 52) underlines that "Areas used for the production of hemp shall only be eligible hectares if the varieties used have a tetrahydrocannabinol content not exceeding 0,2 %.", and: " In order to preserve public health, the Commission shall be empowered to adopt delegated acts in accordance with Article 70 laying down rules making the granting of payments conditional upon the use of certified seeds of certain hemp varieties and the procedure for the determination of hemp varieties and the verification of their tetrahydrocannabinol content referred to in Article 32(6).", and: "Coupled support may be granted to the following sectors and productions: cereals, oilseeds, protein crops, grain legumes, flax, hemp, rice, nuts, starch potato, milk and milk products, seeds, sheepmeat and goatmeat, beef and veal, olive oil, silkworms, dried fodder, hops, sugar beet, cane and chicory, fruit and vegetables and short rotation coppice."
Basically, the lawfulness of the cannabis production and trading as an "agricultural product" and "industrial plant" depends on the THC (tetrahydrocannabinol) percentage that cannot be higher than (currently) 0.2%, in accordance to the methods indicated by the above-mentioned law and specified in Commission Delegated Regulation (EU) 639/2014 and Commission Implementing Regulation 809/2014. According to the same regulation, European farmers cultivating industrial hemp and respecting the imposed limits of THC are entitled to receive CAP payments.
It follows that:
- Only Cannabis sativa L. is considered as an agricultural product in EU;
- Equally only Cannabis sativa L. is considered as an "industrial plant";
- the production of Cannabis sativa L. is subject to compliance with the THC limits that must not be higher than (currently) 0.2%;
- no other substance (i.e. cannabidiol (CBD) or other cannabinoids) is considered for the determination of the lawfulness or unlawfulness of the cannabis production in EU.
Industrial hemp at national level
Based on the United Nations Single Convention the parties (countries) adopted their own narcotic laws making in their turn a clear distinction between narcotic cannabis (higher than 0.2 % or 0.3 %, Switzerland min. 1.0 % in THC) and low-THC industrial hemp (below 0.2 % or 0.3 % or 1.0 %). With these National Narcotic laws all parties acknowledge the competence of the UN and stay within the framework of this organization. They clearly exempt industrial hemp from the jurisdiction of the 1961 Convention. Thanks to these legislative clarifications at national level, a flourishing hemp industry has started to grow significantly particularly in the last ten years.
EIHA position and proposal on hemp extracts in CosIng
Some of the hottest, most talked about ingredients in cosmetics today are cannabis derivatives. Their use has evolved into a major skin care trend with numerous products marketed as oils, balms, creams, lotions, and facial serums. Unfortunately, there is a lot of confusion on cannabis derivatives related to their quality and what they legally may contain. The last change in the CosIng Database, which is not a legally binding document, confirms this negative tendency.
Taking into consideration all the above reflections and assumptions, EIHA points out that:
The reason for international control of “cannabis” and “cannabis extracts” is the fact that they both contain “resin”, considered as a narcotic drug and composed of the psychotropic substance THC in quantities liable to abuse.
“Hemp plant extracts” may be defined as extracts of the cannabis plant that contain various constituents of the cannabis plant, but that have a very low, if any, content of THC. They are obtained from any part of the plant, e.g.: leaves, flowers, infructescence, roots, seeds.
In “hemp plant extracts”, the starting material is already low in THC. After harvest the content of THC is further reduced through purification under the limits set (to be set) by the regulatory authorities. Thus, due to their low THC content, these products cannot be, in practice, abused or the THC recovered from them. “Hemp plant extracts” therefore become “products not covered by the 1961 Convention” - they are neither a narcotic drug nor a psychotropic substance.
Although the “hemp plant extracts” still contain some traces of THC, obviously it was neither the intention of the Single Convention nor the objective of the Regulation (EC) No 178/2002 on food to disqualify products such as “hemp plant extracts” that contain quantities of THC not liable to abuse. The international drug control conventions do not consider this product as dangerous. It would be absurd, if these Regulations would disqualify “hemp plant extracts” by referring to the drug control conventions.
European hemp farmers and industries use hemp seeds, hemp roots, flowers, leaves (after the flowering and mostly even after the seed ripening) for producing different hemp extracts. These products were already
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excluded from the scope of the control regime of the Single Convention as enforceable and enforced regulations complying with the Convention have been in place for two decades. New regulations should be aimed at simplifying and correcting errors, not adding layers of complexity.
Taking all this into consideration, EIHA proposes and recommends the following new INCI items:
• CANNABIS SATIVA LEAF EXTRACT
• CANNABIS SATIVA LEAF/STEM EXTRACT
• CANNABIS SATIVA ROOT EXTRACT
Moreover, EIHA proposes in order to ensure that consumers can purchase a safe product at any time (Art. 3 of Regulation EC/1223/2009), to allow all Cannabis sativa extracts from industrial hemp as cosmetic ingredients, if the THC content in the cosmetic product does not exceed 20 ppm (20 μg THC/g).
EIHA position and proposal on Cannabidiol in CosIng
Pure Cannabidiol (whether produced synthetically or by isolation from Cannabis plants) has been given a clear “carte blanche” by the outcome of the 39th ECDD Pre-review of WHO. This has been acknowledged by all United Nations Member States at the 61st session of the Commission on Narcotic Drugs (E/CN.7/2018/CRP.3) where it was announced that data was being collected for a Critical Review of “[Extracts or] Preparations containing almost exclusively cannabidiol (CBD).”
Pure CBD has never been agreed by the ECDD experts to be critically reviewed, to the contrary, the outcome of the Pre-review clearly places it out of the scope of the work of the Committee. However, a critical review of “Extracts or preparations containing almost exclusively cannabidiol” was convened by decision of the ECDD experts, in November 2017. And yet, EIHA has witnessed that the 40th ECDD meeting has undertaken a Critical Review of Cannabidiol (CBD).
Besides this shaky preparation process, EIHA generally welcomes the final outcome, recommending not to include products considered to be pure Cannabidiol (CBD) in the Schedules of the International Drug Control Conventions, published in a Note Verbale to the United Nations Secretary-General dated July 23rd, 2018.
However, EIHA has formally objected1 to the reasoning of the Experts according to which “... if prepared as an extract or tincture of cannabis [Cannabidiol] is controlled in Schedule I of the 1961 Single Convention on Narcotic Drugs.”
Notwithstanding the fact that Schedule I should only include pharmaceutical drugs and compounds, and therefore ignore CBD which is widely used industrially, in food supplements, pet-food and cosmetics, a misguided reading of this outcome could lead to a differentiation between cannabidiol produced synthetically and by isolation from the Cannabis plants. For example, German DAC/NRF monograph C-052 on Cannabidiol2 mentions a chromatographic purity between 98.0–102.0 % and defines ∆9-THC, ∆8-THC and Cannabinol (CBN) as “specified impurities”. Moreover, it states that the CBD may be of natural as well as of synthetic origin. Without prejudice to other legal requirements concerning the manufacture of the extracts of cannabis and subsequent isolation of pure CBD there from, considering “Cannabidiol” of plant origin as an “extract of cannabis” does not hold up to principles ofany of therelevant international standards; neither the nomenclature of organic chemistry (IUPAC) system, Chemical Abstracts Service (CAS), nor WTO Harmonized System Codes:
The toxicological and pharmacological properties of a substance or extract as well as its potential for abuse mainly depend on its constituents and composition. What matters is the content of a drug component and the substance’s effect, not the origin of the substance or its manufacturing procedure.
Moreover, the impurity profile of an isolated chemical compound (in this case with Δ9-THC as an impurity) may not be unique or characteristic in order to distinguish it from a synthetic version. The impurity profile (by- products) of a synthetic product may even be very similar to the “impurity profile” of the natural isolated product, in particular if the synthetic pathway is a biomimetic one.
On these same grounds, purified Cannabidiol (CBD) obtained from the herbal source is not an Extract of “cannabis” and therefore is not scheduled under the Single Convention (1961).
EIHA only supports the differentiation between plant-derived and man-made Cannabidiol for the purpose of certification by “natural cosmetic” schemes.
When it comes to cosmetics, CBD from natural sources needs work-up steps to obtain a pure product. Thus, for the recovery of pure CBD isolate, several workup and purification steps are necessary. In this way, pure CBD can be obtained, with a very small proportion of other cannabinoids, terpenes and flavonoids from the hemp plant. Thus, natural CBD from natural sources is safer.
• CBD does not show the typical effects that other cannabinoids show
• CBD does not have any potential for abuse
• A ban on CBD from natural sources would be based on the possible content of THC
• CBD is a molecule that hardly penetrates the skin and is accumulated in the stratum corneum.
• In EU Decision n. 701/2019 CBD is mentioned among the cosmetics ingredients without any differentiation between synthetic and plant derived CBD isolate.
Four further examples of why it is not admissible to differentiate between chemical substances isolated from vegetable sources and synthesised are mentioned in Technical Annex to this Position Paper.
Summary of EIHA' proposals to change the current definitions in the CosIng Database
On top of the new three INCI entries and following all the scientific evidences exposed in this position paper, EIHA would like to propose the below wording for the Cosmetic Restriction in CosIng for Cannabidiol:
Pure Cannabidiol (CBD) as such, irrespective of its source, is not listed in the Schedules of the Single Convention on Narcotic Drugs (1961), so it is not a controlled substance. However, it shall be prohibited from use in cosmetic products, if it is isolated from an extract or tincture or resin of Cannabis Sativa L. different from industrial hemp.
Authors names:
Boris Baňas, Bernhard Beitzke, Daniel Kruse, Lorenza Romanese, Catherine Wilson
Sources:
http://eiha.org/media/2014/08/18-12-04_EIHA_contribution_41th_ECDD.pdf
DAC/NRF 2016/2, C-052, Cannabidiol, 12 pages.
Regulation (EC) 1334/2008 on Flavourings, Annex I, Part A.
FDA (2010): Guidance for Industry, Drug Substance Chemistry, Manufacturing and Controls Information. Page 52.
US Department of Health and Human Services, Letter to the DEA, May 2018, Document prepared by FDA’s Controlled Substance Staff, “Basis for the Recommendation to place Cannabidiol in Schedule V of the Controlled Substances Act”, p. 9 ff.
Technical Annex
Case study on food flavourings
A story on pure substances isolated from plant extracts and the same substances produced synthetically is that of flavouring substances. Eventually the distinction between flavouring substances of natural origin and their chemically equivalent synthetic counterparts in the EU Union list had been given up in European regulations, except for the labelling requirements (e.g. Vanillin). Similar evidence-based regulatory practices should be followed by DG SANTE.
Case study on plant derived APIs
We can further substantiate our opinion based on a citation from a Guidance for Industry on Drug Substance Manufacturing published by the USA Food and Drug Administration: “A chemical substance (e.g. plant extract) used to produce a semisynthetic drug substance or a crude drug substance derived from a plant [...] starting material is considered an intermediate”. This statement makes clear that a plant extract used for isolating a pure chemical substance as an Active Pharmaceutical Ingredient (API) is not the API itself, neither it is the medicinal product made from it. The plant extract is only an intermediate/starting material in the processing to yield the pure API.
Obviously, the distinction between CBD produced from the Cannabis plant and the synthetically manufactured CBD is made because the former could still contain traces of psychoactive cannabinoids as impurities. Apart from the fact that synthetic CBD can also contain them, it is scientifically not proven that a CBD produced from the Cannabis plant will have narcotic/psychotropic effects due to the traces of, for example ∆9-THC it may contain. A Human Abuse Potential Study with a pure CBD produced from the natural source shows that this CBD does not produce any of the known THC-effects in the “Drug Liking test”, moreover THC plasma levels were much lower than those to be expected after administration of the equivalent trace amounts of Dronabinol, a fact which points to a non-linear pharmacokinetics.
Also, on these grounds it is not justified to regard as scheduled under the Single Convention a [pure] Cannabidiol derived from an extract of Cannabis sativa L.
Case study on Dronabinol
The similar lapse of logic could be demonstrated on Dronabinol: (-)-trans-delta-9-THC has been placed under Schedule II of the 1971 Convention on psychotropic substances in 1991, and was until recently almost entirely produced synthetically (e.g. Marinol®). Following the logic currently used by the DG Growth, should a naturally derived Dronabinol (e.g. produced by a generic producer from a plant of genus Cannabis, and thus complying with the monograph specification) also fall under the Schedule I of the 1961 Convention on Narcotic drugs for being considered a Cannabis extract? Certainly not!
Case study on Opium alkaloids
The case of opium, that is a natural material controlled as a narcotic drug similarly to cannabis, is interesting to explore. Individual substances obtained from opium do not fall under international control, unless they have been specifically scheduled as a narcotic drug. While morphine, codeine or thebaine are narcotic drugs, other substances extractable from opium, such as noscapine and papaverine, are not under international control. If noscapine and papaverine extracted from opium are not narcotic drugs, then CBD, even when prepared as an extract of cannabis, should not be considered as a narcotic drug unless if it was recommended for scheduling – which was ruled out by ECDD’s 40th meeting.
More evidences
PUBLIC HEALTH AUTHORITY OF THE SLOVAK REPUBLIC replied to EIHA by a letter from November 30, 2016, Ref.: UHVBPKV/9819/2016/Kr which says, among others the following statement: „...cannabidiol can be added to cosmetic products as a pure substance (natural or synthetic), but also as part of extracts from the plant and seeds of Cannabis sativa...“.
