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EIHA Position on Hemp Ingredients in the Cosmetic Database (Cosing) – Updated Version

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EIHA Position on Hemp Ingredients in the Cosmetic Database (Cosing) – Updated Version Brussels, September 2019 EIHA position on hemp ingredients in the Cosmetic Database (CosIng) – updated version 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 1 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). 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.
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