Ref. Ares(2022)4749020 - 29/06/2022
sozialministerium.at
BMSGPK - III/A/6 (Lebensmittelsicherheit und
Verbraucherinnen- und Verbraucherschutz:
stoffliche und technologische Risiken, Gentechnik)
DIRECTORATE-GENERAL FOR INTERNAL
MARKET, INDUSTRY, ENTREPRENEURSHIP
AND SMES
Chemicals and Consumer Industries
Stubenring 1, 1010 Vienna
Consumer Industry
1040 Brussels
Dear
Cannabidiol (CBD) is an ingredient whose use in cosmetic products is booming. Beside the
use of synthetic CBD, CBD obtained from the plant Cannabis Sativa is also used. Different
production methods of herbal CBD are known. Source materials are either flowers, the
leaves (incl. stems) or the whole plant. Mainly extracts with different degrees of
purification are used, with purities of CBD up to 99%. The unintended presence of delta-9-
THC also varies; up to THC-free extracts.
The question that needs to be addressed is the legal classification of these cosmetic
ingredients, especially considering the entry 306 of Annex II of Regulation (EC) No.
1223/2009.
Starting point:
According to Article 14 in conjunction with Annex II, No. 306 of Regulation (EC) No.
1223/2009, cosmetic products should not contain:
"Narcotics, natural and synthetic: any substance listed in Tables I and II of the Single
Convention on Narcotic Drugs signed in New York on 30 March 1961".
Schedule I of the Single Convention contains the following entry: "Cannabis, cannabis
resin, and extracts and tinctures of cannabis:
Cannabis in the Single Convention is defined as follows: "The term 'cannabis' means
the flowering or fruiting tops of the cannabis plant from which the resin has not been
extractedby whatever name they may be designated ( excluding the seeds and leaves
when not accompanied by the tops)."
Cannabis resin in the Single Convention is defined as follows: "The term "cannabis
resin" means the separated resin, whether crude or purified obtained from the
Cannabis plant."
Cannabis plant in the Single Convention is defined as follows: "The term "cannabis
plant" means any plant of the genus Cannabis."
The glandular hairs produce the resin on the cannabis plant. This consists of 80-90%
cannabinoids, as well as essential oils, high polymer phenols, terpenes and waxes. Thus,
the source of the cannabinoids detected, especially CBD, is the resin of the cannabis plant.
CBD is obtained by extraction from the resin. Extraction is a well-known separation
process. One could now conclude that herbal CBD is part of the separated resin in the
sense of the definition and the purification to 99% is a purification of the resin in the sense
of the abouve mentioned definition. On the other hand, the origin of herbal CBD might be
the flowers and fruiting stems, from which the resin has not been extracted.
The Single Convention does not provide an exception with respect to leaves or stems in
the definition of resin. Consequently, the resin of the leaves would also be inadmissible
under the Single Convention. This interpretation based on the commentary of the United
Nations Office on Drugs and Crime (UNODC) (2) is:
"(1) The resin can be found principally in the tops of the plant. If the resin were not
specifically subjected to international control - as is done by its express mentioning in
Schedule 1 annexed to the single convention and its definition in the subparagraph under
consideration - it might, if obtained from the tops, to be considered to be covered by the
convention as part of the tops, i.e. of "cannabis"; but it is held that some leaves and even
from the upper part of the stalk whose capacity to yield resin is, however, said to
disappear after the fruits are mature. It would be difficult to distinguish resin obtained
from the tops from that derived from other parts of the plant. The specific subjection to
control of the resin whatever its origin thus facilitates the tasks of enforcement. (2) [...]
The single convention on the other hand applies its comprehensive control régime to
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cannabis resin of the male as well as the female plants. It does not exclude any part of the
cannabis plant as source of the resin. It states that cannabis resin means the resin
"obtained from the cannabis plant".
Therefore, as the Federal Ministry of Health, we have previously assumed that CBD from
the plant, even if extracted from the leaves, falls under the Prohibitory Entry 306.
However, it is also clear that the Prohibitory Entry 306 does not cover synthetic CBD.
We also saw this view supported by the Commission's COSING entry, which also does not
link synthetic CBD to Prohibitory Entry 306, while herbal CBD (obtained from extracts,
tinctures, or resin of cannabis) is linked to prohibition entry 306 under CosIng.
However, this approach was questioned by the ECJ Judgement of November 19, 2020 (C-
663/18)1.
This case dealt with CBD - extracted from the entire cannabis plant used in liquids. Here,
the ECJ takes into account the objective of the Single Convention and comes to the
following conclusion:
"It follows that the CBD at issue in the main proceedings is not an drug within the meaning
of the Single Convention."
This is primarily justified because CBD has no proven psychotropic effect. It should further
be pointed that according to the EJC that a literal interpretation of provisions of the Single
Convention might lead to the conclusion that CBD, in so far as it is obtained from a plant
of the Cannabis genus and that plant is used in its entirety - including its flowering or
fruiting tops - it constitutes a cannabis extract within the meaning of Schedule I of that
convention and, consequently a “drug” within the meaning of Article 1(1)(j) of that
convention.
In the meantime, the United Nations commission on narcotic drugs (63rd reconvened
CBD) also held votes on some adaption to the Single Convention. There were proposals for
amendments to the Single Convention, which could have led to a clarification of the
above-mentioned question. However, these amendments were rejected. Extracts and
tinctures remain in Annex I. The clarification via a footnote on cannabis and cannabis resin
in Annex I that preparations consisting mainly of CBD and containing no more than 0.2%
1 https://eur-lex.europa.eu/legal-content/DE/TXT/?uri=CELEX%3A62018CJ0663
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delta-9-THC do not fall under international control was also rejected. Only the deletion of
cannabis and cannabis resin from Annex IV was accepted. However, this is of no relevance
for cosmetic products.
Conclusion:
Therefore, it is unclear to us as a competent authority how to assess CBD extracted from
the cannabis plant, in terms of prohibition entry 306.
For the purpose of an harmonized approach within the European Union, the EU
Commission is invited urgently to present its view on the clarification of this issue.
In a further step, it would be appropriate to have an common Risk Assessment of CBD by
an official scientific body (e.g. SCCS). In the context of the review of the obligatory safety
report for cosmetics, currently the responsible persons in Austria are not be able to
present convincingly data to prove the safety of the substance. There is a lack of generally
accepted toxicological parameters (e.g. NOAEL) as a point of departure for the safety
assessment.
Best regards
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