Ceci est une version HTML d'une pièce jointe de la demande d'accès à l'information 'CBD in food'.


Ref. Ares(2019)6805582 - 04/11/2019
ARES(2019)3384042
From:
 (GROW)
To:
- Bio Basic Europe Srl"
Cc:
 (GROW); GROW D4
Subject:
RE: Ares(2019)3357916 - RE: Question about CosIng update
Date:
mercredi 22 mai 2019 16:59:18
Attachments:
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Dear Mr. 
,
Thank you for your email.
We would like to inform you that it falls outside the remit of the commission services to provide
such information.
The Cosmetics Regulation (EC) No. 1223/2009 with its entry 306 of Annex II, makes specific
reference to "Narcotics, natural and synthetic: All substances listed in Tables I and II of the single
Convention on narcotic drugs signed in New York on 30 March 1961
". Please note that there is no
mentioning of THC levels anywhere in the Cosmetics Regulation.
Schedules I and II of the Convention are lists of drugs. According to Art. 1 "definitions" of the
convention, “Drug” means any of the substances in Schedules I and II, whether natural or
synthetic.
The list of drugs in Schedule I (Schedules as at 16 May 2018) includes: CANNABIS and CANNABIS
RESIN and EXTRACTS and TINCTURES OF CANNABIS.
Article 1 of the convention defines these terms as follows:
(b) “Cannabis” means the flowering or fruiting tops of the cannabis plant (excluding the seeds and
leaves when not accompanied by the tops) from which the resin has not been extracted, by
whatever name they may be designated.
(c) “Cannabis plant” means any plant of the genus Cannabis,
(d) “Cannabis resin” means the separated resin, whether crude or purified, obtained from the
cannabis plant.
Based on the above, ingredients derived from cannabis to the extent that they fall within the scope
of the 1961 Convention should be banned in cosmetic products based on entry 306 of Annex II of
the Cosmetics Regulation.
According to the WHO ECDD critical review, cannabidiol “is one of the naturally occurring
cannabinoids found in cannabis plants. It is a 21-carbon terpenophenolic compound which is
formed following decarboxylation from a cannabidiolic acid precursor, although it can also be
produced synthetically”
.
Cannabidiol is not included as such in the Schedules of the Single Convention on Narcotic Drugs of
1961. Therefore, we consider Cannabidiol outside the scope of entry 306 of Annex II to the
Cosmetics Regulation 1223/2009 (CosIng entry on Cannabidiol - Synthetically Produced). However,
if it is prepared from banned substances such as extracts or tinctures or resin of Cannabis
Cannabidiol would fall under the scope of the Convention and the prohibition II/306 should apply.
Based on the above, the prohibition is applicable based on the material used (allowed or
prohibited) for the production of CBD. Please note that the Cosmetics Regulation (EC) No.
1223/2009 makes no reference to purity or the THC content for Cannabis related ingredients.
In addition, according to Article 4 of the Cosmetics Regulation (EC) No. 1223/2009 it is up to the
responsible person (and not the commission services) to ensure that a product complies with the
relevant legal obligations (“For each cosmetic product placed on the market, the responsible person
shall ensure compliance with the relevant obligations set out in this Regulation
). Furthermore,
according to Article 3 of the Cosmetics Regulation (EC) No. 1223/2009 “A cosmetic product made
available on the market shall be safe for human health when used under normal or reasonably










Electronically signed on 31/10/2019 12:33 (UTC+01) in accordance with article 4.2 (Validity of electronic documents) of Commission Decision 2004/563