InfarMed has issued a circular in Portugal to remind manufacturers that CBD extracted from “cannabis for industrial purposes” is currently prohibited in Portugal. However, not all international hemp associations are in agreement with InfraMed’s interpretation, with many of them stating that the conventions do not regulate hemp and its derivatives, but only the medical markets of the substances.
InfarMed, the Portuguese ANSM, has issued a circular reminding that the use of CBD extracted from “cannabis for industrial purposes” is prohibited in Portugal.
According to the Portuguese Medicines Authority, “the inclusion of CBD or other cannabinoids, which exist naturally in the cannabis plant, is not allowed, as they are obtained by the preparation of extracts or tinctures of cannabis or its resin.”
Whether or not this is a position InfarMed or the medicines authority will maintain in the long-term is still unknown. However, if and when developments occur, it’s certain they will be covered here and in our free-to-download cannabis news app.
For Infarmed, CBD Is a Controlled Substance
Citing the Single Convention on Narcotic Drugs of 1961, Infarmed’s president, Rui Santos Ivo, states that “cosmetic products, therefore, cannot contain the following substances/preparations related to the cannabis plant, regardless of their tetrahydrocannabinol (THC) content”.
The InfarMed circular also states that “with regard to the various cannabinoids that are part of cannabis resin, and in particular the substance cannabidiol (CBD), it is the opinion of the International Narcotic Control Board (INCB) that it falls under the Single Convention on Narcotic Drugs of 1961, as an extract/preparation of the cannabis plant, and is listed in Schedule I annexed to that convention. Thus, the aforementioned substances, namely the substance cannabidiol (CBD), as cannabis resin or preparation, are included in Schedule IC, annexed to Legislative Decree No. subject to the control measures applicable to the substances therein.
InfarMed and World Hemp Associations Don’t See Eye to Eye
This is a point of view that is not shared by InfarMed and the main world hemp associations. For them, the conventions do not regulate hemp and its derivatives, but only the medical markets of the substances.
The 1971 Convention clearly underlines this principle by stating that governments “may authorize […] the use of these substances in the industry for the manufacture of non-psychotropic substances or products”.
CBD banned in cosmetics
Infarmed, therefore, highlights that the marketing of cosmetic products containing CBD is prohibited in Portugal. This regulation “prohibits the inclusion in cosmetic products of all substances listed in Schedules I and II of the Single Convention on Narcotic Drugs of 1961, through item 306 of Annex II. In addition, at the national level, these substances are considered controlled, according to the provisions of Decree-Law No. 15/93 of January 22, in its current wording.
In this sense, Infarmed states, “cosmetic products may not contain the following substances/preparations related to the cannabis plant, regardless of their tetrahydrocannabinol (THC) content:
- Cannabis and cannabis resin ;
- Cannabis extracts and tinctures;
- Leaves and flowering/flowering or fruiting tops of the cannabis plant.
Even for substances listed on CosIng, the European regulation of permitted ingredients in cosmetics, which includes by name “Cannabidiol – derived from cannabis extract or tincture or resin” or “Cannabis Sativa leaf extract”, their inclusion in cosmetic products is nevertheless prohibited.
But, for Infarmed, an ingredient listed on CosIng does not mean that its use in cosmetic products is allowed: “its inclusion in cosmetic products is not allowed”.
The circular notes that only hemp seed oil is accepted, pending a likely court case regarding the European authorization of CBD and CBG in cosmetics.
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