Cannabis is a plant that has been used for a variety of purposes throughout history, from medicinal to recreational to industrial. However, its use is subject to legal restrictions in many countries due to its potential psychoactive effects and public health risks.
What is cannabis and its derivatives?
The term 'cannabis' refers to the end of the flowering or fruiting branches of the hemp plant (excluding seeds and leaves that are not accompanied by juices), the sap of which has not been extracted, whatever its application. Cannabis is a plant that contains various chemical substances, called cannabinoids. The best-known cannabinoids are tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is primarily responsible for the psychoactive effects of cannabis and ss,perception, mood and behaviour. CBD has no psychoactive effects, but can also have adverse effects.
Cannabis derivatives are substances or preparations obtained from the plant or its parts, such as resin, extracts, tinctures, leaves, flowers or seeds. These derivatives may have different concentrations of cannabinoids and different forms of presentation, such as oils, creams, capsules, edibles or smokables. Some of these derivatives may be used for medicinal purposes or scientific research, subject to authorisation by the competent authorities. Others can be used for industrial purposes, such as the production of fibres, paper, fabrics, biofuels or cosmetics!
Regulation of Cannabis
In Portugal, cannabis is classified as a narcotic drug and is included in Table I-C of Decree-Law 15/93 of 22 January, as amended. This means that its production, trade, possession and consumption are prohibited for purposes other than medicinal or scientific research. The exception is fibres (stems) and seeds of cannabis strains with low THC content, which can be used for industrial purposes - defined by the 1961 Single Convention on Narcotic Drugs.
Recently there has been a change in European legislation that may have an impact on hemp production in Portugal and other EU countries. The European Parliament approved on 24 November 2021 the increase of the THC impurity level from 0.2% to 0.3% for the cultivation of hemp for industrial uses. The increase in the THC level for industrialised hemp is part of the measures of the new CAP (Common Agricultural Policy of the European Union) reforms, which entered into force on 1 January 2023. This 0.3% limit may vary from country to country in Europe: it is possible to plant hemp with a THC level above 0.3%, provided it is authorised by national regulations.
Regulation of Cannabis in Cosmetics
Finally, it should be noted that cosmetic products are also subject to restrictions regarding the inclusion of cannabis-related substances. Cosmetic products are defined by Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 and this Regulation prohibits the inclusion in cosmetic products of all substances listed in Schedules I and II of the 1961 Single Convention on Narcotic Drugs, through entry 306 of Annex II. Additionally, at the national level, these substances are considered controlled by Decree-Law 15/93.
Therefore, cosmetic products may not contain the following substances or preparations related to the cannabis plant, irrespective of their THC content: Cannabis and cannabis resin, Cannabis extracts and tinctures, Leaves and flowering/flowering or fruiting tops of the cannabis plant.
Exceptions to this prohibition are the use of substances/preparations obtained from seeds or fibres (stems) of the plant with a THC content ≤ 0.3%, such as cannabis seed oil, of varieties listed in the Common Catalogue of Varieties of Agricultural Species.
Regulation of CBD in Cosmetics
The European Commission has been rejecting other ingredients derived from cannabis for use in cosmetic products, such as cannabidiol (CBD), which has been considered by the International Narcotics Control Board (INCB) as an extract or preparation of the cannabis plant or resin covered by the 1961 Single Convention on Narcotic Drugs.
In June 2023, the European Chemicals Agency (ECHA) published France's intention to classify CBD as a substance toxic to reproduction. It is currently the subject of a consultation by the European Commission (EC), which launched a call for data in early June in preparation for the work of a Scientific Committee (SSC) that will rule on the safety of CBD in cosmetics.
There are other origins of CBD that are not covered by Annex II of Regulation (EC) No 1223/2009, but which are under consideration by the European Union and the World Health Organisation.
Do you want to place a cannabis cosmetic on the European market and have questions about the process?
Contact us!
Comments