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cannabis sativa l cbd oil

How does regulation work outside the EU?
In the USA, the US Food and Drug Administration (FDA) does not prohibit or restrict the use of cannabis or cannabis-derived ingredients in cosmetics, and considers the possibility that a product containing these substances can have both a cosmetic and a drug use (for instance, creams to treat dermatitis or acne). Unlike in the USA, however, no therapeutic or medical claim should be asserted for cosmetics in Europe. This applies as well to products containing permitted cosmetic raw materials extracted from Cannabis sativa.

Transparency and traceability
Following baseline regulatory compliance, for the formulation and subsequent claims made about natural and organic cosmetics, transparency and traceability are key to ensure that any substance extracted or derived from hemp used in a product ensures certain verifiable qualities. When using raw materials from Cannabis in cosmetics, brands should choose reliable supply chains that give proof of the traceability of these plant extracts from crop-to-shop. This is a key aspect for regulatory compliance but also for end consumers because it reassures them about the origin and qualities of these substances when used in a cosmetic product.

To this date, cosmetic regulatory compliance of CBD as an ingredient itself relies on the part of the plant from which it is extracted. For instance, seeds when not accompanied by tops are acceptable, although these do not contain CBD, whereas CBD prepared from Cannabis extracts or tinctures from flower/fruiting tops where the resin has not been separated, as well as the separated resin, are not allowed for use. Indeed, the UN 1961 Single Convention on Narcotic Drugs defines controlled cannabis as “the flowering or fruiting tops of the cannabis plant”, but does not consider Cannabis sativa seeds or leaves as controlled substances (as long as they are not accompanied by the tops).

How about detectable THC levels in cosmetics?
Under Regulation (EU) No. 1308/2013, Cannabis sativa L. is considered as an agricultural product and as an “industrial plant” that may be grown legally as long as their THC content does not exceed 0.2%. However, for cosmetics, national legislations from EU Member States on controlled substances may apply. For instance, in France no THC is allowed, while in Luxembourg a THC concentration up to 0.3% is permitted.

Can cannabidiol (CBD) be used in cosmetics?
Cannabidiol (CBD) is a type of cannabinoid that can be synthetically produced or isolated from Cannabis plants and used as a single ingredient. In cosmetics, CBD can function as an antioxidant and facilitate anti-aging properties.

Marijuana and CBD are not the same even if they both come from the same plant. CBD is a single, isolated compound in the cannabis plant, while marijuana contains many naturally occurring compounds, including THC and CBD. Hemp seed oil, extracted from the seeds of Cannabis sativa L., Cannabaceae, has next to no THC or CBD.

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What is hemp?
Hemp is a variety of Cannabis sativa L. Hemp is a dioecious plant, which means that it can be separated into male and female plants. In hemp fields, there is usually a concentration of female hemp and sporadic placed males to pollinate the females and produce nutrient-rich seeds. Hemp has been used for over 10,000 years to make paper and fibres for clothing and fabric, but also in cosmetic products, particularly as an oil but also as other extracts and derivatives.

All cultivars corresponded to < 0.2 % limit of total tetrahydrocannabinol.

Big differences in cannabinoid content between cultivars were found.


Tetrahydrocannabinol/cannabidiol ratio > 1:30 was found in four cultivars.

Bracts from upper and lower inflorescence contains similar cannabinoids content.

Fifteen hemp cultivars were grown and 13 cannabinoids were determined.

The high intrinsic genetic variability rate of C. sativa L. has been further accentuated by the long history of its domestication. Indeed, the different intended uses of the C. sativa L. cultivation’s products have led over the years, to an artificial phenotypic selection of specific features of the domesticated plants, useful for increasing the yield and/or the quality of the commercial interest’s cultivation products [26] . The direct consequence of this selection was the unaware artificial creation of the C. sativa L. varieties, each with specific genotypic and phenotypic features, which at first, induced the taxonomists and botanists to erroneously recognize two or three different species of C. sativa L., embracing a polytypic concept of the Cannabis genus [27] . To further complicate the taxonomic classification of the Cannabis genus, there has been also the fact that C. sativa L. is a crop which tends to exist in “crop-weed complexes”, that is complexes of domesticated forms in cultivation and related ruderal (weedy) forms growing outside of cultivation, developing morphological characteristics also very different from those of the domestic progenitor, as a consequence of adaptation to the wild environment [28] . However, it must be considered that, despite the high genetic variability of C. sativa L., the varieties that genotypically and phenotypically differ, are interfertile. Therefore, taking into account the Darwinian definition of biological species, “a group of organisms that can reproduce with one another in nature and produce fertile offspring”, C. sativa L. varieties cannot be consider as different species of the Cannabis genus. For this reason, to date, the polytypic concept has been definitely given up and replaced by the monotypic one. According to this, a single species of Cannabis genus exists, namely C. sativa L., which includes several varieties or cultivars ( cvs ) that genotypically and phenotypically differ, but they all are interfertile and therefore, they belong to the same species [29] [30] .

Table 1. Industrial hemp cultivars registered and listed in the European Union Plant Variety Database and their origin. All these varieties are certified to contain less than 0.2% of THC of dry weight of leaves and flowering parts of the plant, according to the EU regulation 1307/2013.

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Cannabis sativa L., commonly known as hemp, is an herbaceous, anemophilous plant belonging to the Cannabaceae family.

3. The Cannabinoids Synthesis in C. sativa L.

The major discriminant factor related to the different intended uses of C. sativa L. is the level of the two major and more known phytochemicals characteristic of this crop, namely the only one psychoactive and toxicant compound of the plant, THC, and the non-psychoactive cannabidiol (CBD). Both of them belong to the cannabinoids’ class which includes over of 100 secondary metabolites belonging to the family of terpenophenolic compounds, typical of all C. sativa L. plants. These compounds are synthesized, collected, and stored in stalked glandular trichomes, that are specialized tiny secretory epidermal glands [5] [6] , which are essentially present and abundant on the inflorescence of the female plant, whilst are present in lower numbers on leaves and stems, and are absent on roots and seeds, therefore, these latter organs do not contain cannabinoids [4] [7] [8] . A possible presence of cannabinoids in hempseeds could occur during the harvesting process, as a result of physical contact with the resin secreted by the glandular trichomes located on the bracts that surround the seed [9] [10] . Hence, the presence of cannabinoids in hempseed actually represents a contamination, and the level of this contamination depends on both the cultivar ( cv ) and the cleaning process of the seed. Reasonably, THC contamination in seeds from C. sativa L. varieties which produce a low-THC level—as the industrial hemp varieties—should be extremely low [9] ; anyway, the adoption of a method for the quantification of the possible cannabinoid’s contamination and the level in hempseed products and food may be appropriate [11] [12] [13] .

The better knowledge of the biochemical and biomolecular features of the C. sativa L. species has made it possible to understand the genetics and biochemical mechanisms previously described, which are the basis of the cannabinoids’ synthesis and, in particular, of THC. Furthermore, thanks to the development of specific analysis techniques (e.g., gas chromatography or gas chromatography-mass spectrometry), it is now possible to resolutely and accurately quantify the THC content of C. sativa L. plants in order to distinguish between cvs with high and low THC contents. For these reasons, nowadays, the cultivation of industrial hemp has been reintroduced either in the US, Canada, and Europe. Canada was one of the first country to restore industrial hemp cultivation. Indeed, in 1994, it began to issue licenses for hemp as a research crop and then, in 1998, the cultivation of hemp varieties containing less than 0.3% THC of the dry weight of leaves and flowering parts was legalized, and it is currently permitted, provided that a license from the Office of Controlled Substances of Health Canada has been acquired. To date, Canada is the major hemp-producing and -exporting country, particularly of hemp-based foods, ingredients, and other related products [31] . In the EU, the hemp cultivation reintroduction took place in 2013 with the EU regulation n. 1307/2013 that allowed the growth of C. sativa L. plants for industrial purposes only for those plants with low levels of THC. According to this regulation, the granting of payments under the Common Agricultural Policy (CAP) is conditional upon the use of certified seeds of specific hemp varieties, that is, C. sativa L. cvs with a THC content not exceeding 0.2% of the dry weight of leaves and flowering parts [4] . Thus, the EU has adopted more stringent parameters compared to Canada, to ensure the safety of and to protect the health of citizens. Different genotypes of industrial hemp with a THC content < 0.2% have been selected and registered, and currently, there are about 70 allowed industrial hemp varieties listed in the European Plant Variety Database as agricultural species (Table 1) [37] [38] . Some of these cvs are dioecious as the C. sativa L. plant naturally occurs; other cvs are monoecious and are obtained by ancestral breeding [39] . Often, but not always, the monoecious varieties are adopted for seed production since they give a higher yield of the product of interest, whereas the dioecious cvs are mainly adopted for fibre production. Moreover, the industrial hemp varieties listed in the EU plant variety database are constantly updated based on the results of the annual THC-content’s monitoring and on the possible request for the introduction of new cvs with a low THC amount.

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C. sativa L. plants grown for an industrial purpose, are cultivated to obtain fibre, seeds, and their derivatives. These plants are popularly called “industrial hemp” or “fibre-type” hemp, and they contain low-THC level (i.e., <0.3 or 0.2%), whereas, C. sativa L. plants cultivated for narcotic/recreational purposes are characterized by high-THC level and those cultivated for medicinal purposes are characterized by high-THC and high-CBD levels.

Several works clarified well the cannabinoids’ biosynthetic pathway [14] [15] [16] [17] [18] [19] . According to these studies, a common precursor of all the main cannabinoids exists, and it is the cannabigerolic acid (CBGA). In the cytosol, CBGA is converted into the acidic form of the three main cannabinoids, from which other related cannabinoid compounds will originate, namely tetrahydrocannabinol acid (THCA), that in the acidic form has no psychoactive activity; cannabidiolic acid (CBDA); and cannabichromenic acid (CBCA). This conversion is catalysed by an oxidocyclase specific for each cannabinoid (THCA-synthase, CBDA-synthase, and CBCA-synthase, respectively) (Figure 2). Finally, the acidic form of each cannabinoid undergoes non-enzymatic decarboxylation to their neutral and active form, i.e., THC with psychoactive activity, CBD, and CBC that is found at high levels in juvenile plants [20] [21] , respectively.