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Evolving CBD Regulations – Impact on Cosmetics and Skincare

Luke Grocholl, Head of Regulatory<br>Sigma-Aldrich<sup>®</sup> Flavors & Fragrances

CBD oil

The growing interest in cannabis and cannabinoid products has permeated health and beauty. Although CBD cosmetics continues to be a rapidly growing market, estimated to be worth almost $3.5 billion by 2026 with an almost 25% annual growth1, confusion over rapidly changing and sometimes contradictory regulations continue to be a challenge to the industry.

The Appeal of Cannabinoids in Cosmetics

Cannabidiol or CBD is the non-psychoactive cannabinoid from the cannabis or marijuana plant. Unlike the related cannabinoid THC (tetrahydrocannabinol), CBD is not considered a schedule I controlled substance under the US DEA (Drug Enforcement Agency). The USDA Agricultural Act of 2014, better known as the 2014 Farm Act2, allowed for the cultivation of the very low THC crop Hemp (Cannabis sativa). The 2018 Farm Bill3 further clarified hemp as having <0.3% THC and secured hemp as a distinct crop from controlled cannabis species. The primary driver in opening up hemp to agriculture in the US was the growing interest in CBD for its therapeutic effects. Many studies support the use of CBD to treat anxiety, chronic pain, insomnia, and inflammation.

The interest CBD for cosmetics comes primarily from its anti-inflammatory properties. CBD-infused skin creams could be useful for treating irritated skin. CBD skincare products have also demonstrated activity to treat dry or sun-damaged skin and even has properties to treat acne4. Despite some of these studies, there is neither consensus nor definitive evidence of the benefits of CBD in skincare products or other cosmetics. The proliferation of CBD cosmetics may simply be due to the market trend and more importantly CBD is a new ingredient that can help differentiate a brand’s products from their competition.

CBD Regulations in the USA

With the 2018 farm bill, hemp derivatives such as CBD, that contain <0.3% THC are now legal across the US. CBD is not yet approved as a food ingredient, but the use in cosmetics is allowed since it has been demonstrated to be safe. Any claims of CBD efficacy must be supported through scientific evidence, however. Like all cosmetic ingredients in the US, pre-approval for use of CBD in cosmetics is not required. Furthermore, it cannot be adulterated or misbranded, nor can the cosmetic marketing make any pharmaceutical claims about the product.

As stated above, CBD is allowed as a hemp derivate, as long as the THC amount remains below 0.3%. A recent proposal has added some confusion as to the allowed THC. The amount of THC in hemp and hemp extract may vary at the time of harvest but stabilizes within a few weeks. The proposed Hemp Act of 20225 would allow harvested hemp to have THC levels as high as 1%, however, this does not mean that hemp extracts used in cosmetics could contain THC levels higher than 0.3%. The proposed act only allows for the variance in THC content in hemp at the time of harvest, not at the time of use.

CBD Regulations in Canada and Latin America

In Canada, where recreational marijuana is legal, THC is limited in cosmetic products. CBD can be used in natural health products, but only when the cannabinoids are extracted from the parts of the plant that are not considered cannabis. Because the psychoactive THC is concentrated in the flowers of the plant, CBD products can only use ingredients extracted from the non-viable seeds or mature stalks of the plants. Furthermore, the CBD oil must be ≤0.3% THC.

The status of CBD cosmetics in Latin America varies considerably from country to country. Some regions such as Columbia and Mexico allow the marketing of CBD-containing cosmetics with low levels of THC (≤1% THC). In Uruguay, where recreational cannabis is legal, there a few barriers to marketing CBD-containing cosmetics. In other Latin American countries, however, the legal status of CBD cosmetics is questionable or strictly prohibited.

CBD as a Cosmetic Ingredient in Europe

While the legal status of CBD as a cosmetic ingredient in the Americas is complex, it is even more confusing in Europe. EU regulation (EC) No 1223/2009 defines the accepted and prohibited substances used in cosmetics in the EU. Annex II of this regulation identifies >1600 substances prohibited from intentional addition to cosmetics including “Narcotics, natural and synthetic” which the regulation defines as those substances identified in the 1961 Convention on narcotic drugs. That convention identifies cannabis and its derivatives as narcotics; however, the Convention’s definition of cannabis refers to only part of the plant (the flowering or fruiting tops6). Since this convention does not explicitly identify CBD and further defines cannabis as being extracted from only certain parts of the plant, it could be interpreted that low-THC, CBD extract from parts of the plant other than the flowering, fruiting top would be allowed in the EU. To try and help alleviate some this confusion over CBD, the European Commission added to its Inventory of Cosmetic Ingredients7 entries for synthetically produced CBD and CBD derived from cannabis extracts.

Based on this EU regulation and the additions to the cosmetic ingredient inventory, synthetically produced CBD or CBD extracted from hemp plants other than from the flowering tops of the plant are allowed in EU cosmetics. This interpretation does not address potential THC in such extracts. Here EU, member states provide further detail. In France, for example, CBD is allowed in cosmetics, only if it comes from Hemp (Cannabis sativa L.) and then it cannot be extracted from hemp flowers, and no detectable levels of THC are allowed in these CBD extracts. Swedish regulations, while like the French requirements, allow up to 0.3% THC in the extracts. The situation may be further complicated with the small EU country of Malta becoming the first EU nation to legalize the recreational use of marijuana and larger countries such as Luxemburg and Germany considering similar laws8.

CBD as a Cosmetic Ingredient in the Asia and Australia

The state of CBD as a cosmetic ingredient in Asian countries remains complex. Despite early acceptance, as of May 2021, CBD is not allowed as a cosmetic ingredient in China. CBD is similarly prohibited in Singapore, Indonesia, Malaysia, Philippines, and Vietnam. Where CBD is allowed, the THC level remains a key factor in determining legality. Japan allows the use of CBD as a cosmetic ingredient as long as there is no detected THC. Thailand allows up to 0.2% THC. There are no explicit regulations regarding CBD cosmetics in South Korea, but the Korean food law can be used as a basis for cosmetic products. The Korean Food Code allows for the use of cannabis oil where THC levels are ≤10 ppm and CBD is ≤20 ppm. However, this very low CBD level may discourage the use of cannabis oil in Korean cosmetics.

In Australia, the status of CBD cosmetics is rapidly changing. Until February of 2021, CBD was considered a therapeutic agent and therefore CBD cosmetics were available only by prescription. CBD skincare products can now be purchased in Australia without a prescription, but the hurdle for approval of these products remains high. THC levels in Australian CBD product must remain below 50 ppm, the products must be approved by the Australian Therapeutic Goods Administration (TGA), much like prescription drugs, therapeutic claims must be verified, and the products must be manufactured under strict quality requirements. Despite the added cost of bringing CBD products to market in Australia, consumer demand remains high.

The Future of CBD Cosmetics

As more and more countries and states are legalizing the use of CBD and other cannabinoids, it can be expected that demand for CBD cosmetics will continue to grow. Keeping THC levels below regionally specified levels will remain a key element of market approval for CBD skincare products. Additionally, care must be taken to define the CBD source, the plant species, the part of the plant, extraction and processing methods, to meet local requirements. The variation in local requirements creates some barriers to international marketing efforts, but CBD oil with very low or non-detectable levels of THC sourced from other than the flowering parts of the hemp plan meets most global requirements. As with all cosmetic products, any therapeutic claims must be supported by scientific evidence. The products must also be manufactured in accordance with accepted quality standards for cosmetics. All these factors may add considerable cost to CBD products, but market trends show that consumers often accept paying a premium for CBD skincare products.

References

1.
2021. Global CBD Skin Care Market to Reach $3.4B by 2026. [Internet]. Allied Market Research. Available from: https://www.skininc.com/home/news/21965326/global-cbd-skin-care-market-to-reach-34b-by-2026
2.
2014. Agricultural Act of 2014: Highlights and Implications. [Internet]. USDA.[updated 20 Aug 2019]. Available from: https://ers.usda.gov/agricultural-act-of-2014-highlights-and-implications/
3.
Farm Bill. [Internet]. USDA. Available from: https://www.usda.gov/farmbill
4.
Oláh A, Tóth BI, Borbíró I, Sugawara K, Szöllõsi AG, Czifra G, Pál B, Ambrus L, Kloepper J, Camera E, et al. 2014. Cannabidiol exerts sebostatic and antiinflammatory effects on human sebocytes. J. Clin. Invest.. 124(9):3713-3724. https://doi.org/10.1172/jci64628
5.
2022. [updated] Hemp Act Proposes Higher THC Test Limits but Could Impact CBDs. [Internet]. Available from: https://www.cosmeticsandtoiletries.com/regulations/regional/news/22056035/updated-hemp-act-proposes-higher-thc-test-limits-but-could-impact-cbds
6.
United Nations Conference for the Adoption of a Single Convention on Narcotic Drugs; 1(VI); 1961.. [Internet]. Available from: https://www.unodc.org/pdf/convention_1961_en.pdf
8.
2021. Malta Becomes the First E.U. Country to Legalize Marijuana. [Internet]. New York Times. Available from: https://www.nytimes.com/2021/12/15/world/europe/malta-eu-marijuana-legalize
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