7.2. Marketing requirements for hemp products

When it comes to food products, Regulation (EU) 2022/1393 sets maximum levels for THC in hemp seeds and derived foods. Effective from January 1, 2023, these regulations set specific limits to ensure consumer safety and compliance within the hemp food industry.

For hemp seeds, a maximum limit of 3.0 mg/kg of 'THC equivalents' has been stipulated. Similarly, hemp seed oil is subject to a maximum THC limit of 7.5 mg/kg. These thresholds are crucial for distinguishing hemp-derived products from those with higher THC concentrations, such as marijuana, thereby ensuring that hemp foods remain non-psychoactive and safe for consumption. The European Commission has attributed a Measurement of Uncertainty (MU) of 50% to THC levels. Laboratories must account for this MU when measuring THC in products, adding it on top of the maximum levels adopted in January 2023.

Products failing to adhere to these maximum levels are prohibited from being placed on the market. This stringent regulation underscores the EU's commitment to upholding quality standards and protecting consumers. By enforcing clear and specific THC limits, authorities can ensure that hemp-derived foods are both safe and compliant with regulatory requirements.

These regulations not only safeguard public health but also provide clarity and transparency for producers, retailers, and consumers within the hemp food industry. Compliance with these maximum THC levels is essential for maintaining the integrity of hemp-derived products and fostering consumers trust in the market.

Hemp can be marketed as a feed product under designations listed in the European Catalogue of Feed Materials or the Feed Material Register. If a company wishes to market a hemp-derived feed material not listed in either, it must apply through the Feed Material Register. The product undergoes scrutiny by European associations responsible for the register and the European Commission.

As of now, no products containing flowering tops or leaves are listed in the Catalogue or accepted in the Register, as the Commission lacks data on the effects and functions of CBD and THC on animals. Generally, hemp extracts, isolated CBD, and materials likely to contain cannabinoids are considered feed additives by the Commission. Feed additives require pre-market authorisation, and to date, no company has applied for such authorisation. Therefore, hemp extracts and CBD as feed additives have not been lawfully marketed.

Regarding existing entries in the feed catalogue, Member States and the European Commission are establishing binding maximum THC levels, similar to those for food products. The current catalogue entries include hemp seed, hemp expeller, hemp seed oil, hemp flour, and hemp fibre, as described in Regulation (EU) No 68/2013. The maximum levels should be adopted in the course of 2024.

Under EU regulations, hemp extracts and CBD (both isolate and synthetic) – when intended for the food market – are classified as "novel foods" and not as traditional food due to a lack of evidence demonstrating significant consumption within the European Union before May 15, 1997. As such, an authorisation under Regulation (EU) 2015/2283 is required for these products to be legally placed on the European market.

The designation of "novel food" applies not only to the CBD extract itself but also to any products containing CBD as an ingredient, including hemp seed oil. This prohibition encompasses various extraction methods, whether it's an alcoholic extract, critical CO2 extraction, or another process. Even synthetic CBD falls under the classification of novel food.

Importantly, the novel food status and subsequent prohibition remain unaffected by the degree of dilution of CBD extract in the final product. Whether it's hemp oil with the addition of CBD extract or any other formulation, if CBD is present, it falls under the regulations governing novel foods.

Thus far, no Novel Food application has received approval by EFSA. Consequently, hemp extracts and CBD intended for food use cannot yet be placed on the market. Both individual and collective applications are currently under risk assessment in EFSA, with potential authorisations anticipated to be issued as early as 2025.

Operators willing to market hemp food supplements based on CBD and full spectrum extracts must either pursue an individual application to EFSA or join a consortium with other companies. The European Industrial Hemp Association (EIHA) has established a joint application on behalf of 150 companies, thus reducing the cost that each individual company would pay for the necessary studies to prove hemp extracts safety.

The regulation of hemp-derived ingredients in cosmetics within the European Union is governed by strict guidelines outlined in Regulation (EU) No 1223/2009. While cannabis and extracts of cannabis are prohibited for use in cosmetic products according to Annex II of Regulation (EU) No 1223/2009, CBD itself is not considered a prohibited substance. This distinction arises from the interpretation of the 1961 Convention, which defines cannabis as the flowering or fruiting tops of the cannabis plant, excluding seeds and leaves when unaccompanied by the flowering or fruiting tops. Consequently, CBD is not covered by the prohibition outlined in the convention.

The European Union's Cosmetic Ingredients database (CosIng) lists several cosmetic ingredients derived from the cannabis plant. However, the presence of an ingredient in the database does not automatically indicate its approval for cosmetic use. Especially because the Catalogue is not a legally binding list of approved substances to be used in cosmetics, but it rather serves as a tool for Members States to harmonise the labelling of the cosmetic products in Europe. Some ingredients derived from cannabis flowers are prohibited for use in cosmetics, while others derived from the plant's roots or seeds are permitted.

For example, cannabigerol (CBG) and cannabidiol (CBD), although derived from cannabis, are not subject to the same restrictions as cannabis extracts under the 1961 Convention. These ingredients may be used in cosmetic products, with some products already available on the market and listed on the EU Cosmetics Products Notification Portal.

Despite the availability of certain cannabis-derived ingredients for cosmetic use, all cosmetic products placed on the market must adhere to the general safety requirement outlined in Article 3 of Regulation (EU) No 1223/2009. Additionally, notification of new cosmetic products to the EU Cosmetics Products Notification Portal is mandatory.

In summary, while cannabis and cannabis extracts are prohibited in cosmetics, certain cannabis-derived ingredients like CBD may be used in cosmetic products as long as they comply with safety regulations and are properly notified to regulatory authorities.