CBD considered a «novel food» in some cases by the European Union

The new European regulations on novel foods came into force on January 1, and are set to be a game-changer for the CBD trade in Europe. Indeed, cannabidiol has been officially classified, to a certain extent, as a «novel food». The safety of products containing CBD must therefore be verified before they are marketed, and they must obtain a European marketing authorization.

Between innovation and tradition

Novel food« is defined as a form of food that was not consumed to any significant degree in Europe before 1997. This includes newly discovered foods or additives, but also foods produced in a new way using recent technologies. New production methods can result in the transfer of additional, unverified components that are potentially dangerous for the consumer. Concerning cannabis, solvent extraction and CO² extraction are considered innovations, and products containing CBD extracted in this way fall within the scope of these regulations. This is not the case, however, with pressurized extraction techniques, which are considered traditional. Innovation, tradition - where does the line lie for CBD?

The European Industrial Hemp Association (EIHA), which was consulted by the European Commission in preparation for the new regulations, pointed out that hemp has traditionally been used in food and industry in Europe. However, it contains CBD in small quantities. She therefore suggested CBD naturally present in the hemp plant is not considered «novel». On the basis of this recommendation, the European Commission defines as food innovation only cannabis extracts containing CBD in quantities greater than those found naturally in the plant. EIHA specifies that hemp varieties registered in the European catalog contain between 1% and 5% of CBD. This percentage serves as a guideline for private operators. They are advised not to market products containing more than 5% of CBD without authorization.

These new regulations can be confusing. What's important to remember is that hemp seeds, hemp flour, hemp proteins and hemp oils produced by the press method and without additives - provided that the source varieties are listed in the European catalog and contain less than 0.2% THC - are considered traditional. It is therefore only CBD isolates and oils containing CBD that are considered innovations.

These regulations do not apply to medicinal products. It is also forbidden to attribute hypothetical therapeutic virtues to novel foods. This information has been passed on to the health authorities of EU member states, and although the regulations are not binding, states are invited to comply with them.

Countries that already apply these regulations

Some countries have already aligned themselves with the new European regulations. Irish health authorities (Food Safety Authorities), for example, have warned private operators of CBD's new legal status. They specify that it is up to operators to have their products checked and to apply for a European marketing authorization. The health authorities can check products on the market at any time, and demand the necessary authorization if necessary.

The Danish authorities have also aligned themselves with the new regulations, specifying that they apply to «pure CBD and hemp-derived products highly concentrated in CBD or other cannabinoids». If the Danish Medicines Agency considers that a marketed product corresponds to this definition and that it is not a medicinal product, then it is entitled to demand that it be withdrawn from the market if it has not obtained the necessary authorization.

Austria didn't even bother - it went all out. bans CBD from food and cosmetic products in anticipation of the new regulations. A press release from the Ministry of Social Affairs states: «In order to counter the marketing of unauthorized products, the BMASGK [Austrian health authorities] has declared a definitive ban on trade in these products».

In Spain, CBD have also been banned as food supplements, but the implementation of this directive is rather hazardous. The Spanish Medical Cannabis Observatory has asked the government to regulate CBD once and for all.

Despite the Brexit, the UK has decided to transpose the European law on food innovations. The British Food Standards Agency said it would ask its employees to withdraw the products from sale until they obtain authorization. A spokesman for Cannabis Trades Association BFA employees have the right to enter your business and inspect stock to determine its innovative status«. This is a major blow to the already significantly developed UK CBD trade.

What this means for the European CBD market

For the time being, the European CBD market has experienced a chaotic development, with a proliferation of products with more or less verified origins. The aim of these regulations is to regulate the market while protecting European consumers. However, putting the market in order is likely to take time, and Europe is losing precious time in the face of global competition. EIHA has called on European institutions to adopt a competitive strategy on the global CBD scene in view of the increased competition from Asia (China), Canada and now of the United States. Especially since the WHO has already decreed CBD as «well tolerated and with a good safety profile».

Private operators have to have their products approved by the centralized procedure and thus obtain a European marketing authorization. This can take up to 18 months. Products must pass scientific tests, including toxicological tests, to verify their safety. The authorization then specifies conditions of use, official designation of the product as a food, marketing requirements and post-introduction monitoring. Czech company Cannabis Pharma has already applied for such an authorization for trans-cannabidiol.