CBD & Novel Food Regulations
The Rise of CBD
Not even a decade ago, CBD was virtually unknown to consumers interested in food supplements and alternative medicine. Even regular users of cannabis, whether for medical or recreational reasons, largely overlooked cannabidiol.
Throughout history, people celebrated the cannabis plant for its health benefits. Prohibition in the 20th century made cannabis nearly impossible to access. This caused much of its medicinal reputation to fade.
Today, CBD has reemerged, but its rise has brought new legal challenges.
The CBD novel food regulation reshaped how Europe handles hemp extracts. For many years, laws allowed only hemp varieties with less than 0.2% THC—the intoxicating compound—to be legally cultivated. Farmers grew these hemp plants solely for industrial purposes, such as fiber and seed oil production.
How CBD Changed the Hemp Industry
In 1998, regulations relaxed, allowing hemp flowers and leaves for use in the food industry. This reignited interest among farmers and consumers. As more countries joined the European Union, hemp cultivation and consumption steadily grew.
Although hemp contains only trace amounts of THC, it is rich in other cannabinoids like CBD. Cannabidiol became the key driver, repositioning cannabis as a valuable medicinal plant.
From 2015 onward, the CBD industry flourished. Hemp extracts rich in CBD appeared everywhere—from online stores to pharmacies—with the European market booming until early 2019.
However, in 2019, the European Commission abruptly added cannabinoids to its Novel Food Catalogue. This change abruptly halted the booming industry. It required all hemp extracts and CBD products to pass safety approval before marketers could sell them for human consumption—even if they contained zero THC.
What Are Novel Foods?
The first Novel Food regulation was introduced in 1997 by Regulation (EU) 258/97 with the aim of establishing a food safety mechanism to control newly developed, synthetic, or genetically produced food. An updated version of the regulation came into force on 1st January 2018 (Regulation (EU) 2015/2283).
This means any food not used for human consumption in significant amounts within the Union before 15 May 1997.
Description for hemp in EU novel Food Catalogue:
In 2020, 15 different novel food applications were approved. Novel food examples like chia seeds, cacao-derived sugars, coffee leaves infusion, and even proteins extracted from pig kidneys among others, got all approved this year. Some of them have waited for 2, some 3, and some up to 5 years to go through the whole process.
At the moment, every cannabinoid being psychoactive or not, synthetic or natural, falls in the novel food category.
Description for cannabinoids in EU novel Food Catalogue:
EFSA novel food application process requirements
Under the CBD novel food regulation, getting approval for CBD products in Europe is a long and complex process. Based on current estimates, obtaining a full novel food license from EFSA could take anywhere between 16 and 60 months, with the average being around 35 months.
The process becomes even slower and more expensive if every single cannabinoid must undergo extensive laboratory testing, including:
- Identity tests (such as UV‐VIS, IR, NMR, GC–MS, LC–MS)
- Physicochemical property analysis (appearance, melting point, boiling point)
- Solubility testing in water and common solvents
- Particle size, shape, and distribution measurements
- Establishing minimum purity values
- Determining density and viscosity for liquid forms
- Stability tests over time
In addition, each cannabinoid would require setting strict specifications for:
- Maximum levels of contaminants
- Acceptable limits for impurities and degradation products
- Relevant physicochemical, biochemical, and microbiological parameters
Beyond laboratory testing, applicants must also supply detailed supporting data, including:
- History of use of the novel food or its source
- Proposed uses, intake levels, and target populations
- Absorption, distribution, metabolism, and excretion profiles
All these steps make it clear: the EFSA approval process for CBD products will be both lengthy and costly, but it remains a necessary step for achieving full legal compliance in the EU market.
The Novel Food Catalogue
The EU Novel Food Catalogue is technically a non-binding reference document, but its influence on the hemp and CBD industries has been massive. Following the addition of cannabinoids to the catalogue under the CBD novel food regulation, many farmers, producers, and consumers have suffered major setbacks.
Most agree that hemp extracts need regulation—covering production, processing, and labeling. However, critics argue that requiring full novel food applications is overly burdensome. The World Health Organization (WHO) has stated that “CBD is generally well tolerated with a good safety profile,” questioning the need for such bureaucracy.
People used hemp extracts long before 1997. While modern extraction methods have evolved, many feel the EU’s response is excessive. With over 100 cannabinoids in hemp, some speculate that pharmaceutical lobbies are influencing the process to limit competition from CBD food supplements.
Today, even large companies struggle with the costs of EFSA novel food applications. Although pioneers like Cannabis Pharma s.r.o. succeeded, only 5 out of more than 50 applications have been accepted so far.
Still, small businesses can find hope: by working with partners experienced in CBD compliance, there are still pathways to stay competitive under the evolving EU framework.
EIHA Novel Food Applications
To help companies meet the costly requirements of the CBD novel food regulation, the European Industrial Hemp Association (EIHA) formed a Novel Food Consortium in 2019. The aim is simple: to reduce the financial burden by sharing application costs across members.
Rather than spending an estimated €350,000–€500,000 per product, participating companies contribute based on their turnover and benefit from a united application. This collaborative approach significantly lowers costs and accelerates compliance for smaller businesses.
The EIHA consortium also funds essential toxicological studies on both CBD and THC. These studies should support safer dosage guidelines and may help raise THC limits for food products. Members can use this data to support their product marketing and safety claims.
To carry out the research, EIHA has partnered with ChemSafe, a professional service provider specialising in toxicology. Their work is crucial to advancing the novel food process, despite several regulatory delays. A temporary suspension occurred due to the CBD footnote in the UN narcotics treaty.
We believe that combining forces to offer a united solution to a common challenge is the right approach. That’s why Essentia Pura is a proud member of the EIHA and part of the Novel Food Consortium.
The Novel Food application process is already tough. The European Commission stopped reviewing CBD applications this summer. Namely because the UN added a CBD footnote to the international narcotics treaty. This halted the process for many months, and more delays are likely.
Lobbying industries victimized cannabis in the past century, and they continue to target it today. But thanks to EIHA, we are strong together!
About us
At Essentia Pura, we specialize in manufacturing high-quality white label and private label CBD products, helping businesses launch their own unique CBD brands. With cutting-edge hemp extraction methods and a commitment to compliance and quality, we support companies in the nutraceutical, pharmaceutical, and cosmetic industries. Whether you’re looking for ready-to-market formulations or custom solutions, we’re here to help you succeed in the growing CBD market.