What Do the Upcoming Novel Foods Regulations Mean for the CBD Industry?
The Novel Foods Regulations 2018 are a set of rules introduced by the EU to protect consumers from potentially dangerous foods and ingestible substances.
The law defines 'novel foods' as any item that didn't enjoy widespread consumption in the UK or EU prior to May 1997. And it includes new ways of processing or extracting that weren't available in the past.
For instance, an apple would not fall under the category of 'novel food' since it is unprocessed and people in Britain have been eating them for thousands of years. CBD, however, is a novel product because, prior to 1997, few people in the UK or EU were consuming it and it is a new extract of the whole hemp plant.
Officials officially confirmed CBD extract as a novel food in January 2019. That means that vendors who want to sell cannabidiol to the market must go through the full-application procedure required under the Novel Foods Regulations and submit it by 31 March 2021. Brands that fail to meet the deadline can no longer legally sell cannabis or CBD-containing products in the UK.
What Do The Rules Require Of The CBD Industry?
Generally speaking, the cannabis industry welcomes the new rules. They are a tool to ensure product safety and improve its public image. However, there are some issues.
For instance, the new rules state that companies will need to carry out their own toxicology studies instead of relying on publicly-available information to support their applications. The Advisory Council for Novel Foods and Processes (ACNFP) says that there are 'gaps in the toxicological data package and human bioavailability,' meaning that vendors will need to include these details if they wish to continue selling CBD products as food.
The new rules also require CBD brands to create dossiers for each product they sell that record the ingredients and toxicology. Previously, manufacturers had wondered whether they could submit a 'pillar product' application, and then create additional lines based on the original.
The ACNFP, however, states that companies are not allowed to do this. They must submit a full application for each product for it to be legal. The justification for this, according to the council, is that there may be differences between 'minor components' and, therefore, product-level data is important. Major differences in the bioavailability of CBD could also depend on other ingestible ingredients. So any CBD-containing food product would require individual validation.
What Do The Rules Mean For CBD Retailers?
For individual CBD retailers, the new rules represent a significant challenge. The Novel Food application process takes around 24 months and costs between £30k and £80k. It also requires a lot of work, including data gathering, analytical lab work and auditing of the manufacturing process.
Given the difficulty and expense of the process, many enterprises in the industry are looking for solutions. One approach is to club together with other CBD brands to lower the application costs. Firms are sharing data, testing together, and then simply re-labelling the same product. The approach is fine for generic brands, but those looking to differentiate themselves may not like this idea.
Another approach is to go to agencies that offer specific assistance with the application process. These services essentially take over the job of gaining the proper approvals for products, helping the process to go more smoothly. Aspects of their services include completing the application form, submission, and responding to questions from the European Food Safety Authority.
Lastly, companies are moving away from food-like products (ingested through the mouth) to topicals that customers can apply to their skin. Since balms and lotions do not pass through the mouth, they do not count as food and, therefore, do not fall under the Novel Foods Regulations.
CBD topicals have become more popular in recent years because of their ability to deliver benefits to specific areas of the body. When users apply balms to their skin, the cannabidiol makes its way through the dermis where it can interact with local endocannabinoid receptors.
Retailers are marketing topicals as having a host of benefits, including anti-aging and wellness support. They're also combining CBD with other health-promoting ingredients to increase the impact of their products.
Ultimately, the upcoming Novel Foods arrangements are a challenge individual vendors will need to meet head-on. Adapting – by switching to topical treatments – while also getting application support will make brands more trusted in the long-term. If you work with a CBD wholesaler, they should be able to register their products with the FSA for you.
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