What is the Novel Food Act and Why is it Important for CBD Extractors?

What Exactly is the Novel Food Act and Why Was it Created?

Novel foods are food products that do not have a significant history of being consumed. They can be considered: new foods, like phytosterols and phytostanols, which were added to butter substitutes to reduce cholesterol, traditional foods, like chia seeds which have been consumed for years in other parts of the world, and new processes, like when bread is treated with ultraviolet light to increase the level of vitamin D.

The Novel Food Act Legislation was created by the European Commission in response to the arrival of food products derived from GM crops (plants used in agriculture, whose DNA has been modified using genetic engineering methods). It is to ensure that foods entering the market are safe for the consumer and the environment. Before a novel food can be legally marketed in the UK, it is required to have a pre-market safety assessment and authorization. This applies to any food and food ingredient that has not significantly been used in the UK or EU for human consumption before May 1997.

The food must also be either:

  • food ingredients with a new or intentionally modified primary molecular structure
  • micro-organisms, fungi, algae or cell culture
  • plants or animals
  • food produced by new production process that significantly changes the product nutritionally or in relation to the food safety risks
  • minerals or engineered nano-materials

What Does the Novel Food Act Mean for the CBD/Hemp Industry?

The novel food status of CBD extracts was confirmed in January 2019, and the Novel Foods Catalogue has recently been amended to reflect the incorporation and inclusion of CBD products. The Novel Foods Catalogue is the recording of decisions made on the novel food status of foods and food supplements. The European Commission uses this tool to show the decisions made on novel food status, and it’s these decisions that lead to legal status. This makes it understood that CBD extract products are legally considered novel foods.

The Novel Food Act is significant for CBD oil extraction as it clearly displays and communicates what the product’s ingredients are and that they meet the necessary standard requirements. It gives the consumer confidence that the product is of high quality and properly manufactured. The content of any application for CBD products should follow the application process for all novel foods. An important part of any application will be a consideration of the product’s safety. CBD extractors and companies will need to include details of the toxicological studies they have undertaken, or propose to undertake with clear details of the reasoning for these particular tests. Without such information it is unlikely that the CBD products will then be validated through the application process.

Where Does it Go From Here?

Although CBD was placed in the Novel Foods Catalogue in January of 2019 for an already existing and emerging industry, more attention has been given to what products go onto shelves in pharmacies and stores. Products will continue to be subjected to having their contents and ingredients examined and monitored. Another complexity for CBD extractors is to consider how time consuming and costly the application process can be in order to receive proper authorization from the Novel Food Act. Despite that fact, this should be a necessary step for each company to undertake so that they can stand by their products, allowing customers to know exactly how it was made, the amount of CBD that is included and that it is safe to consume. Once all those factors have been met it will give CBD companies an advantage in the market, knowing their products have been given the stamp of approval and giving buyers and consumers the confidence of purchasing from a trusted and reputable company.

Laura Eder

Laura Eder has more than 19 years of experience in the life-cycle management of pharmaceuticals and medical devices. She has had her Regulatory Affairs Certificate (RAC) since 2012. Through her time spent in the world of pharmaceuticals, she has developed a comprehensive knowledge and understanding of FDA regulations, as well as worldwide regulations. She has created an outstanding relationship with the FDA's Office of Prescription Drug Promotion (ODPD) for over 15 years submitting websites, commercials, and promotion materials without issue. Early in 2019, she transitioned into the CBD industry as the Regulatory Manager where she helped to guide the company through several significant regulatory milestones. Leading a team to complete ISO 9001:2015, as well as GMP 111 (dietary supplements) and 117 (food) certifications in record time. The audits with SGS were completed in just three months due to her leadership skills, experience and understanding of what would be needed for this industry. Following that Laura started her own consulting business for a short period before joining Vantage. Once she saw the opportunity at Vantage where she could use her pharmaceutical knowledge and experience in the CBD industry she knew it was the perfect relationship. Since being at Vantage Laura has again completed another successful audit. The annual surveillance audit this past February 2022 which was conducted by SGS at the pharmaceutical level and no findings was the final outcome. Laura is looking forward to moving the CBD industry forward ethically and legitimately with transparency to government agencies such as the FDA.

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