CBD and the Novel Foods Dossier- A Practical Overview
This article focuses on the requirements for a Novel Food application, as well as some practical tips for ensuring the best chance of success should you choose to file a Novel Food application. As previously discussed here in my blog post about the Window of Opportunity related to Novel Foods in the United Kingdom (UK) and the European Union (EU), a “validated” Novel Food application must be submitted to the UK Food Standards Agency (FSA) prior to March 31, 2021 in order for a product to lawfully be sold in the UK throughout the period of the risk assessment for the particular product or formula. There has been significant confusion as to what these applications consist of, what their format needs to be, and what type of information needs to be contained in the applications. (To read our other articles on the Novel Foods Directive as it applies to CBD, click here and here.)
At this point in time it is useful to provide a bit of context related to how the UK’s FSA will work with the EU’s European Food Safety Authority (EFSA). As you are likely aware, the UK is set to leave the EU at the end of the year (Brexit). Through various discussions I have had with consulting companies, European attorneys, as well as members of the FSA, it is safe to assume that post-Brexit, the regulations setting forth the guidelines for a Novel Food application in the UK will be similar, if not identical, to the regulations promulgated by the EU’s EFSA. Based on that credible assumption, I will focus on the EFSA’s guidance on the submission of applications for authorizations of novel foods in the European Union.
The EFSA issued a guidance document regarding submitting applications for the authorization of novel foods in the EU within the scope of Article 10 of Regulation (EU) 2015/2283 and according to Commission Implementing Regulation (EU) 2017/2469. The guidance is currently composed of a completeness checklist which outlines the data requirements for applications on novel foods in the context of Regulation (EU) 2015/2283 and four tables on the scientific studies provided in the technical dossier. The EFSA recommends that applicants use the completeness checklist and the summary tables during the preparation of a technical dossier on novel foods to ensure that the criteria for the completeness of the data for the risk assessment are met. All of this is to say that unless an application contains all of the information set forth on the completeness checklist and the four tables provided by the EFSA, the product will likely not satisfy (and successfully complete) its risk assessment, which is done by the relevant food safety agency after the application is submitted.
Without displaying the completeness checklist or any of the four tables in this blog, it is useful to know some of the types of information that satisfies these requirements. The dossier must include exact specifications of the product, the product’s parameters (ie, what constitutes the product), and the effect of any deviation from those parameters. The technical dossier must include qualitative and quantitative data on the composition of the novel food, including identities and quantities of impurities or byproducts, residues, and chemical or microbiological contaminants. The dossier should also include information about the stability of the product, as well as information about what happens to the product if/when it degrades.
Information about the product itself is of paramount importance. The technical dossier must also include information about how the product is manufactured, or what goes into the production process for the particular product. This includes information about the growth of the hemp used to make the product, how it is harvested, how the raw material is converted into the ingredient for the product, and what measures are included throughout the production process to ensure quality control.
The dossier also needs to include information about the product’s intended use. The reviewers of the dossier want to know who the product is intended for and if there are any usage recommendations/requirements. It is also important to describe the effect the product will have on the consumer and if there are any precautions and/or restrictions for the end user.
One aspect of the technical dossier that the evaluators will focus on is the product’s absorption, distribution, metabolism, and excretion (ADME). These factors examine the product’s interaction with the human body and how it can affect the body in light of exposure to other naturally occurring chemicals in the body or even with any ingested chemicals or drugs in the body.
Of the utmost importance, the reviewers want to know if there are any safety risks from using the product. For example, they want specific information as to whether there is any potential for harm, addiction, or abuse related to using the product. Additionally, information related to any susceptible or vulnerable groups (children, teens, elderly, and pregnant women) should be included where applicable.
As you may have determined by now, having a CBD product approved for distribution in the UK or EU requires much more than a simple Certificate of Analysis. The amount of information that needs to be included in a Novel Food application is quite significant, not to mention the fact that the information contained in a successful Novel Food application must be backed with technical and scientifically certified findings.
We have had numerous discussions with law firms, testing services, laboratories, and industry consultants to determine how to position our clients for a successful Novel Food application. Contact us to discuss your Novel Foods strategy.
July 6, 2020
This article was written by Kight Law attorney Philip Snow. Kight Law represents hemp and CBD businesses in the US and throughout the world. To schedule a consultation with Philip, please click here and mention this article.