Novel food or not? That is the question...


18 September 2023


Deciding whether a product is novel or not is the first step in a complex regulatory process. So how do you get it right? A novel food gap assessment will ensure you develop the right strategy for your product.


According to the European Commission’s Regulation EU 2015/2283, the term ‘novel food’ refers to any food that has not been significantly consumed by humans in the market before 15 May 1997. Article 4 of the same regulation states that it is the responsibility of food business operators to verify if their product is novel or not.


While it’s true that legislation and associated safety assessments vary from market to market, the basic principle of making the product innovator accountable for this decision applies nearly everywhere. Get it wrong and you risk being challenged not only by the relevant safety authorities, but competitors and consumers too. Leaving the business facing possible legal action, fines and loss of reputation.

But understanding how to determine whether a food product should be classified as novel – and requires a safety assessment and regulatory approval – is not an easy task. It demands a detailed understanding of both the process and regulatory framework.



Mind the gap


That’s why it’s always advisable to carry out a comprehensive novel food gap assessment to first confirm whether the material in question is novel or not. And if so, the exact safety and regulatory data that needs to be provided to support your stated conclusion, as well as the subsequent novel food regulatory submission.


This process generally involves gathering all available scientific information and data related to the product in question, including historic use in the market, composition, production process, potential allergenicity, toxicity and nutritional content. This is achieved by:

  • Analysing historic use of data to assess if the material has been significantly consumed by humans within the specified timelines.
  • Analysing the collected data to identify any areas where information may be lacking or insufficient to fully assess the safety and suitability of the material for human consumption.
  • Using the available data to carry out a comprehensive risk assessment to evaluate potential risks associated with the material, such as allergenicity, toxicity and any other health concerns.
  • Establishing a strategy for a subsequent novel food submission. This is likely to include planning additional scientific studies, toxicological assessments, allergenicity tests and other relevant research to fill in missing information.
  • Providing clients with an estimated time and cost for the novel food submission process in the market(s) of interest.



Strategy for success


The importance of a novel food gap assessment can’t be emphasised enough. It’s a crucial first step in this complex regulatory environment. By identifying and addressing data gaps early in the process, potential risks and uncertainties can be evaluated and minimised, rather than causing problems at a later stage. Plus, you benefit from a defined regulatory pathway and a more informed and evidence-based approval process. 


Do you need support with a novel food gap assessment or application?

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