Mathilde Do Chi is the CEO of Forward Food Law, a food law and regulatory consultancy in global alternative protein regulations. She is an
In this sixth installment of her special series, Mathilde discusses the challenges companies face when demonstrating the safety of novel foods since existing standardized testing methods may not fully capture their complexity.
Demonstrating the safety of innovative food ingredients
Necessary to improve our global food system, innovative food ingredients are a key enabling tool in achieving the future of food.
However, before being put on the market, companies producing such ingredients must demonstrate that they are safe for human consumption according to local regulations.
Although they have to generate a set of data common to all food categories, generating such data for such ingredients as novel foods may be overwhelming for companies.
© HPS Food & Ingredients
Due to the versatility of innovative food ingredients which include novel foods like UV-treated wine, sunflower protein isolate, and cultivated meat, demonstrating novel foods’ safety may be challenging especially since standardized testing methods may not capture the intricacies of this food category.
To begin with, most jurisdictions will require companies to generate data on the following to demonstrate the safety of the food in question:
- Identity,
- Specifications,
- Product Process,
- Nutritional Information,
- Compositional Data,
- History of Use,
- Proposed Uses, Use Levels, Anticipated Intake,
- Allergenicity,
- ADME, and
- Toxicological Information.
What are recognized testing methods?
Food safety data shall be generated according to international or national testing methods which are produced by several entities either governmental or non-governmental.
Such entities establish standardized testing methods for specific parameters according to the mandate they were given.
Who produces these standards?
1. OECD
The Organisation for Economic Co-operation and Development (OECD) is a unique forum where the governments of 37 democracies with market-based economies collaborate to develop policy standards to promote sustainable economic growth.
They produce the “OECD Test Guidelines”, internationally recognised as the standard for non-clinical environment and health safety testing of chemicals and chemical products.
Each standard provides details for a certain chemical to be tested in the same manner in laboratories around the world.
2. AOAC
The Association of Official Analytical Collaboration (AOAC) International is an independent,
third-party, not-for-profit association & voluntary consensus organisation that develops and validates standards, methods and technologies of global use.
Under their Official Methods of Analysis (OMA) program, they assess whether a method can be considered approved by having it undergo rigorous, systematic scientific scrutiny to ensure it is highly credible and defensible.
3. ISO
The International Standardization Organization (ISO) is a non-governmental entity that brings global experts together to agree on the best way of doing things ranging from making a product to managing a process.
ISO standards related to food cover a wide variety of topics such as reference methods used in microbiological analysis of the food chain from farm to fork.
The challenges for novel foods
Due to the wide variety of novel foods that exist, the aforementioned standards and methods may not be suitable for demonstrating their safety as they do not necessarily produce conclusive results. It stems from the uniqueness of each food that may be produced in numerous ways which often prompted companies to use a non-standardized method to assess specific parameters.
Using a non-standardized method may trigger clock stops, or delays, in the risk assessment phase conducted by food safety agencies as companies may be requested to argue why they did not choose a standardized method.
Modernizing risk assessment methods by assessing their suitability to novel foods is crucial to ease and shorten the placement of novel foods in a given market like the European Union.
For proof, the EU Regulation 2015/2283 on novel foods states that from the submission of the novel food dossier to its acceptance by the European Commission, the whole process should take around 17 months but in most cases, approvals are granted between 24 to 36 months.
Modernising risk assessment methods
There are ongoing programs to assess the suitability of existing risk assessment methods and their modernization regarding novel foods.
The OECD focuses on plants, trees or micro-organisms or introduced novel traits and produces consensus documents compiling technical information for use during the regulatory assessment of products of biotechnology and are intended to be mutually recognised among OECD Member Countries.
Similarly, the AOAC works on a new multi-year program funded by stakeholders to collaboratively address current and newly emerging analytical needs applicable to novel foods from alternative protein sources.
If you want to learn more about the EU novel food regulatory approval process, sign up for Mathilde Do Chi’s brand new self-paced online course for non-lawyers launching on Monday, 7th of October 2024.
It includes expert tips and exclusive resources to help companies navigate the framework with ease and was initially given as a workshop to EIT Food and leading VCs in the food and Agritech space.
Visit Mathilde’s website here for more information on food law.
