All you need to know to commercialise alternative protein

Is your business interested in commercialising alternative protein?

In today’s world, consumers and businesses are increasingly concerned about the environmental impact of animal-derived products. Global consumption is rising, especially in developing markets, which strains the environment and poses health risks. Consequently, many businesses are developing sustainable protein alternatives, such as plant-based proteins, single-cell proteins, insect proteins, and lab-grown products.

In the EU, most alternative proteins are considered novel foods, requiring a comprehensive safety assessment before they can be sold. This regulatory process is challenging, time-consuming, and costly.

Understanding Novel Foods and their regulatory process

Novel foods are defined as foods that had not been consumed to a significant degree by humans in the EU before 15 May 1997.

1. All novel foods or ingredients require a safety assessment and pre-market authorization before being included in the Union list to be sold in the EU.
2. The process starts with the submission of a novel food dossier to the European Commission (EC).
3. The EC has 1 to 3 months to perform a validation check whether the application is complete.
4. The EC then requests EFSA to perform a risk assessment.
5. EFSA performs their own validation check & will evaluate the application within 9 months from the date of receipt of a valid application.
6. EFSA then publishes their opinion & forwards it to the EC, the MSs & the applicant.
7. The EC has 7 months to publish a draft act authorizing the novel food, with a decision made during Standing Committee meetings.

Navigating the complex regulatory landscape in the EU can be difficult. Our team of experienced regulatory consultants has created a free guide for you: “Regulatory Approval for Alternative Proteins in the EU – Steps to Success.”

You can download it by clicking the button on the right side of this page.

Do you have a specific question regarding your product?

With years of experience, our regulatory team will be happy to cooperate with you to develop the most efficient strategy to bring your product to market quickly, avoid pitfalls, save you time and money. Beyond the EU, we also have expertise in other regions, including the UK, US, Canada, and Singapore.

Contact us to discover how we can assist you every step of the way.