Regulatory Affairs for novel food 

Accelerate the path to regulatory success for novel food in the EU

As humanity continues to explore beneficial ingredients for consumption, numerous companies aspire to introduce their innovative products to the EU market. Often offering clear consumer benefits, these products may be classified as novel food1 or contain novel food ingredients. Navigating the regulatory landscape to bring these products to market can be a significant challenge.  With a dedicated regulatory affairs team, Argenta is well-equipped to guide you to success.

Microscope looking at plant material

Successful registration of novel food products requires navigating complex regulatory terrain

Novel foods and novel food ingredients cannot be sold in the EU without undergoing a comprehensive safety assessment to ensure they are safe for human consumption. Without the right guidance and support, cutting through regulatory complexity can be challenging.
Registration is nuanced and complex

Regulatory agencies have stringent requirements for the safety and quality of nutritional products. A lack of specific knowledge about the regulatory processes and technical requirements for novel foods can put successful registration at risk.

Safety evidence must be compelling

Successful registration requires submitting a robust dossier to the European Commission that includes strong evidence of the product's safety. Upon receipt, the European Food Safety Authority (EFSA) conducts a scientific safety assessment.

Product qualification can be tricky 

In some cases, a product may qualify as traditional food2. This entails a different regulatory approach and procedure for market entry. Making the wrong decision can lead to substantial delays and increased costs. 

An experienced partner for regulatory strategy and submission of novel food dossiers

Strong technical expertise and agency relationships

Our dedicated regulatory team specialised in novel food registrations in the EU can help you determine if your product is considered 'novel' and guide you in the regulatory process.
With extensive experience working with the European Food Safety Authority (EFSA) and other regulatory organisations, we enable timely approval of novel food products.

Experts in regulatory strategy and submissions

Our team of regulatory experts has a proven track record of submissions. We’ll craft a robust regulatory strategy, support pre-submission meetings with regulatory agencies, help clarify agency feedback, and prepare high-quality responses to agency questions.
Our deep network, experience, and technical knowledge allow for efficient negotiation and rapid responses to regulatory agencies.

Helpful, transparent communication

Our open, transparent approach to client partnerships helps streamline workflows and ensure on-time delivery. As part of this, our team will guide you carefully through the registration process, ensuring alignment and quality control at every stage.

 

How do you determine if your product is novel?

At Argenta, our expert regulatory team specialises in navigating the complexities of Novel Food registrations within the EU. We can help you determine whether your food product is considered 'novel' or 'traditional' and guide you towards the best pathway for a successful registration. Get in touch with our team today, and let us simplify the process for you.

 

Novel Food consultation procedure:

  • The food business operator must verify if their food or ingredient is novel and falls under Regulation (EU) 2015/2283.
  • If unsure, the food business operator can consult the competent authorities of the EU Member State where they intend to first sell the food, following Commission Implementing Regulation (EU) 2018/456.
  • The EU Member State will reach a conclusion on the novel status of the food, which the EC will publish on their website.
  • Once approved by the EC, the novel food is listed in the EU Union List of Novel Foods (Regulation (EU) 2017/2470).
Traditional food procedure:

  • An applicant must follow the notification procedure in Article 14 of the Novel Food Regulation (EU) No. 2015/2283 and provide evidence to demonstrate the safety of the product.
  • The notification is sent to the EC and is then evaluated by EFSA.
  • Once the traditional food has received a positive EFSA opinion and has been approved by the EC, it is listed in the EU Union List of Novel Foods (Regulation (EU) 2017/2470).
1. Foods or food ingredients that have not been consumed to a significant degree in the EU before15th May 1997 are considered “novel,” under Novel Food Regulation (EU) No. 2015/2283. Examples of novel foods or novel ingredients are: 1) Newly developed foods (e.g. alternative-proteins including cell-based meats, insect proteins, novel plant proteins); 2) New products/ingredients produced from existing food (e.g. coffee flour, coriander seed oil); 3) Food produced using new manufacturing processes (or novel technologies (e.g. nanomaterials); 4) Food that is traditionally consumed outside of the EU.  
2. Traditional foods from third countries are also considered as Novel Foods in the EU. To qualify, a traditional food must have at least 25 years safe history of use & have been consumed by a significant proportion of the population. Examples of traditional foods include: cocoa fruit pulp, haskap berries, herbal infusion from coffee leaves.