NOT SURE IF YOUR PRODUCT IS A NOVEL FOOD?
Foods or food ingredients that have not been consumed to a significant degree in the EU before 1997 are considered “novel,” under Novel Food Regulation (EU) No. 2015/2283.
Examples of novel foods or novel ingredients are:
- Newly developed foods e.g. alternative-proteins from cell-based meats, insect proteins, novel plant proteins
- New products/ingredients produced from existing food (e.g. coffee flour, coriander seed oil)
- Food produced using new manufacturing processes ( or novel technologies (e.g. nanomaterials)
- Food that is traditionally eaten outside of the EU
Novel food and novel food ingredients cannot be sold on the EU market unless they have undergone a thorough novel food safety assessment to prove that the food is safe for human consumption. Applicants must provide evidence that their product is safe. To do this, they need to submit a novel food dossier to the European Commission (EC). Once the dossier has been received, a scientific safety assessment is performed by the European Food Safety Authority (EFSA).
Once the novel food has been approved by the EC, it is listed in the EU Union List of Novel Foods (Regulation (EU) 2017/2470).
An outline of the novel food registration process is presented below:
(!) time extensions due to additional information requests; EC – European Commission; EFSA – European Food Safety Authority; PAFF Committee – Standing Committee on Plants, Animals, Food and Feed
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
To register a traditional food, an applicant needs to follow the notification procedure outlined in Article 14 of the Novel Food Regulation (EU) No. 2015/2283 & provide evidence to demonstrate the safety of the product.
The notification is sent to the EC and if the product is considered safe then the product will be approved. If the safety of the product is unclear, then the product will be evaluated by EFSA.
An outline of the traditional food notification process is presented below:
It is the responsibility of the food business operator (the person or company placing the product on the market) to verify if their food or food ingredient is novel & falls within the scope of the novel food Regulation (EU) 2015/2283.
If the food business operator is are still unsure whether the food is novel, they may consult the competent authorities of the EU Member State where they first intend to sell the food. The consultation procedure is outlined in Commission Implementing Regulation (EU) 2018/456.
Once the EU member state reaches a conclusion on the novel status of the food, the EC will publish the outcome on the EC website.
- Initial assessment of the “novelty” of a food or food ingredient: assess the regulatory status and identify correct regulatory pathway to market the product
- Collect information to support significant degree of consumption in the EU prior to 15 May 1997, or safe history of use in a third country for at least 25 years
- If required, assistance with the novel food consultation procedure
- Traditional food notifications
- Evaluate existing data, identify gaps and provide expert regulatory advice for the generation of additional data or justifications for omissions
- Advice on data protection
- Assist collecting additional data, monitor studies and review study reports
- Compile, write and submit novel food dossiers
- Post-submission support: liaise with EFSA and European Commission, answer supplementary information requests and provide regulatory support
NOT SURE IF YOUR PRODUCT IS NOVEL?
Contact us if you have questions or need regulatory assistance.