Food Projects
Food regulatory consulting services and assistance at any phase of a project
Argenta has expertise in EU novel food regulations to help overcome regulatory barriers and ensure the fastest route to market. Our services are tailored to your needs and we are available to offer assistance at any phase of a project or evaluation process. However, it is essential to decide on a realistic and correct strategy at the early stages of a novel food registration project in order to avoid delays and minimise costs.
Argenta work with applicants to identify the most appropriate strategy for obtaining authorisation.
Our regulatory and scientific experience also means we can often anticipate questions and potential pitfalls in order to reduce delays before a product can be taken to market.
Alternative Protein
Novel Food
Health Claims
Enzymes, Additives and Flavours
Food for Special Medical Purposes
Novel food regulatory consultancy
Food or food ingredients that have not been consumed to a significant degree in the EU before 15 May 1997 are considered “novel,” as per Regulation (EU) Nº 2015/2283. This could be a newly developed food such as nutrients or extracts produced from existing food, food produced using new manufacturing processes, as well as food that is traditionally eaten outside of the EU.In the latter case, under specific conditions the product could fall under the definition of a traditional food from a third country. Novel foods or novel food ingredients cannot be sold on the EU market unless they have undergone a thorough assessment to prove that the food is safe for human consumption, and received a pre-market authorisation from the European Commission.
As of 1 January 2018 there is a centralised authorisation procedure in place for evaluation of novel food applications. All applications should be submitted to the European Commission and if a scientific safety assessment is required, it will be carried out by European Food Safety Authority (EFSA), who rigorously evaluates the information to ensure the product is safe for consumers.
Novel food services
- 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
- Collaborate with authorities to confirm the ‘non-novel’ status of a food
- Evaluate existing data, identify gaps and provide expert advice for the generation of additional data or justifications for omissions
- 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 the product is novel? Contact us if you have questions or need regulatory assistance.