Novel Food: Safty and Regulatory Clarity for Your Product Development
Innovative ingredients offer great opportunities to develop differentiated products. At the same time, the EU Novel-Food-Verordnung (EU) 2015/2283 sets clear requirements for ingredients and processes that were not consumed to a significant extent by humans in the European Union before 15. Mai 1997. For such ingredients, a regulatory assessment is generally required before they can be placed on the market.
For brands, start-ups and trading companies working with a contract manufacturer, this means that not every innovative ingredient is automatically permitted for use in food products. What matters is whether an ingredient has already been authorised, under which conditions it may be used and which labelling requirements apply. The key reference is the Union List of authorised novel foods established under Implementing Regulation (EU) 2017/2470, which is regularly update.
We support you in identifying potential regulatory risks at an early stage. During the development phase, we work with you to assess whether an ingredient may fall within the scope of the Novel Food Regulation, whether it is listed on the Union List and whether the planned dosage, target group and product category comply with the applicable authorisation. This provides greater planning certainty for formulation, sourcing and market launch from the outset.
This is particularly relevant for botanical extracts, algae, fungi, microbial ingredients, novel production processes and certain isolated or highly concentrated substances.Even when an ingredient itself appears to be well known, its specific form, manufacturing process or intended use may be assessed differently under Novel Food legislation. The European Commission provides the Novel Food Catalogue as a source of guidance. However, the catalogue is not legally binding and does not replace an individual regulatory assessment.
Our aim in contract manufacturing is to combine innovation with compliance. That is why we consider regulatory requirements from the very beginning of the product development process, rather than addressing them only at the final stage. This helps reduce coordination efforts, avoid costly detours and create a reliable basis for a successful product launch.
Are you planning a product with innovative ingredients?
We support you from the initial assessment through to a viable manufacturing solution with a practical, efficient approach and a clear focus on the regulatory requirements of the EU market.