Regulatory support
for food and feed additives and
novel foods

Bringing a new additive or novel food to market can be a complex and resource-intensive process. Regulatory requirements are governed by different regulations and extensive technical guidance, and successful registration requires both scientific expertise and a thorough understanding of the regulatory process.

Our team combines strong technical expertise with more than 25 years of experience in regulatory and registration projects in the European Union. We support companies with the registration of feed additives, food additives, enzymes and novel foods, from the initial feasibility assessment through dossier preparation and submission.

At an early stage, we help you understand what will be required to achieve registration and identify potential challenges before they affect your project. This includes:

• Data gap analysis – Which data and studies are already available, and what additional studies are required?

• Regulatory strategy – What is the most appropriate regulatory route for your product?

• Study planning – Which efficacy, safety, characterisation or other studies are needed?

• Study placement – Where can the required studies be performed in compliance with applicable regulatory and quality requirements?

• Timeline and bottleneck assessment – Which activities are on the critical path and where could delays occur?

• Budget planning – What are the expected costs of the studies and regulatory activities?

Based on this assessment, we develop a clear and practical registration plan, including the studies required, expected timelines and estimated costs. This allows you to establish a realistic project budget and make informed decisions before committing significant resources.