EFSA novel food advice now open to SMEs for 2025
Are you a small or medium-sized business (SME) planning to launch a novel food in the European Union? If so, this is your chance to receive free EFSA novel food advice before submitting your application. The European Food Safety Authority (EFSA) has launched its second call for expressions of interest, specifically targeting SMEs preparing for novel food approvals.
Whether you’re still in early development or putting the final touches on your application, EFSA is offering tailored support to help you get it right from the start. Keep reading to learn how this advisory service can simplify your regulatory path and how to apply before the June 12, 2025 deadline.
What is EFSA’s SME advisory service?
EFSA’s initiative helps SMEs navigate the complex novel food application process in the EU. Through this call, eligible SMEs can access the General Pre-Submission Advice (GPSA) service in one of two formats:
- Early advice meetings for those still developing their novel food
- Pre-submission meetings for applicants close to finalizing their dossiers
These virtual consultations are designed to address your specific questions about the rules, requirements, and documentation needed to move forward with confidence.
Why apply for EFSA novel food advice?
For many SMEs, navigating EU regulations for novel food approval can be daunting, especially without prior experience. EFSA’s free advisory service offers several advantages:
- Clarifies regulatory expectations and content requirements Avoids
- common mistakes that delay approvals
- Improves submission quality from the outset
- Saves time and resources during the intake phase
- Boosts your application’s success rate
Last year, 47 SMEs benefitted from this service. Most participants found the sessions highly valuable, particularly those unfamiliar with EFSA procedures.
Who’s eligible?
To qualify for EFSA’s 2025 advisory service, your business must meet the following criteria:
- Be an SME under the EU’s definition
- Intend to submit a novel food or traditional food application to the European Commission
- Have limited or no prior experience submitting novel food applications
- Submit questions that fall within the scope of EFSA’s GPSA services
Even if you participated in the 2024 edition, you’re welcome to apply again-as long as your request concerns a different novel food.
Application timeline and process
If you’re planning to take advantage of this opportunity, make sure you stay on top of the timeline. Here are some key dates to remember:
- Deadline to apply: June 12, 2025 at 13:00 CEST
- Meetings scheduled: April to July 2025 (rolling basis)
To apply, you’ll need to fill out the Expression of Interest form through Microsoft Forms. Your submission should include a description of your novel food, intended market, timeline for submission, and your regulatory questions.
EFSA will review each application as it’s received. If you meet the criteria, they’ll contact you to schedule your advice session.
What to expect in your meeting
In early advice meetings, EFSA will guide you on:
- Regulatory scope and EFSA’s role
- Key documents and how to use EFSA platforms
- Confidentiality protocols and study notification requirements
In pre-submission meetings, you’ll receive insight into:
- Common dossier pitfalls
- Administrative and scientific expectations
- Documentation do’s and don’ts
No informal assessments will be conducted. EFSA provides advice only within the limits of current guidance.
Need help preparing your EOI?
At Quality Smart Solutions, we support SMEs in the food and ingredient sectors with regulatory strategy, document preparation, and application reviews. If you’re considering applying for EFSA novel food advice, our team can guide you through the eligibility requirements and help prepare a compelling submission.
Contact us or fill out the form below to get a free consultation with one of our experts and explore how we can help you with your EU compliance journey.
