Nervonic Acid Regulations in the EU: What You Need to Know

How Can You Prepare a Successful Novel Food Application?

If you’ve decided to go down the official route (and I applaud you if you have), then the next question is—what do you actually need to prepare?

A successful novel food application for nervonic acid must include detailed information on ingredient identity, production method, compositional purity, safety testing, intended use, target population, and proposed daily intake—organized in line with EFSA’s technical guidance.

At first glance, this feels intimidating. But once you break it down, it’s actually just a set of logical building blocks.

Here’s a simplified table to guide your documentation prep:

When we assist clients, one of our key strategies is to leverage safety data from countries where nervonic acid is already used in food and supplements—like China, the U.S., and Japan. This gives the EU reviewers context and confidence.

And don’t forget your analytical methods¹. EFSA loves repeatable science. So make sure you have third-party labs verifying your composition with validated methods like GC-MS or HPLC.

What Are Some Real-World Success Stories With Novel Foods?

Sometimes, knowing that others have succeeded can make the mountain feel more climbable.

Several ingredients once seen as “too novel” have since been successfully authorized in the EU, thanks to solid data, transparent supply chains, and persistent regulatory work—offering valuable lessons for nervonic acid developers.

Here are some examples I often share with our team when we’re coaching clients:

So what does this tell us?

• Being new doesn’t mean being rejected.
• Scientific data speaks louder than buzzwords.
• Working with the right regulatory experts shortens the timeline dramatically.

In fact, we’ve already prepared nervonic acid dossiers for review—ready for submission with customization based on the client’s product category and region.

How Does the EU Compare With Other Markets Like the U.S. or Japan?

Now this is something I often get asked during trade shows—especially from brands that are expanding globally.

Compared to the U.S. and Japan, the EU has stricter requirements for pre-market approval of novel ingredients like nervonic acid, while other regions offer more flexibility, provided that safety and quality data are available.

Let’s look at a quick side-by-side view:

So if your brand operates globally, you can launch in easier markets first, build up user data and testimonials, and use that portfolio when applying to the EU.

Many of our customers at Santa Biotech do exactly that—launch in Asia or North America first, then enter Europe with proof, data, and confidence.

What Should OEM Brands Know Before Entering the EU with Nervonic Acid?

I want to speak to those of you working with OEM or private label strategies—because I’ve walked through this with dozens of clients.

If you’re planning to launch a nervonic acid-based product into the EU through OEM, it’s critical to ensure your manufacturer can provide full documentation, pre-approval status, EU-compliant labeling, and strategic formulation support.

Here are a few things to check before you go too far:

At Santa Biotech, we support all of this—from GRAS dossiers to EFSA-facing product specs. We’ve even had customers fly in to walk through paperwork with us in person.

So if you’re serious about launching in the EU, start the conversation early. The earlier you align your OEM with the EU rules, the smoother your path to shelves and success.

Conclusion

The EU market can be challenging for nervonic acid—but with the right knowledge, preparation, and partnerships, it’s absolutely within reach.