Staphyt’s Geoffroy Moulin Offers 3 Tips for Bringing New Products into the EU

The regulatory environment in the European Union (EU) can be complex and difficult to navigate.

To help manufacturers chasing the European market avoid costly delays, Geoffroy Moulin, Crop Business Development Manager Team Leader at Staphyt, provides these three tips for bringing new products into the EU.

1. Prioritize early-stage planning and global data alignment.

From the very beginning, define and establish a data package that meets the requirements of multiple regions (e.g., EU and Brazil). This helps reduce redundant studies and optimizes your submission strategy.

Address potential technical and safety issues early on to prevent them from becoming major roadblocks during the registration process.

Identify your regulatory match by determining exactly how your product is classified, whether it falls under the Plant Protection Products Regulation (EC) No. 1107/2009 or the Fertilizing Products Regulation (EU) No. 2019/1009, as each has vastly different requirements.

2. Tailor your strategy to specific bioproducts pathways.

For the first time in the EU, applications for new biological active substances are outpacing traditional chemicals (there have been 35 biological active substance applications compared to 20 conventional in the last five years).

If your product qualifies as a low-risk natural extract, the development cost for an active substance dossier can be significantly lower (e.g., €600k versus €7M-€10M for synthetic chemicals) and faster to submit (one to one-and-a-half years versus three to five years). With the current discussion on the facilitating package, there may be faster evaluation in the near future.

You should also consider national versus EU pathways for biostimulants. While the EU Regulation 2019/1009 allows for market access across all 27 member states, it currently only covers four types of microbial biostimulants and does not fully include some specific types of plant nutrition products. In some cases, registering under national laws (country by country) may offer a quicker path to market.

3. Utilize local expertise for zonal and national compliance.

EU registration is not a single “one-size-fits-all” step. It involves both EU-level approval and country-level registration.

Navigate the zonal system. For plant protection products, the EU is divided into Northern, Central, and Southern zones. You must strategically choose a “Rapporteur Member State” to assess your application on behalf of others in that zone.

Conduct local field trials. While some lab studies can be international, field trials often must be conducted within specific European climates and agricultural zones to prove efficacy and safety for that region.

Expert guidance is “non-negotiable.” Because of the complex bureaucracy and constant regulatory changes, partnering with experts who have direct experience with authorities is essential for successfully navigating “beyond the legal texts” to meet the specific expectations of national regulators.