Regulation (EU) 2019/1009
Biostimulants
Personalized support for bringing your biostimulant products to market across all European Union countries. Expert guidance for EU and national regulatory pathways.
Two Regulatory Pathways
Since July 2022, there are two possible registration pathways for biostimulants: Regulation (EU) 2019/1009 (European pathway) and national regulations. RRA can assist you in developing your regulatory strategy for both routes.
Our Services
- Strategic analysis of regulatory pathways to efficiently bring products to target markets
- Drafting of regulatory documentation for marketing authorization applications
- Support (preparation & participation) for pre-submission meetings
- Monitoring of laboratory analyses
- Support for setting up efficacy trials across Europe
- Submission of authorization dossiers to competent authorities
- Effective follow-up of evaluation process and interaction with authorities
- Regulatory consultancy services
Team Capability Development
- Active collaboration with notified bodies
- Close contact with national authorities
- RRA actively participated in development of standards 17700:2024 within CEN 455
- Expertise in demonstrating biostimulant claims under Regulation (EU) 2019/1009
- Regular regulatory monitoring within our team
- Continuous training of our experts
- Active participation in workshops and conferences on biostimulants
Feel free to contact our Bios'TEAM with any questions.
With years of expertise in bringing plant nutrition products to market, RRA supports you through one or all stages of your project.
After 10 years, still as responsive to requests and meticulous in their work. Thank you Thomas and thank you to your team.
With Studio Tum, I've had the opportunity to collaborate with Nic-nac on several projects (large and small format printing, vehicle lettering, sign placement, etc.). Each time, the service has been impeccable: responsiveness in management, quality of execution, and attention to detail. As a designer, it's a pleasure to be able to count on such a reliable and professional partner. I highly recommend them!
Great product, excellent responsiveness and communication. I highly recommend it.
Ready to Start Your Biostimulants Project?
Contact our biostimulants experts to discuss your specific regulatory needs for European or national market authorization.