Learn how Fitosoil supports biostimulant testing and EU regulatory compliance under Regulation (EU) 2019/1009 with ENAC-accredited analysis and CE marking expertise.
As agriculture evolves to meet the demands of climate change, soil health, and sustainability, biostimulants are emerging as a powerful ally in modern crop management. These innovative products don’t just feed plant, they activate natural physiological processes that improve growth, resilience, and nutrient efficiency.
What Are Biostimulants and Why Do They Matter?
Biostimulants are formulations containing substances or microorganisms that, when applied to plants or soil, stimulate natural processes to improve:
- Nutrient uptake
- Abiotic stress tolerance (e.g., drought, salinity)
- Crop quality and productivity
Unlike fertilizers, which supply nutrients directly, biostimulants enhance a plant’s innate biological processes. Common biostimulant components include:
- Humic and fulvic acids
- Protein hydrolysates and amino acids
- Seaweed and botanical extracts
- Beneficial microorganisms (e.g., mycorrhizal fungi, rhizobacteria)
Their growing importance is linked to several agricultural challenges and trends:
- Need to improve nutrient use efficiency
- Rising climate variability and crop stress
- Regulatory pressure to reduce synthetic agrochemicals
- Push for sustainable farming under the EU Green Deal and Farm to Fork Strategy
Regulation of Biostimulants in the EU and Globally
The European Union formally integrated biostimulants into its regulatory landscape with Regulation (EU) 2019/1009, which came into effect on 16 July 2022. This regulation introduces Plant Biostimulants as a new functional category and enables CE marking for compliant products.
Key compliance requirements include:
- A clear, non-nutrient mode of action
- Demonstrated efficacy through scientific evidence
- Strict safety standards (e.g., contaminants, pathogens)
- Technical Documentation for conformity assessment
- Coordination with Notified Bodies for CE certification
Outside the EU, regulation varies:
- In the U.S., oversight is divided between the EPA and USDA, with efforts underway to clarify definitions.
- Countries such as Brazil, India, and China are creating their own frameworks, although global harmonization is still a work in progress.
Fitosoil’s Analytical and Regulatory Services for Biostimulants
At Fitosoil Laboratorios, we specialize in providing scientific, regulatory, and analytical support to companies developing and marketing biostimulants. With over 30 years of experience in agrochemical testing and ENAC- ISO 17025 accredited methodologies, we are your trusted partner for ensuring compliance and efficacy in this fast-evolving sector.
WE offer a full-service platform for biostimulant developers, manufacturers, and marketers—from lab testing to regulatory dossier preparation:
1. Physico-Chemical & Compositional Analysis
- Humic/fulvic acids, amino acids, total organic carbon
- Nutrients (macro and micro), phytohormones, alginates, polysaccharides
2. Microbiological Testing
- Identification and quantification of beneficial microbes
- Pathogen control (e.g., Salmonella, E. coli)
3. Contaminants and Safety Assessment
- Heavy metals (Cd, Pb, Hg, Ni, Cr, As)
- Pesticide residues and microbial contaminants
4. Claim Substantiation and Field Trials
- Experimental trial coordination and data interpretation
- Documentation for CE marking and regulatory submissions
5. Regulatory Support
- Technical Documentation aligned with Regulation (EU) 2019/1009
- Label review, instructions for use, and Notified Body liaison
All analyses are conducted using high-end instrumentation, including ICP-OES, GC-MS/MS, HPLC, and UV-VIS spectrophotometry, under ENAC-accredited procedures.
Ready to Certify Your Biostimulant Product?
Whether you’re developing a novel biostimulant or preparing for CE certification, Fitosoil provides the scientific and regulatory backbone to bring your product to market safely, efficiently, and in full compliance.
Contact us to learn how we can support your innovation in sustainable agriculture.
About Fitosoil
Fitosoil is an ISO 17025-accredited private laboratory specialising in advanced analysis for the agri-food, environmental, industrial, and public health sectors. Our expert team and cutting-edge technology help our clients to comply with regulations, ensure safety, and improve their processes. As part of the Cotecna Group, a world leader in inspection, certification and analysis, we are committed to providing quality and reliable services. At Fitosoil, we provide accurate, customised analytical solutions tailored to each client's specific requirements.