Services

We provide expert consultancy and full regulatory support for companies developing and marketing fertilising products, including biostimulants, mineral and organic fertilisers, soil improvers, liming materials, and more.

Our core services include:

1. CE Compliance under Regulation (EU) 2019/1009

• Preparation of full technical documentation for Modules A, B + C, and D1
• Direct communication and coordination with Notified Bodies
• Preparation of Safety Data Sheets (SDS) and product labels in accordance with REACH and CLP
• Detailed legal and technical regulatory guidance for CE-marked products

We help you understand and implement the requirements of the Fertilising Products Regulation, ensuring that your products meet all applicable criteria for market placement within the EU.

2. National Registrations

• Country-specific submissions and application preparation
• Guidance on local requirements and administrative processes
• Coordination with accredited laboratories and Competent Authorities
• Preparation of SDS and labelling in the official local languages

We support clients in meeting national-level obligations in EU and non-EU countries, ensuring your products are properly registered and market-ready in each target region.

3. Mutual Recognition under Regulation (EU) 2019/515

• Drafting of Mutual Recognition Declarations for products legally placed on the market in another EU Member State
• Support with labelling and documentation in local languages

Mutual recognition allows you to benefit from existing approvals in other EU countries. We guide you through the process of leveraging this legal route efficiently and with full compliance.

Additional expertise:

• Consulting on organic farming inputs and sustainable crop production techniques
• Support with data compilation, risk assessment, and scientific justification for your products

Fertibio provides tailored solutions based on your company’s goals, ensuring legal certainty and scientific robustness throughout the product lifecycle.