Regulatory Consulting
Agrolab’s Regulatory Department provides a full range of services including the complete registration procedure: from study management & monitoring to the finished dossier and support before, during and after submission.
Let Agrolab’s experts help you navigate through the registration process and ensure the best possible time to market for your products.
- Registration services and project management in EU North Zone
- Completeness check
- Strategic consultancy, registration recommendations
- Preparation of registration dossiers
- Management and monitoring of studies
- Efficacy studies / Biological Assessment Dossiers
- Environmental behaviour (E-fate Modelling / exposure assessment incl. higher tier approaches)
- Ecotoxicology assessments (incl. higher tier approaches)
- Food safety, dietary risk assessment and residues
- Toxicology and human exposure
- Label translations and recommendations
The new fertilizer directive, 2019/1009, enters into force on June 2022.
This regulation provides a broader definition of fertilizers to include; biostimulants, growth media, soil improvers, manure and sludge.
This regulation defines products based both on product use and material.
Agrolab’s Regulatory Experts are in continued dialog with the National Authorities and can advise your company on fees and time to market of your fertilizer/biostimulant.
- Preparation of registration dossiers according EU Regulation 528/2012/EC
- Registration services and project management
- Environmental fate and ecotoxicological evaluation
- Registration services and project management
- Completeness check
- Strategic consultancy, registration recommendations
- Preparation of registration dossiers
- Management and monitoring of studies
