Regulation (EC) NO 1107/2009
Plant Protection Products
Strategic regulatory expertise for placing plant protection products on the market. Our experts support you at every stage of the approval and authorization process.Â
Comprehensive PPP Regulatory Support
RRA offers strategic regulatory expertise backed by years of experience in plant protection products. We stand by you at all stages of placing PPP on the market or renewing their marketing authorization.
Active Substances
Obtain approval for new active substances and renew existing approvals under Regulation (EC) No 1107/2009.
- Strategic regulatory consulting
- Pre-application meeting stewardship
- Approval application drafting
- Submission & evaluation monitoring
Team Capability Development
Authorization for new products, renewal of existing authorizations, and use extensions across EU Member States.
- Zonal applications & mutual recognition
- Technical equivalence demonstrations
- Dossier preparation (BAD)
- LoA & DMT data management
Active Substances
Our experts help you obtain approval for new active substances and renew the approval of existing ones, ensuring full compliance with EU regulatory requirements.
Active Substances
Obtain approval for new active substances and renew existing approvals under Regulation (EC) No 1107/2009.
- Strategic regulatory consulting
- Pre-application meeting stewardship
- Approval application drafting
- Submission & evaluation monitoring
Team Capability Development
Authorization for new products, renewal of existing authorizations, and use extensions across EU Member States.
- Zonal applications & mutual recognition
- Technical equivalence demonstrations
- Dossier preparation (BAD)
- LoA & DMT data management
Approval Application Completion
Our team prepares active substance and representative product applications adhering to the latest requirements and technical guidelines to ensure full compliance while anticipating all potential issues.
Drafting of all sections (including risk assessments and CLP risk characterization):
- Identity and mode of action
- Physico-chemical aspects
- Analytical methods
- Toxicology
- Environmental fate
- Ecotoxicology
- Residue (if necessary)
- Efficacy
Submission & Evaluation
- Submission of active substance and representative product application to relevant authorities in proper format
- Submission of MRL application or exemption request to EFSA
- Efficient monitoring of the evaluation process
- Continuous interaction with relevant authorities
Our job does not end when the file is submitted. We remain available to respond to any requests for further information.
Our experts guide you through the different phases of drafting, submission and evaluation of your approval application for active substances.
RRA is at the heart of the deliberation process that will enable you to find the best strategy and achieve your goal.
Formulated Products
Our experts help you obtain authorization for new plant protection products, renew existing authorizations, and broaden their uses across all EU Member States.
Strategic Analysis & Consulting
Compare applications with regulatory requirements (Reg 284/2013, Part A) to advise on optimal procedures.
- New authorization by zone
- Use extension (minor and/or major)
- Authorization renewal
- Mutual recognition procedures
- Pre-application meeting stewardship
Technical Equivalence
Assistance in demonstrating equivalence of new active substance sources with respect to reference sources.
- Equivalence study design
- Data comparison & gap analysis
- Dossier preparation (BAD)
- LoA & DMT data management
Application Drafting
Our team prepares applications adhering to the latest requirements and technical guidelines, ensuring full compliance while anticipating all potential issues.
Drafting of all sections (including risk assessments and CLP risk characterization):
- Physico-chemical aspects
- Analytical methods
- Toxicology
- Environmental fate
- Ecotoxicology
- Residue (if necessary)
- National and European biological dossiers (BAD)
Data Management & Submission
- Management of access to active substance data (LoA and DMT)
- Submission of registration dossier to relevant authorities in proper format
- Efficient monitoring of the evaluation process
- Continuous interaction with relevant authorities
- Response to requests for further information
Laboratory Studies & Field Trials
Laboratory choice is vital. Knowledge of the product being tested and of the test principle is important for proper design and to anticipate any potential pitfall.
Efficacy and residue trials are conducted in different countries through our company Redebel for trials in Belgium or through Rhizome for European projects.
Our job does not end when the file is submitted. We remain available to respond to any requests for further information.
Our experts guide you through the different phases of drafting, submission and evaluation of your approval application for plant protection products.
RRA is at the heart of the deliberation process that will enable you to find the best strategy and achieve your goal.
RRA in Numbers
Three decades of expertise, hundreds of successful submissions, and a proven track record of excellence.
30+
Years Experience
280+
Dossiers Delivered
40+
Countries
96%
First-Time Approval
Ready to Start Your PPP Project?
Contact our plant protection experts to discuss your specific regulatory needs and develop a strategic approach for market authorization.