Get your active substances and plant protection products approved
In the EU, plant protection products are regulated under
Regulation (EC) No 1107/2009. This regulation lays down the criteria and procedures for active substance approval and product authorisation. It covers conventional, synthetic chemicals, as well as biocontrol solutions such as micro-organisms, natural substances and semiochemicals.
ARCHE Consulting can support you with the preparation and submission of active substance and product dossiers (core dossiers as well as national addenda), in line with the most recent guidance and modelling/risk assessment practices.
ARCHE Consulting offers a comprehensive range of services to help you comply with EU, zonal, or national regulations for the approval or renewal of your active substances/products. We also assist with
sustainability requirements for crop protection product authorisation by leveraging our extensive experience in regulatory compliance, risk and exposure assessment. Our scientists provide valuable insights and recommendations to ensure that your projects are both effective and safe, from conception to completion.
- Performing data gap analyses and preliminary risk assessments, to identify data gaps and critical issues as early as possible.
- Providing strategic regulatory advice.
- Engaging with member states in the pre-submission phase and following up on applications until approval.
- Staying up to date with technical guidance and member state requirements, to ensure the preparation of high-quality dossiers meeting the evaluators’ instructions.
- Technical equivalence applications.
- Active substance approvals/renewals.
- Product (re-)authorisations.
- Basic substance applications.
- Higher tier exposure calculations and risk assessments (e.g. population modelling).
- Analyses of monitoring data and proposing emission-reduction measures