DEVREG offers its consultancy services on pegistration of PPPs (pesticides, herbicides, fungicides, biopesticides) in the EU, based on a highly regulated, multi-step process, under:
- Regulation (EC) No 1107/2009 – authorization of plant protection products
- Regulation (EC) No 396/2005 – maximum residue levels (MRLs)
- Regulation (EU) 2024/… updates & ongoing amendments
- Assessment of active substance and product eligibility
- Identification of data gaps
- Planning the registration path (EU, zonal, mutual recognition)
- Cost and timeline forecasting
Dossier preparation for registration of plant production products:
DEVREG has the capability and expertise to prepare and submit dossiers for registration of formulated products, including:
- Comprehensive Draft Registration Report (dRR), including all relevant sections
- Physical–chemical data & compatibility studies
- Toxicological and environmental classification according CLP Regulation
- Operator, worker, bystander exposure models
- GAP table & efficacy summary
- Efate modelling
- Risk assessments (human health, environmental, ecotoxicology, dietary, groundwater)
Zonal & Interzonal, and national applications.
Regulation 1107/2009 divides Eu into three zones for PPP evaluation and authorisation:
- Northern zone
- Central zone
- Southern zone
Applications are evaluated on a zonal basis, but for some uses the EU is considered a single zone and a single Member State can evaluate a PPP on behalf of the entire EU; these uses are greenhouse uses, post-harvest treatments, treatment of empty storage rooms or containers and seed treatments
And designated zRMS assess applications on behalf of other countries in their zone (generally, openfield uses) and sometimes on behalf of all zones (protected and indoor uses).
DEVREG services include:
- Preparation of zonal dossiers
- Liaison with the zonal/interzonal rapporteur Member State (zRMS)
- Mutual recognition applications in other EU countries
- Response to Member State comments and data requests
- Communications with Authorities, including Rapporteur Member States (zRMS/izRMS), National competent authorities (ANSES, MAPA, DGAV, BVL, Ctgb, etc.)
- Support during peer review and expert meetings
Coverning a signification number of EU Member States, directly by our technical and regulatory staff or through national consultants with high expertise on these regulatory areas, manage and follow submissions, etc.