How to build a Plant Protection Product dossier compliant with European Regulation?
To register a product in the EU Member States or in UK, the applicant will have to check that it has access to the active substance data package and to a registered source of active substance. In addition, the applicant will complete a dossier addressing the data requirements relevant to the properties and risk assessment of the product (according to regulation (EU) 284/2013) .
Active Substance data
The PPP dossier will be written under a format known as the dRR (draft Registration Report). This dRR will contain a core dossier, intended for evaluation by the zonal Rapporteur Member State (zRMS) and national addenda for evaluation by the concerned Member States (cMS).
A dRR is divided into 12 parts.
Part A – Risk management
Part B0 – Background
Part B1-B2 and B4 – Identity – physical and chemical properties
Part B3 – Efficacy
Part B5 – Method of Analyses
Part B6 – Toxicity
Part B7 – Residues
Part B8 – Environmental fate
Part B9 – Ecotoxicology
Part B10 – Groundwater metabolites
How to submit a plant protection product dossier ?
The main stream of application procedure is the zonal applications.
The PPP dossier will be submitted to the zRMS, which will evaluate the core dRR on behalf on all Member State within the same zone. Other Member States, if any, are called cMS.
To this extend, the EU is divided under several administratives zones.
3 Zones for open field uses : North ,Centre and South.
1 Zone for glasshouse/indoor uses
1 Zonal Rapporteur Member State (zRMS) per Zone
The process for new PPP is ruled by Articles 28 – 39 + Annex I of Regulation 1107/2009/EC. The renewal process is ruled by the Article 43.
When is a zonal application required ?
Zonal application is required in each case a scientific evaluation is necessary to conclued if the applicant request meets the regulation criteria. This will be the case for:
- registration of new PPP;
- renewal of existing PPP;
- amendment of PPP registration.
- Packaging modification or addition.
- Label extension.
- Restriction removal.
- Formulation change.
What is a Mutual recognition?
Mutual recognition (MR), ruled by Article 40 of Regulation 1107/2009/EC, is an alternative to the zonal procedure.
Under certain conditions, a registration obtained in a MS can be transposed in another MS.
- The PPP must be the same in the two MS, with same uses and comparable agricultural and climatic conditions.
- The risk assessment must comply with the national requirements of the targeted MS for new registration.
Mutual Recognition offers a fastest registration timeline because the recieving Member States authority will rely on the evaluation already undertaken by the Reference Member State. However, MR is limited to the uses already registered in the reference Member State.