Regulatory Affairs of plant protection products and active substances
Our Regulatory Affairs team acts in the framework of Regulation (EC) No. 1107/2009 to prepare, submit and follow-up on plant protection product applications.
We guide you through the regulatory process in all of the European Union member states and the associated countries.
Consulting services
- Consultation on questions regarding application and authorization procedures with EU authorities
- Supervision of applications up to product authorization and beyond
Technical capabilities
- Compilation of dossiers in the CADDY.xml format
- Submission and administration of applications in Germany via the electronic applicant portal with Germany as Zonal Rapporteur Member State, Concerned Member State, or mutual recognition
- ESFC submissions replace the previous PPPAMS system for emergency authorizations under Article 53 of Regulation (EC) No 1107/2009. The use of ESFC for other PPP applications will follow in the future. We will also support you in this regard.
- Creation and submission of poison centre notifications (PCN)
- Submission of Dossiers with IUCLID
Applications
- Preparation of national addenda for product approval and re-approval according to Regulation (EC) No. 1107/2009
- Preparation of product labels including translations and adaptions according to national requirements
- Technical translations of Safety Data Sheets (SDS) from EU languages into German and English
- Review of classifications according to Regulation (EC) No. 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP Regulation)
Submission
- Submission of applications for authorization in all member states of the European Union and associated countries
You can take advantage of individual services or a full-service package according to your needs.
