PHYTO

PHYTO

We offer advice on phytosanitary products, assisted by technicians specialized in different scientific fields, from agronomy to chemistry, as well as human toxicology and eco-toxicology.
Our goal is to identify and propose innovative solutions that allow our customers to develop their products considering the continuous innovations in the regulatory and scientific fields, at sustainable costs.
We also assist agrochemical companies in regulatory activities not strictly related to plant protection products, specifically fertilizers and bio-stimulants, offering a wide range of Regulatory consulting Services dedicated to the entire market of the agricultural inputs.

SERVICES for Plant Protection Products
Project management services
  • Identification of goals
  • Preliminary risk assessment
  • Data gap analysis
  • Planning and monitoring of field trials (efficacy, selectivity and residues)
  • Strategic advice
Monitoring of field and laboratory studies
  • Study/field trials programs
  • Support to clients in selecting CROs and ensuring two-way communications
  • Managing and monitoring of laboratory tests
  • Laboratory/trial visit
Elaboration of technical and administrative dossiers
  • Preparation of dossiers for new product or renewal (dRR – zonal dossier)
  • Data collection and evaluation
  • Human Health risk assessment (EFSA, 2014 and national models)
  • Consumer risk assessment (PRIMo and national models)
  • E – fate calculations
  • Fauna and flora risk assessment (Tier I and Tiers II, National risk mitigation measures)
Application for Mutual Recognition
Label extension dossiers for major and minor uses
Follow – up with the Authorities
Post-approval follow-up
National (D.lgs n. 75/2010) and European fertilizers (Reg. (EC) n. 2003/2003)
  • Classification and labelling
  • Registration under the appropriate category
  • Compliance with the updated regulatory requirements
“Plant Resistance Improvers”, “Basic Substances” and other new products
  • Product’s review
  • Identification of the most appropriate category
  • SIf needed, request for the inclusion of a new category
  • Processing of the new submission dossier
Field trials and laboratory analysis
  • Product’s review and definition of the parameters to be evaluated
  • Collaboration with CROs (Contract Research Organisations) and laboratories
  • Managing and monitoring of laboratory tests
Assistance and legal consultancy
  • Assistance for compliance/non-compliance with national (D.lgs n. 75/2010) and/or European standards (Reg. (EC) n. 2003/2003)
  • Support in case of Authority inspections
Audit to the manufacturing plants and verification of national and Community requirements

Processing of technical reports for the registration/approval of organic fertilizers and soil improvers establishments or plants (Articles 23-24 of Reg. (EC) n. 1069/2009) and traceability internal report (HACCP)

Training courses related to all the above mentioned issues

ALESSIA ROSSETTI
AREA RESPONSIBLE
ALESSIA ROSSETTI
Regulatory Affairs Specialist

alessia.rossetti@kahlbergconsulting.com

Phone +39 02 6700319