Fields - Plant protection products - Annex II and Annex III

Context:

The Annex II and Annex III dossiers gather studies which allow preparing a specific risk assessment for Human Health and the environment.

A.S.C. can help you to :

understand if Regulation (EC) No.1107/2009 really applies to your substance and/or product and its uses
define a registration strategy on an Worldwide, European or National scale,
notify a new substance or ask for an approval for a new preparation
prepare a dossier for a formulated product in the framework of post-Annex I re-registration
prepare formal documents for extension of use, ADEs (trial permits), bis products, parallel import, mutual recognition, change of composition etc.

At your request, A.S.C. can :

evaluate the existing studies and identify missing or critical data gaps
monitor all types of Good Laboratory Practice (GLP) studies,
estimate any missing critical parameter with a Quantitative Structure Activity Relationship (QSAR),
define the endpoints,
prepare risk assessments according to the International, European or National models:

risk to operators, workers and bystanders (UK-POEM, BBA, PHED, EUROPOEM II…),
risk to consumers (EFSA models, WHO or national),
fate and behaviour in the environment (FOCUS GW, FROGS and FOCUS SW models),
effect on non-target organisms,

write each section of the dossier in OECD format (Annex II) or in dRR format (Annex III) as well as attached documents (safety data sheet, label...)
adapt existing dossiers to match the specific requirements of any country with appropriate parameters
submit the dossier to the Authorities and follow it up to make sure the procedure goes smoothly
react to new requirements, prepare any waiver or exemption demand, until the approval is granted

Do not hesitate to contact us and to ask for advice, whatever is your implication in Regulation (EC) No.1107/2009 (synthesis, formulation, distribution,...) on active substances and Plant Protection Products.