Under the European Plant Protection Products (PPPs) Directive 91/414/EEC all new and reviewed PPPs intended for use in the EU must appear on a positive list (Annex I) before Member States (MS) can authorise their marketing and use (Annex III). For an active substance to be considered for inclusion on Annex I or Annex III, notifying companies must submit a complete data package (dossier) on both the active substance and at least one PPP containing that active substance. An important component of the dossier is environmental concerns, including ecotoxicology, fate and behaviour and risk assessments.

Detailed guidance documents on data requirements are available at the National and European levels, and the complexity in assessing the fate and behaviour of PPPs in the environment often leads to difficulties in demonstrating acceptable exposure risks to regulators. Often lower-tier risk assessments will predict unacceptable adverse effects in the environment and additional higher-tier risk assessment evaluations are required.

ARCHE has extensive expertise and a proven track record in delivering solutions to environmental problems encountered by our clients at all stages in the registration/review of PPPs. ARCHE provides a comprehensive range of services to support applications for Annex I listing of new and existing active substances according to the requirements of Directive 91/414/EEC. We prepare Annex III dossiers for products, including the accompanying BAD (Biological Assessment Dossier). Our consultants have the expertise to prepare all sections of the dossier and carry out the required risk assessments. We can prepare all or part of a dossier, depending on a clients needs..

ARCHE can offer you the following services: 

- Review of environmental sections of dossiers (fate and behaviour and ecotoxicological sections)

- Identifying data gaps and designing higher-tier studies

- Exposure modelling (FOCUS suite of models)

- Development of higher-tier exposure scenarios

- Preparation, submission and follow-up in relation to whole or part of the dossiers

- Product stewardship

- Liaison with the RMS and other authorities (e.g. EFSA) throughout evaluation

- Representation of clients in meetings with regulatory authorities and at EU Technical Review meetings