Rivendell 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. Rivendell has acted as the ‘only representative’ for many non-EU based clients, in order to facilitate their support of active substances under re-registration at EU level.

Rivendell consultants are actively involved in several task force programmes. The requirements vary from task force co-ordination and management to dossier preparation and study generation. Rivendell has also successfully negotiated with task forces on behalf of clients wishing to join or obtain data access for a particular global region.

Rivendell successfully obtains registrations in individual Member States in accordance with existing national regulations. Through our EU offices in Ireland, Spain and Slovenia, we have the necessary multilingual capability and regional specialisation to communicate very effectively and efficiently with the EU member state authorities. We also represent clients in meetings with regulatory authorities. In conjunction with Rivendell USA, we offer services for global management of active substances.

Rivendell was heavily involved in projects for reclassification of product portfolios according to the Dangerous Preparations Directive (DPD). With the advent of the Global Harmonisation System (GHS), further changes to the classification and labelling requirements for plant protection products will now be required.

In summary, our range of services for plant protection includes:

• Review of existing data packages to identify data gaps and suitability of data for submission (‘data gap analysis’)
• Preparation, submission and follow-up in relation to whole or part dossiers according to OECD Dossier Guidance: all tiers of summary dossiers for all sections, completeness checks, listing of endpoints
• Risk assessments for operators, workers, bystanders, consumers, the environment and non-target organisms
• Dossier compilation, copying and submission to Rapporteur Member State (RMS) and additionally circulation to European Food Safety Authority (EFSA) and other Member States at the time of peer review
• Liaison with the RMS and other authorities (e.g. EFSA) throughout evaluation
• Preparation, submission and follow-up in relation to Annex III (product) dossiers and BADs (Biological Assessment Dossiers)
• Design, implementation and completion of cost-effective testing programmes: management of study programmes, from single studies to large programmes involving several test facilities at different global locations
• Task force co-ordination, participation and management
• Global management of active substances, through our global network of offices
• Preparation and submission of applications for registration under existing national rules at Member State level
• Representation of clients in meetings with regulatory authorities and at EU Technical Review meetings
• Representation of clients in data access negotiations with other companies or task forces
• Due diligence audits prior to company purchase
• Classification and labelling of preparations, and preparation of MSDS
• Literature searches and reviews