Rivendell provides regulatory services for the support of biocidal active substances under the Directive 98/8/EC review programme (the Biocidal Products Directive, or BPD). We have considerable experience working with a wide range of active substance/product type combinations, in particular preservatives and pest control products. Since the beginning of the review programme, Rivendell has worked on submissions for over 10 product types. Our consultants have the expertise to prepare all sections of a dossier and carry out the required risk assessments, including the development of approaches to risk assessments in cases where Emission Scenario Documents (ESDs) are not available. We can prepare all or part of a dossier, depending on a clients needs. As with plant protection products, Rivendell also act as the ‘only representative’ for some non-EU based clients, in order to facilitate their support of active substances under the BPD.

Rivendell consultants are also actively involved in several task force programmes for biocidal active substances. 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 biocide clients wishing to join or obtain data access for a particular global region. In cases where data access is denied, we work with clients to develop alternative datasets to address data protection issues.

Rivendell has also successfully obtained national registrations in individual Member States in accordance with existing biocidal legislation. Through our EU offices in Ireland, Spain and Slovenia, we have the necessary multilingual capability and regional specialisation to communicate effectively and efficiently with the EU member state authorities. We also represent clients in meetings with national regulatory authorities and scientific bodies (e.g. Evaluation Meetings at an EU level) on a regular basis.

Rivendell also have an administration team in house that is specifically equipped and experienced in the compilation of hard-copy and electronic copies of submissions.

In summary, our range of services for biocides includes:

• Review of existing data packages to identify data gaps and suitability of data for submission (‘data gap analysis’)
• Review of data and properties of active substance as part of a ‘feasibility study’ to ascertain the potential success of a submission through to Annex I, IA listing
• Preparation, submission and follow-up in relation to whole or part dossiers: Documents I-III of summary dossiers for all sections including completeness checks, listing of endpoints and all related documentation as well as Document IV
• Risk assessments for human health and the environment, including the development of approaches where Emission Scenario Documents (ESDs) are not available
• Development of data waivers and reasoned scientific justifications for non-submission of data, where appropriate
• Preparation of IUCLID dataset
• Dossier compilation, copying and submission to Rapporteur Member State (RMS) and additional circulation to non-RMS Member States as part of evaluation process
• Liaison with the RMS and other authorities throughout evaluation
• 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
• Preparation and submission of applications for registrations under existing national rules at Member State level
• Representation of clients in meetings with regulatory authorities and at Evaluation Meetings at an EU level
• 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