As more active substances obtain Annex 1 inclusion, the re-registration of plant protection products at Member State level is becoming increasingly important for companies. Often the products and uses that need to be re-registered will cover a wider variety of uses and formulations than those assessed to support Annex 1 inclusion, this increasing data requirements and risk evaluations at the national re-registration stage. Exponent's high level of technical expertise and regulatory experience makes us the ideal choice for addressing Member State requirements and dealing with issues not addressed at Community level:
National Operator Exposure Risk Assessments: Over the years Exponent’s team has gained a great deal of experience in addressing operator, worker and bystander exposure in line with national requirements using both deterministic and probabilistic techniques.
National Diets: Exponent has been involved in the collation of national diets throughout Europe. This combined with innovative solutions to addressing consumer exposure issues enables us to estimate and refine exposure at the Member State Annex III level.
Higher Tier Environmental Risk Assessments: National environmental protection aims vary between countries as do the acceptability of mitigation measures such as the use of buffer zones. Whether dealing with endangered species issues or country-specific avian and mammalian risk assessments, we use a combination of deterministic and probabilistic approaches to refine exposure at the national level.
National Environmental Scenarios and Protection of Ground Water Under Vulnerable Conditions: This is a critical issue in many c tountries and our expertise in simulation modelling,which includes national scenarios in addition to FOCUS groundwater and surface water scenarios is a great asset in effectively addressing Member State concerns.
Efficacy and Crop Safety: These aspects are not assessed at Community level but are critical for re-registration. Furthermore, the uses and/or good agricultural practice assessed for Annex 1 inclusion could significantly differ from that required to support efficacy claims. Exponent can advise how best to address these differences and in the preparation of biological assessment dossiers targeted to meet Member State requirements.
Annex 1 inclusion also offers opportunities for companies to register products containing new sources of active substance using unprotected Annex II data and Exponent can assist in preparing Annex III dossiers for this purpose.