6. National requirements

General requirements

The risk assessment must fulfil the national and zonal requirements and methodology specified in the Northern Zone Guidance applicable at the application date in Norway. In principle the assessment procedure of mutual recognitions should be a simplified process. Of this reason we do not accept or evaluate additional new studies which have not been evaluated or taken into account by the reference Member State (please see exemptions for bees in the section "*Environmental risk assessment"). However, the risk assessment should be updated to be in accordance with the methodology specified in the Northern Zone Guidance. This means that the product only will be approved if the risk is acceptable with the data/endpoints already evaluated in the original RR at the same time as the national and zonal requirements in the Northern Zone Guidance applicable at the application date in Norway are met.

If new data is necessary for approval of the product, the applicant should instead apply for approval of a new product according to article 33 in the Regulation.

As an EFTA state we are free to limit products containing active substances approved under Council Directive 91/414/EEC or the transitional measures in Article 80 of Regulation (EC) No 1107/2009 access to the market. These criteria will apply when assessing such substances.

Specific requirements for the different parts of the evaluation are given below.

Environmental risk assessment 

The environmental risk assessment (e-fate and ecotoxicological risk assessment) needs to address the general zonal and specific national requirements specified in the Northern Zone Guidance applicable at the application date in Norway. A safe use with these approaches should be demonstrated in the risk assessment.

Please note that there are specific Norwegian requirements for soil, groundwater and surface water modelling which must be fulfilled. If additional modelling is required, the risk assessment must be updated accordingly with PEC-values relevant for environmental conditions in Norway with accepted risk mitigation measures.

All focal species relevant for Norway needs to be included if a higher tier risk assessment for birds and mammals is required, as described in the guidance document on higher tier risk assessment for birds and mammals in the Northern Zone. The current version of the guidance document may be found here.

Data and risk assessment for bees as described in The Northern Zone Guidance will be required when the product originally was evaluated according to the data requirements in Commission Reg. (EU) No 284/2013. In these cases, we allow submission of additional studies when the original submission is not in accordance with the data requirements and the methodology in the Northern Zone. Product applications originally evaluated according to the data requirements in Commission Reg. (EU) No 545/2011, containing active substances approved under Council Directive 91/414/EEC or according to the transitional measures in the Regulation, will be assessed on a case-by-case basis and may be dismissed if available data (also from e.g. ongoing a.s. assessments or other product assessments) indicate unresolved or high risk to bees.

When field studies are included in the risk assessment, a justification of the relevance of the studies for Norwegian environmental conditions should be provided. Climate, persistence of the active substance and/or metabolites, the ecosystem’s ability to recover, species and life stage composition are examples of factors which may impact the outcome of a field experiment and may differ between different parts of Europe. Results from field studies not considered relevant to Norwegian conditions may be disregarded.

Residues  

A calculation of the risk for established MRLs to be exceeded when the product is used as suggested should be submitted. For outdoor use, the calculation shall only be based on results from residue trials performed within the Northern and Central Europe residue zone (NEU). For indoor use, one residue zone applies for all of the EU.

A compilation of the residue studies carried out within the Northern and Central Europe residue zone (NEU), corresponding to the use applied for, should be submitted unless included in the reference Member States’ registration report. The compilation shall include information on the application rate that has been used in the studies, the number of treatments and growth stage at application and at what pre-harvest intervals possible residues were measured.

Health hazard

The health risk assessment must fulfil the national and zonal requirements and methodology specified in the Northern Zone Guidance applicable at the application date in Norway. A safe use with these approaches should be demonstrated in the risk assessment.

In addition, the following should be considered:

• If field studies are used in the risk assessment, these must have been carried out under conditions relevant to Norway. This must be justified.
• A reduction in doses by application of higher dilutions of the product can be accepted, as long as this reduction will not increase the dermal absorption in such extent that this will result in an unacceptable exposure level.