Zonal Harmonisation: Birds and Mammals Risk Assessment
Interim Scheme for Minor Crops
It is noted that this scheme is relevant under Regulation 1107/2009 as it applies in Northern Ireland only.
This scheme forms part of a wider programme of measures to secure early benefits from zonal harmonisation. Under the scheme relevant applications for authorisation will not be subject to a review of the bird and mammal risk assessment by HSE. There is still some way to go before a fully harmonised approach to bird and mammal risk assessment and risk mitigation and associated management is agreed. This scheme is intended to serve as an interim measure until greater harmonisation is achieved. Longer-term discussions between central zone Member States with this aim are anticipated.
The interim scheme will cover all applications for uses on crops grown on limited areas where the UK is a 'concerned Member State' (in the zonal process) or through mutual recognition, and where the UK assessment is based on a Uniform Principle assessment conducted by another Member State (the zonal rapporteur). The scheme is directed at limited area crops (defined for the purpose of the scheme as those grown on fewer than 5000ha in Great Britain). Rather than drawing up an extensive list of minor crops it is more convenient to define eligibility on the basis of those crops excluded from the scheme on the basis that the total area grown exceeds the cut-off value used.
Application of the scheme will reduce the regulatory burden for industry and allow HSE to focus on other assessments for more extensive uses. Restricting the scheme to limited area grown crops is to ensure that any environmental impact that might result from relying on assessments performed by another Member State will be very limited, noting that in any case, other Member States has concluded the risk is acceptable.
HSE recognises that, although EFSA guidance in this area is already available, the approach to bird and mammal risk assessment between Member States differs, particularly at the higher tiers. There is thus scope for the outcome of a zonal or mutual recognition authorisation to differ from the position that would have been reached had the application been made directly to HSE.
In operating the new scheme, it is therefore possible that occasional situations will arise where similar uses are treated differently in regulatory terms. For instance, an application made under the zonal arrangements and evaluated by another Member State could be approved, but a similar application made to the UK refused, or vice versa. HSE will keep the scheme under review but if anomalies do arise, then it is likely the situation would be resolved by applying the outcome of the UK evaluation to both authorisations.
In introducing this scheme HSE recognises that there will be situations (such as the possibility that either a product or products containing the same active substance may be applied to several minor crops, ie the total area treated is greater than 5000 ha) where the risks in the approach proposed may be greater. Situations like this will be considered in the context of the wider review.
Relevant applications made under either the zonal procedure, where the UK is not the zonal rapporteur (ZRMS), (Article 33 of Regulation (EC) 1107/2009) or the mutual recognition procedure (Article 40) will, from the date of this regulatory update, be considered under this scheme. The scheme will also apply to applications for extension of authorisations for minor uses submitted under the mutual recognition procedure (see Article 40 paragraph 2).
The scheme will apply to both ongoing applications and new applications. However, earlier decisions will not be reviewed without a new application for consideration.
When HSE assess the ongoing applications, they will review the ZRMS bird and mammal assessment only with respect to uses on crops on the annexed list. In doing so it may be necessary to contact the applicant for further information (with the possibility that an additional fee module will be charged). For crops/uses not on the list, HSE will accept the ZRMS conclusions.
For new applications submitted after the introduction of the scheme, applicants should highlight which uses should be excluded from further review (in their covering letter and/or national addenda). If you are uncertain about eligibility for the scheme, please contact HSE before you submit an application.
The scheme will be reviewed periodically to ensure it meets its aims of reducing costs to applicants and to HSE whilst, at the same time, not compromising environmental standards.