United Kingdom
July 28, 2014
Source: Health and Safety Executive
Summary
HSE Chemical Regulation Directorate (CRD) will no longer require an assessment of the retention of active substances during storage of treated seed.
Background
Regulatory Update 14/2013 ‘Zonal Harmonisation Programme’ explained that HSEwas to examine areas of risk assessment where an EC harmonised position would be appropriate under Regulation 1107/2009.
One project reviewed the long-established UK data requirements for seed treatments, covering aspects of efficacy and physical/chemical properties of the formulation. The project considered assessments carried out by other Member States, and compared these to the protection provided by existing UK requirements.
This review has changed the UK Requirements on stored treated seed.
Evidence to support the retention of active substance on stored, treated seed
Efficacy Guideline 208, ‘Seed Treatments – Efficacy and Physical/Mechanical Data Requirements’ describes the UK National requirements for seed treatments, both Efficacy and physical/chemical studies.
Included in this is a UK requirement to consider the retention of active substance when treated seed was intended to be stored before sowing. This could be addressed either by seed loading studies (before and after storage), or by effectiveness trials using stored seed (and a case therefore that sufficient active was retained on the seed during storage). The period of storage for most crops, to encompass the possibility of using treated seed in the following season, was considered to be typically 18 months. In the absence of suitable studies, the seed treatment product label specified a restriction to ‘sow treated seed within one month’.
New UK Requirements
Following consultation with other Member States, it is apparent that retention of active substances during storage of treated seed is not widely considered. HSE has decided to adopt a more harmonized regulatory appraisal, which will no longer automatically consider this aspect. There will be no requirement to submit data (seed loading studies or effectiveness trials) using stored treated seed; and no restriction in the absence of data. Instead, all seed treatments will carry the following precautionary general statement:
‘Sowing treated seed that has been stored for prolonged periods (beyond the season of treatment) may adversely affect effectiveness and/or crop safety’
This revised system does not preclude companies from choosing to support a specific label claim concerning the period of time treated seed may be stored before sowing. In such instances, data should be generated as described in Guideline 208, with the storage period in any studies reflecting the length of time proposed on the label.
Implementation
The implementation date for this revised system will be 1st November 2014. For those applications currently under evaluation by CRD, companies may refer to this update if they wish to revise any proposed label claims or restrictions
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