DormFresh must now inform you that following receipt of a letter from CRD our 1,4SIGHT® (1,4-dimethylnaphthalene) registration in the United Kingdom has been denied. The reason stated for this rejection is due to CRD’s perception that data gaps exist. CRD has rejected our recent submission of additional data and comments in some specific areas. It appears that the opinion of CRD is not harmonized with other European Member States.
After careful consideration and discussion with our regulatory consultant and business partners DormFresh is now reevaluating its options with a view to pursuing this registration at a future date.
CRD’s decision comes at a time following active substance approval (Annex 1) [which was fully endorsed by CRD], European MRL and Netherlands Registration all being confirmed and other National Registrations progressing. These decisions will allow the importation of 1,4SIGHT® treated potatoes into the UK.
It is now clear that there is no immediate remedy given CRD’s current position. Any options to pursue the UK registration further will be on a 2 – 3 year timeline. This is a huge disappointment to DormFresh given this naturally occurring compound found in potatoes was originally discovered and developed in the UK.