On 29th June 2016 HSE introduced new processes and procedures for the authorisation of plant protection product applications under Regulation (EC) No 1107/2009. Changes to the criteria for the Detailed Technical Sift are now being introduced, following receipt of feedback. The key changes being introduced, on 27th November 2017, are:
General issues (e.g. discrepancies in the GAP, label, addressing EFSA data gaps) relevant to all specialist areas have been included in a new separate section Minor issues, those not considered reasons for rejecting an application but may need to be addressed for an authorisation, will be highlighted to applicants in the conclusion of the DTS. Highlighting these issues early in the evaluation process will provide additional time for them to be addressed by applicants Based on experience a number of rejection criteria have been removed from each specialist area Links to UK and EU guidance documents have been included to support applicants preparing an application for submission The mammalian toxicology section has been separated out into mammalian toxicology and operator exposureThe changes to the DTS criteria are outlined in the guidance document ‘Overview of the Processes and Procedures for the Authorisation of Plant Protection Productions in the UK under Regulation (EC) No 1107/2009. http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/applicant-guide/applicant-guide-contents.htm?utm_content=&utm_medium=email&utm_name=&utm_source=govdelivery&utm_term=
GPP 4: Treatment and disposal of wastewater where there is no connection to the public foul sewer. GPP 4 provides guidance on environmental best practice for Northern Ireland, Scotland and Wales. http://www.netregs.org.uk/media/1471/gpp4-20171114-online-v2.pdf
HSE advise that the Environmental Fate and Behaviour MACRO (v4.3b) higher tier drainflow spreadsheet is now available to download from http://www.hse.gov.uk/pesticides/topics/pesticide-approvals/pesticides-registration/data-requirements-handbook/fate/macro.htm There is also the option for higher tier drainflow assessments to be performed using the Webfram model. Applicants should note that either approach to refining first tier exposure assessments is acceptable and it is not necessary to pass both methods. Applicants are encouraged to use either of the harmonised tools as soon as possible in regulatory submissions to the UK. However HSE will continue to accept individual Applicant approaches to running higher tier MACRO simulations for a period of six months (to June 2018)
GPP 20 Dewatering underground ducts and chambers. http://www.netregs.org.uk/media/1477/gpp-20-publisher-pdf-version.pdf