Speciality Chemicals Magazine MAR / APR 2021 | Page 24

‣ evidence identify any concerns to human health or the environment . It is also “ looking at ways of considering decisions on ASs taken in other jurisdictions ”. “ There may be a common application where there is no divergence between the two regimes . Future applications for renewal of current authorisations and approvals will also need to be made under both the GB and the EU regimes ,” Flynn said . The GB national AS review programme , Snaith observed , will seek to attain effective protection while remaining “ manageable and proportionate ”. How priorities will be balanced between a continuing reliance on using assessments by other regulators or doing more unilaterally remains to be decided . The HSE has consulted stakeholders on what they hope to see in the AS programme . Among the key things they have mentioned are :

• No need for significant resource in addition to other review programmes

• A data call-in system , akin to the US EPA system

• Grouping of ASs for review and reviewing classes of chemicals together , or ASs across legislation , or by function ( such as sugar beet insecticides , blackgrass herbicides , etc .)

In its interim review programme , the HSE is considering decisions made in other jurisdictions , Snaith added , such as AS expiry dates being extended . GB could use decisions the EU and other jurisdictions make as the basis for its own decisions . Again , there is a balance to be drawn between leaving decisions for GB ’ s own review programme and not duplicating work unnecessarily .

PPPs

Similarly for PPPs , noted Brian Woolacott , head of PPP delivery , all existing authorisations continue to be valid in the whole UK and the HSE will continue to process PPP applications for both GB and NI . From 2021 onwards , however , applicants require authorisation under both the GB and NI regimes to gain access to both markets Applicants can submit applications in the same format as before . Minor changes have been made to the application form but there have been none in the data requirements or the format for supporting information documentation . Any applications made before the end of the transition period would , with some exceptions , be processed as usual and those issued during this time will remain valid in GB and NI . Those issued thereafter will specify whether they are valid in GB , NI or both , and the application forms will include an option to select authorisation in GB , NI or both . What has changed as regards PPPs is that the HSE “ will reflect the extension to AS expiry dates in product authorisations as appropriate ”, Flynn observed . No formal application is required for this and authorisation holders will be notified when this has been applied to their products . Applications for GB product renewal under Article 43 of Regulation 1107 / 2009 will not be required until a decision is taken to renew the AS under the GB regime . The HSE will no longer accept new applications for mutual recognition ( MR ) of authorisations in EU member states ( MSs ) but will process any existing applications to a conclusion under the GB regime . “ Where possible , the HSE will maintain a common MAPP number ,” said Woolacott . “ Similarly , we aim to

24 SPECIALITY CHEMICALS MAGAZINE ESTABLISHED 1981