The HSE Podcast

After UK Transition: Working with Chemicals - Episode 1 - PPP

December 8, 2020

After UK Transition: Working with Chemicals - Episode 1 - PPP

Plant Protection Products (PPP) - Rachel Brown - PPP lead in CRD (Future Readiness) Transition Programme at HSE and Duncan Williams - Lead for Pesticides Post 2020 Transition Project at DEFRA. We discuss what the UKIM bill means for PPP products/applications, the implications for businesses involved in the manufacture, distribution and supply of pesticides and the data businesses will need to supply to HSE.

 

Visit our website for further information and detailed guidance on the chemical regimes

 

*The information in this podcast was correct at time of publication.

Podcast transcript

Good day and a warm welcome to the HSE podcast brought to you by the Health & Safety Executive to guide you through the changes in chemical regulations which are happening as a result of the UK leaving the EU.  In this episode we’ll be hearing from our experts about how plant protection products, otherwise known as PPP Regulations, will be changing from the 1st January 2021 once the transition period is over.  From that date a new independent pesticides regulatory regime will operate and Great Britain will take responsibility for placing PPP’s on the market in this country.

My name is Mick Ord and before I introduce you to our guests, I’d like to point you in the direction of the HSE website where the information we refer to today can be found.  The place to go is www.hse.gov.uk/brexit.  And what I’d also urge you to do is to subscribe to our free bulletin service to stay up to date with all the latest news and guidance on pesticides so you have all the relevant information at your fingertips and you can do this via the website.

Rachel Brown is the HSE’s Transition Programme Manager for Pesticides and Duncan Williams is Team Leader for Pesticides at Defra, the Department for Environment, Food and Rural Affairs.

Mick:
Duncan I’ll start with you if I may.  What are the main changes that will apply to plant protection products from January 2021 in terms of PPP regulations?

Duncan:
Ok, so at the end of this year the transition period for leaving the EU will end so that means from the 1st January next year we’ll be operating a new independent pesticides regulatory regime in Great Britain by which I mean England, Scotland and Wales.  It’s slightly different in Northern Ireland, so we’ll come onto them shortly.  So in Great Britain the EU Legislation is essentially carried over into national law.  So, all the regulatory requirements of the current EU regime, all the technical standards, are carried over unchanged into our national regime.  It will look and feel very similar to the current EU regulations, except we’ll be taking our own decisions rather than being covered by EU decisions.

That means there’ll be some degree of divergence from EU decisions over time for example maybe different decisions at different times or sometimes different decisions and of course any EU decisions which come into force after the end of this year, won’t apply in Great Britain.  If they come into force before the end of this year, they will and they will be carried forward.  So that’s things like active substance decisions, Maximum Residue Level (MRL) setting and so on.

Mick:
What about businesses operating in Northern Ireland – what’s going to happen to them?

Duncan:
Ok, so under the Northern Ireland Protocol, the EU Plant Protection Product Regulations and also the EU Maximum Residue Level Regulations – they’ll continue to apply directly in Northern Ireland so there’s less change.  So in Northern Ireland the position is basically remaining as much as it is now during the transition period.  That means EU active substance approval decisions, MRL decisions, they will all continue to apply directly in Northern Ireland.  They’ll still have responsibility for product authorisations under that EU Framework and that function will continue to be delivered by HSE for Northern Ireland.

Mick:
How similar will the new GB regulations be to those from the old EU process?

Duncan:
Very similar.  The name of the legislation actually remains the same.  We’ll still be referring to EU Regulation 1107/2009 as it applies in Great Britain.  Some changes have been made to the legislation so that the regulations can operate properly in a national context outside the EU.  For example the EU Regulations for various centralised decision making processes and so on built into them which have had to be replaced by national processes but there’s no substantive policy change. All the retained EU law, retained EU law is what we call the legislation we’ll keep in Great Britain afterwards, that’s been put online at legislation.gov.uk  and you can see the changes which have been made to it.  The regulatory requirements remain the same and the body of EU technical guidance which underpins the legislation that’s used to make decisions, all of that is carried over as well and will continue to be used in Great Britain after the 1st of January so there’s no change in the standards of protection, the big difference is that decisions will be taken by national bodies rather than through EU processes and EU institutions.  So that’s HSE, Defra and the Scottish and Welsh Governments working closely together.
HSE remains the national regulator for the whole of the United Kingdom on behalf of the UK Government and the devolved administrations in Scotland, Wales and also Northern Ireland.   HSE will continue to do the majority of the work and decision making and we’ll all be working very closely together in a shared governance framework.  HSE will continue to accept applications in much the same way they do now.

Mick:
Rachel, how will the application forms be different to those from the old EU process?

Rachel:
So as Duncan says, the name of the legislation actually remains the same, so we are still going to be referring to EU Regulation 1107/2009, as it applies in Great Britain and this means that a lot of our templates and application forms will actually appear to be unchanged.  We will continue to accept applications in the same way as we do now, and will still need a registration report in the same format in support of an application and there’ll only be some really minor changes to the application form such as whether an application is relevant for GB or NI and these will be published on our website in time for use after Day 1.

Mick:
Will existing PPP Product authorisation previously granted by the UK still be valid and if so for how long?

Rachel:
Yes, on Day 1, all the existing Plant Protection Product authorisations previously authorised in the UK, they’ll continue to be valid in both GB and NI. We won’t be issuing any new product notices at all.  The existing notices and their current expiry dates will all remain unchanged.

Mick:
Will GB continue to issue parallel trade permits from 2021?

Rachel:
We will no longer be able to accept applications for parallel permits into Great Britain.  These are an EU measure and we just can’t operate that outside the EU context.
However, we have put in place some transitional measures to allow time for businesses to adjust and can continue to issue parallel trade permits for sale and use in Northern Ireland.

Mick:
How long will current parallel trade permits be valid for?

Rachel:
So for GB, the existing permits which were granted prior to 31st December 2020, they’ll be allowed to continue until 31st December 2022 or they may expire on their existing expiry date if that is an earlier date before December 2022.   The withdrawal action will be published for all those existing parallel import permits and we are hoping that will be done in the first part of 2021.  This will allow time for stocks to be used up or for any new applications made under national regimes if necessary.

Mick:
Back to you again Duncan.  What is the situation with reference to active substance approval – will they continue to be valid until their expiry date?

Duncan:
On Day 1, 1st January 2021, all active substance approvals which are in place will continue to be valid, they’ll be carried forward in Great Britain obviously the EU regime continues to apply in Northern Ireland anyway so no changes there. We’ll have a new statutory register for active substances in Great Britain. This will be clearly published on the HSE’s website and it will show all the active substances which are approved in GB.  It will replace the EU’s list of active substances which are in Commission Implementing Regulations if you are familiar with those and the content is the same at Day 1.   So all of those active substance approvals   are carried forward and with that new national statutory register, basically an active substance has got to be approved and listed on that register for it to be included in any Plant Protected Products for use in GB.

It’s worth noting that we’ve made some transitional provisions so that the old EU regime can link smoothly to the new national one.  One of these is that in Great Britain, the expiry dates of active substances where they were due to expire in the EU within 3 years of the end of the transition period.

Those ones will be granted a 3 year extension under the Great Britain regime and this is because applications for renewals have to be made 3 years before the expiry date and obviously if it’s within 3 years of the end of transition, that date will have already passed when the national regime comes into force so the extension is necessary to have an orderly transition to the new regime.  So this means active substances which were due to expire in the 3 year period from 1st January 2021 right through to the end of 2023, they will be extended for a further 3 years in Great Britain.   Just for reassurance, we can act sooner if we needed to for any reason so for example if there was new important data or scientific evidence about concerns with a particular substance, then there is provision within the legislation for action to be taken sooner should that be warranted.

Mick:
What happens when it expires Duncan?

Duncan:
If an active substance approval expires then obviously the products relating to that active substance have to be withdrawn but if you want a renewal for that active substance, then you need to make an application for that renewal under the GB regime.  That application will be assessed by the HSE and then a decision will be taken under the GB regime.  Obviously, that would just apply in Great Britain not Northern Ireland or in the EU.  We will be developing a system for renewing approval of active substances – I mentioned we would have a 3 year extension to the expiry dates for those active substances which are due to expire within 3 years and that will allow time for us to finalise and apply the new ways of working and any new EU decisions on active substances or on Maximum Residue Levels which are taken and come into force before the end of this year, those ones will be carried over.  If those EU decisions are after the end of this year, then they are not carried over and the applications are needed under the GB regime.

Mick:
Will companies need to supply different data to the HSE than they were required to do when we were in the EU?

Duncan:
So the documentation supporting an application will, as far as possible, be the same as it is now so HSE will accept applications in the same way.  They will still require registration reports or assessment reports in the same format in support of applications for authorisations or approval.
Mick:
And so will GB continue to accept alternative sources of active substances deemed equivalent by the EU?

Duncan:
Again, it will be a GB process for that.  You’d need to submit an application to HSE and it’s basically the same process as is currently in place to establish the equivalence of an alternative active substance source that’s followed now.

Mick:
Rachel, the UK will no longer have a formal arrangement for mutual recognition.  What are the implications for businesses involved in the manufacture or distribution and supply of pesticides?

Rachel:
Yes, that’s right Mick.  For Great Britain, HSE can no longer accept any applications for mutual recognition of authorisations in EU member states.  Any existing ones will continue in place though, if we’ve already granted the authorisation before the end of December.  The exception is that for applications considered under the Northern Ireland regime, we will be able to accept mutual recognition applications.  If we’ve got any applications on going, ones in the queue that haven’t been completed yet, these will be completed to conclusion under the GB national regime and going forward for authorisation in GB you will be required to submit a stand alone GB application.

Mick:
In 2024 businesses involved in the production and supply of treated seeds in GB will need to do things differently as well – can you just explain the changes?

Rachel:
Yes, this is quite a specific area but under the EU regulations, seed can be treated in any member state with a product authorised for that purpose in that member state.  That treated seed can then be traded and used freely in any other member state.  This is going to change in the future for Great Britain.  So again, we’ve put some transitional provisions in place to allow time for businesses to adjust.  The current arrangements will be allowed to continue in Great Britain until 31st December 2023.
So until that date, any seed which has been treated with a product authorised for that purpose in another member state can still be traded and used in Great Britain.  However, after the 31st December 2023, only seed which is treated with a product authorised for that purpose in GB can be traded and used.  Now this could mean that new authorisations for use in GB may be required so that’s why the current arrangements are being allowed to continue until 2023 to allow time for the necessary applications and authorisations to be made to the GB authority.  Any existing arrangements in Northern Ireland, can continue to apply.

Mick:
And how will the adjuvant application process work after 1st January 2021?

Rachel:
So for adjuvants there isn’t actually a change there.  The process for registering adjuvants in the UK will remain as it currently is.  Adjuvants are currently considered under national rule, rather than EU rule so there’ll be no change for GB and NI.  All the existing adjuvant registrations will remain valid in GB and NI going forward.

Mick:
Duncan, how will Maximum Residue Levels (MRLs) be set in GB after 1st January 2021?

Duncan:
Existing MRL’s at the end of the year are all carried over into the national regime so there’s no immediate, practical change.  After 1st January, we will be making our own decisions in GB, setting MRLs based on our own assessments so you’ll need to submit an application to HSE to set an MRL in GB.  The regulatory framework, the technical guidance for setting those MRLs, is all carried over and we will have a statutory register for GB MRLs which will be publically available on the HSE website.  It’s worth noting this means that whilst MRLs in GB and the EU and Northern Ireland will be aligned as of 1st of January, moving forward there will be some degree of divergence from the EU MRLs over time.

Mick:
And what does the UK Internal Market Bill mean for PPP products and applications?

Duncan:
The UK Internal Market Bill is currently going through Parliament and the Bill includes a new principle of mutual recognition to allow the operation of the UK internal market for goods.  That will allow any goods which meet the relevant regulatory requirements relating to sale, in the part of the UK where it’s produced or imported into, to then be sold in any other part of the UK.  Now this new mutual recognition principle will not affect product authorisation or active substances approvals.  Each part of the UK will remain responsible for deciding which pesticide products can be authorised for sale and use in their respective territories just as they are now, though in practice we almost always have joint decisions applying across the piste by agreement.

The position is slightly different for Maximum Residue Levels.  The intention of the Bill is that the mutual recognition principle will apply to rules on Maximum Residue Levels in the same way as it will apply to rules on goods generally to ensure effective functioning of the UK’s internal market.   This will avoid the potential for new internal trade barriers on sale of food which has been produced lawfully should there be any divergence in Maximum Residue Levels decisions.  This ensures that treated produce from Northern Ireland is able to be placed on the market in Great Britain for example.   There’s a caveat in that EU rules will continue to apply directly in Northern Ireland itself so treated produce will only be able to be placed on the market in Northern Ireland in accordance with the EU MRL regulations.  In practice, all the administrations delegate their regulatory functions to HSE to undertake on their behalf so that helps to ensure a consistent approach.  We’ve got structures in place to work closely together to continue to take joint decisions wherever possible.

Mick:
I’m going to now ask you both specific questions for specific sectors.  What actions do people and businesses need to take - Rachel?

Rachel:
So, if you are a pesticide manufacturer or authorisation holder, the key message is that current authorisations and approvals do all remain in place, but for the future you need to consider where you wish to make your new pesticide applications.  So, from the 1st January 2021, you are going to have to make applications under both the GB and EU regimes to gain access to both GB and Northern Ireland markets.
Future applications for renewal of current authorisations and approvals will also need to be made under both the Great Britain and EU regimes.  Do talk to HSE about your expected pipeline of applications.  Do come and ask us any questions if you are unsure of what to do.

Duncan:
If your business is involved in trading in food produce, the main thing to be aware of is that from 1st January next year, the Maximum Residue Levels in Great Britain and the EU might start to diverge over time.  I think the key takeaway is just to ensure you understand the requirements in your target market.  It’s not for immediate action because they’ll all be the same at Day 1, but they’ll likely diverge over time.   If you are a pesticide user or someone who advises on pesticides, again there’s no immediate change, the same products will be authorised on the other side of the end of the year, so in the short term just continue to use only authorised products always following the instructions on the label.  Over time there may be some extra things to think about if you’re growing food produce intended for export for example to the EU and again, make sure you understand  the requirements for treated produce in your target market as it might affect the choices  you make about what pesticides to use.

Mick:
So, quite a lot to take in if you’re involved in the manufacture, supply or distribution of pesticides.  Remember you can rewind the podcast at any time or listen again at your convenience.  A big thank you to Rachel and Duncan our resident experts on PPP.  You can, of course, also logon to our website, www.hse.gov.uk/brexit<http://www.hse.gov.uk/brexit>, where you’ll find in written form, everything we’ve been chatting about today and much more.   And as I mentioned earlier, you can also subscribe to our free bulletin service to keep you abreast of the latest news and updates as it affects your sector.  You can do this via the website.  You’ll find a subscription box on every page and you can just pop in your email address and leave the rest to us to keep you informed.

Well, that’s all from me, Mick Ord until the next episode, so until then, take care.

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