The HSE Podcast
After UK Transition: Working with Chemicals - Episode - 3 - CLP, REACH & PIC

After UK Transition: Working with Chemicals - Episode - 3 - CLP, REACH & PIC

December 22, 2020

After UK Transition: Working with Chemicals - Episode - 3 - CLP, REACH & PIC

In this episode, we are joined by Alun Williams, Lead for External Comms and Stakeholder Engagement from the Chemicals team at DEFRA and Andrea Caitens, CLP, PIC and REACG Transition Programme Lead, Future Readiness at HSE.

We discuss the key differences between EU to UK REACH, the roles and responsibilities in UK REACH actions that people and businesses need to take in relation to CLP and PIC.

 

Visit our website for further information and guidance on CLP, REACH and PIC.

For any queries, get in touch via REACH & CLP: ukreach.clp@hse.gov.uk PIC: ukdna@hse.gov.uk

Podcast transcript

Welcome to the Health and Safety Executive podcast with me Mick Ord. I hope I find you in good health.  This is the fourth in our series of podcasts designed to guide you and your business safely through some of the regulatory changes which are coming in at the end of the transition period.

Over the past few weeks we’ve looked at BPR and PPP and this week we’re looking at a total of Three Regimes in the one episode – REACH, CLP and PIC.

REACH is of course the Registration, Evaluation, Authorisation and Restriction of Chemicals ; CLP is Chemicals Classification, Labelling and Packaging and PIC is Prior Informed Consent for the export and import of hazardous chemicals, all three of which will change to varying degrees at the end of December 2020.  So whether your company does business in Scotland, Wales, Northern Ireland or England we’ve some important information to relay to you.

After we’ve heard from our two experts, I’ll be giving out some important info about where you can find out more on what we’re talking about in this episode and also how you subscribe to our free eBulletin service so you’re kept in touch with news and developments as they happen.

For this episode, I’ve been speaking to Andrea Caitens a regulatory scientist from the HSE’s Chemicals Regulatory Division.  She’s also the CLP Lead in the Transitions Programme Team.  We’ll be hearing from Andrea shortly about the changes to CLP and PIC, but first from Alun Williams who’s the Lead for External Comms and Stakeholder Engagement from the Chemicals Team at DEFRA.  He’s been telling us about the changes to the UK REACH regulations.

Alun, you say on your website that the key principles for REACH are retained – so what are these principles?

Alun:
The regulatory framework that we are putting in place for UK REACH will retain both the fundamental approach of REACH with its aims of ensuring a high level protection of human health and its key principles of REACH.
These include the “no data, no market” principle, the “last resort” principle on animal testing, access to information for workers and the precautionary principle as well as the provision for Only Representatives otherwise known as O.Rs.

Mick:
What are you doing to mitigate costs to business?

Alun:
Well, we are keeping the transition to UK REACH as simple as possible, avoiding change for change’s sake.  For example, in building the Comply with UK REACH IT system, we have made sure it will work very much like the ECHA owned REACH-IT, including the same software requirements and many of the processes that businesses have been using and understand.

We have put in place “grace period of provisions” of “Grandfathering” and “Downstream User Import Notifications” to minimize the costs for businesses and maintain market access to both the EU and UK market.

Following concerns raised about the current timelines for supplying data to the UK regulator, we have decided to extend these deadlines which would enable industry to mitigate costs without reducing important environmental and health protections.

Mick:
Will UK business still be able to access the EU market?

Alun:
Yes, GB-based businesses wanting to place a chemical on the EU market will need to get that chemical registered with the European Chemicals Agency or ECHA.  That registration must be held by an organisation based in the EU.

GB companies wishing to expert chemicals into the EU/Northern Ireland after the end of the transition period would need to rely on their EU/Northern Ireland based customers to register as importers or they would need to transfer their registrations to an EU/Northern Ireland based legal entity or Only Representive.   ECHA has published guidelines on this.

Mick:
What changes Alun, are being made to the data submission deadlines?

Alun:
We have extended the existing data submission deadlines, set in legislation, as follows.

The initial notification stage for UK downstream users to submit Downstream User Import Notifications or DUINs, as they are colloquially known, has been extended from 180 to 300 days from 1st January, 2021.  As a result, UK downstream users will have the opportunity to assess how existing EU REACH registrants have met the 120 day deadline and use it to inform their own process.

We have also extended the deadline for completing a full registration supported by full data packages to 2, 4 and 6 years from the end of the initial 300 day period.  The deadline for final submission of data underpinning the full registration is dependent on tonnage bands and hazard profile, with the highest tonnage bands and most hazardous chemicals first.

Mick:
Will Northern Ireland be part of UK REACH?

Alun:
So, for the duration of the Protocol, Northern Ireland will remain part of the EU regulatory systems for chemicals to ensure frictionless movement of goods within the island of Ireland, whilst remaining within the UK customs territory.  We are also offering a streamlined process for Northern Ireland chemicals to be notified with UK REACH to facilitate trade from Northern Ireland to Great Britain.  Northern Ireland businesses can notify direct should they wish to do so; otherwise the responsibility will lie with their GB customer.

Mick:
When will companies be able to access the appropriate forms on the website?

Alun:
These will be available when the Comply with UK REACH IT system goes live from the end of the transition period.

Mick:
What will be the functionality of the UK REACH IT system?

Alun:
The Comply with UK REACH IT system will replicate key functions of the EU REACH IT system to provide continuity for GB businesses.  At the point of launch, businesses will be able to use the service to validate existing GB held EU REACH registrations so Grandfathering, as we discussed earlier.  They’ll be able to submit Downstream User Import Notifications.  You’ll be able to submit a new substance registration.  You’ll also be able to submit new  product and process orientated research and development – PPORD – notifications.

Mick:
Is the information they need to supply to the HSE different to the previous requirements in either quantity or nature of content?

Alun:
It’s important that people consider what their new roles are within UK REACH.  So for example a lot of the information will be exactly the same, but perhaps their roles within the process have changed.  So for example if you were previously a downstream user you may now have importer obligations under UK REACH.  We strongly recommend that you go to the HSE website and read the guidance there as to identify what information you’ll need to supply.

Mick:
Andrea, CLP as we know refers to the Classification, Labelling and Packaging.  In 2021 after transition the legislation changes to GB CLP – what are the main changes which will happen?

Andrea:
Businesses based in Great Britain that place chemicals on the GB market and that’s both substances and mixtures, will have to comply with the GB CLP regulation and this will also apply to those suppliers based in Northern Ireland who supply directly to the GB market.
However, it’s important to know that the majority of CLP Regulation remains unchanged and the main duties to classify – that is to identify the intrinsic hazardous properties  and communicate information about those hazards through labelling and to securely and safely package those chemicals will all remain the same.

From the 1st of January, 2021, Great Britain mandatory classification and labelling or GB MCL, will replace the EU harmonised classification labelling system and Great Britain will make its own decisions about mandatory classification and labelling.  All of the existing EU harmonised classification and labelling at the end of the transition period, will be kept as GB mandatory classification and labelling and GB suppliers will need  to comply with MCL in the same way as they did with EU harmonised classification and labelling before.

Those substances with a GB mandatory classification and labelling will be included in the GB MCL list and this will be hosted and managed by HSE as the GB CLP Agency.  GB-based suppliers supplying in the Great Britain market with chemicals and Northern Ireland based suppliers who supply directly to the GB market will deal with HSE as the GB CLP Agency instead of the European Chemicals Agency or ECHA and this will include when notifying substances to the GB notifications database and for submission of requests to use alternative chemical names.

There will be new requirements on GB-based companies currently identified as downstream users and distributors that is those who are currently supplied by businesses in the EU/EEA.  These GB-based downstream users and distributors will become importers under GB CLP after the end of the transition period if the same supply arrangements continue and as such they will have to comply with all the importer’s duties and obligations.

Further information is provided in the scenario table which is currently available on the HSE website.

Mick:
Will this effect businesses exporting to the EU/EEA?

Andrea:
In order for a GB- based exporter to supply chemicals to the EU/EEA, they must identify and importer.  There is no allowance in either the EU or GB CLP Regulations for a third party to act on behalf of the importer and the importer must be directly involved in the supply chain.

The responsibility for the classification, the labelling and the packaging of chemicals exported to the EU from Great Britain will rest with the EU-based importer.  So GB-based exporters are encouraged to work with the importers to agree what information they might be able to provide to help the importer comply with the EU CLP requirements.  So for example this might include what information appears on the CLP hazard label such as the inclusion of a GB supplier’s contact details in the supplemental information section.  But ultimately, the decision over what appears on an EU CLP label, is a matter for the EU and individual member states.

Mick:
What will the GB Mandatory Classification and Labelling (MCL) system look like?

Andrea:
So from 1st January, 2021, the Great Britain mandatory classification and labelling system will replace the EU harmonised classification and labelling system and Great Britain will make its own decisions about mandatory classification and labelling.

The GB MCL will itself have two strands.  Firstly, HSE, as the GB CLP Agency, will consider all published opinions from ECHA’s Risk Assessment Committee or the RAC on EU harmonised classification and labelling.  HSE will then prepare its own Agency Opinion and will recommend to ministers whether or not Great Britain should align with the RAC Opinion.  The minister will decide, with the consent of the Devolved Administrations, whether or not to give legal effect to the new or revised GB MCL entry.
Alternatively, HSE, the Devolved Administrations or GB-based industry, in certain circumstances, can propose mandatory classification and labelling directly.  Following public consultation, HSE will then prepare an Agency Opinion on the proposal and make a recommendation to ministers.   The minister, again with the consent of the Devolved Administrations, will decide whether or not to give a new or revised mandatory classification and labelling legal effect.   Further information on the new GB MCL system will be made available on HSE’s classification webpages in due course.

Mick:
Will GB-based companies still have to notify the classification and labelling of the    substances placed on the GB market under GB CLP?

Andrea:
Yes, GB-based manufacturers and importers will still need to submit notifications but these will be made to HSE rather than to ECHA.  Also existing GB notifications which are already listed in the Classification and Labelling Inventory, will be kept in place and re-notification in Great Britain will not be necessary.  Other exemptions will be available too to help reduce the need to send in notifications and these will be explained on the HSE’s CLP webpages and again, further guidance on submitting notifications to the GB notification database will be available on HSE’s Chemical classification webpages.

Mick:
How will the UN Globally Harmonised System of the classification and labelling of chemicals (UN GHS) be adopted and how will that impact on CLP requirements for GB businesses?

Andrea:
On 1st January, 2021, Great Britain will effectively adopt the GHS in the same way as the EU so   adopting all of the same GHS building blocks – the hazard classes and hazard categories – that the EU has adopted in the EU CLP Regulation.  The UK will continue to play an important role in the UN Sub-Committee of Experts for the Globally Harmonised System and will continue to work to make improvements to the GHS to ensure high levels of protection for people and the environment.  After 1st January, 2021, Great Britain will have more flexibility when deciding whether to continue to adopt the GHS in the same way as the EU.   Any proposals to adopt the GHS differently will be discussed with stakeholders and will be given legal effect through domestic regulations set out in statutory instruments, thereby providing industry time to make any necessary changes.

Mick:
Andrea, how long after 31st January, 2020 will Great Britain businesses have to update their labels?

Andrea:
There is no transitional period after 1st January 2021, for businesses to update their labels to comply with the requirements of GB CLP.  From 1st January, 2021, businesses must classify, label and package the substances and mixtures according to the GB CLP Regulation before placing them on the GB market.  Labels must be in English but additional languages will also be permitted.  In addition, the label will require the address of either the GB supplier or the  Northern Ireland based supplier supplying directly to the GB market.  However, businesses will not have to recall substances or mixtures already placed legally on the GB market to update their labels provided the following conditions are met.
Firstly, the substances or mixtures have already been places on the GB market before 1st January, 2021 and the supplier can provide proof that the substance or mixture was placed on the market before that date and where required, the hazard labelling is in accordance with the GB mandatory classification and labelling (MCL) in the GB mandatory classification labelling list published on the HSE website.

Mick:
Now we are going to talk about PIC – Prior Informed Consent.  What are the main changes to the new GB PIC regime compared to the old EU system, ePIC?

Andrea:
GB-based companies will no longer have access to ePIC and new GB procedures for notifying exports will be in place ahead of 1st January, 2021.  Forms and guidance will be available on HSE’s website.  There will be a GB PIC list setting out which chemicals are subject to the regulation.  When the new requirements come into force on January 1st, 2021, the chemicals in the GB PIC list will be the same as those in Annexes I and V of the EU PIC Regulation.

Mick:
How will the end of the transition period impact on businesses involved in the export and import of PIC listed chemicals?

Andrea:
HSE as the GB PIC Designated National Authority (DNA) will need to be notified of the export of PIC listed chemicals from Great Britain.  This will include exporting them to EU countries or moving them to Northern Ireland.  Businesses will need to notify the first export in any calendar year of a listed chemical to any importing country at least 35 days before the intended date of export.  A PIC export notification for export to the EU or supply to Northern Ireland will cover export of that chemical to any EU country and movement to Northern Ireland.   GB-based companies will no longer have access to ePIC and new GB procedures for notifying exports will be in place ahead of 1st January, 2021 and guidance and forms will be made available on HSE’s website.

Mick:
How does the new PIC regime affect Northern Ireland businesses in terms of importing and exporting PIC chemicals?
Andrea:
The EU PIC regulation will still apply to Northern Ireland and so PIC chemicals can be sent from Northern Ireland to any EU member state without needing to be notified. Northern Ireland based companies exporting PIC chemicals to countries outside the EU will need to comply with the requirements of the EU PIC Regulation.

For movement of PIC chemicals from Northern Ireland to Great Britain, businesses will only need to comply with those requirements of EU PIC that implement the Rotterdam Convention.  For example, the movement of a chemical listed in Part 2 of Annex I to the EU PIC Regulation from Northern Ireland to Great Britain, will need to be notified by the exporter but will not require explicit consent from the Great Britain authorities.

Mick:
Will GB companies need to seek consent for exporting chemicals to EU countries?

Andrea:
The chemicals which require consent before export, including to the EU, HSE will contact the importing country’s Designated National Authority on behalf of the exporter.  Where consent is given by the Designated National Authority of an EU member state, it would be expected to cover export of that chemical to any EU country or to Northern Ireland.

Mick:
Will the information now required by the HSE be any different to that required by ePIC in the old days – both in terms of information about chemicals and also quantities?

Andrea:
The information requirements will be the same as before, but GB-based exporters will no longer have access to ePIC and will need to use the new GB procedures for notifying exports.

Mick:
What are the timescales and deadlines for businesses who want to export a new PIC-listed chemical?

Andrea:
They will need to notify the first export in any calendar year of a listed chemical to any importing country at least 35 days before the intended date of export.

Mick:
Alun, could my roles and responsibilities have changed as a result of moving from EU REACH to UK REACH for example could I have become a downstream user or is there anything I have to do as a result of this?

Alun:
Well the “Downstream User Import Notification” provision is intended to enable existing supply chains to continue unbroken and to provide time for businesses to comply with their new obligations as an importer under UK REACH.  The measure will therefore apply only to existing GB downstream users or distributors under EU REACH who were at any time in the two year period before 1st January, 2021, already a downstream user or distributor under EU REACH, established in Great Britain, in relation to a substance and who did not have an EU REACH registration.  So from the 1st January, 2021, GB companies wishing to register new chemicals for the GB market would need to register those with HSE using the Comply with UK REACH IT system.

Mick:
So Alun, what actions do people and businesses need to take in relation to REACH?

Alun:
Well let’s talk again about “Grandfathering.”  So Grandfathering will only apply to all registrations including intermediates held by GB-based entities including importers and  Only Representatives based in Great Britain and to sole, lead, or joint registrants that exist at the end of the transition period.

All GB-based registrations that exist at the end of the transition period and all registrations held by GB entities at any point since March, 2017, will be grandfathered.  So that means if a UK REACH registration was transferred to an EU, EEA or Northern Ireland based entity in the run up to the end of the transition period, it will still be grandfathered into UK REACH.

Grandfathering will not apply to registrations held by entities established outside of Great Britain regardless of whether they are part of a group of companies which also has a presence in Great Britain.  Those registrations would not be grandfathered unless they had been transferred to a GB entity before the end of the transitional period.

Grandfathered registrations will be legally recognised by UK REACH from Day 1.  Businesses then need to take further action to confirm their registration within 120 days.  But if you are an importer or an exporter, UK REACH will apply in the same was as EU REACH where registration obligations rest with the importer.  You are a distributor under REACH and CLP, if you source a chemical substance or a mixture within GB,  store it and then place it on the market for someone else…  also under your brand, without changing its composition in any way.  For example, retailers and wholesalers are distributors under REACH and CLP.

You are not a distributor if you buy chemicals outside GB and place them straight onto the market GB.  In that instance, you’re an importer.  So therefore, if you buy chemicals within GB and mix them with other chemicals, or dilute them or refill containers with them, before supplying them to others, in that instance, you’re a downstream user.  So for exporters, any GB-based entities currently holding EU REACH registrations would need to transfer their registrations to an EEA-based entity, such as an affiliate or an O.R. in order to continue exporting substances or mixtures to the EU, EEA market.  Alternatively, GB companies could support their EU, EEA-based importers to ensure that they comply with EU REACH.  Further details on how to achieve this are on the ECHA website.

And finally, if you are a downstream user, you may have acquired import obligations under UK REACH as a previous downstream user with a substance covered, by an EU-based registration and in this instance you are able to make use of the notification provision to ensure continuity of supply.  This notification will be required by the Comply with UK REACH IT system within 300 days of the end of the transition period.

For more information you should visit the HSE Brexit pages on UK REACH and if you’d like any further information, you should sign up to the HSE bulletins via the transition service webpages.

Mick:
Andrea, what actions do people and businesses need to take in relation to CLP if they are supplying chemicals?

Andrea:
As I noted earlier, the majority of the CLP regulation remains the same so that includes the key duties to classify, to label and to package chemicals before they are placed on the market in Great Britain.  Therefore, for many suppliers that are already in full compliance with EU CLP now, there’ll be no need to take immediate action unless something changes regarding the classification.

However, some suppliers roles will change particularly those who are identified as downstream users or distributors before the end of the transition period because they obtained substances or mixtures from EU-based suppliers.
These parties will become importers if these supply chains continue after the 1st January, 2021.  Therefore, businesses placing chemicals on the GB market, should confirm what their role or roles within the supply chain will be from the 1st January, 2021 and they should identify their duties under GB CLP accordingly.  Further information to assist suppliers with this is provided in the scenario table on our website and to keep up to date with any further information, please sign up to our eBulletin service via the transition webpages.

The suppliers will, of course, need to make any necessary changes to their labels for example to include the suppliers contact details or to update those details as soon as possible.  However, as I mentioned earlier, businesses won’t have to recall substances or mixtures already legally placed on the GB market to update their labels provided that the substances or mixtures have already been placed on the GB market before the 1st January, 2021 and the supplier can provide proof of this and the hazard labelling is in accordance with the GB mandatory classification labelling which will be provided in the GB MCL list published on the HSE website.

I would encourage businesses supplying to or from the EU or the EEA to speak to their counterparts to ensure that everything is in place to facilitate continuing supply chains or to create new ones.

Mick:
Andrea, you mentioned supplier’s roles changing.  What do businesses need to consider across the roles?

Andrea:
When considering actions, roles and responsibilities, suppliers need to be aware that from 1st January, 2021, Mandatory Classification and Labelling will replace EU Harmonised Classification and Labelling and that substances with a GB Mandatory Classification and Labelling will be included in the GB Mandatory Classified Labelling list and that list will be provided on the HSE website.  Also, GB-based businesses supplying the GB market with chemicals whether they are substances or mixtures and Northern Ireland based suppliers who supply directly to the Great Britain market, will need to deal with HSE as the GB CLP Agency instead of the European Chemicals Agency.  Full information on GB CLP and any new arrangements and processes will be made available on our website.

To keep up to date with any further information, people should sign up to our eBulletin services via the transition webpages.

So – everything you need to know about the changes to REACH, CLP and PIC which come into effect at various times from 1st January, 2021.

A very big thank you to Andrea Caitens and Alun Williams for joining us today and helping us to map out the road ahead for businesses in the chemicals sector.  Remember, what Andrea and Alun have been talking about is in written form on the HSE website.  The address is:  www.hse.gov.uk/brexit<http://www.hse.gov.uk/brexit>
If you have any queries or hit a brick wall then you can always email us on:
eu-exitchemicals@hse.gov.uk and we’ll get back to you as soon as possible.  And of course there’s our eBulletin service.  Just pop your email address into the subscription box which appears on the pages of the HSE website and we’ll keep you informed on the latest news and advice.

Thanks for joining us for today’s podcast and remember to subscribe to this Podcast too – we’d welcome any feedback.   Bye for now from me Mick Ord.  Do join me again soon.

After UK Transition: Working with Chemicals - Episode 2 - BPR

After UK Transition: Working with Chemicals - Episode 2 - BPR

December 21, 2020

After UK Transition: Working with Chemicals - Episode 2 - BPR

In this episode, we are joined by two HSE experts in Dr Nicola Gregg - Biocides Operational Policy Team Leader and Dr Pierre Cruse - International Chemicals Unit Team Leader.

We discuss the changes that will have the greatest impact on businesses following the end of the UK Transition period, how to get an active substance approved in both the EU and GB and how companies can get on the GB version of Article 95.

Visit our website for further information and detailed guidance on biocidal product regimes.

If you have any concerns regarding UK Transition and changes to Biocide regimes, contact HSE at the earliest opportunity via biocidesenquiries@hse.gov.uk

 

Podcast Transcription 

Welcome to the latest HSE Podcast with me, Mick Ord.   This month, with the help of our resident experts, we’ll be guiding you through the new Biocidal Products Regulations – that’s BPR to you and me - and how the new regulatory framework will affect your business as we leave the EU and the transition period comes to an end.

We’ll be finding out what you should be doing now and will be required to do in the future under the new GB regulations and how that will affect companies in Great Britain and Northern Ireland.

Now we’ve left the EU, many of the functions currently being carried out by Europe will soon be transferred to Great Britain but certain EU functions have been removed and we’ll be highlighting these areas and explaining what you need to do to make sure you comply with the new arrangements. Over the next half hour or so we’ll be addressing many of the issues that are concerning businesses and pointing you in the right direction -  so without further ado, let me introduce you to 2 people whose knowledge of the new BPR framework is second to none.  Dr Nicola Gregg and Dr Pierre Cruse are both from the HSE.  Nicola is team leader for Biocides Operational Policy in the HSE’s Chemicals Regulation Directorate and Pierre is team leader at the HSE’s International Chemicals Unit – his team is responsible for developing Government policy on biocides and also the CLP regulations – that‘s the classification, labelling and packaging of substances and mixtures.

I’ll start with you if I may Pierre - Will the new GB framework for Biocides be the same as the EU framework?

Pierre:
I think the answer is in some ways yes and some ways no.  From the 1st January next year, 2021, Great Britain is going to have its own independent regulatory framework for biocidal products.  It’s going to reflect the current EU framework, the EU Biocidal Products Regulation, but they are going to operate independently of each other.  Essentially, the rules and standards are going to be pretty much the same, but some elements to the framework won’t exist, basically those bits that refer to EU processes and institutions that we’ll no longer be dealing in the national system.

Mick:
So in what areas will it be different?

Pierre:
The Great Britain Biocidal Products Regulations – BPR – we call it a lift and shift of the EU’s BPR. What that means essentially is that we copied it into domestic law without any policy changes.  The only bits that have changed are those  which wouldn’t operate correctly in the new Great Britain context, as I say, the bits that refer to European Institutions, the European Chemicals Agency and the European Commission are examples of that.  So for example ECHA, functions that previously sat with ECHA are now going to be transferred to Great Britain bodies, where we are still doing them, and commission decisions which used to be taken by the European Commission, they are now going to be taken by the Secretary of State with consent from Ministers in the Devolved Administrations.

Mick:
So what changes will have the greatest impact on businesses?

Pierre:
I’ll just run through some of the biggest changes and impacts for businesses.  Perhaps the main one is if a company wants an authorisation in both the EU and Great Britain after the end of the transition period, they’ll need to apply separately to both the EU through ECHA and Great Britain.  That also means that future European active substance approvals and product authorisations, won’t be valid in Great Britain and vice versa.

A similar thing applies to active substance approval.  If you want an active substance approval in Great Britain at the end of the transitional period, you need to apply separately from any application you may be making in the EU.  The other thing is that authorisation processes for biocidal products that used to apply across European member states, won’t apply any more to Great Britain.  That means there’ll be no more mutual recognition of product authorisations between the EU and Great Britain.  EU Union authorisations won’t be valid in Great Britain after the end of the transition period and also you won’t be able to use a simplified authorisation that you had in European Union to put a product on the market in Great Britain after the transition period either.

Another key thing that businesses need to be aware of is that HSE won’t be using ECHA’s IT tools, the main one being the register of biocidal products R4BP3 after the end of the transition period.
And we won’t have access to ECHA’s databases anymore and what that means is that applications for biocidal product authorisations have to be sent directly to HSE, not using R4BP3 and using the HSE application forms that we’re going to put in place.   The other thing related to this is that for active substances and products to be supported in Great Britain – if you want to make an application, all the relevant data will need to be resubmitted to HSE, even if you’ve previously submitted it to ECHA.  There are transitional arrangements in the legislation that will tell you exactly when you need to do this and we’ll explain that later in this Podcast.

Mick:
Thanks Pierre.  Over to Nicola then.  When will the new application forms and process details be live on the HSE website Nicola and will they be different to the old forms?

Nicola:
Well we are completely rewriting all of the information on our website including the application forms and all of this will be published by the 1st of January.  Application forms and data will be submitted to HSE, not via R4BP as Pierre has just said but instead by HSE’s upload link and this is a secure, cloud-based platform for sharing files.  Because of the lift and shift that Pierre has also mentioned, the information required is pretty much the same as companies are used to and the data requirements are also the same.

Mick:
Will Great Britain have its own review programme?

Nicola:
Yes, after the first of January, 2021 of course, GB will be responsible for taking our own decisions on active substance approvals at our own national level and because of this, we will establish our own review programme of existing active substances.  It’s important to note that Article 89 of both the EU BPR and the new GB BPR will continue to apply.  This means that as happens now, products containing active substances which are within the scope of the GB review programme can continue to be made available on the GB market while those active substances in the products are still under the review.

Other rules for participation and withdrawal from the review programme will also continue to be similar to what people are used to under the EU review programme such as things like taking over role of participant.

Another issue worth pointing out here is that the priorities and the timelines of the review programme, in the GB review programme, have not yet been determined and we won’t be in a position to make those determinations until we know what the total support of active substances within GB actually is.

Mick:
Thanks for that Nicola.  Well, after the transition period HSE will no longer have access to the ECHA databases.  What are the implications for businesses here in the UK?

Nicola:
That’s correct.  After the 1st January, 2021 GB will not be permitted to access confidential information held by ECHA.   This means that any data or information that companies   previously submitted via these processes will no longer be available to us here in HSE for us to refer to, so the data will need to be resubmitted to us so that we can continue operating our own national regulatory regime.  There are deadlines for resubmission of the data and these are set out on our new GB BPR transitional arrangements and these are legally binding.  Now, HSE appreciates that the requirement for applicants to resubmit their data packages may result in an increased cost to businesses and so we are not going to charge for the work that’s necessary in the resubmitting of the data and I am talking about just the actual resubmitting and all that’s entailed around that, not the eventual evaluation of the data by us.

Mick:
Will the data required by the HSE be the same as that required by ECHA?

Nicola:
Yes it will.  The technical data requirements which must be addressed to support both the approval of an active substance and the authorisation of a biocidal product under a GB regime, will be the same as those specified under the EU regime.

Mick:
What’s the situation for companies which already hold the biocidal product authorisation in the UK under EU BPR – will that still be legal in the UK after the transition period?

Pierre:
Yes it will.  Any biocidal product authorisations and also any active substance approvals that were in place before 1st January, will remain valid in Great Britain all the way through to their expiry date whatever that was.  However, there are a couple of additional requirements which authorisation holders for biocidal products need to be aware of.   The first is that they need to be established in the UK within a year of the end of the transition period that’s by the 31st of December 2022 to continue holding that authorisation and the second is that they need to obtain active substances from suppliers on the GB Article 95 list.  There are also situations where they may have to resubmit the data supporting their products and some examples of this are if they applied for a change to that product or if they are renewing a product or if HSE needs the data.  For example we might need it if we want that to support a “same” biocidal application.

Mick:
And what about companies who have submitted a biocidal products application to the HSE and are still awaiting authorisation on 31st December this year?  Do they need to do anything?

Pierre:
Yes they do.  As Nicola explained earlier, they’ll need to resubmit their application including all the necessary supporting information to HSE.   And also, an important point any company in this situation needs to be aware of is, if they are relying on letters of access to data which is owned by someone else, they also have to make sure that the data owner resubmits their data dossier to HSE and the reason for this is simply that we also need this information to evaluate their application.

There are two deadlines that people need to be aware of for resubmitting applications and data.  The first is the 31st March, 2021 which is 90 days after the end of the transition period and that applies if the UK had been the lead or reference member state for their application under the EU BPR.  The second is 29th June, 2021 if the UK had not been the lead or reference member state and that’s 180 days after the end of the transition period.

Mick:
Similarly, Pierre, what about companies who are awaiting a BPR approval of an active substance, what do they need to do?

Pierre:
The same basically applies.  They need to resubmit their applications and data to HSE with the same deadlines, so 31st March, 2021 if the UK had been the lead or Evaluating Competent Authority for that active substance, or 29th June, 2021 if the UK had not been the lead.  It’s less often the case for active substances if an applicant is relying on letters of access to data owned by someone else.   The same is true for products, the data owner needs to submit their data by the same date, so we can use it in the evaluation.

Mick:
Nicola, a GB version of the Article 95 list is being created.  How do companies get on this list?

Nicola:
A GB version of the Article 95 list will be established after the 1st January, 2021 and it will be operating in the same way as the current EU list.  Now businesses don’t need to do anything to get on the GB list in January, but there are requirements for them to stay on the list.  Businesses already on the EU list will, on the 1st January be automatically included in GB’s list.  However, to stay on that list, businesses will need to submit supporting information to us here at the Health and Safety Executive.  This is the same information as was submitted to ECHA the European Chemicals Agency.  So for example it might have been an active substance dossier or a letter of access or even a mixture of both of those.  If a company is submitting a letter of access, the data owner also needs to submit the dossier and data by the same date as Pierre has already outlined previously.

There’s another requirement as well.  Businesses also have to ensure they are established in the UK, so these requirements, both to be established in the UK and to submit the data and the dossier, have to be met within two years of the end of the transitional period.  So a much longer deadline than the deadlines Pierre has just mentioned.

Mick:
So Pierre, the new GB framework applies only to GB so how does a company get a biocidal product authorised in Northern Ireland?

Pierre:
I think to explain this I first need to give a bit of background to what’s happened in relation to Northern Ireland and why it’s different to what’s happening in Great Britain.
So to explain this, the Withdrawal Agreement between the UK and the EU that was signed when the UK left the EU included an agreement known as the Northern Ireland Protocol.   This was designed as a practical solution to avoiding a hard border on the island of Ireland, but it also ensured that the UK, including Northern Ireland, could leave the EU as a whole.  The Northern Ireland Protocol included a number of special provisions which apply only in Northern Ireland from 1st January, 2021 and not the rest of the UK.    And it’s worth mentioning here that the Northern Ireland Protocol isn’t a permanent arrangement.

It was designed to solve a particular set of problems and it can only do this if it has the consent of the people of Northern Ireland, so it’s in place for an initial four years until 2024 and then there’ll be a vote to determine whether the main provisions will continue to apply, but until then it applies until the end of the transition period.  So one of the main provisions in the Northern Ireland Protocol is that unlike Great Britain, Northern Ireland is going to continue operating under certain specified pieces of European Union law and one of the pieces that’s listed in the Protocol is the EU Biocidal Products Regulation.  So EU BPR will continue to apply in Northern Ireland after the end of the transition period.   This means that a company, if it wants an authorisation in Northern Ireland, will apply in a similar way to how it does to a European member state.   But instead it will apply to the Northern Ireland Competent Authority.   The Northern Ireland Competent Authority is HSE Northern Ireland.  However, in practice HSE is going to be supporting HSE Northern Ireland in this role.  This means, in fact, you’ll submit your application to HSE and we’ll evaluate it on behalf of HSE Northern Ireland.

At the moment, the exact process for applying to Northern Ireland for example which IT system you have to use, is still being confirmed and we will publish information and let people know the answer to this as soon as we know it.

Under the Protocol, Northern Ireland acts a bit like a European member state in some respects, but it doesn’t have all the rights of a European member state.  For Biocides,  an  example is, that it can’t act as a reference or lead member state on behalf of other European member states for biocidal products.  So what this means is if you have an authorisation which was granted by Northern Ireland, the Northern Ireland Competent Authority, this can’t be mutually recognised in other parts of the EU.  So if a company wants to market a product only in Northern Ireland, then it needs to specifically apply to the Northern Ireland Competent Authority.

Another thing that companies need to be aware of is the requirements on where they need to be established to have an authorisation for Northern Ireland.
So if companies are operating under EU BPR, they’ll probably be aware that it says that authorisation holders need to be established in the European Union and under the Northern Ireland Protocol, this is extended to cover Northern Ireland so, if you want an authorisation in Northern Ireland, you have to be established in either Northern Ireland or another country in the European Union.

An important thing to note about this is that a company only established in Great Britain, can’t hold an authorisation in Northern Ireland under these arrangements.  So companies supplying to Northern Ireland from Great Britain, need to make sure that they comply with this requirement and it applies immediately after the transition period ends, there’s no transitional arrangement for that.  So it’s an important thing to note if you’re supplying to Northern Ireland.  Northern Ireland companies may also wish to check any Great Britain suppliers that they have who are supplying biocidal products to them are aware of this requirement and take the relevant steps to comply with it.   It’s worth noting as well that companies which are established in Northern Ireland can also apply for authorisations in Great Britain.  The requirement in Great Britain is that you have to be established in the UK and that includes Northern Ireland, it’s just that it doesn’t work the other way so that if you are in Great Britain only, you can’t have an authorisation in Northern Ireland unless you are also established in Northern Ireland or the European Union.

That’s quite complex, but I hope that I’ve said enough to explain it for companies who are affected by this.

Mick:
I’m sure you have.  Does that mean though that Northern Ireland cannot be the lead for active substance approvals either?

Pierre:
Yes, that’s right but approvals are granted in the EU, will be valid in Northern Ireland.  Essentially, Northern Ireland would be still part of the EU system and decisions taken in the EU about active substances will continue to apply in Northern Ireland.

Mick:
Can authorisations granted in Northern Ireland, either in Northern Ireland only or via a Union or Mutual Recognition Application, be mutually recognised by Great Britain?

Pierre:
No they can’t, not as such.  However, one of the special provisions in the Northern Ireland Protocol is that it makes clear that nothing will prevent businesses in Northern Ireland enjoying what it calls ‘unfettered access’ to the rest of the UK market and the Government has committed to ensuring that Northern Ireland businesses have this unfettered access to Great Britain.
What it means is essentially that there’s going to be no declarations, tariffs, new regulatory checks or customs checks or additional approvals for Northern Ireland businesses who wish to place goods on the Great Britain market.

Mick:
So unfettered access removes the barriers between Northern Ireland and Great Britain.  Does this mean that as long as a product is authorized in Northern Ireland under the EU BPR, it can be freely supplied in Great Britain?

Nicola:
Yes, but not entirely.  There’s a very small number of goods, including biocides, which can pose a particularly high risk to consumers, to humans, to animals and the environment and they are subject to stricter regulation.  We are calling these highly regulated goods, so to protect consumers across the UK, if you are a Northern Ireland business placing highly regulated goods on the GB market, you must first provide some basic information to the GB authorities.   However, as Pierre has just said, you won’t need any additional approval or authorisation.

So for biocides, we’ve put this into practice through a notification system.   Under this notification system, companies will notify HSE of their intention to supply a product on the GB market and as part of this notification system, they have to provide HSE with the same information that they supplied to an EU member state or to the Northern Ireland Competent Authority in support of their original application.  They also must submit a copy of their Northern Ireland authorisation.   It might not be a full authorisation, it might be that Northern Ireland granted some other permit.   Once the information has been submitted, the product may be made available on the market in Great Britain after 90 days so there is a lag period.

Now there is an exception -  if HSE raises any objections which we might do only on very limited grounds – so for example we might identify that the product is unsafe or it’s not sufficiently effective.
If HSE does identify any concerns, then we may request additional information and if this happens, the 90 day period will be suspended for up to another 90 days and during those extra 90 days, that allows companies time to submit further information to HSE and once HSE has got that extra information, there’s then another 90 day period for HSE to consider that extra information.   However, the product does not have to be authorised again in GB and there will be no charge.   Now there are conditions within the notifications system, and this is really important.  Companies -  if they are applying for unfettered access  - have to be established in Northern Ireland.  The active substance must be approved in GB and the active substance source in the product, must be on the GB Article 95 list.

Mick:
If anyone is worried about the various timescales and deadlines we’ve been referring to – what should they do - who should they contact?

Nicola:
Well, the timescales and deadlines are all on our website, but if any company is concerned that they cannot meet those deadlines, we would encourage them to contact us at the earliest opportunity and they can do this via our enquiries email that’s:  biocidesenquiries@hse.gov.uk

Mick:
We’ll be giving that email out again before the end of this Podcast.  Dr. Nicola Gregg and Dr. Pierre Cruse – thanks a lot for joining us.
HGHSGhhhh

So there you go. Everything you wanted to know about Biocides Product Regulation but were afraid to ask. And certainly it’s important that you DO ask if there are elements you don’t understand about the changes.

You can email us   at biocidesenquiries@hse.gov.uk<about:blank>  and we’ll get back to you as soon as we can.

You can also, as I’ve mentioned many times before in this podcast series, log onto the website – www.hse.gov.uk/brexit<about:blank> for a comprehensive breakdown in written form about what we’ve been discussing today and over the previous episodes.
Remember as well to subscribe to our ebulletin service so you can stay in touch with updates and developments as they affect the sector in which your business is involved.  Just pop your email into the subscription box you’ll find on the pages of the HSE website.

A huge thanks you Dr Nicola Gregg and Dr Pierre Cruse our guest experts today.  Stay subscribed to the podcast, take care and you’ll be hearing from us again very soon. Thanks for listening.

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

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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