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.
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?
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.
So in what areas will it be different?
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.
So what changes will have the greatest impact on businesses?
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.
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?
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.
Will Great Britain have its own review programme?
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.
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?
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.
Will the data required by the HSE be the same as that required by ECHA?
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.
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?
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.
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?
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.
Similarly, Pierre, what about companies who are awaiting a BPR approval of an active substance, what do they need to do?
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.
Nicola, a GB version of the Article 95 list is being created. How do companies get on this list?
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.
So Pierre, the new GB framework applies only to GB so how does a company get a biocidal product authorised in Northern Ireland?
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.
I’m sure you have. Does that mean though that Northern Ireland cannot be the lead for active substance approvals either?
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.
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?
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.
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?
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.
If anyone is worried about the various timescales and deadlines we’ve been referring to – what should they do - who should they contact?
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: email@example.com
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.
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 firstname.lastname@example.org<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.