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.

----more----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