The HSE Podcast
After UK Transition: Working with Chemicals - Episode - 6 - Questions and Answers session

After UK Transition: Working with Chemicals - Episode - 6 - Questions and Answers session

March 26, 2021

After UK Transition: Working with Chemicals - Episode - 6 - Questions and Answers session

The latest episode of HSE’s Working with Chemicals podcast series invites industry voices to answer questions from organisations relating to the GB chemicals regulations.
Whatever branch of chemicals industry you work in, we offer advice and guidance to support your business and point you in the right direction.

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

https://www.hse.gov.uk/brexit/chemicals-brexit-guidance.htm

PODCAST TRANSCRIPT

Good day and welcome to Episode 6 of the HSE podcast with me, Mick Ord.

For today’s podcast we’ve got a line-up of guests whom regular listeners will recognise from previous episodes and we’ll also be hearing from a special guest who hasn’t appeared before – he’s the Director of the Chemicals Regulation Division of HSE, Richard Daniels.

What we thought we’d do in this episode is go through each regime with the relevant experts and pick out some of the big themes and questions which have emerged from our discussions with companies since the transition period ended last year.

So many of you have been logging onto the HSE website and getting in touch with us as Richard will explain a bit later and we thank you for that – please continue to do so.

So whichever branch of the chemicals industry you work in, if you have questions relating to the GB chemicals regulations, we hope we can cover it here and reassure you that a) you’re not alone and b) we are doing and will continue to do everything in our power to point you in the right direction.

So without further ado – the regimes we cover in this episode include Biocides, Pesticides, CLP – that’s Classification, Labelling and Packaging of chemicals, and REACH – that’s the Registration, Evaluation, Authorisation and Restriction of Chemicals.

Our first expert today, Dr. Nicola Gregg, is Team Leader for Biocides Operational Policy in HSE’s Chemicals Regulation Division.

 

Mick:

Hi Nicola, first query for you.  I’m a small business that produces coatings and I have an application for a biocide product that I wish to register under Great Britain Biocides Product Regulation (BPR), what format do I need to submit an application in?

 

Nicola:

First of all, it’s worth pointing out that as HSE no longer has access to R4BP, the EU systems, they will need to submit their application directly to us in HSE using our new forms and these forms are available for download from our website.   So they download the form, complete all the details and email them back into us and when we receive the form, we then send out a secure upload link and it’s into that that they submit all your data and information.   Don’t send the information and data in an email, wait for the secure link.  So the sort of information which we would expect to see uploaded would be for example the Active Substance Competent Authority Report (CAR), the Product Authorisation Report (PAR), Summary of Product Characteristics (SPC) all terms which people will be familiar with as well as all the supporting data.   Now for all those reports that I just listed there, we’ve got new templates for these as well on our website.  We’d very much like applicants to use these new templates, unless they’ve already got the information in the EU versions of those templates.  So in other words, if they’ve already got it in the EU version, we don’t expect them to repeat the process and fill out our templates.  For new applications, please do use our new templates. 

 

We also expect that they submit their data in IUCLID - we would prefer IUCLID 6.  If they have got data in older IUCLID versions, submit them and we’ll see if we can access them and obviously if we can’t then we’ll get in touch and we’ll work out how to move forward.

Now we do realise that some of the data that was submitted a long time ago might never have been in IUCLID and that’s OK for resubmissions that we’ve talked about previously, but probably if we receive an application from an applicant and see no IUCLID, our automatic response almost will be – where is your IUCLID file so you just need to explain that you never had a IUCLID file in the first place.

There’s one final thing Mick that I’d just like to highlight as well – that we do need active and product reference lists.  So these reference lists for both the active and the product applications must be on the GB Excel template – that’s one area where we aren’t able to be flexible.

 

Mick:

OK, another question.  I produce wood preservative products and wish to have my product on the market in the GB and NI.  What do I need to do?

 

Nicola:

Well, applications for Northern Ireland, just like the GB applications, will be made directly to HSE using our new forms as I’ve just described and using the same submission methods.  There is one exception however.  That exception is if a company wants to apply for an EU Union authorisation so that would include Northern Ireland, and Union authorisations, these applications follow entirely the EU system so the applications are made using R4BP.  HSE will have no involvement in the processing of Union applications. 

We are still discussing some details with ECHA about mutual recognitions and we can confirm that if a company applies to the EU and wants the product to be mutually recognised into Northern Ireland, they can do that via what we call Mutual Recognition in sequence process.  Now it’s not yet quite clear whether they can apply for Mutual Recognition in parallel into Northern Ireland and when we have a clearer picture on that, we will be able to confirm one way or another.  But mutual recognitions for Northern Ireland again are submitted directly to HSE. 

If I could Mick, I’d like to expand a bit here to talk about the establishment rules because it’s a really important area we’re getting a lot of questions about.  So companies must adhere to the GB and the EU BPR establishment rules.  That means that for the GB market the authorisation holder must be established in UK, but for the Northern Ireland market they must be established in the EU or Northern Ireland.   For the GB market, there is a one year “period of grace” or transitional period ending on the 31st December this year for products already authorised.  So if you’ve already got a product authorised you’ve got one year to make sure that your authorisation holder is indeed established in the UK.    If an application had already been submitted into the EU programme, but a decision wasn’t made by the end of the transitional period, then companies would be resubmitting those applications to us and the establishment rule must be met by the time we’re ready to authorise that product.  

Then the third option is, if you are submitting a completely new application to us under the new GB rules, then the establishment rule must be met at the time of making the application.  

Just coming back to the Northern Ireland situation, the establishment rule should already be met now so for products that are already authorised, that establishment rule should already be in place.   We are aware that this has come as quite a surprise to some so we are making no immediate plans to start revoking products where this obligation hasn’t been met, but we are asking companies to get on with this and to get this in place as soon as possible.   For meeting the establishment obligation in GB or NI, companies may have to apply to us to make a change and if companies are familiar with applying for change applications, that’s exactly what they would do, again using our new forms as I just explained before. 

And then just one last thing – sorry this has been a very long answer – companies can apply to HSE for authorisation in GB and Northern Ireland at the same time using the one application form if this route is relevant to both GB and Northern Ireland.  We hope that will be a bit of a saving where  there’s only one application needed, rather than two separate ones.

 

Mick:

Ok Nicola, one last question for you.  The active substance in my disinfectant product is due to renewal in the EU.  Does HSE intend to conduct an independent review of active substances for biocides and if so, will the EU BPR deadline date for all active substances to be reviewed by 2023, be the same as GB BPR?

 

Nicola:

Right, of course GB is outside of the EU review programme and we will responsible for taking decisions on active substance nationally ourselves.  So we will set up and undertake our own review programme for existing active substances.  The timelines for the GB active substance programme haven’t yet been decided and we will consider these once we know the extent of the work for the GB review programme and we will know that once the resubmission deadlines have passed and these deadlines are the 31st of March and 29th June this year.   So it’s only after those dates that we will have a feel of the extent of the work and we will start consider starting prioritising deadlines, approaches etc, etc.  The good news is that in the meantime Article 89 of GB BPR continues to apply and this allows via resubmission products containing active substances supported in the review programme to continue to be made available while the active substances are still under review. 

 

Mick:

Great thanks Nicola.  That was Dr. Nicola Gregg who’s Team Leader for Biocides Operational Policy in HSE’s Chemicals Registration Division. 

Andrea Caitens is one of the Team Leaders and a Regulatory Scientist from the Chemicals Regulatory Division covering REACH, CLP and PIC, that’s Prior Informed Consent.   Andrea good to speak to you again.  I have an email here.  I am a small business that imports chemical products from other countries.  Will I have ‘importer status’ obligations when importing substances into GB from the EU/EEA?

 

 

Andrea:

The simple answer is yes.  GB based companies will have importer obligations where they import substances or mixtures into Great Britain from the EU or the EEA.  For some companies this could mean a significant change depending on what role they played in the EU to GB supply chains before the end of the transition period.  For example, those who were previously considered to be GB based distributors or downstream users as they were supplied from companies within the EU or the EEA, will now be importers if the same supply arrangements continue.  Such companies should ensure that they are aware of the obligations placed on them as importers via the GB CLP regulation and they should have sufficient competence to carry those duties out.  I would just point out that the supply of qualifying goods from Northern Ireland businesses to Great Britain will not be deemed import under the terms of the Northern Ireland protocol though.

 

Mick:

Thank you.  We have another one for you here.   I have multiple chemical products on the GB market which carry the same classification and labelling.  Can I upload CLP notifications for these in bulk?

 

Andrea:

No is the simple answer.  At the moment, the notification form doesn’t have a bulk upload facility as such any notifications do have to be submitted individually.  However, we are looking at the development of the web form and the notification system as a whole and may make some changes to this in the future.  It should however be noted that there are some exemptions from the duty to notify under GB CLP and this includes for substances that have been registered under REACH or which were notified to ECHA for inclusion in the Classification Labelling infantry before the end of the transition period.  Full details about when the duty to notify applies in Great Britain and all these exemptions is provided on our website and I would urge anybody with the duty to notify to look at these details. 

 

Mick:

Thanks for that Andrea.  Another query now.  My company has chemical products on the market in both Northern Ireland and Great Britain.  Can I have both a GB and EU address on the label to maintain common labelling across the UK?

 

Andrea:

Substances and mixtures placed on the market in Great Britain do have to be labelled in accordance with GB CLP and those placed on the market in Northern Ireland in accordance with EU CLP.  Now the supplier details that are included on the labels should meet their respective requirements.  That said it can be acceptable to include the contact details for both the GB and any EU based supplier on the label.  Where this is appropriate the additional address would have to be included as supplemental labelling information in accordance with the requirements of Article 25(3) CLP and in addition, the inclusion of the additional supplier’s details mustn’t cast doubt on the validity of the information required by Article 17 of CLP or make it more difficult to identify that information. 

The additional supplier should be part of the same supply chain and it would be expected that contacting that supplier would provide appropriate information on the chemical.  Indeed, the supplier must be aware and willing to undertake that role.  Ultimately, I would say it must be clear to the user where to go for additional advice about the substance or mixture concerned and that the contact they go to is able to provide the advice and the information that’s required. 

 

Mick:

Thanks for that Andrea.  Another one now.  I’ve already submitted a REACH registration for my product, do I still need to make a CLP notification?

 

Andrea:

No, as I mentioned earlier, if a substance is registered under REACH there is no requirement to submit a separate CLP notification also.  As I again noted earlier, there are other exemptions from the require to notify in Great Britain, and I would urge all potential notifiers to consider the guidance provided on our website if they haven’t already done so.

 

Mick:

Thank you Andrea.  With me now is Rachel Brown who’s working on the Biocides and Pesticides Transformation Programme.  Rachel, I’ve got a query for you here.  My company is the authorisation holder for multiple fungicidal active substances.  I understand that for renewal of active substances in the short term,  only an administrative application will be needed.  When will the full dossier be required for submission in Great Britain?

 

Rachel:

The GB legislation requires that the supplementary dossier be submitted 30 months before the expiry of the approval of the active substance.  This is exactly the same as previously when we followed the EU legislation.  However, we are going to seek to minimise the action required to meet this legislative requirement and we will provide some further information soon. 

 

Mick:

In circumstances where an EU MRL comes into force which is higher than the current GB MRL, will there be put in place a fast-track mechanism that will permit the GB MRL to be increased to match the increased EU MRL?

 

 

 

Rachel:

There is no fast-track mechanism for adopting an MRL from another jurisdiction as a GB MRL and that includes from the EU.  There’s now an independent GB regime for the regulation of pesticides and we will be delivering our own decisions in GB.   So that means a specific application will need to be submitted to HSE to support a new MRL or an import tolerance.  If an application is submitted, standard processing times will be apply to the evaluation and that’s a 12 month processing time with an additional six months allowed to provide any additional information.  However, HSE will take into account assessments made in other jurisdictions as part of our independent decision-making process so where an MRL is supported by an extrapolation based on data already evaluated, HSE will try to assess the applications in a shorter time frame, but it’s important to note that if the MRL is related to a new product authorisation, then the MRL can only be implemented once the authorisation has been granted.  And for Import Tolerance applications, a proof of authorisation in the third country will also need to be provided. 

 

Mick:

I have a product which has authorised uses on crops to protect against weeds – herbicide – both in Great Britain and Northern Ireland.  Is it possible to submit only one dRR – Draft Registration Report – for Great Britain and Northern Ireland?   A Core Dossier and specific UK addenda?

 

Rachel:

Where a product can be authorised to the same regulatory standards in both Great Britain and Northern Ireland, a common dRR may be submitted and that should enable the product to be submitted in both GB and NI.  However, where the regulatory standards have diverged between GB and NI, for example if an active substance has been renewed in the EU and is applicable in NI but not in GB, then there may be different requirements that need to be met and where this is the case different submissions will be required. 

 

Mick:

Thank you Rachel.   Before we hear from our next expert, I need to define a term used in the first question to him – Grandfathering.  Grandfathering allows you to have continued access to the UK market.  It’s where the relevant EU REACH registrations have been recognised under UK REACH.  Alun Williams is the Lead for External Comms and Stakeholder Engagement in the Defra and Chemicals Team.   Hi Alan, first question for you is – We are a GB importer of an EU REACH registered substance.  Our EU supplier and EU REACH registration holder wants to grandfather the registration to UK REACH.  Can this be done, if so how and when does this need to be completed by?

 

Alun:

Thanks very much for the question Mick.  I should clarify that it is not possible for EU based legal entities to have their EU registrations recognised under UK REACH. 

So in the situation you described, if you’ve been importing a substance covered by the EU REACH registrations in the two years before the end of the implementation period, then it could be possible for you to use a downstream user import notification, colloquially known as a DUIN, that would allow you to suspend the registration duty for up to six years.  UK REACH only applies in the UK therefore legal entities based in the EU and EEA can have no obligations under this regime.  The grandfathering traditional provision is only available to GB based holders of EU REACH registrations, including GB based manufacturers and importers, GB based Only Representatives, ORs as they are also known, and GB based legal entities that held an EU REACH registration and transferred it to an EU based legal entity at any point after 29th March, 2017 which is of course the date the UK notified its intentions of leaving the EU and before the end of the transition period.   If a GB based legal entity transferred their EU REACH registration to another GB based legal entity, only the GB based legal entity to whom the registration was transferred, will be entitled to have that registration recognised under UK REACH.  The grandfathering provision is available until 120 days after the end of the transition period and the process will need to be completed by 30th April, 2021. 

 

Mick:

Thanks for that Alun.  Another query now.  I’m a small company which has multiple products which require REACH notifications.  Can multiple notifications be made, or does each one have to be done separately?  Can this be done using IUCLID files?

 

Alun:

It’s a fair question.  So within 300 days of the end of the transition period you need to use the  Comply UK REACH service to indicate you are an existing downstream user or distributor.  It’s at this point your UK REACH downstream user import notification number which was mentioned earlier, that will be issued to you.   This only needs to be done once per legal entity and covers all substances that you wish to continue importing from the EU.  You then need to populate the additional information spreadsheet template with information about the substances that you wish to continue importing.  It should be noted that some information only has to be included, if it is available to you.  This spreadsheet should list individually, all of the substances which you want to continue importing from the EU.  One per line.  Where a substance is included in the spreadsheet, it must continue at least one of the following identifiers.  The substance name, the cast number, or the EC number.  After that, you should send the completed spreadsheet to the Agency at:  ukreach.dunotification@hse.gov.uk   You should include your legal entity name and DUIN  notification number in the subject line of the email.  It may be easier to fulfil some of the information requirements by attaching a Safety Data Sheet (SDS) to the email rather than including it in the spreadsheet, eg the Article 10(a) Part IV information pertaining to classification.  Where an SDS for a substance is attached to the email along with the spreadsheet, the spreadsheet must also list that substance.  

To return to another part of your question, there is no IUCLID template for DUINs and we are not accepting IUCLID files for the substances.

 

 

 

 

Mick:

 

Final question for you Alun.   My company predominantly produces polymers.  What is the stance on polymers under REACH and are polymers exempt from REACH?

 

Alun:

 

It’s a great question.  So the exemption to the registration of polymers, which applies under Article 2 Part 9 of REACH, has been carried over into UK REACH.   However, the monomers of other substances that form part of the polymer are subject to registration and will need to be registered.   All GB based registrations which exist at the end of the transition period and all registrations held by GB entities at any point since 29th March, 2017, have been grandfathered.  If the monomers and other reactants are supplied to you from within GB, then the registration duty will be higher in your supply chain.  If you import the monomers or other reactants, then you may need to submit a registration or a DUIN. 

 

 

Mick:

 

Great Alun, thanks for that.  Our guest now is the Director of the Chemicals Regulation Division in HSE, Richard Daniels.  Richard can you just give our listeners are quick introduction?  What is the nature of your job, what do you do?

 

 

Richard:

 

I’ve been Director of the Chemicals Regulation Division since the 9th March, 2020, so it’s been a really busy year for me.  I’ve got responsibility for all of the activities in the Division and the regimes to make sure that it operates perfectly well and that includes preparing for the situation we’re in now.  Just by way of background, I joined HSE in 1992 as a Factory Inspector when I finished my PhD at Manchester University and I’ve done lots of things in HSE and before joining the Division, I had the privilege to be Her Majesty’s Chief Inspector of Explosives and headed up our National Explosives Unit, so quite a different job now. 

 

 

Mick:

 

Absolutely.  Do you have any reflections as to how things have been going since the 1st of January?

 

 

Richard:

 

From my perspective I think things have been going really well.  If I reflect back on what on what we’ve got in place and what we’ve achieved – we have an independent, regulatory framework now for Great Britain for chemicals.  That’s up and running and fit for purpose.  That’s been a lot of hard work by people in the Division and with colleagues across the piste.  And that independent system mirrors what people were used to when we were part of the EU.  Some of the EU functions have been taken out because they no longer apply in our context but that means we’ve got immediate continuity for businesses on leaving which was really important for us.  

 

 

 

The Northern Ireland Protocol means Northern Ireland will continue to follow the EU chemical regulations and HSE is close to finalising agreements to support Northern Ireland so we can do their functions on their behalf.  And we’ve actually agreed revised arrangements with Scotland and Wales, so those are all in place now to support all of those devolved administrations.

 

In terms of support to business, we’ve put help desks in place for all of the regimes and we support the national telephone helpline.  For the first two months we dealt with over 1400 contacts across all the regimes.  We’ve also supplied and updated much of our web guidance on the new regimes that apply from the 1st of January and you may be interested – we’ve had over 390,000 views of the website over the first two months which I think is incredible.  In terms of our eBulletins and promoting that guidance, that currently goes out to 240,000 stakeholders.  The podcasts people are listening to now, we’ve got over 2,300 subscriptions and we delivered a number of seminars with Defra and joint events to get them ready for the 1st of January and that reached over 1750 businesses.  They are available on HSE’s YouTube Channel if people didn’t take part in them.  Over half of those actually hadn’t attended any previous involvement with HSE, so we got great penetration into new businesses.  And lastly, we have recruited -  we’ve filled over 110 posts in our new division in terms of the set up and we’ve got plans to recruit even further.   So I think Mick, we’ve done a lot and it’s operating well. 

 

 

Mick:

 

Very impressive.  Could you outline any immediate priorities and plans for the medium to longer term?

 

 

Richard:

 

Thanks Mick.  I think it is important to take a step back.   We’ve heard a lot of immediate activity but at the heart of what we are about as a Division and where - as a Director I want to take us – at the heart of everything we do is about protecting people and protecting the environment through the safe and effective use of chemicals, supporting a sustainable future.   So that’s what I really want  to embed.  We are about protection and supporting the future growth.  Now where I want to get to is actually HSE, we act as a globally respected competent authority that supports the UK to prosper particularly in a post Brexit environment through science led regulation in the effective and safe use of chemicals and associated technology.  So I’m aiming for us to be one of the best if not the best in the world, supporting what the UK needs.    What does that mean in practice?   Well, we need to ensure that HSE delivers are chemical regulation effectively in that independent UK environment. 

 

I am really keen on improving services to both UK businesses and the public.  I want to, where I can, drive down the costs of our regulatory delivery so what businesses have to pay to get the necessary approvals.  I want to, where I can, speed up the time it takes to issue our permissions to business.  I want to make sure that we have world class scientific and regulatory chemical expertise underpinning everything we do.   And I want to make sure that HSE on behalf of the UK, we are engaging and influencing on the global stage in terms of chemical regulatory regimes because many of our businesses don’t just operate in the UK, they operate internationally and I think it’s important we are there to help and facilitate that trade. 

 

In terms of communication, and part of the podcasts, I want to make sure that all of our guidance is clear and that we do respond to businesses needs, and we keep updating that.   And I want to make sure that we are visible to our stakeholders, to our businesses etc, particularly small businesses and those that are operating in a research or innovation environment to make sure that as a regulator we are visible to them, we understand their needs and we are building for the future.  

And podcasts like this we may well do more of in the future so I really would encourage people to watch this space and sign up to our bulletins. 

Mick:

 

I was wondering if you had any take home key messages for those who listen to these podcasts?

 

 

Richard:   

 

Sure, well I think firstly, and I hope it’s coming across that on behalf of HSE, I’d like to say that we are fully committed to our fundamental mission about protecting people and the environment and about improving the way that we do our regulation and how we provide those protections.  And just to reassure people at this time, HSE as a regulator, I believe we have a very good track record of being a modern, proportionate regulator and where necessary we do operate with a degree of pragmatism.   And we have got lots of experience in delivering new services and regimes. Whilst it may take us a little while on where I want to get the Division, bear with us.  Really, it’s about being the best we can to support businesses that protect people and the environment. 

 

In terms of other take home key messages – I would just like to thank people for engaging and working with HSE during the past year and for example listening to these podcasts.  We really do value the feedback and input that we’ve had and we look very much forward to working with people as we develop going forward. 

 

The UK Government is looking at future chemical strategy as part of the 25 Year Environment Plan and we will play a part in that and I think that at the heart of what we do now that independent regulatory decision making in the GB chemicals regime will allow HSE to regulate in a way that suits our economy. 

 

So we’ll continue to support businesses, we’ll continue to provide guidance through the website, eBulletins, our helpdesks at stakeholder events.  I would really encourage people to engage with us, give us feedback, and keep an eye out for future podcasts if we run them, sign up to our bulletin services because we are there to help and support you. 

 

 

Mick:

 

Great – thanks Richard.  That was Richard Daniels, the Director of the Chemicals Regulation Division in HSE.

 

 

A big thanks to all our guests in today’s podcast… that’s Nicola Gregg, Rachel Brown, Andrea Caitens, Alun Williams and Richard Daniels.

 

Remember to log onto the HSE website for more information and if you still need some guidance then contact the helpdesks which cover all the regimes and we’ll get back to you and soon as possible. 

 

The email addresses are included in the notes accompanying the podcast and of course on our website – www.hse.gov.uk

 

Thanks for listening and we wish you a happy and successful year.

After UK Transition: Working with Chemicals - Episode - 5 - CLP, REACH, PIC and Industry voices

After UK Transition: Working with Chemicals - Episode - 5 - CLP, REACH, PIC and Industry voices

February 9, 2021

After UK Transition: Working with Chemicals - Episode - 5 - CLP, REACH, PIC and Industry voices

 

In this instalment, we invite two industry voices to discuss changes to Classification, Labelling and Packaging (CLP), Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and Prior Informed Consent (PIC) regulations. We also explore the actions they have taken to keep their businesses moving following the end of the UK transition period.

 

If you have any concerns regarding UK Transition and the changes to REACH and CLP regulations, contact HSE at the earliest opportunity via ukreach.clp@hse.gov.uk.

 

If you have any questions regarding UK REACH enforcement, please contact the HSE at the earliest opportunity via CRDEnforcement@hse.gov.uk.

 

Podcast Transcript

 

Good day and welcome to episode 6 of the HSE podcast with me Mick Ord. Over the past few months we’ve been discussing the key regulatory changes which have been implemented now that the UK has left the European Union.  In the last episode we heard from businesses about how they had been preparing for changes to PPP (Plant Protection Products) and BPR – Biocides Products Regulations, in the run up to 2021.

 

This time round we’re looking at how people have been preparing for the changes to CLP, that’s the Classification, Labelling and Packaging of substances and mixtures, REACH – that’s the Registration, Evaluation, Authorisation & Restriction of Chemicals, and PIC – Prior Informed Consent, now known as GB PIC, which concerns the import and export of hazardous chemicals.

 

John Mackenzie, Head of Regulatory Affairs at Thomas Swan in County Durham, is back with us I’m pleased to say, as is a new guest on the podcast Dr Chris Howick from Inovyn Chlorvinyls in Runcorn.  They produce mainly chlorine, caustic soda and chlorinated derivatives from plants in the UK and all over Europe. They employ a total of 750 people.  I started by firstly asking Chris about the challenges his company faced in the run up to 2021 as they prepared for the new GB regulations.

 

Chris:

Well I think it’s been an interesting journey from the very announcement of the referendum result.  It caused a lot of discussion in the early days but I think bit by bit as regulations started to come in the UK and preparedness from the regulatory agencies in the EU progressed, it was a little easier to see exactly what we had to do.  I think we had a few stop start processes with the no deal scenarios because we had to get ready to transfer REACH registrations and Biocides registrations across to a European entity or an ongoing European entity for the initial leaving dates and of course we had two or three leaving dates in the end and so we then had to cancel those transfers to bring them back to ensure that they didn’t transfer.  So it’s been quite eventful in that respect but I think to a certain extent it didn’t matter whether there was a free trade deal or not because we were going  to have to go through these actions anyway, so I think it gave us a little bit of extra time preparing it and I think now that that is done we can concentrate on the actions for ensuring that we are compliant with the new UK regimes where there’s a little bit of a grace period before the first sets of deadlines come up with that.

 

 

Mick:

John Mackenzie, was that a similar scenario at your company, in terms of ensuring that your products are REACH compliant?

 

John:

Indeed it was, yes very similar.  I remember contacting some of our suppliers, the smaller guys especially and kind of like the rabbit in the headlights reaction from them like – what you mean we’ve got to change and do things that we didn’t do before, but now it’s gone from there to their saying yes, that’s fine no problem.  So we’ve come on a huge journey from the referendum in 2016 wasn’t it – to now by the time this comes out – we will have left and it’s come from not knowing very much at all about what we are going to have to do to being pretty comfortable that we are on top of things. So yes, it’s been quite a journey.

 

Mick:

Chris, for you in terms of Classification, Labelling and Packaging, CLP, any observations about how the transition period has gone in that particular section?

 

Chris:

I think it’s been a little more straight forward, than the REACH situation, the advantage is although we now have two regulatory regimes, we manufacture at sites throughout the EU but we have a significant presence in the UK and so as far the UK manufacturing assets is concerned, we now have two regulatory regimes, one in the UK and one in the EU.  The advantage is, of course, that we start with the same situation for classification and labelling  because clearly on the 31 of December 2020, the UK had the European CLP regulation and this now transfers to the UK one.  It remains to be seen whether there is differentiation and whether it happens and then to what extent it happens but there are some subtleties in that clearly when we supply companies in the EU from our UK site, those companies often become the importer and so they carry some additional responsibilities by importing material from outside of the EU into the EU and it works the other way round as well.  If we import from one of our sites on the Continent, we now have to ensure that there’s reference to the UK or I should say GB classification regulation there as well and as I say at the moment, we start with the same classification so it’s a technical or administrative task, but we just need to see how that develops in the future and whether the UK will deviate or have a different opinion on a case by case or chemical by chemical basis.

 

 

Mick:

And how did you know that the various actions you describe were required?  Where did you go for that information?

Chris:

Well, we’re very fortunate in that we play an active role in the Chemical Industries Association and also on the polymers side from the British Plastics Federation, so we’re active in those two trade associations for the chemicals and polymers side of our business.  They’ve both been a very good source of information so the regular meetings and organisations of webinars with input from the UK regulators.  On the European side actions, there has been some good, detailed guidance documents on the European Chemicals Agency website as well as the change in obligations from companies and the particular guidance on how you had to navigate through what’s termed the REACH IT, which is the Agency’s submission portal for chemicals as well as what the obligations for companies were for that, particularly on the REACH side rather than the CLP side.  And then, of course, we did get the statutory instruments which of course are phenomenally difficult to read because they refer to the original European legislation.  They only really highlight what  changes by making them a UK regulation.  I think companies, particularly on the continent that found the UK Statutory Instrument thinking they were going to find how they had to comply and it’s  very, very difficult to read even if English is your first language.   I think it’s the guidance that goes with it now and certainly the Government website has got a lot more information on and the HSE and Defra have done some very good roadshows over the last two or three years that have been very informative and I think recordings of those are still available on the internet if companies want to catch up with those.  Those were particularly useful and I would say a lot more informative in the early stages than the initial guidance, but certainly we’ve now got some good documents from the UK regulators as well. 

 

Mick:

What about the situation in terms of the export and import of hazardous chemicals – PIC?

 

Chris:

The Prior Informed Consent side has taken us a little longer to set the systems up because we weren’t sure exactly how the UK was going to do it but with materials transferring between our sites in the EU and our UK sites and vice versa, of course what would just be a seamless transportation before the end of the transition period, now has to be licensed and because the UK is now out, we did have to essentially apply for licenses before the end of the transition period in order to ensure that we had the necessary licenses for export.  ECHA, the European Chemicals Agency work on a 35 day lead time for PIC applications, so those all had to be submitted well in time for the end of the year to ensure that they were in place. 

Going the other way, the UK system is more based on seeking permission and authorisation via email.  The UK has a system which is fit for purpose because of the smaller size of the market.  I don’t think it’s gone for this extensive IT system that there is on the European side, but I think we’ll see how that goes in the HSE and the Competent Authorities in the UK, I think we’ll keep that under review as to whether it needs to be expanded, but again we had to set those up to be ready for the exports to go in January.  We are confident that things are in place and we’ll review it as the New Year progresses.

 

Mick:

John, PIC doesn’t necessarily apply to you does it?  What about CLP and REACH – have you got anything to add?

 

John:

In terms of preparations we’ve made do you mean?  Technically, we are a medium sized enterprise and we don’t have any footprint in the EU, we don’t have an office or another site so what we had to do was to set up a relationship with what’s called an Only Representative or OR for short in the EU so we’ve done that with a German company and it’s a consultants again and what’s going to have to happen is – we transfer our REACH registrations to them first and they then accept them (in the New Year) and that will be our registrations transferred into the EU and then we’ll have to grandfather those into the UK system so it will end up with is REACH registrations in the UK and the EU.  Of course we will only need those in the EU for chemicals that we supply (or products we supply) into the EU.

 

But we’ll end up with two sets of registrations instead of one and also potentially, two sets of costs instead of one because every time you set up a REACH registration, you have to buy into the dossier of data that exists and it can be very expensive, tens of thousands, sometimes hundreds of thousands of pounds or euros, so potentially you will have to pay twice.  Now I don’t expect that our costs are going to be doubled, but they will be significantly greater than they were before.

 

Mick:

I was just going to ask you John, whether you think that that situation is replicated among other businesses of a similar size to yours?

 

John:

I’m sure it will be.  Chris can comment on this as well.  I am sure that every single chemical company who wants to supply into the EU will have increased costs because of the fact that we are having to deal in two jurisdictions now, the UK and the EU.

Mick:

Chris, do you just want to add to what John said there?

 

Chris:

Yes, I think there clearly will be increased costs on what’s termed the sweat equity side which is the amount of time and effort that companies have to put in to actually doing all the administrative side work and submission of dossiers etc.  I think industry is generally trying to come up with a pragmatic solution on the data sharing issues.  Companies set up consortia between themselves to initially develop the EU REACH dossier and that was all based on sharing and each company in the same volume band essentially paying the same amount of money.  We are hoping that some pragmatism will come out of that with their approach to granting data to UK companies registering for UK REACH, but it will be a sort of consortium by consortium approach.  Some companies may take a different view, but clearly companies may have to pay for data access whereas at the moment they don’t have to and I think that the biggest, most significant change by the introduction of the UK system is companies that are today buying from suppliers in the EU, sort of change from being a downstream user in the EU system, to an importer in the UK system.  So, as a downstream user in the EU system there’s no obligation to register but as an importer there is an obligation to register if your supplier hasn’t registered or isn’t going to register so I think that remains something of an unknown situation.  We don’t know how many companies will be caught by that, we just need to see how many EU manufacturers are prepared to register their substances on the UK market and under the UK system. 

 

John:

I think that’s a really good point.  I think the biggest impact in the chemicals industry is on those people who are distributors who have never had to register their chemicals up to now, but now they will have to every time they import from the EU.  One of the things that we did as a company was we did a survey of all our suppliers globally, every single one.  We sent them out some information a couple of years ago, just so they were aware of what was going to be going on and to ask them a few questions and I got some positive answers.  The bigger companies that you would expect, knew what they were doing, were fine with it, it was the smaller companies who didn’t realise that they were  going to have to now register for their imports -and maybe import relatively small amounts - … they didn’t realise they were going to have to register them now.  That’s a couple of years ago and now it’s turned around so we went from about half a dozen, maybe a few more than that, were on what we call the critical list of raw materials that we buy from suppliers, now down to just one, which is a fairly small, minor component in something, and so there has been a big shift in knowledge and information in the industry, so you know it’s changed a lot in the last few years I think. 

 

Chris:

It’s clearly getting better I think but the concern is maybe on the SME side where particularly the import I think of chemical mixtures and this particular one in the polymers sector where quite a common ingredient would be what’s termed as either a stabilizer master batch or a pigment master batch which sort of blends of various stabilisers, anti-oxidants, pigments and a lot of companies would all buy these additives in one formulation, in a formulated product, you know sort of Blue 29 or something and if they are buying those from an EU supplier, in theory each substance in that mixture, will need to be registered or you would need to know it’s been registered and for the supplier of that material, if the ingredient isn’t  hazardous, it’s not classified as hazardous, there is no sort of compulsion to declare exactly what the components are so these materials are being imported with good safety data sheets for the mixture, but it’s very difficult to ascertain what the chemical components are.  As an importer, you have to do a downstream notification and then a registration.  It’s a particular challenge, but I think companies certainly have welcomed the change in the timeline of registrations now to this post two year, four year, six year periods, because particularly those SME’s now have got some time to resolve these issues with their supply chain and I think that’s been very welcome.

 

Mick:

What actions would you recommend Chris for those businesses who don’t feel prepared and maybe fall into the SME category that you’ve just been talking about?

 

Chris:

I think for SME companies in the UK it’s just - have a think and check with your suppliers. Just try and understand what it is you are importing - are you importing a mixture or a pure substance?  And the most important question probably I think that you would need to know ideally in advance of the 27th of October, but certainly by the 27th of October, is whether your supplier is registering that or is somewhere up the supply chain? Are the substances in that mixture, or is that substance, going to be notified and registered under the UK system?   So, there’s a deadline for notifications for those importers by the 27th of October, 2021 .  That’s not a registration, but it’s a notification and ideally check with your suppliers before then that you know that you don’t have the registration obligation, it’s all being taken care of further up the supply chain.  I think that’s the first and probably perhaps the most important aspect and just engage with your supply chain – just say what are you preparing to do?  Is the substance grandfathered into UK REACH or if not is it going to be notified and registered under UK REACH either by your supplier or your supplier’s supplier.  Just ensure that that information is flowing up and down the supply chains.

 

 

Mick:

John, have you got anything to add to that?

 

John:

No, that’s really well covered by Chris.  If anything I would say check with your trade bodies, get some advice from them, see what they say.  They’ll no doubt have information ready to send to you if you need it and check the gov.uk website because they’ve got really good check lists, they’re really rough and ready but they are really good to point you in the right direction.  Of course, the HSE website has got good information on it as well.

 

(Music interlude)

 

Mick:

A big thank you to John Mackenzie and Chris Howick for their thoughts and observations which I hope you found useful. If there are still any areas where you feel you need some more information then log onto the HSE website which is regularly updated – there is a link in the notes accompanying this podcast.  Remember too that you can contact our helpdesk directly. Just email your question to EU-exitchemicals@hse.gov.uk and we’ll respond as soon as possible. Again, the email is in the notes that come with the podcast.

 

And please subscribe to our eBulletin newsletters too.  You do this by popping your email address into the subscription boxes which you’ll find on the HSE website.  We’ll keep you informed of news and updates as they affect the chemicals industry.

 

So many thanks for joining us, good luck with your business for this year.  From me, Mick Ord and the rest of the team….it’s good bye until next time.

 

 

 

 

 

 

 

 

 

After UK Transition: Working with Chemicals - Episode - 4 - PPP, BPR and Industry voices

After UK Transition: Working with Chemicals - Episode - 4 - PPP, BPR and Industry voices

January 28, 2021

After UK Transition: Working with Chemicals - Episode - 4 - PPP, BPR and Industry voices

In this instalment, we  invite two industry voices to discuss changes to Biocidal (BPR) and Plant Protection Product (PPP) regulations and explore the actions they have taken to keep their businesses moving following the end of the UK transition period.

It should be noted that the views of any guests on HSE podcasts/recordings do not necessarily reflect those of the HSE or the wider government. Moreover, further website guidance was released in the time following the recording of this podcast. For the most up to date guidance relating to EU Exit, visit www.hse.gov.uk/brexit/chemicals-brexit-guidance.htm or email EU-exitchemicals@hse.gov.uk

 

Podcast Transcript  

Welcome to the HSE podcast with me Mick Ord.  I hope you’re well and looking forward to happy and prosperous year.

In the past few episodes we’ve been hearing from some of HSEs and DEFRA’s own EU regulatory experts about many of the changes that businesses face, now that the UK has left the European Union, and how they should prepare for it, but for this episode and the next one, it’ll be a bit different.  

We’ll be hearing from the businesses themselves about what the past year has been like for them as they try to plan for life outside of the EU.  The views of people whose businesses are being affected on the ground provide much food for thought and I’m confident that some of the things that they’ve observed will be ringing true for many listeners to this podcast.  What they say will also hopefully help to steer you in the right direction as you maybe tackle some of the hurdles that they’ve been negotiating.

In today’s podcast we’ll be hearing from John Mackenzie, the Regulatory Affairs Manager at the long-established chemicals manufacturer Thomas Swan.  They’re a family owned and run business with a UK base in Consett in County Durham, directly employing around 170 people with other bases in the USA and China.  Also joining us is James Clovis, MD of London-based Gemini Agriculture – a company which specialises in the supply of agrochemicals to the UK market.  James founded the company five years ago.

In this episode I’ve been talking to John and James mainly about how they‘ve been preparing for the changes in the regulations pertaining to PPP – Plant Protection Products – and BPR - Biocides Products Regulations.  First of all I asked John what it was like for his company navigating the transition period last year.

John:

In the beginning it was pretty difficult really because there was so little information.  I have to say that one of the immediate impacts of the vote to leave the EU was actually positive for us because the exchange rates changed and we were able to export more because we became more competitive in some markets and so actually it was a help in the beginning but the regulatory burden is going to be massive because of having to deal with two regulatory authorities – ECHA in Europe and HSE in the UK, but navigating it we just had to find whatever information was out there and initially there wasn’t much.

We’ve have kept in close touch with the Chemical Industries Association, the CIA and they’ve been brilliant with keeping us up to date.  We’ve had regular meetings with them and they’ve organised meetings with the Government Departments BEIS, (Government department for Business, Energy and Industrial Strategy) Defra, HSE and so on, that’s been our main way of navigating it and finding our way through, up until more recently when more information has come out from Government departments.  The impact is mainly going to be dealing with two regulatory authorities like I said.  The regulatory burden is going to be increased in a department where there are only two of us working on regulatory issues.  It’s going to mean quite a lot more work for us and therefore more cost.  

James:

I think John’s nailed it there on the regulatory side.  We’re quite lucky in Gemini because we primarily sell only in the UK.  I think from an import and export point of view that’s where it’s going to impact us the most.  A lot of the technical material comes from India and China which we can’t manufacture within Europe and within the UK and I think it’s going to have a fundamental impact on how we bring products in, you know what processes and what systems we have to work with and also how the parallels go and the extension.  The extension of the active materials for three years is going to be very beneficial in one way.  It kind of gives the UK a bit of longevity in certain products but it’s also going to have a delay because ECHA was dealing with a lot of the Annexe I and Annexe II renewals and I think what’s going to happen now is that we’ll see delays and I think even for generics as well as the multi nationals, we are kind of locked out of those chemicals whether we can access them from a competitive point of view or just from a multinational trying to modify any of their registrations, they’re going to be locked out for an extended period of time.

Mick:

And how can you prepare for something like that?

James:

Well it’s interesting.  I think that from an import/export perspective, I think a lot of people have brought product into the UK whether it’s technical material or finished goods.  I think we’ve seen an increase in product being brought in and stored.  I think we’ve seen an increase in utilisation of certain Toll Manufacturers, there’s an awful lot of those being locked up very early on now.  So I think primarily there’s a lot being brought into the country and is sat in warehouses and I think there are other preparations being made, but it’s trying to be informed as you possibly can and myself and Gemini – we’ve spent a lot of time working with forwarders and the importers trying to make sure that any documentation or approvals that they need, have been submitted well in advance.  

For Northern Ireland we’ve applied for an EORI number extension, the X number I believe it is now and so we are trying to do everything we can but again, we don’t know all the answers yet so it’s trying to prepare as best we can when something pops up, you’ve got to jump on it as quick as you can.

Mick:

John what actions have you taken or at least started to take to ensure your products are biocide compliant?

John:

The main thing we’ve done, well a couple of things really, but one of the big things is that we’ve recently transferred – there’s a thing called the Article 95 list which is a list of active biocides that are allowed to be used in the EU, and so because we are out of the EU now, we had to transfer our registration on that list over onto our representative in the EU.  Now of course being a small company, we had to use a consultant to do that and of course they don’t come cheap, so they are now going to become our representative in the EU working on our behalf and so we are now listed still on the Article 95 list, but with a representative in place rather than have a direct registration ourselves.

The other thing we’ve done though, as a company we’ve decided as a mitigation against the potential border friction that will no doubt occur, we decided that we would apply for a thing called AEO which is Authorised Economic Operator, something which is much more common in Germany and some other European companies but not so common here.  I think the last count I saw was about 700 companies registered in the UK whereas there are about 10,000 or so in Germany.  Anyway, we did that, it was a lot of work but it means that now we are registered on that scheme, that should help with our paperwork, it should reduce cross border friction between UK and EU, but also within the EU itself so it means that the red tape is cut out to a large extent and means we can deal more directly with our customers in the EU.

Mick:

And James what about you on that score – what actions have you started to take? 

James:

What we’ve basically done is, all our registrations are UK Article 34 registrations, we have a couple of parallel imports as well.  So as it stands most of ours will be compliant to the new system and we won’t need to do anything.  

I think REACH is a slightly different kettle of fish and I think moving forward it’s going to take – it depends how you approach it – I think there’s going to be quite a lot of work for certain companies to make sure that all of the intermediates or components are registered in time.  We’ve started working with the supplier of the intermediates and also the Toll Manufacturers as well to make sure everything is REACH compliant when we know exactly what we need to do going forward for that.  

Mick:

We’ll be touching on REACH in the next episode.  James what about PPP compliancy?

James:

As I alluded to earlier, all of our products are already registered with CRD/HSE and we expect that there won’t be much change going forward to the existing registrations.  Going forward for new registrations though, that’s going to be interesting to see if there’s much change at all.  One, to the documentation or requirements but also I think, as I mentioned earlier, to see what happens with the delays on the Annexe I, Annexe II renewals.  From actions there’s not much we can do now, we are basically sat in a holding pattern for certain products waiting for the protection to come down so we can apply for registrations.   There’s not a whole lot on the action side that we need to prepare for.

Mick:

So it really is the information that you need isn’t it?  That’s what you’re looking for and then you can take your actions.  So far, where have you been getting your information from, John you mentioned about the trade body before.  Do you visit the HSE webpages for example?

John:

Yes, I have done.  I have to say until recently at least, the HSE webpages weren’t terribly helpful, but they’ve now improved that dramatically.  Recently, I was having a look at them and they’ve made a big change in the information which is available especially on REACH.  Biocide, it’s getting there.  We’ve also used a lot of other sources too.  I find that the Government websites are pretty good now, there’s a lot of information coming up on gov.uk/transition, but the main source for our information has been our trade body the CIA, at least in the initial stages.  Latterly, more like HSE and gov.uk.

Mick:

That’s good to know.  What about you James?

James:

Very similar to what John’s just mentioned.  We do use the CRD/HSE website for updates.  We do also use the Government emails and updates which are sent through as John mentioned.  And again we use the Crop Protection Association and they’ve disseminated quite a lot of information basically over the last two or three years with most of the changes as well as being involved in a lot of the work.

Mick:

John, and in fact you too James, where would you go to find more information?

James:

I don’t know about John but I think primarily the internet is the No. 1 source for most of the information we’ve tried to find, but we’ve got contacts in CRD as well and without obviously getting anyone in trouble there’s a lot of information you can actually request, so just by talking to some of the CRD members, you do get a good feel for the way things are going and they can also relate it back to specifics that you’re going though.  So I think direct contact with CRD, the Government and emails.

Mick:

And you, John?

John: 

We’ve got a couple of different sources that we’ve got subscriptions to that we pay for information from.  Organisations like Chemical Watch, Kerona, (European Regulatory Consultants) people like that have provided us with information as well.  James is absolutely right, the best place is go to the internet and search on Google and ask a question and see what it comes up with.  HSE has been good as well though.  If you have a specific question for them, they’ve got a helpdesk and I’ve asked them a few questions over the past couple of years and they’ve been really helpful actually and pretty prompt in replying.

Mick:

And what actions would you recommend John for businesses which don’t feel prepared?

John:

If you don’t feel prepared, I would advise, go to the Government website, like I said before, gov.uk/transition they have a checklist which will provide you with a series of questions.  It will ask you a question and whether you say yes or no, it will give you different answers and take you different places and checklists to make sure you’re covered with everything.  We’ve done this two or three times where every time you do it again, it comes up with something else.  It might not be related to biocides we are talking about just now, it might be if you are employing European nationals.  One thing that we’ve found, we’ve got one or two people from Italy, Spain and France working here and they need to consider the documentation that they need to have in place to continue to work in the UK.  There are grace periods.  I think that the European nationals are allowed up until sometime in June to submit whatever documentation they need, but they still need to do it.

Mick:

James have you got any handy hints for people listening who feel - Oh blimey, I’m not prepared?

James:

I think the Hitchhikers Guide to the Galaxy is probably the best advice, but don’t panic!  I think it depends on the size of the company.  I know big companies who’ve been scenario planning for years on the impact of Brexit.  From my side what I would say is, try to find out as much information as you can and I think make contact with trade associations – the CPA has done multiple things for our side of the fence, not only discussing things with Government officials and looking at presentations to the Expert Committee on approval process and things like that.  Most trades associations will be on spot with this so I would contact those but I would also talk to other companies.  You’ll have competitors, you’ll have partners in the industry and try and find out what they’re doing. 

John:

James I really like your reference to the Hitchhikers Guide.  I’ve got written down here in big, friendly letters – don’t panic, the world will not come to an end, the UK will continue to exist, we’ll have new circumstances to adapt to and that we will adapt and we will survive, but it will just look different.  

Mick:

That’s a good point to end this interview on John.  John Mackenzie and James Clovis thanks a lot for joining us today that was really, really useful. 

In a couple of minutes time, I’ll be giving out some really important information not only about the HSE website, but about the HSE’s eBulletin service.  If you have a particular question you need answering, email us and we’ll get back to you as soon as possible. 

 (Music Interlude)

Many, many thanks to John Mackenzie and James Clovis for their time today and for sharing their views on the past few months, their hopes, fears and advice for the future.  I hope you found it useful.

There were quite a few mentions in the interview of the HSE website which is being regularly updated with news and information on PPP and BPR not to mention the other regimes which have been affected by the changes.  We’ve updated our guidance on the chemicals industry – this is available on our website which is linked to the notes on this podcast.  Remember too to subscribe to our e-Bulletin newsletters – you pop your email address into the subscription box which appears on the pages of the website. 

And if you want to contact our helpdesk with a question about the new regulations for the chemicals industry then email them at EU-exitchemicals@hse.gov.uk and we’ll respond as soon as possible.  Again this email is in the notes which accompany the podcast.

We won’t actually be saying goodbye to John Mackenzie as he’ll be joining us in our next podcast where he’ll be discussing – along with another business guest, the changes to CLP, REACH and PiC regulations.

The guest in question is Chris Howick, from Inovyn who, according to their website, manufacture a wide range of chemicals that are used as raw materials in almost every industrial process.  They specialise in Chlorvinyls and have sites in the UK and throughout Europe.

So join me Mick Ord for what will hopefully be an enlightening and useful discussion with our two industry voices….take care and we’ll hopefully catch up with you very soon.

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.

After UK Transition: Working with Chemicals - Introduction to the series

After UK Transition: Working with Chemicals - Introduction to the series

November 23, 2020

After UK Transition: Working with Chemicals - Introduction to the series

In this introductory episode, we discuss the main changes to how chemicals will be regulated in the UK from 1 January 2021 and how HSE can help your business prepare for the end of the transition period. We also discuss the different areas and topics that will be covered during the series.

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 Transcription.  

  

Welcome to a new series of podcasts from the Health and Safety Executive aimed at helping businesses that work with chemicals.  Everything you need to know before and after the end of the transition period. 

 

My name is Mick Ord and over the next few months, I’ll be your guide through some of the changes which are happening as a result of the UK leaving the European Union.  

 

We’ll be releasing a difference episode of our podcast every month or so until the New Year and we’ll be hearing from a range of experts about what you need to do to make sure the transition goes as smoothly as possible for you and that if you hit any obstacles, we’ll point you in the right direction so you get the right answer as soon as possible.  In short, we’re here to help you so subscribe to our podcast, especially if you’re a newcomer to podcasts.  Believe me it’s dead easy. 

 

The information we’ll be giving you is important for over 200,000 businesses involved in the export and import of chemicals throughout the UK from the big multi-nationals to the small one man, or one women business.  

 

Joining me today is someone who’s been living and breathing the changes in the legislation for the chemicals sector over the past 18 months and she’s going to talk to us about why we are launching this podcast and a little bit more detail about what we can expect over the next six months or so.  Kayleigh Roberts is from the HSE and she works in the External Communications and Stakeholder Engagement Team, bit of a mouthful but - Hi Kayleigh, welcome.  

 

Kayleigh: 

Hi Mick, thanks for having me. 

 

Mick:  Our pleasure. First of all, why has the HSE decided to launch this podcast because it’s not something that you’ve done before is it? 

 

 

Kayleigh: 

That’s right Mick this is not something the HSE has done before and in order to help businesses help prepare themselves get ready for the end of the transition period, we want to make sure that we are making as much information available in as many digestible forms as we can to help businesses understand the duties and obligations that they may need to undertake from the 1st, January, 2021.  So although it isn’t something we’ve ever done before, last year we did actually record a series of videos, however, owing to the current public health crisis, we believe that this is a more efficient way to provide information this time round.  

 

Mick: 

Yes, that makes sense. Now as I mentioned in the introduction, you’ve been living and breathing the transition changes over the past year or so, so can you just give us an idea about what you and your colleagues have been doing and what it’s been like being at the centre of these historical changes in legislation? 

 

Kayleigh: 

Yes, as you mentioned, this is something that has never happened before and it’s something that we’ve never had to take into account before so in order to make sure that we’ve got the legislation in place for businesses to take the duties and actions that they need to from the 1st, January, 2021 when the transition period ends, we’ve had colleagues whose primary role is to work on developing that legislation, to amend the previous statutory instruments that would have come in place in 2019 to take into account the Northern Ireland protocol.  So this has been a joint effort of policy and operational colleagues across HSE and we’ve all been working together to make sure that that legislation is laid in Parliament to make sure it’s in place for the 1st, January, 2021. 

 

We’ve also had colleagues working on future trade agreements between the European Union and also the rest of the world and that has involved a lot of trade and negotiation talks which are still ongoing as I speak.  We’ve also had colleagues on the team working on governance, peer reviews and the strategy aspects and also, finally, the team that I work with the communications team, we’re making sure that everything that is taking place and the preparations that are being made for the 1st of January, 2021, are able to be communicated effectively to the stakeholders within the chemicals sector.  

 

It’s been a mammoth effort, it really, really has. It’s brought together teams from other government departments and also been a mammoth effort within HSE itself.   

There’ve been different teams within divisions within HSE which have been working together which may not necessarily have worked so closely before, it’s been a totally different way of working. 

 

Mick: 

It’s interesting you say that because we all watch about the EU and the Government, we all watch that on the news and we don’t really realise what’s going on behind the scenes.  I think it is important that people do know that a lot of people have put a lot of work into this to make it smooth for the businesses.  Now the stuff that we are going to talk about in the podcast today and over the next few months, is it applicable to businesses whether there’s a deal or no deal with the EU? 

 

Kayleigh: 

I think it is important to note Mick when you refer to deal or no deal is that the UK left the European Union on the 31st, January 2020 with a deal and in line with that deal, we entered a transition period which will end on the 31st, December 2020 so what is going on at this moment in time is preparations for either a negotiated future trade agreement or a non-negotiated future trade agreement, we don’t actually use the terms deal and no deal anymore  and I know that that is something which stakeholders within the sector may find a little bit odd, if you will, to get their mind around because we’ve been using the term deal or no deal for a great deal of time but it is important to note that that is not the message which is going out anymore. 

 

Mick: 

OK, I will not be using that term again, don’t worry!  Which sectors in particular are you keen to reach over the next few months? 

 

Kayleigh: 

HSE is involved directly in the regulation of biocides, we are also directly involved in the regulation for classification, labelling and packaging of chemicals and also the export and import of hazardous chemicals which is known as PIC, or Prior Informed Consent and HSE also has involvement in the Pesticides Regulation and also the REACH Regulation, so what we want to do is to target businesses who work in those five chemicals regimes.  We want to target them to make sure they are aware of the duties and obligations that they may need to undertake.   

Some of them might not have needed to have done before or may have not needed to have considered before so we want to make sure that they’ve got all the necessary information that they need to prepare for the 1st of January, 2021. 

 

Mick:  

And what are the timescales and deadlines for businesses who’ll be affected by the changes then Kayleigh? 

 

Kayleigh: 

So, across the five regimes there are actually different timescales that need to be taken into consideration to ensure that legal obligations are met and one thing which I would recommend is visiting the HSE website, we’ve got a lot of information with regard to deadlines that are in place. Like I mentioned, they do vary because what we’ve put in place as part of the regulation is something that we refer to as transitional arrangements and those transitional arrangements basically give businesses different amounts of time to comply with different parts of the regulations to make sure that they are safely using chemicals within the market in Great Britain from the 1st of January, 2021.  

     

Mick: 

Right, so all the information they require either is on, or will be on the HSE website? 

 

Kayleigh: 

Yes, there is a current version of guidance on the HSE website for all five of the chemicals regimes which I mentioned before and that will be constantly reviewed and updated as and when as and when information is available.   We’ve also got a really widely subscribed e-bulletin service and that’s got over 220,000 members you know, that is a really well subscribed service. And we will make sure that any guidance changes or anything like that are also advertised via that route as well so that businesses can be aware that these changes are being made and that there’s new guidance available.   

 

Mick: 

Have many businesses already been in touch with HSE with queries?  What are the areas they are particularly concerned about? 

Kayleigh: 

Concerns vary widely.  You know I think a lot of businesses now are just wanting to start to make the necessary preparations that they can, which is why in part we are doing these podcasts.  We are going to have subject matter experts for all of the regimes that are going to come and discuss the necessary preparations that businesses need to take by regime.  I think businesses are just wanting to make sure that they are adequately prepared for anything that they need to do in the immediate term, after the 1st, January,2021. But also, things that they may need to start preparing for now.  There may be duties and obligations which that come in six months after the end of the transition period that they may need to start taking preparations for now. 

 

Mick: 

What might be the consequences if businesses put off engaging with the HSE for another day because say they are too busy dealing with the everyday stresses and strains of running their own business? 

 

Kayleigh: 

I think that one of the main things that we should take into consideration is that HSE is there for businesses, we operate some helpdesk functions, we’ve got the available guidance, we are also producing further communications products  like this podcast, we are doing events across government and also HSE led events and what I think is important is that businesses who are within these chemicals sectors start to engage with us as soon as possible because there may be some duties and obligations that they need to undertake after the transition period ends, that they were not actually aware would be relevant to them.  They may not have had to do them before, they may not have had to consider them before, so in order to make sure that these businesses have got enough time to make these necessary preparations, I would advise any business who is involved in the regulations if they’ve not engaged with HSE or they do have any questions for us to get in touch as soon as they can.  Like I said we’ve got helpdesk functions across all of the chemicals regimes where you’ve got access to experts within their field who will able to help and guide you and give you any advice that you need. 

 

Mick: 

Brilliant.  Now if someone hits a brick wall when they log on to the HSE website and maybe can’t find the information or guidance they need, what should they do? 

 

 

Kayleigh: 

I would recommend contacting the helpdesk which as I mentioned, operates by regime.  I believe these helpdesk email addresses are actually going to be part of the bio for this podcast, so they will be readily available for stakeholders to actually copy and paste and get in contact with HSE directly that way. 

 

Mick:  

Smashing. Now, remind us once again, briefly if you can, Kayleigh of what areas we can expect to hear about over the coming months in these podcasts. 

 

Kayleigh: 

In the coming months we are going to have subject matter experts available for all of the five regimes that HSE has got regulatory responsibility for to give the information, the duties and obligations, you know the legal side of things that businesses need to make sure that they are considering when they are making preparations for the end of the transition period.  Those subject matter experts are going to be there to go through in further detail all of the transitional arrangements, when things need to be acted on and how they can do that as well so how they can make data submissions to the HSE, or how they can engage with HSE directly. 

 

Mick:    

Remind us again how we log on to the HSE website and especially how people listening can subscribe to the bulletin.  

 

Kayleigh: 

So, the HSE website can be found via any search engine.  If you search HSE chemicals you will be taken to the landing page which has got all of the information and all of the regime guidance pages, also in addition to that the e-bulletin subscription box is always at the bottom of all of our pages and businesses can put information into that, their email address or their businesses email address where they can sign up and select the regimes that they wish to get updates on via the e-bulletin service.  Like I said, that’s really widely subscribed and we do get feedback from stakeholders that is actually a really valuable tool, an alert tool if you will and that’s how we intend to use it this time round like I mentioned, to advertise events, guidance updates and also we will be using it and also advertise these podcasts.  

 

 

Mick: 

Smashing, many thanks Kayleigh.  That was really, really helpful.  Now we may be hearing from you again later in the podcast series, but in the meantime, I would strongly urge you to take a look at the website as Kayleigh explained, subscribe to the e-bulletin, and of course, this podcast.   And if you are particularly concerned about the changes in the various processes and the forms that you will have to fill in, remember, we’re here to help and support you with information whenever we can.  None of us likes change, but believe me, with a bit of guidance and support from us at the HSE, we will do everything in our powers to make sure that you’ve got the right information as we move into 2021.   My name’s Mick Ord, thank you for listening, speak soon.   

 

 

 

    

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