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.
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.
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?
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.
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?
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.
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?
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.
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?
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.
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?
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.
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?
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.
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?
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.
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?
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.
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?
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.
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?
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.
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?
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.
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?
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: firstname.lastname@example.org 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.
Final question for you Alun. My company predominantly produces polymers. What is the stance on polymers under REACH and are polymers exempt from REACH?
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.
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?
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.
Absolutely. Do you have any reflections as to how things have been going since the 1st of January?
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.
Very impressive. Could you outline any immediate priorities and plans for the medium to longer term?
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.
I was wondering if you had any take home key messages for those who listen to these podcasts?
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.
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.