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.

----more----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 a