After UK Transition: Working with Chemicals - Episode - 3 - CLP, REACH & PIC

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.