Beyond REACH – what is the impact of Brexit on the chemical industry?
During our webinar ''Beyond REACH", a list of questions were identified which needed further explanation, read on to learn more
Can I appoint an OR from within the EU/EEA while the REACH regulation still applies in the UK until the end of the transition period?
According to Article 8 of the REACH Regulation, only a natural or legal person established outside the EU may by mutual agreement appoint a natural or legal person established within the EU to fulfil, as Only Representative, the obligations that the REACH Regulation imposes on importers. Your company therefore will not qualify for performing such a transfer before the end of the transition period.
However, a transfer of registration will become acceptable for UK-based manufacturers and formulators when the transition period is over. ECHA recommend that a contractual agreement to appoint an Only Representative, which contains a suspensive conditional clause stipulating that the appointment takes effect at the time when transition period ends is set up prior to the end of the transition period.
The change will need to be notified to ECHA using REACH-IT, as instructed in the 'How to transfer your UK REACH registrations prior to the UK withdrawal from the EU' guide, available on the ECHA website. (https://echa.europa.eu/documents/10162/13552/how_to_transfer_uk_reach_registrations_en.pdf/1fb443ce-79de-6596-aae5-3f1033f1a5fb)
Note that after the successful transfer of the registrations in REACH-IT, the Legal Entity change successor is expected to submit a dossier update to comply with Article 22 REACH to ensure that the dossier reflects the new role (Only representative).
There are ongoing discussions about a trade deal with the EU. Is UK REACH inevitable?
In theory it isn’t, but in practice it is. The discussions have not yet been finalised. However, the UK Government has stated that the UK would not participate in the EHCA or the EU regulatory framework for chemicals after the transition period. Instead the Government proposes to put in place a separate UK chemicals regime (UK REACH). Therefore, all indications are that the UK will have a separate system.
Chemical and manufacturing industry stakeholders continue to call for an agreement with the EU that ensures frictionless trade and regulatory consistency, ideally as close as possible alignment to REACH. The Government has proposed that the final agreement could include an annex on chemicals with provisions for data sharing and cooperation. However, these proposals have not yet been agreed with the EU and discussions are ongoing.
How will PIC be applied in UK REACH?
There are ongoing discussions and thus the details are not yet finalised. Guidance on the submission of 2021 PIC export notifications will be issued by the HSE in due course. As the UK is a Party to the Rotterdam Convention on the Prior Informed Consent procedure, the UK will maintain a Designated National Authority (DNA) that will implement PIC at a global level. We suggest that you sign up to the subscribe to the HSE export and import of dangerous chemicals email newsletter for further information.
We are intending to follow up this webinar when we have more information on the details of the new UK system, including UK REACH, PIC notifications and the Northern Ireland Protocol, please keep an eye on our social media.
What about authorisations and restrictions – will they still apply after the end of the transition period?
Strictly speaking, No. As the REACH Regulation will no longer apply to the UK, and the REACH Authorisations (and pending authorisation applications) and REACH restrictions will lose their legal effect as of that date. However, the HSE have advised that to ensure continuity for business that all existing authorisations will be carried over into the UK system to allow continued use of higher-risk chemicals. Authorisation holders will be required to provide specified data to the HSE within certain deadlines, some of which follow shortly after the start of the regime in January.
New EU REACH authorisations and restrictions would not apply in the UK, unless the UK mirrored these authorisations and restriction in UK law.
What should I do to ensure business continuity ?
Businesses should be looking now at their position under REACH and considering what actions they need to take.
Existing REACH registrations and authorisations will take effect as UK registrations and authorisations under UK REACH. However, registrants and holders of authorisations are still required to provide specified data to the HSE within certain deadlines, some of which follow shortly after the start of the regime in January.
UK businesses, which are downstream users or distributors under EU REACH and receive chemicals from the EU, would become importers subject to registration requirements under UK REACH. Transitional provisions provide for a two-year grace period in which businesses in this position can continue to import without a registration, but also require the submission of certain data to the HSE for substances imported in quantities of more than one tonne.
After the end of the transition period, any UK-based EU REACH registrant can no longer be a registrant. For the purpose of the EU’s REACH Regulation, any registration by such a registrant will therefore be regarded as non-existent. Consequently, either your EU /EEA customers will need to register the respective substance themselves, or alternatively, in order to continue supplying your EU-based customers on the basis of your own registration as a manufacturer or formulator, you may appoint an Only Representative within the EU/EEA or transfer your manufacturing activity to the EU/EEA.
What about fees?
Under the provisions of the REACH Regulation, ECHA have stated that they will charge a fee for the legal entity change when transferring the REACH registration. There will be additional costs regarding UK REACH registration, however, discussions regarding a potential annex on chemicals including data sharing and cooperation are ongoing and details of the fees are not yet known.
Will I need to continue to update my REACH dossier?
No. EU legislation will not apply in the UK after the transition period, and you will no longer be required to update your dossier without undue delay. However, if you have transferred your REACH dossier to a new Legal Entity within the EU, they will need to update the dossier. After the successful transfer of the registrations in REACH-IT, the Legal Entity change successor is expected to submit a dossier update to comply with Article 22 REACH to ensure that the dossier reflects the new role.
Are there platforms that can be used to train personnel in UK-REACH platform, UK-PIC, UK-CLP, UK Poison Centre notifications etc. before the end of the transition period? How can these be assessed?
The discussions are ongoing and the final details of UK-REACH, UK-PIC, UK-CLP and UK-PCN are not known. We would speculate that there will be platforms to train personnel in the new UK Chemicals regime and will follow up this webinar with further details once the discussions have been finalised. Keep an eye on our social media for further updates.
Regarding Poison Centre Notification, the HSE have advised:
Following the end of the Transition Period, the EU CLP regulation, including Annex VIII of Article 45 (which comes into force on 1 January 2021) will only apply in EU member states.
Annex VIII will continue to apply to Northern Ireland (NI) at the end of the Transition Period under the Withdrawal Act and therefore, the EU CLP Regulation would apply to hazardous mixtures placed on the NI market.
Importers and downstream users should continue to voluntarily submit information on hazardous mixtures placed on the Great Britain market in the form of Safety Data Sheets (SDS). Manufacturers may also continue to voluntarily submit this information in the form of SDS. SDS should be submitted to The UK Appointed Body, the Birmingham Unit of the National Poisons Information Service, (NPIS).