Q&As

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The UKs withdrawal from the EU

General

What impact will the withdrawal of the United Kingdom from the European Union have on my UK-based company?

If your business of putting chemical substances, biocidal products or active substances on the market is limited to the territory of the United Kingdom alone, as from the end of the transition period, your activity will no longer be subject to the provisions of the EU chemicals legislation. With regard to obligations arising from the CLP, BPR, PIC, and REACH Regulations, your legal obligations towards ECHA as the EU’s respective regulatory Agency will also cease. Instead, it will be the UK legislation that applies to you.

You will therefore need to follow the legislative developments in the UK. 

For businesses that are part of a cross-border supply chain, linking companies located in the UK with companies located within the  EU Member States after the UK’s withdrawal, detailed advice can be found under the respective headings of these Q&A pages.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

 

Will UK-based companies still be able to rely on helpdesk support for advice and assistance related to the EU chemical legislation?

Yes. With its withdrawal from the EU, the United Kingdom has become a so-called “third country”. The ECHA Helpdesk regularly replies to enquiries from companies based outside the EU/EEA. After the  end of the transition period, UK-based companies should address ECHA via the dedicated contact form. 

After the end of the transition period, the UK will no longer have the obligation to maintain a national helpdesk to provide advice and assistance on matters governed by the EU’s CLP, BPR or REACH Regulations. You are advised to check with the UK authorities if they will nonetheless provide such advice in practice. You may also wish to address your industry association in the UK.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

 

REACH

With a view to the UK withdrawal from the EU, does my UK-based company still need to submit a registration dossier to ECHA for any substance I import or manufacture?

After the date of the withdrawal of the UK, the UK will no longer be an EU Member State. However, your registration obligations will continue until the end of the transition period.  After the withdrawal date you should also follow the legislative development in the UK with regard to domestic registration obligations.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

 

My UK-based company has successfully registered a substance, and ECHA has provided my company with a registration number. How will the UK withdrawal from the EU affect my registration?

Even though the UK will not be a Member State after the withdrawal date, the consequences for registrations will take effect only after the end of the transition period.

After the end of the transition period, any UK-based 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, your EU /EEA customers will need to register the respective substance themselves. 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 (please see Q&A 1538);
  • as a UK-based importer from a non-EU/EEA country, you may transfer your importing activity to a company established in the EU/EEA (please see Q&A 1539);
  • in case your company has registered as an Only Representative, the non-EU/EEA manufacturer may appoint an EU/EEA based Only Representative in place of your company (please refer to Q&A 1417).

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

My UK-based company is currently acting as an Only Representative of a non-EU company. Once the United Kingdom leaves the European Union, how will that affect our status of Only Representative?

Even though the UK will not be a Member State after the withdrawal date, the consequences for Only Representatives will take effect only after the end of the transition period.

According to Article 8 of REACH, Only Representatives shall be legally established within the EU. After the end of the transition period, this will mean the territory of the EU/EEA. The company having appointed you as Only Representative will need to appoint an Only Representative based in one of the EU Member States or the three EEA countries.

This change of Only Representative must take place before the transition period expires. It must be notified to ECHA (through the ‘Legal entity change functionality’ in REACH-IT) without undue delay, and you will be required to provide proof of the new Only Representative’s appointment from the non-EU company.

Please note that the legal entity change fee will be charged per non-EU company represented (i.e. per REACH-IT account).

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

 

My UK-based company has paid the requisite fee to ECHA for the registration of our substance whilst the United Kingdom still applies REACH Regulation during the transition period. Will ECHA charge the payment of a fee for a legal entity change in the case that our company transfers our REACH registrations or the Only Representative status to an Only Representative based in the EU?

Under the provisions of the REACH Fee Regulation, our Agency will indeed charge the foreseen fee. The circumstance of the UK withdrawal from the EU does not provide a legal basis for waiving the charge of fees.

My UK-based company has registered a substance with ECHA. Will we still need to update our dossier after the UK withdrawal?

You will need to keep your dossier updated until the end of the transition period. After the end of the transition period, EU legislation will no longer apply to the UK, and you will no longer be subject to the obligation of updating your dossier without undue delay.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

 

My UK-based company is a downstream user of a chemical substance registered under REACH. After the UK withdrawal, will we need to continue informing our UK supplier of its uses?

After the end of the transition period, EU legislation will no longer apply to the UK, and you will no longer be subject to this obligation.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

 

My UK-based company is a downstream user of a chemical substance registered under REACH. After the UK withdrawal, will we need to continue informing our EU supplier of its uses?

After the end of the transition period, EU legislation will no longer apply to the UK, and you will no longer be subject to this obligation.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

My UK-based company is a downstream user of a chemical substance registered under REACH. After the UK withdrawal, will we need to continue notifying ECHA of its uses?

After the end of the transition period, EU legislation will no longer apply to the UK, and you will no longer be subject to this obligation. 

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

 

My EU-based company is purchasing a chemical substance from a UK-based business partner which has registered the substance under REACH. Can we still rely on the substance having been legally and validly registered within the EU in accordance with the REACH Regulation after the UK leaves the EU?

You will be able to rely on the registration of a UK-based legal entity until the end of the transition period. Thereafter, your business partner will need to appoint an Only Representative established within the EU/EEA or relocate to the EU/EEA for the substance to remain legally registered with ECHA for the EU/EEA. In the absence of such an appointment or relocation by your UK-based supplier, you will need to register the substance yourself as an importer.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

 

My EU-based company is a registrant in a joint submission for which a UK-based company is the Lead Registrant as well as owner of the data to which we have obtained a Letter of Access. What impact will the UK withdrawal from the EU have on our registration?

After the end of the transition period, the registration by the UK-based company will be considered non-existent. If the UK-based Lead Registrant still wishes to continue placing their substance on the EU/EEA market, they must take action. If they are a manufacturer of the substance, they can appoint an Only Representative located in the EU to handle their registration and the lead registrant duties. Alternatively, the UK based manufacturer can transfer their existing registration to the EU/EEA, keeping the manufacturing role, if this transfer is the result of a legal entity change, falling into one of the following scenarios: (A) the UK based manufacturer goes through an acquisition or relocation to the EU/EEA; (B) an intra-group transfer of the whole operation / manufacturing activity to the EU/EEA.

Following the legal entity change to the EU/EEA manufacture, the UK legal entity must cease manufacturing until the end of the transition period.

However, if they are an importer, the only way they can still retain the lead registrant role is by moving their import activities into the EU/EEA and changing the registrant legal entity in REACH-IT to this new legal entity.

If the UK company does not wish to remain on the EU/EEA market and thus does not take the necessary actions, the members of the joint submission must agree on a new lead. The lead role can be taken by any member of the joint submission.

Agreements among registrants should include a provision regulating the case that the appointed Lead Registrant can no longer exercise their function and foreseeing that the shared information is transferred to a new lead registration, as well as arrangements to ensure data and cost sharing can be continued in the future.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

 

What does my UK-based company need to keep in mind when we appoint an Only Representative (OR) in an EU Member State?

You should only appoint an OR who has a sufficient background in the practical handling of substances and of the information related to them, as required by Article 8(2) of the REACH Regulation. As your representative, the OR will bear all responsibilities of importers under the Registration Title and other titles of the REACH Regulation. Among them, the OR shall keep available and up-to-date information on the quantities imported and customers sold to, as well as information on the supply of the latest update of the SDS. Please also remember to inform the importers within the same supply chain of the OR appointment. ECHA’s webpages provide more detailed information on the role of Only Representatives.

Can my UK-based company set up a company on paper only in an EU Member State and transfer its registrations there?

No. Every registrant company is responsible for its registrations and the substances that are covered by these registrations. Therefore, responsible staff and the relevant documentation must be available for inspection at the premises of every registrant. Only Representatives must live up to the requirements in Article 8(2) REACH. A mere address or letterbox is not sufficient and may lead to legal consequences being taken by enforcement authorities. The company that you set up must comply with all local regulations and have legal personality at its place of establishment. Your company will need to notify this change in REACH-IT immediately before the end of the transition period by transferring the registrations, as instructed in the 'How to transfer your UK REACH registrations prior to the UK withdrawal from the EU' guide.

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, and to ensure that the dossier reflects the new role (Only representative, Manufacturer, Importer).

Can my company, which is a UK-based manufacturer or formulator, transfer its REACH registration to an Only Representative (OR) within the EU/EEA? How can my company do this prior to the end of the transition period to avoid our registration being voided as non-existent when the transition period ends?

Yes, such a transfer of registration will become acceptable for UK-based manufacturers and formulators when the transition period is over. 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.

Consequently, we recommend that you, prior to the end of transition period, set up 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. Your company will need to notify this change in REACH-IT immediately ahead of the end of transition period by transferring the registrations to the new Only Representative, as instructed in the 'How to transfer your UK REACH registrations prior to the UK withdrawal from the EU' guide.

Please note that if you act as a formulator (i.e., you import a substance from a third country to the UK, and include the substance in a mixture that you export to the EU/EEA), you can appoint an Only Representative for the quantities of the substance that you formulate into a mixture that you export to the EU/EEA. However, note that for the quantities of the substance that you import to the UK for further export as such to the EU/EEA, you cannot appoint an Only Representative. The reason is that only non-EU manufacturers or formulators can appoint an Only Representative.

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).

 

My company is a UK-based manufacturer of chemical substances. I would like to keep on supplying my customers in the EU/EEA following the UK withdrawal from the EU. What are my options?

After the transition period, you will be regarded as a non-EU manufacturer. Only manufacturers and importers based in the EU/EEA have registration obligations. However, if you wish to continue supplying to your EU/EEA-based customers, you may consider one of the following options:

  • Like any EU/EEA-based legal entity, you can transfer your existing registration to an EU/EEA legal entity, which maintains the manufacturing role if this transfer is the result of a legal entity change, i.e. it must fall into one of the following scenarios:
    • The UK-based manufacturer goes through an acquisition or relocation to the EU/EEA.
    • Intragroup transfer of the whole operations / manufacturing activity (e.g. transfer of the activity from a UK-based mother company to an EU/EEA-based daughter company).
  • With regard to the timing of such a transfer, it must take place ahead of the end of the transition period and be notified to ECHA (through the ‘Legal entity change’ functionality in REACH-IT) without undue delay. Under both scenarios, following the transfer, the UK legal entity is not allowed to benefit from the registration any longer (i.e., they must cease manufacturing activities). After the end of the transition period, when UK-based companies will no longer be bound by the REACH Regulation, manufacturing may restart in the UK, subject to relevant UK law.
  • You can appoint an Only Representative (OR) within the EU/EEA. For further details (particularly with regard to the timing), please refer to Q&A 1464.
  • Alternatively, your EU/EEA-based customers can continue sourcing from you by registering the substance(s) themselves, as importers.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

My UK-based company is an importer of chemical substances. We would like to keep supplying our customers in the EU/EEA following the UK withdrawal from the EU. What are our options?

After the transition period, you will not have registration obligations under REACH, as only EU/EEA-based manufacturers and importers are required to register their substances under REACH. However, you may consider transferring your registration to an EU/EEA-based legal entity, if this transfer is the result of a legal entity change, i.e. the importing business is transferred to a legal entity in the EU/EEA.

With regard to the timing of this transfer, it must take place ahead end of the transition period and be notified to ECHA (through the ‘Legal entity change’ functionality in REACH-IT) without undue delay. Following the transfer, the UK-based legal entity is not allowed to benefit from the registration any longer (i.e., they must cease their importing activities).At the end of the transition period, when UK companies will no longer be bound by the REACH Regulation, import may restart in the UK, subject to relevant UK law.

If you also act as a formulator (i.e., you import a substance from a third country to the UK, and include the substance in a mixture that you export to the EU/EEA), you can appoint an Only Representative (OR) for the quantities of the substance that you formulate into a mixture that you export to the EU/EEA. For further information, please refer to Q&A 1464.

Alternatively, your EU/EEA based customers can register the substance(s) individually as importers and continue sourcing from you.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

My company is a UK-based importer, which has imported a substance under a valid registration prior to the end of the transition period. Can an importer in the EU import it into the EU after that date, and rely on the exemption in Article 2(7)(c) REACH?

No, the re-import exemption cannot be relied on in this situation, because the conditions for this exemption are not fulfilled. The exemption requires the substance to be registered under REACH, exported from the EU by an actor in the supply chain and re-imported into the EU by the same or another actor in the same supply chain, who shows that the re-imported substance is the same as the previously exported substance and that it has been provided with the information required for the safe use of that exported substance.

In the case described in the question, no one has exported the substance from the EU. Therefore, it also cannot be re-imported into the EU by the same or another actor in the same supply chain.

Moreover, there may no longer be a valid REACH registration of that substance, once your registration will have become non-existent after the expiry of the transition period.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland which will become applicable as from the end of the transition period. The reply will be amended in due course accordingly.

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