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 date of the United Kingdom’s withdrawal, 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. You are also advised to follow the UK withdrawal negotiations with the EU which may determine your future obligations.

If your business is in any way part of a supply chain that links you to businesses located within the 27 EU Member States remaining after the UK’s withdrawal, you will face some fundamental changes. You will find more detailed advice under the respective headings of these Q&A pages.

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 will become a so-called “third country”. The ECHA Helpdesk regularly replies to enquiries from companies based outside the EU/EEA. After the UK withdrawal, UK-based companies should address ECHA via the dedicated contact form.

As from the date of withdrawal, 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

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 on 30 March 2019, the UK will no longer be an EU Member State, and therefore the REACH registration obligations will no longer apply to you. After the withdrawal date, you should follow the legislative development in the UK with regard to domestic registration obligations.

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?

Article 3(7) of the REACH Regulation establishes that a registrant must be a manufacturer or importer of a substance or a producer or importer of an article. Article 3 (4), (9) and (11) stipulates that registrants must be established in the EU. After 30 March 2019, the UK will no longer be a Member State of the EU. Hence, 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, as your company will, after the UK withdrawal, be based in a “third country” outside the EU/EEA.

Consequently, your EU-27(EEA) customers will need to register the respective substance themselves. Alternatively, in order to continue supplying your EU-27-based customers on the basis of your own registration

  • as a manufacturer or formulator, you may appoint an Only Representative within the EU-27/EEA or transfer your manufacturing activity to the EU-27/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-27/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-27-based Only Representative in place of your company (please refer to Q&A 1417).
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?

The REACH Regulation is very clear in this regard. According to its Article 8, Only Representatives shall be legally established within the EU. After the UK withdrawal, this will mean the territory of the EU-27/EEA. The company having appointed you as Only Representative will need to appoint an Only Representative based in one of the EU-27 Member States or the three EEA countries.

This change of Only Representative must take place ahead of the UK withdrawal. 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).

My UK-based company has paid the requisite fee to ECHA for the registration of our substance whilst the United Kingdom is currently still a Member State of the European Union. 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-27?

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?

No. As the EU legislation will no longer apply to the UK after the withdrawal date, you will no longer be subject to the obligation of updating your dossier without undue delay.

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?

No. As the EU legislation will no longer apply to the UK after the withdrawal date, you will no longer be subject to this obligation.

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-27 supplier of its uses?

No. As the EU legislation will no longer apply to the UK after the withdrawal date, you will no longer be subject to this obligation.

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?

No. As the EU legislation will no longer apply to the UK after the withdrawal date, you will no longer be subject to this obligation.

My EU-27-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?

No. Your business partner will need to appoint an Only Representative established within the EU-27 or relocate to the EU-27 for the substance to remain legally registered with ECHA for the EU-27/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.

My EU-27-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 date of the UK withdrawal, 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-27/EEA market, they must take action. If they are a manufacturer of the substance, they can appoint an Only Representative located in the EU-27 to handle their registration and the lead registrant duties. Alternatively, the UK based manufacturer can transfer their existing registration to the EU27/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 EU27/EEA; (B) an intra-group transfer of the whole operation / manufacturing activity to the EU27/EEA. Following the legal entity change, the UK legal entity must cease manufacturing until after the UK has exited the EU.

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-27/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.

What does my UK-based company need to keep in mind when we appoint an Only Representative (OR) in an EU-27 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-27 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 ahead of the UK withdrawal 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-27/EEA? How can my company do this prior to the UK withdrawal from the EU to avoid our registration being voided as non-existent when the withdrawal occurs?

Yes, such a transfer of registration will become acceptable for UK-based manufacturers and formulators at the time of the UK withdrawal. 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. As long as the UK is a Member State of the EU, your company therefore will not qualify for performing such a transfer.

Consequently, we recommend that you, prior to the UK withdrawal from the EU, set up a contractual agreement to appoint an Only Representative, which contains a suspensive conditional clause stipulating that the appointment takes effect on the date when the UK withdrawal from the EU takes effect. The date and time of the UK withdrawal is foreseen to be 30 March 2019, 0000 hours CET (i.e., 29 March 2019, 2300 hours BST). Your company will need to notify this change in REACH-IT immediately ahead of the UK withdrawal 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-27 / 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-27/EEA. However, note that for the quantities of the substance that you import to the UK for further export as such to the EU-27/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-27 / EEA following the UK withdrawal from the EU. What are my options?

As a UK-based manufacturer, following the UK withdrawal from the EU 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-27 / EEA-based customers, you may consider one of the following options:

  • Like any EEA-based legal entity, you can transfer your existing registration to an EU-27 / 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-27 / EEA.
    • Intragroup transfer of the whole operations / manufacturing activity (e.g. transfer of the activity from a UK-based mother company to an EU-27 / EEA-based daughter company).
    With regard to the timing of such a transfer, it must take place ahead of the UK withdrawal date 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 UK withdrawal takes effect, 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-27 / EEA. For further details (particularly with regard to the timing), please refer to Q&A 1464.
  • Alternatively, your EU-27 / EEA-based customers can continue sourcing from you by registering the substance(s) themselves, as importers.
My UK-based company is an importer of chemical substances. We would like to keep supplying our customers in the EU-27 / EEA following the UK withdrawal from the EU. What are our options?

As a UK-based importer, following the UK withdrawal from the EU 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-27 / 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-27 /EEA.

With regard to the timing of this transfer, it must take place ahead of the UK withdrawal 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). After the UK withdrawal from the EU, 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-27 / 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-27/EEA. For further information, please refer to Q&A 1464.

Alternatively, your EU-27 / EEA based customers can register the substance(s) individually as importers and continue sourcing from you.

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