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The UKs withdrawal from the EU

REACH

With a view to the UK withdrawal from the EU, does my UK-based company still need to submit a registration dossier for a phase-in substance to ECHA by the 2018 REACH registration deadline? Would we need to do the same for a non phase-in substance?

Until the date of the withdrawal of the UK on 30 March 2019, the UK remains an EU Member State in which the provisions of the REACH Regulation fully apply. You will therefore have to register your substance for the 2018 REACH registration deadline. Moreover, your registration obligations will continue until the date of the UK withdrawal. Even beyond that date, it will be advisable for you to 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 does not hold and is not covered by a REACH Authorisation for an Annex XIV substance and the Latest Application Date is approaching. With a view to the UK withdrawal from the EU, do we need to apply?

Companies using the substance in the UK would need to hold or be covered by an Authorisation between the sunset date and the date of the UK withdrawal. Whenever the sunset dates of respective Annex XIV substances fall after the UK withdrawal date of 30 March 2019, you will not have to apply for a REACH Authorisation to use any such substance.

Note, however, that if an applicant has submitted its application prior to the Latest Application Date, they benefit from transitional arrangements (please see the Q&A 572, “why I should submit the application before the Latest Application Date” on ECHA’s other Q&A webpages). This may become important in the case that the REACH provisions on Authorisation continue to apply in the UK beyond the UK withdrawal, due to either domestic UK law or potential agreements between the EU and the UK.

For UK companies placing an Annex XIV substance on the EU-27/EEA market after the UK withdrawal, please see the Q&A 1428 on downstream users located in the EU-27/EEA relying on an Authorisation granted to a UK supplier, on these webpages.

My UK-based company holds or is covered by a REACH Authorisation for certain uses of an Annex XIV substance. After the UK withdrawal, will my company still need to adhere to the conditions of use determined by this decision?

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. Even before that date, we advise you to follow the legislative development in the UK with regard to domestic authorisation obligations, as you will need to adhere to applicable UK law in this respect. For REACH Authorisations covering a UK-based company’s downstream users located in the EU-27/EEA, please see the respective Q&A on these webpages.

My UK-based company is a downstream user within the UK of a substance covered by a REACH Authorisation in accordance with Article 56 (2) of the REACH Regulation. Will we need to continue to comply with the obligations imposed by the Authorisation decision also 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 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 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. To ensure that you can benefit from a functioning joint submission with a lead registrant, you should ensure that the lead registrant moves to the EU or does a legal entity change to become an EU-27-based Only Representative, or appoint a new lead registrant and transfer the lead registrant role before the date of the UK withdrawal. 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.

My company is a downstream user located in the EU-27/EEA and relies on a REACH Authorisation granted to a UK supplier (or a pending application for an Authorisation). Will our use be covered after the UK withdrawal?

No. As the REACH Regulation will no longer apply to the UK upon the UK withdrawal from the EU, the REACH Authorisations (and pending authorisation applications) will lose their legal effect as of the date of the UK withdrawal.

Therefore, you will need to rely on a supplier with a valid Authorisation (or with a pending authorisation application) in the EU-27/EEA. If your supplier does not hold an authorisation, and you wish to continue to use the substance after the date of the UK withdrawal, you will yourself need to apply for an Authorisation. We recommend that you contact your supplier, to ask them about their intentions.

As for UK-based Authorisation holders (or authorisation applicants), there are a number of situations in which they can transfer their Authorisation (or pending authorisation application):

  1. UK-based manufacturers and formulators can transfer their Authorisation or pending application for authorisation to an Only Representative based in the EU-27/EEA;
  2. UK-based Only Representatives can transfer their Authorisation or pending application for authorisation to a new Only Representative based in EU-27/EEA, appointed by the non-EU manufacturer (also see Q&A 1250). Please note however that UK-based importers cannot transfer their Authorisation to an Only Representative in the EU-27/EEA.
  3. Like any EU-based legal entity, UK-based legal entities can currently transfer their Authorisation or pending application for authorisation where the transfer is the result of the change of legal entity referred to in Q&A 1239 (for instance, as the result of a merger, a split or an asset sale (sale of a production site or business)) and the person to whom it is transferred qualifies as manufacturer, importer or downstream user with regard to the substance(s) and the use(s) covered by the application for authorisation or the decision. A change of legal entity cannot extend the scope of the original application for authorisation or of the Authorisation, e.g. to cover different uses. (Please see Q&As 1239 and 1241 to 1249.).

With regard to the timing of such transfers:

  • In case 1, the transfer can only take effect on the occasion of the UK withdrawal (for detailed advice, please see Q&A 1466).
  • In cases 2 and 3, the transfer 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. It should also be noted that after this transfer, the UK-based company cannot continue its manufacturing / importing / Only Representative activity, as long as the REACH Regulation applies to the UK.

The advice provided above applies to both Authorisations and pending applications.

Based on the Community Rolling Action Plan (CoRAP) 2012-2014 and its updates (lastly the update that ECHA published on 21 March 2017, covering the years 2017, 2018 and 2019), the review of certain substances under the REACH evaluation process is assigned to UK public authorities. What will happen to the respective substance evaluations that will still be pending by the date of the UK withdrawal?

Our Agency, in collaboration with the European Commission and Member State competent authorities, will review all pending substance evaluations in due time for appointing another Member State authority to take over the respective evaluation. The UK withdrawal is also being taken into consideration in the draft CoRAP update for the years 2018-2020 as well as subsequent updates.

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 or ECHA. 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. ECHA will clarify the practical steps that you will need to take, closer to this date. We also recommend that you consult ECHA’s Practical Guide No. 8.

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.

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.

ECHA will clarify the practical steps that you will need to take, closer to this date. Please note that following the successful transfer of the registrations in REACH-IT, you are expected to submit an updated registration dossier, indicating the new Only Representative role.

My EU-27-based company obtains its supplies of a chemical substance from a UK-based importer into the EU. When the UK withdrawal from the EU takes effect, our supplier will become an actor based in a “third country”. If we continue our business relations with our UK-based supplier, would our UK-based supplier be entitled to appoint our company as its Only Representative in the EU-27/EEA and transfer its registration to us, or would we need to register as an importer ourselves?

The latter is the case. You would need to act as an importer of the substance into the EU-27/EEA and submit a new registration. Article 8 of the REACH Regulation only allows manufacturers or producers of articles established outside the EU to appoint an Only Representative. This option will thus not be available to UK-based companies that will have been importers into the EU until the date of the UK withdrawal. Thus, it is not possible to transfer a registration of a UK importer to a newly appointed Only Representative. Non-EU manufacturers of the substance may of course appoint an EU-based Only Representative of the substance. However, such an Only Representative would then need to submit a new registration for the substance.

Can my company, which is a UK-based manufacturer or formulator, transfer its REACH Authorisation (or its Application for Authorisation) to an Only Representative within the EU-27/EEA? How can my company do this prior to the UK withdrawal from the EU to avoid our Authorisation (or application) being voided as non-existent when the UK withdrawal takes effect?

Yes, such a transfer will become possible at the time of the UK withdrawal.

However, as long as the UK is still a Member State of the EU and your company is therefore not located in a “third country”, your company will not qualify for performing such a transfer. Consequently, we recommend that prior to the UK withdrawal from the EU you 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). The Only Representative will need to adhere to all the conditions of use determined by the Authorisation decision, including any specific duties foreseen in the decision for your company. ECHA will clarify the practical steps to take closer to this date.

The Authorisation holder/applicant needs to notify ECHA of the transfer. ECHA will forward the notification to the European Commission.

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.

My EU-27-based company purchases a mixture from a UK-based company. Under the REACH and CLP Regulations, what impact will the UK withdrawal from the EU have on these supplies?

Once the UK withdrawal from the EU takes effect on 30 March 2019, your supplier will no longer qualify as an EU company. Therefore, you will need to ask your UK-based supplier if they will appoint an Only Representative to cover the necessary REACH registrations for the component substances of the mixture. If not, you will need to submit the relevant registrations as an importer yourself to be legally on the EU internal market.

Under CLP, you will now be the importer and thus will have the obligation to ensure that the imported mixture is correctly classified, labelled and packaged. You may also have the notification obligation to the Classification and Labelling Inventory.

My company is a manufacturer of a substance, located outside the EU/EEA. We place the substance on the EU/EEA market through a UK-based importer. What do we need to do in preparation for the UK withdrawal from the EU?

If your substance has been registered by the UK-based importer, its registration will no longer be valid after the UK withdrawal. This means that the imported substance will need to be registered by an EU-27/EEA-based legal entity:

  • You can appoint an Only Representative located within the EU-27/EEA to carry out the required registration of the imported substance.
  • The substance can also be registered directly by its EU-27/EEA-based importer(s).
My company is a manufacturer of a substance, located outside the EU / EEA. We have appointed an Only Representative, who is located in the UK. What do we need to do in preparation of the UK withdrawal from the EU?

You can appoint a new Only Representative, located within the EU-27/EEA. This requires that the old and the new Only Representatives collaborate in making a ‘legal entity change’ in REACH-IT. The new appointment 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.

My EU-27-based company manufactures a registered substance, which as part of the supply chain is stored in a warehouse in the UK and then imported in the EU-27. How can we continue using the stocks stored in the UK after the UK withdrawal from the EU?

Once the UK withdrawal from the EU takes effect, trading the substance back to the EU-27 may be considered as re-import into the EU.

A re-imported registered substance does not need to be registered again, as long as the conditions for re-import set out in Article 2(7)(c) of REACH are fulfilled. These conditions are outlined in Q&A 1076, and further elaborated in the Guidance on registration.

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