Hinweise für Unternehmen / Fragen & Antworten

The UKs withdrawal from the EU

REACH

Does my United Kingdom-based company need to submit a registration dossier to ECHA for any substance I import or manufacture?

The United Kingdom, except for Northern Ireland, is no longer an EU Member State. As such, your registration obligations ended after the end of the transition period (31 December 2020).  

In Northern Ireland, REACH continues to apply. Please refer to Q&A 1700.

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

Any United Kingdom based registrant can no longer be a registrant under REACH, as REACH does not apply to United Kingdom companies, except for Northern Ireland. For the purpose of the EU’s REACH Regulation, any registration by such a registrant is therefore regarded as non-existent.

Consequently, your EU /EEA customers need to register the respective substance themselves, unless you have performed a transfer according to the instructions provided in the ECHA guide 'How to transfer your UK REACH registrations prior to the UK withdrawal from the EU'.  

In Northern Ireland, REACH continues to apply. This means, inter alia, that Only Representatives can continue to be based in Northern Ireland and that manufacturers, formulators or article producers in Northern Ireland do not need to appoint an only representative. Please refer to Q&A 1700.

Do United Kingdom-based companies need to submit an authorisation application for an Annex XIV substance they use or place on the market for a use?

No. Since 1 February 2020, the United Kingdom has withdrawn from the EU and the transition period ended on 31 December 2020. REACH no longer applies to the United Kingdom and therefore United Kingdom-based companies are no longer bound by the authorisation obligations, except for Northern Ireland (see Q&A 1371). Such companies that use an Annex XIV substance or place it on the United Kingdom market for a use no longer need to apply for authorisation. If they place an Annex XIV substance for a use on the EU/EEA market they will need to rely on their EU/EEA importer or an OR to apply for authorisation for this use.

In Northern Ireland, REACH continues to apply. This means, inter alia, that companies based in Northern Ireland are still bound by the authorisation obligation and will need to apply for authorisation unless they are covered by an authorisation in their supply chain or unless an exemption applies. Please refer to Q&A 1700.

Do United Kingdom-based companies holding their own authorisation or relying on an authorisation granted to an upstream actor covering their use still need to adhere to the respective authorisation decision?

No. Following the end of the transition period of the United Kingdom withdrawal from the EU, REACH no longer applies to the United Kingdom and therefore United Kingdom-based companies are no longer bound by the authorisation obligations, except for Northern Ireland (see Q&A 1371). Any authorisations held by United Kingdom-based companies that had not been transferred by the end of the transition period of the UK withdrawal from the EU to EU/EEA-based legal entities ceased to be valid. 

In Northern Ireland, REACH continues to apply. This means, inter alia, that companies based in Northern Ireland are still bound by the authorisation obligations and any authorisations they hold or rely on need to be adhered to. Please refer to Q&A 1700.

My United Kingdom-based company is a downstream user of a chemical substance registered under REACH. Do we need to continue informing our United Kingdom/EU/EEA supplier of its uses and to notify ECHA of its uses?

No, the EU legislation no longer applies to the United Kingdom, and you are no longer subject to this obligation.

In Northern Ireland, REACH continues to apply. This means, inter alia, that registrants can continue to be based in Northern Ireland. Please refer to Q&A 1700.

My EU/EEA-based company is purchasing a chemical substance from a United Kingdom 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/EEA in accordance with the REACH Regulation after the end of the transition period?

No, unless a company is based in Northern Ireland. Your business partner should 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 United Kingdom based supplier, you will need to register the substance yourself as an EU/EEA importer.

For registered substances in stock after the end of transition period, please see Q&A 1712.

In Northern Ireland, REACH continues to apply. This means, inter alia, that registrants can continue to be based in Northern Ireland. Please refer to Q&A 1700.

My EU/EEA-based company is a registrant in a joint submission for which a United Kingdom-based company was the Lead Registrant, as well as owner of the data to which we have obtained a Letter of Access. What impact does the end of the transition period from the EU have on our registration?

Any registration by a United Kingdom based company, except for Northern Ireland, is now considered non-existent, unless they have transferred their registration as indicated in Q&A 1416

If the United Kingdom based company did not take the necessary steps to transfer their registration to an EU27/EEA/NI company, prior to the end of the transition period, the members of the joint submission should 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.

In Northern Ireland, REACH continues to apply. This means, inter alia, that registrants, including Lead Registrants, can continue to be based in Northern Ireland. Please refer to Q&A 1700 for further details.

Can EU/EEA-based downstream users still rely on an authorisation granted to a United Kingdom supplier covering their use?

No. Following the end of the transition period of the United Kingdom withdrawal from the EU, any authorisation held by a United Kingdom-based company that has not yet been transferred to an EU/EEA-based legal entity ceased to be valid. Therefore, EU/EEA downstream users wishing to continue their use of the Annex XIV substance will either need to find an alternative supplier based in the EU/EEA holding a valid authorisation covering their use or they may apply for authorisation themselves.

In Northern Ireland however, REACH continues to apply. This means, inter alia, that authorisations granted to companies based in Northern Ireland remain valid. Please refer to Q&A 1700 for further details.

What does my United Kingdom -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 relevant REACH provisions. 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. Please see also the Q&A section on Only Representatives on ECHA’s web pages.

In Northern Ireland, REACH continues to apply. This means, inter alia, that registrants, including Lead Registrants, can continue to be based in Northern Ireland. Please refer to Q&A 1700.

My EU/EEA-based company obtains its supplies of a chemical substance from a United Kingdom based importer into the EU/EEA, which is now considered “third country”. If we continue our business relations with our United Kingdom-based supplier, would our United Kingdom-based supplier be entitled to appoint our company as its Only Representative in the EU/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/EEA and submit a new registration. Article 8 of the REACH Regulation only allows manufacturers, formulators of mixtures or producers of articles established outside the EU/EEA to appoint an Only Representative. This option will thus not be available to United Kingdom  -based companies that will have been importers into the EU/EEA until the end of transition period. Non-EU/EEA manufacturers of the substance may of course appoint an EU/EEA-based Only Representative of the substance. However, such an Only Representative would then need to submit a new registration for the substance.

In Northern Ireland, REACH continues to apply. Therefore, supplies from Northern Ireland will be considered as transfers within EU internal market and not as imports. Please refer to Q&A 1700.

My EU/EEA-based company purchases a mixture from a United Kingdom-based company. Under the REACH and CLP Regulations, what happens now?

Your supplier is no longer subject to REACH and CLP obligations. Therefore, your United Kingdom-based supplier should have appointed 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/EEA internal market.

Under CLP, you are now the importer and thus 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 and the notification obligations under Article 45 (poison centre notification, please refer to Q&A 1715). 

In Northern Ireland, REACH and CLP continue to apply. This means, inter alia, that REACH registrants can continue to be based in Northern Ireland and that supplies from Northern Ireland are not considered as imports. Please refer to Q&As 1700, Q&A 1701, Q&A 1702.

My company is a manufacturer of a substance, located outside the EU/EEA. We place the substance on the EU/EEA market through a United Kingdom based importer. What do we need to do now?
If your substance has been registered by the United Kingdom based importer, its registration is no longer valid. This means that the imported substance will need to be registered by an EU/EEA-based legal entity:
 
  • You can appoint an Only Representative located within the EU/EEA to carry out the required registration of the imported substance.
  • The substance can also be registered directly by its EU/EEA-based importer(s).
In Northern Ireland, REACH continues to apply. This means, inter alia, that registrants can continue to be based in Northern Ireland. Please refer to Q&A 1700 for further details.
My EU/EEA-based company has registered a substance, which is exported and stored in a warehouse in the United Kingdom and then imported in the EU/EEA. How can we continue this activity?

After the end of transition period, trading the substance back to the EU/EEA may be considered as re-import into the EU/EEA. 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 section 2.2.3.6.

In Northern Ireland, REACH continues to apply after the transition period. This means, inter alia, that substances shipped from Northern Ireland to the EU/EEA are not considered as imports. Please refer to Q&A 1700 for further details.

Which substances have been registered only by United Kingdom-based companies?
Substances registered only by United Kingdom companies are listed in the List of substances registered only by UK companies. This list includes all substances:
 
  • with an active registration by a United Kingdom -based company, and
  • no active registrations by any EU/EEA-based companies
Substances duly registered by a company in EU/EEA need to be transported through the non-EU/EEA to the United Kingdom to reach, for example, a downstream user in Ireland (“Irish land bridge”), or vice-versa. What do the involved companies need to bear in mind?

Substances that have been registered by a company in the EU/EEA may be placed on the market throughout the EU/EEA. The fact that the substance is transported through a third country (such as United Kingdom) is immaterial. For issues related to customs procedures please refer to the relevant readiness notices issued by the European Commission. 

Stakeholders are reminded that specific cases of re-import exist, for example in cases where a substance is first manufactured in the EU/EEA, then exported – for example, to be formulated into a mixture – and then brought back into the EU/EEA again – for example, to be marketed or for further processing. In these cases, please refer to the guidelines on re-import outlined in Q&A 1076, and further elaborated in the Guidance on registration, Section 2.2.3.6.

The registration dossier submitted by a United Kingdom-based Lead Registrant for a substance where my EU/EEA-based company is a member registrant is non-existent under the EU’s REACH Regulation. What shall I do?

Your situation is not different from that of any member registrant “losing” the Lead Registrant for a registered substance. Please see Q&A 1570 for further information.

My company is a United Kingdom-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/EEA import it into the EU/EEA 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.

Can an EU/EEA downstream users still rely on an upstream authorisation held by an EU/EEA manufacturer or importer when they are supplied a mixture of an Annex XIV substance by a United Kingdom formulator in the same supply chain?

No. Following the end of the transition period of the United Kingdom withdrawal from the EU, the supply of a substance from EU/EEA to the United Kingdom becomes an export and the supply of a mixture from the United Kingdom to the EU/EEA becomes an import. 

If the Annex XIV substance is exported to the United Kingdom, where it is formulated into a mixture, the EU/EEA importer (if different from the EU/EEA-based authorisation holder) of the mixture containing the Annex XIV substance and its EU/EEA downstream users will not benefit from the provision in Article 56(2) of REACH, since it applies only to the downstream users of the EU/EEA-based authorisation holder.

Therefore, the use of the imported mixture containing the Annex XIV substance in the EU/EEA can be covered by the upstream authorisation only if the mixture is supplied to the EU/EEA downstream users directly by the EU/EEA authorisation holder. Alternatively, the EU/EEA importer of the mixture or the EU/EEA downstream users will need to apply for authorisation themselves.

In Northern Ireland, REACH continues to apply. This means, inter alia, that the supply chain would not be disrupted upon export of the Annex XIV substance to Northern Ireland and import of the mixture in the EU/EEA. Please refer to Q&A 1700 for further details.

If, as a company located in United Kingdom, I have a stock of substances duly registered under REACH placed on the market before the end of the transition period, can I export it to the EU without having it registered by an EU importer/only representative after the end of the transition period?

Yes. In accordance with Article 41(1) of the Withdrawal Agreement (and as reflected in the Commission’s notice to stakeholders dated 30 March 2020), an existing and individually identifiable good lawfully placed on the market in the EU or the United Kingdom before the end of the transition period may be further made available on the market of the EU or of the United Kingdom and circulate between these two markets until it reaches its end-user.

Importantly, the above does not apply to substances manufactured but not placed on the market yet by the end of the transition period.

In Northern Ireland, REACH continues to apply. For further reference please see Q&A 1700.

Will potential registrants submitting an inquiry to ECHA be informed about contact details and data submitted by United Kingdom companies in the course of their REACH registrations even after the end of the transition period?
Yes, provided that the company concerned agrees with the disclosure of its contact details. In such cases, ECHA will inform potential registrants of the contact details and data submitted and will encourage the parties to negotiate access to data in order to avoid unnecessary animal testing. Please note that, if the data at issue was submitted more than 12 years before, it can freely be used for registration purposes, pursuant to Article 25(3) REACH.

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