Q&As

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The UKs withdrawal from the EU

BPR

I understand that the Commission has also published information on the impact of the UK withdrawal on companies with obligations under the Biocidal Product Regulation (BPR). Where can I find that information?

On 13 September 2017, the Commission published a “notice to business operators” on the impact of the UK withdrawal on the policy webpage of the Directorate General for Health and Food Safety. Simultaneously, it released a set of Q&As to be found on the same webpage. They provide similar information as that to be found on the ECHA webpages. The Commission updated its information on 23 October 2018.

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 the holder of a product authorisation in an EU Member State or of a Union authorisation under the BPR. What effect will the UK withdrawal have on our authorisation?

According to Article 3 of the BPR, an authorisation holder must be established within  the European Union. By virtue of the EEA Agreement as well as the Mutual Recognition Agreement with Switzerland, an authorisation holder can also be established in Iceland, Liechtenstein, Norway or Switzerland. Therefore, by the end of the transition period, you  will need to transfer the authorisation to a new holder established within an EU Member State or one of the afore-mentioned countries. You can trigger the amendment of your existing authorisation by means of an administrative change requiring prior notification before implementation (see point 3 in section 1 of Title I in the Annex to Commission Implementing Regulation (EU) No 354/2013 on changes of biocidal products).

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 effect will the UK withdrawal have with regard to active substances that were originally evaluated by the UK and subsequently approved by the European Commission or an EU Member State?

The UK withdrawal will not have any effect to the validity of the approval of these active substances. The approval of these active substances is a decision taken at EU level.

What effect will the UK withdrawal have on substances that are currently in their notification / subsequent application phase with the UK providing the evaluating Competent Authority (eCA), or for which the application for renewal of approval is normally expected to be submitted in the UK, in case the procedure will not be completed by the time of the UK withdrawal?

For existing active substances in the Review Programme,  the Commission Delegated Regulation (EU) 2019/227 applies. New evaluating competent authorities from among the competent authorities of the remaining 27 Member States have been already appointed, and are in charge of the evaluation of the concerned application since 30 March 2019.

According to the  provisions of the Withdrawal Agreement, during the transition period, a competent authority of the United Kingdom cannot act as evaluating competent authority for any application for approval of active substance/product-type combination. For active substances under assessment outside the Review Programme (ex: new active substance), and for the renewal of approval of already approved active substances for which the UK was the previous evaluating Competent Authority, the European Commission and the EU Member States have agreed on the new evaluating competent authority from among the competent authorities of the EU Member States . Applicants have already been informed.

 

My non-EU company is listed as a supplier under Article 95 of the BPR and established outside the EU. My EU representative is established within the United Kingdom. What effect will the UK withdrawal have on my company’s interests?

According to Article 95(1) and (2) of the BPR, substance or product suppliers listed in the Article 95 list must be established within the European Union. Therefore, you will need to appoint a new representative established within the Union (or EEA countries or Switzerland) and communicate this to ECHA in due time, so that the information on the list is updated before the end of the transition period.

For non-EU companies that were included on the Article 95 list based on an application for Article 95 inclusion (AS-ACC) the change of representative needs to be reflected in R4BP 3 by transferring the respective Article 95 asset in R4BP 3 to the new representative established within the Union through an AA-TRS application. To be processed, the application needs to include a “request for correction” form (duly filled and signed by the non-EU company and the former representative) and a letter of appointment of the new representative.

For non-EU companies that were included on the Article 95 list on other grounds shall inform ECHA of the appointment of representative by submitting the aforementioned documents through the ECHA contact forms.

We recommend doing this two months before the end 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.

 

Will my UK-based company still be able to submit requests for active substance approval or inclusion of a substance on Annex I, after the UK withdrawal?

Yes, but the application will have to be submitted in an EU Member State (or an EEA country or Switzerland). Contrary to the case of a product authorisation, applicants for the approval of an active substance or Annex I inclusion are not "holders"/"owners" of an approval and do not need to be established in the EU. Third country entities can undertake such submissions.  However, being located in an EU Member State (or an EEA country or Switzerland) or having a local representative may facilitate the dialogue with the various bodies during the processing of the applications.

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 ECHA still grant UK-based companies a right to refer to tests or studies on vertebrates that were submitted to ECHA or to a competent authority in connection with a previous application under the BPR or Directive 98/8/EC, also after the UK withdrawal?

The data sharing mechanism under Articles 62 and 63 of the BPR will still be available to such companies, for the purposes of the BPR; for example, where a UK-based company intends to submit an application for active substance approval – and it requires vertebrate data for its application.

In this connection, it should be stressed that it is a legal obligation for companies to make an inquiry to the Agency in the case of vertebrate data (see Article 62(2)(a) of the BPR).

Will my UK-based company still have an access and possibility to submit a dossier via the R4BP 3 submission tool?

Yes. Companies based in third countries have access to R4PB 3 for certain processes, e.g., active substance approval, notifications and submissions. Upon the end of the transition period, the UK companies are regarded as being located in a “third country”.

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 the substance or product-specific data owned by my UK-based company remain protected by the data protection rules of the BPR after the UK withdrawal?

Yes. Data protection applies to all information submitted for the purposes of the BPR or its predecessor, the Biocidal Products Directive.

The manufacturing site of the active substance / biocidal product that my EU-based company is placing on the EU/EEA market is located in the United Kingdom. Do we need to be concerned about the UK withdrawal?

The BPR does not set any specific requirement regarding the location of the manufacturing site(s) of active substances or biocidal products. Therefore, manufacturing can take place in so-called “third countries”, including the UK even after the end of the transition period. You will not need to take any action to continue complying with the BPR. However, shipments to the EU of this active substance / biocidal product will be, as of the end of the transition period, importations, which has consequences from the viewpoint of other sectorial legislation (e.g. the PIC Regulation, customs).

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.

The manufacturing site of a treated article that my EU-based company is placing on the EU/EEA market is located in the United Kingdom. Do we need to be concerned?

The BPR does not set any specific requirement regarding the location of the manufacturing site(s) of treated articles, which can be manufactured in third countries. Treated articles manufactured in third countries can be placed on the EU market if they meet the conditions of the BPR, in particular Articles 58 and 94. However, shipments to the EU of this treated article will be, as of the end of the transition period, importations, which has consequences from the viewpoint of other sectorial legislation (e.g. customs).

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 will happen to treated articles that are manufactured outside the EU and first imported into the UK before the UK withdrawal, and made available on the EU market after the UK withdrawal?

Any treated article placed on the EU market is subject to the provisions of the BPR, in particular Articles 58 and 94. If the treated article was placed on the UK market before the end of the transition period, it is expected to be compliant with the BPR already, and there should be no specific consequences as regards to compliance with the BPR (i.e. active substance approved in the EU, proper labelling information etc.). However, shipments to the EU of this treated article will be, as of the end of the transition period, importations, which has consequences from the viewpoint of other sectorial legislation (e.g. customs).

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 benefits from an authorisation issued by an EU Member State prior to the UK withdrawal date on the basis of the recognition of a UK authorisation. Will my authorisation be affected by the UK withdrawal?

No. There will not be any such effect. The authorisation granted by each EU Member State will remain valid in these EU Member States. However, the authorisation holder has to be established in the EU, EEA country, or Switzerland  before the end of the transitional 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.

After the date of UK withdrawal, will an EU Member State still be able to issue a national BPR authorisation on the basis of the recognition of a UK authorisation?

For mutual recognitions in parallel, see Q&A 1545.

For mutual recognitions in sequence, a concerned Member State (cMS) may proceed to grant a national product authorisation in accordance with Article 33(3) of the BPR provided that the applicant has chosen a new (EU-27/EEA/Switzerland) Reference Member State (RefMS) by the UK withdrawal date.

My company is currently considering to submit an application under the BPR for which the UK authorities could act as evaluating Competent Authority (eCA) or reference Member State (refMS). How should we proceed?

Since the withdrawal date, the United Kingdom can no longer act as an eCA/refMS. This also applies during the transition period.

My company needs to submit an application for renewal of an approval of our active substance for which the UK acted as the evaluating Competent Authority (eCA) during the first approval procedure. Can my company choose another competent authority as eCA?

Yes.After the withdrawal, the United Kingdom can no longer act as an eCA. This also applies during the transition period. This implies that one of the EU Member States, EEA countries and Switzerland has to act as eCA. Article 13(3) of the BPR does not require that the eCA for the first approval shall be the eCA for the renewal, although it is usually recommended as a means to streamline the process. The mentioned provision requires that, when you submit your application for renewal, you shall indicate the name of the competent authority that you propose for evaluating your application for renewal and provide written confirmation that that competent authority agrees to do so. To achieve a smooth process, the services of the European Commission have agreed with the EU Member States, EEA countries and Switzerland on the new evaluating competent authority from among the competent authorities of the EU Member States.

My company needs to apply for a change or renewal of a product authorisation granted in a mutual recognition procedure in which the UK acted as the reference Member State (refMS). Can my company choose another competent authority as refMS?

Since the withdrawal date, the United Kingdom can no longer act as a refMS. This also applies during the transition period. 

Both the Commission Implementing Regulation (EU) No 354/2013 and the Commission Delegated Regulation (EU) No 492/2014 allow the authorisation holder to choose another refMS for the change as well as the renewal procedure. You will, however, need to submit within the application a written confirmation that the new competent authority agrees to act as refMS.

The services of the European Commission and ECHA have been working in a coordinated manner with EU Members States, EEA countries and Switzerland in order to identify new refMSs for some products of the product-types 8 and 18 for which authorisation holders had to apply for renewal before the end of 2018. The name of those refMSs has been directly communicated to the relevant holders.  For other products the MSs at CA level and coordination group will explore the possibilities to identify new refMSs.  

An EU Member State has granted my EU-based company a biocidal product authorisation based on mutual recognition of a UK biocidal product authorisation. Will my company’s product authorisation be affected by the UK withdrawal?

No. Your company has rights stemming from the national product authorisation granted by the authorities of the concerned Member State. As any such decision authorising a biocidal product on a national market is a national one, the UK withdrawal from the EU will not affect the validity of your company’s product authorisation, even if your national authorisation is based on the mutual recognition of a UK authorisation. 

My EU-based company is listed under Article 95 of the BPR as a supplier of a listed active substance for which we had purchased a letter of access (LoA) from a UK-based company. Will the UK withdrawal from the EU affect my company’s listing under Article 95 of the BPR?

No. Data owners granting letters of access do not need to be EU-based. 

Will my UK-based company’s accounts in R4BP 3 remain accessible beyond the date of the UK withdrawal and the end of the transition period, or will ECHA delete them?

Yes, you will continue to have access, as non-EU companies have access to R4BP 3. UK-based companies will be able to perform the same actions allowed for non-EU companies (e.g., submission for Article 95 listings, active substance approval submissions, or submission of notifications following an open invitation for notification). 

Will ECHA continue to grant my UK-based company access to all the information in its R4BP 3 account after the UK withdrawal?

UK-based companies will still have access to their data in R4BP 3.

Can a UK-based company continue to submit applications via R4BP 3 after the UK withdrawal?

A UK-based company can continue to act as a ‘case owner’ in R4BP 3. This means that it will be able, among other things, to submit applications/notifications and monitor the progress of a given case. For instance, UK-based companies can continue to request active substance approvals (or renewals of approval) after the UK withdrawal. However, it is worthwhile recalling here that a biocidal product authorisation can only be granted to an EU (or EEA/Switzerland) based company.

Please note that this reply does not yet take into account the impact of the Protocol on Northern Ireland. ECHA will in due course amend the reply accordingly.

What is the effect of the withdrawal of the United Kingdom on ongoing applications for mutual recognition in parallel for which the United Kingdom is the reference Member State?

As of the withdrawal date, the United Kingdom can no longer act as reference Member State. This also applies during the transition period.

In case an application for mutual recognition in parallel or for Union authorisation is terminated and a new application has to be submitted, how would this affect the legal status of the existing products on the market with regard to Article 89(2) and (3) of the BPR?

With the submission of the initial application assessed by the United Kingdom the applicant fulfilled its legal obligation laid down in the second subparagraph of Article 89(3) of the BPR. As a consequence, the existing products currently benefit from the provisions in Article 89(2) of the BPR.

Therefore, until the end of the transition period, the above-mentioned existing products could continue being made available on the market and used in accordance with the provisions of Article 89(2) and (3), provided that the applicant submits a new application for mutual recognition in parallel (to a new refMS of its choice and to the same Member States concerned in accordance with Article 34(1) and (2) of the BPR, respectively) or a new application for Union authorisation in accordance with Article 43(1) of the BPR, before the end 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.

My company notified to a number of Member States, under Article 27(1) of the BPR, a low risk biocidal product authorised in the United Kingdom via the simplified procedure. What effect would the withdrawal of the United Kingdom have on these notifications?

As of the end of the transition period, the authorisation granted by the United Kingdom ceases to be valid. Therefore, in accordance with Article 17(1) of the BPR, the products notified in the other Member States can no longer be made available on the market nor used.

If you want to keep your product on the market of the notified Member States, your company will need to obtain a new authorisation of the product via the simplified procedure, from an EU Member State, an EEA country or Switzerland prior to the end of the transition period, and then you will have to notify the other relevant Member States, EEA countries or Switzerland.

CLP

After the UK’s withdrawal from the EU, will my UK-based company still need to classify and label our products according to the EU’s CLP Regulation?

As from the end of the transition period, your company will solely be subject to the laws applying in the United Kingdom. Thus, you will no longer need to comply with the CLP Regulation.

Should your company be exporting your product to the EU, you will need to classify and label your product according to the provisions of the CLP Regulation. You will also need to keep yourself informed of any Adaptation to Technical Progress (ATP) by which the European Commission will be updating specific classification and labelling 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.

Will my UK-based company still be obliged to apply the harmonised classification for substances as listed in Annex VI to the CLP Regulation?

As from the end of the transition period, you will no longer be subject to the provisions of the CLP Regulation.

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 my UK-based company still be obliged to seek agreement on the classification of the substances we manufacture in alignment with manufacturers and importers of the same substance within the EU?

As from the end of the transition period, you will no longer be subject to the provisions of the CLP Regulation and thus will no longer have such an 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.

Will my UK-based company still be obliged to notify the classification of substances in the C&L Inventory?

After the end of the transition period, this obligation will no longer apply to you. If you export substances into the EU, your EU-based importer will instead have the obligation to submit the C&L notifications to ECHA. This applies to substances exported as such or in mixtures above the concentration limits triggering classification. Furthermore, the packaging and labelling of any mixture that you export to the EU will need to comply with the provisions of the CLP Regulation.

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.

How will the information that my UK-based company notified to ECHA be used after the UK withdrawal?

The information will remain available under the conditions of the legal notice that ECHA has published along with the inventory. Until the end of the transition period you can still update your notification. You can also mark the notification inactive by indicating ‘cease manufacture’. After the transition period expires, you will no longer have access to this functionality through your 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.

When exporting to the UK, will my EU-based company still need to include in the labels of our products the pictograms and other label elements that the CLP Regulation prescribes?

The label elements that are based on the United Nations’ Global Harmonised System (GHS) will remain obligatory as the UK will still implement the GHS. Thus, for example, the pictograms will be valid within the UK.

When our EU-based company exports to the UK, will the labels affixed to our products still need to be in the English language as required by the CLP Regulation?

After the end of the transition period, the legal language requirements will depend on the future UK legislation. In practice, it is safe to assume a need to continue labelling your product in the English language as the de-facto official language of the UK, based on the information and the format prescribed by the CLP Regulation.

How can my UK-based company transfer C&L notifications to an EU-based legal entity?

If you are a UK-based importer or manufacturer and are transferring your activities to the EU/EEA, you can transfer the C&L notification to your legal successor using the legal entity change (LEC) module in REACH-IT. If you, as the initiating legal entity, have various assets on your account (REACH registration, pre-registration, CLP notification, etc.), you can transfer all the assets as one package, as long as the legal successor is the same legal entity for all assets. The LEC successor will be able to verify the content of the package before accepting the transfer. Transferring only a classification and labelling notification does not incur a fee.

If you are a UK-based manufacturer, and intend to appoint an OR, you cannot transfer the C&L notification to the OR. In light of this constraint, you have two options: either each of the EU-based importers of your substance submits their own notification, or your newly appointed OR submits a new group notification, where the importers are members of the group. Note that a notification cannot be transferred directly to an OR because the CLP Regulation does not include the concept of OR. Hence, an OR cannot submit a notification. It has only separately been agreed that an OR can submit a notification on behalf of a group.

If at present you are the group leader in a group notification, you can transfer the lead role to another member of the group, as explained in Q&A ID 0203.

The transfer of UK-based notifications to EU/EEA legal entities can take place at any point in time, prior to the end of the transition period. Subsequently, the status of assets that have not been transferred to an EU/EEA legal entity by that date, and remain in the REACH-IT account of a UK legal entity, will be marked as 'void'.

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.

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.

 

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

As a company based in the EU, the obligations flowing from the EU chemicals legislation will continue to apply to you. Your interactions with UK-based business partners, however, will be impacted by the UK withdrawal, as the United Kingdom has become a “third country”. However, this impact will be deferred until the end of the transition period and nothing will actually change for you before that. For biocidal products specific arrangement are put in place potentially affecting your company as the UK cannot anymore act as a leading authority during the transition period.  In the end, you may face new and different UK rules on the import and use of chemical substances. You may also need to adapt your interaction in supply chains involving your UK-based business partners. The Q&A sections on the BPR, CLP, PIC and REACH Regulations will provide you with more detailed guidance in that regard.

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 impact will the withdrawal of the United Kingdom from the European Union have on appeal proceedings before the Board of Appeal?

ECHA decisions concerning UK-based companies will only apply until the end of the transition period.

If you, as a UK-based company and an addressee of an ECHA decision, decide to challenge that decision or have already challenged it before the Board of Appeal, this may mean that the contested ECHA decision will then cease to have legal effect. In this case, unless the appellant provides evidence as to the existence of a material interest in ECHA’s Board of Appeal continuing to handle its appeal, the appeal proceedings may be discontinued, as there would be no need for the Board of Appeal to rule on such an appeal.

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 provides chemicals to customers in the EU/EEA. What other effects of the UK withdrawal from the EU than those relating to the BPR, CLP, PIC and REACH Regulations will we need to bear in mind?

The Q&As on this website solely provide advice on the impact of the UK withdrawal in relation to the chemicals legislation that ECHA manages. You will need to find information on its other effects on supply chains across the external frontier of the EU (e.g., customs, tariffs and quotas, rules of origin, standardisation, rules on transport from outside the EU, etc.) from other sources, such as the European Commission or your industry association. Such information is, for instance, contained in this “Notice to Stakeholders” of 22 January 2018 on the “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products”, published on the webpages of the European Commission.

PIC

My UK-based company exports chemicals, which are subject to the PIC Regulation to countries outside the EU. We regularly notify our exports via ePIC. Do we need to continue notifying these exports also from the date of the UK withdrawal onwards and, if yes, to whom and by what means?

Until the end of the transition period, the UK will remain in the single customs area of the EU. Thereafter the PIC Regulation will no longer apply to you. It will be in the hands of the UK legislator to establish rules for exports by companies based in the UK. 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 contact the UK DNA to inform yourself on any national procedures in place regulating your export.

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 will happen to the export notifications that my UK-based company submitted prior to the UK withdrawal, for exports in 2020? Will they remain valid?

Your export notification will stay valid throughout year 2020.

As a UK-based company, do we need to report on our yearly exports/imports of PIC chemicals also after the UK withdrawal?

The PIC Regulation will apply in the United Kingdom until the end of the transition period, as the UK will still remain in a single customs area with the EU. Article 10 of the Regulation obliges exporters to inform, during the first quarter of each year, the designated national authority of their Member State regarding the quantity of the chemical, as a substance and as contained in mixtures or in articles, shipped to each Party or other country during the preceding year. Thus, you have the duty to report on your exports/imports of PIC chemicals until the end of the transition period. In case there is no extension of the transition period, you will have no obligations for reporting data on exports/imports after 2020. However, we recommend that you check with the relevant national authority in the UK to verify whether you will have reporting obligations under the national UK legislation.

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 based in the UK. However, our exports of PIC chemicals are shipped directly to a non-EU country from a branch which is located in an EU Member State. As we hold the contract with the importer in the non-EU country, we need to continue submitting export notifications in ePIC in order to obtain the necessary approval for these exports. How will we be able to do this?

As a UK-based company, after the transition period you will no longer have access to ePIC and will not need to notify your exports in this way. However, in this case, even though you hold the contract for this export, in accordance with Article 3(18)(b) of the PIC Regulation, the EU-based branch of your company will take on the role of the exporter. They should therefore contact their DNA within the EU  (contact details) in case they are not already aware of their obligations under the PIC Regulation.

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 exports chemicals which are listed in Annex III to the Rotterdam Convention on the Prior Informed Consent procedure. Do we have to notify our exports to the EU after the UK withdrawal?

The UK is itself a Party to the Rotterdam Convention. Therefore, you will still have obligations when exporting chemicals that are included in Annex III to the Convention. After the end of the transition period, if you are exporting to an EU Member State, you must first check in the latest PIC Circular whether the EU has provided an import response. In the absence of a response, you should contact the PIC DNA in the UK for further information.

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 exports chemicals subject to the EU’s PIC Regulation (i.e., other than the chemicals listed in Annex III to the Rotterdam Convention) to EU Member States. Will we have to notify our exports to the EU after the UK withdrawal?

Only exporters based in the EU have a legal obligation to notify exports of the chemicals listed in Annex I part 1 and 2 of the EU PIC Regulation.

After the end of the transition period, as the UK will no longer be part of the single customs area of the EU, you will no longer have any obligations in relation to the PIC Regulation. You are, however, advised to inform yourself of any obligations that may derive from national UK legislation.

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 my UK-based company continue having access to ePIC? If not, will we be able to export our data from the system?

After the end of the transition period, UK-based companies will no longer have access to ePIC. Currently, ePIC does not include any functionality allowing data to be exported from the system.

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 my UK-based company be able to access ePIC after the UK withdrawal for the purpose of consulting information on my exports and related data from previous years?

ePIC is the IT tool that is provided for use by relevant stakeholders within the EU for the purpose of administering the implementation of the PIC Regulation. After the end of the transition period, companies based in the UK (as well as the former UK Designated National Authority - DNA) will no longer have access to ePIC or to the data it contains.

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 the PIC data provided by my UK-based company remain public after the UK withdrawal?

Yes, the data will continue to be available on the ECHA website.

After the UK withdrawal, will my EU-based company need to notify an export of a chemical subject to the PIC Regulation to the UK?

Yes. The EU PIC Regulation places obligations on companies based in the EU who wish to export chemicals listed in Annex I to non-EU countries. After the end of the transition period,  any such exports to the UK will need to be notified.

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.

See also QA1568.

After the UK withdrawal, will my EU-based company need to notify an export of a chemical listed in Annex III to the Rotterdam Convention (and therefore also to the PIC Regulation) to the UK?

The UK is itself a Party to the Rotterdam Convention. Therefore, if after the end of the transition period you are planning to export a chemical listed in Annex III to the Rotterdam Convention to the UK, you must check in the latest  PIC Circular whether the UK has provided an import response. In case there is a positive response, it will be sufficient to submit a special RIN request (please see the  factsheet);

in the absence of a response, you must submit an export notification, and an explicit consent from the authorities in the UK will be required in order for the export to take place.

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.

After the UK withdrawal, will my EU-based company need to notify an export of a chemical subject to the PIC Regulation to Gibraltar?

As Gibraltar is currently (i.e., even prior to the UK withdrawal) not a part of the EU customs territory, you will simply need to continue notifying your exports of chemicals subject to the PIC Regulation also after the UK withdrawal.

My EU-based company buys a product from a company based in the UK and it is subsequently shipped directly to my customer who is based in another non-EU country. Do we need to notify the export?

Even though you hold the contract for this export, in this case, in accordance with Article 3(18)(b) of the PIC Regulation, the UK company currently takes on the role of the exporter. After the end of the transition period, the UK company will no longer have any obligations under the EU PIC Regulation. Consequently, no export notification will be needed.

However, please note that the following circumstances may lead to exceptions:

  • Any national legislation regulating exports in place in the UK;
  • If the exported chemical is listed in Annex III to the Rotterdam Convention (as well as being subject to the EU PIC Regulation).

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 imports chemicals subject to PIC from companies based in the UK. Will we have any additional obligations after the UK withdrawal?

Yes, pursuant to Article 10(1) of the PIC Regulation, in the first quarter of the year following the import you should provide details on the import(s) to your Designated National Authority (DNA) by means of ePIC.

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 needs to notify an export of a chemical subject to the PIC Regulation to the UK, and the export will take place after the end of the transition period. In accordance with Article 8(2) of the PIC Regulation, the export should be notified 35 days before the expected date of export, how to proceed?

Pursuant to Article 8(2) of Regulation (EU) No 649/2012 on the export and import of hazardous chemicals, exporters are required to notify their exports 35 days before the expected date of export. To cover exports taking place in the first 35 days of 2021 if there is no confirmation of the extension of the transition period, a procedure will be reactivated to allow EU-based exporters to notify the planned export to the United Kingdom in advance of the end of the transition period. These export notifications will take effect if the end of the transition period is confirmed

Instructions on how to proceed are described in the document “How to notify PIC exports to the UK in the absence of a decision on the UK’s withdrawal from the EU”.

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 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 and the end of the transition period 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 end of the transition period. Whenever the sunset dates of respective Annex XIV substances fall after the end of the transition period, 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). 

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

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 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?

You will need to adhere to the conditions of the authorisation 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 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/EEA, please see the respective Q&A on these webpages.

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 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?

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 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.

 

My company is a downstream user located in the EU/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?

After the end of the transition period, the REACH Regulation will no longer apply to the UK, and the REACH Authorisations (and pending authorisation applications) will lose their legal effect as of that date.

Therefore, you will need to rely on a supplier with a valid Authorisation (or with a pending authorisation application) in the EU/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/EEA;
  2. UK-based Only Representatives can transfer their Authorisation or pending application for authorisation to a new Only Representative based in EU/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/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 at the end of the transition period (for detailed advice, please see Q&A 1466).
  • In cases 2 and 3, the transfer must take place before the end of the transition period and be notified to ECHA (through the ‘Legal entity change’ functionality in REACH-IT) without undue delay. In fact, ECHA recommends to initiate the transfer at least two weeks before the end of the transition period, to allow for a timely update should ECHA identify any issue with the attached documentation. 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. If the UK-based company only intends to implement the transfer at the end of the transition, it can include a suspensive clause in the transfer agreement with the successor company stipulating that the transfer takes effect at the end of the transition period. In this case, after the legal entity change is initiated in REACH-IT, the successor legal entity should review the transfer, but not proceed to accept it before the end of the transition period. (Please see also the instructions in the 'How to transfer your UK REACH registrations prior to the UK withdrawal from the EU' guide).

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

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 will happen to substance evaluations based on the Community Rolling Action Plan (CoRAP) 2012-2014 and its updates that are assigned to the UK authorities and were still be pending at the time of the UK withdrawal?

Our Agency, in collaboration with the European Commission and Member State competent authorities, have reviewed all pending substance evaluations for appointing another Member State authority to take over the respective evaluation. The UK withdrawal has also been taken into consideration in the CoRAP updates for the years 2018-2020 as well as 2019-2021, and will continue to do so for subsequent updates.

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 EU-based company obtains its supplies of a chemical substance from a UK-based importer into the EU. When the transition period ends, 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/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 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 end of transition period. 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.

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.

 

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/EEA? How can my company do this prior to the end of the transition period to avoid our Authorisation (or application) being voided as non-existent when the UK withdrawal takes effect?

Such a transfer will become possible at the end of the transition period.

However, until the end of the transition period your company will not qualify for performing such a transfer. Consequently, we recommend that prior to the end of the transition period, you set up a contractual agreement to appoint an Only Representative which contains a suspensive conditional clause stipulating that the appointment takes effect at the end of the transition period. 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.

Your company will need to notify this change in REACH-IT immediately ahead of the end of the transition period by transferring the applications or authorisations to the new Only Representative: You will need to initiate the transfer before the end of the transition period, similarly to the instructions in the 'How to transfer your UK REACH registrations prior to the UK withdrawal from the EU' guide. In fact, ECHA recommends to initiate the transfer as early as possible, to allow for a timely update should ECHA identify any issue with the attached documentation. See also Q&A 1242 on how to use the legal entity change functionality of REACH-IT for applications for authorisation.

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

After the transition period, your supplier will no longer be subject to REACH and CLP obligations. 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.

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 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 following 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 end of the transition period. 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).

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 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 following the UK withdrawal from the EU?

You can appoint a new Only Representative, located within the EU/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 end of the transition period and be notified to ECHA (through the ‘Legal entity change’ functionality in REACH-IT) 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 EU-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. How can we continue using the stocks stored in the UK after the UK withdrawal from the EU?

After the end of transition period, trading the substance back to the EU 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.

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.

Which substances have been registered only by UK-based companies?

Substances registered only by UK companies are listed in the List of substances registered only by UK companies [XLSX]. This list includes all substances

  • with an active registration by a UK-based company, and
  • no active registrations by any EU/EEA-based companies
My UK-based company has submitted a registration dossier which failed the completeness check. Our deadline to complete the registration is after the UK withdrawal from the EU. How should we proceed with this registration?

To keep substances that are registered under REACH legally on the EU/EEA market, you can either transfer your business to, or appoint an only representative in one of the EU/EEA countries. Only complete registrations can be transferred to another legal entity, i.e., the registration first needs to be confirmed to be complete by ECHA. Therefore, you will need to submit the requested update following the instructions in the completeness check communication and pay the registration fee (if relevant) in good time before the end of the transition period. Leave a minimum of  two weeks before the end of the transition period for ECHA to check the completeness of your dossier and for the transfer of the registration fee (if relevant).

If you do not wish to remain on the EU/EEA market, then following the end of the transition period, the completeness check deadline will no longer be relevant for you.

If the registration is not considered complete, you will not be able to transfer it.

For any questions on your particular situation, please contact ECHA.

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, based in the EU, has purchased and stocked a substance that has been registered by the manufacturer, importer or Only Representative, located in the UK before the withdrawal date. Can I still use or sell on that substance on or after the withdrawal date?

Yes, if the batch of a substance, registered by the manufacturer/importer/Only Representative located in the UK, is placed on the market (See Article 3(12) of the REACH Regulation) of the EU before the  end of the transition period, that substance can continue to be placed on the EU market and be used as of that date.

However, any consignment of a substance imported into the EU market as of the end of the transition period has to be registered in accordance with the EU rules, i.e. it requires the registrant/Only Representative to be established in the EU.

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.

After the UK withdraws from the EU, substances duly registered by a company in EU/EEA may need to be transported through the non-EU UK 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 EU may be placed on the market throughout the EU. The fact that the substance is transported through a third country (such as Switzerland) , or after the end of the transition period the UK, is immaterial. For issues related to customs procedures please refer to these preparedness notices.

Stakeholders are reminded that specific cases of re-import exist, for example in cases where a substance is first manufactured in the EU, then exported – for example, to be formulated into a mixture – and then brought back into the EU again – for example, to be marketed or for further processing. In these cases, please refer to the guidelines on re-import set out by ECHA ("ECHA guidance on registration, section 2.2.3.6. ('re-imported substance')" ).

At the end of the transition period, the registration dossier submitted by a UK-based Lead Registrant for a substance where my EU-based company is a member registrant will become 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 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.

My EU/EEA company is using a mixture supplied by a UK formulator. The REACH Authorisation (or pending application for Authorisation) we rely on for the use is held by the manufacturer / importer on the top of the supply chain. Will our use be covered after the UK withdrawal?

As a general rule, it will be covered until the end of the transition period. After that, the supply of a substance from EU/EEA to the UK becomes an export and the supply of a mixture from the UK to the EU/EEA becomes an import. If the substance is exported to the UK, where it is formulated into a mixture, the importer (if it is different from the applicant/authorisation holder) of the mixture containing that substance into the EU/EEA and its downstream users will not benefit from the provision in Article 56(2) of REACH. The reason is that Article 56(2) applies to downstream users of the applicant for authorisation/authorisation holder (under the conditions set out in that provision), and the importer of the mixture is by definition not a downstream user.

Therefore, your use of the imported mixture can be covered only if the mixture is supplied to you by the applicant or authorisation holder. In other scenarios (i.e. if the importer of the mixture is not the applicant/authorisation holder) you (or the importer supplying the mixture to you) will need to apply for authorisation.

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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