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.

My UK-based company is the holder of a product authorisation in an EU-27 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 in 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. You will therefore need to transfer the authorisation to a new holder established within an EU-27 Member State or one of the afore-mentioned countries before the UK withdrawal. 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).

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?

The European Commission and our Agency, in cooperation with the EU-27 Member States, will prepare the groundwork for a handover of such pending cases.

My UK-based company is listed as a supplier according to Article 95 of the Biocidal Products Regulation. With a view to the UK withdrawal, what do we need to do?

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 representative established within the Union (or the EEA countries or Switzerland) and communicate this to ECHA (by submitting a “request for correction”) in due time, so that the information on the list is updated before the date of the UK withdrawal from the EU. Otherwise, the UK supplier will be removed from the Article 95 list, and biocidal products from this source would no longer be allowed to be made available on the EU market.

We recommend submitting a “request for correction” one month before the UK withdrawal enters into force.

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 (by means of a “request for correction”) in due time, so that the information on the list is updated before the date of the UK withdrawal from the EU.

We recommend submitting a “request for correction” one month before the UK withdrawal enters into force.

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-27 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.

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 its withdrawal, the UK will become such a “third country”.

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-27-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” (such as the United Kingdom will be after the date of its withdrawal). 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 UK withdrawal date, importations, which has consequences from the viewpoint of other sectorial legislation (e.g. the PIC Regulation, customs).

The manufacturing site of a treated article that my EU-27-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 UK withdrawal date, importations, which has consequences from the viewpoint of other sectorial legislation (e.g. customs).

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-27 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 UK withdrawal, 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-27, proper labelling information etc.). However, shipments to the EU of this treated article will be, as of the UK withdrawal date, importations, which has consequences from the viewpoint of other sectorial legislation (e.g. customs).

Currently, the UK is acting as evaluating Competent Authority (eCA) or reference Member State (refMS) in an on-going regulatory procedure related to my company (e.g. active substance approval, renewal of an active substance approval, Union authorisation, simplified authorisation procedure, mutual recognition in parallel, renewal of product authorisations under Commission Delegated Regulation (EU) No 492/2014 or applications for minor or major changes under Commission Implementing Regulation (EU) No 354/2013). What effect will the UK withdrawal have on the pending process?

According to the BPR, the role of evaluating Competent Authority (eCA) or reference Member State (refMS) is attributed to (the Competent Authority of) a Member State. Through the EEA Agreement as well as the Mutual Recognition Agreement with Switzerland, this is extended to further include Iceland, Liechtenstein, Norway, and Switzerland. As a business operator affected by an ongoing procedure for which the UK is currently acting as eCA/refMS, you are advised carefully monitor the UK authority’s progress and take the relevant actions. For example, if you see clear indications that the UK authority will not conclude the procedure by the date of the UK withdrawal, you may consider changing to another evaluating Member State. The services of the European Commission and our Agency will work with the EU-27 Member States, EEA countries and Switzerland to establish a coordinated approach to ensure a timely agreement and technical transfer of the file in case such a change is needed. We will also communicate the agreements reached on such transfers. This will be particularly relevant for the review programme of existing active substances for which the Commission Delegated Regulation (EU) No 1062/2014 assigned the United Kingdom as evaluating Member State in a legally binding manner.

As of the withdrawal date, the United Kingdom can no longer act as an eCA/refMS. This also applies if a withdrawal agreement is concluded since the United Kingdom cannot act as eCA/refMS during the transition period.

My company benefits from an authorisation issued by a EU-27 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-27 Member State will remain valid in these EU-27 Member States.

After the date of UK withdrawal, will an EU-27 Member State still be able to issue a national BPR authorisation on the basis of the recognition of a UK authorisation?

No. This will no longer be possible.

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?

Until the withdrawal date, the UK remains a member of the European Union, with all the rights and obligations that derive from membership. Thus, you may still choose the UK as eCA/refMS. However, with a view to the timing of the UK withdrawal, you should carefully take into account the timelines that are to be expected for concluding the respective regulatory procedure and take the relevant actions. For example, if you recognise a risk that the authority may not conclude the procedure by the date of the UK withdrawal, it may be preferable to choose another eCA/refMS in order to avoid having to seek a change to another eCA/refMS at a later stage.

As of the withdrawal date, the United Kingdom can no longer act as an eCA/refMS. This also applies if a withdrawal agreement is concluded since the United Kingdom cannot act as eCA/refMS 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. 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. The services of the European Commission will work with Members States, EEA countries and Switzerland to establish a coordinated way forward so that the Commission and our Agency can provide clear indications to prospective applicants, in due course.

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?

Yes. 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-27 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.

An EU Member State has granted my EU-27-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-27-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. 
My company handles a low risk biocidal product, authorised in the UK via the simplified procedure. May we notify the placing on the market of that product to EU-27 countries after the UK withdrawal?
No. The BPR will no longer apply to the UK after the UK withdrawal. Therefore, your company will need another country to grant a new authorisation of the product via the simplified procedure, prior to the UK withdrawal (i.e., either an EU-27 Member State, an EEA country, or Switzerland). 
Will my UK-based company’s accounts in R4BP 3 remain accessible beyond the date of UK withdrawal 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-based company.
What effect does the withdrawal of the United Kingdom have with regard to applications for approval of active substances, either within or outside the review programme, that are currently being assessed by the United Kingdom?

As of the withdrawal date, the United Kingdom can no longer act as the eCA. This also applies if a withdrawal agreement is concluded since the United Kingdom cannot act as eCA/refMS during the transition period. The services of the European Commission have been working in a coordinated manner with EU-27 Members States, EEA countries and Switzerland in order to identify new eCAs for concerned existing active substances. The European Commission will adopt and publish, before the withdrawal date, an amendment to the Review Programme Regulation listing the existing active substances and the eCAs that will assess them. The name of the new eCAs has already been directly communicated to the participants in the Review Programme. The services of the European Commission have also identified new eCAs for the assessment of pending applications for approval of those active substances that are not subject to the Review Programme Regulation (e.g. new active substances). The name of those eCAs has also been directly communicated to applicants and will be made known on the ECHA's website.

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 if a withdrawal agreement is concluded since the United Kingdom cannot act as eCA/refMS during the transition period.

Therefore, where the United Kingdom is currently acting as refMS, you are advised to carefully monitor the UK authority’s progress and take the relevant actions. For example, if you see indications that the UK authority will not conclude the procedure by the withdrawal date, you may consider changing to another evaluating Member State. In this case, the new refMS will continue handling the relevant tasks referred to in Article 34 of the BPR.

The services of the European Commission and ECHA have been working in a coordinated manner with EU-27 Members States, EEA countries and Switzerland in order to identify new refMSs for some on-going applications. The name of those refMSs has been directly communicated to the relevant applicants.

However, where no Member State takes over the role of refMS, there could be different consequences depending on the procedural stage at which the application is by the withdrawal date:

  • Where the United Kingdom as refMS has entered, before the withdrawal date, the elements referred to in Article 34(5) of the BPR in R4BP (i.e. the agreed summary of biocidal product characteristics (SPC) and the final assessment report, together with any agreed terms or conditions imposed on the making available on the market or use of the biocidal product), the cMSs may proceed to grant the national product authorisation in accordance with Article 34(6) of the BPR.
  • Where the current refMS (i.e. the United Kingdom) has not entered, before the withdrawal date, in R4BP the above-mentioned elements, the applicant will need to submit a new application for mutual recognition in parallel to a new refMS of his choice and to the relevant cMSs in accordance with Article 34(1) and (2) of the BPR, respectively.
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 his 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, 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 his 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 withdrawal date.

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 withdrawal date 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-27 Member State, an EEA country or Switzerland prior to the withdrawal of the United Kingdom, 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 date of the UK’s withdrawal, 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. However, its provisions may continue to remain valid within the UK on the basis of the Repeal Bill, which will – at least temporarily – convert existing EU law directly into the UK legal system.

Should your company be exporting your product to the EU-27, 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.

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 date of the UK’s withdrawal from the EU, you will no longer be subject to the provisions of the CLP Regulation.

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-27?

As from the date of the UK’s withdrawal from the EU, you will no longer be subject to the provisions of the CLP Regulation and thus will no longer have such an obligation.

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

No, you will not. 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.

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. You can, however, update or remove your C&L notification using your REACH-IT account.

When exporting to the UK, will my EU-27-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-27-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 UKs’ withdrawal from the EU, 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 will the harmonised classification procedure be followed if the date of the UK’s withdrawal from the EU precedes a decision on a proposal submitted by the UK for harmonisation?

Depending on the timing and the terms of the UK withdrawal, the continuation and outcome of the harmonised classification procedure may vary.

General

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

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

You will therefore need to follow the legislative developments in the UK. You are also advised to follow the UK withdrawal negotiations with the EU which may determine your future obligations.

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

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

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

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

What impact will the withdrawal of the United Kingdom from the European Union have on my EU-27-based company?

As a company based in the EU-27, 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 will become a so-called “third country”. Consequently, 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.  

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 date on which the UK withdrawal takes effect and the United Kingdom ceases to be an EU Member State.

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.

My UK-based company provides chemicals to customers in the EU-27/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 10 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?

As the UK will no longer be a Member State of the EU, 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.

What will happen to the export notifications that my UK-based company submitted prior to the UK withdrawal date of 30 March 2019, for exports in 2019? Will they remain valid?

After the UK’s withdrawal, as a UK-based exporter, you will no longer have any obligations under the PIC Regulation. Consequently, ECHA will disable any export notification submitted by any UK-based company so that it can no longer be used by those companies for exporting in 2019 and beyond.

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

As the UK withdrawal will take effect on 30 March 2019, the PIC Regulation will apply in the United Kingdom until that date. Article 10 of 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 will need to report on your exports/imports of PIC chemicals which took place in 2018.. You will have no obligations for reporting data on exports/imports after 2019. 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.

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-27 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, you will no longer have access to ePIC and do 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 available here: https://echa.europa.eu/information-on-chemicals/pic/designated-national-authority) in case they are not already aware of their obligations under the PIC Regulation.

My UK-based company exports chemicals which are subject to the EU PIC Regulation and 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. 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.

My UK-based company exports chemicals subject to the EU’s PIC Regulation (i.e., other than the chemicals subject 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. As the UK will no longer be a Member State 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.

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 UK withdrawal, 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.

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 UK withdrawal, 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.

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-27-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. As the UK will no longer be a Member State of the EU, any such exports will need to be notified.

After the UK withdrawal, will my EU-27-based company need to notify an export of a chemical subject 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 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.

After the UK withdrawal, will my EU-27-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-27-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 UK withdrawal, 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).
My EU-27-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 (https://echa.europa.eu/support/dossier-submission-tools/epic).

REACH

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

Until the date of the withdrawal of the UK on 30 March 2019, the UK remains an EU Member State in which the provisions of the REACH Regulation fully apply. You will therefore have to register your substance for the 2018 REACH registration deadline. Moreover, your registration obligations will continue until the date of the UK withdrawal. Even beyond that date, it will be advisable for you to follow the legislative development in the UK with regard to domestic registration obligations.

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

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

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

  • as a manufacturer or formulator, you may appoint an Only Representative within the EU-27/EEA or transfer your manufacturing activity to the EU-27/EEA (please see Q&A 1538);
  • as a UK-based importer from a non-EU/EEA country, you may transfer your importing activity to a company established in the EU-27/EEA (please see Q&A 1539);
  • in case your company has registered as an Only Representative, the non-EU/EEA manufacturer may appoint an EU-27-based Only Representative in place of your company (please refer to Q&A 1417).
My UK-based company is currently acting as an Only Representative of a non-EU company. Once the United Kingdom leaves the European Union, how will that affect our status of Only Representative?

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

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

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

My UK-based company has paid the requisite fee to ECHA for the registration of our substance whilst the United Kingdom is currently still a Member State of the European Union. Will ECHA charge the payment of a fee for a legal entity change in the case that our company transfers our REACH registrations or the Only Representative status to an Only Representative based in the EU-27?

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

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

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

My UK-based company does not hold and is not covered by a REACH Authorisation for an Annex XIV substance and the Latest Application Date is approaching. With a view to the UK withdrawal from the EU, do we need to apply?

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

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

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

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

No. As the EU legislation will no longer apply to the UK after the withdrawal date, you will no longer be subject to this obligation. Even before that date, we advise you to follow the legislative development in the UK with regard to domestic authorisation obligations, as you will need to adhere to applicable UK law in this respect. For REACH Authorisations covering a UK-based company’s downstream users located in the EU-27/EEA, please see the respective Q&A on these webpages.

My UK-based company is a downstream user within the UK of a substance covered by a REACH Authorisation in accordance with Article 56 (2) of the REACH Regulation. Will we need to continue to comply with the obligations imposed by the Authorisation decision also after the UK withdrawal?

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

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

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

My UK-based company is a downstream user of a chemical substance registered under REACH. After the UK withdrawal, will we need to continue informing our EU-27 supplier of its uses?

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

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

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

My EU-27-based company is purchasing a chemical substance from a UK-based business partner which has registered the substance under REACH. Can we still rely on the substance having been legally and validly registered within the EU in accordance with the REACH Regulation after the UK leaves the EU?

No. Your business partner will need to appoint an Only Representative established within the EU-27 or relocate to the EU-27 for the substance to remain legally registered with ECHA for the EU-27/EEA. In the absence of such an appointment or relocation by your UK-based supplier, you will need to register the substance yourself as an importer.

My EU-27-based company is a registrant in a joint submission for which a UK-based company is the Lead Registrant as well as owner of the data to which we have obtained a Letter of Access. What impact will the UK withdrawal from the EU have on our registration?

After the date of the UK withdrawal, the registration by the UK-based company will be considered non-existent. If the UK-based Lead Registrant still wishes to continue placing their substance on the EU-27/EEA market, they must take action. If they are a manufacturer of the substance, they can appoint an Only Representative located in the EU-27 to handle their registration and the lead registrant duties. Alternatively, the UK based manufacturer can transfer their existing registration to the EU27/EEA, keeping the manufacturing role, if this transfer is the result of a legal entity change, falling into one of the following scenarios: (A) the UK based manufacturer goes through an acquisition or relocation to the EU27/EEA; (B) an intra-group transfer of the whole operation / manufacturing activity to the EU27/EEA. Following the legal entity change, the UK legal entity must cease manufacturing until after the UK has exited the EU.

However, if they are an importer, the only way they can still retain the lead registrant role is by moving their import activities into the EU-27/EEA and changing the registrant legal entity in REACH-IT to this new legal entity.

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

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

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

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

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

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

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

With regard to the timing of such transfers:

  • In case 1, the transfer can only take effect on the occasion of the UK withdrawal (for detailed advice, please see Q&A 1466).
  • In cases 2 and 3, the transfer must take place ahead of the UK withdrawal and be notified to ECHA (through the ‘Legal entity change’ functionality in REACH-IT) without undue delay. It should also be noted that after this transfer, the UK-based company cannot continue its manufacturing / importing / Only Representative activity, as long as the REACH Regulation applies to the UK.

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

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

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

What does my UK-based company need to keep in mind when we appoint an Only Representative (OR) in an EU-27 Member State?

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

Can my UK-based company set up a company on paper only in an EU-27 Member State and transfer its registrations there?

No. Every registrant company is responsible for its registrations and the substances that are covered by these registrations. Therefore, responsible staff and the relevant documentation must be available for inspection at the premises of every registrant. Only Representatives must live up to the requirements in Article 8(2) REACH. A mere address or letterbox is not sufficient and may lead to legal consequences being taken by enforcement authorities or ECHA. The company that you set up must comply with all local regulations and have legal personality at its place of establishment. Your company will need to notify this change in REACH-IT immediately ahead of the UK withdrawal. ECHA will clarify the practical steps that you will need to take, closer to this date. We also recommend that you consult ECHA’s Practical Guide No. 8.

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

Yes, such a transfer of registration will become acceptable for UK-based manufacturers and formulators at the time of the UK withdrawal. According to Article 8 of the REACH Regulation, only a natural or legal person established outside the EU may by mutual agreement appoint a natural or legal person established within the EU to fulfil, as Only Representative, the obligations that the REACH Regulation imposes on importers. As long as the UK is a Member State of the EU, your company therefore will not qualify for performing such a transfer.

Consequently, we recommend that you, prior to the UK withdrawal from the EU, set up a contractual agreement to appoint an Only Representative, which contains a suspensive conditional clause stipulating that the appointment takes effect on the date when the UK withdrawal from the EU takes effect. The date and time of the UK withdrawal is foreseen to be 30 March 2019, 0000 hours CET (i.e., 29 March 2019, 2300 hours BST). Your company will need to notify this change in REACH-IT immediately ahead of the UK withdrawal.

Please note that if you act as a formulator (i.e., you import a substance from a third country to the UK, and include the substance in a mixture that you export to the EU-27 / EEA), you can appoint an Only Representative for the quantities of the substance that you formulate into a mixture that you export to the EU-27/EEA. However, note that for the quantities of the substance that you import to the UK for further export as such to the EU-27/EEA, you cannot appoint an Only Representative. The reason is that only non-EU manufacturers or formulators can appoint an Only Representative.

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

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

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

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

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

However, as long as the UK is still a Member State of the EU and your company is therefore not located in a “third country”, your company will not qualify for performing such a transfer. Consequently, we recommend that prior to the UK withdrawal from the EU you set up a contractual agreement to appoint an Only Representative which contains a suspensive conditional clause stipulating that the appointment takes effect on the date when the UK withdrawal from the EU takes effect. The date and time of the UK withdrawal is foreseen to be 30 March 2019, 0000 hours CET (i.e., 29 March 2019, 2300 hours BST). The Only Representative will need to adhere to all the conditions of use determined by the Authorisation decision, including any specific duties foreseen in the decision for your company. ECHA will clarify the practical steps to take closer to this date.

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

My company is a UK-based manufacturer of chemical substances. I would like to keep on supplying my customers in the EU-27 / EEA following the UK withdrawal from the EU. What are my options?

As a UK-based manufacturer, following the UK withdrawal from the EU you will be regarded as a non-EU manufacturer. Only manufacturers and importers based in the EU / EEA have registration obligations. However, if you wish to continue supplying to your EU-27 / EEA-based customers, you may consider one of the following options:

  • Like any EEA-based legal entity, you can transfer your existing registration to an EU-27 / EEA legal entity, which maintains the manufacturing role if this transfer is the result of a legal entity change, i.e. it must fall into one of the following scenarios:
    • The UK-based manufacturer goes through an acquisition or relocation to the EU-27 / EEA.
    • Intragroup transfer of the whole operations / manufacturing activity (e.g. transfer of the activity from a UK-based mother company to an EU-27 / EEA-based daughter company).
    With regard to the timing of such a transfer, it must take place ahead of the UK withdrawal date and be notified to ECHA (through the ‘Legal entity change’ functionality in REACH-IT) without undue delay. Under both scenarios, following the transfer, the UK legal entity is not allowed to benefit from the registration any longer (i.e., they must cease manufacturing activities). After the UK withdrawal takes effect, when UK-based companies will no longer be bound by the REACH Regulation, manufacturing may restart in the UK, subject to relevant UK law.
  • You can appoint an Only Representative (OR) within the EU-27 / EEA. For further details (particularly with regard to the timing), please refer to Q&A 1464.
  • Alternatively, your EU-27 / EEA-based customers can continue sourcing from you by registering the substance(s) themselves, as importers.
My UK-based company is an importer of chemical substances. We would like to keep supplying our customers in the EU-27 / EEA following the UK withdrawal from the EU. What are our options?

As a UK-based importer, following the UK withdrawal from the EU you will not have registration obligations under REACH, as only EU / EEA-based manufacturers and importers are required to register their substances under REACH. However, you may consider transferring your registration to an EU-27 / EEA-based legal entity, if this transfer is the result of a legal entity change, i.e. the importing business is transferred to a legal entity in the EU-27 /EEA.

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

If you also act as a formulator (i.e., you import a substance from a third country to the UK, and include the substance in a mixture that you export to the EU-27 / EEA), you can appoint an Only Representative (OR) for the quantities of the substance that you formulate into a mixture that you export to the EU-27/EEA. For further information, please refer to Q&A 1464.

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

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

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

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

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

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

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

You can appoint a new Only Representative, located within the EU-27/EEA. This requires that the old and the new Only Representatives collaborate in making a ‘legal entity change’ in REACH-IT. The new appointment must take place ahead of the UK withdrawal and be notified to ECHA (through the ‘Legal entity change’ functionality in REACH-IT) without undue delay.

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

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

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

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