Q&As

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The UKs withdrawal from the EU

BPR

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.

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 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.

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). 
CLP

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.

General

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.  

PIC

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).

My EU27-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 date of the UK withdrawal. hHowever, there is no withdrawal agreement in place. 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. In order to cover exports taking place in the first 35 days from the withdrawal date if there is no withdrawal agreement, a procedure is made available, which allows EU27-based exporters to notify the planned export to the United Kingdom in advance of the withdrawal date. These export notifications will take effect if the United Kingdom is, as of the withdrawal date, a third country without a withdrawal agreement entering into force on that date.

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

REACH

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. In fact, ECHA recommends to initiate the transfer at least one week ahead of the UK withdrawal, 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.

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

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 will still be pending by the date 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 is also being 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.

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.

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 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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