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-based company is placing on the EU/EEA market is located in the United Kingdom. What happens next?

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 United Kingdom. You do not need to take any action to continue complying with the BPR. However, shipments to the EU/EEA/Switzerland from the UK of this active substance/biocidal product are importations which has consequences from the viewpoint of other sectorial legislations (e.g. the PIC Regulation, customs).

In Northern Ireland (NI), the BPR Regulation continues to apply. This means that shipments to the EU/EEA/Switzerland of active substances/biocidal products from NI are not treated as importations for the purposes of the BPR Regulation. Please refer to Q&As 1703-1710 for further details.

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. What happens next?

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/EEA/Switzerland market if they meet the conditions of the BPR, in particular Articles 58 and 94. However, shipments to the EU/EEA/Switzerland of this treated article from the UK are importations, which has consequences from the viewpoint of other sectorial legislations (e.g. customs).

In Northern Ireland (NI), the BPR Regulation continues to apply. This means that shipments to the EU/EEA/Switzerland of treated articles from NI will not be treated as importations for the purposes of the BPR Regulation. Please refer to Q&As 1703-1710 for further details.

What happens to the treated articles that are manufactured outside the EU/EEA and first imported into the United Kingdom before the end of the transition period, and made available on the EU/EEA market after this date?

Any treated article placed on the EU/EEA market is subject to the provisions of the BPR, in particular Articles 58 and 94. Shipments from the United Kingdom (Great Britain) to the EU of a treated article are considered as an import and, consequently, placing on the market of such treated article. If the treated article was placed on the United Kingdom 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/EEA, proper labelling information etc.). 

In Northern Ireland, the BPR Regulation continues to apply. This means that shipments of a treated article from Northern Ireland to the EU are not considered as an import for the purposes of the BPR Regulation. Please refer to Q&As 1703-1710 for further details.

The UK was acting as the reference Member State (refMS) in procedures in sequence (mutual recognition of a biocidal product authorisation in accordance with Articles 33 and 34 of the BPR, applications for minor or major changes under Commission Implementing Regulation (EU) No 354/2013) and renewal of product authorisations under Commission Delegated Regulation (EU) No 492/2014) related to my company’s product and the process is not yet finalised. What effect does the UK withdrawal have on the pending process?

As of the withdrawal date, the United Kingdom can no longer act as a leading authority in processes at Union level and, therefore, it can no longer be a reference MS (refMS) in above indicated processes.

For those applications which were submitted before the UK withdrawal date, the services of the European Commission and ECHA are working in a coordinated manner with EU Members States, EEA countries and Switzerland in order to try to identify new refMSs. The MSs at CA level and the coordination group will explore the possibilities to identify new refMSs.

Where it will not be possible to reach an agreement on identifying a new refMS, the pending process will be terminated.

Thus, the applicants are invited to actively try to identify a new refMS for pending sequence cases by themselves.

If the application for an above mentioned process was submitted after the UK withdrawal date it should be rejected by the relevant cMS(s). The applicant will need to find a new refMS and submit a new application. 

After the end of the transitional period, will an EU Member State still be able to issue a national biocidal product authorisation on the basis of the mutual recognition of a UK authorisation granted before the UK withdrawal?

No. 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 mutual recognition takes place of a national authorisation granted in a Member State and  the applicant has chosen a new (EU-27/EEA/Switzerland) Reference Member State (RefMS).

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

My EU based company benefits from an authorisation issued by an EU Member State prior to the United Kingdom withdrawal date on the basis of the recognition of a United Kingdom authorisation. Is my authorisation affected by the United Kingdom withdrawal?

No. There is no such effect. The authorisation granted by each EU Member State remains valid in these EU Member States. 

In Northern Ireland, the BPR Regulation continues to apply. Please refer to Q&As 1703-1710 for further details.

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

Yes, you should, as, the United Kingdom can no longer act as an eCA.

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 United Kingdom acted as the reference Member State (refMS). Can my company choose another competent authority as refMS?

Yes, you should, as the United Kingdom can no longer act as a refMS.

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.

An EU Member State has granted my EU/EEA-based company a biocidal product authorisation based on mutual recognition of a United Kingdom biocidal product authorisation. Is my company’s product authorisation affected by the United Kingdom 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 United Kingdom withdrawal from the EU does not affect the validity of your company’s product authorisation, even if your national authorisation is based on the mutual recognition of a United Kingdom authorisation.

My EU/EEA-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 United Kingdom-based company. Does the end of the transition period affect my company’s listing under Article 95 of the BPR?

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

CLP

When exporting to the United Kingdom, is my EU/EEA-based company required 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 United Kingdom will still implement the GHS.

Thus, for example, the pictograms will be valid within the United Kingdom. More information is available here.

When our EU/EEA-based company exports to the United Kingdom, do the labels affixed to our products need to be in the English language as required by the CLP Regulation?

The legal language requirements depend on the United Kingdom legislation. In practice, it is safe to assume a need to continue labelling your product in the English language as the official language of the United Kingdom, based on the information and the format prescribed by the CLP Regulation. More information is available here.

PIC

My EU-based company buys a product from a company based in the United Kingdom and it is subsequently shipped directly to my customer who is based in another non-EU country. Do we need to notify the export?
As the product you hold the contract for does not come from an EU country nor is in free circulation within the EU custom territory, it does not fall within the notion of “export” pursuant to Article 3.16 (a) or (b) of the PIC Regulation. Consequently, no export notification is needed under the EU PIC Regulation.
 
However, please note that the following circumstances may lead to exceptions:
 
  • Any national legislation regulating exports in place in the United Kingdom;
  • If the exported chemical is listed in Annex III to the Rotterdam Convention (as well as being subject to the EU PIC Regulation).
 
In Northern Ireland, the PIC Regulation continues to apply. Therefore, if the company shipping the product to a third country (i.e. any other custom territory than those of the EU and United Kingdom) is located in the Northern Ireland, and your company is the holder of the contract, then the EU company should notify the export to your DNA.
My EU-based company imports chemicals subject to PIC from companies based in the United Kingdom. Do we have any obligations under the PIC Regulation?

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.

In Northern Ireland the PIC Regulation continues to apply, therefore, shipments from companies located in Northern Ireland to the EU and vice-versa are not subject to such reporting obligations under PIC.

REACH

My EU/EEA-based company is purchasing a chemical substance from a United Kingdom based business partner which has registered the substance under REACH. Can we still rely on the substance having been legally and validly registered within the EU/EEA in accordance with the REACH Regulation after the end of the transition period?

No, unless a company is based in Northern Ireland. Your business partner should appoint an Only Representative established within the EU/EEA or relocate to the EU/EEA for the substance to remain legally registered with ECHA for the EU/EEA. In the absence of such an appointment or relocation by your United Kingdom based supplier, you will need to register the substance yourself as an EU/EEA importer.

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

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

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

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

If the United Kingdom based company did not take the necessary steps to transfer their registration to an EU27/EEA/NI company, prior to the end of the transition period, the members of the joint submission should agree on a new lead. The lead role can be taken by any member of the joint submission.

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

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

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

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

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

My EU/EEA-based company obtains its supplies of a chemical substance from a United Kingdom based importer into the EU/EEA, which is now considered “third country”. If we continue our business relations with our United Kingdom-based supplier, would our United Kingdom-based supplier be entitled to appoint our company as its Only Representative in the EU/EEA and transfer its registration to us, or would we need to register as an importer ourselves?

The latter is the case. You would need to act as an importer of the substance into the EU/EEA and submit a new registration. Article 8 of the REACH Regulation only allows manufacturers, formulators of mixtures or producers of articles established outside the EU/EEA to appoint an Only Representative. This option will thus not be available to United Kingdom  -based companies that will have been importers into the EU/EEA until the end of transition period. Non-EU/EEA manufacturers of the substance may of course appoint an EU/EEA-based Only Representative of the substance. However, such an Only Representative would then need to submit a new registration for the substance.

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

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

Your supplier is no longer subject to REACH and CLP obligations. Therefore, your United Kingdom-based supplier should have appointed an Only Representative to cover the necessary REACH registrations for the component substances of the mixture. If not, you will need to submit the relevant registrations as an importer yourself to be legally on the EU/EEA internal market.

Under CLP, you are now the importer and thus have the obligation to ensure that the imported mixture is correctly classified, labelled and packaged. You may also have the notification obligation to the Classification and Labelling Inventory and the notification obligations under Article 45 (poison centre notification, please refer to Q&A 1715). 

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

My EU/EEA-based company has registered a substance, which is exported and stored in a warehouse in the United Kingdom and then imported in the EU/EEA. How can we continue this activity?

After the end of transition period, trading the substance back to the EU/EEA may be considered as re-import into the EU/EEA. A re-imported registered substance does not need to be registered again, as long as the conditions for re-import set out in Article 2(7)(c) of REACH are fulfilled. These conditions are outlined in Q&A 1076, and further elaborated in the Guidance on registration section 2.2.3.6.

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

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