Q&As

Vous désirez rechercher la question et la réponse pertinentes dans votre propre langue? Changez la langue dans le menu déroulant ci-dessus.

Retour

Retour

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. In addition, on 17 June 2020, the Commission published a notice to stakeholders on biocidal products.

My United Kingdom-based company is the holder of a product authorisation in an EU Member State, EEA or Switzerland or of a Union authorisation under the BPR. What effect does the end of the transition period have on our authorisation?

According to Article 3 of the BPR, an authorisation holder must be established within the European Union. By virtue of the EEA Agreement as well as the Mutual Recognition Agreement with Switzerland, an authorisation holder can also be established in Iceland, Liechtenstein, Norway or Switzerland. Companies established in United Kingdom, except for Northern Ireland, cannot be holders of such authorisations. 

Companies established in Northern Ireland can maintain their product authorisations in EU Member States or Union authorisations, as per the IE/NI Protocol (see Q&As 1703-1710).

What is the effect of the United Kingdom withdrawal with regard to active substances that were originally evaluated by the United Kingdom and subsequently approved by the European Commission or an EU Member State?

The United Kingdom withdrawal does 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.

Can my United Kingdom-based company submit requests for active substance approval or inclusion of a substance on Annex I?

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

Does ECHA grant United Kingdom-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?

The data sharing mechanism under Articles 62 and 63 of the BPR is still be available to such companies, for the purposes of the BPR; for example, where a United Kingdom-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).

Does my United Kingdom-based company have an access and possibility to submit applications for active substances, Annex I inclusion or technical equivalence via the R4BP 3 submission tool?

Yes, but the application has to be submitted to a Competent Authority in an EU Member State (or an EEA country or Switzerland). Applicants for the approval of an active substance, Annex I inclusion or technical equivalence do not need to be established in the EU therefore third country entities can apply.

Does the substance or product-specific data owned by my United Kingdom-based company remain protected by the data protection rules of the BPR?

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

The manufacturing site of the active substance / biocidal product that my EU-based company is placing on the EU/EEA market is located in the United Kingdom. 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. 

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.

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 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.

Do my United Kingdom-based company’s accounts in R4BP 3 remain accessible, or will ECHA delete them?

Yes, you continue to have access, as non-EU companies have access to R4BP 3. United Kingdom-based companies are able to perform the same actions allowed for other non-EU companies (e.g. technical equivalence, active substance approval submissions, applications for Annex I inclusion of active substances).

What is the effect of the withdrawal of the United Kingdom on ongoing applications for processes 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) for which the United Kingdom was the reference Member State?

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. This also applies during the transition period.

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 the new refMSs for those applications which were submitted before the UK withdrawal date. The MSs at CA level and the coordination group will explore the possibilities to identify new refMSs. 

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.

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

With the submission of the initial application assessed by the United Kingdom the applicant fulfilled its legal obligation laid down in the second subparagraph of Article 89(3) of the BPR. As a consequence, the existing products currently benefit from the provisions in Article 89(2) of the BPR provided that the applicant submitted a new application by 31 December 2020 for mutual recognition in parallel (to a new refMS of its choice and to the same Member States concerned in accordance with Article 34(1) and (2) of the BPR, respectively) or a new application for Union authorisation in accordance with Article 43(1) of the BPR.

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

The authorisation granted by the United Kingdom is no longer 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.

The United Kingdom was acting as the Competent Authority in a regulatory procedure for the United Kingdom market related to my company’s product (e.g. national authorisations of biocidal products in accordance with Article 29 of the BPR, simplified authorisations of biocidal products in accordance with Article 26 of the BPR, renewals of biocidal products, in accordance with Article 31 of the BPR, same biocidal product under Commission Implementing Regulation (EU) No 414/2013 or changes under Commission Implementing Regulation (EU) No 354). What effect does the end of the transition period have on the pending process?

United Kingdom national law applies, and you need to contact the United Kingdom authorities for further information. 

Also note that mutual recognition of a United Kingdom authorisation by EU Member States is not possible since the withdrawal date – see Q&A 1719.

In Northern Ireland, BPR continues to apply. Please see Q&A 1703-1710.

Can I still apply for mutual recognition of a biocidal product authorisation in accordance with Articles 33 and 34 of the BPR in an EU/EEA country of a UK national authorisation?

As of the withdrawal date, the United Kingdom has become a third country and 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 mutual recognition processes. Accordingly, you cannot apply for mutual recognition (e.g. mutual recognition of a biocidal product authorisation in accordance with Articles 33 and 34 of the BPR, 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) of a UK authorisation. 

If the application for an above-mentioned process was submitted after the UK withdrawal date it should be rejected by the relevant concerned Member State(S) (cMS(s)). The applicant will need to find and submit a new application to a new reference Member State, in order to obtain the authorisation.

If a referral is submitted for my product in the context of an ongoing process for mutual recognition in sequence of an authorisation or a process of an application for administrative, major and minor changes of an authorisation, for which the United Kingdom (UK) was the reference Member State?

As of the withdrawal date, the United Kingdom can no longer act as a leading authority in processes at Union level. Therefore, it can no longer be a reference MS (refMS) and cannot address the issues raised by the initiating concerned Member State (cMS). 
The only possibility to resolve the referral would be that a competent authority of an EU Member State/EEA country/Switzerland agrees to act as the new refMS.

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

Thus, the applicants are invited to proceed with the new sequence applications only when a new refMS is found by them.

CLP

Does my United Kingdom-based company still need to classify and label our products according to the EU’s CLP Regulation?

No, your company is subject to the laws applied in the United Kingdom, except for Northern Ireland.

Should your company be exporting your products to the EU/EEA, you need to do that via an importer established in Northern Ireland or the EU/EEA, who has an obligation to classify and label your products according to the provisions of the CLP Regulation. You 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.

In Northern Ireland, the CLP Regulation continues to apply. This means that companies based in Northern Ireland need to comply with the CLP Regulation. Please refer to Q&A 1701 for further details.

Is my United Kingdom-based company obliged to apply the harmonised classification for substances as listed in Annex VI to the CLP Regulation?

No, you are no longer subject to the provisions of the CLP Regulation.

In Northern Ireland, the CLP Regulation continues to apply. This means that companies based in Northern Ireland need to comply with the CLP Regulation. Please refer to Q&A 1701 for further details.

Is my United Kingdom-based company 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/EEA?

No, you are no longer subject to the provisions of the CLP Regulation and thus don’t have such an obligation.

In Northern Ireland, the CLP Regulation continues to apply. This means that companies based in Northern Ireland need to comply with the CLP Regulation. Please refer to Q&A 1701 for further details.

Is my United Kingdom-based company obliged to notify the classification of substances in the C&L Inventory?

No, this obligation no longer applies to you. If you export substances into the EU/EEA, your EU/EEA-based importer has 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. 

In Northern Ireland, the CLP Regulation continues to apply. This means that companies based in Northern Ireland need to comply with the CLP Regulation. Please refer to Q&A 1701 for further details.

How is the information that my United Kingdom-based company notified to ECHA used after the end of the transition period?

The information remains available under the conditions of the legal notice that ECHA has published along with the inventory. However, you can no longer modify it via your REACH-IT account. 

In Northern Ireland, the CLP Regulation continues to apply. This therefore means no changes for Northern Ireland-based companies. Please refer to Q&A 1701 for further details.

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.

I am an EU/EEA-based company importing mixtures from the United Kingdom supplier. Do I have obligations under Article 45 and Annex VIII (poison centre notifications)? Can I consider my obligations fulfilled by a notification already submitted by my United Kingdom supplier?

From 1 January 2021, EU/EEA companies importing hazardous mixtures from the United Kingdom, except from Northern Ireland, have become duty holders under Article 45. Therefore, if you place hazardous mixtures covered by the scope of Article 45 on the EU/EEA market that are supplied by a United Kingdom company you have the obligation to notify to the relevant appointed body(ies) and include the UFI on the label before placing the mixture on the EU/EEA market. Please note that import is considered as placing on the market. More information about which mixtures are in the scope of Article 45 is available on the Guidance on Annex VIII

A notification already made by your United Kingdom supplier before the end of the transition period does not relieve you from your obligations. Each duty holder is required to submit the information according to Annex VIII individually. This is not the case if your supplier is located in Northern Ireland, where the CLP still applies (see Q&A 1701). In this case, if you only act as distributor of the mixture, you do not have direct obligations under Article 45 (please, see the Guidance on Annex VIII for more information on roles and obligations).

Can I transfer my poison centres notifications to an EU/EEA-based legal entity?
No, such functionality does not exist for poison centre notifications. In case of a change of legal entity, the new legal entity needs to submit a new poison centre notification. Please, note that as long as the mixture composition does not change, the same UFI may be used by different legal entities.
What happens to the Annex VIII data submitted via the ECHA Submission portal by United Kingdom-based companies before 1 January 2021?

Annex VIII data submitted before 1 January 2021 via the Submission portal remain in the data base and will not be deleted. These are available for the relevant appointed bodies of the EU/EEA Member States which have got access to the PCN service.

United Kingdom authorities will not get access to the database. Therefore, any notification to the UK should be made through their national notification channels.

How should substances and mixtures be labelled in order to be CLP-compliant after 1 January 2021 if the label contains the contact details of a United Kingdom -based supplier?

A label without contact details of an EU legal entity is not compliant with CLP. According to Article 17(1)a, a substance or mixture classified as hazardous and contained in packaging must bear a label including the name, address, and telephone number of the supplier(s). By definition, a ‘supplier’ means any manufacturer, importer, downstream user or distributor placing on the market a substance, on its own or in a mixture, or a mixture, and each of these entities is defined as a natural or legal person established within the Community (Article 2 CLP). 

Therefore, the required change of the contact details from a United Kingdom-based to an EU/EEA-based supplier is not considered as an update of the label (according to Article 30 CLP), but as a pre-requisite for the placing of substances and mixtures on the EU/EEA-market. This applies through the entire supply chain.

In practice, and in line with provision TBT.8 on marking and labelling in the Trade And Cooperation Agreement between the European Union and The United Kingdom Of Great Britain And Northern Ireland (as published on 31 Dec 2020), it is acceptable to use a sticker with the EU supplier’s details to cover those of the non-EU supplier. Before labels are updated due to other reasons, each supplier in the supply chain needs to add such stickers on the products they supply, with their own or their supplier’s contact details.

It can also be noted that labelling, including supplementary labelling or corrections to labelling, may take place in customs warehouses or other designated areas in the country of import as an alternative to labelling in the country of origin, unless such labelling is required to be carried out by approved persons for reasons of public health or safety.

General

What is the impact of the withdrawal of the United Kingdom from the European Union for my United Kingdom-based company?

If your business of placing chemical substances, biocidal products or active substances on the market is limited to the territory of the United Kingdom, except for Northern Ireland, your activity is no longer subject to the provisions of the EU chemicals legislation. With regard to the obligations arising from the CLP, BPR, PIC and REACH Regulations, your legal obligations towards ECHA as the EU’s respective regulatory Agency have ceased. 

The EU REACH Regulation has been brought into UK law under the European Union (Withdrawal) Act 2018. REACH, and related chemicals legislation, has been replicated in the United Kingdom with the necessary changes to make it operable in a domestic context. More information is available here.

For businesses that are part of a cross-border supply chain, linking companies located in the United Kingdom with companies located within the EU/EEA Member States, you can find detailed advice under the respective headings of these Q&As pages.

In Northern Ireland, REACH, CLP, BPR and PIC continue to apply. Please refer to Q&As 1700 - 1711 for an overview.

Are United Kingdom-based companies able to rely on ECHA helpdesk support for advice and assistance related to the EU chemical legislation?

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

The United Kingdom, except for Northern Ireland, has no 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 United Kingdom.

In Northern Ireland, REACH, CLP, BPR and PIC continue to apply. Please refer to Q&A 1700 - 1711 for an overview.

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

ECHA decisions concerning United Kingdom-based companies only apply until the end of the transition period, except for Northern Ireland.

If you, as a United Kingdom-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.

Legal entities established in Northern Ireland can continue to lodge an appeal with ECHA’s Board of Appeal on ECHA decisions listed in Article 91 of REACH and Article 77 of BPR.

My United Kingdom-based company provides chemicals to customers in the EU/EEA. What are the effects of the United Kingdom withdrawal from the EU other than those relating to the BPR, CLP, PIC and REACH Regulations?

The Q&As on this website solely provide advice on the impact of the United Kingdom withdrawal in relation to the chemicals legislation that ECHA manages. You 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 available, for instance, in the readiness notices published on the webpages of the European Commission.

Northern Ireland Protocol

Does the obligation to notify articles to ECHA’s SCIP database apply to producers, importers and suppliers of articles based in Northern Ireland?
No. The obligation to notify articles to ECHA’s SCIP database stems from the Waste Framework Directive 2008/98/EC, which is not included in Annex II of the Protocol on Ireland/Northern Ireland listing Union law provisions applying to and in the United Kingdom in respect of Northern Ireland.
Which ECHA IT tools are accessible to companies established in Northern Ireland?

The IE/NI Protocol provides that REACH, CLP, BPR and PIC regulations apply to and in the United Kingdom in respect of Northern Ireland. Thus, companies located in Northern Ireland continue to have access to REACH-IT, R4BP, ECHA Submission portal and ePIC for most processes.

Northern Ireland companies with an existing account in these tools associated with the former “UK” entity are required to create new accounts associated to the new entity “UK (NI)”.

With regard to poison centres notifications, companies established in Northern Ireland can use the ECHA Submission portal to notify mixtures to be placed on the EU market, but not for those placed on the Northern Ireland market. The United Kingdom national system has to be used for such purpose.

For applications for national authorisations of biocidal products (Article 29 of the BPR), for simplified authorisations (Article 26 of the BPR) and applications for mutual recognition (Chapter VII of the BPR), the UK(NI) companies need to use the United Kingdom national system to make their applications. For other BPR processes, for example applications for active substance, R4BP 3 can be used.

What does the Protocol on Ireland/Northern Ireland (‘IE/NI Protocol’) mean from the REACH perspective?

The IE/NI Protocol provides that REACH applies to and in the United Kingdom in respect of Northern Ireland. REACH does not apply in other parts of the United Kingdom.

On a practical level, this means that:

  • substances manufactured in or imported to Northern Ireland need to be registered with ECHA, including substances imported from United Kingdom to Northern Ireland;
  • substances shipped from Northern Ireland to the EU/EEA are not considered ‘imported’ from the registration perspective; 
  • an Only Representative based in Northern Ireland is considered equal to an Only Representative in the EU/EEA;
  • a manufacturer, formulator or an article producer in Northern Ireland cannot appoint an only representative;
  • authorisation obligations apply to Annex XIV substances placed on the market for a use or used in Northern Ireland, including substances imported from United Kingdom to Northern Ireland.
What does the Protocol on Ireland/Northern Ireland (‘IE/NI Protocol’) mean from the CLP perspective?
The IE/NI Protocol provides that CLP applies to and in the United Kingdom in respect of Northern Ireland. CLP does not apply in other parts of the United Kingdom.
 
On a practical level this means that:
 
  • substances and mixtures placed on the market in Northern Ireland must be classified, labelled and packaged according to the CLP Regulation;
  • such classification and labelling elements must be notified to the C&L Inventory;
  • companies located in Northern Ireland need to follow the scientific and technical developments in relation to the substances and mixtures they place on the market, and update classification and labelling accordingly;
  • if a company in Northern Ireland holds information leading to a change in harmonised classification, they need to submit a change proposal to the Competent Authority in one of the EU Member States in which the substance is placed on the market. The UK(NI) Authority cannot act in this role, so the company needs to contact a Competent Authority in an EU Member State. 
  • importers and downstream users placing mixtures on the market in Northern Ireland must provide information on emergency health response to the UK/NI Appointed body and include a UFI on the label. EU/EEA companies placing on the market hazardous mixtures supplied by companies established in NI, without performing any activity qualifying as use, will remain distributors with no direct notification obligations under Article 45. However, distributors (e.g. re-branders) must make sure to only place CLP compliant products on the market and ensure that all product identifiers (in particular trade/brand names) and UFIs under which the mixture is placed on the market are covered by a submission to the relevant appointed body in the EU/EEA (Activities leading to submission obligations according to Article 4(10)).
 
For more information on roles and responsibilities according to the specific activity please see the Guidance on Annex VIII.
Do the obligations to notify hazardous mixtures according to Article 45 and Annex VIII of CLP (poison centres notifications) apply to downstream users and importers based in Northern Ireland?

Yes, if they intend to place those mixtures on the EU/EEA market, or Northern Ireland. CLP applies to and in the United Kingdom in respect of Northern Ireland.

Companies established in Northern Ireland can use the ECHA Submission portal to notify mixtures to be placed on the EU/EEA market. However, when placing mixtures on the Northern Ireland market the United Kingdom national system has to be used instead.

CLP does not apply in other parts of the United Kingdom. Therefore, the obligations under Article 45 and Annex VIII do not apply to companies based in Northern Ireland if they intend to place a hazardous mixture on the market of the United Kingdom, except for Northern Ireland.

Does a biocidal product made available on the market and/or used in Northern Ireland need to comply with the BPR?
Yes, the IE/NI Protocol provides that the BPR applies to and in the United Kingdom in respect to Northern Ireland. Biocidal products shall not be made available on the market of Northern Ireland or used unless authorised in accordance with the BPR.
Is a biocidal product or treated article manufactured in Northern Ireland and shipped to the EU/EEA considered an imported biocidal product or treated article in the EU/EEA?

No, shipments of treated articles or biocidal products authorised in accordance with the BPR from Northern Ireland to the EU/EEA are not considered as imports to the EU/EEA.

Is a biocidal product or treated article shipped from the United Kingdom to Northern Ireland considered an imported biocidal product or treated article in Northern Ireland?
Yes, biocidal products or treated articles shipped from the United Kingdom into Northern Ireland are considered as being placed on the EU/EEA market. The company in Northern Ireland receiving the shipment, therefore, is considered as the importer of the biocidal product or treated articles into the EU/EEA.
Can a biocidal product authorisation holder as defined in Article 3(2)(p) of the BPR be based in Northern Ireland?
Yes, it is possible for an authorisation holder as defined in Article 3(2)(p) of the BPR to be established in Northern Ireland.
Can the United Kingdom in respect to Northern Ireland act as evaluating Competent Authority or receiving Competent Authority in the context of the approval of active substances or authorisation of biocidal products?
It is not possible for the United Kingdom, in respect to Northern Ireland, to act as evaluating Competent Authority for active substance approval application or Union authorisation applications. The United Kingdom, in respect to Northern Ireland can act as the receiving Competent Authority for applications for national authorisations of biocidal products (Article 29 of the BPR) and as the evaluating Competent Authority for simplified authorisations of biocidal products (Article 26 of the BPR) for the territory of Northern Ireland. 
Can my company based in Northern Ireland and holder of a product authorisation under the BPR for Northern Ireland apply for the mutual recognition of that biocidal product authorisation in accordance with Articles 33 and 34 of the BPR in an EU/EEA country?
No, it is not possible to apply for mutual recognition of a biocidal product authorisation in accordance with Articles 33 and 34 of the BPR when the reference authorisation has been granted by the United Kingdom authority in respect to Northern Ireland applicable for Northern Ireland.
As a supplier of a biocidal product I would like to apply for national authorisation (Article 29 BPR) or simplified authorisation (Article 26 BPR) in Northern Ireland. How should I submit my application?

It is not possible to submit such an application via R4BP 3. For applications for national authorisations of biocidal products (Article 29 of the BPR), for simplified authorisations (Article 26 of the BPR) and applications in accordance with Chapter VII (mutual recognition procedures) of the BPR, the Northern Ireland companies need to apply through the national system of United Kingdom to make their applications. 

We suggest the applicant to contact the United Kingdom authority in respect to Northern Ireland to obtain further information on how to practically proceed with the submission.

I am based in Northern Ireland and would like to apply for the approval of an active substance and/or technical equivalence, am I eligible to do so?
Yes, it is possible to apply for active substance approval and technical equivalence using R4BP 3 (such applications are possible for companies established in any country). However, the United Kingdom, in respect to Northern Ireland, cannot act as the evaluating Competent Authority for the active substance approval application.
What does the Protocol on Ireland/Northern Ireland (‘IE/NI Protocol’) mean from the PIC perspective?
The IE/NI Protocol provides that the PIC Regulation applies to and in the United Kingdom in respect of Northern Ireland. The PIC Regulation does not apply in other parts of the United Kingdom.
 
This means that:
 
  • shipments of chemicals between Northern Ireland and the EU are not considered as imports or exports, and therefore the PIC Regulation does not apply to such shipments;
  • shipments of chemicals between Northern Ireland and third countries – including United Kingdom after the end of the transition period - are considered as imports or exports and therefore the PIC Regulation applies to such shipments.
In practice, the main obligations for importers or exporters of PIC chemicals based in Northern Ireland are:
 
  • to notify upon the first export of the calendar year for each substance listed in Annex I to the PIC Regulation and each importing country;
  • to report during the first quarter of each year, the quantity of each Annex I PIC chemicals exported from, or imported to the EU in the preceding year;
  • to package and label the chemicals that are intended for export in accordance with the related provisions established in the CLP, BPR and REACH; in particular, a Safety Data Sheet (SDS) in accordance with the REACH Regulation shall accompany chemicals when exported;
  • not to export chemicals and articles as listed in Annex V to the PIC Regulation. 
However, according to Article 6(1) of the IE/NI Protocol, provisions of Union law made applicable by the Protocol which prohibit or restrict the exportation of goods shall only be applied to trade between Northern Ireland and other parts of the United Kingdom to the extent strictly required by any international obligations of the Union.
 
More specifically, this means inter alia the following:
 
  • the export of chemicals listed in Annex I to Regulation (EU) No 649/2012 from Northern Ireland to the United Kingdom has to comply only with the rules of that Regulation that implement the Convention. For example, the export of a chemical listed in Part 2 of Annex I to Regulation (EU) No 649/2012 from Northern Ireland to Great Britain has to be notified by the exporter but there is no requirement to get the explicit consent of the United Kingdom in respect of Great Britain; 
  • the rules on packaging and labelling of chemicals only apply to exports of chemicals from Northern Ireland to the United Kingdom to the extent necessary to comply with Article 13 of the Convention. 
Exporters of PIC chemicals based in Northern Ireland have also to submit a “Special RIN request” for the export of a chemical for the purpose of research or analysis, in quantities that are unlikely to affect human health or the environment and that in any event do not exceed 10 kg from each exporter to each importing country per calendar year.
PIC

My United Kingdom-based company exports chemicals, which are subject to the PIC Regulation to countries outside the EU. We used to regularly notify our exports via ePIC. Do we need to continue notifying these exports and, if yes, to whom and by what means?

The PIC Regulation does not apply in the United Kingdom, except from Northern Ireland.  The United Kingdom legislator has now established rules for exports by companies based in the United Kingdom. Further information can be found here.

As the United Kingdom is a Party to the Rotterdam Convention on the Prior Informed Consent procedure, the United Kingdom maintains 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 and legislation in place regulating your export.

In Northern Ireland the PIC Regulation continues to apply. Northern Ireland-based companies will therefore be subject to the PIC Regulation. Please refer to Q&A 1711 for further details.

As a United Kingdom-based company, do we need to report on our yearly exports/imports of PIC chemicals in 2020?

If you are a United Kingdom-based company, as from 1 January 2021, you will have no obligations for reporting data on exports/imports, including for exports/imports which took place in 2020. However, we recommend that you check with the relevant national authority in the United Kingdom  to verify whether you will have reporting obligations under the national United Kingdom legislation.

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

As a United Kingdom-based company, you 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 care of the export on your behalf. They should therefore contact their DNA within the EU (contact details) in case they are not already aware of their obligations under the PIC Regulation. 

In Northern Ireland the PIC Regulation continues to apply. If your company is based in Northern Ireland, you can continue using ePIC to submit your export notifications. Please refer to Q&A 1711 for further details.

My United Kingdom-based company exports chemicals which are listed in Annex III to the Rotterdam Convention on the Prior Informed Consent procedure. Do we still have to notify our exports to the EU?

The United Kingdom is itself a Party to the Rotterdam Convention. Therefore, you 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 United Kingdom for further information.

In Northern Ireland the PIC Regulation continues to apply. Please refer to Q&A 1711 for further details.

My United Kingdom-based company exports to EU Member States chemicals that are subject to the EU’s PIC Regulation but not listed in Annex III to the Rotterdam Convention). Do we still have to notify our exports to the EU?

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.
The United Kingdom is longer part of the single customs area of the EU, hence your United Kingdom based company has no obligations in relation to the PIC Regulation. You are, however, advised to inform yourself of any obligations that may derive from national United Kingdom legislation.

In Northern Ireland the PIC Regulation continues to apply. Please refer to Q&A 1711 for further details.

Does my United Kingdom-based company continue having access to ePIC? If not, are we able to export our data from the system?

United Kingdom-based companies no longer have access to ePIC. Currently, ePIC does not include any functionality allowing data to be exported from the system.

In Northern Ireland the PIC Regulation continues to apply, and thus companies located in Northern Ireland continue to have access to ePIC. However, companies established in Northern Ireland with an existing account with the former “United Kingdom” entity, are required to create a new account associated to the new entity UK(NI). Transfer of data between accounts is not possible. Since 1 January 2021 the data contained in the previous account is no longer accessible.

Can my United Kingdom-based company access ePIC for the purpose of consulting information on my exports and related data from previous years?

The 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. Companies based in the United Kingdom (as well as the former United Kingdom Designated National Authority - DNA) no longer have access to ePIC or to the data it contains.

In Northern Ireland the PIC Regulation continues to apply. Please refer to Q&A 1711 for further details.

Does the PIC data provided by my United Kingdom-based company remain public after the end of the transition period?

Yes, the data continues to be available on the ECHA website.

Does my EU-based company need to notify an export of a chemical subject to the PIC Regulation to the United Kingdom?

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. Such exports to the United Kingdom need to be notified.

In Northern Ireland the PIC Regulation continues to apply. Therefore, shipments from the EU to Northern Ireland and vice-versa are not subject to PIC obligations. Please refer to Q&A 1711 and QA 1568 for further details.

Does my EU-based company need to notify an export of a chemical listed in Annex III to the Rotterdam Convention (and therefore also to the PIC Regulation) to the United Kingdom?

The United Kingdom 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 United Kingdom, you must check in the latest PIC Circular whether the United Kingdom 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 Northern Ireland the PIC Regulation continues to apply. Therefore, shipments from the EU to Northern Ireland and vice-versa are not subject to PIC obligations. Please refer to Q&A 1711 for further details.

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.

As a Northern Ireland-based company, do we need to report on our yearly exports/imports of PIC chemical?

In Northern Ireland the PIC Regulation continues to apply. If your company is based in Northern Ireland, your obligations to report exports and imports will continue. Please refer to Q&A 1711 for further details.

Regarding exports and imports made to or from non-EU countries in 2020, you will have to report those during the first quarter of 2021. However, exports and imports to/from United Kingdom which took place in 2020, do not have to be reported. Exports and imports to/from United Kingdom in 2021 and the following years, will have to be reported as from the first quarter of 2022.

REACH

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

My company is a United Kingdom-based importer, which has imported a substance under a valid registration prior to the end of the transition period. Can an importer in the EU/EEA import it into the EU/EEA after that date, and rely on the exemption in Article 2(7)(c) REACH?

No, the re-import exemption cannot be relied on in this situation, because the conditions for this exemption are not fulfilled. The exemption requires the substance to be registered under REACH, exported from the EU by an actor in the supply chain and re-imported into the EU by the same or another actor in the same supply chain, who shows that the re-imported substance is the same as the previously exported substance and that it has been provided with the information required for the safe use of that exported substance.

In the case described in the question, no one has exported the substance from the EU. Therefore, it also cannot be re-imported into the EU by the same or another actor in the same supply chain.

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

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

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

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

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

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

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

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

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

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

Categories Display