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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.
According to Article 3 of the BPR, an authorisation holder must be established within in the European Union. By virtue of the EEA Agreement as well as the Mutual Recognition Agreement with Switzerland, an authorisation holder can also be established in Iceland, Liechtenstein, Norway or Switzerland. You will therefore need to transfer the authorisation to a new holder established within an EU-27 Member State or one of the afore-mentioned countries before the UK withdrawal. You can trigger the amendment of your existing authorisation by means of an administrative change requiring prior notification before implementation (see point 3 in section 1 of Title I in the Annex to Commission Implementing Regulation (EU) No 354/2013 on changes of biocidal products).
The UK withdrawal will not have any effect to the validity of the approval of these active substances. The approval of these active substances is a decision taken at EU level.
The European Commission and our Agency, in cooperation with the EU-27 Member States, will prepare the groundwork for a handover of such pending cases.
According to Article 95(1) and (2) of the BPR, substance or product suppliers listed in the Article 95 list must be established within the European Union. Therefore, you will need to appoint a representative established within the Union (or the EEA countries or Switzerland) and communicate this to ECHA (by submitting a “request for correction”) in due time, so that the information on the list is updated before the date of the UK withdrawal from the EU. Otherwise, the UK supplier will be removed from the Article 95 list, and biocidal products from this source would no longer be allowed to be made available on the EU market.
According to Article 95(1) and (2) of the BPR, substance or product suppliers listed in the Article 95 list must be established within the European Union. Therefore, you will need to appoint a new representative established within the Union (or EEA countries or Switzerland) and communicate this to ECHA (by means of a “request for correction”) in due time, so that the information on the list is updated before the date of the UK withdrawal from the EU.
Yes, but the application will have to be submitted in an EU-27 Member State (or an EEA country or Switzerland). Contrary to the case of a product authorisation, applicants for the approval of an active substance or Annex I inclusion are not "holders"/"owners" of an approval and do not need to be established in the EU. Third country entities can undertake such submissions.
The data sharing mechanism under Articles 62 and 63 of the BPR will still be available to such companies, for the purposes of the BPR; for example, where a UK-based company intends to submit an application for active substance approval – and it requires vertebrate data for its application.
In this connection, it should be stressed that it is a legal obligation for companies to make an inquiry to the Agency in the case of vertebrate data (see Article 62(2)(a) of the BPR).
Yes. Companies based in third countries have access to R4PB 3 for certain processes, e.g., active substance approval, notifications and submissions. Upon its withdrawal, the UK will become such a “third country”.
Yes. Data protection applies to all information submitted for the purposes of the BPR or its predecessor, the Biocidal Products Directive.
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 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).
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).
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.
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.
No. This will no longer be possible.
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.
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.
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.
Yes, you will continue to have access, as non-EU companies have access to R4BP 3. UK-based companies will be able to perform the same actions allowed for non-EU companies (e.g., submission for Article 95 listings or active substance approval submissions).
As from the date of the UK’s withdrawal, your company will solely be subject to the laws applying in the United Kingdom. Thus, you will no longer need to comply with the CLP Regulation. However, its provisions may continue to remain valid within the UK on the basis of the Repeal Bill, which will – at least temporarily – convert existing EU law directly into the UK legal system.
Should your company be exporting your product to the EU-27, you will need to classify and label your product according to the provisions of the CLP Regulation. You will also need to keep yourself informed of any Adaptation to Technical Progress (ATP) by which the European Commission will be updating specific classification and labelling obligations.
As from the date of the UK’s withdrawal from the EU, you will no longer be subject to the provisions of the CLP Regulation.
As from the date of the UK’s withdrawal from the EU, you will no longer be subject to the provisions of the CLP Regulation and thus will no longer have such an obligation.
No, you will not. If you export substances into the EU, your EU-based importer will instead have the obligation to submit the C&L notifications to ECHA. This applies to substances exported as such or in mixtures above the concentration limits triggering classification. Furthermore, the packaging and labelling of any mixture that you export to the EU will need to comply with the provisions of the CLP Regulation.
The information will remain available under the conditions of the legal notice that ECHA has published along with the inventory. You can, however, update or remove your C&L notification using your REACH-IT account.
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.
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.
Depending on the timing and the terms of the UK withdrawal, the continuation and outcome of the harmonised classification procedure may vary.
If your business of putting chemical substances, biocidal products or active substances on the market is limited to the territory of the United Kingdom alone, as from the date of the United Kingdom’s withdrawal, your activity will no longer be subject to the provisions of the EU chemicals legislation. With regard to obligations arising from the CLP, BPR, PIC, and REACH Regulations, your legal obligations towards ECHA as the EU’s respective regulatory Agency will also cease. Instead, it will be the UK legislation that applies to you.
You will therefore need to follow the legislative developments in the UK. You are also advised to follow the UK withdrawal negotiations with the EU which may determine your future obligations.
If your business is in any way part of a supply chain that links you to businesses located within the 27 EU Member States remaining after the UK’s withdrawal, you will face some fundamental changes. You will find more detailed advice under the respective headings of these Q&A pages.
Yes. With its withdrawal from the EU, the United Kingdom will become a so-called “third country”. The ECHA Helpdesk regularly replies to enquiries from companies based outside the EU/EEA. After the UK withdrawal, UK-based companies should address ECHA via the dedicated contact form.
As from the date of withdrawal, the UK will no longer have the obligation to maintain a national helpdesk to provide advice and assistance on matters governed by the EU’s CLP, BPR or REACH Regulations. You are advised to check with the UK authorities if they will nonetheless provide such advice in practice. You may also wish to address your industry association in the UK
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.
ECHA decisions concerning UK-based companies will only apply until the date on which the UK withdrawal takes effect and the United Kingdom ceases to be an EU Member State.
If you, as a UK-based company and an addressee of an ECHA decision, decide to challenge that decision or have already challenged it before the Board of Appeal, this may mean that the contested ECHA decision will then cease to have legal effect. In this case, unless the appellant provides evidence as to the existence of a material interest in ECHA’s Board of Appeal continuing to handle its appeal, the appeal proceedings may be discontinued, as there would be no need for the Board of Appeal to rule on such an appeal.
The Q&As on this website solely provide advice on the impact of the UK withdrawal in relation to the chemicals legislation that ECHA manages. You will need to find information on its other effects on supply chains across the external frontier of the EU (e.g., customs, tariffs and quotas, rules of origin, standardisation, rules on transport from outside the EU, etc.) from other sources, such as the European Commission or your industry association. Such information is, for instance, contained in this “Notice to Stakeholders” of 10 January 2018 on the “Withdrawal of the United Kingdom and EU Rules in the Field of Industrial Products”, published on the webpages of the European Commission
As the UK will no longer be a Member State of the EU, the PIC Regulation will no longer apply to you. It will be in the hands of the UK legislator to establish rules for exports by companies based in the UK. As the UK is a Party to the Rotterdam Convention on the Prior Informed Consent procedure, the UK will maintain a Designated National Authority (DNA) that will implement PIC at a global level. We suggest that you contact the UK DNA to inform yourself on any national procedures in place regulating your export.
After the UK’s withdrawal, as a UK-based exporter, you will no longer have any obligations under the PIC Regulation. Consequently, ECHA will disable any export notification submitted by any UK-based company so that it can no longer be used by those companies for exporting in 2019 and beyond.
As the UK withdrawal will take effect on 30 March 2019, the PIC Regulation will apply in the United Kingdom until that date. Article 10 of regulation obliges exporters to inform, during the first quarter of each year, the designated national authority of their Member State regarding the quantity of the chemical, as a substance and as contained in mixtures or in articles, shipped to each Party or other country during the preceding year. Thus, you will need to report on your exports/imports of PIC chemicals which took place in 2018.. You will have no obligations for reporting data on exports/imports after 2019. However, we recommend that you check with the relevant national authority in the UK to verify whether you will have reporting obligations under the national UK legislation.
As a UK-based company, you will no longer have access to ePIC and do not need to notify your exports in this way. However, in this case, even though you hold the contract for this export, in accordance with Article 3(18)(b) of the PIC Regulation, the EU-based branch of your company will take on the role of the exporter. They should therefore contact their DNA within the EU (contact details available here: https://echa.europa.eu/information-on-chemicals/pic/designated-national-authority) in case they are not already aware of their obligations under the PIC Regulation.
The UK is itself a Party to the Rotterdam Convention. Therefore, you will still have obligations when exporting chemicals that are included in Annex III to the Convention. If you are exporting to an EU Member State, you must first check in the latest PIC Circular whether the EU has provided an import response. In the absence of a response, you should contact the PIC DNA in the UK for further information.
Only exporters based in the EU have a legal obligation to notify exports of the chemicals listed in Annex I part 1 and 2 of the EU PIC Regulation. As the UK will no longer be a Member State of the EU, you will no longer have any obligations in relation to the PIC Regulation. You are, however, advised to inform yourself of any obligations that may derive from national UK legislation.
After the UK withdrawal, UK-based companies will no longer have access to ePIC. Currently, ePIC does not include any functionality allowing data to be exported from the system.
ePIC is the IT tool that is provided for use by relevant stakeholders within the EU for the purpose of administering the implementation of the PIC Regulation. After the UK withdrawal, companies based in the UK (as well as the former UK Designated National Authority - DNA) will no longer have access to ePIC or to the data it contains.
Yes, the data will continue to be available on the ECHA website.
Yes. The EU PIC Regulation places obligations on companies based in the EU who wish to export chemicals listed in Annex I to non-EU countries. As the UK will no longer be a Member State of the EU, any such exports will need to be notified.
The UK is itself a Party to the Rotterdam Convention. Therefore, if you are planning to export a chemical listed in Annex III to the Rotterdam Convention to the UK, you must check in the latest PIC Circular whether the UK has provided an import response. In case there is a positive response, it will be sufficient to submit a special RIN request (please see the factsheet); in the absence of a response, you must submit an export notification, and an explicit consent from the authorities in the UK will be required in order for the export to take place.
As Gibraltar is currently (i.e., even prior to the UK withdrawal) not a part of the EU customs territory, you will simply need to continue notifying your exports of chemicals subject to the PIC Regulation also after the UK withdrawal.
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).
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).
Until the date of the withdrawal of the UK on 30 March 2019, the UK remains an EU Member State in which the provisions of the REACH Regulation fully apply. You will therefore have to register your substance for the 2018 REACH registration deadline. Moreover, your registration obligations will continue until the date of the UK withdrawal. Even beyond that date, it will be advisable for you to follow the legislative development in the UK with regard to domestic registration obligations.
Article 3(7) of the REACH Regulation establishes that a registrant must be a manufacturer or importer of a substance or a producer or importer of an article. Article 3 (4), (9) and (11) stipulates that registrants must be established in the EU. After 30 March 2019, the UK will no longer be a Member State of the EU. Hence, any UK-based registrant can no longer be a registrant. For the purpose of the EU’s REACH Regulation, any registration by such a registrant will therefore be regarded as non-existent, as your company will, after the UK withdrawal, be based in a “third country” outside the EU/EEA. Consequently, your EU-27(EEA) customers will need to register the respective substance themselves. Alternatively, in order to continue supplying your EU-27-based customers on the basis of your own registration, as a manufacturer you will need to either relocate to the EU-27 or to appoint an Only Representative within the EU-27/EEA. As a UK-based importer from a non-EU/EEA country, you will have the option to legally establish yourself as an importer based within the EU-27. In case your company has registered as an Only Representative, the non-EU/EEA manufacturer will need to appoint an EU-27-based Only Representative in place of your company.
The REACH Regulation is very clear in this regard. According to its Article 8, Only Representatives shall be legally established within the EU. After the UK withdrawal, this will mean the territory of the EU-27/EEA. The manufacturer having appointed you as Only Representative will need to involve an Only Representative based in one of the EU-27 Member States or the three EEA Member States, and you will need to change the Only Representative in REACH-IT.
Under the provisions of the REACH Fee Regulation, our Agency will indeed charge the foreseen fee. The circumstance of the UK withdrawal from the EU does not provide a legal basis for waiving the charge of fees.
No. As the EU legislation will no longer apply to the UK after the withdrawal date, you will no longer be subject to the obligation of updating your dossier without undue delay.
Companies using the substance in the UK would need to hold or be covered by an Authorisation between the sunset date and the date of the UK withdrawal. Whenever the sunset dates of respective Annex XIV substances fall after the UK withdrawal date of 30 March 2019, you will not have to apply for a REACH Authorisation to use any such substance.
Note, however, that if an applicant has submitted its application prior to the Latest Application Date, they benefit from transitional arrangements (please see the Q&A 572, “why I should submit the application before the Latest Application Date” on ECHA’s other Q&A webpages). This may become important in the case that the REACH provisions on Authorisation continue to apply in the UK beyond the UK withdrawal, due to either domestic UK law or potential agreements between the EU and the UK.
For UK companies placing an Annex XIV substance on the EU-27/EEA market after the UK withdrawal, please see the Q&A 1428 on downstream users located in the EU-27/EEA relying on an Authorisation granted to a UK supplier, on these webpages.
No. As the EU legislation will no longer apply to the UK after the withdrawal date, you will no longer be subject to this obligation. Even before that date, we advise you to follow the legislative development in the UK with regard to domestic authorisation obligations, as you will need to adhere to applicable UK law in this respect. For REACH Authorisations covering a UK-based company’s downstream users located in the EU-27/EEA, please see the respective Q&A on these webpages.
No. As the EU legislation will no longer apply to the UK after the withdrawal date, you will no longer be subject to this obligation.
No. As the EU legislation will no longer apply to the UK after the withdrawal date, you will no longer be subject to this obligation.
No. As the EU legislation will no longer apply to the UK after the withdrawal date, you will no longer be subject to this obligation.
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.
After the date of the UK withdrawal, the registration by the UK-based company will be considered non-existent. To ensure that you can benefit from a functioning joint submission with a lead registrant, you should ensure that the lead registrant moves to the EU or does a legal entity change to become an EU-27-based Only Representative, or appoint a new lead registrant and transfer the lead registrant role before the date of the UK withdrawal. 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.
No. As the REACH Regulation will no longer apply to the UK upon the UK withdrawal from the EU, the REACH Authorisations 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 in the EU-27/EEA. If this is not the case, whilst you wish to continue to use the substance after the date of the UK withdrawal, you will need to apply for an Authorisation, yourself. We recommend that you contact your supplier, to ask them about their intentions.
As for UK-based Authorisation holders, there are two situations, in which they can transfer their Authorisation:
- UK-based manufacturers and formulators can transfer their Authorisation to an Only Representative based in the EU-27/EEA; and
- UK-based Only Representatives can transfer their Authorisation to an Only Representative based in EU-27/EEA. Please note however that UK-based importers cannot transfer their Authorisation to an Only Representative in EU-27/EEA.
Our Agency, in collaboration with the European Commission and Member State competent authorities, will review all pending substance evaluations in due time for appointing another Member State authority to take over the respective evaluation. The UK withdrawal is also being taken into consideration in the draft CoRAP update for the years 2018-2020 as well as subsequent updates.
You should only appoint an OR who has a sufficient background in the practical handling of substances and of the information related to them, as required by Article 8(2) of the REACH Regulation. As your representative, the OR will bear all responsibilities of importers under the Registration Title and other titles of the REACH Regulation. Among them, the OR shall keep available and up-to-date information on the quantities imported and customers sold to, as well as information on the supply of the latest update of the SDS. Please also remember to inform the importers within the same supply chain of the OR appointment. ECHA’s webpages provide more detailed information on the role of Only Representatives
No. Every registrant company is responsible for its registrations and the substances that are covered by these registrations. Therefore, responsible staff and the relevant documentation must be available for inspection at the premises of every registrant. Only Representatives must live up to the requirements in Article 8(2) REACH. A mere address or letterbox is not sufficient and may lead to legal consequences being taken by enforcement authorities or ECHA. The company that you set up must comply with all local regulations and have legal personality at its place of establishment. Your company will need to notify this change in REACH-IT immediately ahead of the UK withdrawal. ECHA will clarify the practical steps that you will need to take, closer to this date. We also recommend that you consult ECHA’s Practical Guide No. 8.
Such a transfer of registration will become acceptable for UK-based manufacturers at the time of the UK withdrawal. According to Article 8 of the REACH Regulation, only a natural or legal person established outside the EU may by mutual agreement appoint a natural or legal person established within the EU to fulfil, as Only Representative, the obligations that the REACH Regulation imposes on importers. As long as the UK is a Member State of the EU, your company therefore will not qualify for performing such a transfer. Consequently, we recommend that you, prior to the UK withdrawal from the EU, set up a contractual agreement to appoint an Only Representative, which contains a suspensive conditional clause stipulating that the appointment takes effect on the date when the UK withdrawal from the EU takes effect. The date and time of the UK withdrawal is foreseen to be 30 March 2019, 0000 hours CET (i.e., 29 March 2019, 2300 hours BST). Your company will need to notify this change in REACH-IT immediately ahead of the UK withdrawal. ECHA will clarify the practical steps that you will need to take, closer to this date.
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.
Yes, such a transfer will become possible at the time of the UK withdrawal.
However, as long as the UK is still a Member State of the EU and your company is therefore not located in a “third country”, your company will not qualify for performing such a transfer. Consequently, we recommend that prior to the UK withdrawal from the EU you set up a contractual agreement to appoint an Only Representative which contains a suspensive conditional clause stipulating that the appointment takes effect on the date when the UK withdrawal from the EU takes effect. The date and time of the UK withdrawal is foreseen to be 30 March 2019, 0000 hours CET (i.e., 29 March 2019, 2300 hours BST). The Only Representative will need to adhere to all the conditions of use determined by the Authorisation decision, including any specific duties foreseen in the decision for your company. ECHA will clarify the practical steps to take closer to this date.
The Authorisation holder/applicant needs to notify ECHA of the transfer. ECHA will forward the notification to the European Commission.