Brexit & REACH
On 23 June 2016, the majority of the United Kingdom (UK) voted to leave the EU and on 29 March 2017, Prime Minister Theresa May invoked Article 50 of the Treaty on European Union, the formal mechanism for leaving the EU. On November 2018 EU 27 leaders advocated the draft Brexit withdrawal agreement and approved the draft political declaration about future UK -EU relations. However, the UK Parliament may or may not support the withdrawal agreement settled between the UK and the EU Member States. If the UK Parliament decides not to back up the withdrawal agreement, this will mean that the UK is due to leave the EU on 29 March 2019, at 11:00 PM (UTC). It also may mean that there won’t be a two-years transition period to allow the EU and the UK to make a trade deal and thus all EU laws may stop applying to the UK immediately. On the other hand all of the options could be still on the table.
With this in mind, what are the implications of “no deal” for UK REACH registrants and how can they preserve their market access to the EU/EEA after 29 March 2019 but also after a potential “deal” is reached and a transitional period ends ( currently foreseen as the 31st of December 2020)?
Under this scenario, where the UK leaves the EU without a deal, UK-based companies that have registered their substances under REACH would need to take actions before an abrupt exit from the EU, if they want to preserve their access to EU and EEA market areas.
This would mean that before the UK becomes a “third country” outside the EU, and as a risk mitigation measure, UK registrants, specifically UK manufacturing companies and UK Only Representatives need to transfer their registrations to an EU/EEA based legal entity such as a subsidiary or to an Only Representative.
In addition, UK based importers may consider transferring their registration(s) to an EU-27/EEA-based legal entity, as long as it is the result of a legal entity change. The transferring of the registration(s) must take place ahead of the UK withdrawal from the EU and must be notified to ECHA without delay. Unfortunately, in the case of UK importer registrations, transferring of their registrations to an EU Only Representative is currently not possible.
Furthermore, UK downstream users that are currently importing chemicals from an EU/EEA country will have registration obligations after the 29th of March 2019 if they want to continue doing business in EU/EEA market areas.
CEFIC ( European Chemical Chemistry Council) advises that already now, companies should review their SIEF/Consortia agreements obligations in order to prepare for the future transfer of dossier rights to an EU subsidiary or to an Only Representative so they can take over the EU REACH requirement.
UK REACH Service
Purpose of the Service
The purpose of the service is to provide the non-UK Customer with UK REACH services according to the provisions of UK REACH Regulation. As the appointed Only Representative in the UK REACHLaw manages all related UK REACH regulatory requirements necessary for placing the Customer’s substances on the UK market.
The service is for Customers located outside the UK placing their chemical products on the UK Market.
The scope of the services provided below represents the general approach towards service delivery. Upon separate request the scope of the services may be adjusted depending on the specific service needs of the Customer.
UK REACH Co-Registration Service
REACHLaw provides Customer services for compliance with registration requirements under UK REACH. This includes the preparation of registration dossier in IUCLID format to HSE. REACHLaw will also manage the communications between the relevant consortium or lead registrant in order to obtain the required letters of access. Further, REACHLaw will verify substance identity, conduct the necessary negotiations to obtain the letter of access, communicate with other registrants, submit the registration in the required format, manage the necessary HSE payments and provide the Customer with a registration certificate once registration has been accepted and maintain the registration in accordance with the requirements of HSE.
UK REACH Lead Registration Service
REACHLaw’s UK REACH Lead Registration involves the preparation of technical lead registration in IUCLID format to HSE. We will also collect relavant substance specific information from both the Customer and relevant data holders, analyse the information, conduct relevant tests, prepare the Chemical Safety Report/Assessment including necessary Exposure Scenarios and submit the dossier to the HSE. In addition, REACHLaw will manage the data sharing, cost sharing and registration cooperation agreements. After a successful lead registration REACHLaw will provide to the Customer with proof of registration including the UK REACH registration number.
UK REACH Safety Data Sheets
REACHLaw will compile the CSR-aligned extended safety data sheets to comply with UK regulatory requirements. Exposure scenarions may need to be included in the SDS and will be prepared based on the exposure assessment.
EU REACH RIGHTS TRANSFER
Purpose of the Service
The purpose of the service is to provide the Customer all necessary regulatory support, irrespective of the outcome of the Article 50 TEU negotiations, as a risk mitigation measure to transfer the Customer’s REACH rights to Customer’s selected legal entity appointed as only representative to preserve Customer’s REACH rights intact in any eventuality upon the UK’s exit from the EU.
The service is for EU REACH registrants located in the UK placing their chemical products on the EU Single Market.
The scope of the services provided below represent the general approach towards service delivery. Upon separate request the scope of the services may be adjusted depending on the specific service needs of the Customer.
Transfer of UK manufacturer REACH registrations to an EU-27 legal entity as only representative
Purpose of the service: As the UK leaves the EU, manufacturers in the UK who are REACH registrants will undergo a status change from a manufacturer in a Member State to a manufacturer in a third country according to REACH regulation and ECHA guidance. To preserve REACH registrations intact it is necessary to transfer registrations to an EU-27 legal entity as an only representative. ECHA will provide the necessary special IT-support to achieve this transfer.
REACHLaw responsibilities: REACHLaw will provide resources and expertise for the transfer and will support the appointed only representative to preserving and maintaining the Customer’s EU REACH registrations and other related rights according to REACH regulation and ECHA requirements.
Customer responsibilities: The Customer provides REACHLaw with all necessary company and substance related information in the format as requested by REACHLaw.
Deliverables of the service: The initial transfer service is delivered when the registrations have been transferred to the appointed legal entity. REACHLaw will then continue to support the appointed Only Representative
EU REACH & UK REACH out-tasking service
Purpose of the service: As the UK leaves the EU, REACHLaw stands ready to take on the responsibility also for managing the Customer’s ongoing compliance activities in relation to UK REACH so that upon Customer’s regulatory status change the Customer’s rights are preserved intact as far as enabled the ECHA specially supported IT-functionality for this purpose.
REACHLaw responsibilities: REACHLaw provides resources and expertise for the transfer of REACH related rights and obligations and will accept responsibility for managing the Customer’s various REACH processes according to mutual agreement with Customer.
Customer responsibilities: The Customer provides REACHLaw with all necessary company, substance and process related information in the format as requested by REACHLaw.
Deliverables of the service: The service is delivered when the agreed tasks have been transferred under the management of REACHLaw
Brexit regulatory consulting service
Purpose of the service: Additional consulting can be ordered by Customer in writing (for example by email) and it is invoiced on a time and material basis. The price of consulting is as per price list. The minimum charge for consulting provided outside Finland is for one day (8 hours); if the actual time needed for consulting is less than 8 hours, travel time shall only be charged in so far and to the extent that consulting and travel time exceed 8 hours in total. Consulting services and related travel and accommodation costs will be invoiced on a monthly basis. Typical Brexit regulatory consulting services are meetings in person to resolve issues related to transfer of rights subject to status changes as a result of the UK’s exit from the EU.
REACHLaw responsibilities: REACHLaw provides the Brexit regulatory consulting services as per agreement with the Customer.
Customer responsibilities: Customer provides the necessary documentation as per agreement with REACHLaw.
Deliverables of the service: As per agreement.