UK Regulatory News

' In an email exchange with GPC dated April 2nd, 2021, HSE provided a much-welcomed clarification regarding the requirements that non-GB manufacturers must meet in order to qualify for DUIN. ...

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In an email exchange with GPC dated April 2nd, 2021, HSE provided a much-welcomed clarification regarding the requirements that non-GB manufacturers must meet in order to qualify for DUIN.

In their email, HSE stated that DUIN is only available for companies that imported/used EU REACH-registered substances into Great Britain (GB) in the two years before the end of the Transition Period (1st January 2019 - 31st December 2020). Alternatively, a non-GB manufacturer may submit a DUIN via a GB-based Only Representative (OR) in order to maintain access to the British market. In this case too the availability of DUIN is conditioned upon the substance being placed on the British market in the two years before the end of the Transition Period.

On the opposite, if a substance is imported into Great Britain after the end of the Transition Period as part of a new supply chain, then the criteria to submit a DUIN are not met. The importer will therefore be required to carry out the full registration of the imported substance, unless the non-GB based manufacturer of that substance appoints a GB-based OR to fulfill that obligation on behalf of the importer.

Last update: 2021-04-05

Grandfathering is a transitional arrangement under UK REACH that allows GB-based manufacturers and importers of a substance registered under EU REACH to continue ...

Grandfathering is a transitional arrangement under UK REACH that allows GB-based manufacturers and importers of a substance registered under EU REACH to continue to import or manufacture that substance in Great Britain past the end of the Brexit transition period. Provided that they submit some initial information on that substance, manufacturers and importers that qualify for grandfathering may then postpone the registration of their substance by 2, 4 or 6 years depending on its hazard profile and tonnage band.  

Companies qualify for grandfathering if: 

• They are a GB-based manufacturers or importers; and  

• They hold an EU REACH registration, or held an EU REACH registration and transferred it to an EU-based legal entity, at any point between 29th March 2017 and 31st December 2020 

Grandfathering allows GB-based legal entities to transfer their EU REACH registration into UK REACH, with no additional registration fee. To do so, they need to comply with the following requirements. 

• Before 31st April 2021: 

• open an account on Comply with UK REACH;  

• submit initial data (evidence of their existing EU REACH registration, identity of the registrant, identity of the substance etc.); and 

• submit any relevant information from their EU REACH registration dossier. 

• Before 28th October 2023/2025/2027 (depending on the tonnage band and hazard profile of their substance, as displayed in the table below): 

• submit registration data, as set out in art. 10 of UK REACH and EU REACH. 

If a company fails to submit the initial information before 31st April 2021, it will not benefit from the deadline extension of 2, 4 or 6 years. Instead, it will need to complete the full registration of that substance before placing it on the GB market, regardless of whether the substance is already registered under EU REACH. 

update: 2021-02-28

Northern Island (NI) is part of EU regulatory systems for chemicals to ensure frictionless movement of goods within the island of Ireland, whilst remaining within the UK customs territory. NI busi...

Northern Island (NI) is part of EU regulatory systems for chemicals to ensure frictionless movement of goods within the island of Ireland, whilst remaining within the UK customs territory. NI businesses will retain their current EU REACH status and obligations allowing them to maintain current supply chains to the EU/EEA.

Northern Ireland notifications is a light-touch notification system and is applicable to Great Britain-based importers, or downstream users, of qualifying Northern Ireland goods (QNIGs) registered under EU REACH by a company which is based in Northern Ireland and wants to maintain access to the Great Britain market (England, Scotland and Wales).

Great Britain-based importers, who:

1. were importing before 1 January 2021, must submit information on the substances they import into GB from NI in quantities of a tonne or more. They must do this within 300 days of the end of the transition period
2. intend to commence importing after 31 December 2020 must submit the required information before commencing importing

The notification and information can be submitted by either the GB importer or the NI supplier.

Businesses based in Northern Ireland and wishing to do this should first inform their GB customer of their intentions.

Update: 2021-02-27

Following the end of the Brexit transition period on 1st January 2021, the UK REACH Regulation is now in force. UK REACH, which has been described as mirroring its EU counterpart, applies instead ...

Following the end of the Brexit transition period on 1st January 2021, the UK REACH Regulation is now in force. UK REACH, which has been described as mirroring its EU counterpart, applies instead of EU REACH in respect of Great Britain (England, Wales and Scotland.) The main consequence is that EU REACH registrations issued by ECHA will no longer be valid in the UK. In order to be placed on the GB market, a substance will thus need to be registered under UK REACH.

With the aim of assisting the many exporters likely to be affected by the repeal of EU REACH in the Great Britain, UK REACH provides for comprehensive transitional arrangements. Such arrangements concern both EU and non-EU based exporters dealing with substances already registered under EU REACH and wishing to maintain access to the UK.

UK REACH may apply to you if your business falls under one of these two situations: 

You are a non-GB-based manufacturer exporting chemical substances registered under EU REACH to the UK, and who wishes to maintain access to the GB market. You can: 

• Let your GB-based downstream user/distributor/formulator file a Downstream User Import Notification (DUIN) by 27 October 2021, followed by full registration of your substance within 2, 4 or 6 years depending on tonnage band and hazard profile, or
• Appoint a GB-based OR to carry out the DUIN followed by full registration of the substance under UK REACH.

You are a non-GB-based manufacturer who wishes to export chemical substances that are not registered under EU REACH to the UK. You must:

• Complete full registration of your substance immediately. You can appoint a GB-based OR to carry out that requirement on your behalf.

Global Product Compliance has a GB-based OR facility, ‘GPC UK’, ready to assist its existing and future clients in complying with UK REACH.

Update: 2021-01-22

  According to a statement released by ECHA on January 11, 80% of all EU-REACH registrations held in the UK have been or are in the process of being transferred back into the EU. The re...

According to a statement released by ECHA on January 11, 80% of all EU-REACH registrations held in the UK have been or are in the process of being transferred back into the EU.

The remaining 20%, for which the transfer process had not been initiated before 31st December 2020, have now become invalid. As a consequence, ECHA warns, holders of non-transferred registrations are not allowed to place the corresponding substances on the EU market anymore.

As to the registrations that are currently being transferred, ECHA calls upon all actors concerned both in the UK and the EU to complete the transfer process by 31st March 2021. All registrations that have not been transferred will become invalid past this date.

Source: ECHA

Update: 2021-01-12

  The UK will exit the transition period on December 31, 2020.  From 2021, the EU REACH Regulation will be brought into UK law under the European Union (Withdrawal) Act 2018 and this ...

The UK will exit the transition period on December 31, 2020.  From 2021, the EU REACH Regulation will be brought into UK law under the European Union (Withdrawal) Act 2018 and this chemical regulation is also known as UK REACH. REACH, and related legislation, will be replicated in the UK with the necessary changes to make it functional from 1st January 2021. The key principles of the EU REACH Regulation will be retained in UK REACH.

The Health and Safety Executive (HSE) will play a key role in the UK's chemicals regulatory process together with the Department for Environment, Food and Rural Affairs (Defra) and the Environment Agency (EA) to ensure the effective and safe management of chemicals to safeguard human health and the environment.

The Department for Environment, Food and Rural Affairs (Defra), early in September 2020, had announced tonnage band specific, staggered submission deadlines that will apply for the full submission of data. The full registration dossiers would hence need to be submitted within 2, 4 or 6 years, starting from October 28, 2021.

EU/EEA/non-UK manufacturers exporting to Great Britain may choose to appoint a GB-based OR to fulfil their UK REACH obligations. Substance registration via OR in this case will be considered as a new substance registration.  This would be classed as a new substance registration: full registration duties would apply, and the appropriate registration fee would be charged. If the EU/EEA/non-UK manufacturer’s GB-based OR registers within the relevant deadline, the GB importers would be treated as a downstream user under UK REACH, and would therefore not need to become registrants themselves. If the OR submits a notification of import or registers within 300 days of the end of the Transition Period, this will relieve their GB customer of the duty to notify the Health & Safety Executive (HSE) within 300 days. 

GB based downstream users or distributors may make use of the notification provision in the first instance, and consider further steps depending on their suppliers’ intentions in relation to the GB market. GB downstream users and distributors sourcing from the EU/EEA are advised to liaise with their suppliers, to ensure that a notification is completed by one or other party within 300 days of the end of the Transition Period. These measures apply only to existing UK downstream users or distributors under EU REACH who were, at any time in the 2-year period before 1st January 2021, already a downstream user or distributor under EU REACH established in the UK in relation to a substance.

According to the officials, an Only Representative (OR) will have to be a natural person or legal entity established physically in the UK and equipped with sufficient knowledge in the practical handling of the substances and information related to them; Appointed by a mutual agreement with a manufacturer, formulator or article producer, established outside the UK and responsible for complying with the legal requirements for importers under UK REACH.

Global Product Compliance (Europe) AB has already set up a UK based OR entity ‘GPC UK’, to support its existing and new potential clients, to be able to comply with the challenges posed because of Brexit on substance exports to the UK. 

For more information or queries, please write to us at compliance@uk.gpcregulatory.com

With Brexit being implemented from 31st January 2020, the UK has formally left the EU with a withdrawal deal and it is currently into an 11-month transition period. The UK is no longer a mem...

With Brexit being implemented from 31st January 2020, the UK has formally left the EU with a withdrawal deal and it is currently into an 11-month transition period. The UK is no longer a member state of the EU and until the end of the transition period market access would continue the same terms as before. During this transition period, the UK will continue to remain strongly committed to the effective and safe management of chemicals. The UK will exit the transition period on the already set date 31st December 2020. 

The formal, ninth and final round of talks on a post-Brexit free trade treaty between the EU and the UK which had begun on September 29 were called off early in this month due to lack of progress. The UK and Europe are however set to resume the trade talks later this week. 

At the end of the Transition Period, the EU REACH Regulation will be brought into UK law under the European Union (Withdrawal) Act 2018 and will be known as UK REACH regulation. REACH, and related legislation, will be replicated in the UK with the necessary changes to make it functional from 1st January 2021. The key principles of the EU REACH Regulation will be retained in UK REACH.  

The Health and Safety Executive (HSE) will play a key role in the UK's chemicals regulatory process together with the Department for Environment, Food and Rural Affairs (Defra) and the Environment Agency (EA) to ensure the effective and safe management of chemicals to safeguard human health and the environment. 

The Department for Environment, Food and Rural Affairs (Defra), early in September 2020, had announced tonnage band specific, staggered submission deadlines that will apply for the full submission of data. The full registration dossiers would hence need to be submitted within 2, 4 or 6 years, starting from October 28, 2021.  

In a private and very recent (October 2020) communication of Global Product Compliance (Europe) AB with the Health and Safety Executive (HSE), they have indicated that, the chemicals legislation that will apply in the UK after the end of the transition period (31st December 2020) is subject to ongoing EU-UK trade negotiations, and the precise details are still being decided. Having said that, the legislation is likely to be very similar to that which was drawn up for a “no deal” scenario. The HSE authorities have indicated that the future legislation is likely to be similar to that which was drawn up for a “no deal” scenario (UK REACH) and as specified in the original ‘no-deal’ Statutory Instrument for UK REACH. The SI will be amended to account for any changes, including the date in which it comes into force any changes to REACH that can be retained as EU law. The notification/registration processes for the UK and non-UK based companies under UK REACH will be as per the most recent government guidance as published on 1st September 2020. The authorities have indicated that, UK REACH will apply to UK companies and non-UK companies will not have any duties under UK REACH. However, a non-UK manufacturer, formulator or producer of articles will have to appoint a UK-based only representative (OR) to fulfil the obligations of the UK importers. 

Global Product Compliance (Europe) AB has already set up a UK based OR entity ‘GPC UK’, to support its existing and new potential clients, to be able to comply with the challenges posed because of Brexit on substance exports to the UK.  

For more information or queries, please write to us at compliance@uk.gpcregulatory.com 

GPC invites you to our webinar on UK REACH regulations and its impacts for manufacturers of cosmetic products and raw materials on Nov. 6th at 14:00 (CEST)/18:30 (IST). Register here.