Since the UK has decided to exit from the EEA, starting from January 1st 2021, European companies will need to comply to UK-REACH to keep marketing substances in UK, even if the substances are already registered in EEA according to REACH.
The competent authority is UK Health and Safety Executive (HSE). UK-REACH will have the same rules of EU-REACH: the registrations will be divided into tonnage bands as in EU-REACH (registration starting for substances produced/imported > 1 t/y) and the data that need to be provided will be the same or very similar, as well as the basic principles (one substance/one registration, no data/no market) and performing in vivo tests on animals as a last resort. Furthermore, the figures of the “Lead Registrant” and the “Co-Registrant” will still exist. Before a new substance can be registered, an “Inquiry” must be sent to the HSE, as in the EU-REACH. The “Chemical Safety Report” must be provided for registrations in the tonnage band ≥ 10 t/y and if the substance is classified, the exposure scenarios must also be provided.
Depending on the role that the company covers in EU-REACH and UK-REACH, various scenarios can be identified, one of the most common is: an EU / EEA based manufacturer of a substance produced in EU / EEA and already registered in EU-REACH, sells in both EU and UK. This company up to now fulfilled all its obligations, with the EU-REACH registration, which continues to be valid for the European market. From 1 January 2021, the downstream user based in the UK becomes an importer and, therefore, must ensure that the substance is covered by the UK-REACH registration. The downstream user based in the UK must send the HSE a “Downstream User Import Notification” (DUIN) by 27 October 2021 to communicate their intention to continue importing the substance.
Alternatively, the UK based downstream user can encourage his EU / EEA based supplier to appoint a single representative, called OR (Only Representative), to register the substance in the UK on behalf of the supplier.
Once the OR has been appointed, the EU / EEA based supplier must send a letter to all UK customers to advise them that they will register the substance via the OR and that, therefore, they will not have to comply with their obligations under the UK REACH for the registration of the substance.
After the DUIN, a full registration is needed. The deadlines are listed below (quantities referred to the ones exported to UK, excluding the quantities exported to Northern Ireland):
|Quantities||Eccezione a seconda delle proprietà tossiche||Scadenza per Registrazione|
|≥ 1000 t/y||Substances CMR (carcinogenic, mutagenic or toxic to reproduction) ≥ 1 t/a||October 27th 2023|
|Toxic substances in water (very toxic, acute or chronic) ≥ 100 t/a|
|Substances in“Candidate List” (on December 31th 2020)|
|≥ 100 t/y||Substances in“Candidate List” (on October 27th 2023)||October 27th 2025|
It is important to highlight that all of above applies if the substance of interest has already been registered in EU-REACH. Before placing a new manufactured / imported substance with tonnage ≥ 1 t / y not already registered in EU-REACH on the UK market, it must be registered in UK-REACH.
At the end of the “Transition Period”, thanks to the “Northern Ireland Protocol”, Northern Ireland will continue to follow EU-REACH; so the term “UK” does not consider Northern Ireland.
As for EU-REACH, also in UK-REACH the isolated intermediates ≥ 1 t / y must be registered and also in this case there is a distinction between:
– isolated intermediates on site, for which the Stictly Controlled Consitions (SCC) must be applied
– transported isolated intermediates, for which the SCCs must be applied along the entire supply chain.
Also in UK-REACH, as in EU-REACH, substances produced or imported for PPORD research and development purposes are exempt from UK-REACH registration if the research and development activities take place in England, Scotland and Wales. If you export EU-REACH PPORD-exempt substances to the UK, you must ensure that the importer provides the HSE with information regarding the PPORD exemption.
UK will have its own CLP regulation which will be very similar to EU-CLP, with various obligations for manufacturers, importers, downstream users and distributors as regards the classification, labeling and packaging of chemicals and mixtures. The UK, like the EU, will also adopt UN GHS (United Nations Glabally Harmonized System). As for EU-CLP, UK-CLP notifications must be sent to the HSE.
Other regulatory regulations
As of 01.01.2021, regulatory frameworks will be put in place in the UK also for the biocides and PIC regulation. Registrations of active substances and biocidal products must be sent to the HSE. Substances that fall under the PIC must be notified to the HSE if exported from Great Britain; substances to be exported to Great Britain must be notified to ECHA before export in accordance with the EU PIC Regulation (EU no. 649/2012).
Further information can be found here:
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