In this article Dr. Iain MacKinnon, Managing Director of Dr. Knoell Consult Ltd, the UK-based affiliate of the knoell group of companies, follows up on a question posed in a previous article written in early 2020: ““Will there/won’t there be UK REACH come January 2021?”” – to which the answer is of course “Yes!” – and considers the current status of chemicals regulations in the United Kingdom.
“On 1st January 2021 a raft of UK chemicals regulations, UK REACH among them, came into force, just not in the whole UK! As a result of the Northern Ireland Protocol the new UK regulations only apply in Great Britain (GB); Northern Ireland (NI) remains under EU regulations such as REACH. This was not foreseen by us in early 2020 and is a twist that companies doing business in NI should pay heed to. For companies manufacturing in NI but shipping to customers in GB, “light touch” arrangements are in place to allow compliance with UK REACH.
“At knoell we are working with many companies affected by UK REACH and are building up some familiarity with it. Fortunately, UK REACH is so similar to REACH that we can apply much of our experience with the latter to the former. However, there are some differences not least the transitional arrangements which, under some circumstances, permit registration to be delayed by up to 6 years.
“GB-domiciled companies had until 30th April 2021 to grandfather their REACH registrations into UK REACH. Recently we have heard that “grandfathering was re-opened” as some companies missed the deadline and may be re-opened again if other companies approach the Health & Safety Executive (HSE) for similar reasons. This is a broadly welcome step but could impact how Substance Groups nominate Lead Registrants or select data for registration.
“We are currently focused on preparation and submission of Downstream User Import Notifications (DUINs) and inquiry dossiers. This is the route to registration for GB-based importers of substances made outside GB. Similar to REACH, UK REACH allows a non-GB manufacturer to appoint an Only Representative (OR) based in GB, such as Dr. Knoell Consult Ltd., to take care of registration in place of the importers. ORs also follow the “DUIN + inquiry dossier” route. It can’t be stated often enough but there is a deadline (assumed to be fixed) for submission of DUINs: 27th October 2021. Many importers will not have full details of purchased formulated products but thankfully need only submit information “to the extent that it is available”. However, all imported substances must be registered. Submitting a DUIN is a useful insurance policy to buy time to determine suppliers’ registration intentions.
“Recently we have begun to see increasing levels of enquiries relating to other chemicals legislations such as the BPR (for Biocides), CLP (mainly in relation to Safety Data Sheets(SDS)), or in relation to Plant Protection Products. Again, for now the UK regulations are very similar to their EU equivalents as they existed on 31st December 2020.
“Currently an SDS in EU format is valid in GB. However, the relevant EU regulation changed on 1st January 2021 which is after the UK left the EU so this change does not apply in GB. GB SDS are, therefore, still in the format of a “2020 vintage” EU SDS. This format is only valid in the EU until 2022. Without a change in the UK, SDS format for EU and GB will start to diverge.
“For biocides, it may be necessary to resubmit information to the HSE to obtain or maintain access to the GB market. For example, there is now a GB version of the Article 95 list which includes companies on the EU list. They will remain on the GB List for at least 2 years but to extend this, relevant information must be resubmitted to the HSE by the end of 2022 and you need to be located in the UK so may need a representative.
“For Plant Protection Products, relevant EU legislation – for example Regulation (EC) 1107/2009 – has been copied across to UK law and all existing approvals or authorisations remain valid in GB. Active substance approvals which had been due to expire before December 2023 have had their deadlines extended for 3 years.
“In summary, “having a foot in both camps” in terms of physical location and also familiarity with EU and UK regulations and their practical application is a real strength and allows companies like knoell to guide clients through the post-Brexit regulatory landscape with some confidence.”