With 2020 dominated by the global pandemic, Brexit seems to be creeping up on the UK relatively undercover. But behind the scenes, our exit from the EU raises big issues across the cosmetics and chemical sectors in terms of REACH compliance. We know there will be short term challenges as we adjust to new laws and logistical arrangements, but will there also be long-term opportunities? In the context of scientific advancement and animal welfare, the new UK REACH regulation presents both.
Impact of Brexit on REACH regulation
Let’s remind ourselves of the current position. The UK Government has confirmed that the EU REACH Regulation will be brought into UK law. REACH, and related legislation, will be replicated in the UK with the necessary changes to make it operable in context. The key principles of the EU REACH Regulation will be retained. The independent chemical regulatory framework that will operate in the UK from the 1 January 2021, will be known as UK REACH.
From 1 January 2021 the UK REACH and the EU REACH regulations will operate independently from each other. Companies that are supplying and purchasing substances, mixtures or articles to and from the EU/EEA and the UK will need to ensure that the relevant duties are met under both pieces of legislation.
In the event of no deal, the government states “the UK would not be legally committed to medium- or long-term regulatory alignment with the EEA.”
The challenges faced by being outside EU REACH
The challenges are serious, as DEFRA has acknowledged in its initial guidance for industry:
“If (EU REACH) data cannot be accessed, firms would need to submit new testing proposals and conduct new data tests, and may incur substantial costs for doing so” and “This may cause difficulties for firms to source and access existing chemical research, which could cause duplication of animal testing with the EEA, with resulting loss of animal welfare and ethical considerations.”
As of October 2018, UK companies held 12,000 EU REACH registrations – the number will be much greater now, two years on. While it’s acknowledged that these registrations will be adopted (“grandfathered”) into the UK system, the test data needs to be re-submitted, and this could be problematic for UK businesses. If they don’t own the test data, they’ll need to access it.
Widespread experiences with EU REACH have already shown that data sharing arrangements can be complex, costly and time consuming. UK companies will find themselves outside ECHA’s dispute mechanism which gives ECHA legal powers to force data sharing. They will be under commercial pressures, especially post-COVID, and may find that conducting a repeat test is simpler, faster and cheaper.
In the case of new animal tests, a testing proposal must first be submitted and approved, and we have yet to discover what stance the UK authorities will take when interpreting the principle of using animal testing only as a last resort.
To avoid a wave of repeat animal studies, UK authorities urgently need to come to an enforceable reciprocal data sharing agreement with ECHA, but applying this retrospectively to existing registrations would be challenging. Many data sharing agreements and Letters of Access state that data can be used only for the purpose of EU REACH.
The opportunities presented by UK REACH
Every challenge brings an opportunity, and here the UK has a chance to showcase both our longstanding love of animals and our commitment to scientific excellence by upholding and exceeding the standards already set out in EU REACH.
The global movement to replace animal testing has strong roots in the UK. From early campaigns by charities such as FRAME in the 1990s, to industry thought leaders prepared to be controversial and challenge the status quo (think Mark Constantine of Lush and Anita Roddick of The Body Shop), and recent initiatives by our blue chip companies such as Unilever to pioneer non-animal approaches using the latest in vitro and in silico methods, the UK has been at the forefront of both scientific progress and ethical advancement in this field. It’s never been more important for all stakeholders – including international businesses selling their products into the UK – to stand together for both scientific and regulatory progress.
If the UK can emerge from this tumultuous period in our history with our fundamental love for animals and passion for great science fully intact, the scientific and ethical benefits will continue to ripple out from our small island nation across the global community. The future is ours to choose, and surely, we can’t let a huge wave of new animal tests pass by unchallenged?
Click here to view a full list of XCellR8’s REACH compliant, 100% animal-free assays for endpoints including skin sensitisation, skin corrosion and skin and eye irritation.