That the draft Regulations laid before the House on 19 October be approved.
Relevant document: 34th Report from the Secondary Legislation Scrutiny Committee (special attention drawn to the instrument)
My Lords, the regulations have three main purposes: they fulfil the UK’s obligation to effectively implement the Northern Ireland protocol with regard to REACH; they provide for access by Northern Irish goods to the Great Britain market; and they amend the existing transitional deadlines for GB businesses to submit information about their chemicals and their safe use into the domestic REACH system. The SI also makes some technical amendments to ensure that cross-references in the UK REACH regulation are up to date at the end of the transition period. After the transition period, UK REACH will regulate the GB market, while EU REACH will apply to Northern Ireland.
The provisions that implement the protocol are straightforward. They redefine the scope of the domestic REACH regime from the UK to Great Britain. They provide for the Northern Ireland competent authority function to continue to be exercised jointly by the Department of Agriculture, Environment and Rural Affairs and the Department for the Economy. The provisions also ensure that there will still be effective enforcement arrangements for REACH in Northern Ireland.
The provisions concerning chemicals moving from Northern Ireland to Great Britain reflect our commitment to unfettered access for Northern Ireland businesses as well as the need to ensure that UK authorities have the appropriate information and regulatory safeguards in respect of chemicals placed on the GB market.
The instrument permanently removes the requirement for a full REACH registration for chemicals that are, or are in, qualifying Northern Ireland goods being placed on the GB market. It replaces that with a light-touch notification process, which will ensure that the HSE will know what chemicals are being placed on the GB market. Information necessary to ensure safe use will also still be passed down the supply chain within Great Britain. Substances of very high concern entering Great Britain from Northern Ireland will still need a UK REACH authorisation. This is necessary in order to manage the risk to GB consumers and workers, and the environment, from these hazardous chemicals. This simply replicates the approach taken at present to placing these substances on the EU market, where the authorisation process ensures that due account is taken of local environmental and other factors. We need to ensure that this happens where these chemicals are being placed on the market and used within Great Britain.
The changes to the deadlines for the submission of notification and registration information to the Health and Safety Executive follow a review of the data submission deadlines in the transitional provisions of UK REACH. The Government had committed to keep these deadlines under review when the first REACH exit SI was debated in the House last year, and the review involved detailed discussions with a range of industry and NGO stakeholders. The initial notification period for existing downstream users and distributors is being increased from 180 to 300 days. The deadline for submitting full registration information, which is currently two years across the board, is replaced by a phased approach that spreads the duty over two, four and six years from the end of that 300-day period.
The phased approach takes a risk-based approach by requiring the submission of data on the highest tonnages and most hazardous chemicals first. The aim is to give companies more time and capability to comply with the legislation by reducing and spreading costs, and giving them more time to negotiate mutually beneficial data-sharing arrangements with other companies in the UK and the EU. This will lead to a reduction in non-compliance and the provision of higher-quality data, leading to GB authorities having access to better data that will facilitate better decision-making. In the meantime, GB authorities will have access to significant other sources of data, so we will still be able to make robust regulatory decisions before full data is submitted to the HSE under UK REACH.
I should like to inform the House that we have worked with the devolved Administrations on this SI and they have given consent. I can confirm that this instrument will be able to function with or without a deal with the European Union. I can also confirm that it has been considered by the JCSI and that no issues have been drawn to the attention of the House.
I should like to turn to the report by the Secondary Legislation Scrutiny Committee. It is fair to say that the report does not primarily relate to this SI so much as to broader concerns about the future of chemicals regulations, now that the UK has left the EU. In addition to whether this SI changes our ability to regulate effectively before the Health and Safety Executive receives the data about the chemicals on the GB market, these concerns relate to the potential costs to industry of the transition to UK REACH, the HSE’s preparedness to take on its new role as the agency responsible for implementing UK REACH and potential outcomes from negotiations with the EU.
We published an impact assessment at the beginning of 2019, alongside the first REACH exit regulations. We have acknowledged that the costs to industry of supplying data into UK REACH could be significant. We have no reason to disagree with industry’s own estimates, but I should emphasise the considerable uncertainty. In particular, actual costs will depend on the behaviour of companies here and in the EU, and the terms by which they can agree to continue to share the data needed for the purposes of both UK and EU REACH. One of the purposes of this SI is to help businesses reduce and manage those costs by extending the deadlines for data submission. The aim of reducing costs is also why the UK has been looking to agree an approach to data sharing with the EU as part of a free trade agreement. That would enable us to significantly reduce the requirements on companies to submit data directly to the HSE.
The committee’s report is also concerned that the HSE will not immediately have access to the full chemical safety data currently held by the European Chemicals Agency. The Government recognise that our chemicals regime needs to be based on data and evidence, just like any system for regulating chemicals. At the same time, we are using transitional arrangements to smooth the move to UK REACH. These are taken a step further in the risk-based provisions in this SI. Here, also, our negotiation aims would assist us greatly in meeting the need for the data to underpin UK REACH while avoiding costs to industry. However, it takes two to reach a negotiated settlement. If that is not the outcome—and the committee is concerned that it will not be—it would be irresponsible not to make sure that UK REACH can stand by itself and is robust.
The concerns about costs and delays in the HSE receiving registration data sit uneasily together. If we want the HSE to have the full data on chemical safety, there will be a cost. If we want to avoid all the cost, it comes at the price of the HSE not having the data and having to rely wholly on other sources for regulatory purposes. What the Government are endeavouring to do, in previous SIs and in this instrument, is to balance those two needs.
Finally, the committee report questions whether the HSE will be fully prepared to take on the role of the chemicals agency under UK REACH—in particular, its capacity on day one. We have emphasised on a number of occasions that the HSE, along with the Environment Agency, is building on a significant level of expertise. I repeat that Defra is putting significant resources into the build-up to UK REACH, and that the HSE is recruiting heavily for REACH and other chemicals regimes for which it is responsible. The HSE has mapped the workload and regulatory drivers. This indicates that it is not necessary to have a fully staffed organisation on day one. Instead, the approach to recruitment gives time to train and build up the functions and services of UK REACH before key deadlines on registration and evaluation kick in. That is what is important. It is also important to remember that we are carrying over key elements from the EU system, such as the authorisation list and the candidate list for substances of very high concern, and that work does not need to be repeated.
Turning back to the draft SI, I emphasise that this is a simple but necessary instrument. It is necessary to make sure that the Northern Ireland protocol is implemented properly, and to provide easy access to the Great Britain market for Northern Ireland goods, in line with the Government’s commitments. The SI is also necessary in order to make a reduction in the burdens on industry, while still providing for an effective chemicals regulatory regime. I beg to move.
My Lords, not surprisingly, REACH never fails to generate high levels of interest in the House, and today is no exception. We have had a wide range of contributions. A number of questions have been asked, and I will do my best to answer as many as I can.
First, I turn to the Motion in the name of the noble Baroness, Lady Hayman of Ullock. The Motion indicates that it is based on the report of the Secondary Legislation Scrutiny Committee and, like that report, it is concerned more with the wider issues of chemicals regulation than with the SI in front of the House today. As such, I suggest that its regrets are somewhat misdirected.
The Motion regrets that these regulations fail to provide an analysis of the cost of the UK REACH regime, but this SI is not setting up the UK REACH regime; that was done by the REACH etc. (Amendment etc.) (EU Exit) Regulations 2019, which the House considered last year. As I said in my opening speech, we published an impact assessment alongside those regulations. All that the present SI is doing is making amendments to provide for the Northern Ireland protocol to change some of the transitional provisions to extend deadlines for the date of submission and update some cross-references. We have not provided an analysis of the cost of UK REACH alongside this SI because it would not reflect what the SI does.
The Motion also regrets that this SI introduces additional costs and burdens for UK businesses; the noble Lords, Lord Fox and Lord Cameron, and others also raised this concern. That is the opposite of what the SI does. It reduces costs and burdens. Extending the transitional deadlines will enable businesses to spread the administrative load over seven years instead of two. They can prioritise the highest-volume and highest-risk chemicals, and they will have time to agree the best terms for the continued sharing of the data on chemicals that is necessary for both UK and EU REACH.
The provisions for the Northern Ireland protocol also put in place the minimum level of burdens that are compatible with the protection of human health and the environment. Northern Irish producers will be able to access the GB market on the basis of a light-touch notification without having to follow it up with full registration.
The Motion also regrets that the SI creates unacceptable risks around the availability of chemicals safety data. The noble Baroness expressed concern about the cost to businesses and called on the Government to reduce them. That is what we are doing in this SI, but then, when we do reduce costs, she says we are creating unacceptable risks instead. The noble Baroness cannot have it both ways.
I agree with her and with the noble Baroness, Lady Donaghy, my noble friend Lord Lucas, and the noble Lords, Lord Fox and Lord Teverson, that the Health and Safety Executive’s ability to take on the tasks of the agency is essential to the success of UK REACH. The HSE is very well-placed to be a success in that role, as we have stressed many times. Remember that the HSE and the Environment Agency have played a very active part in EU REACH over the years, taking on some of the most complex substance dossiers.
The HSE has mapped the regulatory drivers and the likely workload, and so it understands what its priority tasks will be. For example, it will be handling applications for authorisations, and is aware that it may receive upwards of 10 applications in the first year. On the back of this, it has focused on outlining the process for authorisations and will have recruited key staff, such as occupational hygienists, to work on the authorisation process. It is also identifying independent scientific experts who will be involved in the development of opinions on authorisation applications.
There was the issue of so-called in-flight authorisations —that is, applications that the EU will not have finished dealing with by the end of the transition period. We dealt with that in regulations last year. There was the issue of the potential costs to businesses. That is why we are negotiating for an approach to data sharing with the EU and why the SI before the House today extends the deadline for data submission. There were concerns about the duplication of animal testing. That is why the last-resort principle is enshrined as a protective provision in the Environment Bill. I could go on.
I would like to try to get through as many of the questions that were asked in the debate as possible. A number of noble Lords, including notably my noble friend Lady Altmann, the noble Baroness, Lady Donaghy, and the noble Lord, Lord Teverson, raised the issue of standards and levels of protection after the end of the transition period, a point also raised forcefully by the noble Lord, Lord Rooker. It will remain a core purpose of REACH to ensure a high level of protection of human health and the environment. The duties and obligations on industry are carried into UK REACH unchanged. This includes the principle that it is for businesses to ensure that they manufacture, place on the market and use chemicals that do not adversely affect human health and the environment.
REACH will also continue to be underpinned by the precautionary principle. We have included provision in the Environment Bill to be able to amend REACH to prevent it from being frozen in time. In answer to both the noble Viscount, Lord Hanworth, and the noble Lord, Lord Hunt, we have deliberately included a range of safeguards. Any amendment to REACH must remain consistent with its aims and principles. We have listed over 20 protective provisions, such as those overarching aims and principles that cannot be changed. I hope that is an indication of our commitment.
My noble friend Lord Lucas referred to alternatives to animal testing, particularly the scope for using computer modelling to predict chemical hazards such as toxicity. The noble Baronesses, Lady Hayman and Lady Donaghy, made the same point. I strongly agree with them about the opportunity here. We do not support animal testing unless it is unavoidable. A range of alternative approaches is available, including computer-based quantitative structure activity relationship models, or QSARs. Under EU REACH, the UK was the member state that consistently pushed for the most rigorous application of the last-resort principle by industry and regulators. Under UK REACH, we will no longer be held back by more reluctant players and will be well-placed to encourage the appropriate use of alternative methods of assessing hazard.
My noble friend also spoke about various products such as ammonium sulfamate, asulum and glyphosate. I should note that, as herbicides, these are regulated under separate plant-protection product legislation rather than REACH. From next year we will be taking our own independent decisions in Great Britain on which pesticides can be used, and of course I hope we can move continuously towards reducing our use of such chemicals.
My noble friend Lord Trenchard spoke about the possibility of divergence from EU REACH and was in favour of it, unlike other noble Lords in this debate today. REACH is frequently seen as a gold standard and we have no intention of diverging from the EU just for the sake of it. Equally, we should not allow UK REACH to become frozen. That is why we have made provision in the Environment Bill to enable us to amend it.
There may be good reasons for taking a different approach on different substances to reflect our circumstances here, but that does not mean reducing standards or levels of protection. For example, the UK has been at the forefront of opposing animal tests where alternatives exist. We have already discussed the last-resort principle, and we could be far more rigorous in applying that principle in future. Another example concerns Poland’s proposal to the EU to ban the use of methanol in windscreen-washing fluids because of its abuse by Polish alcoholics. That may be sensible for Poland, but it is not something that applies in this country. We can make sure that UK REACH remains up to date and operates in an effective and efficient manner that works for us, but we can do so in a way that is flexible.
The noble Lord, Lord Cameron, argued that we should try to remain as aligned as possible with EU REACH, taking a somewhat different position. As I said, we have no intention of diverting for the sake of it but there may be circumstances where it makes sense for the United Kingdom. Under UK REACH, companies will still need to know about the properties, hazards and potential risks of the chemicals that they manufacture and place on the market. This means that industry will not have to develop different sets of data for use with UK REACH and EU REACH.
The noble Lord, Lord Fox, raised a number of issues that I have already addressed in response to the noble Baroness, Lady Hayman, and others. On costs, an issue also raised by the noble Baroness, Lady Donaghy, the main cost for businesses is in accessing the data that they need to support their registrations, but there is considerable uncertainty about what the costs may be in practice. The Chemical Industries Association and Cefic, the EU organisation representing chemicals manufacturers, have jointly recommended that consortia should restrict charges to administration. One of the purposes of the changes in this SI is to provide time for industry to reach sensible agreements around data and cost sharing.
With regard to the need for data, UK REACH maintains the core principle of “no data, no market”. That principle is necessary; it is the means by which the regulator can check that companies are properly meeting their duty to ensure the safe management of chemicals. It also provides assurance to the public that businesses understand the hazards and risks of the chemicals they are using and know how to manage them.
The noble Lord also spoke about the HSE’s preparedness, a point echoed by many noble Lords, including the noble Lord, Lord Teverson. I am confident that the HSE is well-placed and equipped to carry out its role as the agency under UK REACH. The Environment Agency is equally well-placed to assist HSE by providing expert advice on environmental matters. Defra continues to provide additional resources to the Health and Safety Executive and the Environment Agency. The HSE is currently recruiting, in total, 130 extra staff to cover the transition to the UK system across all the chemicals regimes that it operates, including scientists and, as I said earlier, occupational hygienists. Forty of these extra staff are being recruited specifically for REACH. The Environment Agency has also increased its resource, with an additional recruitment plan for early 2021. My noble friend Lady McIntosh also asked about the HSE’s ability to cope. As I say, Defra continues to provide additional resources to the HSE and the Environment Agency, which are, as I have explained, busy frantically recruiting.
The noble Lord, Lord Whitty, asked a number of questions, many of which I have already addressed. He asked for an update on negotiations and their implications for the discussion that we are having today. I am afraid I am not in a position to do that; I can only apologise. I can tell him that the enforcement function in Northern Ireland is the HSE Northern Ireland.
Putting aside the wider issues that have—quite legitimately—been such a dominant feature of the debate, I must however return to the SI in front of the House. As I said earlier, it is simple but necessary. Without it, the UK would not fulfil its obligations under the Northern Ireland protocol. We would also not fulfil the commitment that we made to the House in March 2019 to keep the data deadlines under review and then to take further steps as appropriate. I commend the SI to the House.