Date laid: 19 October 2020
Parliamentary procedure: affirmative
These draft Regulations propose changes to implement the Northern Ireland Protocol in relation to the regulation of chemicals under the EU REACH regime. As a result, different regulatory regimes will apply in Northern Ireland (NI) and Great Britain (GB) after the end of the Transition Period (TP). The instrument includes measures to reduce the resulting barriers to trade between NI and GB and to give NI goods easier access to the GB market. The instrument also proposes to extend deadlines for the submission of safety data on chemical substances when registrations of such substances are transferred from the current EU to the new GB regime, in response to concerns raised by industry. We remain deeply concerned, however, about the impact and costs of introducing the new domestic REACH regime and the readiness of the Health and Safety Executive (HSE) to take on its new regulatory role at the end of the TP, especially as the recruitment and training of expert staff is not yet complete and HSE will not have access to the full chemicals safety data currently held by EU REACH.
The draft Regulations are drawn to the special attention of the House on the ground that they are politically or legally important and give rise to issues of public policy likely to be of interest to the House.
1.The purpose of these draft Regulations, laid by the Department for Environment, Food and Rural Affairs (Defra) with an Explanatory Memorandum (EM), is to help to ensure the UK meets its obligations under the Northern Ireland Protocol (“the Protocol”), so that the EU regime for the Registration, Evaluation, Authorisation and Restriction of Chemicals (“EU REACH”) can continue to apply to Northern Ireland (NI) after the end of the Transition Period (TP), while the new domestic REACH regime introduced by an earlier EU exit instrument will now apply only to Great Britain (GB), rather than the whole of the UK as originally intended. The draft Regulations also provide for the continued access of NI goods to the GB market and propose amendments to extend the transitional provisions included in the earlier EU Exit instrument to mitigate potential disruption to industry from the move to the new regulatory arrangements.
2.At present, chemicals are regulated by EU Regulation (EC) No 1907/2006 (“the EU REACH Regulation”), which sets out statutory requirements for the registration, evaluation, authorisation and restriction of chemicals, and establishes a European Chemicals Agency (ECHA) as the EU-wide regulator. An earlier EU Exit instrument established a stand-alone UK regulatory regime (“UK REACH”) to control the production, import and placing on the market of chemicals, and to identify hazards and manage risks in relation to the production and use of chemicals. At the time, Sub-Committee B of the Secondary Legislation Scrutiny Committee drew the instrument to the special attention to the House, highlighting concerns about the possible impact of the changes, especially in relation to the additional responsibilities being transferred to the Health and Safety Executive (HSE) and its readiness to act as the national regulator, the potential costs for the UK chemicals industry, and the failure of the Department to provide enough information about this impact.
3.Defra explains that under Article 5(4) of the Protocol, the EU REACH Regulation will continue to apply in NI, while the new domestic REACH regime will apply only in GB, so that NI and GB will be subject to different regulatory regimes for chemicals at the end of the TP. This instrument proposes amendments to the earlier EU Exit instrument to reflect the more limited application of the new domestic REACH regime and the continuation of EU REACH in NI.
4.The instrument also proposes amendments to address the barriers to trade between NI and GB that are a consequence of the operation of two separate REACH regimes, and to ensure that NI chemicals will have easier access to the GB market. Defra explains that while frictionless trade between NI and GB is a stated aim of all parties to the Protocol, “there is a recognition that the risks relating to certain categories of highly regulated goods such as chemicals mean special arrangements are necessary”.
5.Under the new domestic REACH regime, a person placing a chemical substance on the GB market will need to notify HSE, as the responsible GB agency, so that the regulatory authorities know which chemical substances are entering and being used in GB. The notification will provide basic information about the substance. Defra says that while under the new arrangements only GB-based entities may make such notifications, this instrument introduces an exception to enable NI suppliers, rather than their GB customers, to notify HSE directly. In such a scenario, the duties relating to the notification will apply to the NI supplier rather than the GB importer.
6.The instrument further proposes that where NI chemicals are already being traded into the GB market, the notification must be made to HSE within 300 days of the end of the TP and that, where the trade is made for the first time after the end of the TP, the notification must be made before the substance is placed on the GB market. This notification requirement replaces the more onerous duty to register fully the substance in GB.
7.The instrument also provides that NI suppliers can apply directly to HSE for an authorisation where they want to place a substance of very high concern on the GB market, instead of relying on their GB customer to make that application. Defra says that these provisions will apply to qualifying Northern Ireland goods, as defined by a previous EU Exit instrument.
8.Under the REACH regime’s “no data, no market” principle, companies need to register chemical substances with the relevant agency before these substances can be used or put on the market. This requires the submission of safety data on these substances and involves complex copyright and ownership issues, with some data being owned jointly by multiple companies. The original EU Exit instrument provided for an automatic transfer of UK-held EU REACH registrations into the new domestic REACH regime as long as the registration data for the substance that was originally submitted to ECHA would subsequently be submitted to HSE, as the agency responsible for the new domestic regime. The original instrument provided for transitional arrangements to give businesses time to obtain the data.
9.Defra says that this instrument implements a commitment made in both Houses during the passage of the original EU Exit instrument “to keep under review the REACH data submission deadlines which the transitional provisions place on manufacturers and importers of chemicals in GB”. This commitment was given in response to concerns that businesses would not always be able to obtain the data or, lacking ownership of the data, only at significant cost. Defra says that this instrument now proposes a new phased approach to the submission of data, following informal consultation with representatives of the chemicals industry and other stakeholders.
10.Specifically, the instrument proposes that the initial notification stage for existing downstream users that will become importers of chemicals from the EU/European Economic Area (EEA) or NI after the end of the TP is extended from 180 to 300 days, starting from 1 January 2021. According to Defra, this is to give downstream users time to see whether existing GB registrants transfer their EU REACH registrations into the new domestic regime after the end of the TP. Where such a transfer is done by the GB registrant, the downstream users of that substance will not need to notify HSE.
11.The deadline for providing the remaining registration information in the case of existing GB registrants or completing a full registration for those importing from the EU/EEA or NI, is to be extended to run subsequently in a phased manner by two, four and six years. This would mean a total of two, four and six years, and the additional 300 days for the initial notification, to supply the full information. Defra says that this phased approach will operate by reference to tonnage bands and hazard profile, with the highest tonnages and most significant hazards coming first. The EM states that the aim of this phased approach is to “allow companies sufficient time to negotiate access to information where necessary and to form joint registrations. It is expected to reduce the burden on industry and ensure the completeness and quality of the information on substances in the GB REACH system.”
12.There remain significant concerns about the new domestic regime and the way it seeks to replace EU REACH. Following an evidence session with industry stakeholders, the House of Lords EU Environment Sub-Committee wrote to the Minister about the practical challenges and high costs of submitting chemicals safety data to the new domestic system, the impact this could have on small companies, the preference of stakeholders for a data-sharing agreement with the EU and the readiness of HSE for its new role.
13.We have also received a submission from the ChemTrust, raising further concerns, including that extending the period for submitting full registration data to more than six years will “make it difficult, if not impossible, for the HSE to implement legally enforceable restrictions on and authorisations for chemicals without this data”. We put this concern to Defra which told us that:
“It is not correct to imply that HSE will not have access to any information about substances in the absence of the full registration data. They will, for example, be able to look at the substantial amount of publicly available information, from the EU and elsewhere, and what action is being taken internationally in respect of particular substances, including by the EU. HSE will also have the power to request information from industry.”
14.ChemTrust also asked about the possibility of co-operation with ECHA and remaining within and aligned to EU REACH. In response, the Department explained that:
“The Government’s position on not remaining within the jurisdiction of the European Courts of Justice (ECJ), means that we are not seeking alignment with EU REACH or participation in the European Chemicals Agency (ECHA).
In February, the Government published its approach to negotiating a future relationship with the EU. That includes a proposal for a chemicals annex as part of the EU Free Trade Agreement. A deal on data sharing with the EU could mitigate the need for industry to provide full data packages.
It would not be appropriate to automatically implement future EU decisions under UK REACH. This is because the EU will no longer consider the impact of their decisions on Great Britain. We can take their decisions into account but we will need to consider, in each case, whether they are right for Great Britain.”
15.We are publishing the submission by ChemTrust and Defra’s full response on our website.
16.We asked the Department whether the UK would continue to have access to the EU REACH database via NI which will remain under the EU REACH regime. Defra explained that:
“Under the Northern Ireland Protocol the UK (on behalf of NI) should have access to systems that are strictly necessary to the operation of the NIP. We have reached agreement with UKTF [the European Commission’s Task Force for Relations with the UK] confirming access to a number of systems and talks remain ongoing with key Commission stakeholders regarding outstanding networks, systems and databases.”
17.We also asked whether, given the significant challenges that businesses face in having to submit data under the new domestic REACH regime and the impact this could have on industry and consumers, the Government had considered a data-sharing agreement with the EU in this area. The Department responded that:
“In February, the Government published its approach to negotiating a future relationship with the EU. That includes a proposal for a chemicals annex as part of the EU Free Trade Agreement. A deal on data sharing with the EU could mitigate the need for industry to provide full data packages.
We continue to push for it, but the EU continues to reject any sectoral annexes. However, securing the chemicals annex is still very much our preferred outcome. This would be in the interests of both UK and EU businesses, including those who will want to continue selling their chemicals into the GB market.”
18.We also asked the Department how HSE would obtain commercially sensitive and/or confidential data, in particular data that is currently held by EU REACH and that is required for the effective regulation of chemicals. Defra responded that:
“[T]here is the ability for HSE to request data from registrants, as well as using data from international sources and literature reviews into account when making decisions on whether further action is required to address a risk from a chemical. Where confidential data is submitted under REACH it is in the company-specific dossiers; these company-specific dossiers will continue to be required under UK REACH. It is important to recognise that the REACH process is not linear, so regulators will not need to wait for information from registration packages before they consider if the use of a substance should be controlled through an authorisation requirement or restriction.
The amount of information which will be publicly available to HSE regarding hazard end-points from EU registration dossiers, is very close to that which is available with EU REACH-IT access. This information will continue to be available as the public availability and communication is written in to EU REACH — so HSE will be able to use this information to inform their recommendations.
Therefore, the Agency will be able to look at a variety of sources to inform the decisions — this also includes using years of experience of chemical regulation within EU REACH and the new substance regime which ran prior to that.
None of this should be taken as suggesting that it is not important for the UK to build its own comprehensive REACH database in due course. It does, however, mean that we can take a balanced and proportionate approach to doing so.”
19.We note the Department’s explanation but remain deeply concerned about the costs to industry of having to obtain data and that, in the absence of complete access to EU REACH or a data sharing agreement with the EU in this area, the full chemicals safety data will not be immediately available to HSE when the new domestic REACH regime is launched on 1 January 2021. This could undermine HSE’s ability to regulate chemicals safely and effectively.
20.We understand that there will be additional costs for UK businesses which will lose any existing EU REACH registrations for their chemicals. UK businesses will have a number of options if they wish to continue to export their substances to the EU/EEA, including having their EU/EEA customers register the substance with EU REACH, appointing an “Only Representative” within the EU/EEA to take over the tasks and responsibilities for complying with EU REACH or transferring their manufacturing activity to the EU/EEA. We acknowledge that this matter lies outside the scope of these Regulations but draw it to the attention of the House as a significant feature of their broader context.
21.We also asked the Department whether HSE had sufficient expertise and resources to take on its new regulatory role. Defra told us that:
“In the overall management of REACH, HSE will have key functions as the Agency, working with the Environment Agency, while other functions will lie with ministers in Defra and the Devolved Administrations.
We will have a strong and effective regulator in place to operate UK REACH, building on existing expertise in the Health and Safety Executive (HSE) and the Environment Agency (EA). Both organisations have considerable experience, having worked on some of the most complex dossiers under EU REACH. Both organisations are continuing to bring in new staff to build their capacity.
HSE are recruiting in total 130 extra staff to cover the transition to the domestic system across all the regimes they operate — these staff will be scientists, administrators, occupational hygienists and socio-economists. For REACH specifically this results in a significant increase (more than three-times the staff currently in post) in the amount of staff currently involved in the system. This is the largest recruitment exercise ever undertaken in this area and underlines the importance and priority of chemical regulation to HSE.”
22.Asked about HSE’s progress in recruiting 130 new staff, the Department explained that recruitment was “currently underway” and that HSE “aims to have 100 recruits in post by January and 130 by the end of the financial year — these will be split over all the chemical regimes but around 40 of these staff will be specifically for REACH”. Defra further explained that:
“As the recruitment has been staggered, different posts are at different points in the recruitment process – HSE are currently interviewing for a large number of scientist posts and offers of employment will be made at the end of this month. To date HSE has made around 30 offers of employment to staff across all regimes (this includes posts to help with the implementation of the NI Protocol).”
23.Defra added that:
“HSE is recruiting heavily — however, to ensure they understand the potential workload on Day 1 for UK REACH, they have also worked with stakeholders to estimate the volume of work, as well as using prior knowledge gained from their experience of the EU system e.g. the number of UK companies with EU authorisation applications outstanding who may need to start to reapply under UK REACH. This has enabled HSE to plan training and recruitment in order to build up the functionality and services needed as UK REACH develops.
HSE is also in the fortunate position in having experienced staff, who have been involved in the more technical process of the EU system and can share their experience in order to build competence in others. In the current climate of Covid-19 we have developed remote training modules to ensure training can start as soon as possible.”
24.We also asked the Department about the costs of a domestic REACH regime and any extra funding that had been allocated to HSE. Defra told us that:
“The costs of UK REACH include building a new IT system and putting in place the capacity in HSE, EA and Defra to operate the new regime.
We have already provided extra resources to both HSE and EA to prepare for the end of the transition period and we expect to spend about £20m this financial year on the new UK REACH regulatory system. This figure includes the operation and maintenance of the REACH IT system and staff resourcing in Defra, HSE and EA.
Decisions on budgets for UK REACH in 2021/22 will be taken in the light of the outcome of the current spending review.”
25.We are concerned that fewer than two months before the new domestic REACH regime is to replace EU REACH, recruitment and training of expert staff at HSE is far from complete, and it is clear that HSE will not have all the staff in post that it will need to exercise its regulatory functions under the new regime from 1 January 2021. We note particularly that HSE has made around 30 job offers to date, compared to its target of recruiting 130 new staff. While HSE aims to complete this target by the end of the financial year 2020/21, the new domestic regime will become operational on 1 January 2021. It is also not clear how many of the job offers made by HSE have been accepted and given that staff may also have to give notice, we are further concerned about the operational consequences of HSE not being able to complete its recruitment by 1 January 2021.
26.We are also concerned that the Department has not provided an analysis of the costs of the new domestic REACH regime. The House may wish to seek assurance from the Minister that sufficient funding will be made available in the 2021/22 financial year, at a time when there are significant pressures on public spending.
27.The chemicals sector is the UK’s second biggest manufacturing industry, and it is estimated that some 61% of chemical exports went to the EU in 2017, with a value of £18 billion, and that around 73% of chemical imports came from the EU. The House expressed strong concerns when the original proposals to establish a domestic regulatory regime for chemicals to replace the current EU regime were debated in 2019. While this instrument proposes to extend certain data submission deadlines to help industry transition to the new arrangements, we remain deeply concerned about the costs to industry and that the new domestic REACH regime will not have access to the full chemicals safety data currently held by EU REACH. Moreover, HSE has not yet completed the recruitment and training of the expert staff it will need when the domestic REACH regime replaces EU REACH on 1 January 2021. The draft Regulations are drawn to the special attention of the House on the ground that they are politically or legally important and give rise to issues of public policy likely to be of interest to the House.
Date made: 3 November 2020
Parliamentary procedure: made affirmative
These Regulations make provision for the second national lockdown in England. They require people to stay at home except for listed reasons, and limit gatherings to two people, if from different households, in a public space. The Regulations also require the closure of a number of businesses and impose restrictions on those which remain open. The exceptions and penalties retain a familiar form. The Regulations will cease to have effect on 2 December, 28 days from the date on which they came into force (5 November).
The Government state that when this instrument expires: “we will return to a tiered system on a local and regional basis according to the latest data and trends”. These Regulations, however, revoke SIs 2020/1103, 2020/1104 and 2020/1105, which introduced the previous three-tier system. A new tiered system will therefore have to be put in place. It is essential that the Government provide an analysis of the performance of the previous three-tier system and a clear, evidence-based explanation for any differences between the previous system and the new one to be put in place post-lockdown.
These Regulations are drawn to the special attention of the House on the ground that they are politically or legally important and give rise to matters of public policy interest.
28.These Regulations were laid by the Department of Health and Social Care and are accompanied by an Explanatory Memorandum (EM). No Impact Assessment was prepared.
29.The Regulations were debated in the House of Lords on 4 November before they came into effect on 5 November 2020. The motion to approve was debated alongside one motion to decline to approve and five regret motions. These are set out at Appendix 1 as an illustration of the concerns raised.
30.Many of these restrictions and exceptions, which apply only in England, are similar to those set out in the previous three-tier regulations, although there is an additional exemption for Remembrance Sunday events (part 3):
31.The EM also refers to guidance which recommends that Clinically Extremely Vulnerable people should minimise social contact (but the legislation does not go so far as to require them to shield). Similarly, guidance has been published about visits to care homes which recommends “visitor numbers should be limited to a single constant visitor wherever possible, with an absolute maximum of two constant visitors per resident”.
32.The general guidance on the lockdown also includes a specific prohibition on staying away from your main residence: “Overnight stays and holidays away from primary residences will not be allowed. This includes holidays abroad and in the UK. It also means you cannot stay in a second home, if you own one, or staying with anyone you do not live with or are in a support bubble with.”
33.We reiterate a concern which we raised in an earlier report that the distinction between requirements imposed by law and advice given through guidance should be clearly and accurately communicated to the public.
34.We welcome the fact that paragraph 1 of the EM sets out data on the infection rate which has prompted the decision to impose another national lockdown:
“Data from the Office of National Statistics COVID-19 infection survey for the most recent week of the study (17–25 October) estimates that an average of 568,100 people had COVID-19 in the community in England — over 30% higher than their estimate from the previous week and equivalent to 1 in 100 people. This is in line with estimates from the latest interim results from the Real-time Assessment of Community Transmission (REACT) Study, led by Imperial College. The Government’s expert modelling group SPI-M estimates that the reproduction rate, or R rate, for the UK is between 1.1–1.3, with the epidemic estimated to grow between 2% and 4% per day, with potentially faster growth in certain areas.”
35.In response to our questions in relation to previous instruments, however, the Government have said that a number of factors are taken into account in deciding how to respond to the pandemic, not just the R Rate. We question why, on this occasion, no other factors, other than the R Rate, are mentioned.
36.In the debate, concerns were raised about the absence of an Impact Assessment or Risk Analysis, comparing the benefits of lockdown against its long-term risks. Questions were also asked about the quality of the data, whether it was reliable, and the degree to which other factors had been taken into account like the economic impact, long-term debt, unemployment, disruption of education, damage to mental health and the effects of delays in treatment for other medical conditions. The House may wish to continue to press the Minister for a full explanation of the rationale, and evidence-base, for a national lockdown.
37.On 31 October, the Prime Minister announced that, due to rapid increases in the rate of infection both in England and in other countries, the relevant Local Covid Alert Level measures (Tiers 1–3) would be replaced from 5 November by national restrictions. The new measures will apply in England for four weeks to 2 December, at which point the Government “will look to return to a regional approach, based on the latest data”.
38.In his opening remarks in the debate, the Minister, Lord Bethell, said that when this instrument expires “we will return to a tiered system on a local and regional basis according to the latest data and trends” (column 742) but did not make clear what that system would be. A number of questions were asked about the short-term exit strategy from this lockdown and longer-term exit strategy from the pandemic.
39.At paragraph 6.6, the EM states that the policy intention of the instrument is to impose “a nationwide lockdown for 28 days in order to prevent the spread of Coronavirus, thus easing NHS capacity and ensuring that the health system is not overwhelmed during the winter months. It is expected that, at the end of that period, the previous local alert levels introduced in October will once again be brought into force. This policy is subject to review.”
40.The instrument, however, revokes SIs 2020/1103, 2020/1104 and 2020/1105, which introduced the three-tier system, so it is not clear to which “local alert levels” system the EM refers.
41.We also note that the EM provides no analysis of the performance of the three-tier system which this instrument replaces or the degree to which it was successful in reducing local infection rates. Whatever system is put in place after these Regulations expire, it is essential that the Government provide an analysis of the performance of the previous three-tier system and a clear, evidence-based, explanation for any differences between the previous system and the new one to be put in place post-lockdown.
42.We also recommend that, to improve compliance, the way that any future requirements are set out in law and communicated needs to be clearer. The public has appeared confused by both the quantity and the complexity of the previous provisions.
2 SLSC Sub-Committee B, (Session 2017–19, HL Paper 281).
5 Downstream users are companies that use registered substances but do not hold an EU REACH registration for these substances themselves.
6 See EU Environment Sub-Committee, ‘Ministers challenged on unresolved chemicals concerns’ (12 October 2020): https://committees.parliament.uk/committee/444/eu-environment-subcommittee/news/119977/ministers-challenged-on-unresolved-chemicals-concerns/ [accessed 12 November 2020].
7 Secondary Legislation Scrutiny Committee, scrutiny evidence page: https://committees.parliament.uk/committee/255/secondary-legislation-scrutiny-committee/publications/8/scrutiny-evidence/.
8 European Union Committee, , (Twenty Third Report, Session 2017–19 HL Paper 215), p 3.
9 DHSC, ‘Guidance on shielding and protecting people who are clinically extremely vulnerable from COVID-19’ (13 November 2020): https://www.gov.uk/government/publications/guidance-on-shielding-and-protecting-extremely-vulnerable-persons-from-covid-19/guidance-on-shielding-and-protecting-extremely-vulnerable-persons-from-covid-19 [accessed 13 November 2020].
10 DHSC, ‘Visiting arrangements in care homes for the period of national restrictions’ (5 November 2020): https://www.gov.uk/government/publications/visiting-care-homes-during-coronavirus/update-on-policies-for-visiting-arrangements-in-care-homes [accessed 12 November 2020].
11 Cabinet Office, ‘New National Restrictions from 5 November ‘ (31 October 2020): https://www.gov.uk/guidance/new-national-restrictions-from-5-november [accessed 12 November 2020].
12 , (Session 2019-21 HL Paper 57).
14 HM Government, ‘Prime Minister’s statement on coronavirus (COVID-19): 31 October 2020): https://www.gov.uk/government/speeches/prime-ministers-statement-on-coronavirus-covid-19-31-october-2020 [accessed 12 November 2020].