HANSARD
REACH etc. (Amendment etc.) (EU Exit) Regulations 2019
- Motion to Approve
- 3:51 pm
- That the draft Regulations laid before the House on 5 February be approved.Relevant documents: 15th and 17th Reports from the Secondary Legislation Scrutiny Committee (Sub-Committee B)
- My Lords, these regulations concern the registration, evaluation, authorisation and restriction of chemicals, otherwise known as REACH. These regulations apply to the whole of the UK, with the exception of paragraph 1 of Schedule 11, which makes technical amendments to the England and Wales regulations that transposed the EU directive on the disposal of polychlorinated biphenyls, or PCBs. We have worked with the devolved Administrations on this instrument and, where it relates to devolved matters, they have given their consent.Our chemicals sector is world leading and one of the UK’s largest manufacturing exporters by value. We fully realise the sector’s economic importance and its importance to the way we all live our lives. At the same time, we also recognise the risks to human health and the environment if chemicals are not used properly. The UK is strongly committed to the effective and safe management of chemicals to protect both the public and the environment. That will not change when we leave. This is why we clearly set out our negotiating position in the White Paper published in July last year.We want frictionless trade which maintains strong chemicals regulation through a common rulebook for sectors such as chemicals that would be supported by arrangements that cover all relevant compliance activity such as REACH, and continued active participation in the European Chemicals Agency, ECHA, so that UK businesses can continue to register chemical substances directly, rather than working through an EU-based representative.However, we must also be ready should we leave without a withdrawal deal. The building blocks of REACH will all remain, and we are keeping the fundamental approach of REACH, with its aims of ensuring a high level of protection of human health and the environment, as well as enhancing innovation and competitiveness. This is why we seek a smooth transition and an outcome which minimises friction, disruption and delay at our borders and supports the continued chemical supply chains with the EU.Delivering day one functionality has been a key priority since 2016. To achieve this, we have been working with both industry and the UK regulators. Since 2016, Defra, in partnership with BEIS and HSE, has run an extensive programme of stakeholder engagement with the chemicals industry with the aim of reaching as wide an audience as possible, particularly targeting SMEs and downstream users of chemicals. This programme included regular ministerial meetings with Ministers from Defra, BEIS and DExEU.Last summer, we held a series of informal briefings for the chemicals sectors, NGOs and other stakeholders on the proposals contained in the instrument. We followed this up with detailed guidance. Since October, this effort has been even more intense. We have engaged directly with more than 1,700 stakeholders. Building on this, we launched the ongoing business readiness campaign in January to spread coverage to as many businesses as possible. We have used online adverts to promote stakeholder events and both social and traditional media outlets for increased stakeholder engagement. In the last week, my officials have also been in Frankfurt and Brussels to spread the message to EU business.
- 4:00 pm
- To give a sense of scale, we will grandfather more than 12,000 registrations into UK REACH—35% of them from 2018—representing 5,700 chemicals. Looking forward, we would expect 50 to 100 new chemicals to be registered each year. REACH places a registration duty on importers of chemicals. This will be new for companies that import from the EU/EEA as they are currently covered by their supplier’s registration. We are therefore giving them a two-year grace period, which will give them time to adapt and will protect supply chains. In the meantime, they must send information to the agency within 180 days in what is described as a light-touch notification procedure to provide assurance that they know how to manage the chemicals safely. We expect downstream user notifications to be over 10,000. I should emphasise that we will keep both two-year deadlines—for grandfathering and for downstream user registrations—under review.
- Although we are providing two years for industry to adapt, there have been questions about why we need these data at all. The “no data, no market” principle is key to REACH, and will remain key to the safe use of chemicals in the UK as well. Surely it would be irresponsible to set up a UK regulatory system without data on the chemicals being used in the United Kingdom. That would leave the UK regulator with no data through which to regulate industry and assure the safe use of chemicals in the UK.
- The UK Chemical Industries Association and Cefic, the EU chemicals trade body, have published their joint recommendation that the data used to register under EU REACH should be made available for UK REACH at no extra charge. We have heard similar messages from other EU trade bodies. Some chemical consortia have amended their contracts to enable this to happen. That is welcome news and I endorse the industry’s efforts.
- We are determined that there should be no need for any additional animal testing for a chemical that has already been registered, unless it is subject to further evaluation showing that the registration dossier is inadequate or there are still concerns over the hazards and risks of the chemical. That is why this instrument continues the core aim in EU REACH of avoiding duplicate animal testing.
- Both the legislation and the systems we are putting in place are fully operable. The building blocks of REACH will remain: industry’s primary duty to understand the hazards and risks of chemicals and ensure safe use, tied to the principle of “no data, no market”; registration by the industry of the chemicals it produces and places on the market—registration is not a regulator-led approval scheme; dossier evaluation by the regulator of at least 5% of registration dossiers to check compliance and quality; substance evaluation, namely investigation by the regulator of outstanding concerns about a chemical, often leading to a requirement on industry to fill the knowledge gaps; the authorisation process, which forces industry to apply for and justify continued use of “substances of high concern”; and restriction of the most dangerous chemicals where unacceptable risks remain.
- The SI changes, in Schedule 1—in Article 3—the definitions of the various industry duty holders so that they refer to the UK rather than the EU. This is a simple but essential change. Without it, UK industry would no longer have any duties, including to ensure the safe use of the chemicals it produces and uses.
- Just as HSE inherits the role and functions of ECHA, the responsibilities of the European Commission pass to the Secretary of State. For example, the Secretary of State will make decisions to authorise the use of a substance of very high concern or to restrict chemicals on the basis of an opinion from HSE. The Secretary of State would need to bring a statutory instrument to Parliament to make new restrictions or add to the list of chemicals where industry needs an authorisation.
- As REACH covers environmental protection, which is devolved, the Secretary of State must act with the consent of the devolved Administrations where a decision relates to an area of devolved competence. A safeguard clause allows the Secretary of State and devolved Administrations to take urgent action where it is needed to protect human health or the environment. This must be followed up with the normal restriction process to see if there should be a UK-wide control.
- We will continue to ensure the highest levels of protection for human health and the environment, based on robust evidence and strong scientific analysis. At the same time, we are taking steps to provide industry with the legal certainty it needs to operate and to preserve the supply chains for the chemicals we depend on. For these reasons, I beg to move.
- To leave out from “that” to the end and to insert “this House declines to approve the draft Regulations because Her Majesty’s Government has provided insufficient information on the impact of the proposed changes, in particular in relation to (1) the additional responsibilities being transferred to the Health and Safety Executive and its readiness to act as the national regulator, (2) the potential costs for the chemical and advanced manufacturing industries in the United Kingdom, (3) the potential duplication of testing on animals, and (4) the need to uphold environmental protections; and calls on Her Majesty's Government to lay new regulations following full consultation with the chemical, manufacturing and consumer goods industries, and the environmental sector, with the aim of delivering a regulatory regime of the highest standard”.
- My Lords, I declare my interests as in the register, but everybody in this Chamber has an interest because chemicals touch every part of everybody’s lives in this country. That is why the Minister is completely correct that it is vital for this country to have a safe and effective management regime for chemicals. Safety should be the primary concern, alongside environmental sustainability.Along with other Peers, I worked on the Nuclear Safeguards Bill, which the Government rightfully decided deserved primary legislation, not least because it involved an international treaty but also because it is a complex and important safety regime. During the proceedings on that legislation, which the Government brought to this House and the other place, it was improved and full debate was had. The chemicals and chemical regulation regime is just as complex and important, if not more so, than nuclear safeguarding, and this should have been brought to your Lordships’ House and the other place as primary legislation. It is regrettable that this was not the case.It is also extremely unfortunate, to say the least, that the Government have left it so late to bring this statutory instrument in front of your Lordships. When this was tabled it was anticipated that this could be three days before the measures in this statutory instrument would be required. Given its importance and complexity, that is beyond remiss and looks like brinkmanship. Despite the fulsome description of consultation, roadshows and so on, the response I have had from industry and civic society—a broad range of stakeholders—has been that this is not a satisfactory statutory instrument, which is why I have tabled this fatal amendment.I will try to highlight some of the flaws. I am afraid to say it will not be a short speech, because there are quite a lot of flaws. I apologise—but not much, because this issue has to be laid before your Lordships and these issues need to put on the public record. I will ask a number of questions. As the Minister has set out, this regime is effectively ready to roll, so I am sure he will not have trouble answering these questions.
- 4:15 pm
- On data, I completely agree with the no-data no-product rule set out by the Minister. It is essential that we have data and nobody on these Benches is proposing otherwise. As the Minister set out, data for REACH is jointly submitted by a consortia of companies. The problem of grandfathering becomes complex in this area. The Government state that the UK can download this data. That has clearly been confounded by copyright and ownership issues around data. Companies will need permission to reuse that data for the system. In some cases, the data neither belongs to them, nor to one other company, but to a chain of different companies. The copyright to the data belongs with those companies. The notion that somehow this data is transportable and all you need is for a trade association to agree to that is a naive view. A recent survey carried out by the Chemical Business Association revealed that three-quarters of major UK companies do not currently own the data that they need in order to get the registrations they would require under UK REACH, so I hope that the Minister understands that issue. It is all very well saying that the data can be ported and there is no need to duplicate it, but the data is owned.
- Animal testing is an issue of great importance to everyone in your Lordships’ House and REACH has successfully minimised animal tests through data sharing and other measures. That point was heavily promoted by the British delegation when REACH was created. The organisation, Cruelty Free International, estimates the number of tests across REACH’s 11 years to be around 4 million. All of us would agree that that is far too many, but considerably fewer than would have been necessary without REACH. There is genuine potential for duplication. It is all very well the Minister saying that that will not happen but it will because there will be regulatory divergence when there are two systems. As soon as you have regulatory divergence, it is inevitable that the HSE in this country and the ECHA in the rest of Europe will demand different or parallel data. That will come to pass and that is the point at which more testing will be required, and some of that testing will be on animals. When pressed by a parliamentary committee, Minister Coffey admitted that there could be an increase in animal testing if the UK is no longer a member of REACH, and that is unacceptable.