My Lords, this debate was always going to raise great passions and I understand the different views on each side of the debate. I thank noble Lords for their contributions, and reassure the noble Baronesses, Lady Hayman of Ullock and Lady Jones of Whitchurch, that the Government agree that the operation of UK REACH should be transparent and accountable.
This is why under Clause 29(3) the OEP may give advice to a Minister on any proposed changes to environmental law, including any relevant amendments to the REACH regulation. This advice would be published and the OEP could comment if it thought the Government were seeking to inappropriately amend a protected provision. The Bill protects key provisions relating to the fundamental principles of REACH. I urge noble Lords to look at the very long list in Schedule 20 on page 250 of the Bill. I am sure they have done; this is explicitly outlined.
The Government will not change what REACH sets out to achieve, including a high level of protection of human health and the environment, which is set out in Article 1. Any breach of these provisions’ protected status could be subject to legal challenge, including by the OEP. In addition, any proposed amendment to the REACH regulation must be consulted on, ensuring transparency in the process. Therefore, the Government do not consider this amendment to be necessary.
I turn to Amendment 289, also tabled by the noble Baroness, Lady Jones of Whitchurch. I hope it reassures the noble Baroness to know that the aims of this amendment are already achieved in Article 117 of REACH, which sets up a rolling programme of reports. Although it is not a protected provision, it is part of UK REACH and it requires reports from the Health and Safety Executive and the Secretary of State in the operation of REACH every five years, starting in 2022 and 2023 respectively. The Health and Safety Executive must publish a report on the operation of UK REACH by April 2022. The Secretary of State must then publish a general report by April 2023. These duties then recur every five years. The Secretary of State’s report must cover the Health and Safety Executive, as the UK agency, and progress towards the development of alternative test methods, including funding provided for that purpose.
The noble Baroness, Lady Hayman, asked about the duplication of testing—as indeed did a number of noble Lords. The Government are very keen to avoid the need for duplication or repeats of animal tests carried out for the purposes of EU REACH. That is why we will recognise the validity of data generated by any animal testing already done. Industry and the Health and Safety Executive must follow the “last resort” principle, so any proposal to carry out an animal test must be given rigorous scrutiny before it goes ahead. Before developing a new alternative for testing for a particular hazard, it is necessary to see whether one is even feasible. An alternative then needs to be developed and scientifically validated. This is done through the OECD to encourage the widest adoption.
On the amendments tabled by the noble Baroness, Lady Bakewell of Hardington Mandeville, the Government share her aim of avoiding unnecessary animal testing, which is why we have enshrined the “last resort” principle as a protected provision in Schedule 20 to the Bill.
On Amendments 277 and 282 specifically, the concept of “read across” from one chemical to a similar one is already encouraged and widely practised in REACH, but it needs to be considered in each case whether it is appropriate and not applied in a blanket manner. For example, reading across from a less to a more dangerous chemical could result in risks to human health or the environment going unidentified. The Bill ensures that amendments to UK REACH are carefully considered through consultation, drawing on the scientific expertise in the Health and Safety Executive and acting with the consent of the devolved Administrations on devolved matters. The Government believe that we should follow those good practices right from the beginning.
On Amendment 281, the powers in Schedule 20 to the Bill to amend UK REACH would enable such targets to be built if that was felt to be appropriate. Any amendments would have to be consulted on and consistent with the aims and principles of UK REACH, as set out in Article 1. The Government consider that this would be the better route if we concluded that targets were desirable.
There is also an important practical issue. There is an accepted scientific process for developing new test methods. Before developing a new alternative for testing of a particular hazard, as I said, it is necessary to see whether one is even feasible. The alternative then needs to be developed and scientifically validated. This process is done through the OECD to encourage the widest adoption.
On Amendment 296, the Government agree that the HSE, as the UK REACH agency, must operate in a transparent manner, including on matters connected to animal welfare. That is why the general duty in Article 109 to adopt rules about transparency has been included among the protected provisions listed in this schedule. But the Government do not believe it would be appropriate to use the protected provisions to freeze the detailed processes that REACH lays down, such as the publication and consultation arrangements contained in Article 40(2).
Similarly, on Amendment 294, Article 13 already contains the powers we need to amend the REACH annexes to replace animal tests with alternatives where appropriate, and the Government do not think it would be sensible to freeze those processes by fixing them in primary legislation.
On Amendment 295, the Government agree with the aim that companies should share data on chemicals to avoid duplicate animal testing and to reduce costs. However, the articles affected by this amendment contain prescriptive detail, such as the speed at which companies should pass information to each other. Again, the Government believe we should continue to be flexible and not remove that possibility by including them as protected provisions.
Finally, regarding Amendment 297, while it may be appropriate to amend the REACH annexes in the future to follow evolving scientific consensus on animal testing, the power to amend them is already contained within REACH itself. It is therefore unnecessary to add an overlapping power in the Bill.
The noble Baroness, Lady Hayman, asked me about the resource adequacy of the HSE. It has 130 extra staff and the Environment Agency has had considerable increases in its resources. Defra continues to add resources to both. Probably one demonstration that that resource is adequate is that 9,000 grandfathered registrations have already been notified on to the UK system and 5,000 chemical substances are on it so far. The next deadline is 300 days, which is
On enforcement and oversight, UK members of the European Chemicals Agency’s committees frequently pressed the agency to be more rigorous in avoiding the use of animal tests, and we shall work with the Health and Safety Executive to ensure good enforcement of that principle within UK REACH. I add that the use of cell cultures has grown hugely in the past few years and taken over some of the primary testing of animals. Most animal testing is now restricted to medical research and, as the noble Baroness, Lady Fox, stated, it is a strongly regulated market; you no longer see beagles forced to smoke cigarettes. Also, the cost of keeping animals, fortunately, makes keeping them for testing almost prohibitive, in many circumstances.
It always makes me anxious coming to the questions of the noble Lord, Lord Teverson, because I know what a specialist he is in this field and have read a number of his contributions to SI debates in the past. On his first point, although EU REACH still applies to Northern Ireland, and he is absolutely right that the domestic REACH system regulates the Great Britain market, it also contains some provisions that apply to Northern Ireland businesses to facilitate their access to Great Britain.
On chemicals and the EU trade and co-operation agreement, the Government welcome the friendly co-operation the EU and UK have had on chemicals regulation, which the chemicals annexe will support. The UK’s proposal for a chemicals annexe included an arrangement to share REACH registration data. We worked closely with industry in the UK and EU in developing this proposal but, unfortunately, it was not possible to reach agreement in this area. As the noble Lord will understand, the EU was not prepared to discuss the UK’s data-sharing ask.
UK REACH will retain the fundamental approach and key principles of EU REACH, and the Government are keeping the transition as simple as possible. We have extended the deadlines for businesses to provide all the registration data needed to comply with UK REACH. In trying to minimise the costs and burdens on chemicals businesses, we have developed these grace-period provisions, grandfathering and downstream user import notifications to minimise disruption to businesses and supply chains. We will keep all these timeframes under review. On the TCA, we asked to share information between companies, but this was not included, as the noble Lord will know. On that basis, I ask noble Lords to withdraw or not move their amendments.