That the Grand Committee do consider the Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020.
My Lords, this draft statutory instrument was laid before Parliament on 15 October. Through this instrument, we are making the necessary arrangements to implement the terms of the withdrawal agreement and the Northern Ireland protocol in law for chemicals regulations. This will ensure that these regulations function effectively from the end of the transition period and that the existing high standard of protection for human health and the environment will be maintained.
In preparation for our exit from the European Union, a statutory instrument was made last year to ensure that the regulatory framework for chemicals remained functional after exit and to provide certainty for businesses and the public. It achieved that by making technical amendments to the retained EU law, such as changing EU-specific references and transferring functions and powers currently held by the European Commission to the appropriate authorities in each of the UK’s constituent nations.
Since the 2019 regulations were made, the withdrawal agreement, including the Northern Ireland protocol, has been agreed. The protocol requires that EU legislation will continue to apply in Northern Ireland after the end of the transition period. The existing EU exit legislation therefore needs to be amended to reflect the fact that retained EU law will be substantively applicable in Great Britain only.
If approved, these draft regulations will make the necessary amendments to three retained EU regulations as well as to EU-derived domestic legislation. I appreciate that the technical and composite nature of the regulations makes this particularly complex; the decision to present these proposals as a single instrument was for the benefit of the House, to reduce pressure on parliamentary time and to ensure that we are able to deliver an orderly transition. As this is such a technical instrument, I shall provide a concise summary of the regulations and the changes that we are making for noble Lords.
Of the three retained EU regulations to be amended, the first is the biocidal products regulation. This governs the placing on the market and use of products that contain chemicals which protect humans, animals, materials or articles from harmful organisms like pests or bacteria. This market covers a wide range of products such as wood preservatives, insecticides such as wasp spray, or anti-fouling paint to remove barnacles from boats.
Secondly, the classification, labelling and packaging of substances and mixtures regulation ensures that the hazardous intrinsic properties of chemicals are properly identified and effectively communicated to those throughout the supply chain, including to the point of use. The current classification laws are sophisticated and incorporate a detailed technical system of classification criteria. This classification is partly done through standardised hazard pictograms and symbols and warning phrases associated with specific hazards, such as explosivity, acute toxicity, or carcinogenicity.
Lastly, the export and import of hazardous chemicals regulations require the export of listed chemicals to be notified to the importing country and, for some chemicals, the consent of the importing country must be obtained before export can proceed.
This instrument makes three main changes, which I shall summarise. First, we are updating some transitional provisions in the 2019 regulations so that they apply from the end of the transition period, when the retained law comes into force, rather than from exit day. It should be noted that while this instrument’s title references genetically modified organisms, the only amendments to the relevant legislation are to update two references to “exit day”.
Secondly, it removes Northern Ireland from the scope of the 2019 regulations by omitting references to Northern Ireland and changing UK-specific references to read “Great Britain”. The instrument also revokes changes made to domestic legislation in Northern Ireland in the 2019 regulations, which are no longer required due to the protocol. Lastly, this instrument legislates for the Government’s commitment on unfettered access for these chemical regulations as well as the need to ensure that UK authorities have the appropriate information and regulatory safeguards in respect of chemicals placed on the market in Great Britain.
The Health and Safety Executive currently acts as a UK competent authority within the EU regimes for chemicals regulation. Under this instrument, it will become the GB regulatory authority. The Health and Safety Executive for Northern Ireland will be the regulatory authority with responsibility for Northern Ireland, and we are working closely with Northern Irish colleagues to prepare for the end of the transition period and support them afterwards. Both organisations have demonstrated their resilience through the pandemic, and I am confident that they have the capacity to undertake any new responsibilities brought about by EU exit.
This instrument was not subject to consultation as it does not alter existing policy. Published guidance has been followed and, in line with it, a full impact assessment has not been conducted as the instrument does not meet the de minimis threshold. However, I assure noble Lords that the changes brought about by it have been communicated through a series of stakeholder events throughout autumn and guidance published on the HSE website in October.
The devolved Administrations have also been fully engaged in the development of this instrument and have provided consent for the elements that relate to them. We are also in the process of agreeing a provisional common framework for chemicals that aims to maintain existing standards and promote common approaches to chemicals policy in the future.
In conclusion, this instrument will provide important continuity and clarity to the chemicals industry, ensuring that the legal requirements that apply to chemicals regulation are clear following the end of the transition period. I hope that colleagues of all parties will join me in supporting the draft regulations, and I commend them to the Committee. I beg to move.
My Lords, I thank all noble Lords who have contributed to this debate. I too add my thanks to the officials, who have helped us understand the detail of this SI and whose support has proved invaluable.
In winding up, I will address some of the important points raised during the discussions. First, my noble friend Lady Altmann mentioned the CLP and the MCL list. This will copy all existing harmonised EU classifications on 1 January, and HSE will be able to carry out its responsibilities to update.
The noble Baroness, Lady Bennett, talked about the chemical cocktail effect. I will ensure that the Health and Safety Executive writes directly to her and that a record is sent to all Members in the Committee and placed in the Library. The noble Baroness also talked about REACH. The REACH regulation is not included in this SI. Defra has the policy responsibility for the REACH regulation and has brought forward separate legislation on it, which I understand was debated yesterday.
The noble Baroness, Lady Bennett, and my noble friend Lady McIntosh talked about GMOs. The responsibility for aspects of GMO policy is spread throughout government. However, regarding contained usage, there will be no reduction in standards, and existing protections covering human health and the environment are maintained and will continue to work in the same way post EU exit.
The noble Baroness, Lady Sherlock, and my noble friend Lady McIntosh talked about resourcing and recruitment. The Health and Safety Executive has identified a total of 147 posts to be filled by the end of the financial year. We have made good progress and at present we have filled 108 of the 147 posts—73%—and are confident that this means we will be ready for the end of the transition period. Of the 73% of posts we have filled to date, we expect the vast majority to start in January, with the remainder taking up post before April. Several campaigns are still ongoing and due for completion in January 2021. We will continue to seek recruitment into our outstanding posts as a priority until the end of March. In total, we are recruiting an additional 117 brand new posts into the Chemicals Regulation Division relating specifically to EU exit. This represents a 45% increase in our baseline staffing number—260—from January 2020, and demonstrates our significant commitment to take on the new functions required.
My noble friend Lady McIntosh raised the issue of animal testing and asked whether, if we cannot access animal testing data, that would require applicants to do more tests. The Health and Safety Executive will apply the principle in the biocidal products regulation that vertebrate tests “shall not be repeated” and may be undertaken
“only as a last resort.”
Therefore, if the data owner has not submitted the study to the HSE, we would expect the applicant to make every effort to obtain access to it. Should the applicant not be able to reach agreement on data access with the data owner, decisions would need to be made on a case-by-case basis and we would need to discuss options with the applicant. We would accept a vertebrate study only if all options had been exhausted; I understand that this is the “last resort” principle.
My noble friend also talked about GMOs and contained use. We will not reduce standards and changes to legislation will follow the usual scrutiny and consultation.
The noble Baroness, Lady Parminter, talked about timescale changes and Article 37 of the CLP. This instrument amends the timescales put in place by the SI made in 2019 due to operational concerns raised since then. These amendments will ensure that the HSE has sufficient time to carry out its operational responsibilities. In addition, the current wording of the EU regulation states that decisions are taken “without undue delay”. However, those affected by regulatory decisions should be clear about when those decisions will take place. Therefore, our amendments specify that a decision is required within three months of a recommendation being made to Ministers and that, within one month of the decision, the HSE must update the GB MCL list.
The noble Baroness also asked about certainty for business. The decision to amend the timescales so that they are operationally deliverable was made under the advice of and after consultation with the specialist regulatory scientists in the HSE and the devolved Administrations. The system mirrors the EU system as much as possible so that the industry will be familiar with the assessment process.
The noble Baroness, Lady Parminter, also mentioned environmental assessment as part of the process. As part of the technical assessment, the HSE must look at the impact that a substance’s intrinsic hazards may have on environmental end-points. The HSE is supported by the Environment Agency in undertaking this work.
The noble Baroness, Lady Sherlock, and my noble friend Lady Altmann referred to unfettered access. The Government’s approach to unfettered access and the Northern Ireland protocol was set out in the main Command Paper and subsequent business guidance. This outlines that there will be some specific requirements for movements from Northern Ireland to GB for items categorised as highly regulated goods. Chemicals are highly regulated goods because they can pose a significant risk to human health and the environment.
The noble Baroness, Lady Sherlock, asked whether the Health and Safety Executive undertakes assessments for biocidal products during the 90-day period. All chemicals are highly regulated goods because they can pose a significant risk to human health and the environment. There is a transparency requirement for a Northern Ireland business to notify the Health and Safety Executive with information that it would submit to the EU before the biocidal product is placed on the market.
On the noble Baroness’s question about finances, I can confirm that, for the 2020-21 financial year, an additional £6.1 million was made available, with £1.6 million for the DWP and £4.5 million to help Defra to prepare for delivering the new chemicals framework. This represents a 60% increase on the 2019-20 financial year.
As many noble Lords will attest to, our chemicals sector is world-leading and vital for other key industries, such as the pharmaceutical, automotive and aerospace industries. We want to make sure that this continues. We also need to provide certainty for businesses in Northern Ireland to ensure both that the statute book is fully functional for the end of the year and that those businesses have unfettered access to the market in Great Britain. This instrument seeks to do that and meet our obligations under the protocol.
I am sure that noble Lords are all with me on the fact that we need to provide continuity and clarity to the chemicals industry following the end of the transition period. I want to ensure that legal requirements that apply in relation to chemicals regulations are clear and provide certainty to all. We must maintain our high level of protection in the workplace and for others, which this instrument will do.
I hope that I have covered all the points that were made. I will look at Hansard and, if there any points that I have not covered, I will make sure that noble Lords are written to.