Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020
(3 years, 4 months ago)
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Baroness Stedman-Scott
That the Grand Committee do consider the Chemicals (Health and Safety) and Genetically Modified Organisms (Contained Use) (Amendment etc.) (EU Exit) Regulations 2020.
The Parliamentary Under-Secretary of State, Department for Work and Pensions (Baroness Stedman-Scott) (Con)
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.
Baroness Altmann (Con)
My Lords, I thank the Minister for her excellent explanation of the statutory instrument before us. As she mentioned, there are three issues in one. They have some complexities attached, but in my view the aim of the statutory instrument is important and welcome. I hope all noble Lords will be content with it.
All three issues, although separate, are important from the point of view of public health and safety. When we are dealing with biocidal products or the classification and labelling of potentially hazardous products, as well as imports and exports of hazardous chemicals and pesticides, it is only right that the Government make sure that they address the various issues that will need to be taken care of as we leave the EU.
I welcome the Northern Ireland protocol and recognise the need to separate GB from Northern Ireland, which is entailed in these instruments. I also welcome the fact that small businesses are not exempt because, when we are dealing with products and issues of this nature, it is really important that we and the public can be confident that all kinds of hazards are being considered.
I want to ask my noble friend the Minister about a particular issue. I also, by the way, put on record my thanks to her for arranging for interested Peers a very helpful briefing, attended by her and ministerial and official colleagues; it was very much appreciated. The issue concerns the resourcing of our hugely well respected HSE. The Health and Safety Executive will need to assess these various issues. I welcome the fact that the Government are introducing time limits; Article 37(5) of the CLP regulation, for example, currently states “without undue delay”. Providing a timeframe for approval is most helpful. How confident are the Government that the HSE is equipped to do this in the timescale required and with the resourcing implications of these timescales?
I also understand that the GB MCL list must be updated. I would like some clarification on the readiness of that list and the capacity both to identify the various potential problems and to notify those who will be affected.
I do not have much else to add on this matter. I welcome the instruments and thank my noble friend for her explanation of them.
Baroness Bennett of Manor Castle (GP) [V]
My Lords, it is a pleasure to follow the noble Baroness, Lady Altmann. I share her concerns about the Health and Safety Executive’s resourcing—something that there has been considerable public concern about in the context of Covid-19 and the many other threats that we see, particularly to workplace and public safety.
I feel that I should warn the noble Baroness, Lady McIntosh of Pickering, who will follow me in this debate—as she did in the debate on the previous statutory instrument, where she made a particularly excellent contribution—that I plan to be brief. I have two brief sets of questions.
My first question relates to the Explanatory Memorandum to the statutory instrument that this statutory instrument amends. It states:
“Each Administration of GB will continue to be able to make its own decisions about the release of GMOs in its territory. The existing processes for each Administration reaching its own decisions at national level will continue as now.”
I am aware that, as we speak, the internal market Bill is still the subject of debate and negotiation, we might say, in the Chamber, but I wonder whether the Minister can tell me how the rights to control the release of genetically modified organisms and the sale of products containing genetically modified organisms will relate to that Bill and the rules being made around it. Also, of course, there is the inevitable complication of how this will affect products going between Northern Ireland and Great Britain.
Also, that Explanatory Memorandum talks about the release of genetically modified organisms. Of course, no one can control the spread of genetically modified organisms and the genes that they contain; it is worth highlighting that point given that we share extensive borders. No Administration on these islands can control the spread of those genes or, potentially, those organisms.
Briefly, my second point addresses the biocidal products side of this statutory instrument. I note in particular research published last month in the peer-reviewed Science of the Total Environment journal that refers to the insecticides part of this statutory instrument. This research showed that two products—fipronil and imidacloprid—widely used in flea treatments for domestic animals, particularly dogs and cats, were showing up in very high levels in our rivers. Fipronil showed up in 99% of samples in 20 rivers, and in one case it was measured at 38 times the safe level. Are the Government looking at this issue, and indeed many other broader issues, as a matter of urgency?
One issue that is increasingly being thrown up by the science is what is known as the cocktail effect: the potential impact that the mixing of different chemicals, and interactions between antimicrobial resistance and different chemicals, might have on antimicrobial resistance, on human bodies and on the environment in general. It is very much rising up the agenda.
Baroness McIntosh of Pickering (Con) [V]
My Lords, I too welcome the regulations before us and thank my noble friend for moving them so eloquently. If she would permit me, I will put a couple of questions to her.
My noble friend explained the role of the Health and Safety Executive in becoming the regulatory authority for Great Britain under these regulations. We heard this week from my noble friend Lord Goldsmith, in connection with the REACH regulations that we considered in a similar statutory instrument Committee, that the department has recruited only 30 of the 300 staff needed to act to bring in GB REACH under this new regime, albeit that is a separate statutory instrument. Given the enhanced role that the HSE will play in setting up GB REACH, will my noble friend confirm that there will be sufficient staff in the Health and Safety Executive and that it will have sufficient resources to take on this additional role? Presumably it will already have been involved in liaising with ECHA or whichever EU body is concerned with this, but I have grave concerns that we will overtask the Health and Safety Executive with new responsibilities and find that it is understaffed and underresourced. I would be very grateful to have an assurance in that regard.
My next concern relates to paragraph 2.2 of the Explanatory Memorandum, which refers specifically to the fact that the biocidal products regulation
“sets timelines for Member State evaluations, opinion-forming and decision-making.”
It goes on to say that it
“promotes the reduction of animal testing by establishing mandatory data sharing obligations and encouraging the use of alternative testing methods.”
I am fully signed up to and very much support the mandatory data-sharing obligations and the use of alternative testing methods. What checks does my noble friend envisage there will be on these mandatory data-sharing obligations? I presume she will reassure me that we have come a long way from certain shops, which I will not name, that claimed that none of their products were tested on animals, only for us to find out after we had all bought them that in fact they had been. How do we know this data is tested and accurate?
Secondly, I am fully signed up to and would encourage the use of alternative testing methods, but can my noble friend explain what these alternative testing methods are and what regime is in place, and how these are monitored to ensure that they are fit for purpose? Again, this is an area that captures the public mood. The public want to buy products—cosmetics or whatever—that have not been tested on animals. This is something that captures the public imagination, so what alternative testing regime is in place?
Finally, paragraph 2.5 on page 2 of the Explanatory Memorandum to these regulations, to which my noble friend referred in her introduction, talks of
“measures for the contained use of genetically modified micro-organisms with a view to protecting human health and the environment.”
I feel that we still need to know a lot more about, and understand better, the use of GMOs. My question to my noble friend is a simple one. We were covered by the EU regime in this regard, and are now transitioning out and will, after 31 December, have left the European protections that we have previously enjoyed. Will my noble friend give a commitment today that any future use beyond the contained use which we currently understand will be brought forward by legislation—most likely, I presume, secondary legislation? Will she give a commitment that there will be no change to the current contained use, as set out today, without a further chance to have scrutiny of the necessary regulations ?
Having put forward my concerns, I hope that my noble friend will be able to give me the reassurance I am seeking.
Baroness Parminter (LD) [V]
Like my colleagues, I thank the Minister and the civil servants for organising the briefing meeting and for so patiently taking those of us who were there through this complex statutory instrument.
I certainly do not oppose the statutory instrument. I accept that there are no policy changes and that it is about operationalising existing legislation and implementing the Northern Ireland protocol. However, it is another SI that brings home the reality of Brexit and the loss of co-operation with the European Chemicals Agency, which, over decades, has built up its reputation as a centre of knowledge on the safe management of chemicals for the benefit of both humans and the environment.
We all share, I am sure, the hope that there is still a possibility of co-operation between the UK and the ECHA if there were to be a deal between the UK and the EU. Irrespective of that, the UK is now creating its own regulatory process, which will be a major headache for our businesses, with two time-consuming, separate processes if they want to sell products in both the UK and the EU, obstacles around data sharing and data rights, and indeed more expense.
As the noble Baroness, Lady Altmann, rightly highlighted, there is the risk of divergence, as the rules can be interpreted in different ways, with two different legal regimes. Clearly, that will mean divergence not just between the EU and the UK but, as this SI makes clear, between Northern Ireland and the rest of the UK.
One issue that I would like to touch on that other colleagues have not—I do not wish to repeat the excellent points that they have already made—is the fact that this SI specifies, for the first time, timeframes for the decision-making by the HSE and UK Ministers to approve substances after 31 December. Currently, the legislation states “without undue delay”. I contend that it could be seen as pre-emptive to batten down the hatches so firmly in this legislation by setting timeframes for those decisions.
Why? As the Minister made clear in her opening remarks, there has been no consultation on this statutory instrument. While of course businesses will always say that they want more certainty, we do not know that that is something that the business community really felt was an imperative. Secondly, as the noble Baroness, Lady McIntosh of Pickering, and others have made clear, the HSE has yet to have the capacity, and indeed the certainty of resources, to be able to deliver all those duties. So there is a real question mark about whether sufficient time is being given to undertake all the necessary tests, and to consult appropriately with affected stakeholders, so that the HSE and Ministers can form a judgment.
It is disappointing that in the Explanatory Memorandum there is no mention of undertaking environmental assessments, whereas it does mention working with economists to produce a proportionate impact estimate. That is particularly worrying, given that once the Environment Bill comes on to the statute book, all departments and agencies, including the HSE, will be obliged to apply the Government’s policy statement on environmental principles, including interpreting the precautionary principle. Therefore, like other colleagues, I hope the Minister can reassure us that there will be sufficient time and resources to undertake all the necessary tests so that business and the British public have continued confidence in the safety of the chemicals that will be used in our country.
Baroness Sherlock (Lab) [V]
My Lords, I thank the Minister for her explanation of these regulations and all noble Lords who have spoken for their contributions. I too am grateful for the briefing that we received from the officials, which transformed these rather complicated regulations into something that I could at least wrestle with in a fairly basic manner.
If I have understood them correctly, I think the Government’s intention is that, from the end of the transition period, the existing EU regimes at that point in time will be saved into national law through the provisions of the withdrawal Act, and that the primary point of these regulations is to correct deficiencies arising from Brexit beyond what was provided for in the 2019 regulations. Then, of course, there is the issue of Northern Ireland, where the protocol means that some areas of law in Northern Ireland will remain aligned with the EU.
I have questions about two areas on which I would like to get more information. First, on the question of Northern Ireland, the Minister mentioned unfettered access. Paragraph 17(1) of the Command Paper The UK’s Approach to the Northern Ireland Protocol says, about trade going from Northern Ireland to the rest of the UK, that
“this should take place as it does now. There should be no additional process or paperwork and there will be no restrictions on Northern Ireland goods arriving in the rest of the UK—that is, there will be unfettered access, as provided for by the Protocol.”
The thing is that, on the face of it, these regulations stop totally unfettered access for some goods, or at least they place a barrier to be overcome before a product can be marketed from Northern Ireland into GB. I am not saying that is a bad thing, just that it is different.
For instance, the regulations provide that for the BPR, where a Northern Ireland-based business has obtained an authorisation or permit for a biocidal product and wants to market that product in GB, the HSE will treat the product as authorised in the whole of the UK but only as long as certain conditions are met, including that the active substance is on the GB approved list and that the business notifies the HSE by submitting the same information that was submitted in support of the original authorisation. Once that authorisation has been submitted, the product can be sold in GB after 90 days, provided that the HSE does not raise any objections. If the HSE has any concerns about its safety or efficacy, it can request further information—another 90-day delay.
The HSE also has a safety valve. A product can be prohibited, or its sale or use restricted, if that can be justified on certain grounds, including environmental, the protection of health or life, the protection of vulnerable groups or animals or plants, and various other things, including artistic, historic or archaeological values.
I want to understand what is happening here. Is the HSE conducting an independent assessment of the safety and efficacy of a product, or is it simply checking that the product has met the regulatory requirements of the EU and then noting the information? If it is the former, then it is obviously possible that the HSE will reach a different view from that of the EU regulators. Indeed, because there is no dynamic alignment with EU standards after transition, it is entirely possible that our regimes will diverge over time. If so, how does that sit with the statement in the Command Paper that there will be no restrictions on Northern Ireland goods being marketed into the rest of the UK?
The second area I want to explore, as did most other noble Lords, is the role of the HSE in relation to these provisions and indeed Brexit. That was raised by the noble Baronesses, Lady Altmann and Lady Bennett, and other noble Lords. Essentially, the organisation is having to establish a new, independent regulatory regime for GB and have a regime aligned with the EU for Northern Ireland, all the while dealing with the huge challenge of helping to make workplaces Covid-secure during the pandemic, and in the context of having had its budget pretty much halved over the last decade.
I will ask the Minister some questions. First, on staffing, the noble Baroness, Lady McIntosh of Pickering, mentioned a commitment to recruit 300 staff, I think to cover the REACH business, of which only 50 had been hired. We were told in briefing that the HSE had plans to recruit 100 more staff by the end of January and up to 130 by the end of the financial year. Can the Minister clarify whether these are two separate figures? Is the figure I mentioned of 100 and 130 just for the DWP-funded activity? If so, can she tell us how many of those staff have been recruited?
Secondly, how much additional money has the HSE been given specifically to cope with its new role in a post-Brexit world, separate from extra Covid funding, and what is that as a percentage of its budget? It is quite clear that the Committee wants to hear a categorical assurance from the Minister that Ministers have satisfied themselves that the resources available to the HSE are adequate to enable it to deal not just with Covid, but with its new regulatory and inspection regime. On a related point to that made by the noble Baroness, Lady Altmann, I would like to know specifically on the BPR authorisations what assessment has been made as to the capacity of the HSE to make all the necessary evaluations within 90 days of receiving the submissions specified in the regulations.
I have asked enough questions and other noble Lords have asked good ones too. I look forward to the Minister’s reply.
Baroness Stedman-Scott (Con)
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.
The Deputy Chairman of Committees (Baroness Pitkeathley) (Lab)
My Lords, that completes the business before the Grand Committee this afternoon. I remind Members to sanitise their desks and chairs before leaving the Room.