Official Report: Minutes of Evidence

The Chairperson (Ms Ferguson): I welcome Alan Ramsey, director of trade, innovation and priorities sectors division, Department for the Economy; and Warren Bell, Department for the Economy. You are very welcome, gentlemen. Please brief the Committee when you are ready.

Mr Alan Ramsey (Department for the Economy): Thank you. We are grateful for the opportunity to brief the Committee on the published replacement EU act on the EU Biocidal Products Regulation (EU) No 528/2012, specifically the expiry of certain regulatory data protections under article 95 of the act. The Committee was briefed at the proposal stage by our colleague Mark McGregor on 26 February. No formal comments were submitted by the Committee, and no immediate policy concerns were identified during the briefing. I can confirm that no material changes have been made since the regulation was first proposed. We have been engaging with the Health and Safety Executive (HSE) so that we can provide oral evidence today.

In summary, the regulation amends the EU Biocidal Products Regulation (EU) No 528/2012, which is under heading 24 of annex 2 of the protocol, to extend certain article 95 data protection periods that expired on 31 December 2025. The EU's review programme for existing biocidal active substances is heavily delayed, and the intent is to avoid a window in which competitors can rely on others' data without compensation, while keeping the system workable until the review programme ends.

In practical terms, the regulation does three things. First, it extends the protection for relevant datasets to align with the extended review programme end date, which is 31 December 2030. Secondly, it amends the rules so that data can become protected again. Thirdly, it adds a compensation element to address any gap between 1 January of this year and the date that the amending regulation applies, which is 15 June — next week.

As the Committee is aware, the biocidal products regulation sets the rules for approving and selling biocidal products, such as disinfectants, insecticides and preservatives, to protect human and animal health and the environment, while allowing products to move freely across the EU market. It is a highly technical area, and the Health and Safety Executive will continue to analyse what, if any, implications it may have for NI businesses. However, because the data protection rules do not directly affect which products may or may not be supplied in NI and GB, the differences in position are not anticipated to cause any issues for GB-NI trade.

While the NI biocidal market is small, the Health and Safety Executive recognises that the individual businesses in Northern Ireland may, nevertheless, have experienced impacts during the interim period, including a possible loss of protection for data that they had generated and paid to generate. The regulation is intended to mitigate the effects by restoring data protection and enabling data owners, including those based in Northern Ireland, to seek compensation where others have benefited from the temporary absence of protection. The Health and Safety Executive will keep that under review and engage with the stakeholders as appropriate.

If the regulation is delayed, the unprotected period will continue, data owners will remain exposed to uncompensated reliance, and other businesses will face ongoing uncertainty as to future liabilities. The affected data would remain unprotected for the remainder of any review programme, with continued risks to investment incentives, market behaviour and regulatory alignment.

Chair, I hope that that is a useful overview. We are happy to take any questions. The key point is that there has been no material change from the proposal stage.

The Chairperson (Ms Ferguson): Thank you, Alan.

Mr Buckley: Thank you, Alan. I have a number of questions. First, the correspondence between the House of Lords Northern Ireland Committee and the Government does not give us much detail on the progress. That Committee specifically asked whether there was any detail on the compensation scheme. The Government came back and said that there was no operational detail. Has there been any update on that since that correspondence nearly a month ago?

Mr Ramsey: I do not believe so. At that stage, the Government had not confirmed the operational aspects of the scheme. Warren, are you aware of any updates?

Mr Warren Bell (Department for the Economy): No. I have been liaising with the HSE, and there have been no further updates on that.

Mr Buckley: OK. The HSE talked about carrying out a specific piece of work on that. It talks about it being complex, but it is doing some work on whether there are any interactions between the GB and EU regulatory schemes. HSE will not conclude its assessment until the final form of an agreement is clear, so it is clear that that particular aspect falls into the wider talks about sanitary and phytosanitary (SPS). Has any specific information been provided to you, or, indeed, to HSE through you, on the current status?

Mr Ramsey: Our understanding is that the biocidal products regulation will fall within the scope of the agri-food agreement between the UK and the EU. I am not sure whether we have any further detail. Do we, Warren?

Mr Bell: There have been no further updates since the update last month.

Mr Buckley: OK. The regulation is about data protection and extensions of certain periods. Therefore, in theory, it should protect some Northern Ireland businesses that might be captured by that and might be at risk of losing data. The regulation is about data protection periods, but were any other products to be added or removed from the biocidal product regulations, would that matter come before the Committee?

Mr Ramsey: I do not think so, Jonathan, because the list is confined to the remaining products that are on the review programme, so I do not anticipate that changing.

Mr Buckley: After the period for data collection ends and the review recommends adding or removing things from the list, your understanding is that it would not come before the Committee in a subsequent regulation or in another form to, for example, add or take away things. Is that correct?

Mr Ramsey: I do not think that we could say anything 100% for sure on that, Jonathan. At the moment, we are working on the basis of information that we have on the 360-plus items that are on the list. I do not think that we can be definitive about anything outside that at this stage.

Mr Buckley: OK. The House of Lords Committee also referred to Northern Ireland manufacturers and supplier events, asking whether they were:

The Government came back to say that there had been no interaction with Northern Ireland businesses in that regard. Do we have any understanding as to whether the supply chain for Northern Ireland was referenced by any of the GB companies in its deliberations?

Mr Ramsey: We do not have that information, Jonathan, I am afraid. We could ask. We could go to the UK Government and the HSE and enquire about that.

Mr Buckley: That would be useful, since the biocidal market in Northern Ireland is very small. Therefore, the onus is on the GB supply chain to flag concerns. That is all from me, Chair. Thanks.

Dr Aiken: I do not know whether you have seen the correspondence from the House of Lords Northern Ireland Scrutiny Committee to Steve Timms. It is the same thing that Jonathan was talking about. It says that when a call for evidence went out in Europe, there were "widespread industry concerns". Do you know or have you tried to find out what those widespread concerns were?

Mr Ramsey: I think that it was just a concern about the loss of protection for that six-month period; that is, from 1 January of this year. The way that the model works means that anyone who had invested in getting the regulatory data would be compensated for that investment through other people seeking to get regulatory cover. They pay them, essentially, for the work that they have done. There was a concern that there is the potential for other companies to get a free ride by coming in and basically enjoying the fruits of others' investments.

Dr Aiken: It seems strange. It is one of the first times that we have seen that, when people look at European regulations, they see that industry had "widespread" concerns. I do not know what those widespread concerns are. If we are saying that there is no change, it may just mean adding an additional word. The fact that there were widespread industry concerns stands out. I would not have an issue with the regulation, but it makes me nervous when someone talks about "widespread industry concerns" and we do not know what they are.

The Chairperson (Ms Ferguson): Will you set out what it would mean if the regulation were not applied?

Mr Bell: I refer to the final paragraph: if the regulation is delayed, the uptake period will continue, data owners will remain exposed to uncompensated reliance, and other businesses will face ongoing uncertainty as to the future liabilities. If the act were not to be adopted, the gap would become the default position. The affected data would remain unprotected for the remainder of any review programme, with continued risk to investment incentives, market behaviour and regulatory alignment.

Dr Aiken: For clarification, it does apply, does it not? It is not a question of whether it applies; it does apply. It applies now. No matter what we say or do here, it does not make any difference; it applies now.

Mr Bell: The fifteenth of June.

Dr Aiken: Yes.

Mr Buckley: This is about extending it.

Dr Aiken: Yes, this is just to extend it. We have no vires here, really.

The Chairperson (Ms Ferguson): Thank you, Warren and Alan, for your presentation this morning.