HSE Chemicals Legislative Reform Proposals

3.1.1 Biocides are products which are supplied with the intention of killing or controlling harmful organisms. They include a wide range of product types including insecticides, rodenticides, wood, fabric and construction material preservatives, disinfectants, water treatment chemicals and anti-fouling coatings on ships. They are regulated in GB under assimilated Regulation (EU) No 528/2012 on making available on the market and use of biocidal products (GB BPR).

3.1.2 Biocides are essential to society to control pests and to protect public health and infrastructure. However, they can also pose risks to people, animals and the environment if they are improperly used. To mitigate these risks, GB BPR puts in place a two-step process to ensure that biocides may only be supplied and used when the risks are demonstrated to be at an acceptable level.

3.1.3 At the first step, active substances (the active ingredients which give biocides their controlling effect) are subject to a thorough scientific risk assessment to ensure that their risk profile is acceptable and that they have the intended biocidal effect against the target organism. Following this, at the second step businesses may apply for authorisation for products containing, consisting of, or generating approved active substances. At this point a further risk and efficacy assessment is carried out on the product, considering its specific formulation and intended uses. HSE acts as the competent authority in GB on behalf of ministers and undertakes the necessary evaluations at both steps.

3.2 Transition from EU BPR to GB BPR

3.2.1 The regulatory regime set out in GB BPR was first established when the UK was a Member State of the EU, under the EU Biocidal Products Directive (Directive 98/8/EC). This was later replaced by the EU Biocidal Products Regulation (Regulation EU No 528/2012) on making available on the market and use of biocidal products (EU BPR).

3.2.2 Under the EU regulatory regime, work on evaluating active substances was shared between EU Member States and centrally co-ordinated by the European Chemicals Agency (ECHA). Biocidal products were authorised by Member States but with mutual recognition arrangements and a facility to authorise certain products across the EU.

3.2.3 When the UK left the EU, EU BPR was retained in GB under Section 3 of the European Union (Withdrawal) Act 2018. To coincide with EU Exit, amendments were made to GB BPR using powers in the EU Withdrawal Act. These amendments focused on adapting decision-making and institutional arrangements so that they were appropriate for the UK outside the EU. They did not permit wider policy changes. Therefore, in other aspects GB BPR remains identical to the EU BPR.

3.3 BPR Active Substance Review Programme

3.3.1 HSE inherited the EU’s review programme of existing active substances (defined as those in biocidal products on the EU market on 14 May 2000). At the time of Exit, 243 active substance/product type combinations had been approved. Following transitional arrangements put in place after Exit, approximately 330 active substance/product type combinations were resubmitted, representing about 72% of the EU total at that time. HSE, acting as the competent authority for biocides, is now responsible for evaluating the approximately 330 remaining active substances on a GB-only basis. This forms the GB Active Substance Review Programme (GB ASRP).

3.3.2 Alongside the active substances still waiting to be reviewed, those which were approved while the UK was in the EU are starting to expire. Normally first approvals of active substances last 10 years. Between the end of 2020 and the end of 2026, 111 active substance/product type approvals will have expired, though over time this will increase as the full set of approvals issued to date reach their expiry.

3.3.3 When active substance approvals expire, GB BPR requires an application to be made to renew the approval, which HSE must then evaluate. To prioritise its work in the early years after the UK left the EU, HSE gained agreement from ministers to postpone all expiry dates that fell between the end of the transition period (31 December 2020) and the end of 2026 until 31 January 2027, subject to a renewal application being received. However, the provisions that allow postponements to be issued are tightly defined and extensions will not be possible indefinitely. Therefore, they cannot provide a long-term solution.

3.3.4 Resourcing the active substance workload, both the GB ASRP and renewals, is a major challenge for HSE. Even based on optimistic estimates of the regulatory resources HSE will have available over the coming years, it is anticipated that the GB ASRP will take at least several decades to complete. Also, if the increasing number of renewals cannot continue to be postponed, HSE’s resources will need to be devoted increasingly towards renewing existing approvals rather than addressing the large backlog of first approvals. This will further slow progress on the GB ASRP.

3.3.5 These delays severely compromise HSE’s ability to regulate biocides efficiently and effectively which risks undermining the purpose of the biocides regime to protect people and the environment, in line with HSE’s strategy. Reforms are urgently needed to put the GB biocides regime on a sustainable footing.

3.3.6 Implications for the UK internal market and Northern Ireland (NI)

As outlined, the territorial scope of these proposals is GB. The Government is committed to protecting the whole UK internal market, including mitigating any regulatory barriers between NI and the rest of the UK. HSE’s general approach to mitigating regulatory barriers that may arise under GB BPR is to closely monitor EU regulatory decisions that apply in NI, to communicate these in a timely fashion to stakeholders so that they can plan and act where required. Where decisions introduce any regulatory differences between NI and GB, HSE works with stakeholders and the NI authorities to identify any potential impacts and any regulatory actions that may be needed to mitigate these.

3.3.7 This general approach will not change following the proposed reforms. However, by introducing additional flexibility into the GB regulatory framework, it will be easier for HSE to manage the flow of regulatory decisions in GB in such a way as to minimise any differences with NI where this is appropriate. Therefore, the reforms will support the Government’s commitment to protecting the UK internal market and minimising any barriers to trade in biocides between NI and the rest of the UK. This is explained further below for individual proposals where relevant.

3.3.8 To address these issues, HSE is exploring reforms in four areas, which collectively would significantly streamline and improve the flexibility of the regime, enabling it to function much more effectively in GB. These are:

• 3.3.8.1 Changes to support the recognition of international biocides approvals, and where appropriate, authorisations
• 3.3.8.2 Removal of active substance approval dates and calling in active substances for review
• 3.3.8.3 Expanded essential use provisions
• 3.3.8.4 Legislative powers to amend GB BPR

3.4 Changes to GB BPR to support the recognition of international biocides approvals

3.4.1 In line with the RAP, HSE is exploring introducing new provisions that would allow recognition of biocide approvals in foreign jurisdictions, where there is assurance that the foreign jurisdiction has similar standards for evaluation. This could apply to both active substances and biocidal products, though the case is more straightforward for active substances for reasons explained below.

3.4.2 Under the current provisions, HSE will always evaluate an application dossier before making a recommendation to the Secretary of State to approve an active substance, or before authorising a biocidal product. The proposal to recognise foreign approvals means removing this domestic evaluation and instead relying on the fact that approvals in trusted foreign jurisdictions have already been evaluated under similar standards. This would save the time and cost of undertaking evaluations for both applicants and HSE and has the potential to create substantial savings for applicants per application. Depending on how it is implemented HSE estimates that it could save up to 97% of the application fee (the current fee of the order of £160,000 could be replaced with a fee of around £5,000 per application – see 3.8.3), or it could operate without fees if recognition does not require an application to be made.

3.4.3 A list of countries, jurisdictions and other bodies would be deemed trusted jurisdictions where it can be established that regulatory standards for biocides are similar to and at least as high as those in Great Britain. Trusted jurisdictions could be listed in legislation, for example in a Schedule to an Act or set out in a statutory instrument so that it can be amended and updated. Given the close similarity in the GB and EU regimes, it would be likely that the EU would be included in any list, though the potential for any other countries or jurisdictions to be included is still being explored. HSE welcomes feedback on the prospects for recognising approvals or authorisations from outside the EU in response to this consultation.

3.4.4 To support the principle of recognition, several new powers would be required. These could include:

1. A power given to the Secretary of State (SoS) to approve biocidal active substances when they are approved in trusted jurisdictions. Another option is that approvals in listed jurisdictions are automatically approved (without a specific decision from the Secretary of State), while granting the Secretary of State powers to refuse an approval on specified grounds (see below, paragraph ‎3.4.5). Decisions would be subject to consent from ministers in Scotland and Wales, as at present.
2. A power given to the SoS to add further trusted jurisdictions to a list (for example in a Schedule to an Act or set out in a statutory instrument) where they meet suitable criteria – these are expected to include that standards and evaluation procedures are at least equivalent to those in GB.
3. A power to request information from any applicant as is necessary to advise the SoS on whether to recognise any active substance approval from a trusted jurisdiction. For example, it may be necessary to obtain more detailed information on the scientific evaluation or data underlying a foreign approval before it is recognised if there are specific issues of concern. HSE would likely seek regulation-making powers to set out any procedures for requesting information in more detail (see below, section ‎3.7). Data protection considerations may also require that an applicant submits data to HSE as a condition of recognising a foreign approval, but this is still being explored (see section ‎3.4.9).

3.4.5 A clause would also be required stating that the SoS or the competent authority (Scottish or Welsh Ministers for devolved matters) may refuse to approve an active substance approved in a trusted jurisdiction on specified grounds. While it is expected that most EU active substance approvals would be recognised, this is to ensure that there is flexibility not to do so where it would be harmful to GB interests. Grounds for refusal could include:

1. Absence of the target organism in GB or evidence that a biocidal product or active substance would not be efficacious against the target organism in GB
2. Where the SoS or the competent authority considers that it has not been demonstrated by the trusted jurisdiction that the biocidal active substance or biocidal product meets the criteria for approval/authorisation
3. Protection of the environment or public health in GB
4. Protection of cultural heritage in GB
5. Reasons of public policy or public security

3.4.6 HSE is also considering the introduction of a separate a power for it, as competent authority, to use any evaluation available to it, which it considers reliable, from any foreign jurisdiction to inform any evaluation of an active substance or biocidal product. This allows necessary further efficiency in processing applications, by enabling use of reliable information from jurisdictions where it may not be possible to fully recognise approvals due to differences in standards or methodologies. This proposal would rely on any evaluation being legally available to HSE to use.

3.4.7 The principle of recognising foreign approvals or authorisations could be extended to biocidal products. Like recognition of active substance approvals, this would require a power for the competent authority to authorise biocidal products authorised in trusted jurisdictions and also a power to refuse authorisations on specified grounds (similar to those listed in 3.4.5). However, recognising biocidal product authorisations from other jurisdictions may be less straightforward than recognising active substance approvals. Biocidal product evaluations are more likely to differ between countries, due to factors such as differences in product uses, climatic conditions, target species, resistance status, etc. Nevertheless, there would still be substantial efficiencies where this approach can be applied.

3.4.8 Recognising foreign approvals or authorisations also raises the question of how any subsequent decisions in the foreign jurisdiction would be handled, such as renewal, restriction or non-approval of an active substance. One option is for these decisions also to be recognised, similar to initial approvals. Another option would be for restrictions or bans to trigger a review in GB (similar to the call-in proposals described below, see ‎3.5.3). An intermediate option would be that a ban or restriction in a foreign jurisdiction would normally be recognised, but with an opportunity for applicants to submit a data package and pay for re-evaluation in GB in case of any concerns. However, for candidates for substitution² or products containing them, some further evaluation is likely to be needed in GB even if another jurisdiction renews, because regulatory decision making depends on whether there are suitable alternatives on the market and this may differ between countries.

3.4.9 HSE is aware that recognising foreign approvals or authorisations raises questions of data protection and data ownership. For example, if a company provided a data package to support an active substance approval in another country and GB recognises that approval, it would need to be determined whether, and how, that data could be protected if other companies then benefit from that approval in GB. As indicated above, one option could be to require an applicant to submit the underlying data package when a foreign approval or authorisation is recognised to support data protection in GB. HSE is considering these issues and would welcome feedback on matters to consider if the recognition approach is pursued.

² Candidates for substitution are active substances with specific intrinsic hazardous properties which are considered to be of higher concern. They are defined in Article 10 of GB BPR.

To what extent do you agree or disagree with the principle of enabling approvals of biocidal active substances granted in foreign jurisdictions to be recognised in Great Britain?

If you answered ‘don’t know’, please go to the next question. Otherwise, please briefly explain the reason(s) for your response.

To what extent do you agree or disagree with the principle of enabling authorisations of biocidal products granted in foreign jurisdictions to be recognised in Great Britain?

If you answered ‘don’t know’, please go to the next question. Otherwise, please briefly explain the reason(s) for your response.

Are you aware of any practical difficulties that might affect an approach to recognise active substance approvals granted outside GB?

If ‘yes’, please briefly explain what these practical difficulties might be.

Are you aware of any practical difficulties that might affect an approach to recognise biocidal product authorisations granted outside GB?

If ‘yes’, please briefly explain what these unintended consequences might be.

Are there any unintended consequences which you think may result from an approach to recognise active substance approvals granted outside GB?

If ‘yes’, please briefly explain what these unintended consequences might be.

Are there any unintended consequences which you think may result from an approach to recognise biocidal product authorisations granted outside GB?

If ‘yes’, please briefly explain what these unintended consequences might be.

To expand on HSE’s knowledge base, do you have any additional information about whether it would be appropriate to recognise active substance approvals granted outside the EU?

If ‘yes’, please provide any relevant and useful information here:

To expand on HSE’s knowledge base, do you have any additional information about whether it would be appropriate to recognise biocidal product authorisations granted outside the EU?

If ‘yes’, please provide any relevant and useful information here:

There are currently three proposed approaches to how subsequent decisions in recognised foreign jurisdictions - such as renewal, restriction or non-renewal of an active substance - should be handled in GB BPR. Please rank these approaches – so ‘1’ is your preferred approach, ‘2’ is your second preferred approach, etc.

(Note: candidates for substitution, or products containing them, would need further evaluation in GB irrespective of whether they are renewed in another jurisdiction)

Please briefly explain the reason(s) for your preferred approach (the approach you ranked number 1).

3.5.1 In addition to recognising foreign approvals, HSE is exploring the removal of all active substance approval expiry dates. Instead, approvals would be issued on the condition that the Secretary of State or the competent authority may ‘call in’ active substances at any time for review, using a risk-based approach. This would remove the current pressures to prioritise resources towards renewing existing approvals, and instead introduce flexibility for HSE to prioritise its evaluation work where it would have the greatest impact on reducing risks.

3.5.2 This would apply to active substances where the recognition approach above had not been taken, and therefore where there would otherwise still be a need for full evaluation and renewal by HSE. HSE is considering whether renewals should also be removed where a foreign approval has been recognised; this is closely linked to how renewals in the foreign jurisdiction are handled (see ‎3.4.8).

3.5.3 An active substance could be called in for a full re-evaluation in light of new evidence (similar to a renewal under the current system) or could be focused on specific parts which are of particular interest. Examples of such new evidence could include new studies indicating a previously unforeseen risk, a new mandatory classification and labelling decision, or adverse data from use of biocidal products containing the active substance.  In some cases, this could be planned in advance (for example if a range of active substances are to be re-evaluated in light of new guidance). Alternatively, if there is an urgent concern there would also remain the possibility to carry out unplanned reviews.

3.5.4 HSE is still considering the detailed operation of this proposal, such as the methodology of the risk-based approach to trigger a call-in and the sequencing and requirements for applicants. It is likely that secondary legislation would be needed to set out details.

3.5.5 Operating a call-in system may require industry to track new information on an active substance and make it available to HSE, to help inform whether active substances should be called in for review. This would be an alternative to the current renewal system, where a full renewal dossier must be submitted at defined intervals. There are several ways this could operate, for example, industry providing a periodic return to HSE on any new evidence likely to trigger the need for re-evaluation or making information available to HSE if requested. The impacts would need to be considered during development of secondary legislation. However, such a proposal would be implemented in such a way as not to increase burdens on HSE or industry, particularly considering that many applicants already monitor the performance of biocides on the market and collect adverse data.

3.5.6 Removal of expiry dates from biocidal products

HSE is also considering whether the same principles should be applied to biocidal products. This would mean that expiry dates are removed from all biocidal product authorisations meaning they would continue indefinitely unless called in for review. HSE, acting as competent authority, would selectively call-in authorised products for re-evaluation if there is emerging evidence of risk or based on other relevant considerations, for example if it is appropriate to re-evaluate authorised products based on changed risk criteria or guidance changes.

3.5.7 Another possible model would be to retain the current system for products, so that expiry dates remain in place and authorisation holders must apply for a biocidal product authorisation to be renewed before it expires if they wish to keep the product on the market. This could be done while removing expiry dates and operating call-in arrangements to active substances.

3.5.8 There are advantages and disadvantages to either approach. Removing expiry dates from products would be consistent with the approach being considered for active substances. It would allow HSE to better time product re-evaluations to follow shortly after active substance re-evaluations, allowing the conclusions to be considered. This may achieve greater efficiency and consistency than an approach where active substance and product re-evaluations could happen at different times.

3.5.9 Alternatively, continuing with the current renewal system for products ensures that product evaluations are updated to consider new evidence, guidance and evaluation criteria at more predictable intervals than if expiry dates were removed in favour of call-in arrangements.

3.5.10 HSE would welcome the views of respondents on whether the proposals outlined for active substances (removal of expiry dates with the possibility to call in for review) should also apply to biocidal products.

To what extent do you agree or disagree with HSE’s proposal to remove biocidal active substance expiry dates, and replace the process of periodic renewals with a process where active substances are called in for review based on new information?

If you answered ‘don’t know’, please go to the next question. Otherwise, please briefly explain the reason(s) for your response.

To what extent do you agree or disagree that there should be arrangements to require industry to provide information so that HSE can make evidence-based decisions on call in of active substances for review?

If you answered ‘don’t know’, please go to the next question. Otherwise, please briefly explain the reason(s) for your response.

HSE is considering different possibilities for how requirements to obtain new information could operate. Do you have any suggestions as to how we could best implement this approach? Tick the relevant answer.

If you have responded yes, please provide further information:

To what extent do you agree or disagree that biocidal product expiry dates should be removed, and the process of periodic renewals replaced with a system where biocidal products are called in for review based on new information?

If you answered ‘don’t know’, please go to the next question. Otherwise, please briefly explain the reason(s) for your response.

3.6.1 Where the Secretary of State decides not to approve an active substance in the GB ASRP, they can issue (with consent from ministers in Scotland and Wales) an ‘essential use derogation’ if the active substance is considered essential to society according to criteria set out in the legislation. This allows products containing the active substance to remain legally on the market and in use for a temporary period, while an application is prepared to approve the active substance. Current essential use provisions are set out in Article 22 of assimilated Regulation (EU) No 1062/2014 of 4 August 2014 on the work programme for the systematic examination of all existing active substances contained in biocidal products referred to in Regulation (EU) No 528/2012 of the European Parliament and of the Council (‘the Review Regulation’).

3.6.2 To count as essential, an active substance must meet the criteria set out in Article 5(2) of GB BPR, namely:

• it is shown by evidence that the active substance is essential to prevent or control a serious danger to human health, animal health or the environment
• not approving the active substance would have a disproportionate negative impact on society when compared with the risk to human health, animal health or the environment arising from the use of the substance

3.6.3 The essential use criteria are stringent so as not to provide a route to bypass the normal regulatory requirements. However, there have been cases where specific active substances have fallen within the criteria. Examples have included active substances that are critical for water treatment, preservation of wood in essential infrastructure, to avoid bacterial contamination in food and drink manufacture, and in transportation applications.

3.6.4 Currently active substances outside the GB ASRP cannot receive essential use derogations. Nevertheless, these active substances could also meet the criteria for being essential to society.

3.6.5 Loss of an important active substance or product has the potential for major adverse social and economic consequences. Although the purpose of the biocides regime, to protect people and the environment, must not be undermined, essential active substances or biocidal products will sometimes fall out of compliance with the GB BPR requirements for reasons unrelated to their risk profile. For example, this could happen because businesses who were previously supporting an active substance decide no longer to do so for purely commercial reasons.

3.6.6 HSE believes that to avoid the risk of such disruption, which could be significant and affect everyday life in the country and GB’s competitiveness, it should be possible for temporary derogations to be issued from the normal authorisation requirements for biocidal product whenever they are societally essential. Currently the provisions enabling this to happen are too inconsistent and leave the risk that HSE has no way of permitting essential products even when there are severe consequences if they must cease to be used.

3.6.7 HSE proposes that this could be remedied by granting a power to the Secretary of State to issue an essential use derogation at any time, and to any active substance that meets the criteria for being essential. It would then be possible for products containing that active substance to be authorised for the period of any derogation. To avoid potential abuse, it would be appropriate to include similar safeguards to those in place now, namely:

• there must be a public consultation on any proposed derogation
• any derogation must only apply as long as the conditions for being essential apply
• appropriate risk mitigation measures must be applied to minimise any exposure to people, animals and the environment
• it must be ensured that alternatives are being sought or an active substance application is being prepared during the period of the derogation

3.6.8 HSE will always consider UK internal market implications when deciding which substances should be considered essential. Where active substances are considered essential in GB, HSE will also work with NI authorities to consider whether action is required in NI to facilitate the same outcomes.

To what extent do you agree or disagree that the Secretary of State should have the power to issue an essential use derogation for any active substance at any time when it meets criteria for being societally essential, such as those defined in Article 5(2) of GB BPR?

If you answered ‘don’t know’, please go to the next question. Otherwise, please briefly explain the reason(s) for your response.

Are there any unintended consequences which you think may result from ‘expanded essential use provisions’ proposal?

If ‘yes’, please briefly explain what these unintended consequences might be.

3.7.1 GB BPR, like other chemicals legislation, is assimilated EU law. Although it was amended after the UK left the EU to be operable in GB, it is largely identical to the EU Biocidal Products Regulation.

3.7.2 Currently, there are no ongoing powers which allow GB BPR to be amended through secondary legislation. The Retained EU Law Act 2023 provides powers for assimilated law to be amended, subject to certain conditions. However, most of the powers expire in June 2026 and cannot be used if amendments are required beyond that date.

3.7.3 As assimilated EU law, GB BPR includes more prescriptive operational and procedural detail than is typical in UK law. Currently this detail requires primary legislation to amend, making it very cumbersome to introduce changes to improve the operability and efficiency of the regime.

3.7.4 To remedy this, HSE proposes to seek appropriate powers to amend GB BPR through secondary legislation. The scope of these powers will need to be clearly defined. Any powers to amend GB BPR through secondary legislation would be subject to parliamentary scrutiny but HSE envisages that such powers would include powers to:

1. Specify detailed arrangements for implementation of the international recognition power
2. Specify, amend or revoke detailed matters of operation in GB BPR and its supporting regulations, including procedures, timeframes and information requirements relating to any application or other procedure mandated in GB BPR
3. Specify matters in relation to how GB BPR and its supporting regulations will be enforced
4. Specify timeframes and information requirements in relation to any request for information as a condition for any active substance approval to continue
5. Address new risks to human health or the environment which may arise within the purposes of BPR 
6. Put in place transitional arrangements relating to any of the new provisions 
7. A further provision allowing amendments which reduce burdens on business while not reducing standards of health or environmental protection 

To what extent do you agree or disagree with HSE’s proposal to introduce powers to amend GB BPR using secondary legislation in the areas outlined?

If you answered ‘don’t know’, please go to the next question. Otherwise, please briefly explain the reason(s) for your response.

3.8.1 Estimated costs and savings of the proposals on biocides are based on previous impact assessments of the regulations, internal expert estimates and workplans for active substance and product assessments in GB and the EU. The figures are initial and reflect the early stage of policy development. They will be refined via further research, industry engagement and subsequent consultation on detailed proposals.

3.8.2 On recognising international biocides approvals, HSE estimates that for active substances, the vast majority (perhaps 97% to 99% based on an assessment of the number of active substances on the GB and EU Article 95 lists) would be eligible for recognition.

3.8.3 If EU and other international active substance approvals were recognised as they were issued (without the need for a GB applicant), then this would save the entirety of the assessment and fee that HSE would otherwise charge. This would be around £160,000. Alternatively, if HSE adopted a system whereby HSE would only recognise an EU or other international approval following an application and dossier submission in GB, this would be expected to incur a limited HSE review similar to a completeness check, charged at around £5,000.

3.8.4 HSE anticipates that choice of the recognition model would affect whether data protection could be claimed in GB, i.e. the ability for the company that owns data underlying an approval to charge others for access to that data. Subject to further analysis, HSE anticipates that granting data protection would rely on the data owner submitting a data package to HSE when a foreign approval is recognised. If there is no application, and no data protection, alternative active substance suppliers (other than the person who owns the data underlying the foreign approval) could benefit from the GB approval and supply the active substance for use in biocides without compensating the data owner. This could have implications for competition and the attractiveness of the GB market to investment and innovation, though we have not attempted to model this further at this stage.

3.8.5 For products, HSE estimate that between around one-third and two-thirds could be eligible for GB recognition of international authorisations. This estimate is based at the top end (two-thirds) on an assessment of the proportion of products authorised in GB that are also authorised in the EU; and at the bottom end (one-third) on an expectation that differences in authorised products in other jurisdictions would mean that more required detailed review by HSE.

3.8.6 HSE estimates that those products eligible for recognition of international authorisations might incur an assessment fee of between £200 and £1,000. The remainder would continue to require a fuller assessment and fees of around £58,000.

3.8.7 For both active substances and products, the timing and sequencing of approvals and authorisation based on international recognition will depend on the flow of such decisions from suitable international regulators. We do not currently anticipate that GB applicants for international recognition would make any savings or incur any additional costs in terms of dossiers of evidence as we understand that they would send to HSE the same dossier they had sent to any international regulator.

3.8.8 On removing active substance approval dates and calling in active substances for review, HSE estimate that around 29% of active substances might be in scope of being called in for review (based on an estimate of the number that are candidates for substitution), but this is a rough initial estimate and the actual number called in each year will depend on HSE’s assessment of risk for individual actives. In other cases, HSE might choose to recognise renewal decisions issued by the EU or other suitable international regulators.

3.8.9 For any active substances called in by HSE without an international decision to recognise, HSE estimate that assessment costs and fees might be between 25% and 100% of the current fee of around £220,000 – although such cases are expected to be very rare. Potential cost savings are due to HSE being able to focus the review just on the particular area of concern.

3.8.10 For any active substances called in by HSE with an international decision to recognise, initial estimates are that assessment costs and fees might be between around £25,000 and £30,000.

3.8.11 We do not anticipate that active substances going through the GB review process would incur any additional costs or make any savings in terms of dossiers of evidence as they would send to HSE what they had already shared with international regulators.

3.8.12 For products, again HSE estimate that perhaps 29% might be in scope of being called in, but actual numbers would depend on HSE decision-making based on intel on risk of individual products. For those products that would be called in, HSE estimate that assessment costs and fees might come to between around 75% and 100% of the current cost of around £5,700. As above, any savings are due to HSE being able to focus their review just on the particular area of concern.

3.8.13 For GB products that are not also on EU markets (around 32%), HSE estimate that they would save money on the compilation of a dossier of evidence where they are no longer subject to fixed renewal dates.