Biotech regulatory gaps

#33 — Phage therapy shows AMR promise but faces significant clinical, licensing, and testing barriers.

Public Accounts Committee

Recommendation: Another area of research interest is phage therapy, which involves using viruses as antimicrobials to kill bacteria and is less likely to lead to resistance.84 Dr Partridge told us that in his view phage therapy holds great promise as a …

Gov response: 6.1 The government agrees with the Committee’s recommendation. Recommendation implemented 6.2 The government is committed to ensuring evidence informs AMR policy, through providing research funding aligned with the NAP top 10 research priorities, collaborating on …

Accepted

#9 — Continue implementing Precision Breeding Act and seek exemption in EU SPS negotiations

Environment, Food and Rural Affairs Committee

Recommendation: The Government should continue implementing England’s Precision Breeding Act, actively progress regulatory procedures to bring precision bred plants to market, and seek a targeted exemption for precision breeding in negotiations with the EU on the SPS agreement. (Recommendation, Paragraph 34) …

Gov response: The secondary legislation needed to implement The Genetic Technology (Precision Breeding) Act 2023 for plants in England commenced on 13 November 2025. This marks a major milestone in delivering regulatory reform for precision breeding and …

No Published Response

#8 — EU genomic technology framework delay undermines UK precision breeding advantage

Environment, Food and Rural Affairs Committee

Recommendation: The EU’s forthcoming new genomic technology (NGT) framework could take several years to be finalised, and waiting for alignment between the EU and UK on precision breeding would undermine England’s first-mover advantage and stall the development and release of PBOs. …

Gov response: The secondary legislation needed to implement The Genetic Technology (Precision Breeding) Act 2023 for plants in England commenced on 13 November 2025. This marks a major milestone in delivering regulatory reform for precision breeding and …

No Published Response

#7 — Ensure new EU regulations for GB agriculture incorporate specific climatic and scientific data

Environment, Food and Rural Affairs Committee

Recommendation: The Government should ensure in negotiations that GB will only adopt new EU regulations on PPPs and mycotoxin limits where GB climate, growing conditions and scientific data have been fully considered in their development. It should seek assurances, as a …

Gov response: The government is committed to ensuring that the SPS Agreement delivers positive outcomes for businesses across the UK, while safeguarding our high standards. The Common Understanding is clear that the European Commission should consult the …

No Published Response

#6 — Legislative divergence risks inappropriate EU regulations for GB production systems

Environment, Food and Rural Affairs Committee

Recommendation: Legislative divergence between the UK and EU has occurred given the EU no longer considers GB-specific scientific evidence, such as climatic conditions relevant to mycotoxin formation or the agronomic need for certain plant 34 protection products (PPPs). As such, full …

Gov response: The government is committed to ensuring that the SPS Agreement delivers positive outcomes for businesses across the UK, while safeguarding our high standards. The Common Understanding is clear that the European Commission should consult the …

No Published Response

#27 —

Environmental Audit Committee

Recommendation: The Government should consult on mandatory PFAS disclosures across supply chains within six months, requiring manufacturers and importers to report the presence and purpose of PFAS in products placed on the UK market to support safe handling and disposal. (Recommendation, …

Response Pending

#22 —

Environmental Audit Committee

Recommendation: Whilst PFAS-containing consumer products remain on the market, the Government should introduce interim limits on PFAS levels and require standardised labelling to ensure consumers are fully informed. Implementation should be led by the Department for Environment, Food and Rural Affairs, …

Response Pending

#21 —

Environmental Audit Committee

Recommendation: The Government should set limits on the levels and types of PFAS permitted in food, giving producers, retailers, and regulators a consistent basis for protecting public health. This should include establishing and monitoring 45 limits on PFAS entering the food …

Response Pending

#17 —

Environmental Audit Committee

Recommendation: The Government should invest in long-term research on the health effects of PFAS exposure in the UK population. Within 12 months, it should publish a delivery plan setting out epidemiological studies to assess the cumulative impact of multiple PFAS and …

Response Pending

#16 —

Environmental Audit Committee

Recommendation: While gaps remain in understanding the toxicity of every individual PFAS, the evidence indicates that several PFAS are associated with a wide range of adverse health effects. Studies of highly exposed groups show clearer and more immediate risks, underscoring the …

Response Pending

#15 —

Environmental Audit Committee

Recommendation: The Government should consult on the establishment of an industry-funded mechanism to rapidly assess the properties and risks of newly developed PFAS before they are permitted for use, and invest in the development of 44 safer alternatives. This mechanism should …

Response Pending

#14 —

Environmental Audit Committee

Recommendation: The Government should draw on independent scientific and regulatory expertise in taking a group-based approach for PFAS regulation within three months of the EU’s forthcoming assessment. This should include assessing options for grouping PFAS with similar structures, so that future …

Response Pending

#13 —

Environmental Audit Committee

Recommendation: Without a broad, group-based restriction on PFAS, the Government risks a “whack-a-mole” approach. (Conclusion, Paragraph 56)

Response Pending

#12 —

Environmental Audit Committee

Recommendation: Due to the impracticality of assessing thousands of PFAS one by one, and the risk that new substances emerge faster than they can be evaluated, the UK’s current approach leaves regulators struggling to keep pace with industry innovation. While the …

Response Pending

#11 —

Environmental Audit Committee

Recommendation: Replacing one PFAS with another can perpetuate long-term environmental and health risks and can lead to regrettable substitutions, whereby banned substances are rapidly replaced by chemically similar and potentially harmful alternatives. (Conclusion, Paragraph 54)

Response Pending

#10 —

Environmental Audit Committee

Recommendation: The Government should commission the Health and Safety Executive under UK REACH to bring forward restrictions on PFAS in non-essential consumer products (e.g. food packaging, cookware and school uniforms) without delay and begin a phased restriction from 2027. (Recommendation, Paragraph …

Response Pending

#9 —

Environmental Audit Committee

Recommendation: The Government should adopt an essential-use approach to regulating PFAS, prioritising the rapid restriction of PFAS in non-essential applications. Clearly defined exemptions should be set for essential uses, with time-limited derogations where substitutes are still being developed. (Recommendation, Paragraph 46)

Response Pending

#8 —

Environmental Audit Committee

Recommendation: The Government should reform UK REACH by March 2027 to avoid further delay in restricting PFAS. The Government should set targets at half the statutory maximum timescales and ensure that the Health and Safety Executive has the resources to meet …

Response Pending

#7 —

Environmental Audit Committee

Recommendation: UK REACH must be reformed to enable swifter restrictions on PFAS to ensure the UK can align with emerging evidence to act more quickly on substances of concern. (Conclusion, Paragraph 37)

Response Pending

#1 —

Environmental Audit Committee

Recommendation: PFAS are highly persistent, bioaccumulative chemicals with the potential for long-term environmental and human harm, despite ongoing scientific uncertainties around the toxicity of different PFAS. (Conclusion, Paragraph 22)

Response Pending

#16 —

Science, Innovation and Technology Committee

Recommendation: The Government should consider requiring any manufacturer making genomic tests available to consumers in the UK to register a legal representative in the UK, with responsibility for ensuring that products supplied to consumers in the UK meet all relevant UK …

Gov response: MHRA’s public consultation explores the registration of medical devices in the UK and the outcome of this will help to inform future policy on this recommendation.

Under Consideration

#3 —

Science, Innovation and Technology Committee

Recommendation: Most manufacturers of genomic tests sold directly to consumers can self-certify the conformity of their products to performance requirements. The Medicines and Healthcare products Regulatory Agency has suggested that this restricts its ability to ensure that genomic tests on the …

Gov response: The outcome of MHRA’s public consultation will help to inform future policy on how DTC genomic tests are regulated and in turn, how they are assessed prior to being placed on the UK market.

Under Consideration

#1 —

Science, Innovation and Technology Committee

Recommendation: A range of benefits and concerns have been raised regarding the availability of genomic testing for direct purchase and use by consumers. These apply to all types of genomic tests, but are arguably most acute for tests used for medically-related …

Gov response: The Government recognises both the opportunities and risks raised by direct-to-consumer genomic tests and is committed to ensuring effective and proportionate regulation. The MHRA is working to develop a robust, world-leading regulatory regime for medical …

Under Consideration

#2 —

Public Accounts Committee

Recommendation: The Department and regulators have been slow to follow best practice in facilitating innovation. The Government’s 2019 White Paper ‘Regulation for the 4th Industrial Revolution’ found that only 29% of businesses believed that government’s approach to regulation facilitates innovation. The …

Gov response: 2: PAC conclusion: The Department and regulators have been slow to follow best practice in facilitating innovation. 2: PAC recommendation: Government should require regulators to engage meaningfully with businesses to explore potential new ideas and …

Not Addressed

#18 — Commission ONR to develop proposals for a replacement methodology to SUPDC.

Energy Security and Net Zero Committee

Recommendation: The Government should commission the Office for Nuclear Regulation to develop proposals for a replacement methodology to SUPDC. The ONR could consider the risks posed by different nuclear technologies, recognising that some novel technologies may pose greater or lesser risks …

Gov response: as part of new models, as well as the potential benefits of new nuclear for achieving Net Zero and our energy security, we are committed to reviewing the criterion following EN-7’s designation. We note the …

Not Accepted

#7 — Urgently move psychedelic drugs to Schedule 2 to facilitate medical research.

Home Affairs Committee

Recommendation: We welcome the UK Government’s commitment to reducing barriers to researching psychedelic drugs under Schedule 1 to the 2001 Regulations. Pending the outcomes of the ACMD’s ongoing review of Schedule 1 controlled drugs, we recommend the UK Government urgently moves …

Gov response: The Government awaits the ACMD’s advice, which it will consider carefully before taking a decision. This process is a statutory requirement that must be met before amending the Misuse of Drugs Regulations 2001. In December …

Under Consideration

#38 —

Environmental Audit Committee

Recommendation: The Government must commit, within six months, to funding the research and development of non-incineration PFAS destruction technologies through UK Research and Innovation and Innovate UK. (Recommendation, Paragraph 125) 48

Response Pending

#37 —

Environmental Audit Committee

Recommendation: The Government should assess the volume of PFAS containing waste expected from forthcoming restrictions and determine whether UK high- temperature incineration capacity is sufficient. The Government should write to the Committee with its findings and proposed actions within six months. …

Response Pending

#36 —

Environmental Audit Committee

Recommendation: PFAS contamination cannot be addressed without reliable destruction capacity. Current UK incineration capacity is insufficient to treat the increasing volume of PFAS containing waste diverted from landfill, and significant gaps remain in the availability, scalability, and verification of other destruction …

Response Pending

#35 —

Environmental Audit Committee

Recommendation: The Government must publish formally approved guidance for PFAS remediation to provide businesses, local authorities and regulators with the certainty needed to deliver timely, safe and effective remediation. (Recommendation, Paragraph 116)

Response Pending

#34 —

Environmental Audit Committee

Recommendation: The Government should support the development and deployment of scalable, cost-effective PFAS remediation technologies by directing investment through UK Research and Innovation into research, innovation and practical support. (Recommendation, Paragraph 115)

Response Pending

#33 —

Environmental Audit Committee

Recommendation: Industry urgently needs clear direction and Government approval on viable remediation methods so that contaminated materials can be treated safely and at scale. (Conclusion, Paragraph 114)

Response Pending

#32 —

Environmental Audit Committee

Recommendation: Existing PFAS contamination in the environment must be addressed alongside prevention. Even with strong restrictions on future PFAS use, the UK already faces significant legacy contamination. Without action now, this legacy burden will pose long-term risks to public health and …

Response Pending

#31 —

Environmental Audit Committee

Recommendation: The Government should apply the polluter pays principle to prevent ongoing and historic PFAS contamination and consult by March 2027 on establishing a national PFAS Remediation Fund. The Government should: • explore the implications of an emissions levy for PFAS …

Response Pending

#30 —

Environmental Audit Committee

Recommendation: The Government has not applied the polluter pays principle adequately to deter future PFAS emissions nor has it allocated sufficient government funding to tackle the remediation of PFAS in the environment where liable parties cannot be identified. (Conclusion, Paragraph 107)

Response Pending

#29 —

Environmental Audit Committee

Recommendation: Remediating PFAS contamination in the environment is expensive and technically complex. The current regulatory approach that permits continued use of PFAS until harm is proven means that these substances can legally continue to accumulate in the environment, steadily increasing the …

Response Pending

#28 —

Environmental Audit Committee

Recommendation: The Government must set out in its response a timeline to divert PFAS waste from landfill towards safer treatment or destruction technologies to manage increasing volumes of PFAS waste without causing further environmental contamination. (Recommendation, Paragraph 95)

Response Pending

#26 —

Environmental Audit Committee

Recommendation: Lack of supply chain transparency fundamentally undermines the UK’s ability to manage PFAS at end-of-life, leaving councils, waste operators and regulators unable to prevent products with PFAS entering landfill, and leading to further pollution of waterways, soil and the wider …

Response Pending

#24 —

Environmental Audit Committee

Recommendation: The Government should provide full detail, in its response, on how its PFAS monitoring strategy will support enforcement and remediation. This should include a clear explanation of how monitoring results will be used to identify risks, guide remediation activity, and …

Response Pending

#23 —

Environmental Audit Committee

Recommendation: Whilst the PFAS Plan sets out monitoring commitments, it lacks the specificity needed to inform and deliver action. Without clear requirements on what to monitor, the methods to use, and the thresholds for concern, and without adequate funding and laboratory …

Response Pending

#20 —

Environmental Audit Committee

Recommendation: Although the Government has begun setting statutory limits for PFAS in drinking water, which is a welcome step, significant gaps remain in managing and limiting human exposure to PFAS through food and agricultural pathways. (Conclusion, Paragraph 76)

Response Pending

#6 —

Environmental Audit Committee

Recommendation: The Government should make use of existing EU-UK dialogue mechanisms to support UK alignment with EU REACH to avoid unnecessary regulatory divergence. Whilst UK Government may choose a different approach in some areas, without such alignment, UK manufacturers risk accidentally …

Response Pending

#5 —

Environmental Audit Committee

Recommendation: UK REACH, in its current lagging and slow-moving form, risks leaving the UK behind international best practice and limits the Government’s ability to respond swiftly to emerging scientific evidence on PFAS. This increases the likelihood of further regulatory divergence between …

Response Pending

#4 —

Environmental Audit Committee

Recommendation: The Government must act in line with the environmental principles, taking preventative and precautionary action to reduce cumulative PFAS exposure to both people and the environment. We expect the Government to set out in its response how its approach to …

Response Pending

#3 —

Environmental Audit Committee

Recommendation: Voluntary action on PFAS and self-regulation by industry are not sufficient to ensure transparency, accountability or reduce PFAS emissions. (Conclusion, Paragraph 24)

Response Pending

#2 —

Environmental Audit Committee

Recommendation: The Government’s PFAS Plan disproportionately focuses on expanding PFAS monitoring rather than preventing or remediating contamination. Applying the Government’s own environmental principles demands decisive action now to limit further release and exposure. (Conclusion, Paragraph 23)

Response Pending

#17 —

Science, Innovation and Technology Committee

Recommendation: As well as companies offering products to consumers that combine genomic testing with analysis of the genomic data obtained through the test, some companies offer secondary analysis of genomic data obtained through a previous genomic test from a different company. …

Gov response: MHRA’s public consultation explores the scope of medical device regulations in the UK and the outcome of this will help to inform future policy on this recommendation.

Under Consideration

#15 —

Science, Innovation and Technology Committee

Recommendation: Prenatal genomic testing could influence decisions on terminating fetuses, leading to specific concerns in addition to the issues concerning other types of direct-to- consumer genomic testing. The Government should consider if any restrictions should be placed on the conditions that …

Gov response: Under the UK Medical Device Regulations 2002, the MHRA could only take action against the use of certain genomic tests if a compliance or safety issue associated with the device had arisen. The MHRA proactively …

Under Consideration

#14 —

Science, Innovation and Technology Committee

Recommendation: Although there is potential for the results of a genomic test to be upsetting, this is not a sufficient reason to prevent consenting adults from using these tests. However, a range of submissions to our inquiry and our predecessor Committee’s …

Gov response: Under the UK Medical Device Regulations 2002, the MHRA could only take action against the use of certain genomic tests if a compliance or safety issue associated with the device had arisen. The MHRA proactively …

Under Consideration

#12 —

Science, Innovation and Technology Committee

Recommendation: Concern was raised with us that companies providing genomic tests directly to consumers could profit from supplying the tests while leaving the NHS to deal with consumers and their results following the test. Addressing this issue, representatives of several major …

Gov response: Genomic counsellors play a key role in the genomic pathway and are an important but limited resource whose roles are first and foremost focused on activity commissioned by the NHS, covering referrals from NHS clinicians. …

Under Consideration