Biotech regulatory gaps
Absence of clear regulatory guidance from bodies like MHRA for genetically engineered (GE) phages and enzymes.
177 items
5 sources
1 inquiry
Strongest theme matches
Mixed across source types and ranked by classifier confidence plus text match strength.
PFD report
69match
Bradley Cockel
The drug involved, and several of its chemical compounds, were not fully controlled by legislation, leading to regulatory gaps and potential public health risks.
Matched on
terms: gaps, regulatory
Committee recommendation
53match
#9 - Continue implementing Precision Breeding Act and seek exemption in EU SPS negotiations
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) Implementation timeline
Matched on
terms: regulatory
Committee recommendation
53match
#6 - Legislative divergence risks inappropriate EU regulations for GB production systems
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 adoption of EU rules in this area would risk embedding regulatory decisions that are inappropriate for GB production...
Matched on
terms: regulatory
Committee recommendation
52match
#16 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 need for precautionary action, given the extreme persistence and bioaccumulation of PFAS in the body, to protect the...
Matched on
terms: gaps
PFD report
49match
Jack Knapman
Despite DNP's toxicity and planned reclassification as a poison, there's no clear government department or organisation designated to monitor and prevent its sale for human consumption, risking further deaths.
Matched on
classifier match
PFD report
49match
Abdul Oryakhel
There is a lack of understanding regarding the dangers of e-bike/e-scooter lithium-ion batteries and chargers, coupled with an absence of British or European safety standards.
Matched on
classifier match
Committee recommendation
49match
#33 - Phage therapy shows AMR promise but faces significant clinical, licensing, and testing barriers.
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 way of treating infections, but also that there are numerous barriers to their further development and use in...
Matched on
classifier match
Committee recommendation
48match
#15 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 prevent regrettable substitutions, incentivise safer alternatives and enable faster, more effective regulatory decisions, with proposals published within 12...
Matched on
terms: regulatory
Committee recommendation
48match
#14 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 restrictions can be applied more swiftly, and effectively as new evidence emerges. (Recommendation, Paragraph 57)
Matched on
terms: regulatory
Committee recommendation
48match
#16 - First Report - Direct-to-consumer genomic testing
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 regulatory requirements.
Matched on
terms: regulatory
Committee recommendation
48match
#3 - First Report - Direct-to-consumer genomic testing
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 UK market provide reliable results. The Government should require manufacturers of direct-to-consumer genomic tests to have the performance...
Matched on
terms: regulatory
Committee recommendation
48match
#1 - First Report - Direct-to-consumer genomic testing
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 purposes. Despite concerns around direct-to-consumer tests existing for many years, evidence of harm has mostly not been systematically...
Matched on
terms: regulatory
Committee recommendation
48match
#2 - Sixteenth Report - Principles of effective regulation
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 Department aims to promote innovation in various ways, primarily through the Regulatory Horizons Council and the Regulators’ Pioneer...
Matched on
terms: regulatory
Committee recommendation
48match
#24 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 underpin regulatory enforcement. (Recommendation, Paragraph 84)
Matched on
terms: regulatory
Committee recommendation
48match
#6 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 being placed at a competitive disadvantage, and the UK public may face greater exposure to PFAS due to...
Matched on
terms: regulatory
Committee recommendation
48match
#5 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 Great Britain and Northern Ireland, creating trade barriers both ways, and detrimental consequences for UK goods in the...
Matched on
terms: regulatory
PHSO casework decision
48match
P-003990 - Medicines and Healthcare products Regulatory Agency (MHRA)
Mrs C says Medicines and Healthcare products Regulatory Agency (MHRA) did not act in line with its applicable policies/standards when it made its decision to change the policy on sodium valproate.
Matched on
terms: regulatory
PFD report
45match
Victoria Meppen-Walter
Concerns were raised regarding the easy online availability and regulation of chloroquine, along with the associated risks of its misuse.
Matched on
classifier match
PFD report
45match
Grand Canyon
Current regulations for Crash Resistant Fuel Systems (CRFS) in rotorcraft are inadequate, failing to mandate retrofits or provide a public register. This leaves a high risk of post-crash fires and prevents informed public decision-making.
Matched on
classifier match
Committee recommendation
44match
#36 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 technologies. (Conclusion, Paragraph 123)
Matched on
terms: gaps
Committee recommendation
44match
#29 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 long term environmental and financial burden. (Conclusion, Paragraph 106)
Matched on
terms: regulatory
Committee recommendation
44match
#20 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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)
Matched on
terms: gaps
Committee recommendation
41match
#8 - EU genomic technology framework delay undermines UK precision breeding advantage
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. (Conclusion, Paragraph 33)
Matched on
classifier match
Committee recommendation
41match
#7 - Ensure new EU regulations for GB agriculture incorporate specific climatic and scientific data
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 core requirement of any SPS framework, that GB scientific evidence, including agronomic and climatic data, will be incorporated...
Matched on
classifier match
Committee recommendation
40match
#12 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 burden of proof currently rests with Government before substances are banned, it is likely that without adopting a...
Matched on
classifier match
Committee recommendation
40match
#9 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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)
Matched on
classifier match
Committee recommendation
40match
#18 - Commission ONR to develop proposals for a replacement methodology to SUPDC.
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 of radioactive release. These proposals should include the option of dispensing with SUPDC altogether and replacing its role...
Matched on
classifier match
Inquiry recommendation
36match
COVID-M4.1 - Establish Pharmaceutical Expert Advisory Panel
The UK government should establish a standing pharmaceutical expert advisory panel, in consultation with the Department of Health and Social Care and the Department for Science, Innovation and Technology. The panel should include ministers, civil servants and representatives from industry and academia, and be led by an independent Chair with experience of working in a relevant industry. The...
Matched on
classifier match
Committee recommendation
36match
#27 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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, Paragraph 94) 46
Matched on
classifier match
Committee recommendation
36match
#22 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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, working with the Food Standards Agency and the Office for Product Safety and Standards. This should take effect...
Matched on
classifier match
Committee recommendation
36match
#21 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 chain through agricultural processes. The Government should publish these limits within three months of the publication of the...
Matched on
classifier match
Committee recommendation
36match
#17 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 the establishment of biomonitoring programmes for groups with higher exposure. For communities and occupations with known or suspected...
Matched on
classifier match
Committee recommendation
36match
#13 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
Without a broad, group-based restriction on PFAS, the Government risks a “whack-a-mole” approach. (Conclusion, Paragraph 56)
Matched on
classifier match
Committee recommendation
36match
#11 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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)
Matched on
classifier match
Committee recommendation
36match
#10 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 47)
Matched on
classifier match
Committee recommendation
36match
#8 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 these accelerated timelines. (Recommendation, Paragraph 38)
Matched on
classifier match
Committee recommendation
36match
#7 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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)
Matched on
classifier match
Committee recommendation
36match
#1 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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)
Matched on
classifier match
Committee recommendation
36match
#7 - Urgently move psychedelic drugs to Schedule 2 to facilitate medical research.
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 psychedelic drugs to Schedule 2 in order to facilitate research on the medical or therapeutic value of these...
Matched on
classifier match
Committee recommendation
36match
#35 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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)
Matched on
classifier match
Committee recommendation
36match
#33 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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)
Matched on
classifier match
Committee recommendation
36match
#23 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 capacity, the Environment Agency cannot enforce limits or identify risks in time to act. (Conclusion, Paragraph 83)
Matched on
classifier match
Committee recommendation
36match
#14 - First Report - Direct-to-consumer genomic testing
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 inquiry highlighted a potential need for restrictions on direct-to-consumer genomic testing of children. Professional bodies in the UK...
Matched on
classifier match
Committee recommendation
32match
#38 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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
Matched on
classifier match
Committee recommendation
32match
#37 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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. (Recommendation, Paragraph 124)
Matched on
classifier match
Committee recommendation
32match
#34 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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)
Matched on
classifier match
Committee recommendation
32match
#32 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 the environment, and mounting costs will continue to fall on government (and taxpayers) and water companies (and water...
Matched on
classifier match
Committee recommendation
32match
#31 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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 on the UK REACH candidate list, to deter ongoing environmental contamination and hold polluters responsible; • consider options...
Matched on
classifier match
Committee recommendation
32match
#30 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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)
Matched on
classifier match
Committee recommendation
32match
#28 - 9th Report - Addressing the risks from Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS)
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)
Matched on
classifier match