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Twentieth Report Contents

Instruments drawn to the special attention of the House

Draft Genetic Technology (Precision Breeding) Regulations 2025

Date laid: 25 February 2025

Parliamentary procedure: affirmative

These draft Regulations would implement, in England, the new regulatory framework for ‘precision bred plants’ and for the food and feed produced from them that was introduced by the Genetic Technology (Precision Breeding) Act 2023 (“the Act”). The Act established ‘precision bred organisms’ (PBOs) as a new class of regulated products which have been produced by the application of modern biotechnology, such as gene editing, but which only contain genetic features that could have resulted from traditional breeding processes. The aim of the new framework is to enable a regulatory approach that is more proportionate to risk, reduces costs to business and encourages innovation and investment in the development of PBOs. The Department for Environment, Food and Rural Affairs (Defra) says that this could help to develop crops with improved nutritional value, resistance to disease and resilience to climate change.

The Committee has received several submissions which are strongly critical of the new regulatory approach. The main concerns relate to a lack of detection methods, traceability and labelling requirements and the absence of a full assessment of the potential impacts of the new rules. There are particular concerns about the impact on the UK internal market and on trade with the EU, as well as on organic producers. We have published the submissions and Defra’s responses in full on our website.

This is a complex and sensitive policy area about which there are strongly held views, and there remain questions about some aspects of the new regulatory approach and the explanations provided by Defra. In particular, concerns have been raised about the lack of labelling requirements despite apparent strong consumer preferences for mandatory labelling of products containing PBOs, and the impact of the new regulatory approach on trade and on organic producers. The House may wish to question the Minister further on these issues.

The draft Regulations are drawn to the special attention of the House on the ground that they are politically or legally important and give rise to issues of public policy likely to be of interest to the House.

1.These draft Regulations would implement, in England, the new regulatory framework for ‘precision bred plants’ and for the food and feed produced from them that was introduced by the Genetic Technology (Precision Breeding) Act 2023 (“the Act”). The Act established ‘precision bred organisms’ (PBOs) as a new class of regulated products, distinct from genetically modified organisms (GMOs) and defined as plants and animals which have been produced by the application of modern biotechnology, such as gene editing, but which only contain genetic features that could have resulted from traditional breeding processes. These draft Regulations propose regulatory provisions for precision bred plants only; they do not include provisions to implement the Act in relation to precision bred animals.

2.The Department for Environment, Food and Rural Affairs (Defra) explains that under the current framework, all plants produced by modern biotechnology and the marketing of food and feed derived from these plants are regulated as GMOs. The underlying rationale of the current framework is that it is the technology used to produce these plants, rather than their characteristics, that should determine how they are regulated. According to Defra, this approach is over 30 years old, was adopted before precision breeding techniques were developed and is no longer appropriate. Instead, modern biotechnology, such as gene editing, can now be used to develop “more precisely and efficiently” organisms with genetic changes that could have occurred through traditional breeding.

3.The aim of the new framework is therefore to reverse the current approach and shift the focus from the technology used to the outcome, enabling a regulatory approach that is more proportionate to risk. Defra says that:

“This is in line with scientific advice and approaches adopted internationally. By creating a more enabling regulatory environment, this will reduce costs to business and encourage innovation and investment into the development of Precision Breeding technologies. This could help develop crops with improved nutrition, resistance to disease and resilience to climate change.”

4.The previous Government introduced a simpler notification system for research and development trials involving precision bred plants in England in 2022.1 The changes made in 2022 reduced the burden on developers using genetically modified plants in field trials if those plants could have been produced using traditional processes. These draft Regulations would replace the 2022 rules, have the same effect in relation to research trials but go further to allow a route to market for precision bred plants outside the current GMO framework.

Key elements of the new framework

5.Specifically, the instrument proposes new processes for:

6.The new framework provides for a two-tiered approach to authorisation: a “rapid” Tier 1 route for precision bred plants about which there are no safety concerns or for which safety issues are understood and accepted in traditionally bred food and feed; and a Tier 2 route for precision bred plants about which there are safety concerns, for example in relation to increased allergens, and which would be subject to safety assessments as part of the authorisation process. According to Defra, this would involve bespoke assessments, targeting specific safety concerns or uncertainties. Developers would not be required to provide detection methods for their PBOs as part of the new authorisation process and once authorised, precision bred plants would not require authorisation renewals.

Supporting material and guidance

7.The new framework is complex: the draft Regulations run to 40 pages and are supported by an Explanatory Memorandum (EM) and a De Minimis Impact Assessment (DMA). In addition, Defra and the FSA have produced guidance on:

External submissions

8.We have received several submissions which question the Department’s new regulatory approach and raise a wide range of concerns about the proposals. This report draws on the issues raised in these submissions and the responses provided by Defra and the FSA. We have published the submissions and the responses from Defra and the FSA in full on our website.2

Centrality of the guidance

9.The guidance on the types of genetic changes introduced by modern biotechnology that could arise through traditional breeding processes is essential to understanding the requirements of the new framework and which genetically modified plants may qualify as PBOs. We therefore regret that this guidance appears to have been published only when we asked to see it, and that the EM, as a consequence, does not include a link to where this guidance is now available. We recommend that Defra revises the EM to include links to this and all other published guidance documents.

10.Given the significance of the guidance, we also asked Defra why the descriptions in it had not been included in the legislation itself. This issue was also raised in some of the submissions we received. The submission from Beyond GM, for example, questioned whether the length and complexity of the instrument and supporting guidance “was better suited to the kind of oversight given to primary legislation”; why the concept of genetic changes that could arise by traditional processes was not fully explained in the instrument itself, even though it is the “core definitional boundary of the entire regulatory system”, and why the “fundamental scope” of the new framework, that is which organisms are included or excluded, had been left to guidance.

11.The Department explained:

“Part 1 of the Genetic Technology (Precision Breeding Act) 2023 provides definitions for precision bred organisms and traditional processes. The purpose of the technical guidance is to complement the regulations and provide detailed information for those intending to submit release and marketing notices.

The Act sets the standard by listing the traditional plant breeding techniques that can generate the types of genetic changes present in precision bred plants. However, exhaustive descriptions of all the techniques that could produce precision bred plants would be vast and not suited to primary legislation. The guidance has been developed with ACRE [the Advisory Committee on Releases to the Environment] to reflect the current state of the art. As precision breeding technology is advancing rapidly, Defra will continue to update the technical guidance to keep pace with developments.”

12.The FSA added:

“Establishing and maintaining technical guidance will give the FSA flexibility and adaptability with the most technical elements of assessment, given the nascent nature of the technology and pace of innovation in the applications of precision breeding techniques in the agri-food system. This means the FSA can ensure that the evidence collected and submitted by applicants continues to be sufficient and appropriate. [ … ]

Matters of food and feed safety and public health require a rapid response from the FSA and therefore it is important that guidance can be adjusted swiftly to address any emergent safety issues. This agile approach will allow the FSA to learn as PBOs develop and tailor advice, where required, to trends in products (such as biofortification), resulting in better guidance for developers.”

13.We note the need for flexibility highlighted by Defra and the FSA but also consider that drawing on extensive guidance for fundamental aspects of the new regulatory approach makes it more difficult for businesses and consumers to navigate a highly technical and complex regulatory framework.

Concerns about risk, risk assessments and verification processes

14.Defra says that the new regulatory approach is in line with advice from the UK’s Advisory Committee on Releases to the Environment (ACRE)3 which takes the view that the characteristics of organisms determine risk, rather than the technology used to produce them and concludes that precision bred organisms present “no greater risk to health or the environment than traditionally bred counterparts”. According to Defra, the Advisory Committee on Novel Foods and Processes (ACNFP) reached the same conclusion that there was “no evidence that precision bred organisms are intrinsically more hazardous than traditionally bred organisms”.4

15.A submission by GM Watch and Professor Michael Antoniou (“GM Watch”) criticised that the claim that PBOs present no greater risk to health or the environment than traditionally bred counterparts “lacked robust empirical evidence”. The submission argued that a “significant number of peer-reviewed scientific publications state that the risks of gene-edited plants are similar to, or greater than, those of older-style GM plants”. GM Watch suggested that “detailed risk assessment involving whole genome sequencing and detailed molecular “omics” analyses5 (proteomics, metabolomics) is needed” for each precision-bred plant on a case-by-case basis.

16.Similarly, the submission from Beyond GM criticised that the instrument “does not require detailed safety or risk assessments from developers, either as part of Defra’s environmental release process or Defra’s precision bred confirmation process” and that FSA’s food and feed marketing authorisation process, while requiring the developer to demonstrate that food safety is not affected, is “solely reliant on developer declaration in the form of a narrative statement”. Beyond GM questioned how the Government would “ensure adequate safety evaluation in the absence of mandatory risk assessments”.

17.The submissions also raised concerns about the verification process for PBO applications under the new framework. GM Watch questioned how the verification of precision bred status would work in practice, criticising that the new framework “lacks mandatory analytical processes” that would help to establish whether any given GMO qualifies as a PBO, and that there was “no requirement” on the notifier/applicant to prove that their PBO only contains genetic sequences that could arise from traditional processes, instead only requiring “a description of the analysis and procedures used” to confirm the precision based designation. GM Watch suggested that without the mandatory application of scientific methods, the system “relies heavily on self-declaration by applicants”, creating “significant regulatory uncertainty” about whether genetic changes in PBOs could only arise from traditional processes, as required by the legislation. Beyond GM also criticised that the new framework would be “based on self-certification”, operated with “an apparent presumption of approval” and had “limited assessment obligations”.

18.In relation to risk and risk assessment, the FSA explained that:

“Based on their review of case studies6 [ … ] and their knowledge of the wider literature, ACNFP members did not find evidence that PBOs are intrinsically more hazardous than traditionally bred organisms; they concluded that it was the alteration in trait that could lead to phenotypes of concern regarding the safety of the food or feed, rather than specifically the technology used to achieve the trait. The ACNFP recognised that most organisms produced by PB will be similar in risk profile to their traditionally bred counterparts where the same change has been achieved and a risk assessment is not required. By definition, the spectrum of genetic changes introduced by precision breeding techniques are identical to those that could occur through traditional breeding. A requirement of the PBO marketing notice is to provide information on checks for unintended genetic changes.

It is possible that in some instances unintended compositional effects may occur during development of a PBO. However, this is also the case with organisms produced through traditional breeding. If an applicant cannot demonstrate that the application of modern biotechnology does not introduce genetic changes to the organism that are expected to lead to significant compositional changes, the PBO must be assessed by the FSA. Applicants are required to provide experimental data to evidence their conclusions, where necessary, to facilitate this assessment. To request omics data of all PBOs where not required of traditionally bred organisms would be disproportionate. During the planning and production of PBOs, developers are expected to take all reasonable measures to identify and limit any such unintended effects.”

19.The FSA also explained that under the framework it was required to report information to the Secretary of State “who has discretion on decision making” and who can only authorise a PBO for food and feed uses where satisfied that the food or feed would not “have adverse effects on animal or human health; would not mislead consumers; would not have adverse effects on the environment; and would not be nutritionally disadvantageous”.

20.Defra provided the following explanation:

“Defra’s position, based on independent scientific advice, is that Whole genome sequencing (WGS) is not necessarily required to demonstrate the precision bred status of an organism. Developers may choose to include sequencing data when submitting their marketing notices, however this is not a requirement.

Schedules in the regulations set out a series of questions that must be answered in marketing notices. These are questions that our scientific advisors have asked for in order to be able to determine whether a plant has been precision bred. They include questions about the methods used to develop the plants, which will inform what needs to be checked. There are also questions about how these checks were carried out by the notifier. The regulations are not prescriptive about the analytical techniques that need to be used, particularly in the light of technical advances. But they must demonstrate that the notifier has addressed the question satisfactorily. WGS may be used to address questions in the regulations, but more information will also be required.

For example, those submitting precision bred organism marketing notifications must include descriptions of how any transgenic DNA has been removed and describe the analysis which has been undertaken to confirm removal of these sequences. As part of this, rationale for the depth of analysis undertaken must also be provided.”

21.We are not in a position to adjudicate between the conflicting views, as presented in the submissions and in the responses by Defra and the FSA, on the risks associated with PBOs and the verification and authorisation processes. We note, however, that there are concerns about these elements of the new framework. The House may wish to seek further assurances from the Minister on these aspects of the new regulatory approach.

Concerns about traceability and a lack of mandatory detection methods

22.The submissions raised a number of concerns about how PBOs could be detected and traced under the new arrangements. GM Watch, for example, criticised the absence of detection methods in the draft Regulations without which “breeders and farmers will not be able to maintain their non-GMO status, nor will they be able to protect themselves against allegations of patent infringement for using patented genetic sequences, as they will not be able to test for those sequences in the seeds [ … ] that they use for breeding or that they produce in their breeding programmes”. Beyond GM pointed to a literature review commissioned by the FSA in 2023 which “highlighted the need for a robust, science-based framework to detect precision-bred GMO products, emphasising that such products often display subtle genetic modifications which are “very challenging to distinguish” from those produced by traditional breeding”. Beyond GM suggested that the “ambiguity presents significant challenges for regulatory bodies and enforcement”, making it “essential to adopt advanced analytical methods that incorporate multiple lines of evidence”.

23.A submission by Slow Food in the UK (“Slow Food”) criticised that according to the DMA, unlike GMOs, PBOs would “no longer require a unique identifier” which assists with traceability through the food system, adding that it was unclear how information in the public registers would be “matched to the ingredients available to producers, and how that will be traded through supply chains”.

24.Defra responded:

“To our knowledge, there are currently no scientific methods that provide unequivocal identification of genetic changes associated with precision bred plants without prior knowledge of the altered genome and suitable reference materials. If these data were available, there would be no way of knowing whether the genetic change resulted from the application of precision breeding technology or traditional breeding practices.

In order to help those breeders and farmers who wish to grow non-precision bred plant varieties only, the government wants to ensure that there is accessible marketing information to enable this. The government is exploring a variety of methods and tools to communicate information on the precision bred status of plant varieties.

To facilitate the marketing of precision bred varieties of the main agricultural and vegetable species, a Precision Bred Plant Variety List for England is proposed in addition to the existing GB [Great Britain] and NI [Northern Ireland] variety lists. Information regarding applications made and varieties accepted onto the list, including variety name, will be published in the Plant Varieties and Seeds Gazette. The Animal and Plant Health Agency through their Delivering Sustainable Futures project are looking to improve the accessibility and usability of the Gazette.

Views on the proposed Precision Bred Plant Variety List for England are being sought through the public consultation on Plant Varieties and Seeds Framework for Precision Bred Plant Varieties7 [ … ] which also seeks feedback on the provision of information on precision bred seed and other plant reproductive material.”

25.The FSA explained:

“Under General Food/Feed Law traceability requirements, food business operators will be required to be able to identify their immediate suppliers, as well as the businesses to which their products are supplied (a “one up, one down” approach). This information must be provided to competent authorities, if requested. This will also be the case for food and feed produced from PBOs. [ … ]

[The] literature review on analytical methods for the detection of precision bred products highlights that there are no methods of providing unequivocal detection of the genetic change in most PBOs defined by the Genetic Technology (Precision Breeding) Act, without prior knowledge of the altered genome sequence and suitable reference materials. For those PBOs where detection may be possible, it is not currently feasible to distinguish whether the genetic changes are the result of genome editing, natural variation, or traditional breeding methods. In cases where detection was possible, this is likely to be lost in subsequent generations.

In our response to this report [on the literature review], we concluded that due to proportionality and feasibility reasons we did not plan to take forward the recommendations in the report to aid ongoing policy development on precision breeding, we welcomed further research in this area to ensure we have the most up to date scientific information available when reviewing policy and/or developing new policies related to genetic technologies.

The FSA is science and evidence led. We regularly conduct horizon scanning and independently review new evidence that becomes available that is relevant to food and feed safety. In the case of detection, we will continue to monitor new developments in this area. The consensus is that currently there are no methods that provide unequivocal detection of PBOs.”

26.We note the conclusion by Defra and the FSA that there are currently no scientific methods that provide unequivocal identification of PBOs and therefore complete traceability. This prompts questions as to whether, if there are no robust scientific methods for identifying and tracing PBOs, any products containing PBOs should be clearly labelled as such, and how organic producers, which, by law, have to be PBO-free, will be able to demonstrate their PBO-free status. These issues are considered below.

Concerns about a lack of mandatory labelling

27.The EM does not offer any explanation of whether products that contain PBOs will need to be labelled accordingly under the new framework. The EM acknowledges, however, that there may be consumers wishing to buy food that does not contain PBOs who “may have to research suitable products such as organic food”. The DMA assumes that “there may be a minority of consumers” who may wish to buy non-precision bred products. In contrast, the submission by Beyond GM pointed to the FSA’s own research which found that 77% of participants thought it would be “important when buying a food item to know if it had been precision bred”.8 Asked about mandatory labelling of PBO food, the Department told us:

“Products of precision breeding will only contain genetic changes that could also occur through traditional breeding. The scientific advice is that these organisms pose no greater risk than traditionally bred counterparts.

The Precision Breeding Act 2023 does not contain provisions for mandatory labelling of any precision bred organism, or derived food, feed, or plant reproductive material. This was debated and approved in Parliament. As such, there are no labelling requirements in the Genetic Technology (Precision Breeding) Regulations 2025.”

28.The absence of labelling requirements was a significant concern raised in the submissions we received. Beyond GM criticised that the failure to provide clear and readily accessible information at the point-of-sale would “undermine the trust in the biotech sector and cast doubt on the integrity of genetic engineering technologies on the basis of ‘if they won’t label it, what are they hiding?’”. Beyond GM also criticised that this approach “disproportionately burdens businesses and consumers wishing to avoid PBOs”, leaving them to “navigate a complex set of electronic registers that provide technical detail about precision-bred GMOs but no information about the foods or products that contain them”. GM Watch also criticised the absence of mandatory labelling, as did GM Freeze which concluded that under the proposed framework “producers and consumers will not be able to select products that are PBO-free”.

29.A joint submission from the Soil Association, Organic Farmers and Growers, and the English Organic Forum (“the joint submission”) also expressed concerns about the impact on consumers, criticising the “lack of information around the public register of PBO” and how such a register “would allow consumers to join the dots between existing PBOs and products/brands that would be using them”. The joint submission concluded that placing the emphasis on consumer research “offers an unreasonable and unrealistic pathway to granting members of the public an informed choice should they wish to avoid those products”.

30.Asked further about the issue of mandatory labelling and consumer choice, Defra reiterated that this issue had featured in debates in both Houses of Parliament during the passage of the Act and that in both Houses, “amendments to require mandatory labelling of PBOs failed to gain sufficient support”. Defra emphasised that:

“Based on the scientific advice that the risk associated with precision bred plants is no greater than for traditionally bred counterparts, we do not consider that mandatory labelling focused on the breeding technology or process used is appropriate. The UK maintains high standards on the information that is provided on food labels, whether that be mandatory or voluntary, so that consumers can have confidence in the food that they buy. All food and drink sold on the UK market must comply with food labelling rules. The fundamental principle of food labelling rules is that information provided to the consumer must not mislead and must enable the safe use of food.

Registers published by Defra and FSA will contain information about precision bred organisms, including those approved for use in food and feed. The public registers will enable businesses to develop product lines to meet customers’ market demand for food and feed made without precision bred products. In addition, businesses will be able to voluntarily label that their products contain precision bred crops.”

31.The FSA also emphasised that there was “no justification” for mandatory labelling on grounds of consumer safety, as there was no evidence that PBOs were intrinsically more hazardous than traditionally bred organisms. The FSA added that:

“As with any food, if there is a need to provide safety information for a particular population group, (for example, hypersensitive consumers or people with certain health conditions) this can be required as appropriate. The UK Government has been clear that there are no plans to require labelling of products to indicate they have been produced using PB techniques.

The FSA has conducted consumer research which told us that consumers saw a range of risks and benefits to PB food but on balance consumers thought the benefits outweighed the risks if properly regulated; they trust the FSA to regulate PB food; the public register builds towards confidence and reassurance; more proactive information provision (public education campaign, education in school curriculum, labelling, for example) would reassure them that regulation was happening; they wanted labelling to enable them to make choices at the point of purchase.

The FSA Board considered this issue at Board meetings in 2023 and 2024. The Board has actively discussed the views of consumers throughout the development of the proposals and recognises the importance of these views. This was a key focus of the Board’s discussion and associated Board paper at the March 2023 Board meeting.9

The power to decide on the mandatory labelling of PBOs for non-safety related purposes in England sits with the Secretary of State for Defra. FSA officials have shared results of the consumer research and public consultation with Defra.”

32.We note that without mandatory labelling and unless producers label their food containing PBOs voluntarily, consumers would have to conduct their own research, including by accessing the new public registers to establish whether products they wish to buy may contain PBOs. We consider that it is neither realistic nor reasonable to expect consumers to carry out their own research using what are likely to be highly technical public registers. It is important that consumers will be able to access clear and non-technical information easily about food containing PBOs.

33.We recognise that Parliament decided against mandatory labelling during the passage of the Act. There remain concerns, however, about labelling and consumer choice, as expressed in the submissions we have received. We note that Defra has committed to “ensure that food and feed produced from precision bred organisms is considered in any future work to ensure that labelling remains fit for purpose, maintains consumer confidence and provides a level playing field”. The House may wish to seek clarification from the Minister on how the Department intends to do this.

Lack of a full Impact Assessment

34.Defra has produced a DMA, rather than a full Impact Assessment (IA), as it expects the draft Regulations to have a “low level of impact on businesses” and to not introduce new costs or benefits above the threshold required for a full IA (which currently is an annual net cost/benefit of £10 million for businesses or the third sector). Defra estimates the annual net cost for business to be £8.26 million and expects approximately 18 field trials per year towards the end of the ten-year assessment period (that is by 2034/35) and around 75 businesses, mainly small or medium sized, to have an interest in marketing PBOs. We found the DMA informative, and we regret that it is only available on request. We recommend that the Department publishes the DMA, so that it is readily available alongside the draft Regulations and the EM on legislation.gov.uk.

35.Several submissions criticised the absence of a full IA. Beyond GM, for example, expressed concern that Defra had not produced a full IA despite “establishing an entirely new regulatory framework with cross-cutting impacts” and highlighted that the IA that had been produced for the Act10 had been considered “not fit for purpose” by the Regulatory Policy Committee (RPC).11 According to Beyond GM, the absence of a full IA for the instrument undermined “the concept of evidence-based policy”.

36.GM Freeze expressed concern about the lack of a full IA because a number of potential impacts with “varying degrees” of probability and severity should have been formally assessed. GM Freeze also criticised some of the information provided in the DMA, including the statement that “there may be a minority of consumers who may wish to buy non-Precision Bred food products”.

37.While the DMA does provide an analysis of some of the potential impacts of the new regulatory approach, we agree that it would have been preferable to have the formal and comprehensive assessment of all potential impacts, and the independent scrutiny by the RPC, that would have been available had a full IA been produced. This is particularly relevant, as a key factor in the RPC’s rating of the original IA for the Act as “not fit for purpose” was that it had failed to consider adequately the full range of potential impacts of the new regulatory approach.

38.We are not convinced by Defra’s claim that only a minority of consumers would wish to avoid food containing PBOs. The Department refers to a YouGov survey it commissioned in 2022 which found that “over half (57%) of respondents thought the use of gene editing in crops/plants for food production was acceptable, 16% were undecided, while 27% thought the use was unacceptable”. We note that this claim cannot be verified as Defra has not published the survey on the ground that it was commissioned for internal use only to test the effectiveness of departmental communications about the Act. The submissions we received refer to other research which suggests that consumers may be more sceptical. On request, the Department shared with us further information about the YouGov survey, including that it was an online survey and that it had a sample size of just over 2,000 adults. However, the figures provided by the Department appear to be in response to a single question in a larger survey. We do not know precisely what question was asked, on which other issues feedback was sought or what the responses were to those other questions. Thus, it is impossible to assess the value of the Department’s evidence on this point, and therefore we do not consider this an acceptable use of data: if survey data cannot be published because it was commissioned for internal use only, it should not be subsequently drawn on in a DMA to justify potentially contentious policy decisions.

Concerns about the impact on organic producers

39.The DMA acknowledges that because UK organic legislation prohibits the use of GMOs and PBOs in organic production, organic farmers will have to check that the material they source is not precision bred. Defra also acknowledges that this is more challenging as a proportion of seed used by organic farmers is not organically produced, so these farmers will need to ensure that any non-organic material they use is not precision bred. The Department says that the challenge of “ensuring precision bred material does not enter organic supply chains has been raised as a practical concern by some stakeholders and Defra is continuing to run a series of engagements with stakeholders to explore this further”.

40.The submissions expressed strong concerns about this issue. Beyond GM, for example, criticised that the absence of traceability provisions would particularly impact sectors which are required to remain PBO-free (organic producers) or choose to be so (premium, artisanal and Geographical Indication sectors). The joint submission criticised that while the DMA was “written in full knowledge of the concerns that we have raised about the uncertainty this legislation poses for organic supply chains”, it failed to identify any “tangible solutions”.

41.Asked for further explanation of how organic producers will be able to avoid PBO products, Defra responded:

“The impact on organics was considered in the DMA. The impact was predicted over a 10-year period, starting from when the regulations come into force. The expectation is that the identity of precision bred crops will be maintained and they will be separated from traditionally bred material until uncertainty about international regulations and other measures are resolved. This means that exposure of organic production to precision bred material will be limited in this period. [ … ]

We are however preparing for the medium/longer term when precision bred commodity crops are marketed outside of identity preservation schemes and there is ongoing dialogue between Defra and the organic sector on non-legislative options for supply chain coexistence between precision bred and non-precision bred plants and on-farm practical measures to ensure coexistence. This is in line with approaches taken internationally. As part of this process, the British Society of Plant Breeders, representing the plant breeding industry, have committed to maintaining a register of precision bred varieties to complement the statutory Defra and FSA registers.

In order to help those breeders and farmers who wish to grow non-precision bred plant varieties only (e.g. the organic sector), the government wants to ensure that there is accessible marketing information to enable this. The government is exploring a variety of methods and tools to communicate information on the precision bred status of plant varieties.”

42.The Department also explained:

“The Genetic Technology (Precision Breeding) Act (the Act) does not contain powers to legislate for coexistence measures between PB and non-PB crops. As such, coexistence measures will be developed and implemented by industry.

We have worked closely with the sector to identify ways to mitigate the unintentional inclusion of precision bred inputs in organic production. We expect industry to build on upon previously agreed coexistence measures, such as the industry-led precision breeding register, to enable successful coexistence between PB and non-PB crops.

[ … ] There are no obligations on growers with marketable precision bred plants to put in place containment measures or restrictions. However, we are facilitating discussions between organic and conventional farmers to develop industry-led coexistence measures between precision bred and non-precision bred plants.”

43.We note that developing co-existence measures for precision-based and non-precision-based farming remains work in progress, and that the submissions we have received suggest serious concerns by organic, premium, artisanal and other producers about the impact of the new regulatory approach on their businesses. The House many wish to press the Minister further on how the Department is engaging with these producers to address their concerns.

Concerns about the impact on the UK internal market and trade with the EU

44.Given that the new regulatory framework would only apply in England, we asked about the impact on the UK internal market and whether, for example, PBO food and feed products with a market authorisation for England could also be put on the market in Wales, Scotland and Northern Ireland, even if the use of PBO products was not allowed there. Defra confirmed that PBOs will continue to be regulated as GMOs in Scotland, Wales and Northern Ireland but also said that:

“Under the mutual recognition market access principle of the UK Internal Market Act 2020, and in the absence of an exclusion from that principle, products of precision breeding that are approved for sale in England can be sold into Scotland and Wales. Precision bred products that undergo further processing in Scotland or Wales would need to comply with local GM regulations.”

45.Defra added:

“The Government is engaging and will continue to engage with the Scottish and Welsh Governments to understand the specific impacts on businesses in Scotland and Wales.

Information on precision bred seed of the main agricultural and vegetable species will be available on the Precision Bred Variety List for England. Farmers, agronomists and seed merchants, including in the devolved nations, will be able to access information about precision breeding in crop varieties to inform purchasing decisions.”

46.The fact that under the UK Internal Market Act PBOs with authorisation for England could be put on the market in Scotland and Wales, even though PBOs are not authorised there, raises questions about the ability of the Devolved Governments to enforce their policy choices in areas where responsibility has been devolved. The House may wish to question the Minister further on the potential impact of the new PBO framework on devolution. We also note that the need to comply with local GM legislation in relation to PBO products that undergo further processing in Scotland or Wales, will add further complexity and therefore costs for businesses trading across the UK.

47.In relation to Northern Ireland, Defra explained:

“Under the Windsor Framework, mutual recognition does not apply to precision bred organism legislation. Therefore, precision bred products must comply with GM legislation before it can be sold in Northern Ireland.”

48.We note that because PBOs are currently not recognised in the EU and therefore in NI, producers with PBO authorisation in England will have to label their products as GMO for trade with NI or the EU. This is a matter of concern which was also reflected in the submissions. The joint submission, for example, criticised this “major barrier to international trade”, exacerbated by a lack of labelling requirements, and said that the issue raised “fundamental questions about this country’s ability to trade with our EU neighbours”. The submission by Slow Food highlighted that while the value of food and drinks exports was £24.4 billion in 2023, over 80% of these exports were to countries which prohibit gene editing and/or GMOs.

49.Asked about the trade impact and why it had not been addressed more comprehensively in the DMA, Defra responded that:

“[T]he nature of interactions between the Precision Breeding Act and other pieces of legislation with impact on the devolved nations, including the UK Internal Market Act, and the Windsor Framework, is complex and evolving. It would not be practicable to economically assess or analyse all possible outcomes in a DMA.

The development of the DMA also involved discussions with trade officials on the likely effects of this legislation on UK exports to the EU but similarly to the above, any assessment would have been based on an evolving set of legal and political issues, the effects of which are yet to be determined. Therefore, detailed economic analysis on this issue was not amenable to include in the DMA.

Defra and the Food Standards Agency are continuing to engage with the devolved governments and with the Department for Business and Trade on internal market implications of the Precision Breeding Act.

Our approach to labelling and traceability is aligned with several other countries that have implemented similar regulations for precision bred organisms, including Japan, Argentina, Canada and the USA.”

50.We note that Defra and the FSA are continuing to engage with the Devolved Governments. The House may wish to press the Minister on what form this engagement is taking.

51.Specifically in relation to trade with the EU, Defra explained that the Department was “engaging with the EU and closely following their development of any new regulatory approaches to plants produced by new genomic techniques”, adding that:

“The EU is considering a proposal that is similar in aim to the Precision Breeding Act. Until new rules for plants produced by new genomic techniques (NGTs) are in force in the EU, precision bred organisms will be regulated as GMOs in the EU and exports must meet all relevant requirements for GMOs, including labelling.”

52.We note that the EU is in the process of agreeing a similar approach, through the regulation of plants, food and feed obtained by so-called new genomic techniques.12 However, the absence of a full analysis of the impacts of the new framework on international trade in the DMA underlines our view that a full IA would have been helpful, in particular as the trade impact could be substantial, as suggested in the submissions. While we welcome Defra’s engagement with the EU, it provides limited assurance to exporters who depend on being able to demonstrate that their products are GMO-free for their exports but who may struggle to do so under the proposed new framework and may therefore face additional complexity and costs. The House may wish to question the Minister further on how the Department will work with exporters and address their concerns.

Conclusion

53.The proposed new regulatory framework for PBOs is a complex and sensitive policy area and concerns have been raised by stakeholders about Defra’s new approach. There remain questions about the explanations provided by the Department, in particular regarding: the lack of labelling requirements despite apparent strong consumer preference for the labelling of products containing PBOs; the lack of information on the potential impact of the new regulatory approach on the UK internal market, on EU trade and on organic producers; and the Department’s use of data to support its claims. We consider therefore that a policy of maximum transparency around these concerns should be the norm. The House may wish to question the Minister further on the issues raised.

1 Draft Genetically Modified Organisms (Deliberate Release) (Amendment) (England) Regulations 2022, later made as (SI 2022/347), see: SLSC, 29th Report (Session 2021–22, HL Paper 156).

2 SLSC, ‘Scrutiny evidence’: https://committees.parliament.uk/committee/255/secondary-legislation-scrutiny-committee/publications/8/scrutiny-evidence/.

3 Advisory Committee on Releases to the Environment, ‘ACRE advice concerning Defra’s consultation on the regulation of genetic technologies’: https://www.gov.uk/government/publications/acre-advice-the-regulation-of-genetic-technologies/acre-advice-concerning-defras-consultation-on-the-regulation-of-genetic-technologies [accessed 19 March 2025].

4 Advisory Committee on Novel Foods and Processes, ‘Statement of the Advisory Committee on Novel Foods and Processes (ACNFP) on Precision Bred Organisms (PBOs)’: https://acnfp.food.gov.uk/StatementofACNFPonPBOs-January2023 [accessed 19 March 2025].

5 Omics analysis is the collective characterisation and quantification of entire sets of biological molecules and the investigation of how they translate into the structure, function and dynamics of an organism or group of organisms (see: https://en.wikipedia.org/wiki/Omics).

6 See Annex A, Advisory Committee on Novel Foods and Processes, ‘Statement of the ACNFP on Precision Bred Organisms’: https://acnfp.food.gov.uk/PGTStatJuly23PG1 [accessed 19 March 2025].

7 Defra, ‘Plant Varieties and Seeds Framework for Precision Bred Plant Varieties’: https://consult.defra.gov.uk/defra-aphw-plants-varieties-and-seeds/precision-bred-plant-varieties-and-seeds-framework/ [accessed 19 March 2025]. The consultation closes 14 April 2025.

8 Food Standards Agency, ‘Consumer perceptions of precision breeding: Executive Summary’: https://www.food.gov.uk/research/consumer-perceptions-of-precision-breeding-executive-summary [accessed 19 March 2025].

9 Food Standards Agency, ‘FSA Board Meeting—March 2023: Agenda and Papers’: https://www.food.gov.uk/board-papers/fsa-board-meeting-march-2023-agenda-and-papers [accessed 19 March 2025].

10 Defra, The Genetic Technology (Precision Breeding) Bill: Impact Assessment (26 May 2022): https://publications.parliament.uk/pa/bills/cbill/58-03/0011/GeneticTechnologyBill_IA_0526.pdf [accessed 19 March 2025].

11 Regulatory Policy Committee, ‘The Genetic Technologies (Precision Breeding Techniques) Bill: RPC Opinion’: https://www.gov.uk/government/publications/the-genetic-technologies-precision-breeding-techniques-bill-rpc-opinion [accessed 19 March 2025].

12 Council of the EU, ‘New genomic techniques: Council agrees negotiating mandate’: https://www.consilium.europa.eu/en/press/press-releases/2025/03/14/new-genomic-techniques-council-agrees-negotiating-mandate/ [accessed 19 March 2025].



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