GMWatch publishes scientific analysis of the weakened regulations and accompanying guidance documents
GMWatch has published a scientific critique of the UK Government’s Genetic Technology (Precision Breeding) Regulations 2025 and the corresponding ACRE (Advisory Committee on Releases to the Environment) and FSA (Food Standards Agency) guidance documents on new GM gene-edited “precision bred” (GM-PB) plants.
The critique is authored by GMWatch co-director Claire Robinson and molecular geneticist Prof Michael Antoniou. It explains why the Regulations and guidance documents are scientifically invalid and fail to protect public health and the environment from risky new generation GMOs.
In particular, the critique shows that the ACRE guidance document for applicants, published in November 2025, is so flawed that it significantly weakens the already ill-conceived 2025 Regulations.
For example:
• ACRE fails to adequately define and characterise the “natural variation” to which GM-PB plants are claimed to be equivalent. The ACRE guidance document enables the applicant for approval of a claimed GM-PB plant to self-declare that it could have arisen naturally or through conventional breeding when in fact this is only one – idealised – potential outcome of gene editing, among many potential outcomes that go far beyond anything that could arise in nature or conventional breeding.
• The ACRE guidance document ignores evidence that gene editing can give rise to biological outcomes that are frequently very different from, and go far beyond, those that could arise in nature, or in conventional breeding, or in chemical- or radiation-induced random mutagenesis breeding, and that they pose different and potentially higher risks. This is because the processes of altering the DNA in each of these methods are different, causing different types of intended and unintended changes, which in turn lead to different risks.
• ACRE ignores the likelihood and scale of genetic changes in gene editing vs nature. While some types of changes caused by gene editing may also occur in nature, or conventional breeding, or mutagenesis breeding, the ACRE guidance document fails to take into account the likelihood, frequency, spatial scale, and timescales with which such changes might occur in the different breeding systems. Upscaling mutations (DNA damage), as occurs in gene editing, also means upscaling risk.
• The tests needed to establish nature-equivalence are not required. The 2025 Regulations stipulate that to qualify as a GM-PB plant and thus escape risk assessment, monitoring and labelling, the gene editing process must not alter the plant’s toxicity, allergenicity and nutritional content in a way that would affect its safety.
Yet in order for an applicant for approval of a GM-PB plant to demonstrate that this is the case, they would have to consider the full spectrum of both intended and unintended changes caused by the entire process of gene editing (including the obligatory and highly mutagenic tissue culture stage). These changes would have to be analysed using adequate methods – long-read whole genome sequencing, followed by “omics” molecular analysis. However, the ACRE guidance document does not require these to be carried out. So the declared natural-like status of a GM-PB plant would be nothing more than an evidence-free ‘wish’, as opposed to a verifiable fact.
Even worse, the secondary legislation that set out how the regulations would be implemented forbids government regulators from ever finding out that a GM-PB organism is different from, and more risky than, conventionally bred organisms. Even when it is.
The critique also shows that the UK Food Standards Agency (FSA) has deserted its responsibility of ensuring that food is safe to eat. It reflects without question the weak wording of the 2025 secondary legislation that only requires the applicant to avoid introducing genetic changes that are “expected to” (our emphasis) alter the toxicity, allergenicity, or nutritional content in a way that could affect the food safety of the GM-PB organism – entirely ignoring the way gene editing can result in unintended DNA damage that can lead to unexpected outcomes.
In similar vein, the FSA’s guidance document states that all the applicant has to do in order to avoid independent risk assessment is to “consider whether genetic changes may be reasonably anticipated [our emphasis] to alter levels of substances other than those targeted (including potentially harmful substances), or change nutritional quality (nutrition).”
So if the applicant declares that they didn’t “expect” or “anticipate” their GM-PB plant to be toxic, allergenic, or have an altered nutritional quality, they just might escape all legal consequences, even if the plant is later proven to have all three problems. Naivete, dishonesty, and irresponsibility are baked into the guidance as legal defences.
In sum, the Regulations and the accompanying guidance documents are a recipe for a “don’t look, don’t find” approach to the risks of new generation GMOs.
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