Research and analysis

ACRE guidance: marketing notices for precision bred organisms

Published 27 February 2025

Applies to England

This is draft guidance. It is published for reference alongside the draft Genetic Technology (Precision Breeding) Regulations 2025.

The Genetic Technology (Precision Breeding) Act 2023 (“the act”) establishes the requirements that must be met before precision bred plants can be placed on the market.

The requirements include having a confirmation from Defra that the plants are precision bred.

Those seeking confirmation of precision bred status must submit a ‘marketing notice’ to Defra. This notice must contain the information set out in Schedule 2 and 3 of the Genetic Technology (Precision Breeding) Regulations 2025.Marketing” is defined in s5(3) of the act. Its meaning is wider than a financial transaction, for example, and covers making available with or without consideration.

The information provided in the marketing notice will be assessed by the Advisory Committee on Releases to the Environment (ACRE). ACRE will advise Defra on whether it considers the plant to be precision bred within 90 days of receiving the information. This timeframe can be extended if ACRE needs more information from the developer. Defra will confirm precision status or explain why it is not issuing a precision bred confirmation to the developer.

Notification scope and limitations

A plant which has been altered using modern biotechnology may only be marketed in England following confirmation from Defra that it meets the definition of a precision bred organism (as defined in Part 1 of the act).

Precision bred confirmation is given to the individual organism described in a marketing notice but applies to all ‘qualifying progeny’ of that organism. ‘Qualifying progeny’ means any progeny of the plant whose genome does not contain any genetic changes resulting from the application of modern biotechnology, apart from any genetic changes inherited from that or any other marketable precision bred plant. The progeny of crosses between (confirmed) precision bred plants, or precision bred plants, and traditionally bred plants do not require new marketing notices to be submitted.

Multiple precision bred plants may be notified under a single marketing notice if requirements in regulation 5(4) of the Genetic Technology (Precision Breeding) Regulations 2025 are met, but new plants cannot be added retrospectively to an existing precision bred confirmation. If a new plant line is developed, which contains the same genetic changes as one with a precision bred confirmation, a new marketing notice must be submitted to Defra.

Purpose of this guidance

This guidance provides developers with more detail on what information is expected under requirements in Schedule 2 and 3 of the Genetic Technology (Precision Breeding) Regulations 2025. It follows the same format as headings in Schedule 2 of those Regulations. Answers should be descriptive and explanatory - developers are not expected to provide primary experimental data. This should be gathered and retained in the event of any enforcement measures being pursued regarding notified precision bred plants.

1 and 2. Notifier information

The developer must provide the name, address, email, and telephone number of the person with overall responsibility for marketing the precision bred plants. This refers to the person or organisation that has overall responsibility for ensuring the requirements of the Genetic Technology (Precision Breeding) Regulations 2025 are complied with.

Where the person with overall responsibility is an organisation, the developer must also provide details of a person who may be contacted in relation to the marketing notice. It is acceptable to refer to a position within an organisation rather than a named individual (such as Marketing Authorisation Lead).

Notifier information will not be published on the public register.

3. General description

The requirements for a ‘General Description’ are set out in Schedule 3 to the Genetic Technology (Precision Breeding) Regulations 2025. This includes a requirement to:

• state the genus and species of the notified plants
• describe the types of genetic changes made, how these were introduced, and how these affect any characteristics of interest

Information provided in this section is intended to be a high-level summary of the proposed precision bred organisms that gives an overview of the genetic changes made and how these have altered specific characteristics. As such, developers are not expected to provide names of genes or locations of non-coding regions that have been targeted.

A description of the type of genetic changes made should identify the number of targeted insertions, deletions, substitutions, or inversions that have been introduced by modern biotechnology. Developers must also provide information on the molecular effects of genetic changes made and give a summary of how these changes alter characteristics of the precision bred plant (such as improved powdery mildew resistance). If cisgenic or intragenic constructs have been inserted, the developer should establish the copy number and provide a summary of how the inserted constructs alter or introduce new characteristics to the organism.

A brief description of how the genetic changes were made must be included. For example, whether site directed nucleases were employed and whether their activity was mediated via stable transformation. Where cisgenic or intragenic insertions have taken place, developers must state the method of construct delivery, for example, agrobacterium mediated or biolistic particle delivery.

A ‘General Description’ for a marketing notice may resemble: “Solanum lycopersicon (tomato) plants were transformed with CRISPRCas9 and appropriate guide RNAs (using Agrobacterium) to target 4 different genes that encode susceptibility to powdery mildew. Incorrect repair by non-homologous end joining (NHEJ) led to indels being introduced at target sites, which resulted in early termination of encoded proteins. This has led to improved resistance to powdery mildew.”

The General Description of any precision bred organism cannot be regarded as commercially confidential as established by 18(4)(b) of the Genetic Technology (Precision Breeding) Act 2023. This information will be published on Defra’s Precision Breeding register. 

4. Intended use

Developers should indicate how they expect their precision bred plants to be used in the supply chain. For example, whether the likelihood is that it will be imported for food or animal feed use or cultivated in England for industrial use other than for food or feed. Developers may also choose to provide information on any novel cultivation or husbandry practices associated with the plants, and any measures likely to be adopted to realise benefits relating to the plant’s altered characteristics. This may include a broad description of the potential health or environmental impacts of the organism, and how its intended use may deliver this.

5. Intended changes made

Whereas section 3 requires a summary of the precision bred plant that is accessible to all stakeholders, this (and subsequent) sections necessitates more detailed information. ACRE will use this information to provide a recommendation to Defra on whether notified plants are precision bred organisms. Information on intended changes made includes a description of the genetic changes that have been deliberately introduced to the organism using modern biotechnology, and how these alterations change the characteristics of the precision bred plants.

Genomic information must include the size and number of any insertions, deletions, substitutions, or inversions. Developers must also provide the loci of these alterations within nuclear or non-nuclear genomes, including gene identifiers and alternative names (where possible) and position of the target site in relation to the closest flanking coding sequences if in an unannotated non-coding sequence (for example, 15bp deletion in exon 2 of gene x, 3bp substitution in upstream promotor of gene y). If multiple copies of the same gene have been targeted, developers must provide the above information for all targets. Where genetic material has been inserted into the genome (such as cisgenic or intragenic constructs) developers must indicate the number of copies inserted and the orientation of insertion and describe all the inserted genetic elements including their name, function, and the species from which they originated.

To satisfy requirements for descriptions of alterations to characteristics of the precision bred plant, developers must state the primary (or hypothetical) function of targeted sequences or inserted genetic elements. Developers must also provide information on the molecular effects of genetic changes made (such as frameshift mutation resulting in knock out of gene x, base substitution resulting in targeting of miRNA to mRNA for gene y), and describe the broad phenotypic outcomes observed following genetic manipulation (such as improved drought tolerance, later flowering time, altered metabolic efficiency).

Any genetic changes introduced by modern biotechnology must be stable. Developers should demonstrate that genetic changes made are capable of being inherited following either sexual or asexual reproduction. Developers are not expected to monitor or prevent the accumulation of natural mutations in precision bred organisms following confirmation of precision bred status.

6. Unintended changes made

This section requires developers to detail the analysis and procedures performed to check for any unintended genetic changes that have been introduced to their plant through application of modern biotechnology.

Developers must describe the approaches used to look for unintended genetic changes that are attributable to the use of modern biotechnology. Appropriate techniques will vary depending on the genetic changes made and methods used to perform precision breeding but may include PCR, sequencing, Southern Blotting, or other techniques (such as NGS of regions with high sequence similarity to the target site as determined by BLAST). Developers may also wish to justify the measures taken by including descriptions of how techniques used during the breeding process have minimised the potential for unintended alterations to the genome, such as the use of validated highly specific guides.

The presence of unintended editing events does not preclude a plant from being a precision bred organism unless it results in changes that could not arise through traditional processes. However, any unintended genetic changes resulting from the application of modern biotechnology must be described as set out in section 5. Where developers have removed unintended genetic changes, the process by which this was performed (such as segregation) must be described, as well as outlining how removal was confirmed.

7. Technology used

Responses must include a description of the methods used to generate genetic changes described in sections 5 and 6. This includes the delivery method by which the genetic changes are introduced into the plant (such as agrobacterium, biolistic particle delivery or electroporation) as well as specifying the editing technology used to perform precision bred changes (such as CRISPR-Cas12b, TALENs, Cisgenesis).

Developers must also specify whether any recombinant DNA was introduced to the organism as part of this process. Where rDNA results in the generation of a transgenic intermediate (such as selectable markers, Cas9, gRNAs, Ori), developers must indicate the loci of insertion as well as providing the name of the genetic elements inserted, their function, and the organisms from which they originated must be described.

8. Confirmation of precision bred status

This section requires developers to confirm that their notified plant meets the criteria of the Genetic Technology (Precision Breeding) Act 2023. Any genetic changes which have been introduced by modern biotechnology could also have arisen through traditional processes (such as the absence of transgenes).

Developers must describe the analyses and procedures undertaken to confirm the absence of transgenes that may have been introduced into the genome whether unintentionally, or deliberately during intermediate stages of development. Appropriate techniques will vary depending on the genetic changes made and methods used to perform precision breeding but may include PCR, sequencing, Southern Blotting, or other techniques (such as PCR of regions flanking known insertion sites). Developers may also wish to provide a reasoned argument describing why genetic changes outlined in sections 5 and 6 could also have arisen through traditional processes (such as genetic change mirrors an existing polymorphism, the same types of genetic changes are known to occur in other traditional breeding processes).

9. Notification of multiple precision bred plants

Modern biotechnology may be used to alter multiple organisms in the same manner. Provided that these organisms meet the requirements in regulation 5(4) of the Genetic Technology (Precision Breeding) Regulations 2025, they may be notified to Defra Secretary of State as part of a single marketing notice. Section 9 requires the number of organisms to be disclosed, as well as confirmation that requirements in regulation 5(4) of the Regulations are met. Developers must also provide descriptions of any variations in the intended and unintended genetic changes introduced to all notified organisms, in line with requirements outlined in section 5 and 6.

Should developers wish to make use of this provision, they must complete sections 3 to 8 in relation to a single organism of their choice (Precision Bred Plant “1”). Section 9 must then be completed using Precision Bred Plant “1” as a comparator, where descriptions of variation in intended and unintended genetic changes are in relation to Precision Bred Plant “1” (for example, “1” has a 3bp deletion in gene x, whereas Precision Bred Plant “2” has a 5bp deletion).