ACRE guidance: release notices for precision bred organisms
Published 27 February 2025
Applies to England
© Crown copyright 2025
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This is draft guidance.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”) and the Genetic Technology (Precision Breeding) Regulations 2025 together establish the requirements for releasing precision bred plants into the environment for research and development purposes (such as field trials) in England. This includes a requirement for developers to submit a ‘Release Notice’ to Defra at least 20 days before the field trials takes place.
Developers must determine whether their plants are precision bred organisms using the technical ’guidance on producing Precision Bred Organisms’. They must then submit a notice which meets the information requirements set out in Schedules 1 and 3 to the Genetic Technology (Precision Breeding) Regulations 2025. Material from plants notified for release must not be marketed. This means that developers will have to consider taking measures to minimise the likelihood of precision bred material from field trials entering the food or animal feed chains inadvertently. Developers can read ACRE’s best practice ‘guidance on releasing precision bred plants into the environment in research and development trials’.
If developers intend to market their plants, they will first need to receive confirmation from Defra that their plants are precision bred, using ACRE’s guidance on marketing notices. They will also require an authorisation before marketing any precision bred plant for food and feed purposes (Food Standards Agency).
Notification scope and limitations
Multiple precision bred plants may be notified under a single release notice provided they meet the requirements of regulation 3(5) of the Genetic Technology (Precision Breeding) Regulations 2025. This means that all plants must be from the same species and only contain the types of genetic changes described in the release notice under the ‘General Description’ heading.
The release of a precision bred plant into the environment need only be notified once. Its continued use in subsequent research and development trials does not have to be re-notified. In addition, if notifiers develop a new plant line using modern biotechnology to produce any combination of the types of genetic changes described in an existing release notice, a new release notice is also not required.
Developers are responsible for identifying all genetic changes made prior to release. If there are differences between the newly developed organism and any that have previously been notified, the newly developed organism will require submission of a new release notice prior to its release into the environment.
Purpose of this guidance
This guidance provides developers with more detail on what information is expected under requirements in Schedule 1 and 3 of the Genetic Technology (Precision Breeding) Regulations 2025. It follows the same format as headings in Schedule 1 to these Regulations and responses are expected to follow the same format as a pro-forma. Answers should be descriptive and explanatory - developers are not expected to provide primary experimental data. Primary experimental data should be retained so that it can be made available 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 who is proposing to release the precision bred plants from under their control. This refers to the person or organisation that has overall legal responsibility for ensuring the requirements of the Genetic Technology (Precision Breeding) Regulations 2025 are complied with, in relation to the release of the precision bred plants.
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 release notice. It is acceptable to refer to a position within an organisation rather than a named individual (such as the Authorisation Lead). Information on this individual will not be published on the public register.
3. Description of other persons
A developer may wish to provide seed or other reproductive material to others outside of their organisation to carry out field trials on their behalf. In such cases, developers should provide a brief description of these ‘other persons’ involved in the release. For example, ‘the release will involve farmers and other research institutes. It is important to note that the developer identified in Section 1 is responsible for ensuring compliance with the Genetic Technology (Precision Breeding) Regulations 2025.
4. General description
The requirements for a ‘General Description’ are set out in Schedule 3 of 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 introduced, the techniques of modern biotechnology used, and the altered characteristics of the plants
Information provided in this section should provide 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 a summary of how these changes are expected to alter characteristics of the precision bred plant (for example, 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.
Developers may release precision bred plants with different combinations of genetic changes to investigate the effect that these changes have on the characteristics of interest. In such cases, developers are not expected to specify the specific combinations of changes that have been introduced to different precision bred plants, provided the total complement of genetic changes introduced has been described.
A brief description of how the genetic changes were made must be included. For example, whether site directed nucleases were employed and their activity 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 release notice covering several precision bred plants may resemble: “The group are investigating Solanum lycopersicon (tomato) with improved disease resistance to powdery mildew. Plants were transformed with CRISPRCas9 and appropriate guide RNAs (using Agrobacterium) to target four different genes which encode susceptibility to powdery mildew. Incorrect repair by non-homologous end joining (NHEJ) led to indels being introduced at target sites, which are expected to result in early termination of encoded proteins. Different combinations of these genetic changes will be assessed for efficacy in 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.
5. Confirmations
Developers must confirm that they will take measures, where necessary, to minimise the likelihood of material from notified precision bred plants being marketed. This includes limiting the possibility that precision bred seed or other reproductive material can enter the food or animal feed chains because of cross-pollination or persistence of vegetative material at the site. A description of the measures planned may be included in the notice, but this is not required.
Developers must also confirm that they have read ACRE’s guidance on producing precision bred organisms and assessed that all the plants they intend to release meet the criteria for precision bred organisms in Part 1 of the act.