Guidance

Submitting a marketing notice for a precision bred plant

Published 13 November 2025

Applies to England

This guidance comes under the Genetic Technology (Precision Breeding) Act 2023 and the Genetic Technology (Precision Breeding) Regulations 2025.

If you plan to ‘market’ a precision bred plant, you must get confirmation of its precision bred status from the Department for Environment, Food and Rural Affairs (Defra). To do this, you must submit a ‘marketing notice’ to Defra.  

‘Marketing’ is defined in section 5(3) of the act. It means making available, even if there is no ‘consideration’ (payment).

Defra will publish information from your marketing notice on a public precision breeding register.

Scope of marketing notices 

Marketing multiple plants 

You can submit one notice for multiple precision bred plants if they: 

• are from the same species  
• have the same altered characteristics resulting from genetic changes and these were introduced by the same technique of modern biotechnology 
• have been analysed to confirm they contain only genetic sequences that could arise by traditional processes  

These requirements are set in regulation 5(4) of the Genetic Technology (Precision Breeding) Regulations 2025.  

You cannot add new plants to an existing precision bred confirmation.  

If you develop a new plant line using modern biotechnology, you will need to submit a new marketing notice. This applies even if the plant has the same genetic changes as one with a precision bred confirmation.

Marketing ‘qualifying’ progeny 

If Defra confirms a plant’s precision bred status, you can market both: 

• the individual organism described in your marketing notice 
• all ‘qualifying’ progeny (descendants) of that organism 

‘Qualifying’ means any genetic changes that resulted from modern biotechnology were inherited from either: 

• the marketed plant  
• any other marketable precision bred plant 

Progeny includes plants produced by vegetative propagation (asexual reproduction).  

You also do not need to submit a new notice for the progeny of crosses between: 

• two or more confirmed precision bred plants 
• precision bred plants and traditionally bred plants 

However, you must submit a new marketing notice for progeny if they contain additional genetic changes resulting from the application of modern biotechnology.

How to submit your marketing notice 

To submit a marketing notice, you will need to fill out a template. This template ensures your notice meets the information requirements set out in schedules 2 and 3 to the Genetic Technology (Precision Breeding) Regulations 2025.  

Email pb-regulation@defra.gov.uk for a copy of the template.  You should return your completed template to the same address.

What to include in your marketing notice 

This section provides more detail on what to include in your template. 

Your answers should be descriptive and explanatory. You are not expected to provide primary experimental data.  

However, you should keep this data and make it available in the event of any enforcement measures related to the notified precision bred plants. 

If you are submitting a notice for multiple plants, you must complete sections 3 to 9 in relation to a single plant of your choice (the initial precision bred plant). You will then need to provide information on other plants in section 10 of your notice.

1 and 2. Notifier information 

You must provide the name, address, email and telephone number of the person who is proposing to market the precision bred plants.  

This is the person or organisation with overall responsibility for ensuring the requirements of the Genetic Technology (Precision Breeding) Regulations 2025 are met. 

If an organisation has overall responsibility, you must also provide the details of a person who can be contacted about the marketing notice. You can refer to their position rather than their name (such as the ’Marketing authorisation lead’). 

Defra will not publish personal details on the public precision breeding register.

3. General description 

You must give and describe: 

• the genus and species of the notified plant 
• types of genetic changes made 
• techniques of modern biotechnology used to introduce the changes 
• how these changes affect characteristics of the plant 

The general description of any precision bred organism cannot be regarded as commercially confidential, as established by section 18(4)(b) of the act. Defra will publish this information on the public precision breeding register.

Types of genetic changes and effects on characteristics  

You should give an overview of the genetic changes made and how these have altered specific characteristics.  

You are not expected to provide names of genes or locations of non-coding regions that you have targeted. 

Your description of the type of genetic changes should include: 

• the number of targeted insertions, deletions, substitutions or inversions introduced by the application of modern biotechnology 
•  the molecular effects of genetic changes made 
• a summary of how these changes alter characteristics of the precision bred plant – such as “improved powdery mildew resistance” 

If you have inserted cisgenic or intragenic constructs, you should provide: 

• the copy number 
• a summary of how the inserted constructs alter or introduce new characteristics to the plant

Modern biotechnology techniques 

You must briefly describe how you made the genetic changes. For example, you should state if you have used site directed nucleases and their activity has been mediated via stable transformation.  

If you have inserted cisgenic or intragenic constructs, you must state the method of construct delivery. For example, “agrobacterium mediated” or “biolistic particle delivery”. 

Example general description  

An example of a general description could be:  

Solanum lycopersicon (tomato) plants were transformed with CRISPR-Cas9 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.

4. Intended use 

You should outline how you expect the precision bred plant to be used in the supply chain. For example:  

• “imported for food or animal feed use” 
• “cultivated in England for industrial use other than for food or feed” 

 If relevant, you should also provide information on: 

• novel cultivation or husbandry practices associated with the plant 
• potential beneficial health or environmental impacts of the plant, and how its intended use could achieve these

5. Intended changes made 

In section 5, explain the intended genetic changes you have made. This should be more detailed and technical information than your general description in section 3.  

The Advisory Committee on Releases to the Environment (ACRE) will use this information to provide a recommendation to Defra on whether notified plants are precision bred organisms. 

You should include a description of: 

• the genetic changes you have deliberately introduced to the plant using modern biotechnology 
• how these alterations change the characteristics of the precision bred plants

Genetic changes 

You must include: 

• genomic information on the size and number of any insertions, deletions, substitutions or inversions 
• the loci of these alterations within nuclear or non-nuclear genomes, including gene identifiers and alternative names (where possible) 
• the 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 you have targeted multiple copies of the same gene, you must provide this information for all targets.  

If you have inserted genetic material has been inserted into the plant genome (such as cisgenic or intragenic constructs), you must: 

• state the number of copies inserted and the orientation of insertion 
• describe all the inserted genetic elements, including their name, function, and the species from which they originated

Altered characteristics 

You must explain the: 

• primary (or hypothetical) function of targeted sequences or inserted genetic elements 
• 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” 
• broad phenotypic outcomes observed following genetic manipulation – such as “improved drought tolerance”, “later flowering time” or “altered metabolic efficiency” 

You will need to show that any genetic changes introduced by modern biotechnology are stable. To do this, you should demonstrate that genetic changes can be inherited following either sexual or asexual reproduction.  

You are not expected to monitor or prevent the accumulation of natural mutations in plants following confirmation of precision bred status.

6. Unintended changes made 

You must describe any unintended genetic changes resulting from modern biotechnology in the same way as you described intended changes in section 5.  

Unintended editing events will only prevent a plant from being confirmed as precision bred if they result in changes that could not arise through traditional processes.

7. Checks for and removal of unintended changes 

You must describe the approaches used to look for unintended genetic changes introduced to the plant through modern biotechnology.  

You should use appropriate techniques depending on the genetic changes and methods you have used to perform precision breeding. For example, you could use: 

• polymerase chain reaction (PCR) 
• sequencing 
• Southern blotting 
• other techniques (such as next-generation sequencing of regions with high sequence similarity to the target site as determined by Basic Local Alignment Search Tool) 

You can justify your approach by describing how techniques used during the breeding process have minimised the potential for unintended alterations to the genome. For example, you could outline your use of validated highly specific guides. 

If you have removed unintended genetic changes, you must describe: 

• the process you performed to do this (such as segregation) 
• how you confirmed the removal

8. Technology used 

You must describe the methods used to generate the genetic changes described in section 5.  

This includes the: 

• delivery method you used to introduce the genetic changes into the plant (such as agrobacterium, biolistic particle delivery or electroporation) 
• editing technology used to perform precision bred changes (such as CRISPR-Cas12b, TALENs, cisgenesis) 

You must also specify if you introduced any recombinant DNA to the plant as part of this process.  

If the insertion of recombinant DNA results in the generation of a transgenic intermediate (such as selectable markers, Cas9, gRNAs, Ori), you must provide the: 

• name of the genetic elements inserted 
• function of these genetic elements 
• organisms the genetic elements originated from

9. Confirmation of precision bred status 

You must confirm that your plant meets the criteria for a precision bred organism as described in the act.  

You must describe the analyses and procedures carried out to confirm the absence of transgenes that may have been introduced into the genome. This includes transgenes introduced unintentionally or deliberately during intermediate stages of development.  

You should use an appropriate technique depending on the genetic changes and methods you used to perform precision breeding. For example, you might use: 

• PCR 
• sequencing 
• Southern blotting 
• other techniques (such as PCR of regions flanking known insertion sites) 

You can also provide a reasoned argument describing why the genetic changes outlined in sections 5 and 6 could have arisen through traditional processes. For example, you could show that the genetic changes mirror an existing polymorphism or are known to occur in other traditional processes.

10. Notification of multiple precision bred plants 

If you are submitting a notice for multiple precision bred plants, in section 10 you must:  

• state the number of plants your notice covers 
• confirm that requirements in regulation 5(4) of the regulations are met 
• describe the intended and unintended genetic changes in each notified plants, in line with requirements outlined in sections 5 and 6 

Your description must use the plant described in section 3 to 9 (‘precision bred plant 1’) as a comparator. You should explain how intended and unintended genetic changes vary in relation to this plant.  For example: “‘Precision bred plant 1’ has a 3bp deletion in gene x, whereas ‘precision bred plant 2’ has a 5bp deletion”.

After you submit your marketing notice 

ACRE will assess your marketing notice. Defra will contact you if they need more information. 

Within 90 calendar days of receiving all necessary information, ACRE will advise Defra on whether it considers the plant to be precision bred.  

This timeframe can be extended if  ACRE needs more information from you to inform its advice.  

Defra will then contact you and either: 

• confirm precision status 
• explain why they are not issuing a precision bred confirmation 

They will then publish information from your marketing notice, the ACRE report and their decision to the public precision breeding register. 

Defra will not publish personal information on the register. Details that Defra will publish are listed in section 10 (4) of The Genetic Technology (Precision Breeding) Regulations 2025.  

Section 18 of the act outlines how Defra will treat any commercially confidential information provided in your marketing notice.