Precision Fermentation Business Support Service (BSS)

Precision fermentation product means food or food ingredients containing components such as proteins, sugars, carbohydrates, vitamins and/or fats, produced by precision fermentation. Following fermentation, the desired product is separated from the fermentation broth and purified before being incorporated into food. 

Precision fermentation is a specialised form of fermentation that uses single-celled prokaryotic or eukaryotic microorganisms grown in a controlled environment. It uses biotechnological methods to cultivate microorganisms (such as bacteria, yeast, or other microbes) to produce specific target molecules, including proteins, lipids, and vitamins. 

Unlike traditional fermentation, which relies on natural microbial processes to generate broad metabolic products, precision fermentation is designed to produce high purity, well defined compounds. This is often achieved through the use of engineered microbial strains and advanced biotechnology. 

After fermentation, the resulting ingredient is extracted and purified from the fermentation broth ensuring that no live production organisms remain in the final food product. 

Prospective applicants can engage with FSS/FSA before submitting a dossier to gain clarity on essential requirements and applicability of the guidance.

Businesses responding to a Request for Information can access additional support through the service to help them understand and address any missing information identified in their dossiers.  

Advice provided as part of this service will be general in nature and provided without prejudice. It will not form part of the statutory process and should not be viewed as an authoritative or binding statement as to the likely outcome of an application. 

Support provided will not extend to the writing, or refinement, of dossiers. It will not substitute the need for prospective applicants to do their own work to prepare an application that meets the requirements outlined in Regulation (EU) 2015/2283.

The following are not included as part of the BSS Pilot’s pre-submission support function: 

• information that goes beyond that which is available in the legislation, rules, guidance documents or guidelines applicable to the application
• the design of the studies to be submitted and questions related to hypotheses to be tested, unless already covered in pre-existing guidance 
• formally reviewing prospective applicants’ draft dossiers and providing written feedback  

To be eligible to engage with the BSS Pilot pre-submission support, prospective applicants must:   

• be a registered company in one or more jurisdictions  
• intend to submit an application for authorisation to place a precision fermentation product on the UK market

To  engage with the service, prospective applicants must submit a  pre-submission enquiry form (PSEF1).

Within ten business days of the PSEF1 form, FSS/FSA will:

1. verify the applicant’s eligibility and that the questions raised in the PSEF1 are within scope of the pre- submission support service
2. notify the applicant as to whether their request has been accepted or declined

Support provided in Tier 1 will include up to two one-to-one meetings with the applicant to discuss the specifics of their application and any technical questions that they might have. These meetings will provide an opportunity for: 

FSS/FSA to get a greater understanding of the proposed product and its associated hazards.

The prospective applicant to enhance their knowledge of the regulatory process and receive further clarity in respect to any technical questions.
 

Applicants in Tier 2 will receive enhanced support in the form of written advice and, where possible, one-to-one meetings.

One-to-one meetings will only be offered to Tier 2 applicants if FSS/FSA has sufficient resources, and there are compelling reasons to do so. Compelling reasons could include:

• the product being non-routine or highly innovative, for example a first of kind innovation
• the product is expected to be high profile and/or controversial 
• the provision of advice could significantly affect application timeframes or cost, for example the prospective applicant has expressed they are ready to submit their dossier but are questioning if they should undertake an additional study which would come at significant additional time and cost
• the product’s development would stall unless further clarity is provided on the regulatory framework, and this clarity is unable to be sourced elsewhere, such as from an independent regulatory specialist

Tier 3 support will include light-touch support from FSS/FSA in the form of written guidance and public-facing webinars.    

One-to-one meetings with Tier 3 applicants will only be offered in exceptional circumstances. 

The following are not included as part of the post-submission support service:   

• information that goes beyond the information available in the legislation, rules, guidance documents or guidelines applicable to the application
• formally reviewing applicants updated dossiers and providing written feedback 
• discussions with the applicant that FSS/FSA does not perceive will deliver any benefit in respect to progressing the application  

To be eligible to engage with the BSS Pilot post-submission support function, applicants must meet all the below criteria:  

• have applied for market authorisation to place a precision fermentation product on the UK market prior to the establishment of the BSS Pilot, unless otherwise agreed by FSS/FSA
• have been issued a Request for Information by FSS/FSA about their application, for which FSS/FSA is awaiting a response, or be seeking to raise a ‘highly relevant’ development in respect to their application with the FSS/FSA and
• have submitted a post-submission enquiry form (PSEF2) 

In addition to the above general eligibility requirements, FSS/FSA will also offer limited post-submission support to applicants that have:  

• applied for market authorisation to place a precision fermentation product on the UK market prior to the BSS Pilot launch
• not had a meeting before submitting their dossier  
• subsequently been issued a request for information (RFI) by FSS/FSA

Applicants falling into the last category should also submit a PSEF2 in order to access the service.

In deciding whether an applicant is eligible to use the service, FSS/FSA will also consider if, in the context of the questions raised in the applicant’s PSEF2, further discussion would help to progress the application.

To engage with the service, applicants must submit a post-submission enquiry form (PSEF2)

Within ten business days of submission of the PSEF2 form FSS/FSA will:

• verify the applicant’s eligibility and if the questions raised in the PSEF2 are in scope of the service
• notify the applicant as to whether their request has been accepted or declined