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English Cymraeg

FSA 22-09-15 - Regulated Products Service: regular update to Business Committee

This paper provides a regular update on the on the current status of the regulated product service to ensure transparency on the progress of the service and proposes a set of key performance indicators to assist with measuring the performance of the service.

Last updated: 31 August 2022
Last updated: 31 August 2022

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1. Summary

1.1    The Business Committee is asked to note the current status of the Regulated Products Service.

2. Introduction

2.1    FSA and Food Standards Scotland (FSS) have been receiving applications for food and feed products which require authorisation prior to entering the market. The approval process for applications has various stages prior to recommendations being made to Ministers in England, Scotland and Wales.  Where Ministers decide to authorise, the authorisation must be set out in legislation before products may be placed on the market within the nations. In order for regulated products to be placed on the market in Northern Ireland, they must be authorised via the European Commission’s authorisation process. 

2.2    As agreed with the FSA Chair and Chief Executive, starting in March 2022, this regular update is provided at each Business Committee. The accompanying performance pack provides detailed analysis of the work flowing through the service.

3. Snapshot of Applications Received by Regulated Product Service

3.1    As of 31st July 22, we have 381 applications progressing through the service.  Fig. 1 shows the progress of applications per quarter, and the information below it explains the different stages. There is also a detailed breakdown of the applications we are progressing in Fig 2.

Figure 1 shows the to date progress of applications per quarter

Quarter Total contacts Incomplete applications Applications progressing Pre-validation Risk assessment Risk management Authorisation
Quarter 4 2020/21 987 791 196 111 65 10 10
Quarter 1 2021 183 135 48 23 14 10 1
Quarter 2 2021 105 81 24 16 5 3 -
Quarter 3 2021 111 74 37 32 2 3 -
Quarter 4 2021 108 84 24 22 2 - -
Quarter 1 2022 123 97 26 26 - - -
Total 1617 1262 355 230 88 26 11


Total Contacts: Number of individual contacts received on the Regulated Products Application Portal.  

Incomplete Applications: Number of contacts on the application portal, that were either not appropriate applications, had critical information missing for them to progress, or were applications that were subsequently withdrawn by applicants.  All applicants are given an opportunity to provide the necessary information before we process as incomplete 

Applications Progressing: Total number of live applications progressing through the service. 

Pre-Validation Stage: Applications being reviewed by Policy and SERD before being deemed suitable for progress into Risk Assessment. Applications can be held here for some time as missing evidence is sought and provided. 

Risk Assessment: Applications currently with SERD to formulate a risk assessment opinion. 

Risk Management: Applications that have been passed back to policy to consider risk management options. 

Authorisation: Applications where Ministers have agreed to authorise, but we need to complete the parliamentary Statutory Instrument process before the authorisations can be written into legislation.  

Figure 2 Detailed breakdown of live applications in the Regulated Products Service as of end of July 2022

Breakdown of all applications by regime Total number of applications progressing Number of applications at pre-validation Number of applications at risk assessment Number of applications at risk management Number of applications at authorisation Applications completed
Novel food (excluding CBD) 32 20 10 2 - 6
Novel food CBD 133 122 11 - - -
Feed additives 135 68 45 11 11  
GMO 29 17 1 11 - 9
Novel food traditional 3 1 2 - - -
Food contact materials (recycled) 7 2 5 - - -
Food contact materials (plastics) 3 1 2 - - -
Food additives 15 6 8 1 - -
Flavourings 4 3   1 - -
Feed for particular nutritional users (PARNUTS) 2 - 2 - - -
Novel food status 2 - 2 - - -
Smoke flavourings 9 9 - - - -
Food enzymes 1 1 - - - -
Other 5 5 - - - -
Feed detox 1 1 - - - -
Total 381 256 88 26 11 18

3.2    There are 256 applications at the pre validation stage, of which 122 are CBD applications.   Following the publication of the CBD product list, resource is now being focused on progressing applications in this pre-validation stage of the process. 

3.3    We have 88 applications progressing through Risk Assessment, which are for a range of different regimes. This stage is typically a significant contribution to the time to authorisation. We expect the number of applications in Risk Assessment will continue to grow during the first years of operation of the service as the service builds to a steady state. 

3.4    For public transparency, we continue to update our Register of Regulated Product Applications, which lists the progress of applications once they have been validated. 

4. Authorisations 

4.1    A total of 18 applications, which includes Novel Foods, GMO and Smoke Flavouring products, have been approved and authorised by Ministers and the legislation has come into force in England, Wales and Scotland.  We are also working on laying a Statutory Instrument for 11 Feed Additive applications, in September after the summer recess. The ministers have already confirmed their agreement to authorise those applications. 

4.2    The next batch of potential authorisations will include 23 applications including GMO, Novel     Food, Feed Additives, Food Additives and Flavouring products. Consultations on these applications will be launched shortly. Consultations will run for a period of 8 weeks, as the applications are considered routine. Recommendations will be made to Ministers once we have considered the consultation responses. 

5. Online Application System 

5.1    A new application system is being developed to replace the current application portal.  As part of this work, we are reviewing the guidance we provide potential applicants to help them make appropriate applications at the right time.  The new system will also reduce some administrative tasks and provide better information to applicants on who is managing their application and the progress of it. 

5.2    In order to provide the best possible product we will test the new application system with a range of users in October. Subject to the feedback we receive and further development of the system, we will provide continuous improvement over the coming months and the new application system is expected to go live before the end of the year.      

6. Conclusions 

The Business Committee is asked to note the current status of the Regulated Products Service.