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Regulated Products

Penodol i Loegr

Certain products require authorisation before they can be sold in the UK, these are called regulated products.

Certain food and feed products, called regulated products, require authorisation before they can be sold in the UK. The FSA with Food Standards Scotland (FSS) carry out a risk analysis process for regulated products and provide advice to ministers, who decide whether the product can be placed on the market in England, Wales and Scotland. 

Objectives in 2021/22 

The aim of the regulated products process is: 

  • to make timely and evidence based recommendations to Ministers, on new and existing regulated food and feed products, to enter the GB market
  • to provide confidence that FSA advice delivers public health protection

Our objective for 2021/22 was to refine detailed operational procedures underpinning the process to ensure they were fully embedded in FSA work.

Progress against objectives

Operational outcomes

Figure 15: Contacts made to the regulated products application service 2021/22

This chart show that the number of contacts made to the regulated products applications service was 994 in quarter 4 2020/21 and then in 2021/22, was 182 in quarter 1, 105 in quarter 2, 111 in quarter 3 and 108 in quarter 4.

In Q4 of 2020/21, the number of individual contacts made to the service was very high due to a surge in cannabidiol (CBD) applications. There was a high volume of contacts that which could not be progressed any further.

Figure 16: Live applications at all stages of the application process 2021/22

This chart shows that the number of live applications at all stages of the applications process was 567 was 994 in quarter 4 2020/21 and then in 2021/22, was 402 in quarter 1, 404 in quarter 2, 428 in quarter 3 and 420 in quarter 4.

Live applications show the total of all applications in the process, regardless of stage. A high number of the contacts shown in Figure 16 did not progress through the service as they were incomplete applications, or inappropriate for this process. The number of live applications peaked in Q4 of 2020/21, coinciding with the FSA deadline on CBD applications. The level came down in the next quarter as applications progressed.

The approval process for regulated product applications broadly comprises four stages. Figure 17 details at which stage the live applications were being held.

Figure 17: Total live applications 2021/22: 420

This diagram shows the 420 total live applications in 2021/22 comprised 310 at validation stage, 60 at risk assessment stage, 41 at risk management stage and 9 at authorisation stage.
  • validation: 310
  • risk assessment: 60
  • risk management: 41
  • authorisation: 9

Regulated products applications represent the largest volume of work in the system. Our planning assumptions suggested that the FSA could expect to receive around 350 regulated products applications each year. This did not account for the impact of the regulatory approach to CBD, which led to a surge of applications around the March 2021 deadline. Other applications are in line with this planning assumption.

Back to the Main report: Activities and Performances 2021/22.