Welcome to the second edition of the Food Standards Agency's (FSA’s) Market Authorisations Newsletter. We hope you will find this seasonal ‘selection box’ of updates related to regulated products a handy resource.

In each edition we will bring together links to new entries to the register of regulated product applications, newly published safety assessments, consultations and authorisations and much more.

If you missed the first edition, which was published in September, you can find the link at the bottom of the page.

We would love to hear from you if you have feedback – please email us with your thoughts and suggestions.

In this newsletter:

• General update
• Cell-cultivated products
• Feed additives
• Food improvement agents
• Food contact materials
• GMOs for use in food and feed
• Novel foods

General update

The FSA Board discussed several issues related to regulated products at their December meeting, which are mentioned in more detail below.  Since transparency is a guiding principle for the FSA and key to maintaining public confidence, our Board meetings are available for interested parties to watch. You can register your interest and read papers that are presented to the Board here.  If you are unable to watch live, videos of the previous meeting are also available.

Market authorisation process reforms

As you may be aware, we, alongside FSS, have been working to streamline the authorisation process for regulated products.

On 11 December, the FSA Board discussed a paper on the Market Authorisation Service, which gave a progress report on reforms and improvements to the process and outlined next steps. The Board’s discussions can be viewed here.

Delivery of the two proposals previously identified as critical to making the authorisation process more efficient is underway:

1.  Removing requirements for the periodic renewals of authorisations for three regulated product regimes (feed additives, smoke flavourings and genetically modified organisms for use in food and feed);
2.  Allowing authorisations to come into effect following ministerial decision and then be published in an official public register or list, rather than by statutory instrument.

We have now drafted legislation to bring these reforms into force and, pending the necessary consents, we aim to introduce legislation at the end of January. If agreed by both Houses of the UK Parliament, we intend that the changes would be brought into force in April, which will enable the fourth tranche of authorisations (scheduled for 2025) to benefit from the streamlined process.  Alongside the legislative process, we have also been preparing for implementation of these reforms, developing the online registers and guidance.

Whilst these reforms will significantly reduce authorisation timelines, we know there is more to be done, and will be continuing to prioritise improvements that will speed up approval timelines significantly, without compromising safety, transparency and accountability.

We will continue to provide updates in future editions of this newsletter.

Cell-cultivated products

As mentioned in our previous newsletter, earlier this year the FSA, in partnership with FSS, submitted a bid for funding to the UK Department of Science, Innovation, and Technology’s (DSIT’s) Engineering Biology Sandbox Fund, to run a regulatory sandbox on cell-cultivated products (CCPs).

We are delighted to have been awarded £1.6 million from the Fund and the sandbox will run it in partnership with FSS between February 2025 and February 2027, operating across the four nations of the UK.

The programme team will work with a small number of CCP companies and academic participants to:

• Test, create and run a new pre-application support service: tailoring support for individual CCP companies to reduce delays, resolve key questions, and ensure high-quality dossiers.
• Agree on food safety considerations: working with sandbox participants to identify common safety hazards and tests that companies should conduct to generate data to prove hazard mitigation. We will also form a sub-committee of the Advisory Committee on Novel Foods and Processes (ACNFP) with expertise on this technology.
• Address essential policy questions across the four nations that must be answered before CCPs go to market. Part of this will be to decide what information consumers will require about CCPs, including any labelling requirements.

The work achieved by the sandbox will also allow us to keep pace with emerging technologies and apply our new insights when authorising other innovative foods.

Feed additives

Bovaer

There has been widespread media coverage and discussion on social media about a feed additive called Bovaer being trialled to reduce methane emissions from dairy cows to help combat climate change. We have written a blog answering some of the questions that are being raised here. 

Dossier requirements and recommendations

The FSA/FSS, with the help of the Advisory Committee on Animal Feedingstuffs (ACAF), have compiled a list of requirements and recommendations to inform current and future applicants of common areas where dossiers often fall short, as well as throw light on common ACAF interpretation of European Food Safety Authority (EFSA) guidance principles. These have been uploaded to the feed additives authorisation guidance page of the FSA website, under “Detailed guidance”.

These can be accessed here.

Published safety assessments

Three FSA/FSS safety assessments have been published since the last newsletter issue, relating to the following feed additive applications:

• RP1026/1027 (6-phytase (VTR-phytase)
• RP2059 (up to 75% inert copper in a PARNUT bolus)
• RP1823 (zinc-L-selenomethionine)

These can be accessed here.

Future authorisations

Earlier this year we ran public consultations on a total of 26 feed additive applications. We have considered the responses received and a summary of responses was published on 28 October.

Statutory Instruments (SIs) have been laid before parliament in England, Scotland and Wales authorising twenty-five feed additives and one feed intended for particular nutritional purposes (PARNUT). Pending conclusion of the parliamentary process, the authorisations will come into force across Great Britain (GB) in December and the registers of authorised products will be updated to reflect this.

Risk managers across the GB nations are currently considering a number of applications that have progressed from risk assessment. These include various food and feed regimes. We plan to publish our next set of applications for consultation by the end of January and will be writing out to relevant applicants to inform them of this prior to the consultation. We will also contact relevant stakeholders when the consultation is published.

Progress of applications running through the service is detailed on our Register of Regulated Product Applications.

Food improvement agents

Food additives and smoke flavourings

Following the publication of an FSA/FSS safety assessment of sodium alginate in August (which can be accessed here), this application has now entered risk management, after which the FSA and FSS will make recommendations to ministers across GB on the authorisation of this application.

Food contact materials

Plastics

The safety assessment for 2-hydroxyethyl methacrylate phosphate (RP1190), which can be accessed here) was published in July and this application has now entered the risk management phase of the market authorisation process.

GMOs for use in food and feed

Published safety assessments

One FSA/FSS safety assessment has been published since the last newsletter issue, relating to the following GMO application:

• RP307 (Genetically Modified MS11 Brassica Napus and MS11 × RF3 Brassica Napus) (1026/1027 (6-phytase (VTR-phytase)

This can be accessed here.

Novel foods

Published safety assessments

Seven FSA/FSS safety assessments have been published since the last newsletter, relating to the following novel food applications:

• RP1908 (UV-treated baker’s yeast)
• RP2101 (Lacto-N-tetraose (LNT))
• RP2106 (3-Fucosyllactose (3-FL)
• RP1550 (UV-treated Agaricus bisporus mushroom powder)
• RP1468 (Pasteurised Akkermansia muciniphila)
• RP1770 (Galacto-oligosaccharides - Oligomate 55N)
• RP1109 (Cellobiose)

These can be accessed here.

Cannabidiol (CBD)

Following publication of the first FSA/FSS safety assessments on CBD (which can be viewed here), we, together with FSS, are working on risk management implications of the first CBD safety cases, and with regard to England and Wales, looking at implications for the CBD Public List.

As outlined in our recent Board paper, we are currently on track to make recommendations to ministers on our first CBD applications in Spring/Summer 2025, following a public consultation.

The FSA will make recommendations on CBD applications to ministers in England and Wales, and FSS to ministers in Scotland. Under the Windsor Framework arrangements, prepacked retail agri-food goods containing GB-authorised products would be permitted on the Northern Ireland market if moved via the Northern Ireland Retail Movement Scheme (NIRMS).

The FSA Board discussed the paper on CBD on 11 December, the video of the meeting can be found here.