Welcome to the first edition of the Food Standards Agency's (FSA’s) market authorisations newsletter of 2025. So far this year we’ve already completed an important milestone in the world of market authorisation reforms, read on for more details.
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 previous edition, which was published in December, you can find the link towards the end of this email.

If you have any feedback, we would love to hear from you – please email us with your thoughts and suggestions.

In this newsletter:

• General update
• Feed additives
• Food improvement agents
• Food contact materials
• GMOs for use in food and feed
• Novel foods
• Precision breeding

General update

The FSA Board discussed several issues related to regulated products at their December meeting, which were summarised in the previous edition of this newsletter (find the link towards the end of this email). 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 previous meetings are also available.

Market authorisation process reforms: upcoming changes and what they mean for you

On 29 January, the FSA introduced draft legislation in Parliament to bring forward two reform proposals which we outlined in our December newsletter.
The draft legislation is the Food and Feed (Regulated Products) (Amendment, Revocation, Consequential and Transitional Provision) Regulations 2025 (‘reform SI’). It is expected to come into force on 1 April, subject to successfully completing debates in both Houses of Parliament. Until the reform SI comes into force, the current legislation and guidance will continue to apply and should be followed.

The reforms will make the authorisation process more efficient, by:

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.

Businesses will continue to be legally required to report to FSA and FSS if they have reasons to believe that placing the food or feed product on the market could do harm to consumers. Businesses will continue to be required to undertake any post market monitoring and post market environmental monitoring requirements where applicable, including supplying these reports to the FSA/FSS. The FSA and FSS have the powers to take action to protect public health and food safety, as and when necessary. For example, by reviewing authorisations at any time as new evidence emerges, and advising ministers on whether to revoke, modify or suspend authorisations.

Alongside the legislative process, we have also been preparing for implementation of these reforms by developing the online registers and guidance.

Next steps:
Ahead of the changes coming in, we will contact businesses that have a renewal application in the Market Authorisations Service, to explain how the reform SI impacts those applications.

We will also update the existing market authorisation guidance on the FSA and FSS websites when the reform SI comes into force. The updated guidance will reflect the technical changes made by the reform SI to the approval process. It will also remind businesses of their legal obligations to report to the FSA and FSS if they have safety concerns about a product and explain how to provide information about an existing authorisation.

Consultation on market authorisation of ten regulated products

We are currently seeking views in relation to ten applications for the market authorisation of regulated products. The consultation, which closes on 19 February, encompasses:

• a new specification of an existing permitted food additive
• a new use for an existing permitted feed additive
• a new authorisation for one food flavouring 
• removal of eight food flavourings (one application covering eight food flavourings)
• a new authorisation for one food contact material (FCM)
• three new authorisations for three genetically modified organisms (GMOs) for food and feed uses
• a new authorisation of one novel food
• an extension of use of an existing novel food

Further information is given under the relevant sections below. Full details of the consultation, together with the risk management recommendations, can be found here. Interested parties are invited to respond via the online survey.

Feed additives

Bovaer®

There has been widespread media coverage, discussion and misinformation on social media regarding the authorisation of feed additive 3-nitrooxypropanol (‘3-NOP’). This additive, more commonly referred to by its brand name, Bovaer® is a zootechnical feed additive in the category of substances which favourably affect the environment, to reduce methane emissions in ruminants for milk production and for reproduction.

As part of the FSA’s market authorisation process, feed additives must go through the FSA's rigorous safety assessment process, which ensures products are safe for the target animal, consumers, workers, and the environment. An application for the authorisation of Bovaer was received on 28 April 2021 and assessed through the standard FSA/FSS market authorisation approval process. As part of the safety assessment for Bovaer, we consulted external experts from independent Scientific Advisory Committees and Joint Expert Groups, to ensure the best available evidence was used.

The application for Bovaer was included in a public consultation, which launched in May 2023. The consultation pack can be found here. This consultation included the risk management opinion, including factors (such as environmental, trade, and consumer impacts) that the FSA/FSS identified as relevant to this application. This opinion, alongside any stakeholder responses received, was used to inform Ministerial decision-making as to whether to authorise these products.

Bovaer was subsequently approved for use 21 December 2023 in England, Wales and Scotland.

Further information on the process of regulating feed additives, and specific concerns surrounding Bovaer® can be found on the FSA website, where the Deputy Director of Food Policy has published a blog, which can be found here.

Published safety assessments

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

• RP1298 (6-Phytase (Ronozyme® HiPhos))
• RP1154 (Bacillus licheniformis DSM5749 and Bacillus subtilis DSM5750 (BioPlus® 2B))
• RP1341 (Endo-1,4-beta-xylanase, alpha-amylase and subtilisin protease (Avizyme® 1505))
• RP1893 (Bacillus velezensis CECT 5940 (Ecobiol®))
• RP2010 (Weizmannia faecalis DSM 32016 (TechnoSpore® 50))
• RP1780 (Diclazuril (Coxiril®))
• RP2109 Liquid L-lysine base produced with Corynebacterium glutamicum NRRL B-67439 or NRRL B-67535
• RP1742 (Lactobacillus acidophilus CECT 4529)
• RP2019 (Bacillus subtilis DSM 32324, Bacillus subtilis DSM 32325 and Bacillus amyloliquefaciens DSM 25840 (GalliPro® Fit))

These can be accessed here.

Future authorisations

Risk managers across the Great Britain (GB) nations are currently reviewing a number of applications that have progressed from risk assessment. We aim to publish our next set of applications for consultation in Spring 2025 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.

We are currently consulting on an application relating to a feed additive:

• RP694 (Saccharomyces cerevisiae CNCM I-10792-hydroxy-4-methoxybenzaldehyde), new use for an existing permitted feed additive

Details of the consultation, together with the risk management recommendations, can be found here. The consultation closes on 19 February.

Recent authorisations

Since the last newsletter, the snappily titled Feed Additives (Authorisations) and Uses of Feed Intended for Particular Nutritional Purposes (Amendment of Commission Regulation (EU) 2020/354) England) Regulations 2024 have come into force, alongside equivalent legislation in Wales and Scotland.
These regulations authorise twenty-five feed additives and one feed intended for particular nutritional purposes (PARNUT).

Food improvement agents

Flavourings and smoke flavourings

We are currently consulting on two applications relating to flavourings:

• RP1466 (2-hydroxy-4-methoxybenzaldehyde), new authorisation
• RP2184, removal of eight permitted flavouring substances from the domestic list. These are:
  • 2-Phenylpent-2-enal (FL No. 05.175)
  • 2-Phenyl-4-methyl-2-hexenal (FL No. 05.222)
  • 2-(sec-Butyl)-4,5-dimethyl-3-thiazoline (FL No. 15.029)
  • 4,5-Dimethyl-2-ethyl-3-thiazoline (FL No. 15.030)
  • 2,4-Dimethyl-3-thiazoline (FL No. 15.060)
  • 2-Isobutyl-3-thiazoline (FL No. 15.119)
  • 5-Ethyl-4-methyl-2-(2-methylpropyl)-thiazoline (FL No. 15.130)
  • 5-Ethyl-4-methyl-2-(2-butyl)-thiazoline (FL No. 15.131)

Details of the consultation, together with the risk management recommendations, can be found here. The consultation closes on 19 February.

Food additives

We are currently consulting on an application for a new specification of an existing food additive:

• RP1112 (steviol glycosides (E960b) produced by fermentation)

Details of the consultation, together with the risk management recommendations, can be found here. The consultation closes on 19 February.

Food contact materials

We are currently consulting on an application for a new food contact material:

• RP1190 (phosphoric acid, mixed esters with 2-hydroxyethyl methacrylate (HEMAP) (CAS No. 52628-03-2)

Details of the consultation, together with the risk management recommendations, can be found here. The consultation closes on 19 February.

Genetically modified organisms (GMOs) for use in food and animal feed

We are currently consulting on three applications relating to GMOs for food and feed uses:

• RP1123 (GMB151 soybean), new authorisation
• RP1123 (GHB811 cotton), new authorisation
• RP1506 (genetically modified maize DP4114 x MON 810 x MIR604 x NK603 and sub-combinations), new authorisation

Details of the consultation, together with the risk management recommendations, can be found here. The consultation closes on 19 February.

Novel foods

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

• RP2119 (2’-Fucosyllactose derived from genetically modified Corynebacterium glutamicum APC199)
• RP2155 (2’-Fucosyllactose derived from genetically modified Escherichia coli BL21 (DE3))
• RP2121 (3’-Sialyllactose sodium salt derived from genetically modified Escherichia coli BL21 (DE3))
• RP11 (Cannabidiol isolate)
• RP349 (Cannabidiol isolate)

These can be accessed here.

Future authorisations

We are currently consulting on two applications relating to novel foods:

• RP1033 (isomaltooligosaccharide), extension of use
• RP956 (magnesium L-threonate), new authorisation

Details of the consultation, together with the risk management recommendations, can be found here. The consultation closes on 19 February.

Cannabidiol (CBD)

The public list of CBD food products which are linked to an application for authorisation going through the novel foods process was last updated on 14 November. A breakdown of the 320 amendments included in the update is as follows:

• Product removals total: 86
• General admin total: 234 (134 status updated to validated; 100 amendments)

A breakdown of alterations to the CBD Public List by application/CBD business:

• Excite for life: 20 product names changed from '4' to 'for'
  
  
• Charlotte's Web; Dushey Med: 4 products removed
  
  
• Charlotte's Web; Savage Cabbage (RP230, RP231): 54 products removed
  
  
• CROP England: 26 products changed from RP427 to RP438
  
  
• Infinity CBD:  All 35 chocolate products altered name
  
  
• Naturecan: 1 product reinstated
  
  
• Pure Life Naturals: 6 products removed
  
  
• RP70: 16 products removed
  
  
• RP85: 9 products removed
  
  
• RP126/127/91: 7 products reinstated
  
  
• RP242: 13 products removed
  
  
• RP225 and RP238: Incorrectly joint RP number with RP427 - removed from 11 product listings
  
  
• RP346: 134 products status change to validated

All of the companies that had products removed from the list have been contacted and notified of the removals.

Precision breeding

In September last year, the Government confirmed their intentions to take forward the Precision Breeding (PB) policy. The Secretary of State for Environment, Food and Rural Affairs recently announced that the secondary legislation necessary to implement the Genetic Technologies (Precision Breeding) Act 2023 for plants in England will be laid by the end of March 2025.

To ensure that the new regulatory framework for the authorisation of precision bred organisms (PBOs) works effectively, we are making adaptations to our applications portal. Changes to the portal will ensure that PBO applications can be made and processed quickly and efficiently. We will be undertaking user testing of the portal prior to it going live later this year. We are also updating our guidance to ensure a smooth applicant experience. Additionally, a new public register is being developed which will contain information relating to PBOs authorised for use as food/feed in England.