Minutes of the 96th ACAF meeting held on Wednesday 12th February 2025

These minutes are subject to confirmation by the Committee. 

Members are required to declare any personal interest in matters under discussion. Where Members have a particularly close association with any item, the Chairman will limit their involvement in the discussion. In cases where an item is to be discussed in their absence, a Member may make a statement before leaving. 

This meeting was held online using Microsoft Teams.

Attendance

Committee Chair

Martin Briggs

Committee Members

Emily Burton 

Nick Jonsson

Hannah Kane

Susan MacDonald

Donald Morrison

Derek Renshaw

Mike Salter

Adam Smith

Christel Wake

Helen Warren

Nick Wheelhouse

FSA members

Nathan Allen

Krystle Boss

Aaron Bradshaw

Emily Davies

Beth Hall

Michelle Hutchinson

David Kovacic 

Francisco Matilla

Barry Maycock

James Metcalfe

Abigail Timothy

Johann Trotter

Alba Ureña Rusillo

1. Apologies 

Katrina Campbell and Chris McAlinden sent their apologies.

2. Welcome

The Chair welcomed members of the Committee, Secretariat and observers from the Devolved Administrations.

3. Risk Assessment update

The Regulated Products Team Leader Francisco Matilla-Garcia provided an update, noting that this is the last meeting of the financial year and that we have processed 50 applications over the course of the year through our three assessment routes, which is 10 more than predicted. The Committee were thanked for their continued hard work and contributions. Members were also informed that we are currently formalising RFI guidance, which involves determining deadlines and ensuring applications are up to standard. This guidance will then be shared with applicants once finished. An update was also provided relating to the appointment of Interim Chair wherein we will follow the internal process for selection.

4. Policy update

Animal Feed Policy Advisor, Beth Hall, provided an update for policy sharing that three new applications have been received since the last meeting. With regards to reform, the draft statutory instrument is now undergoing the parliamentary scrutiny process. This means that after April 1^st renewals will no longer be processed and there will be no expiry dates on authorisations. The feed additives register will also be revised in line with this date. Members were informed that a feed additive application is also currently going through consultation.

Emily Burton provided members with a brief update in relation to the Science Council.

5. Minutes from 95th Meeting

The Committee reviewed the minutes from the 95^th ACAF meeting and provided feedback to be reviewed by the Secretariat.

6. Dossier for assessment: RP1592 Interban®

No conflicts of interest were declared for this item.

The Committee assessed an application for the new authorisation of the additive Interban®, which falls under the category “coccidiostats and histomonostats”. The Committee discussed the application and the resubmission of the dossier following initial rejection by EFSA owing to their protocol on pre-notification of efficacy trials not being adhered to. Members confirmed that the updated dossier provided was acceptable for assessment.

The Committee reviewed the identity and characterisation of the additive, with members noting that owing to a recent change in taxonomy the production strain had not been adequately identified at the species level. The applicant would be asked to provide further detail of the taxonomy update on the production strain. The reporting of the whole genome sequencing data was not acceptable for assessment, the applicant would be asked to provide updated WGS reporting ensuring it is reported correctly.  Testing of amyl alcohols was only performed on five out of the possible eight forms. The applicant would be asked to clarify why these five forms were selected when there are eight possibilities. The protocol used for routine monitoring of impurities was not provided for assessment. The applicant would be asked to clarify the methods through which they routinely monitor for impurities. Members noted that rice hulls are used as an ingredient in the manufacturing process, as rice hulls can contain GMO further detail on the product used would be required for assessment. The applicant would be asked to provide further detail on the rice hulls used in the manufacturing process, including, if they contain genetically modified organisms, and if the producer/applicant regularly test for aflatoxins. The applicant would also be asked if the mineral oil used is feed/food grade.

The Committee reviewed the stability data provided for assessment, concluding that the additive is stable for 24 months at 30°C. The pelleting conditions described in the dossier were not indicative of standard conditions and would need to be reflected in the conditions of use for the additive. The applicant would be informed of this conclusion and asked to update the label and conditions of use to reflect this. If available, the applicant would be asked to provide pelleting stability data in line with standard UK conditions.

It was noted that the contraindications of the additive were inconsistent between the label and the conditions of use. The conditions of use should be revised to reflect these contraindications and the stability of the additive.

The data provided to demonstrate the safety for the consumer was evaluated by the Committee, who noted that the active ingredients have been previously evaluated by EFSA. Members reviewed the studies provided and the available EFSA opinions, concluding that the additive is not genotoxic. Whilst evaluating the dossier, Members noted that a publication released in 2024 highlighted the potential for resistance to the antimicrobial effects of narasin and salinomycin with continued use of the active agent. Members would further review the data available on narasin offline.

The data provided to support safety for the user and worker were reviewed by Members, who concluded that the additive is a potential irritant to the eyes and skin, and appropriate measures should be taken to avoid contact. The additive is also a skin and respiratory sensitiser, and measures should be taken to ensure contact with skin and inhalation is avoided. No concerns were raised by the Committee regarding the additive’s safety for the environment.

The data provided to demonstrate the efficacy of the additive was reviewed by the Committee, who concluded that the additive has the potential to be efficacious under the proposed conditions of use. The provided post-market monitoring plan was assessed by Members, and it was concluded that further information would be required for assessment. Members noted that AMR monitoring for resistance to narasin in a range of organisms would be required, especially for the monitoring for potential co-selection of resistance to vancomycin in enterococci. The applicant would be made aware of the surveillance data available and asked to provide an updated post-market monitoring plan to reflect suitable surveillance measures.

7. Dossier for assessment: RP2156 Copper lysinate sulfate

Helen Warren declared an indirect conflict of interest but was allowed to remain in the meeting for the discussion.

The Committee assessed an application for a new authorisation of the additive copper lysinate sulfate, which falls under the category of “nutritional additives”, functional group “compounds of trace elements” and is intended for use in all animal species.

The additive is a complex of copper and the amino acid lysine. Sulfate is also present in the complex.

Members were satisfied with the batch-to-batch variation and testing for impurities provided. It was noted that the applicant had only provided information for a limited number of physical and chemical characteristics, including melting point and solubility in water and ethanol. The applicant would be asked to provide information for the chemical and physical properties described in the EFSA guidance, or alternatively, provide a clear justification for why each property is not deemed relevant. Members examined the infra-red spectrum of the complex and agreed with the applicant’s assertion that the additive was not simply a mixture of the two raw materials. Although a CAS number had been provided for the unreacted mixture of the two raw materials (copper sulfate pentahydrate and L-lysine), a CAS number had not been provided for the reacted mixture. The applicant would be asked to provide a CAS number for the complex.

Stability studies were not provided, as this is a mineral-based additive. However, Members noted that there was no evidence that the complex remains stable over time. The applicant would be asked to demonstrate stability of the complex. The Committee assessed the capacity for homogenous distribution in feedingstuffs and noted that the coefficient of variation was high. Whilst this may be in part due to the high measurement uncertainty for copper, it was not possible to conclude on homogeneity with the data provided. The applicant would be asked to provide additional studies to demonstrate homogeneity in both premixtures and feedingstuffs.

Members noted that certificates of accreditation had not been provided for the laboratories performing analysis for the identification and characterisation of the additive. The applicant would be asked to provide these.

The Committee considered safety for the target species. It was noted that the complex likely dissociates into copper, lysine and sulfate under physiological conditions, but the contribution of the additional lysine and sulfate to the diet was expected to be minimal. The applicant provided a single combined tolerance/ bioequivalence study in chickens for fattening. Members concluded that the additive is well tolerated and safe for chickens for fattening. Members noted that for nutritional additives (with the possible exception of xenobiotic substances), a tolerance study in a single species is acceptable. The Committee agreed that the lysine component of the complex was not a xenobiotic and therefore the results of the tolerance study could be extrapolated to all species.

The Committee discussed consumer safety and noted that the applicant had not submitted any specific marker residue studies. The ACAF were unable to conclude on consumer safety and agreed that additional data was required to quantify the copper levels in edible tissues (including skin and fat for chickens) and products (including milk and eggs), in order to demonstrate that the additive would not increase consumer exposure to copper. The applicant would be asked to provide marker residue studies in laying hens and dairy cows.

Members considered user safety and agreed that although the additive has low dusting potential, it should still be considered hazardous via inhalation due to the high proportion of small (<50 µm) particles and high copper content in the dust, which is in exceedance of the Occupational Exposure Limit (OEL). Respiratory protection for users would be recommended due to the copper content and particle size distribution.

The Committee reviewed the Phase I assessment provided for safety for the environment. Members discussed general concerns regarding copper in the environment and the potential impact on the issue of antimicrobial resistance (AMR). However, as the proposed doses respect the maximum permitted copper levels in feed for each animal category, Members concluded that the additive could be considered safe for the environment and that a Phase II assessment was not necessary.

The applicant provided a single combined tolerance and bioequivalence study in chickens for fattening as evidence of efficacy. Members noted that there were some limitations to the study, including a lack of evidence that the additive was homogeneously distributed in the feed, which made it difficult to interpret the findings.

Addendum: Members discussed the bioequivalence study further offline and concluded that despite the limitations of the study, copper lysinate sulfate could be considered bioequivalent to an alternative source of copper (copper sulfate). The Committee therefore concluded that copper lysinate sulfate is efficacious as a source of copper for all animal species.

8. Dossier for assessment: RP2157 Bovacillus™ 10 and Bovacillus™ WS

Martin Briggs declared an indirect conflict of interest and stayed in the meeting for the discussion.

The Committee assessed an application for an additive, Bovacillus™, which is a microorganism product that contains the active substances Bacillus paralicheniformis DSM 33902 and Bacillus subtilis DSM 33903. This additive falls under the category “zootechnical”, functional group “gut flora stabiliser” and is available in two forms, a solid form (Bovacillus™ 10) and a solid water-soluble form (Bovacillus™ WS). The applicant is seeking a new authorisation for use in salmonids.

Members discussed the WGS analysis for AMR genes, highlighting missing data. The applicant is asked to provide evidence in relation to this gene. The Committee accepts that Bovacillus™ WS is shown to be stable in water for 48 hours, however this must be detailed in the conditions for use/on the label. The applicant is asked to provide an updated label containing this information. The applicant stated that “an acceptable homogeneity in water is expected”, however no evidence of this has been provided. Furthermore, in the response to the request for further information, it is stated that “based on the test results from the assessment of the stability of the product in water, where we obtained nine very similar test results, we infer that the strains of the product can be sufficiently dispersed in water.” The applicant is asked to provide data to demonstrate that the additive is homogenously distributed in water.

Within the manufacturing process, the applicant has provided details of production plants in Germany and Czech Republic as well as referring to the use of “any other suitable production plant designated by Chr. Hansen”. The applicant is asked to provide FAMI-QS certificates for all additional plants where the additive will be produced, as well as each manufacturing plant’s HACCP, noting any differences between each plan. The applicant has provided a list of raw materials used during the manufacturing process; however, the quantitative composition of these materials has not been provided. It should be highlighted that any information that is described as confidential will not be shared. Members agree that the quantitative composition of the raw materials is necessary to perform a complete risk assessment of the additive, therefore the applicant is asked to provide the quantitative composition of the fermentation media. The applicant has provided a SDS for monosodium glutamate however this has not been provided in the list of raw materials. The applicant is asked to clarify if this raw material is used during the manufacture of the additive and where it is used or confirm if it was provided in error. The Committee noted that some MSDS provided weren’t in English or were outdated. The applicant is asked to provide MSDS from less than two years ago and in English for the following: Struktol SB 509, glucose, dextrose, calcium carbonate, maltodextrin and Erol DF20K.

The Committee were able to conclude positively on the stability of the additive at 25°C for two years, however, could not conclude on stability at 30°C as the study provided under these conditions was for a lower concentrated version of the additive than the ones under assessment. The applicant is asked if they wish to submit data for the additives under assessment at 30°C or accept the conclusion for 25°C for 2 years. Members highlighted that the applicant has stated the storage temperature as “ambient”, and that a time of exposure has not been specified in the pelleting stability study. This should be included on the label; therefore, the applicant is asked to provide an updated label including this information.

The active agents in this application qualify for QPS status and therefore the additive is regarded as safe for the target species, the consumers and the environment. Both forms of the product contain a lot of small particles, to which workers could be exposed by inhalation. Therefore, the additive is considered a potential respiratory sensitiser, and measures should be taken to minimise such exposure. Studies were carried out on the effects on eyes and skin on the Bovacillus® 10 solid form of the product, members concluded that with this study, both formulations are considered non-irritant to eyes and skin. A study was not conducted on skin sensitisation and due to the proteinaceous nature of the active agents, the additive is considered as a potential dermal sensitiser.

The Committee discussed the three efficacy studies, noting that they were carried out to a high standard and demonstrate evidence of improvements in both milk yield and milk quality. Members concluded that the additive has the potential to be efficacious. 

9. Extrapolation of efficacy: RP1258 Enviva PRO 202 GT

No conflicts of interest were declared for this item.

Members discussed the potential extrapolation of efficacy results from turkeys for fattening to turkeys reared for breeding and concluded that they were satisfied with this extrapolation as it falls in line with the guidance.

10. Response to RFI: RP1696 Bacillus velezensis ATCC PTA-6737

Emily Burton declared a direct conflict of interest and left the meeting for this item.

Members reviewed the additional documents provided by the applicant, concluding that the additive is potentially efficacious for use in all growing poultry species.

11. Draft safety assessments: RP1275

The Committee was presented with the first draft of the Committee’s Advice document for application RP1275.

12. Titanium dioxide assessment

Members were given a brief overview of the upcoming titanium dioxide assessment and what to expect from the paper that will be presented at the April ACAF meeting.

13. Any other business

Members had previously raised concerns about the safety of the use of compressed air in manufacturing processes. The Secretariat researched this topic between meetings and provided an overview of their findings.

An update on upcoming applications was also provided.

Next ACAF meeting: 3^rd April 2025 on Microsoft Teams.