Minutes of the 93rd ACAF meeting held on Tuesday 17th September 2024

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

Nick Jonsson

Committee Members

Martin Briggs

Emily Burton

Katrina Campbell

Matthew Fisher

Hannah Kane

Susan MacDonald

Chris McAlinden

Donald Morrison

Derek Renshaw

Mike Salter

Adam Smith

Christel Wake

Helen Warren

Nick Wheelhouse

FSA members

Nathan Allen

Sarah Bannell

Alexander Cooper

Emily Davies

Beth Hall

Michelle Hutchinson

David Kovacic

Francisco Matilla

Barry Maycock

James Metcalfe

Lucy Smythe

Shila Sultana

Johann Trotter

Alba Ureña Rusillo

1. Apologies 

No apologies were received.

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 relating to the number of applications undergoing different routes of risk assessment: 23 applications are currently undergoing assessment with ACAF, 13 applications have been assigned for the ORO process, 7 assigned for ABB and 4 assigned for a combination of ORO/ACAF assessment. An update on applications RP1280, RP1460 and RP1579 was provided, as all three have now been withdrawn by the applicant. Members were notified that the Code of Practice and the Annual Progress Report have now been published on the ACAF website. It was highlighted that the use of AI apps is not allowed in Committee meetings.

4. Policy update

Animal Feed Policy Advisor, Beth Hall, provided the policy update as Mark Bond is now in secondment for six months. The Committee was briefed on the number of applications received since the last meeting, of which there have been fourteen, three of which are for new authorisations. A new Policy Advisor within the feed additives team, Sarah Bannell, was also introduced.

5. Minutes from 92nd Meeting

The Committee reviewed the minutes from the 92^nd ACAF meeting and provided feedback to be reviewed by the Secretariat.

6. Dossier for assessment: RP1644 Sacharromyces cerevisiae Y1242

Hannah Kane and Helen Warren declared indirect interests, but these were deemed not to pose a conflict, and they remained in the meeting. Emily Burton declared a direct interest. Her participation was limited to some technical written comments, and she left the meeting for the discussion.

The Committee assessed an application for the additive Saccharomyces cerevisiae Y1242 (Vistacell), which falls under the category of “zootechnical additives”, functional group “gut flora stabilisers”. The applicant is seeking a new authorisation for use in dairy cows, cattle for fattening, piglets, horses, other growing ruminants and other dairy ruminants.

Members noted numerous omissions and deficiencies concerning the identity and characterisation of the additive. It was observed that the Certificates of Analysis (CoA) provided for testing of impurities were not recent. However, the Secretariat confirmed that they were within 5 years of the date of submission so additional CoAs would not be requested. Members also queried the origin of the specifications for microbial impurities, specifically coliforms, moulds and total bacteria. The applicant would be asked to explain why those specifications were chosen. The applicant had provided testing for three samples of a single batch for dusting potential. The applicant would be asked to provide testing for three batches. An analysis was provided for particle size distribution, which showed an average particle size for the product but the proportion of particles that could be inhaled by users was not identified.  The applicant would be asked to provide analysis of the particle size distribution in the dust using laser diffraction, in accordance with ISO 13320:2009.

Members noted that S. cerevisiae is suitable for the EFSA Qualified Presumption of Safety (QPS) approach. However, the applicant had provided minimal information regarding the origin of the strain and had not provided evidence that the strain is deposited in a culture collection. Furthermore, the applicant had failed to provide any Whole Genome Sequence analysis or antimicrobial susceptibility testing. The Committee discussed the latter, noting that the qualification for S. cerevisiae as a QPS is absence of resistance to antimycotics used for medical treatment of yeast infections. Members agreed that the strain had not been adequately characterised, and the applicant would be asked to provide WGS analysis for the strain, in addition to phenotypic testing to determine the Minimum Inhibitory Concentration (MIC) for panel of clinically relevant antimycotics (to be determined by the applicant). The applicant would also be asked to provide additional information on the origin of the strain and a valid certificate of deposition. The Committee reviewed the manufacturing process and noted that SDSs were not provided for all the raw materials used, and that the FSSC certificate provided had expired. The applicant would be asked to provide recent SDSs for all raw materials used in the manufacturing process, in addition to a valid FSSC certificate.

Members reviewed the stability and homogeneity data provided by the applicant. The methodological information supplied for both was limited, and the Committee concluded that stability in pelleted feed could only be demonstrated for three months. The applicant would be asked to provide more detailed information regarding the pelleting process used in the study (including retention time) and to reflect this information in the conditions for use and label. The Committee concluded that the additive is stable for two years when stored at room temperature, and 12 months in a premixture.  Again, the applicant would be asked to ensure that this information is reflected in the conditions for use and label. Homogeneity in feed was not demonstrated with the limited data provided by the applicant. The applicant would be asked to provide additional evidence for homogeneity, including more detailed methodology.

The Committee reviewed a response to a previous request for information that had been sent to the applicant regarding the conditions of use and noted that the wording of the response was unclear. The applicant would be asked to clarify whether there were any contraindications or restrictions in the handling or use of the additive. Members also noted that the applicant had failed to provide several of the methods of analysis used throughout the dossier.  The applicant would be asked to provide a description of all methods of analysis used throughout the dossier. The Committee concluded that the additive is not a skin or respiratory irritant, and not a skin sensitiser. However, the additive should be considered a respiratory sensitiser. Consequently, respiratory protection for users/workers would be recommended.  The applicant would be advised to update the product SDS and label to reflect these recommendations.

The applicant submitted three long-term efficacy studies for each of the following animal categories: dairy cows, cattle for fattening and piglets. The applicant also submitted two short-term efficacy (digestibility) studies for horses. The Committee noted that the efficacy section was poorly written, with many errors and inconsistencies between the dossier and the supplementary study reports. Due to numerous deficiencies in study design and reporting, the Committee was unable to accept any of the efficacy studies provided for dairy cows and therefore could not conclude on efficacy in dairy cows. Consequently, the Committee was unable to extrapolate and conclude on efficacy in other dairy ruminants. The Committee noted that the efficacy studies provided for cattle for fattening provided weak evidence for efficacy but had several deficiencies.

The Committee accepted that two of the studies in piglets showed some evidence of efficacy. However, the third trial was discounted due to the confounding effect of feed refusal. Without the required three trials, the Committee was unable to conclude on efficacy in piglets. Members agreed that the two short-term efficacy studies in horses demonstrated weak evidence of efficacy. The Committee agreed that if efficacy had been demonstrated in food-producing animals, they would have been able to extrapolate to efficacy in horses. However, as this was not the case, the Committee was unable to conclude on efficacy in horses.  The applicant would be asked to provide additional efficacy data or accept that the Committee is unable to conclude on efficacy for any animal categories.

Addendum: The Committee further discussed the efficacy studies provided for cattle for fattening offline. Members discounted one of the trials due to significant weaknesses in design and reporting. The Committee agreed that the remaining two studies provided weak evidence of efficacy, but in the absence of a third study, the Committee is unable to conclude on efficacy in cattle for fattening or other ruminants for fattening.

7. Dossier for assessment: RP1696 Bacillus velezensis ATCC PTA-6737

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

An application was evaluated for PB6 (Bacillus velezensis ATCC PTA-6737). The applicant requests renewal of use for turkeys for fattening and turkeys reared for breeding. Modifications are also requested (i) to extrapolate the use of PB6 to the category “all growing poultry”, (ii) to modify the recommended dose for chickens for fattening from 1 x 10⁷ CFU/kg to 1 x 10⁸ CFU/kg and iii) to authorize the use of PB6 with halofuginone. The additive falls under the category “zootechnical”, functional group “gut flora stabilisers”.

Members noted that the applicant referred to an increase in the minimum concentration of the active agent in the additive and a change of carrier in a RFI response, however in the application it was stated that the manufacturing process of the additive has not been changed. The applicant would be asked to clarify whether the manufacturing process has been changed, and if so, to specify in detail what the changes are. The applicant would also be asked to clarify why there is higher efficiency in the fermentation process as there was no mentioned of a change in the fermentation process in the application.

Members reviewed the certification provided in RFI annexes, they stated that the FAMI-QS certificate provided is supplied from Kemin Singapore, however, the HACCP plan supplied is from Geneferm Taiwan. The applicant would be asked to clarify which plant manufactures the active ingredient and provide its corresponding certification. The Committee highlighted contradicting statements relating to the presence of AMR genes. The applicant would be asked to clarify if AMR genes are present, and if they are present, why they are not expected to be of any significance. Members also discussed the conflicting statements found relating to the presence of plasmids. A study from 2007 using in vitro tests (plasmid extraction and isolation) did not detect any plasmids in the strain, however, the WGS “in silico” analysis detected a plasmid. In section 2.2.2.2., it is reported that “no relevant plasmid sequences were detected in the strain.” The applicant would be asked to clarify if plasmids are present, and if so, why they are being regarded as “not relevant”. It was discussed by members that the MSDSs provided are very old and some do not have dates. The applicant would be asked to provide more recent MSDSs for all ingredients that include a date. Members discussed the use of PB6 with halofuginone and concluded that halofuginone is compatible with the additive. The applicant would be asked to include this on the label of the product. The exposure time undertaken during the pelleting and storage trial was discussed by members. The RFI response indicated two exposure times, 45s-1m30s and 45+/- 15s, the applicant would be asked to clarify the exposure time and to also update the conditions of use label reflecting the exposure time at 90°C.

Members concluded that the additive should be considered a potential respiratory sensitiser. It was highlighted that the SDS classifies the additive as a respiratory irritant, however, no data has been provided to support this. The applicant would be asked to provide a rationale as to why the additive has been classed as a respiratory irritant and to present this classification on the label of the final product. The applicant has referred to an EFSA report, which states that the additive prior to modification is non-irritant to the eyes and skin. The applicant would be asked to provide the complete studies to allow for a full risk assessment on the effects of the additive on eyes and skin. Members also stated that as skin sensitisation has not been studied, the additive will need to be considered to be a skin sensitiser.

The Committee found several discrepancies in the three efficacy trials presented. Two of the trials were carried out in the UK, however the tables contain commas instead of decimal points, which is the standard notation for European studies. The quality statement in both trials, where it claims ISO9002 as the standard compliance has not been dated or signed. The applicant would be asked to provide the original full report or each trial, with appropriate redaction, and to provide a rational for these discrepancies in the study reports that have been provided.

8. Response to RFI: RP1258 Enviva Pro 202 GT

No conflicts of interest were declared for this item.

In their response, the applicant stated that as they were using the same seed stock that had been kept in LN2 since the previous authorisation they did not need to show stability. Members discussed this explanation provided and concluded that evidence for genetic stability is necessary. Therefore, the applicant would be asked to provide more recent analysis of the genetic stability of the additive of the stock seed source.

Members were satisfied with the rest of the queries in the applicant’s response, regarding the FAMI-QS certification, MSDS of ingredients, stability of the additive, retention time during the pelleting process and the updated proposed label text.

The Committee concluded that the additive remains a respiratory sensitiser to the user/worker as dust can deposit in the respiratory system, therefore, the use of a respiratory mask is required when handling the additive.

9. Response to RFI: RP1366 Econase XT

Adam Smith declared an indirect interest but was allowed to remain in the meeting for the discussion.

Members were satisfied with the analysis provided for dioxins/polychlorinated biphenyls (PCBs) and Enterobacteriaceae. The applicant had provided recent Safety Data Sheets (SDSs) for all raw materials used in the manufacturing process and valid ISO 9001 and FAMI-QS certificates. Members were satisfied with the response provided regarding the stability of the additive and the application would be progressed to the draft Safety Assessment stage.

10. Response to RFI: RP1400 L-lysine

No conflicts of interest were declared for this item.

The Committee reviewed the responses to the request for information noting that the HACCP documentation provided was suitable for assessment. The data provided on pelleting stability did not include the retention time and the pelleting conditions were not included on the proposed label. The applicant would be asked to provide an updated label including the pelleting conditions. The additive’s stability in water was reviewed, and the applicant’s justification for the absence of further data assessed. The Committee concluded that the applicant had adequately addressed the query, however, owing to the presence of microbial contamination, the applicant would be asked to provide further data on the excipients (fermentation byproducts) in the final form of the additive that could be contributing to the microbial growth observed.

The applicant did not provide any further studies on the additives skin and eye irritation potential. Owing to the high pH of the additive in its concentrated liquid form further skin and eye irritation studies would be required to conclude on its potential irritancy to the skin and eyes. The applicant would be reminded that in the absence of further data on the additive in its concentrated form would be regarded as a potential skin and eye irritant.

11. Draft safety assessments: RP1026/RP1027, RP1154, RP1298, RP1341, RP1421, RP1512 and RP2059

Members were presented with draft Committee’s Advice documents for applications RP1154, RP1298, RP1341, RP1421 and RP1512.

The Committee was also presented with the final drafts of the Committee’s Advice document for applications RP1026/RP1027 and RP2059. The Committee provided feedback on final corrections and approved the opinions to be finalised and sent to Risk Managers.

12. Post-market monitoring RP1070, RP1071 and RP1072

No conflicts of interest were declared for this item.

The Committee reviewed the proposed post-market monitoring plans for each of the three applications. A decision was made to further review the documentation provided offline prior to drawing a conclusion on the post-market monitoring.

13. Recommendations to applicants

Members were invited to review for the last time the final iteration of this recommendation document to be shared with applicants.

14. Any other business

There were a few items reserved for any other business. The first was to highlight a document that provides Members with an update on the outcomes of the FSA’s Regulated Products Decision Panel.

Members were then informed about the upcoming process of reviewing EFSA guidance from 2024 at the next ACAF meeting.

A question was posed to the Committee regarding the interpretation of Directive 2007/43/EC and other similar legal texts laying down rules for the protection of animals reared for human consumption. The Secretariat asked whether any study not adhering strictly to these rules should automatically be ruled out, and whether that criteria could be used as part of the initial suitability evaluation of feed additive applications. The Committee valued the importance of carrying out trials adhering to the legal principles and recognised that these texts already allow ample flexibility to applicants. They also recognised that not all infringements would be expected to have the same level of impact in animal welfare or the evaluation of efficacy but reinforced the idea that legal welfare principles should always be complied with. The Committee recommended that each case should be considered individually.

An update on upcoming applications was provided.

Next ACAF meeting: 30^th October on Microsoft Teams.