Minutes of the 84th ACAF meeting held on Thursday 8th June 2023

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

Nicholas Jonsson

Committee Members

Martin Briggs 

Katrina Campbell 

Matthew Fisher 

Christine McAlinden 

Susan MacDonald 

Donald Morrison 

Derek Renshaw 

Mike Salter 

Adam Smith 

Helen Warren 

Nick Wheelhouse 

FSA members

Nathan Allen 

Alexander Cooper 

Michael Dickinson 

Donal Griffin 

Emily Hudson 

Michelle Hutchison 

Francisco Matilla 

Barry Maycock 

Hannah Reid 

Lucy Smythe 

Johann Trotter 

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. 

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 Donal Griffin gave an update on the status of feed additive applications currently being processed by the Regulated Products Risk Assessment Team. Currently four applications are undergoing suitability checks and fifty-four are ready to commence the assessment process. Twenty applications are currently under assessment by the Committee. Lastly, twenty-three applications have been completed or are going through opinion completion, and one has been published on the FSA and ACAF websites. 

Members were briefed on the completed recruitment campaign for new Committee and Secretariat members to increase work capacity and widen expertise. Nicholas Jonsson was officially appointed as ACAF Chair. Three full members and an associate member have also been recruited, Dr. Olivia Champion, Prof. Emily Burton, Ms. Hannah Kane and Dr. Oonagh Markey. A new Head of Regulated Products Risk Assessment for the FSA has been appointed, Chris Rundle.   

4. Policy Update 

Feed Additives Senior Policy Advisor, Mark Bond, briefed the group on the status of a currently ongoing public consultation on thirteen feed additives running for eight weeks closing the 20th of July. Members were briefed on a current proposal for an urgent authorisation of several cobalt-compound feed additives. Due to an administrative error, these products were legally due to be withdrawn from the market. This authorisation extends the availability of the products in the market for a set amount of time, allowing for a risk assessment to be completed. 

5. Minutes from 84th Meeting 

The Committee reviewed the minutes from the 84th ACAF meeting and provided feedback to be reviewed by the Secretariat. 

6. Dossier for assessment: RP1072 – Avatec (chickens) 

No conflicts of interest were declared for this item. 

An application was evaluated requesting a re-authorisation of “Avatec” (lasalocid A sodium) as a feed additive for its use in chickens for fattening and chickens reared for laying, under the category “coccidiostats and histomonostats”.  

The Committee was briefed by the Secretariat on the relationship between applications RP1070, RP1071 and RP1072, and how the information provided for these applications, particularly RP1072, would need to be considered to evaluate the other two applications. For this item, the Secretariat presented the most recent additional data of a new tolerance study and new efficacy studies for evaluation. In parallel, a request had been sent to the applicant to update other areas of the dossier for a later evaluation by the Committee. 

Members evaluated the new tolerance study using doses of 90, 112.5 and 135 mg Avatec/kg, noting that the diets used were of higher dietary energy levels than the three tolerance studies presented in the previous version of the document, aligning better with average UK poultry diets. It was concluded that the NOAEL from this study was 135 mg Avatec/kg. The study was not conducted to GLP and so, to support the validity of the study, the applicant would be asked to provide evidence of quality systems and auditing processes undertaken by participant contractors. The study used only male broiler chickens as test subjects, and therefore there was no consideration of effects on egg production, reproduction or histopathology of female reproductive organs. The ACAF concluded that they could not extrapolate the conclusions from this tolerance study to chickens reared for laying, and requested that the applicant should be asked to provide data in female chickens. 

Five efficacy studies were evaluated by Members, concluding they were conducted to a high standard, in line with recommendations laid out in the technical guidance. The additive showed significant effects on different endpoints between the treated and untreated groups, including reduced mortality, reduction of intestinal lesions and improvement of feed conversion ratio. Members discussed whether the evidence of efficacy was sufficient, given the lack of consistency of results across studies and the sometimes-marginal positive effects reported. It was concluded that, based on the fact that at least three studies presented evidence of efficacy, the additive was considered to have the potential of being efficacious when used at 90 mg Avatec/kg in chickens for fattening. Members agreed that the conclusion could be extended to chickens reared for laying. 

7. Dossier for assessment: RP1101 – Actisaf Sc 47 live 

Helen Warren declared an indirect conflict and remained in the meeting for discussion.  

An application was evaluated for the additive Actisaf Sc live yeast. The application sought renewal of authorisation under the category “zootechnical additives”, functional group “gut flora stabilisers” for its use in rabbits for fattening and non-food producing rabbits. 

The Committee noted that testing for filamentous fungi was absent from the dossier. The applicant would be asked to provide data for the testing of filamentous fungi. Testing for dusting potential had been provided by the applicant, however, the resulting data was presented in incorrect units, therefore, the applicant would be asked to provide the results for dusting potential in the appropriate units as described in the EFSA guidance. It was noted that the pelleting data presented did not include the conditioning temperature and the time at which the product was held at this temperature. The applicant would be asked to provide the pelleting conditions for each of the studies presented. The methods used for impurities testing were assessed by Members, with methods used in testing for aflatoxin B1 found to be absent from the dossier. The applicant would be asked to provide the methods used in the testing for aflatoxin B1. 

The Committee noted that the information provided for the manufacturing process was not given in adequate detail, with the points of addition of each ingredient absent from the flow diagram. The MSDS documents for each of the components utilised in the process, appropriate HACCP documentation and the final products MSDS were not included in the dossier. The applicant would be asked to review the description of the manufacturing process and ensure it is complete and comprehensive, with the points of each of the ingredient’s incorporation highlighted. The MSDS documents for each of the components utilised in the process and the MSDS for the final product are also required. The applicant would also be asked to provide appropriate HACCP documentation.  

Evaluation of the stability studies in feed highlighted that clarification was required over the conditions of use of the additive, with uncertainty over the form of the additive used and the comparability of the study-conditions to commercial conditions. Homogeneity data presented was based on theoretical studies which Members deemed inappropriate for assessment. The applicant would be asked to provide clarification over the form of the additive used in each stability study as well as the conditions of the studies and their comparability to commercial conditions. The applicant would be asked to provide practical studies to demonstrate homogeneity of the additive. Members noted inconsistencies in the units used in the conditions of use section of the dossier, the applicant would be asked to correct this error and provide an updated version of the document.  

When evaluating the safety of the additive for the user, the Committee noted that the studies for eye and skin irritation were conducted on only one form of the additive. The applicant would be invited to submit further studies for the other forms of the additive and reminded that the Committee will be unable to conclude on eye and skin irritation for the forms for which data is absent. In the absence of information on dusting potential expressed in the correct units, the Committee was unable to tell whether workers could be exposed to unacceptably high amounts of dust when handling the product. 

8. Dossier for assessment: RP1105 – Histidine E. coli KCCM 80212 

No conflicts of interest were declared for this item 

An application was evaluated for L-Histidine Monohydrochloride Monohydrate. The applicant requests a new authorisation under Regulation (EC) No 1831/2003 for all animal species. The additive falls under the category “Nutritional Additives” and functional group “Amino acids, their salts and analogues”.  

Prior to the meeting, the Secretariat had asked the applicant to provide a translation of several missing annexes and updated certificates and to clarify the conditions of use of the additive. Members reviewed this information and raised no further queries. 

It was noted by members that the batch-to-batch analysis of the additive showed the variation of the results to be small and the heavy metal contamination and mycotoxin contamination were within acceptable limits. The microbial contamination for salmonella, yeasts and moulds, and E. coli was shown to be negative. Members noted that the applicant had not provided the data for one of the three batches tested for dioxin and PCB contamination, and requested that they should be asked to provide the missing data. The Committee discussed the applicant’s claim that the bacterial endotoxin activity of histidine, as shown in test reports from several batches, was low compared with that normally found in animal feed, and concluded these values to be acceptable.  

It was discussed whether further testing by scanning electron microscopy would be required to characterise the percentage of particles with a diameter below 1 μm, given results indicating that 5-10% of the product was composed of particles smaller than 50 μm. Upon revision of the test reports provided, it was concluded that no particles below 1 μm had been detected and therefore no further testing would be required. It was noted that melting point, boiling point and solubility data would not be required for this application given the formulation of the additive, and that the minimum inhibitory concentration (MIC) values were acceptable.  

The applicant referred to an ingredient in the manufacturing process flowchart, however it was unclear what the substance was. The applicant would be asked to clarify what they are referring to in the process flowchart. Members noted that the manufacturing process referenced some ingredients for which no MSDS had been provided. The applicant would be asked to provide an MSDS for the missing ingredients and the complete HACCP plan. 

The homogeneity data was discussed and considered to be satisfactory, however, the experimental data underpinning the application’s conclusions was not provided in the annex. The applicant would be asked to provide the data and how they came to the values, including details on the method used, addition level, batch size, mix time and where sampled and if any samples were discarded.  

It was discussed that the proposed label text claimed a shelf life of a minimum of 3 years, however stability testing had been undertaken for 1 year at 25⁰C and 6 months at 40⁰C, therefore, the applicant would be asked to revise the shelf life of the additive or provide a justification supporting the 3-year stability claim.  

It was noted that the safety data presented for the user/worker indicated a potential risk for workers to be exposed to an unacceptably high amount of dust with a high proportion of small particles (less than 50 µm diameter), but the inhalation toxicity of the product was low. Members noted that there was a disparity between the conclusions presented in the dossier and SDS regarding skin sensitisation. The applicant would be asked to provide an SDS reflecting the worker safety assessment made in the dossier.  No further concerns were raised on the safety of the additive for the user/worker.  

Efficacy was not evaluated for the additive as this is not required for amino acids, amino acid salts and analogues already authorized as feed additives.  

Addendum: The application had been selected for the Risk Management Review route of assessment, for which a peer-review assessment of the EFSA opinion was undertaken. The Committee reviewed offline the information provided by the applicant in response to their queries and determined there was no conflict with the previous safety conclusions from the peer-review process. Following internal FSA conversations, the application will move back to the Risk Management Review route.  

9. Response to RFI: RP552 – Pediococcus pentosaceus 322922  

No conflicts of interest were declared for this item. 

The Committee discussed the responses provided for various queries sent to the applicant, concluding that questions on antimicrobial resistance, details on the testing facilities and official control methods had been correctly addressed. The applicant characterised the dusting potential and particle size distribution appropriately, but the Committee requested that the applicant should be asked to provide an MSDS for the final product. Members noted that the applicant had provided a commercial sample label for a similar product but not for the product under authorisation. The applicant would be asked to provide a sample label text for the product under authorisation, including data on stability of the product in water. The Committee re-evaluated the efficacy clarification provided and ratified their conclusion that the additive was not shown to be efficacious in difficult to ensile forages. The applicant would be asked to provide further data on efficacy of the product in difficult to ensile forages or accept the conclusion of the Committee.  

10. Response to RFI: RP709 – ProAct 360 (subtilisin protease) 

Adam Smith declared a direct conflict and left the room for the discussion.  

The Committee discussed the responses provided for numerous queries sent to the applicant, with Members concluding the responses to be adequate for whole genome sequence analysis, SDS documentation, dusting potential and discrepancies between studies provided and the additives MSDS. The applicant had been asked to provide the processing time for the pelleting process, whilst the response demonstrated the processing time to be below what was expected, it was deemed acceptable for assessment. Members noted that FAMI-QS certification had been provided, however, HACCP documentation was still absent. The applicant would be asked to provide HACCP documentation. The Committee reviewed the information provided on the potential effects on the target animals' gut microflora and concluded they were unable to support the applicants claims that the additive will have no effect. The applicant provided a lengthy response to the Committees request for the individual data from the 13-week rat oral toxicity study. Members concluded this response provided adequate data for assessment. Members assessed the response for the safety of the additive for users/workers and concluded adequate data had not been provided, the applicant would be invited to provide further data for assessment and reminded in the absence of data the Committee will be unable to conclude on eye irritation, skin irritation, skin sensitisation and respiratory sensitisation. 

11. Response to RFI: RP746 – Agal-Pro BL and Agal-Pro BL-L 

Adam Smith declared an indirect conflict of interest and was allowed to stay for the discussion. 

Members were satisfied with the applicant’s characterisation of the differences between the two forms of the product. It was noted that in the applicant’s response to whether any fermentation products remained present in the final product, an MSDS was provided only for some ingredients. The applicant would be asked to provide an MSDS for all ingredients. Members were satisfied with the applicant’s response that testing for sterigmatocystin, T2 toxin and citrinin is not required as part of Aspergillus niger testing protocol. 

It was stated that the applicant did not provide the HACCP plan as requested, since a table on quality assurance was provided instead. The applicant would be asked to provide the full HACCP plan. Members were satisfied with the updated information provided showing FAMI-QS and ISO 14001:2015 certification. The document provided by the applicant to support the dusting potential data could not be opened, so the applicant would be asked to provide the document again.  

12. Response to RFI: RP1015 – Lactococcus lactis NCIMB 30117 

No conflicts of interest were declared for this item. 

The Committee were satisfied with the data provided by the applicant for the testing of Salmonella. The applicant provided a label text claiming stability in water for 48 hours at up to 37oC. Members noted that the application showed stability in water for 7 days at 5⁰C and less than 24 hours at 20⁰C, however no evidence of stability over 48 hours was provided. The applicant would be asked to provide data to support the stability of the additive in water for 48 hours at ambient temperature or update the label based on the evidence presented.  

The Secretariat previously asked the applicant to provide the HACCP plan, however members stated the information provided in the response was not sufficient and that some ingredients listed lacked an MSDS. The applicant would be asked to provide the complete HACCP plan and to provide an MSDS for the ingredients used in the production process.  

Members were satisfied with the up-to-date certificates provided for FSSSC and FAMI-QS. The SDS for the additive was evaluated, concluding it was unclear and that it did not specify whether the additive is a potential skin and eye irritant and a respiratory sensitiser, as previously asked in the RFI. The applicant would be asked to provide an SDS that matches the assessment made in the application.   

13. Response to RFI: RP1071 – Avatec (turkeys) 

No conflicts of interest were declared for this item. 

The applicant provided an extensive response to the FSA’s request to clarify the cause of the isolated high-concentration residues in abdominal fat shown at the 5-day time point of the test report provided. Upon evaluation of the clarification provided, the ACAF concluded that the 5-day high values recorded should be considered as outliers, and therefore, a withdrawal period of 3 days could be considered safe. 

14. Draft opinions 

Members were presented with draft Committee’s Advice documents for applications RP416, RP420 and RP791. Feedback was provided to be reviewed by the Secretariat. 

The Committee was also presented with the final draft of Committee’s Advice documents for applications RP666, RP694 and RP748. The Committee provided feedback on final corrections and approved the opinions to be finalised and sent to Risk Managers. 

15. Efficacy workshop 

The ACAF Chair gave a thorough presentation on the principles underpinning the evaluation of the efficacy section of feed additive dossiers and led a constructive discussion on future approaches to this assessment. The ACAF concluded that a formal division between strong and weak evidence of efficacy would be adopted in future Committee’s Advice documents. This will be reflected by adopting the terminology “the additive can be considered to be efficacious” and “the additive has the potential to be efficacious”, respectively. 

16. Any Other Business 

The new dates for Committee meetings from September to December 2023 were confirmed to be September 15th, October 31st and December 14th.  

Next ACAF meeting: Wednesday 26th of July 2023 on Microsoft Teams