ACAF Annual Report 2024/25 - The Committee’s work in 2024/25 

Application 

Description 

Meeting Date 

Committee Response 

RP1421 

HiPhorius™  

(6-phytase (EC 3.1.3.26) solid (10 and 40) and liquid (20L and 50L) forms) 

• Zootechnical additive: digestibility enhancer 

• For use in poultry, swine, and aquaculture. 

Apr 2024 

Jul 2024 

Sep 2024 

Oct 2024 

• The additive was first assessed in April 2024. The Committee concluded that the additive is efficacious in growing birds however further discussion was held offline regarding experimental issues with the studies provided. 

• ACAF requested a report from Policy regarding the legal status of the studies and their eligibility for consideration. 

• Due to gaps in technical documentation, additional information was requested from the applicant. 

• In July, the Committee reviewed the response to the request for information which was deemed reasonable. 

• In September 2024 the Committee was presented with the draft of the Committee’s Advice documents. 

• In October 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

RP1280 

Formaldehyde 

GB pre-validation request for additional use for turkeys for fattening. 

(This application was withdrawn September 2024) 

• Technological: Hygiene condition enhancers 

• Chickens for fattening, laying hens, weaned piglets and pigs for fattening. 

 Apr 2024

Jul 2024 

• The additive was assessed previously in December 2023 and the Committee concluded that efficacy was demonstrated under the proposed conditions of use. 

• Due to gaps in technical documentation, additional information was requested from the applicant.  

• In April 2024, Members decided to postpone discussion of this application until further information has been provided by the applicant relating to the identity of the additive. 

• In July 2024, the Committee reviewed the response to the request for information. Members were still not able to conclude on identity or safety of the product. Further information was requested. 

RP1579 

Pediococcus acidilactici CNCM I-4622 

(This application was withdrawn Aug 2024) 

• Zootechnical additive: Physiological condition stabilisers 

• All insect species and categories 

 Apr 2024 

 Jun 2024 

 Jul 2024 

• The additive was assessed previously (RP29) and was concluded to be safe for the target species, consumers, and the environment.  

• Efficacy was assessed by the Committee in the April 2024 meeting. Members could not conclude positively on the efficacy of this additive. 

• The draft Committee's Advice document was reviewed in June 2024. 

• In July 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

RP1335 

Bio D® 1.25% 25-hydroxycholecalciferol 

• Nutritional additive: Vitamins, pro-vitamins and chemically well-defined substances having similar effect 

• Poultry for fattening, ornamental birds, other poultry (layers, broiler breeders) and all pigs. 

Apr 2024 

Jun 2024

Aug 2024

• An additive with the same active ingredient is already authorised for use in poultry, pigs and all ruminants, however this additive is produced by the non-QPS organism, Pseudonocardia autotrophica. 

• In April 2024, after reviewing the information provided, the Committee decided that the application could not be considered for full risk assessment by ACAF at this stage. 

• This assessment was approved by Decision Panel on 25 June 2024. Assessment route: ABB. 

• The FSA/FSS published a Safety Assessment in August 2024.  

• The FSA/FSS concluded the additive and production strain were correctly identified. It is not a dusty product; however, the particle size distribution was not characterised fully. The additive is stable for 24 months at room temperature and acceptably stable in premixtures and feed. Stability during pelleting could not be determined. Homogeneity in feed was demonstrated. The presence of live cells from the production organism in the final form of the product could not be ruled out. 

• The FSA/FSS cannot conclude on the safety of the additive Bio D® 1.25% for the target species and consumers as currently formulated when produced by P. autotrophica M301 (DSM 32858). 

• The additive is not a skin irritant or sensitiser and is not an eye irritant. The additive has a low dusting potential which would limit exposure through inhalation; however, uncertainties remain on its particle size distribution. Conclusions could not be drawn on the systemic toxicity potential of the additive, and the presence of live cells from the production strain in the final product could not be ruled out. These factors pose a concern for the safety for the user/worker. 

• The additive can be considered safe for the environment. 

• 25-hydroxycholecalciferol can be considered efficacious for the target species at the proposed doses of inclusion. Conclusions on chickens for fattening can be extrapolated to ornamental birds. 

RP1072 

Avatec® 150G  

 Lasalocid A sodium 

• Coccidiostats and histomonostats: Coccidiostats 

• Chickens for fattening; Chickens reared for laying. Turkeys for fattening; Minor avian species (pheasants, guinea fowl, quails and partridges), except laying birds 

Apr 2024 

Sep 2024 

Oct 2024 

Dec 2024 

• The additive was assessed previously in June 2023. An RFI was sent to the applicant. 

• In the April 2024 meeting, the applicant confirmed the removal of chickens reared for laying from the remit of the authorisation.  

• The Committee concluded that the additive is an eye irritant, but is not a skin irritant or skin sensitiser, the additive should be regarded as harmful by inhalation and appropriate PPE should be used when handling. 

• Members reviewed the updated information, and the Committee concluded that the additive can be considered efficacious at the proposed dose. 

• Further information was requested from the applicant. 

• In September 2024, the Committee reviewed the proposed post-market monitoring plans. A decision was made to further review the documentation provided offline prior to drawing a conclusion on the post-market monitoring. 

• In October 2024, the Committee reviewed the response provided by the applicant and concluded that no further information would be required from the applicant as the information provided was adequate for assessment. A draft safety assessment was reviewed. 

• In December 2024, the Committee provided feedback on final corrections and approved the opinions to be finalised on the safety assessment.  

RP1137 

CanBiocin K-9 Heritage Probiotic Blend ® 

(This application was withdrawn May 2024) 

• Zootechnical: gut flora stabiliser 

• For use in dogs 

Apr 2024 

• The additive was assessed previously in December 2023 

• In April 2024, the Committee concluded that the whole dossier should be resubmitted. The applicant would therefore be asked to withdraw the application.  

RP1243 

L-methionine (C. glutamicum & E.coli) 

• Nutritional additive: Amino Acids, their salts and analogues 

• All animal species and categories 

Apr 2024 

Jul 2024 

Oct 2024 

Dec 2024 

• The additive was assessed previously in September 2023. An RFI was sent to the applicant. 

• In April 2024, due to gaps in technical documentation, additional information was requested from the applicant.  

• Further information was requested from the applicant in July 2024 as the Committee could not conclude on the additive. 

• In October 2024 the Committee was presented with the draft of the Committee’s Advice documents. 

• In December 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

RP1282 

Levilactobacillus brevis DSMZ 21982 

• Technological additives: group K silage additives 

• All animal species and categories 

Apr 2024

• The additive was assessed previously in October 2023. An RFI was sent to the applicant.  

• In the April 2024 meeting, Members were satisfied with the response and information provided by the applicant however, further information was required in order to conclude on the additive. 

• Members stated that the additive is assumed to be very dusty with the potential to cause respiratory sensitisation in exposed workers and suitable measures will need to be taken to protect workers from inhalation exposure. 

RP1298 

Ronozyme®  HiPhos 

• Zootechnical additive:  digestibility enhancer 

• Poultry, weaned piglets, pigs for fattening and sows 

Apr 2024 

Jun 2024 

Sep 2024 

Oct 2024 

Dec 2024

• The additive was assessed previously in October 2023. An RFI was sent to the applicant.  

• In the April 2024 meeting, Members were satisfied with the response and information provided by the applicant however, further information was required in order to conclude on the additive. 

• In June 2024 Members reviewed the information provided by the applicant, it was deemed insufficient, and further information was requested to ensure laboratories used are compliant with internationally recognised standards. 

• In September 2024, the Committee was presented with the draft of the Committee’s Advice documents. 

• In October 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

• The FSA/FSS published a Safety Assessment in December 2024.  

• The FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly characterised, and that it is stable for 24 months with loss of activity compensated for through additive overfill. No further concerns were raised for the identity section of the additive. 

• The proposed level of inclusion of the additive in feed is safe for the target species, the consumer and the environment. The active substance is non-irritant to the skin and eyes; however, it is regarded as a potential respiratory sensitiser and, in the absence of skin sensitisation tests, a potential skin sensitiser. 

• Ronozyme® HiPhos is efficacious in poultry, weaned piglets, pigs for fattening and sows at the proposed dose range of 500 – 4,000 FYT/kg of feed. 

RP1341 

Avizyme® 1505  

Containing endo-1,4-beta-xylanase produced by Trichoderma reesei (ATCC PTA 5588), subtilisin protease produced by Bacillus subtilis (ATCC 2107) and alpha-amylase produced by Bacillus amyloliquefaciens (ATCC 3978) 

• Zootechnical additive: Digestibility enhancer 

• All avian species for laying, for fattening, reared for breeding and reared for laying (except ducks) 

Apr 2024 

Jul 2024 

Sep 2024 

Oct 2024 

Dec 2024

• The additive was assessed previously in December 2023 when Members reviewed the complementary information provided by the applicant to address the areas of concern identified in the EFSA 2020 opinion. An RFI was sent to the applicant.  

• In the April 2024 meeting, The Committee reviewed the updated bioinformatics data. Members were unable to conclude on the presence of AMR genes in the final product. MSDS documents were also unsuitable for assessment and no skin sensitisation studies were provided; further information was requested from the applicant. 

• In July 2024, Members reviewed the information provided and agreed that it was suitable for assessment. The Committee did not accept the applicant justification for not providing MSDS documentation. Further information was requested from the applicant. 

• In September 2024 the Committee was presented with the draft of the Committee’s Advice documents. 

• In October 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

• The FSA/FSS published a Safety Assessment in December 2024.  

• The FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly characterised, and that the additive is stable in premixtures and feedingstuffs for 16 months at 20°C. The additive is stable during pelleting at 90°C for 30 seconds. Homogeneity in feed was also demonstrated. 

• The additive can be considered safe for the target animal, the consumer and the environment. The additive is a mild irritant to the skin and eyes and is not a dermal sensitiser. The additive contains enzymes that are potential respiratory sensitisers, and measures should be taken to avoid contact through inhalation. 

• It was concluded that Avizyme® 1505 is efficacious for all avian species for fattening, reared for breeding and reared for laying (except ducks), and for all avian species for laying (except ducks) at the proposed inclusion rates detailed under the conditions of use of the additive. Efficacy in ducks at the proposed inclusion rate was only demonstrated for the first 42 days. 

RP1512 

 PB6 

 Bacillus velezensis    ATCC PTA-6737 

• Zootechnical additives: gut flora stabiliser 

• Authorised for use in weaned piglets and weaned minor porcine species. 

• Requested to renew the authorisation and extend its use to all pig species 

Apr 2024

Jun 2024

Sep 2024

Oct 2024

Dec 2024

Feb 2025

• The additive was assessed previously and authorised for use in weaned piglets and weaned minor porcine species and as a feed additive for sows. In January 2024, the applicant requested to renew the authorisation and extend its use to all pig species.  

• In April 2024, the Committee concluded that the additive is efficacious in weaned piglets and has the potential to be efficacious in sows and growing pigs. They also concluded that since the additive is regarded as a respiratory sensitiser at any level of inhalation exposure, and as the dusting potential values given are quite high, measures will be needed to minimise worker exposure by inhalation. More information was requested from the applicant to support other sections of the dossier. 

• In June 2024, the Committee reviewed the information provided by the applicant, it was deemed unsatisfactory and further information was requested regarding testing methods, compliance with international standards and MSDS documentation. 

• In September 2024, the Committee was presented with the draft of the Committee’s Advice documents. 

• In October 2024, the Committee reviewed the documentation submitted by the applicant and concluded that no further information would be required from the applicant at this stage. 

• In December 2024, The Committee was presented with the final draft of the Committee’s Advice document, feedback was provided on final corrections. 

• The FSA/FSS published a Safety Assessment in February 2025.  

• The FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly identified and characterised, and that it is stable for 18 months at room temperature, for 6 months as part of a mineral premix and a finished mash feed, and for 3 months after pelleting when held at a maximum of 90°C for 45 seconds. Homogeneity was also demonstrated. 

• The ACAF concluded that the additive is presumed safe for the target species, the consumer and the environment due to its Qualified Presumption of Safety (QPS) status. The additive is not an irritant to skin or eyes but should be treated as a potential skin and respiratory sensitiser. 

• The ACAF concluded that the additive is efficacious in weaned piglets at a dose of 1 x 107 CFU/kg complete feed. The Committee also concluded that the additive has the potential to be efficacious in sows and minor reproductive species at a dose of 1 x 108 CFU/kg complete feed. The Committee could not accept the applicant’s specific request for extrapolation from piglets to all growing pigs due to lack of evidence for efficacy when fed at the lower dose (1 x 107 CFU/kg) proposed in pigs. However, given the presence of three significant piglet trials and three significant sow trials the Committee was satisfied that the studies provided supported efficacy in all pigs when the higher dose of 1 x 108 CFU/kg was utilised for pigs in the fattening phase. 

RP552 

Pediococcus pentosaceus DSM 32292 

• Group K -Silage Additive 

Apr 2024 

Aug 2024

• The application had been previously assessed by the Committee; the applicant provided all information requested by Members in 2023. 

• In April 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

• The FSA/FSS published a Safety Assessment in August 2024.  

• The FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly identified and characterised, and that the additive can be considered safe for the target species, consumer, and the environment. The additive was identified as potentially harmful by contact with skin or eyes and a respiratory sensitiser. 

• It was concluded that the additive can be considered efficacious for moderately difficult to ensile forages. No conclusion could be reached on efficacy for difficult to ensile forages. 

RP634 

KemTRACE™ Chronium  

Chromium Propionate 

• Zootechnical feed additive: Other zootechnical additive 

• All growing poultry species 

Apr 2024 

Aug 2024

• EFSA published an opinion in 2022. 

• The Committee reviewed the application, supporting information and all RFI correspondence provided by the applicant in 2022. 

• In April 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

• The FSA/FSS published a Safety Assessment in August 2024.  

• The FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly characterised, and that it is stable for 24 months at 25oC at 60% humidity, for 6 months as part of a premixture. 

• Homogeneity in feed was also demonstrated. The mixture was pelleted at 90oC, but retention time was not given by the applicant, therefore no conclusion could be drawn on pelleting stability. No further concerns were raised for the identity section, Section II, of the dossier. 

• The proposed level of inclusion in feed is safe for the target species, but no margin of safety could be determined. 

• No conclusion could be drawn on the prenatal developmental toxicity potential of the additive, and therefore, on the safety of the additive for consumers. The additive is non-genotoxic, and no concerns about its metabolism were raised, however, no conclusion could be drawn on the applicant’s proposed 0-hour withdrawal period, given the impossibility to conclude on the prenatal developmental toxicity potential of the additive. 

• The active substance is non-irritant to the skin, however another major ingredient, propionic acid, is corrosive to skin and eyes, and the additive should be considered as such. As the active ingredient is corrosive to skin and eyes and it may be sprayed onto the feed, it would be prudent to regard it as potentially harmful by inhalation. The additive is not a skin sensitizer. 

• The additive poses an acceptable risk to the environment. 

• Chromium propionate has the potential to be efficacious for all growing poultry at the maximum proposed dose of 0.4 mg/kg of complete feed with 12% moisture. 

RP812 

Intellibond® C 

 Dicopper Chloride Trihydroxide (3b409) 

• Nutritional additive: Compounds of trace elements 

• All animal species 

Apr 2024 

Jun 2024 

Aug 2024

• In 2023 the Committee reviewed the application, supporting information and all RFI correspondence provided by the applicant; members could not conclude on the safety of the additive for marine sediment compartment when used in sea cages.  

• The Committee concluded no further information is required from the applicant and the dossier will move to the draft safety assessment stage of the process. 

• In April 2024, the Committee was presented with the draft of the Committee’s Advice documents. 

• In June 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

• The FSA/FSS published a Safety Assessment in August 2024.  

•  The FSA/FSS concluded, based on the ACAF’s evidence, that the additive was fully identified and characterised, and no further concerns were raised for this section of the dossier. The use of the additive at recommended levels of incorporation into feed can continue to be considered safe for the target species and the consumer.  

• Regarding user safety, the additive was determined to be non-corrosive and is not a skin sensitiser, however, is a skin irritant and should be regarded as a potential eye irritant. 

• The ACAF concluded that the additive poses an acceptable risk to the environment when used at the proposed levels for terrestrial species and land-based aquaculture systems. However, members could not conclude on the safety of the additive for marine sediment compartments when used in sea cages. 

•  It was concluded that the proposed minor modifications to the specifications and other provisions would not affect efficacy and therefore efficacy could be extrapolated from the original authorisation to the modified authorisation. 

RP814 

Intellibond® Z 

zinc chloride hydroxide monohydrate 

• Nutritional additive: Compounds of trace elements 

• All animal species 

Apr 2024 

Jun 2024 

Aug 2024 

• The Committee reviewed the application, supporting information and all RFI correspondence provided by the applicant. The RFI response was reviewed in December 2023, Members noted that in the absence of data the additive would be considered a potential eye irritant; it was also considered not to be a dermal sensitiser.  

• The Committee concluded that the additive remains safe when used at the proposed levels for terrestrial species and land-based aquaculture systems. However, members could not conclude on the safety of the additive for marine sediment compartments when used in sea cages.  

• In April 2024, the Committee was presented with the draft of the Committee’s Advice documents. 

• In June 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

• The FSA/FSS published a Safety Assessment in August 2024.  

• The FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly identified and characterised and that the changes made to the manufacturing process did not pose an unacceptable risk to safety. 

• The additive is safe for consumers and the target animal species. The additive is not a skin irritant or dermal sensitiser and is unlikely to form harmful amounts of respirable dust. The additive should be considered a potential eye irritant. The additive poses an acceptable risk to the environment under the proposed conditions for terrestrial species and land-based aquaculture systems. The Committee were unable to conclude on the safety of the additive for marine sediment when used in sea cages. 

• The ACAF concluded that the proposed minor modifications to the specifications and other provisions would not affect efficacy and therefore efficacy could be extrapolated from the original authorisation to this application. 

RP1015 

Lactococcus lactis NCIMB 30117 

• Silage additive 

• For all animal species and all types of forage 

Apr 2024 

• The Committee reviewed the application in 2023, Members requested additional information from the applicant. 

• The RFI response was reviewed in December 2023, Members were satisfied with the response, and no further questions were raised.  

• In January 2024 Members gave feedback on the draft Committee's Advice document. 

• In April 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

RP1039/RP1040 

VTR-xylanase 

Containing endo-β-1,4-xylanase 

• Zootechnical additive: digestibility enhancer 

• (RP1039) for suckling & weaned piglets and minor growing porcine species 

• (RP1040) for all avian species 

Apr 2024 

Jun 2024 

Aug 2024

• The Committee first considered these two linked dossiers in April 2023. Due to gaps in technical documentation, additional information was requested from the applicant.  

• The Committee reviewed the additional information provided in December 2023 and were satisfied.  

• In April 2024 the Committee was presented with the draft of the Committee’s Advice documents. 

• In June 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

• The FSA/FSS published a Safety Assessment in August 2024.  

• The FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly characterised, and that it is stable for 12 months in its powder form when stored at 25°C, and for 18 months in its liquid form when stored at 5°C. The additive is stable at 70°C for 15 seconds during pelleting. Homogeneity in feed was also demonstrated. No further concerns were raised for section II of the dossier. 

• The additive can be considered safe for the target species, consumers and the environment. The additive should be regarded as a skin sensitiser in both its powder and liquid form. The liquid form of the additive is not a skin irritant. In its powder form, the additive should be considered a potential skin irritant. The additive should be considered an irritant to the eyes in both forms. As an enzyme preparation, the additive should be considered a potential respiratory sensitiser. 

• VTR-xylanase is efficacious for weaned piglets, suckling piglets, minor growing porcine species, laying hens and other laying birds at 2,000 U/kg, and in chickens for fattening and minor avian species at 1,000 U/kg. 

RP1111  

PP102I 

Bifidobacterium longum CNCM I-5642  

• Zootechnical: (4e) Physiological condition stabiliser 

• For use in dogs and cats 

Apr 2024 

Jun 2024 

Aug 2024 

• In July 2023 Members assessed this dossier; additional information was requested from the applicant.  

• The applicant provided additional information which was assessed in December 2023 and found to be satisfactory.  

• In April 2024, the Committee was presented with the draft of the Committee’s Advice documents. 

• In June 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

• The FSA/FSS published a Safety Assessment in August 2024.  

• The FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly characterised, and that it is stable for 8 months when stored at 4°C, and in premixtures for 48 weeks at 32°C at 70% humidity, and for 88 weeks at 23°C at 60% humidity. Homogeneity in feed was also demonstrated. 

• As an organism suitable for the QPS approach to assessment, the additive can be considered safe for the consumer, the target animal, and the environment. The additive is not an irritant to the skin. The additive is an irritant to the eyes and should be considered a potential skin sensitiser and respiratory sensitiser. 

• Bifidobacterium longum CNCM I-5642 is efficacious for dogs at the proposed dose of 1 x 109 CFU/dog daily. 

RP1366 

ECONASE® XT 

Containing an endo‐1,4‐beta‐xylanase produced by Trichoderma reesei CBS 114044 

• Zootechnical additive: digestibility enhancer 

• For use in laying hens, minor poultry species and fattening pigs 

Jun 2024 

Sep 2024 

Oct 2024 

Dec 2024 

Feb 2025

• In June 2024, the Committee assessed the dossier and concluded that the additive is safe for the target species, consumers and the environment; it is not an eye or skin irritant or a skin sensitiser but should be considered a respiratory sensitiser. Members also concluded that the additive is efficacious in laying hens, minor poultry species and fattening pigs. 

• Further information was requested from the applicant regarding testing requirements of the additive. 

• In September 2024 Members reviewed the responses provided by the applicant and noted that the information provided was unsatisfactory; further information was requested for assessment.  

• In October 2024, the Committee was presented with the draft of the Committee’s Advice documents. 

• In December 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

• The FSA/FSS published a Safety Assessment in February 2025.  

• The FSA/FSS concluded, based on the ACAF’s advice, that all five forms of the additive and the production strain were correctly characterised. The liquid and solid forms of the additive are stable for 24 months at 25°C and 20-23°C, respectively. The solid forms are stable for pelleting to 95°C for 32-33 seconds and in a premixture for 6 months. All forms of the additive are stable in pelleted and mash feed for 3 months and capable of homogenous distribution in feed. 

• ECONASE® XT can be considered safe for the target species, consumers and the environment. All forms of the additive are considered non-irritating to skin and eyes and are not skin sensitisers but are potential respiratory sensitisers. 

• The additive is efficacious in laying hens, minor poultry species other than laying birds, laying birds of minor poultry species and pigs for fattening. 

RP1400 

L-lysine 

• Nutritional additive: amino acids, their salts and analogues 

• All animal species 

Jun 2024 

Sep 2024 

Oct 2024 

Dec 2024 

• The dossier was assessed by the Committee in June 2024. Members concluded that the additive was correctly identified. Members also concluded that it does not pose an issue for environmental safety.  

• The Committee requested further information be supplied by the applicant regarding skin and eye irritation and manufacturing details.  

• In September 2024 members were satisfied with the response provided by the applicant. No further information was requested.  

• In October 2024 the Committee was presented with the draft of the Committee’s Advice documents. 

• In December 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

RP1460 

Miya-Gold®  

(Clostridium butyricum FERM BP-2789) 

(This application was withdrawn Sept 2024 but may still require an opinion) 

• New use and modification of the existing  

• Zootechnical: gut flora stabiliser 

Jun 2024 

• In June 2024, the Committee assessed the dossier, primarily focusing on efficacy. 

• The applicant requested a new use and modification of the existing authorisation. 

• Members noted numerous issues with the documentation provided, therefore efficacy could not be concluded on. 

• Further information was requested from the applicant to support the efficacy of the additive.  

RP1026/RP1027 

VTR-phytase 

• Zootechnical feed additive: digestibility enhancer 

• All avian species, including ornamental, exotic and game birds (RP1026) and all pigs (RP1027) 

Jun 2024 

Jul 2024 

Sep 2024 

Oct 2024 

• In June 2024, Members discussed the applicant’s response to the request for information and the documentation provided. 

• New studies provided confirmed that the additive is a powerful skin sensitiser but not an eye irritant.  

• Members noted that the applicant did not repeat the stability or homogeneity tests within a reasonable amount of time, therefore the available information was presented to the Committee. No conclusion could be drawn on the stability during pelleting and storage or the homogeneity of the additive. 

• In July 2024, the Committee was presented with the draft of the Committee’s Advice documents. 

• In September 2024, the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections 

• The FSA/FSS published a Safety Assessment in October 2024.  

• The FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly characterised. No conclusion could be reached on the stability and homogeneity of the product. No further concerns were raised for Section II of the dossier. 

• The additive can be considered safe for the target species, consumers and the environment. The active substance is non-irritant to the skin and eyes, but the additive should be regarded as skin and respiratory sensitiser. Given the high dusting potential of the powder formulation, it is advised to limit user/worker exposure through inhalation. 

• VTR-phytase has the potential to be efficacious for all avian species, sows and pigs for fattening, and is efficacious in piglets when used at the proposed dose of 500 U/kg of complete feed with 12% moisture. Conclusions can be extrapolated to all Suidae at the corresponding developmental level. 

RP1070 

Avatec® 150G 

Lasalocid A sodium   

(Renewal – Safety concern) 

• Coccidiostat proposed for use in game birds. 

• Linked to applications RP1071 and RP1072. 

Jun 2024 

Sep 2024 

Oct 2024 

 Dec 2024 

• In January 2024, the Committee considered this request for authorisation in the context of two other related applications (RP1071 & RP1072). Due to gaps in existing documentation, additional information was requested from the applicant.  

• In June 2024, Members discussed the applicant’s response to the request for information; the documentation and information provided to demonstrate genetic stability was deemed insufficient. Further information was requested from the applicant. 

• In September 2024, the Committee reviewed the proposed post-market monitoring plans; a decision was made to further review the documentation provided offline prior to drawing a conclusion. 

• In October 2024, the Committee reviewed the information and documentation provided by the applicant in response to an RFI. The Committee concluded that the information provided was sufficient for assessment and that no further information would be required from the applicant. The Committee was also presented with the draft of the Committee’s Advice documents at this meeting. 

• In December 2024, the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

RP1317 

Vitamin D 

25-hydroxycholecalciferol (25-OH-D3) produced by a genetically modified strain of Saccharomyces cerevisiae SC0639 

• Nutritional additive: vitamins, pro vitamins and chemically well-defined substances having a similar effect 

• Applicant requested a modification to extend to ruminants. 

Jun 2024 

Oct 2024 

Dec 2024 

Feb 2025

• In December 2023, the Committee assessed RP1317 alongside RP1350 as they share some technical documentation. Due to gaps in existing data, additional information was requested from the applicant. The applicant was asked to confirm that the production strains were the same in both applications, to confirm that they can be assessed together.  

• In June 2024, the Committee reviewed the information and documentation provided by the applicant in response to an RFI.  

• The Committee concluded that the information provided for microbial testing and safety assessments were insufficient for assessment. Additional information was requested from the applicant. 

• In October 2024, the Committee was presented with the draft of the Committee’s Advice documents. 

• In December 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

• The FSA/FSS published a Safety Assessment in February 2025.  

• The FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly identified and characterised using whole genome sequencing, and upon receiving additional information, members were satisfied with the manufacturing process.  

• Stability was determined to depend on the manufacturer and the composition of the stabilised form. The additive was also concluded to be homogeneously distributed in complete feed for turkeys. No further concerns were raised relating to identity.  

• The ACAF concluded that the additive is safe for the target species, the consumer and the environment. The additive is not an irritant to skin or eyes but should be treated as potentially harmful if inhaled and as a potential skin sensitiser.  

• Upon receipt of further information relating to the inclusion rate of the additive, the ACAF concluded that the inclusion of the additive demonstrates similar effects on performance parameters when compared to vitamin D3. The Committee therefore concluded that the additive is effective in raising serum/plasma 25-OH-D3 levels in comparison with vitamin D3 for ruminants when used according to the proposed conditions of use. 

RP140/ RP141/ RP142/ RP284 

Coxidin® 

Monensin sodium 

• Coccidiostat 

• Use in chickens for fattening, chickens reared for laying (up to 16 weeks of age), turkeys for fattening (up to 16 weeks of age) and turkeys reared for breeding (up to 16 weeks of age) as target species. 

Jun 2024 

• In June 2024, results from the post-market monitoring plan for a previously evaluated application of Coxidin® (monensin sodium) were presented to the Committee for assessment. Three anticoccidial sensitivity tests were provided, with variable endpoint results.  

• The Committee concluded that, on their own, these reports did not show the existence of resistance to monensin sodium as a coccidiostat, and that based on the efficacy testing carried out as part of the application, the additive appears to remain efficacious for the control of Eimeria spp. 

RP1154 

BioPlus® 2B 

Bacillus subtilis DSM5750 and Bacillus licheniformus DSM5749  

• Already authorised as zootechnical feed additive for use in feed and water for weaned piglets, pigs for fattening, sows, calves for rearing, turkeys for fattening and suckling piglets. 

• Applicant proposed a new use in calves for fattening and other growing ruminants at the same developmental stage, and piglets (suckling and weaned) 

Jul 2024 

Sep 2024 

Oct 2024 

Dec 2024

• The dossier was first assessed in the July 2023 meeting. Due to gaps in the technical documentation, additional information was requested from the applicant.  

• In July 2024, the Committee discussed the responses provided for various queries sent to the applicant, concluding that the questions relating to batch-to-batch variation, impurities, microbial contamination, stability and homogeneity of the final product had been correctly addressed and genetic stability had been demonstrated. The Committee requested further information from the applicant regarding materials and manufacturing. 

• Members concluded that efficacy could be extrapolated from weaned piglets to suckling piglets for the period in which solid feed is given, and from calves for rearing to calves for fattening. 

• In September 2024, the Committee was presented with the draft of the Committee’s Advice documents. 

• In October 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections.  

• The FSA/FSS published a Safety Assessment in December 2024.  

• The FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly characterised and both microorganisms were confirmed to be QPS. No concerns were raised for Section II of the dossier. 

• The additive can be considered safe for the target species, consumers and the environment. The active substances are presumed to be respiratory sensitisers. In the absence of data, the additive should be considered a potential skin and eye irritant, and a skin sensitiser. It is recommended that methods are adopted to minimise worker exposure to the additive. 

• BioPlus® 2B, when used at the proposed doses of 1.3 x 109 CFU/kg of complete feed (12% moisture) and 6.5 x 108 CFU/L of drinking water, has the potential to be efficacious for calves for fattening and other growing ruminants at the same developmental stage, as well as suckling piglets during the period in which solid feed is given. For suckling piglets, it is recommended to feed the additive to lactating sows simultaneously. 

RP1393 

RONOZYME® WX 

containing endo-1,4-beta-xylanase (produced by Aspergillus oryzae DSM 33700) 

• Applicant requested an extension for use in all poultry and pig species. 

Jul 2024 

Dec 2024 

Feb 2025 

• The dossier was first considered by the Committee in December 2023. Due to gaps in the technical documentation, additional information was requested from the applicant.  

• In July 2024, the Committee discussed the response provided for various queries sent to the applicant. Members were satisfied with the response however more information was requested from the applicant as Members could not conclude on the efficacy for gestating sows without additional data and therefore extrapolation to all stages of a pig’s life was not possible. 

• In December 2024, the Committee was presented with the draft of the Committee’s Advice documents. 

• The FSA/FSS published a Safety Assessment in February 2025.  

• The FSA/FSS concluded, based on the ACAF’s advice, that the additive was fully identified and characterised. It was concluded that RONOZYME® WX (CT and L), manufactured with the A. oryzae DSM 33700 strain, did not raise any safety concerns regarding the genetic modification of the production strain. Members concluded positively on the stability and homogeneity of the additive. However, the pelleting stability for RONOZYME® WX (CT) was only tested for 20 seconds, and therefore this should be made clear on the label as some of the uses may require longer conditioning times. 

• The additive is considered safe for the target species, the consumer and the environment. The additive RONOZYME® WX (CT and L) is not a skin irritant and RONOZYME® WX (L) is not an eye irritant. RONOZYME® WX (CT) is a potential eye irritant. No information on skin sensitisation was provided; therefore, the additive is regarded as a potential skin sensitiser. The additive should be classified as a respiratory sensitiser due to the proteinaceous nature of its active ingredient (enzyme). 

• It was concluded that the additive is efficacious in all poultry species and in all pigs (Suidae) at a minimum recommended level of 100 Fungal Xylanase Units (FXU)/kg and 200 FXU/kg complete feed, respectively, with the exception to gestating sows, as no data was provided. 

RP1644 

Sacharromyces cerevisiae Y1242 

(This application was withdrawn January 2025) 

• Zootechnical additives: gut flora stabilisers 

• For use in dairy cows, cattle for fattening, piglets, horses, other growing ruminants and other dairy ruminants. 

Sep 2024

• In September 2024, the dossier was assessed by the Committee.  

• Members noted numerous omissions and deficiencies concerning the identity and characterisation of the additive. It was also noted that the efficacy section contained many errors and inconsistencies between the dossier and the supplementary study reports. The Committee could not conclude on efficacy due to lack of data.  

• Further information and documentation were requested to support the assessment of the additive.  

RP1696 

Bacillus velezensis ATCC PTA-6737 

• Zootechnical additive: gut flora stabiliser 

• Applicant requested a modification (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 

Sep 2024

Oct 2024                                         

Dec 2024 

Feb 2025

• The dossier was assessed in the September 2024 meeting. On reviewing the application, Members stated they required further information from the applicant to support the assessment of the dossier. 

• Members noted conflicting statements throughout the identity section of the dossier which the applicant was asked to clarify; Members also requested the applicant provide clarity surrounding the manufacturing and fermentation processes. Discrepancies were also found in the trials presented which the applicant was asked to comment on.  

• In October 2024, the Committee reviewed an RFI response referring to two applications containing the same additive (Bacillus velezensis ATCC PTA-6737); the Committee were satisfied with the applicant’s response. 

• Members also stated that the minor changes in the manufacturing process do not raise any safety concerns.  

• The Committee concluded that the additive is non-irritant to the eyes and skin. The committee could not conclude on efficacy and requested more information from the applicant.  

• In December 2024, the Committee discussed the applicant’s response. Members agreed that that the reports provided were not acceptable, therefore, members will not be able to conclude on efficacy. 

• In February 2025, Members reviewed the additional documents provided by the applicant, concluding that the additive is potentially efficacious for use in all growing poultry species.  

RP1258 

Enviva® PRO 202 GT 

Preparation of 3 strains of Bacillus velezensis (previously known as B. amyloliquefaciens) 

• Already authorised as gut flora stabiliser for use in chickens and minor poultry species for fattening and chickens and minor poultry species reared for laying. 

• Applicant has requested that authorisation is extended to turkeys for fattening and turkeys reared for breeding. 

Sep 2024

Oct 2024 

Dec 2024 

Feb 2025 

• The dossier was assessed in September 2023. The Committee concluded that there was sufficient evidence to support efficacy, but additional information was requested from the applicant to demonstrate the identity and characterisation.  

• In September 2024, the Committee reviewed the information supplied by the applicant and requested that the applicant 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.  

• 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. 

• In October 2024, the Committee was presented with the draft of the Committee’s Advice documents. 

• In December 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

• February 2025 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.  

• The FSA/FSS published a Safety Assessment in February 2025.  

• he FSA/FSS concluded, based on the ACAF’s advice, that the additive was correctly identified and characterised, and that the additive can be considered safe for the target species, the consumer and the environment. 

• The additive should be considered a skin sensitiser, respiratory sensitiser and a potential irritant to eyes for the user/worker. 

• The additive proved to be efficacious in chickens for fattening. The results can be extrapolated to turkeys for fattening and turkeys reared for breeding. 

RP1649 

Patent Blue V 

(sodium salt of 2-[(4-diethylaminophenyl)(4-diethylimino-2,5-cyclohexadien-1-ylidene)methyl]-4-hydroxy-1,5-benzene-disulfonate) 

(Renewal – Safety concerns) 

• Sensory additive: colourants, substances that add or restore colour in feedingstuffs 

• For use in all non-food producing species. 

Oct 2024 

• In October 2024, the Committee assessed the dossier and noted that the additive presented in the dossier did not have the same specifications as the original authorisation.  

• Members also noted that data provided to assess identity and characterisation were not suitable; the applicant also omitted impurity studies relevant to the assessment. 

• No studies were provided for safety for the user/worker, owing to the absence of data the Committee concluded that the additive should be considered a respiratory and skin sensitiser and an eye and skin irritant.  

• A request for further information to support the additive seeking authorisation was sent to the applicant.  

RP1888 

Lactiferm®  

Enterococcus faecium NCIMB 11181 

(This application was withdrawn January 2025) 

• Zootechnical additives: gut flora stabiliser 

• Use in chickens for fattening, chickens reared for laying, other poultry species for fattening or reared for laying and ornamental birds. 

• New Authorisation (extension in species) 

Oct 2024 

Dec 2024 

• In October 2024, the Committee reviewed this dossier and carried out an assessment on the efficacy section.  

•  Members stated that three out of the six trials show a positive effect for efficacy, however, the remaining three studies showed little potential for efficacy.  

• It was concluded that not enough evidence for efficacy has been provided in chickens for fattening to be able to extrapolate to all growing poultry and ornamental birds. 

• A request for further information to support the efficacy of the additive was sent to the applicant.  

• In December 2024 Members discussed the applicant’s response and reviewed the information and documentation provided, the Committee determined that evidence provided was insufficient and therefore could not conclude on efficacy.  

RP2074 

FUMzyme®  

(fumonisin esterase EC 3.1.1.87) from Komagataella phaffii (DSM 32159) 

• Technological additive: substances for reduction of the contamination of feed by mycotoxins 

• The enzyme is produced by a genetically modified (GM) yeast strain, Komagatealla phaffii DSM 33835. 

Oct 2024

• In October 2024, the Committee reviewed the dossier and noted that the applicant needed to provide clarity in certain areas and requested the applicant supply further information regarding the identity and characterisation of the additive. 

• Members could not conclude on eye irritancy using the test provided. No studies for skin sensitisation were provided, therefore the additive should be considered a potential skin sensitiser. The additive is also an enzyme product, therefore should be regarded as a potential respiratory sensitiser. Members confirmed that this additive would be classed as non-irritant to the skin. 

• The Committee could not conclude on efficacy highlighting some concerns around the dairy cattle and fish studies. 

• A request for further information to support the additive seeking authorisation was sent to the applicant.  

RP1055/RP1582 

Huvezym® neXo 

Peparation of endo 1,4 betaxylanase, endo 1,4   
betaglucanase and xyloglucan-specific-endo-beta-1,4-glucanase)  

(RP1055 was withdrawn December 2024) 

• Preparation of enzymes produced by Trichoderma citrinoviride B-125 DSM 33578. 

• Proposed for use in poultry, ornamental birds and piglets (RP1055) and pigs for fattening, sows, minor species for fattening and reproduction (RP1582). 

Oct 2024 

• The Committee assessed these two linked dossiers in the July 2023 meeting.  

• Due to gaps in existing documentation, additional information was requested from the applicant.  

• The Committee assessed the applicant’s response in October 2024 and found the information supplied satisfactory. 

• The Committee discussed the applicant’s request to extrapolate tolerance from laying hens to breeder poultry, highlighting that according to EFSA guidance this extrapolation is not possible without an additional study in breeding hens considering only performance endpoints.  

• The Committee were able to conclude that the additive is efficacious in weaned and suckling piglets, and sows. Further clarification was provided for chickens for fattening, allowing members to conclude positively on efficacy for chickens for fattening.  

• A request for further information to support the additive seeking authorisation was sent to the applicant.  

RP1904 

Biomin® C5  

Enterococcus faecium (DSM 33761), Pediococcus acidilactici (DSM 33758), Bifidobacterium animalis (DSM 16284), Limosilactobacillus reuteri (DSM 33751) and Ligilactobacillus salivarius (DSM16351) 

• Zootechnical additive: gut flora stabilisers 

• For use in chickens for fattening, chickens reared for laying, turkeys for fattening and reared for breeding and minor avian species other than laying species. 

Dec 2024 

• The dossier was assessed in December 2024. Based on the original data provided, the Committee were unable to conclude on the efficacy of the additive.  

• Supplementary data provided by the applicant was reviewed by the Committee offline and Members concluded that the additive has the potential to be efficacious for chickens for fattening under the proposed conditions of use. This conclusion can be extrapolated to chickens reared for laying, turkeys for fattening and reared for breeding and minor avian species other than laying species based on the data provided.  

RP2071 

Enterosure™ Conc 

 Bacillus velezensis (ATCC PTA-6737) and ATCC PTA-127114), Bacillus licheniformis (ATCC-127113) 

• Zootechnical additive: gut flora stabilisers 

• For use in all growing avian species 

Dec 2024 

• The dossier was assessed in December 2024. All three strains are suitable for the EFSA Qualified Presumption of Safety (QPS) approach. 

• The application referred to Enterosure™ Conc, but also to a less concentrated form in a calcium carbonate carrier, termed Enterosure™; the Committee agreed that for the purposes of the discussion, both forms would be considered.  

• The Committee were unable to conclude on safety for the target species with the data provided.  

• The Committee concluded that Enterosure™ Conc (extrapolated to Enterosure™) was not a skin or eye irritant but should be considered a respiratory sensitiser; it was assumed to be a skin sensitiser. The Committee recommended measures to protect users from respiratory and dermal exposure. 

• Due to experimental issues with one trial Members were unable to conclude on efficacy.  

• The Committee noted some discrepancies within the documents provided and were unsatisfied with the information provided in support of the authorisation. Further information and documentation were requested from the applicant. 

RP2107 

Availa® Cr  

Chromium chelate of DL-methionine 

• Zootechnical additives: other zootechnical additives 

• For salmonids 

Dec 2024

• An application containing the same additive for use in dairy cows (RP16) was previously submitted to FSA and partially assessed by the Committee. 

• During the December 2024 meeting the Committee supported the conclusion of the previous assessment for the identity of the additive, no causes for concern were identified. 

• The Committee could not conclude on the safety for target species. The Committee concluded that chromium methionine should be regarded as mutagenic at the site of exposure. Members agreed that the additive is non-irritant to skin and eyes and is not a skin sensitiser. 

• The Committee evaluated the efficacy studies stating they show efficacy of the additive in relation to growth performance. More evidence was required to determine efficacy.  

• A request for further information to support the additive seeking authorisation was sent to the applicant.  

RP1275 

Quantum® Blue  

6-phytase (EC 3.1.3.26) produced by Trichoderma reesei 

• Zootechnical additive: Digestibility enhancer 

• For use in fin fish. 

Dec 2024 

Feb 2025

• The Committee considered the dossier in September 2023 and concluded that the product was efficacious for trout but no other fin fish.  

• Additional information was requested from the applicant, and this was reviewed in January. There were still gaps in the existing documentation, so a further request for information was sent to the applicant.  

• The response to the RFI was reviewed by the Committee in December 2024.  

• Members were satisfied with the information provided by the applicant. However, more information was requested regarding methods used to measure yeasts and moulds.  

• In February 2025 the Committee were presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections. 

RP1592 

Interban®  

10 % Narasin and 0.2 % Diclazuril 

• Coccidiostats and histomonostats 

• Chickens for fattening and chickens reared for laying 

Feb 2025 

• In February 2025, the Committee discussed the application and the resubmission of the dossier; Members confirmed that the updated dossier provided was acceptable for assessment.  

• The Committee 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. Members also concluded that the additive is not genotoxic. 

• 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 further reviewed the data available on narasin offline. 

• The Committee 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. 

• A request for further information to support the additive seeking authorisation was sent to the applicant.  

RP2156 

Copper lysinate sulfate 

(This application was withdrawn January 2025) 

• Nutritional additives: compounds of trace elements 

• For use in all animal species. 

Feb 2025 

• In February 2025, the Committee assessed the application. The Committee noted that the applicant had only provided information for a limited number of physical and chemical characteristics.  

• Members concluded that the additive is well tolerated and safe for chickens for fattening, it was also considered safe for the environment; members were unable to conclude on consumer safety. 

• 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. 

• Following an offline discussion the Committee concluded that copper lysinate sulfate is efficacious as a source of copper for all animal species. 

• A request for further information to support the additive seeking authorisation was sent to the applicant. 

RP2157 

Bovacillus 10 ® and Bovacillus® WS   

(Bacillus paralicheniformis DSM 33902 + Bacillus subtilis DSM 33903) 

• Zootechnical additive: gut flora stabiliser 

• Use in salmonids 

• Bovacillus® 10 (solid) Bovacillus® WS (water soluble)  

Feb 2025 

• In February 2025, the Committee assessed the dossier and discussed the information provided by the applicant to support the identity and characterisation of the additive; further information was requested from the applicant.  

• The Committee discussed the efficacy studies and concluded that the additive has the potential to be efficacious.  

RP1499 

Balancius® Muramidase (solid and liquid forms) 

(ABB Assessment) 

• Zootechnical: Other  

• New use- extension in species 

Dec 2024 

• In December 2024, the Committee provided feedback on an internal safety assessment prepared for an additive containing muramidase produced by Trichoderma reesei DSM 32338.  

Application 

Description 

Meeting 

Committee's response 

RP2059  

Tracesure® 

Copper bolus  

Applicant requested a modification of entry number 59 of the PARNUT regulation 2020/354 to allow inclusion of up to 75% copper.  

Jul 2024 

Sep 2024 

Oct 2024 

• The application was first considered in October 2023. The risk assessment considered safety for target animal, safety for the consumer, safety for the user and safety for the environment. The Committee requested that the applicant provide a more comprehensive risk assessment supported by quality assured studies.  

• In July 2024 the Committee was presented with the draft of the Committee’s Advice documents. 

• In September 2024 the Committee was presented with the final draft of the Committee’s Advice documents, feedback was provided on final corrections.  

• The FSA/FSS published a Safety Assessment in October 2024.  

• The FSA/FSS concluded, based on the ACAF’s advice, that copper in a bolus ballast is inert and that leaching of copper into the rumen is highly unlikely. The copper in a bolus ballast is not bioavailable to the animal, therefore the risk of toxicity to target animals and consumers is low. The use of up to 75% inert copper as an alternative to up to 20% inert iron in a PARNUT bolus poses no additional risk to the target animals, consumers, users or the environment.