An application was submitted to the Food Standards Agency in October 2022 from Huvepharma NV (“the applicant”) for the authorisation of a new use (extension of species) of an additive consisting of diclazuril. It was submitted under the category of ‘coccidiostats and histomonostats’ as a coccidiostat for its use in chickens reared for laying and pheasants. In its previous assessments, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not definitively conclude on the risks associated with the use of diclazuril in acid soils from Coxiril®. However, based on new data provided, the FEEDAP Panel reached the conclusion that no risk to the terrestrial compartment or sediment is expected when diclazuril is used in chickens reared for laying and pheasants under proposed conditions, in both acidic and non-acidic soils. There are no concerns for groundwater, but due to limited data, no conclusions can be drawn for the aquatic compartment. Diclazuril does not bioaccumulate, so the risk of secondary poisoning is unlikely. FSA/FSS has reviewed the applicant’s authorisation application, supporting documentation, and other regulators’ risk assessments, most notably the EFSA risk assessment opinion, and considers sufficient evidence has been demonstrated to conclude without the need for further questions or risk assessment.

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in February 2021 from Mile High Labs International (“the applicant”) for the authorisation of cannabidiol (CBD) isolate as a novel food. The novel food is an isolated, ≥98% pure form of CBD which is intended to be used as a food ingredient in food supplements for adults excluding pregnant and lactating women and other specifically identified vulnerable groups, beverages, and confectionary. To support the FSA and FSS in their evaluation of the application, the Advisory Committee on Novel Foods and Processes (ACNFP) were asked to review the dossier and supplementary information provided by the applicant. Please note the Committee did not consider any potential health benefits or claims arising from consuming the food, as the focus of the novel food assessment is to ensure the food is safe, and not putting consumers at a nutritional disadvantage. The novel food was assessed based on the data provided. This review indicated it was appropriate for the provisional ADI for 98% or greater CBD to form part of the evidence for this assessment. For CBD a provisional Acceptable Daily Intake (ADI) of 10 mg/day for a healthy 70kg adult has been published by the FSA and was considered in assessing this novel food. The provisional ADI (section 2.7) was recommended, subject to the existing advice to consumers that pregnant and breastfeeding women and people taking any prescription medication should avoid the consumption of CBD. Consumers on regular medications should seek advice from a medical professional before using any type of CBD food product. In addition, children and prospective parents trying for a baby are advised against consumption of CBD, as are those who are immunosuppressed, due to remaining data gaps and residual uncertainties concerning the safety of CBD for these groups of consumers. These contraindications would also apply to this novel food. The FSA and FSS concluded that the applicant had provided sufficient information to assure the novel food, isolated cannabidiol (CBD), was safe under the proposed conditions of use. The anticipated intake levels and the proposed use in food supplements was not considered to be nutritionally disadvantageous. The views of the ACNFP have been taken into account in the regulatory assessment which represents the opinion of the FSA and FSS.

An application was submitted to the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in February 2022 from The Akkermansia Company SA, Belgium (“the applicant”) for the authorisation of Pasteurised Akkermansia muciniphila as a novel food. The novel food is derived from a strain of human gut bacteria and produced through fermentation and subsequent pasteurisation and lyophilisation. The resulting product is a powder intended for use in food supplements and Foods for Special Medical Purposes. The target population is the general population above twelve years old. To support the FSA and FSS in their evaluation of the application, the Advisory Committee on Novel Foods and Processes (ACNFP) were asked to review the dossier and supplementary information provided by the applicant. Please note the Committee did not consider any potential health benefits or claims arising from consuming the food, as the focus of the novel food assessment is to ensure the food is safe, and not putting consumers at a nutritional disadvantage. The FSA and FSS concluded that the applicant had provided sufficient information to assure the novel food, Pasteurised Akkermansia muciniphila, was safe under the proposed conditions of use. The anticipated intake levels and the proposed use in food supplements was not considered to be nutritionally disadvantageous. The views of the ACNFP have been taken into account in the regulatory assessment which represents the opinion of the FSA and FSS.

An application was submitted to the Food Standards Agency in April 2021 from Victory Enzymes GmbH (‘the applicant’) for the new authorisation of an additive (VTR-phytase) containing 6-phytase, under the category ‘zootechnical additives’ and functional group ‘digestibility enhancers’. The additive is proposed to be used at an inclusion rate of 500 U/kg of complete feed (12% moisture) for all avian species and all pigs. To support the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in evaluating the dossier, the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to review the dossier and the supplementary information from the applicant. 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. The views of ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.

An application was submitted to the Food Standards Agency in May 2023 to extend the scope of the conditions of use associated with an existing feedstuff for particular nutritional purposes (PARNUT). Intraruminal boluses can be used to provide a long-term supply of trace elements and vitamins to grazing animals, specifically ruminants with functional rumen. Under this use, they are classified as a PARNUT. Up to 20% inert, non-bioavailable iron can be added to the bolus as a means to increase density and ensure that the bolus is retained in the reticulum of the animal. The applicant proposed the inclusion of up to 75% inert, non-bioavailable copper in a bolus as an alternative to iron. To support the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in evaluating the dossier, the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to review the dossier and the supplementary information from the applicant. 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. The views of the ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.

An application was submitted to the Food Standards Agency in June 2022 from BIOMIN GmbH (‘the applicant’) for the renewal authorisation of an additive consisting of Enterococcus faecium DSM 21913, Bifidobacterium animalis ssp. animalis DSM 16284 and Ligilactobacillus salivarius DSM 16351 (Biomin® C3), under the category of ‘zootechnical additive’ and functional group ‘gut flora stabiliser’ for its use in chickens for fattening, chickens reared for laying and minor poultry species other than laying and for the extension of use of the additive under the same category for its use in all poultry species for fattening and reared for laying/breeding. The additive is proposed to be used at a minimum inclusion rate of 1 × 108 CFU/kg in complete feed or 5 × 107 CFU/L in drinking water. The FEEDAP Panel concluded that Biomin® C3 remains safe for chickens for fattening, chickens reared for laying, and minor poultry species other than laying, as well as for consumers and the environment, under the authorized conditions of use. The Panel concluded that extending the use of the additive to all poultry for fattening and reared for laying/breeding is safe for the target species, consumers, and the environment. The additive is efficacious at a minimum inclusion level of 1 × 108 CFU/kg in complete feed and 5 × 107 CFU/L in water. The additive should be considered as a potential respiratory sensitiser but as non-irritant to eyes and skin. Conclusions could not be drawn on the potential to cause skin sensitisation. FSA/FSS has reviewed the applicant’s renewal and extension of use application, supporting documentation, and other regulators risk assessments, most notably the EFSA risk assessment opinion and consider sufficient evidence has been demonstrated to conclude without further questions or risk assessment. This document represents the opinion of the FSA and FSS.

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) received an application from Kyowa Hakko Bio Company Ltd, Japan (“the applicant”) for the authorisation of 2’-fucosyllactose (2’-FL) as a novel food in March 2022. The novel food is intended to be used as a source of human identical milk oligosaccharide, 2’-FL, and is manufactured by microbial fermentation using a genetically modified strain of Escherichia coli W, and then refined to yield the purified powder. This new application is seeking to use the novel food within the following food categories: dairy products and analogues, bakery wares, table-top sweeteners, foods for special groups, beverages, and food supplements. Food supplements are not intended to be used if other foods with added 2’-FL or breast milk are consumed the same day. The intended uses and use levels for the novel food are the same as those that have already been authorised for 2’-FL produced by fermentation with genetically modified strains of E. coli BL21 (DE3), E. coli K-12 DH1, and Corynebacterium glutamicum ATCC 13032. However, this application is also seeking to use 2’-FL as a food supplement for infants, which is not currently authorised. To support the FSA and FSS in their evaluation of the application, the Advisory Committee on Novel Foods and Processes (ACNFP) were asked to review the safety dossier and supplementary information provided by the applicant. The views of the Committee were taken into account by the FSA and FSS who concluded that the applicant had provided sufficient information to assure the novel food, 2-FL, was safe under the proposed conditions of use. The anticipated intake levels and the intended use in food and food supplements was not considered to be nutritionally disadvantageous. This safety assessment represents the opinion of the FSA and FSS.

An application was submitted to the Food Standards Agency in March 2021 from Trouw Nutrition GB (‘the applicant’) for the renewal and modification of authorisation of an additive (IntelliBond® Z) containing zinc chloride hydroxide monohydrate, under the category of ‘nutritional additives’ and functional group ‘compounds of trace elements’. The additive is proposed to be used at a maximum inclusion rate of: • 200 mg/kg in dogs and cats • 180 mg/kg in salmonids and milk replacers for calves • 150 mg/kg in piglets, sows, rabbits and all fish species other than salmonids • 120 mg/kg in all other species and categories To support the Food Standards Agency (FSA) and Food Standards Scotland (FSS) in evaluating the dossier, the Advisory Committee on Animal Feedingstuffs (ACAF) were asked to review the dossier and the supplementary information from the applicant. 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 renewal. The views of ACAF have been taken into account in the safety assessment which represents the opinion of the FSA and FSS.

An application was submitted to the Food Standards Agency (FSA) in November 2021 from Huvepharma NV (‘the applicant’) for the authorisation of 25-hydroxycholecalciferol (Bio D® 1.25%) as a feed additive under the category of ‘nutritional’ additives, functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’. The additive contains a minimum of 1.25% 25-hydroxycholecalciferol and seeks authorisation for a modification of its production process using Pseudonocardia autotrophica M301 (DSM 32858) as a production organism, and to be used at a maximum dose of: 100 µg/kg, 80 µg/kg, 50 µg/kg of complete feed with 12% moisture in poultry for fattening, other poultry and pigs, respectively; 50 µg/kg, 40 µg/kg, 25 µg/kg in drinking water in poultry for fattening, other poultry and pigs, respectively. 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. This Safety Assessment represents the opinion of the FSA and FSS.