Food Standards Scotland

Abstract In a representative sample of Scottish adults, we evaluate 33 pathways to meeting the UK Climate Change Committee’s (CCC) recommendations to reduce all meat and dairy consumption by 20% by 2030, rising to a reduction of 35% in meat by 2050. Our pathways take into account existing dietary guidance, and modelled outcomes include intakes of 54 nutrients, obesity, type 2 diabetes and cardiovascular disease, all-cause mortality, cost of diets, greenhouse gas emissions, water and land use, and eutrophication. Nearly all modelled pathways are estimated to have benefits for most nutrition, health, and environmental outcomes, without negatively affecting diet costs. These benefits could be increased with targeted reductions in red meat among high consumers of red meat, and gram-for-gram replacement of meat and dairy with substitutes ranging from vegetables to beans to eggs to plant-based dairy alternatives.

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.