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Draft Endorsed by the FEEDAP Panel * 18 May 2017 Submitted for public consultation 15 June 2017 End of public consultation 15 September 2017 Adopted by the FEEDAP Panel 21 February 2018 Implementation date 1 September 2018 * Sections 3.1 and 3.2 were also endorsed by the EFSA Panel on Genetically Modified Organisms (GMO), EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF) and EFSA Panel on Food Additives and Nutrient Sources Added to Food (ANS) on 18 May (GMO) and 7 June (CEF and ANS) 2017. This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the characterisation of microorganisms used as feed additives or as production organisms. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2018.EN-1389/full

The present period is characterized by a growing world population and a higher demand for more and better quality food, as well as other products for an improved standard of living. In the future, there will be increasingly strong competition for arable land and non-renewable resources such as fossil carbon-sources, water, and some minerals, as well as between food, feed, fuel, fiber, flowers, and fun (6 F’s). Proteins of animal origin like milk, meat, fish, eggs and, probably, insects are very valuable sources of essential amino acids, minerals and vitamins, but their production consumes some non-renewable resources including arable land and causes considerable emissions. Therefore, this study´s objective was to calculate some examples of the land use (arable land and grassland) for production of edible animal protein taking into consideration important animal species/categories, levels of plant and animal yields, the latter estimated with and without co-products from agriculture, and the food/biofuel industry in animal feeding. There are large differences between animal species/categories and their potential to produce edible protein depending on many influencing variables. The highest amounts per kilogram body weight are produced by growing broiler chicken followed by laying hens and dairy cows; the lowest yields in edible protein and the highest land need were observed for beef cattle. This review clearly indicates that the production of food of animal origin is a very complex process, and selective considerations, i.e., focusing on single factors, do not provide an assessment that reflects the complexity of the subject.

[Table: see text]. This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the safety for the target species.

This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the efficacy of feed additives. Draft Endorsed by the FEEDAP Panel 28 November 2018 Submitted for public consultation 4 December 2017 End of public consultation 28 January 2018 Adoption by the FEEDAP Panel 17 April 2018 Implementation date 1 September 2018 This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2018.EN-1411/full

[Table: see text]. This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the identity, characterisation and conditions of use of the additives.

l‐Glutamic acid, N,N‐diacetic acid, tetrasodium salt (GLDA‐Na4) (Kelforce®) is sought to be used as a zootechnical feed additive in chickens for fattening to improve the absorption of zinc from feed, reducing zinc emissions through manure and thus, affecting favourably the environment. The product has not been authorised in the European Union as a feed additive. Kelforce® is intended to be marketed as a liquid and solid formulation, containing ≥ 47% and ≥ 30% of GLDA‐Na4, respectively. Kelforce® is safe for chickens for fattening at the maximum level of 1,000 mg GLDA‐Na4/kg complete feed. Based on the toxicological profile of GLDA‐Na4 and the consumer exposure to GLDA‐Na4 and to nitrilotriacetic acid trisodium salt (NTA‐Na3; an impurity of the additive), the use of Kelforce® at the maximum proposed level in feed of chickens for fattening is of no concern for consumer safety. Due to its low inhalation toxicity, the exposure to GLDA‐Na4 is unlikely to pose a risk by inhalation. However, owing to the high‐dusting potential of the solid formulation, a risk from such high level of dust, even if toxicologically inert, cannot be excluded. Kelforce® is not a skin/eye irritant or skin sensitiser. No risks for the terrestrial compartment were identified at the maximum use level of the additive. Risks for the aquatic compartment cannot be excluded based on the secondary effect of the additive on green algae. In the absence of data, the Panel cannot conclude on the safety for the sediment compartment or the possible ground water contamination. The risk of bioaccumulation and secondary poisoning caused by the additive is considered very low. Owing to the inconsistent and conflicting results from the studies assessed, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot conclude on the efficacy of the additive. The Panel made a recommendation regarding the levels of formaldehyde and cyanide in the active substance.

Sodium and potassium alginate are intended to be used as technological additives (functional groups: emulsifiers, stabilisers, thickeners, gelling agents and binders). Sodium alginate is intended to be used in feedingstuffs for pets, other non food‐producing animals and fish, with no maximum recommended use level. Potassium alginate is intended to be used in feedingstuffs for cats and dogs at levels up to 40,000 mg/kg feed (on dry matter). Since the functional properties of the additives are determined by the alginate content, sodium and potassium alginate were considered equivalent. The maximum dose considered safe for cats, dogs, other non food‐producing animals, salmonids and other fish is 40,000 mg alginates (sodium and potassium salts)/kg complete feed. The use of alginates in feedingstuffs for fish is of no concern for the consumer. Alginates are reported not to be irritant to the skin but mildly irritant to the eyes. They are considered as potential sensitisers to the skin and the respiratory tract. Alginates are high‐molecular‐weight polymers naturally occurring in brown algae. Their use in feedingstuffs for fish does not pose a risk for the aquatic environment. Alginates are effective as stabilisers, thickeners, gelling agent and binders. No conclusion could be drawn on the efficacy of alginates as emulsifiers.

[Table: see text]. This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the safety for the consumer.

Sodium saccharin is intended to be used as a sweetener in feed and water for drinking for piglets, pigs for fattening and veal calves. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers the proposed maximum use level of 150 mg sodium saccharin/kg feed as safe for calves and pigs for fattening. For piglets (sucking and weaned piglets), a lower level of 100 mg sodium saccharin/kg complete feed is considered safe. The corresponding maximum safe concentrations in water for drinking are 30 mg/L for piglets and 50 mg/L for pigs for fattening, respectively. The maximum safe concentrations of sodium saccharin in feed and water for drinking are derived under the premise that only one source, feed or water for drinking, contains the additive. The FEEDAP Panel concludes that no concern for the consumer would result from the use of sodium saccharin in feed and water for drinking at the dose considered safe for the target species. The precautions for handling the product proposed by the applicant are considered to be sufficient to ensure user safety. The FEEDAP Panel concludes that the use of sodium saccharin at the dose considered safe for target species is unlikely to have detrimental effects on the terrestrial and freshwater compartments. The high mobility and relative persistence of saccharin and the high persistency of its degradation product 4‐hydroxysaccharin indicate that groundwater contamination above 0.1 μg/L is likely to occur. Since the function of sodium saccharin in feed for the target species is essentially the same as that in food, the FEEDAP Panel concludes that no demonstration of efficacy is necessary.

The question of how to feed the growing world population is very old, but because of the increase of population and possible climate change, currently it has an explosive impact. Plant breeding can be considered as the starting point for the whole human food chain. Therefore, high, stable and highly digestible yields of phytogenic biomass with low external inputs of non-renewable resources, such as water, fuel, arable land, fertilizers, etc.; low emissions of gases with greenhouse potential during cultivation; and high resistance against biotic and abiotic stressors, including adaptation to potential climate change, and a low concentration of undesirable substances in the plants are real challenges for plant breeders in the future. Virtually unlimited resources such as sunlight, nitrogen and carbon dioxide from the air as well as the genetic pool of microbes, plants and animals can be used to breed/develop optimal plants/crops. Biofortification of plants may also be an objective of plants breeders, but it is more important for human nutrition to avoid micronutrient deficiencies. A lower concentration of undesirable substances in the plants can be considered as more important than higher concentrations of micronutrients in plants/feeds. Animal nutritionists have various possibilities for feed additive supplementation to meet animal nutrient requirements. Examples to reduce undesirable substances in feed plants are discussed and shown in the paper. In summary, plant breeding has a large and strategic potential for global feed and food security. All breeding technologies may contribute to solving important global challenges, such as sustainable use of limited global resources, improved use of unlimited resources, adaption to climate change and lowering global greenhouse gas emission. More publically supported research seems to be necessary in this field. All methods of plant breeding that contribute to a more resource-efficient production of high and stable yields of available biomass should be used/combined.