Guidance on the renewal of the authorisation of feed additives.

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 renewal of the authorisation of additives for use in animal nutrition. [Table: see text].

Safety and efficacy of l-lysine monohydrochloride and concentrated liquid l-lysine (base) produced by fermentation with KCTC 12307BP as feed additives for all animal species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of a concentrated liquid l-lysine (base, minimum 50%) and a l-lysine monohydrochloride (HCl, minimum 99%) produced by fermentation with a genetically modified strain of (KCTC 12307BP). Both forms of l-lysine are intended to be used in feed for all animal species and categories. Neither the production strain nor its recombinant DNA were detected in the final products.

Safety and efficacy of l-threonine produced using CGMCC 13325 as a feed additive for all animal species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l-threonine produced by fermentation when used as a nutritional additive in feed and water for drinking for all animal species and categories. The product under assessment is l-threonine produced using a genetically modified strain of CGMCC 13325. The Panel notes that three out of five batches of the additive do not comply with the minimum specification of 98.

Safety of potassium diformate (Formi™ LHS) as a feed additive for sows, from ADDCON EUROPE GmbH.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of potassium diformate as a feed additive for sows (brand name Formi™ LHS). The additive was re-evaluated by the Panel in 2009. In its assessment on the renewal of the additive adopted by the FEEDAP Panel in 2020, the Panel concluded that the information provided by the applicant did not fulfil the minimum requirements to support that Formi™ LHS remained safe under the approved conditions for target species, consumers and users.

Safety of 31 flavouring compounds belonging to different chemical groups when used as feed additives for all animal species.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of 31 compounds belonging to different chemical groups, when used as sensory additives in feed for all animal species. Twenty-two out of the 31 compounds were tested in tolerance studies in chickens for fattening, piglets and cattle for fattening. For the remaining nine compounds, read across from structurally similar compounds was proposed.

Assessment of the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine for all animal species.

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine (MintrexZn) for all animal species. The FEEDAP Panel has delivered three opinions (during 2008 and 2009) on the safety and efficacy of the additive. The additive was authorised in 2010 as 'Zinc chelate of hydroxy analogue of methionine' containing 17.

Assessment of the application for renewal of authorisation of 6-phytase produced by CBS 122001 as a feed additive for pigs and poultry, from Roal Oy.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of 6-phytase produced by CBS 122001 (brand name: Finase EC). The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The Panel concludes that the additive remains safe for poultry for fattening, breeding and laying, and all pigs, the consumer and the environment under the authorised conditions of use.

Safety and efficacy of l-lysine monohydrochloride and concentrated liquid l-lysine (base) produced by fermentation with KCCM 80216 as feed additive for all animal species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of concentrated liquid l-lysine (base, minimum 50%) and l-lysine monohydrochloride (HCl, minimum 99%) produced by fermentation with a genetically modified strain of (KCCM 80216) as nutritional additives for all animal species. Neither the production strain nor its recombinant DNA was detected in the final products. The additives do not pose any safety concern associated with the genetic modification of the production strain.

Assessment of the application for renewal of authorisation of endo-1,4-β-xylanase produced by CBS 109.713 and endo-1,4-β-glucanase produced by DSM 18404 for poultry species, ornamental birds and weaned piglets, from BASF SE.

Natugrain TS/TS L is the trade name of the feed additive under assessment and contains endo-1,4-β-xylanase and endo-1,4-β-glucanase produced by genetically modified strains of . The product is currently authorised for use as a feed additive for poultry species, ornamental birds, weaned piglets and pigs for fattening. This scientific opinion concerns the renewal of the authorisation of this additive for poultry species, ornamental birds and weaned piglets.

Oil spill in northeastern Brazil: Application of fluorescence spectroscopy and PARAFAC in the analysis of oil-related compounds.

Between November 2019 and February 2020, 53 water samples were collected along 430 km of coastline in northeastern Brazil, which was the location of an oil spill that occurred in August 2019. Synchronous fluorescence matrices (SFMs) were acquired to avoid regions affected by Raman Stokes scatterings and second harmonic signals, and then, the SFMs were converted into excitation-emission matrices (EEM) by shear transformation. The matrix coupled with parallel factor analysis (PARAFAC) was used in the study of fluorescent components present in the collected waters.

Volatile profile of cork as a tool for classification of natural cork stoppers.

An untargeted approach, focused in the profile of volatile organic compounds (VOCs), was applied to differentiate natural cork stoppers with different levels of porosity, coded as Group 1 (low porosity), Group 2 (intermediate porosity) and Group 3 (high porosity). Statistically significant alterations were found in the levels of several VOCs between cork stoppers of low and intermediate porosity when compared with those of high porosity (Group 1 vs. 3 and Group 2 vs.

In vivo toxicometabolomics reveals multi-organ and urine metabolic changes in mice upon acute exposure to human-relevant doses of 3,4-methylenedioxypyrovalerone (MDPV).

3,4-Methylenedioxypyrovalerone (MDPV) is consumed worldwide, despite its potential to cause toxicity in several organs and even death. There is a recognized need to clarify the biological pathways through which MDPV elicits general and target-organ toxicity. In this work, a comprehensive untargeted GC-MS-based metabolomics analysis was performed, aiming to detect metabolic changes in putative target organs (brain, heart, kidneys and liver) but also in urine of mice after acute exposure to human-relevant doses of MDPV.

Assessment of the application for renewal of authorisation of pyridoxine hydrochloride (vitamin B) as a feed additive for all animal species.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of pyridoxine hydrochloride (vitamin B) produced by chemical synthesis as a feed additive for all animal species. The applicant has provided data demonstrating that the additive in the market complies with the conditions of the authorisation. The FEEDAP Panel confirms that the use of pyridoxine hydrochloride under the current authorised conditions of use is safe for the target species, the consumers and the environment.

Safety and efficacy of l-valine produced by fermentation using CGMCC 7.358 as a feed additive for all animal species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l-valine produced by fermentation using a non-genetically modified strain of (CGMCC 7.358). The additive is intended to be used in feed and water for drinking for all animal species and categories.

Assessment of the application for renewal of the authorisation of Calsporin (DSM 15544) as a feed additive for weaned piglets.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of Calsporin ( DSM 15544) as a zootechnical additive for weaned piglets. The product under assessment is based on viable spores of a strain originally identified as . During the course of the current assessment, the active agent has been reclassified as DSM 15544.

Safety and efficacy of Nutrase P (6-phytase) for chickens for fattening, other poultry for fattening, reared for laying and ornamental birds.

Nutrase P is available in powder, granulated, thermostable granulate and liquid forms. It is based on a 6-phytase produced by a genetically modified strain of . The production strain contains four copies of the ampicillin resistance gene and one copy of a bleomycin resistance gene.

Assessment of the application for renewal of authorisation of manganese chelate of hydroxy analogue of methionine for all animal species.

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of manganese chelate of hydroxy analogue of methionine (MintrexMn) for all animal species. The FEEDAP Panel has delivered three opinions (in 2008, 2009 and 2010) on the safety and efficacy of the additive. The additive was authorised in 2010 as 'Manganese chelate of hydroxy analogue of methionine' containing 15.

Safety and efficacy of STENOROL (halofuginone hydrobromide) as a feed additive for chickens for fattening and turkeys.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the coccidiostat STENOROL containing halofuginone hydrobromide (halofuginone HBr) as active substance. The FEEDAP Panel was not able to conclude on the safety of STENOROL for chickens and turkeys for fattening at the highest proposed use level. No incompatibilities or interactions with feedingstuffs, carriers, other approved additives or medicinal drugs are expected.

Safety of methanethiol [12.003] when used as a feed additive for all animal species.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety of methanethiol [12.003] belonging to chemical group 20 (aliphatic and aromatic mono- and di-thiols and mono-, di-, tri- and polysulfides with or without additional oxygenated functional groups). Methanethiol [12.

Safety and Efficacy of l-histidine monohydrochloride monohydrate produced by fermentation using KCCM 80212 as a feed additive for all animal species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l-histidine monohydrochloride (HCl) monohydrate produced by fermentation using KCCM 80212 when used as a nutritional additive in feed for all animal species. The production strain is genetically modified. The production strain and its recombinant DNA were not detected in the final product.

Safety and efficacy of concentrated liquid l-lysine (base) and l-lysine monohydrochloride produced by fermentation with KCCM 80190 as feed additives for all animal species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on concentrated liquid l-lysine (base) and l-lysine monohydrochloride (HCl) produced using KCCM 80190 when used as nutritional additives in feed and water for drinking for all animal species. The active substance is l-lysine. The production strain is genetically modified.

Assessment of the application for renewal of authorisation of Biosprint ( MUCL 39885) as a feed additive for weaned piglets.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of the product Biosprint ( MUCL 39885) as a feed additive for weaned piglets. Biosprint is composed of only viable cells of MUCL 39885. is considered by EFSA to have qualified presumption of safety status.

Safety and efficacy of PB6 (ATCC PTA-6737) as a feed additive for chickens for fattening, chickens reared for laying, minor poultry species (except for laying purposes), ornamental, sporting and game birds.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the renewal of the authorisation of PB6, the extension of use to ornamental, sporting and game birds and a modification on the concentration of the said additive. The product under assessment is based on viable spores of a strain originally identified as . During the course of the current assessment, the active agent has been redesignated as ATCC PTA-6737.

Safety and efficacy of Correlink™ ABS1781 (NRRL B-67259) as a feed additive for all growing poultry species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Correlink™ ABS1781 (hereafter designated as Correlink™ ABS1781) when used as a feed additive for chickens for fattening, turkeys for fattening, chickens reared for laying, turkeys reared for breeding and minor growing poultry species. The product under assessment is based on viable spores of a strain originally identified as , which in the course of the current assessment, was reclassified as NRRL B-67259. The bacterial species is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment.

Safety and efficacy of Correlink™ ABS747 ( NRRL B-67257) as a feed additive for all growing poultry species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Correlink™ ABS747 (hereafter designated as Correlink™ ABS747) when used as a feed additive for chickens for fattening, turkeys for fattening, chickens reared for laying, turkeys reared for breeding and minor growing poultry species. The product under assessment is based on viable spores of a strain originally identified as , which in the course of the current assessment, was reclassified as NRRL B-67257. The bacterial species is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment.