Safety and efficacy of a feed additive consisting of copper(II)-betaine complex for all animal species (Biochem Zusatzstoffe Handels- und Produktionsges. mbH).

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety and efficacy of a copper(II)-betaine complex as nutritional feed additive for all animal species. Based on the results of a tolerance study carried out in chicken, the FEEDAP Panel concluded that the additive is safe for chickens for fattening when used up to the current maximum authorised levels of copper in feed; this conclusion was extrapolated to all animal species and categories at the respective maximum copper levels in complete feed authorised in the European Union. The FEEDAP Panel concluded that the use of the copper(II)-betaine complex in animal nutrition at the maximum copper levels authorised for the animal species poses no concern to the safety of consumers.

Safety of a feed additive consisting of a tincture derived from the roots of L. (gentian tincture) for all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of a tincture derived from L. (gentian tincture). It is intended to be used as a sensory additive for all animal species.

Safety and efficacy of a feed additive consisting of vitamin B2 (riboflavin) produced by CGMCC 13326 for all animal species (Kempex Holland B.V.).

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA was asked to deliver a scientific opinion on the safety and efficacy of vitamin B2 (riboflavin) produced by CGMCC 13326 as a nutritional feed additive for all animal species. The additive is produced by a genetically modified production strain. Although the production strain harbours some genes coding for resistance to antimicrobials, viable cells and DNA of the production strain were not detected in the final product.

Amazon Amandaba-Sociodemographic Factors, Health Literacy, Biochemical Parameters and Self-Care as Predictors in Patients with Type 2 Diabetes Mellitus: A Cross-Sectional Study.

Background: Health literacy (HL) and its domains (functional, critical, and communicative) appear to be related to self-care adherence in people with type 2 diabetes mellitus (DM2). This study aimed to verify if sociodemographic variables are predictors of HL, if HL and the sociodemographic factors affect biochemical parameters together, and if HL domains are predictors of self-care in DM2.

Methods: We used the baseline assessment data from 199 participants ≥ 30 years in the project, "Amandaba na Amazônia: Culture Circles as a Strategy to Encourage Self-care for DM in Primary Health Care," which took place in November and December 2021.

Safety and efficacy of a feed additive consisting of a zinc(II)-betaine complex for all animal species (Biochem Zusatzstoffe Handels- und Produktionsges. mbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a zinc(II)-betaine complex as nutritional additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening. This conclusion could be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total zinc in feed are not exceeded.

Safety and efficacy of a feed additive consisting of endo-1,4-beta-xylanase produced by ATCC PTA-5588, protease produced by CBS 148232, and alpha-amylase produced by ATCC SD-6525 (Axtra® XAP 104 TPT) for chickens for fattening, laying hens and minor poultry species (Genencor international B.V.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of endo-1,4-beta-xylanase produced by ATCC PTA-5588, protease produced by CBS 148232, and alpha-amylase produced by ATCC SD-6525, Axtra® XAP 104 TPT, for chickens for fattening, laying hens and minor poultry species. In the previous assessment, a series of shortcomings did not allow to conclude on the safety of the product. The shortcomings included uncertainty on the presence of viable cells of one of the production strains; uncertainty on the identity of the production strains of the ■■■■■ used in the manufacturing process of the protease and their presence in the final additive; and uncertainty about the test item used for the toxicological testing of the xylanase.

Modification of the conditions of the authorisation of FERM BP-2789 (Miya-Gold®) for chickens for fattening, chickens reared for laying and minor avian species (excluding laying birds) (Miyarisan Pharmaceutical Co. Ltd).

The additive Miya-Gold® consists of viable cells of FERM BP-2789.The additive is currently authorised in the EU for use as a feed additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), piglets (suckling and weaned) and piglets of minor porcine species. The authorisation for chickens and minor poultry species for fattening and reared for laying is at a minimum level of 2.

Safety of 27 flavouring compounds providing a milky-vanilla flavour and belonging to different chemical groups for use as feed additives in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of 27 compounds to provide a milky-vanilla flavour belonging to different chemical groups, when used as sensory additives in feed for all animal species. Fifteen of the 27 compounds were tested in tolerance studies in chickens for fattening, piglets and cattle for fattening. No adverse effects were observed in the tolerance studies at 10-fold the intended level.

Safety of a feed additive consisting of sodium saccharin for suckling and weaned piglets, fattening pigs, calves for rearing and for fattening (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of sodium saccharin as a sensory feed additive (flavouring compound) for suckling and weaned piglets, fattening pigs, calves for rearing and for fattening. In a previous assessment, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) could not conclude on the safety of the additive for the environment because concentrations of the additive or its degradation product 4-hydroxysaccharin in groundwater above 0.1 μg/L were likely to occur.

Safety and efficacy of a feed additive consisting of a tincture derived from the fruit of L. (dill tincture) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the fruit of L. (dill tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 0.

Safety and efficacy of a feed additive consisting of endo-1,3(4)-beta-glucanase produced by CBS 589.94 (RONOZYME® VP (CT/L)) for chickens for fattening and weaned piglets (DSM Nutritional Products AG).

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 and efficacy of endo-1,3(4)-beta-glucanase produced by CBS 589.94 (RONOZYME® VP (CT/L)) as a zootechnical feed additive for chickens for fattening and weaned piglets. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats and the tolerance trials provided, the additive was considered safe for chickens for fattening and weaned piglets at the proposed conditions of use.

Assessment of the feed additive consisting of ammonium chloride (Amoklor™) for all ruminants, dogs and cats for the renewal of its authorisation and its extension of use to sows (Latochema Co Ltd).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of authorisation of ammonium chloride (Amoklor™) as a zootechnical additive for all ruminants, dogs and cats and its extension of use in sows for urinary health. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions.

Efficacy of the feed additive consisting of NRRL B-67257 (Correlink™ ABS747) as a feed additive for all growing poultry species (Elanco GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of a product consisting of viable spores of NRRL B-67257 as a zootechnical additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and minor poultry species. The additive has the tradename Correlink™ ABS747 and is not currently authorised in the European Union. It is intended for use in complete feed for the target species at a minimum inclusion level of 1.

Assessment of the efficacy of a feed additive consisting of ferrous lysinate sulfate for all animal species (Phytobiotics Futterzusatzstoffe 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 efficacy of ferrous lysinate sulfate for all animal species. The safety of the additive for the target species, consumer, user and the environment has already been assessed previously, however the efficacy remained inconclusive due to limitations in the study with chickens for fattening. In the present assessment, the applicant submitted a new efficacy study in weaned piglets.

Safety and efficacy of the feed additive consisting of 6-phytase (produced by DSM 33699) (RONOZYME® Hiphos GT/L) for poultry, pigs for fattening, weaned piglets and sows (DSM Nutritional Products Ltd).

The additive RONOZYME® Hiphos (GT/L) contains 6-phytase produced with a genetically modified strain of the filamentous fungus , it is currently authorised for poultry, pigs for fattening, weaned piglets and sows. The applicant has requested to change the production strain, substituting strain DSM 22594 for DSM 33699. RONOZYME® Hiphos (GT/L), manufactured with the production strain DSM 33699, did not give rise to safety concerns with regard to the genetic modification of the production strain.

Safety and efficacy of a feed additive consisting of a tincture derived from the fruit of Mill. ssp. var. (sweet fennel tincture) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a tincture from the fruit of Mill. ssp. v var.

Safety and efficacy of a feed additive consisting of a tincture derived from the fruit of (Mill.) Fuss (parsley tincture) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA 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 a tincture derived from the fruit of (Mill.) Fuss (parsley tincture) when used as a sensory feed additive for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 0.

Assessment of the feed additive consisting of (previously ) DSM 19457 for all animal species for the renewal of its authorisation (Biomin 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 (previously ) DSM 19457 as a technological additive for use in forage for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no evidence to lead the FEEDAP Panel to reconsider its previous conclusions.

Safety and efficacy of a feed additive consisting of lasalocid A sodium (Avatec® 150G) for chickens for fattening and chickens reared for laying (Zoetis Belgium SA).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat lasalocid A sodium (Avatec® 150G) for chickens for fattening and chickens reared for laying. Taking into account the results of all tolerance studies submitted for the re-evaluation of the additive, the FEEDAP Panel considers that lasalocid A sodium from Avatec® 150G is safe at a maximum content of 90 mg/kg complete feed for chickens for fattening. A margin of safety cannot be established.

Safety and efficacy of a feed additive consisting of an essential oil from the gum resin of L. (asafoetida oil) for use in dogs and cats (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil obtained from gum resin of L. (asafoetida oil), when used as a sensory additive (flavouring) in feed for dogs and cats. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of asafoetida oil is safe at the proposed conditions of use of 1.

Safety and efficacy of a feed additive consisting of an essential oil from the aerial parts of L. (dill herb oil) for use in dogs and cats (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil obtained from the aerial parts of L. (dill herb oil), when used as a sensory additive (flavouring) in feed for dogs and cats. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that dill herb oil is safe at use levels in complete feed of 7 mg/kg for dogs and 5 mg/kg for cats.

Safety and efficacy of a feed additive consisting of 6-phytase produced by CGMCC 7.370 (VTR-phytase powder/liquid) for all pigs and all avian species (Victory Enzymes GmbH).

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 and efficacy of 6-phytase (VTR-phytase) as zootechnical feed additive for all pigs and all avian species. The additive VTR-phytase consists of 6-phytase and it is available in solid and liquid forms. VTR phytase (liquid/solid) was produced by a genetically modified strain of (CGMCC 7.

Safety and efficacy of a feed additive consisting of an essential oil from the fruit of L. (cumin oil) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil obtained from the fruit of L. (cumin oil), when used as a sensory additive in feed and water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of cumin oil up to the maximum proposed use levels in feed of 15 mg/kg complete feed is considered as safe for all animal species.

Efficacy of the feed additive consisting of NRRL B-67259 (Correlink™ ABS1781) as a feed additive for all growing poultry species (Elanco GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of a product consisting of spores of NRRL B-67257 as a zootechnical additive for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding and minor poultry species. The additive has the tradename Correlink™ ABS1781 and is not currently authorised in the EU. It is intended for use in complete feed for the target species at a minimum inclusion level of 1.

Safety of a feed additive consisting of halofuginone hydrobromide (STENOROL®) for chickens for fattening and turkeys (Huvepharma N.V.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety for the target species of the coccidiostat halofuginone hydrobromide from STENOROL® when used as a feed additive for chickens for fattening and turkeys. In its previous assessment, the FEEDAP Panel could not conclude on the safety of STENOROL® for the target species at the highest proposed use level of 3 mg halofuginone hydrobromide/kg complete feed. On the basis of the new data provided, the FEEDAP Panel updates its previous conclusions on the safety for the target species as follows: halofuginone hydrobromide from STENOROL® is safe for chickens for fattening and for turkeys up to a maximum of 12 weeks of age at the highest proposed concentration of 3 mg/kg complete feed.