Anti-factor H autoantibodies in patients with lupus nephritis.

INTRODUCTION: Lupus nephritis (LN) is a disease marked by autoantibodies against complement components. Autoantibodies against negative complement regulator factor H (anti-FH) are prevalent in aHUS, are associated with deletion of factor H-related protein 1 (FHR1) gene, and have overt functional consequences. They are also observed in C3 glomerulopathies. The frequency and relevance of anti-FH in LN are poorly studied. AIM: The aim of our investigation was to screen for the presence of anti-FH and FHR1 gene deletion in a cohort of LN patients and to evaluate their association with LN activity. METHOD: ELISA test and Western blot for detection of anti-FH and FHR1 deletion were used, respectively. Patients' clinical and laboratory parameters regarding anti-FH role were processed by statistical analysis. RESULTS: Anti-FH were found at low level in a small number of LN patients - 11.7% (7/60) and were not associated with deletion of FHR1. Anti-FH did not correlate with ANA titers, anti-dsDNA, C3/C4 hypocomplementemia, eGFR, proteinuria, or active urinary sediment in LN patients. A weak correlation was found between anti-FH and anti-C3 levels. Anti-FH were linked with endocapillary proliferation and histological activity index. Four anti-FH positive patients had severe to moderate LN as per the BILAG renal score. CONCLUSIONS: Anti-FH autoantibodies are an accessory finding in LN and are more likely to manifest during the active phase of the disease. Due to their low frequency and plasma levels, they do not seem suitable for routine laboratory investigation in patients with LN.

Safety of a feed additive consisting of endo 1,4 ß-d-mannanase produced by Thermothelomyces thermophilus DSM 33149 (Natupulse® TS/TS L) for chickens and turkeys for fattening, minor poultry species for fattening and ornamental birds (BASF SE).

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 of a feed additive consisting of endo-1,4-ß-d-mannanase produced by Thermothelomyces thermophilus DSM 33149, intended for use as a zootechnical additive (functional group: digestibility enhancers) for chickens for fattening, turkeys for fattening, minor poultry species for fattening and ornamental birds. The safety and efficacy of the additive have been already assessed previously; however, the FEEDAP Panel could not conclude on the safety of the additive for the target species, consumers and the users due to lack of reliable data on the potential genotoxicity of the additive. In the present assessment, the applicant submitted a new in vitro mammalian cell micronucleus test. After the assessment of the data newly submitted, the FEEDAP Panel concluded that the use of the feed additive in animal nutrition under the conditions of use proposed is of no concern for target species and consumer safety. The additive is not irritant to the eyes or skin. Owing to the proteinaceous nature of the active substance, the additive should be considered a respiratory sensitiser. The Panel cannot conclude on the potential of the additive to be a skin sensitiser.

Assessment of the feed additive consisting of Lentilactobacillus buchneri (formerly Lactobacillus buchneri) DSM 22501 for all animal species for the renewal of its authorisation (Chr. Hansen A/S).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of the additive consisting of Lentilactobacillus buchneri DSM 22501 as a technological feed additive to improve ensiling of fresh material 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 new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive is not irritant to skin and eye, but owing to its proteinaceous nature it should be considered a respiratory sensitiser. No conclusions could be drawn on the skin sensitisation potential of the additive. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Pediococcus pentosaceus DSM 14021 for all animal species for the renewal of its authorisation (Chr. Hansen A/S).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Pediococcus pentosaceus DSM 14021, a technological additive for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the Panel considers that any exposure through skin and respiratory tract is considered a risk. The Panel cannot conclude on the eye irritation potential of the additive due to the lack of data. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Patent Blue V for all non-food-producing animal species for the renewal of its authorisation (Versele-Laga NV).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Patent Blue V as a sensory feed additive for non-food-producing animals. The additive is already authorised for use with non-food-producing animals. The applicant has not provided evidence that the additive currently on the market complies with the existing conditions of authorisation. The FEEDAP Panel cannot conclude whether the additive remains safe for the target species due to the non-compliance with the specifications and the lack of adequate data on the potential aneugenicity of the additive. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a dermal and eye irritant nor a dermal and respiratory sensitiser. Since the potential genotoxicity of the additive was not ruled out, the exposure to the additive of the unprotected users should be minimised. The Panel retains that the previously made conclusion on the efficacy remains valid.

Safety and efficacy of a feed additive consisting of l-isoleucine produced with Corynebacterium glutamicum CGMCC 20437 for all animal species (Eppen Europe SAS).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 as a nutritional feed additive for use in feed and in water for drinking for all animal species. The production strain is non-genetically modified, qualifies for the QPS approach to safety assessment when used for production purposes, is susceptible to the relevant antibiotics and contains no antimicrobial resistance genes of concern. No viable cells of the production strain were detected in the final product. The additive does not give rise to any safety concern regarding the production strain. l-Isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 is considered safe for the target species, the consumer and the environment. Regarding the use in water, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) reiterates its concerns over the safety for the target species of l-isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons. In the absence of data, the FEEDAP Panel is not in a position to conclude on the potential of l-isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 to be irritant to skin and/or eyes, or as a dermal sensitiser. Due to the high dusting potential, exposure by inhalation is likely. l-Isoleucine produced by fermentation with Corynebacterium glutamicum CGMCC 20437 is considered as an efficacious source of the essential amino acid l-isoleucine for non-ruminant animal species. For the supplemental l-isoleucine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen.

Safety and efficacy of a feed additive consisting of a tincture derived from the flowers of Syzygium aromaticum (L.) Merr. & L.M. Perry (clove 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 and efficacy of a tincture from the dried flower bud of Syzygium aromaticum (L.) Merr. & L.M. Perry (clove 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 ~ 1.66%. The product contains on average 0.511% phenolic acids (of which 0.0344% were flavonoids), 0.039% eugenol, 0.00019% methyleugenol and 0.00008% estragole. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of clove tincture is very unlikely to be of safety concern for the target species up to the maximum proposed use level of 50 mg clove tincture/kg complete feed for all animal species, except for horses, for which the proposed use level is 200 mg/kg complete feed. The FEEDAP Panel considers that the use in water for drinking alone or in combination with use in feed should not exceed the daily amount that is considered very unlikely to be of safety concern when consumed via feed alone. No safety concern would arise for the consumer and the environment from the use of clove tincture up to the maximum proposed use levels in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the additive, exposure of unprotected users to methyleugenol and estragole may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. Since the flower buds of S. aromaticum and their preparations were recognised to flavour food and their function in feed would be essentially the same, no demonstration of efficacy was considered necessary.

Safety and efficacy of a feed additive consisting of an essential oil obtained from the wood of Juniperus deppeana Steud. (cedarwood Texas 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 wood of Juniperus deppeana Steud. (cedarwood Texas oil), when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the essential oil under assessment is safe up to the maximum proposed use levels in complete feed of 15 mg/kg for veal calves (milk replacer), cattle for fattening, sheep, goats, horses, dogs, salmonids and ornamental fish. For the other species, the calculated safe concentrations in complete feed were 5 mg/kg for chickens for fattening, 8 mg/kg for laying hens, 7 mg/kg for turkeys for fattening, 10 mg/kg for piglets, 12 mg/kg for pigs for fattening, 14 mg/kg for sows and dairy cows, 8.5 mg/kg for rabbits and 4 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive was considered safe at 4 mg/kg complete feed. The use of cedarwood Texas oil in water for drinking was considered safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumers and the environment were identified following the use of the additive up to the maximum proposed use level in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. Since the individual components of cedarwood Texas oil are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Efficacy of a feed additive consisting of Saccharomyces cerevisiae DBVPG 48 SF (BioCell®) for ruminants (Mazzoleni S.p.A.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae DBVPG 48 SF (BioCell®) as a zootechnical feed additive for horses, pigs and ruminants. In a previous opinion, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive has the potential to be efficacious at the proposed conditions of use for horses, dairy ruminants and all pigs. However, the Panel was not in the position to conclude on the efficacy of BioCell® for calves, and, consequently, for other ruminants for fattening or rearing. The applicant provided three additional efficacy trials in veal calves to support the efficacy of BioCell® for ruminants for fattening or rearing. The three studies showed positive effects of the supplementation with the additive at 1.7 × 109 colony forming unit (CFU)/kg complete feed on the performance of veal calves. Considering the previously submitted studies in dairy cows and the new submitted trials, the FEEDAP Panel concluded that the additive has the potential to be efficacious for all ruminants at the proposed condition of use: 4.0 × 108 CFU/kg complete feed for dairy ruminants and 4.0 × 109 CFU/kg complete feed for ruminants for fattening and rearing.

Efficacy of the feed additive consisting of Saccharomyces cerevisiae CNCM I-4407 (Actisaf® Sc47) for cattle for fattening (Lesaffre International).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of Saccharomyces cerevisiae CNCM I-4407 (Actisaf® Sc47) as a zootechnical feed additive (functional group: gut flora stabiliser) in cattle for fattening. The additive is already authorised for use in feed for dairy cows, calves for rearing, lambs for fattening, dairy goats, dairy sheep and dairy buffaloes. In a previous opinion, the EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) concluded that Actisaf® Sc47 was safe for cattle for fattening, the consumers and the environment. Additionally, the Panel considered that Actisaf® Sc47 is not a skin irritant, and no conclusions could be drawn on the additive's eye irritancy and dermal sensitisation potential. Due to the lack of adequate data, the Panel could not conclude on the efficacy of the additive in cattle for fattening at the proposed conditions of use. In the current application, the applicant submitted three trials to support the efficacy in cattle for fattening. However, two of them were not considered for the assessment. The other trial showed an improved zootechnical performance of the animals at the proposed use level of 4 × 109 CFU/kg complete feed. Considering the additive is authorised in dairy cows and calves for rearing and the requirements of the current Guidance on the assessment of the efficacy of feed additives, no further demonstration of efficacy is necessary to extrapolate the conclusions previously reached to all ruminants. The significant positive effect shown in one trial in cattle for fattening supports the above extrapolation. Therefore, the FEEDAP Panel concludes that Actisaf® Sc47 is efficacious as a zootechnical additive for cattle for fattening at the proposed conditions of use.

Assessment of the feed additive consisting of l-cystine for all animal species for the renewal of its authorisation (Bretagne Chimie Fine [BCF Life Sciences]).

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 the authorisation of l-cystine as nutritional feed additive. The additive is authorised for use in all animal species (3c391). The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed concluded that the use of the feed additive in animal nutrition remains safe for the target species, the consumers and the environment. As regards the safety for the user, l-cystine is not an irritant to skin or eyes and is not a skin sensitiser. Exposure by inhalation of persons handling the additive cannot be excluded. The present application for the renewal of the authorisation does not include any modification proposal that would have an impact on the efficacy of the additive and therefore there is no need for reassessing the efficacy.

Efficacy of a feed additive consisting of endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 (ROVABIO® ADVANCE) for weaned piglets (Adisseo France SAS).

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 ROVABIO® ADVANCE (liquid and solid) which contains endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase produced with Talaromyces versatilis IMI 378536 and DSM 26702 as a zootechnical feed additive for weaned piglets at the recommended use level of 1800 U xylanase and 1250 U glucanase per kg feed. In a previous assessment, three long-term trials in weaned piglets were submitted. Two of them were considered to support the efficacy of the additive while a third trial was not further considered due to the large number of veterinary treatments applied. A new trial was provided to support the efficacy of the additive, but it did not show a significant improvement of the performance parameters at the minimum recommended use level. Due to the lack of sufficient data, the FEEDAP Panel is not in the position to conclude on the efficacy of the additive for the target species.

Safety of the feed additive consisting of endo-1,4-ß-xylanase (produced with Trichoderma reesei CBS 143953), subtilisin (produced with Bacillus subtilis CBS 143946) and α-amylase (produced with Bacillus amyloliquefaciens CBS 143954) (Avizyme® 1505) for all poultry species (Danisco (UK) Ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of the feed additive consisting of endo-1,4-ß-xylanase (produced with Trichoderma reesei CBS 143953), subtilisin (produced with Bacillus subtilis CBS 143946) and α-amylase (produced with Bacillus amyloliquefaciens CBS 143954) (Avizyme® 1505) as a zootechnical feed additive for all poultry species. The additive is authorised in feed for chickens and turkeys for fattening, ducks and laying hens. In 2020, the FEEDAP Panel issued an opinion for the renewal of the authorisation of the additive for the species/categories for which there is an authorisation, a reduction of the minimum recommended level in turkeys for fattening and the extension of use to all poultry species. In that assessment, the Panel could not conclude on the safety of the additive due to uncertainties on the characterisation of the production strains and the possible presence of their viable cells and DNA in the final product. Moreover, limitations were identified in the xylanase specifications and xylanase method of analysis. The applicant submitted information to address the limitations previously identified. The Panel concluded that the additive is safe for the target species under the proposed conditions of use. The use of Avizyme® 1505 in animal nutrition is considered safe for the consumer and the environment. The additive is a mild irritant to skin and eyes; it is not a dermal sensitiser but should be considered a respiratory sensitiser. The additive is efficacious in ducks at 75 U endo-1,4-ß-xylanase, 1000 U subtilisin and 100 U α-amylase/kg of complete feed. In other poultry species for fattening (including turkeys), reared for breeding and reared for laying, the additive is efficacious at 187.5 U endo-1,4-ß-xylanase, 2500 U subtilisin and 250 U α-amylase per kg of complete feed and at 300 U endo-1,4-ß-xylanase, 4000 U subtilisin and 400 U α-amylase per kg of complete feed for all poultry species for laying (except for ducks).

Assessment of the feed additive consisting of endo-1,4-beta-xylanase (produced with Trichoderma reesei MUCL 49755) and endo-1,3(4)-beta-glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10) for laying hens and minor poultry species for fattening and laying for the renewal of its authorisation (AVEVE BV).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the feed additive consisting of endo-1,4-beta-xylanase (produced with Trichoderma reesei MUCL 49755) and endo-1,3(4)-beta-glucanase (produced with T. reesei MUCL 49754) (AveMix® XG 10/AveMix® XG 10 L) for the renewal of its authorisation as a zootechnical feed additive for laying hens and minor poultry species for fattening and laying. The applicant declared a change in the carrier material used in AveMix® XG 10 from soybean meal to calcium carbonate + wheat flour or calcium carbonate + sepiolite. The applicant provided evidence that the additive AveMix® XG 10 with calcium carbonate + wheat flour and AveMix® XG 10 L comply with the conditions of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) noted that no data were submitted to support compliance of the formulation of AveMix® XG 10 with calcium carbonate + sepiolite with the conditions of the authorisation. The FEEDAP Panel concluded that both formulations of the additive (powder and liquid) remain safe for laying hens and minor poultry species for fattening and laying, consumers and the environment. AveMix® XG 10 formulated with calcium carbonate + sepiolite and AveMix® XG 10 L are not irritant to skin and eyes. No conclusions on the irritation potential of AveMix® XG 10 formulated with calcium carbonate + wheat flour could be drawn. The additive in both formulations is considered a respiratory and skin sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Safety of a feed additive consisting of sepiolite for all animal species (Sepiol S.A. and Tolsa S.A.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of sepiolite as a technological feed additive for all animal species. In 2022, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an Opinion on the safety and efficacy of the same additive. The Panel concluded that sepiolite used as a feed additive is safe for the consumers and the environment, and efficacious as a thickener-suspending agent, binder and anticaking agent in feed for all animal species under the proposed conditions of use. The additive was not considered an eye or skin irritant. However, it was considered a respiratory irritant, a respiratory and dermal sensitiser; owing to the dusting potential and its silica content, the additive was considered a risk by inhalation. Regarding the target species, in the previous Opinion, the Panel concluded on the safety of the additive for dairy ruminants. However, no conclusion could be drawn for all other species/categories. Based on the tolerance studies in chickens for fattening, weaned piglets and trout evaluated in the current assessment, and the one in dairy cows previously assessed, the Panel concluded that the inclusion of sepiolite at the maximum recommended level of 20,000 mg/kg complete feed is safe for all animal species.

Scientific opinion on the characterisation of Ensifer adhaerens CGMCC 19596 used in the production of the feed additive consisting of vitamin B12 (cyanocobalamin) for all animal species (Hebei Huarong Pharmaceutical Co., ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the characterisation of the feed additive consisting of vitamin B12 (cyanocobalamin) produced by fermentation with Ensifer adhaerens (CGMCC 19596). The additive is intended to be used as a nutritional additive for all animal species. In a previous opinion, the FEEDAP Panel could not conclude on the characterisation of the production strain, due to uncertainties on whether the production strain E. adhaerens CGMCC 19596 was genetically modified. However, since viable cells and DNA were not detected in the product, the FEEDAP Panel concluded that vitamin B12 (cyanocobalamin), produced with E. adhaerens CGMCC 19596 would not raise safety concerns as regards the production strain. In the present submission, the applicant provided supplementary information regarding the origin and history of modifications of the strain. Based on the data provided, the FEEDAP Panel concluded on the characterisation of the production strain E. adhaerens CGMCC 19596, which can be considered not to be genetically modified.

Consumer safety of feed additives containing selenium.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety for the consumer of products from animals fed diets with feed additives containing selenium as an active substance. Based on the limited data set available and the several uncertainties, the FEEDAP Panel concluded that the use of organic selenium at the currently maximum authorised use level of 0.2 mg supplemented selenium from organic sources/kg complete feed (within a maximum of 0.5 mg total selenium/kg complete feed) leads to an exceedance of the UL for all the population categories (except elderly and very elderly), suggesting a concern for consumer safety. It was not possible to conclude on the safety of the currently maximum use level of 0.5 mg total selenium/kg complete feed for all consumer categories. Additional data from studies specifically designed to measure deposition of selenium in tissues and products from animal origin resulting from the use of the different sources of selenium would be required to perform a proper risk assessment.

Safety and efficacy of a feed additive consisting of sodium ferrocyanide and potassium ferrocyanide for all animal species (Eusalt a.i.s.b.l.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of sodium ferrocyanide and potassium ferrocyanide as technological feed additives for all animal species. In its previous opinion on the safety and efficacy of the additives, the FEEDAP Panel concluded that the use of sodium ferrocyanide and potassium ferrocyanide is safe, when added to sodium chloride at a maximum content of 80 mg ferrocyanide anions (anhydrous)/kg for turkeys for fattening and laying hens and other laying/breeding birds, all porcine species and categories, all ruminant species and categories, rabbits, horses, salmonids and other minor fin fish, dogs and cats. However, the Panel could not conclude on the safety of the additives for chickens for fattening and other poultry species for fattening or reared for laying/breeding other than turkeys, and for all species/categories other than the above listed. In the current assessment, the applicant is proposing a maximum content of 60 mg ferrocyanide anions (anhydrous)/kg sodium chloride for chickens for fattening and other poultry species (except turkeys) for fattening or reared for laying/breeding and for all species/categories other than the listed above. The FEEDAP Panel concluded that sodium ferrocyanide and potassium ferrocyanide are safe at a maximum content of 80 mg ferrocyanide anions (anhydrous)/kg sodium chloride for: turkeys for fattening and reared for breeding, laying hens and other laying/breeding birds, all porcine species, all ruminant species, rabbits, equines, salmonids and minor fin fish, dogs and cats. The Panel concluded also that a maximum content of 60 mg ferrocyanide anions (anhydrous)/kg sodium chloride is safe for chickens for fattening and minor poultry species for fattening or reared for laying/breeding and all other animal species.

Safety and efficacy of a feed additive consisting of Saccharomyces cerevisiae CNCM I-1079 for dogs and all other Canidae (Danstar Ferment AG).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae CNCM I-1079 as a zootechnical feed additive for dogs and all other Canidae. The additive is intended for use in feed for dogs and all other Canidae at a proposed minimum inclusion level of 1 × 109 CFU per kg of complete feed. Saccharomyces cerevisiae is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. Since the identity of the active agent has been clearly established and no concerns are expected from other components of the product, the additive is considered safe for the target species. Since the additive is intended to be used only in feed for dogs and other non-food-producing animals, an assessment of the safety for the consumer and the environment is not needed. The non-coated form of the additive was shown to be non-irritant to skin and eyes. No conclusion can be drawn on the eye irritation potential of the coated form of the additive due to the lack of data. The additive in both forms, should be considered a skin and respiratory sensitiser and any exposure through skin and respiratory tract is considered a risk. The Panel was not in the position to conclude on the efficacy of Saccharomyces cerevisiae CNCM I-1079 at the proposed conditions of use.

Assessment of the feed additive consisting of endo-1,4-beta-xylanase (produced with Trichoderma reesei MUCL 49755), endo-1,3(4)-beta-glucanase (produced with T. reesei MUCL 49754) and polygalacturonase (produced with Aspergillus fijiensis CBS 589.94) (AveMix® 02 CS) for weaned piglets for the renewal of its authorisation and for its extension of use to suckling piglets (AVEVE BV).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of endo-1,4-beta-xylanase (produced with Trichoderma reesei MUCL 49755), endo-1,3(4)-beta-glucanase (produced with T. reesei MUCL 49754) and polygalacturonase (produced with Aspergillus fijiensis CBS 589.94) (AveMix® 02 CS/ AveMix® 02 CS L) as a zootechnical feed additive for weaned and suckling piglets. The additive is already authorised for use with weaned piglets. This scientific opinion concerns the request for the renewal of the authorisation of the additive for weaned piglets and the extension of use to suckling piglets. The applicant provided evidence that the additive currently in the market complies with the conditions of the authorisation. There was no new evidence that would lead the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider its previous conclusions that the additive is safe for weaned piglets, the consumer and the environment under the authorised conditions of use. This conclusion applied also to the new target species (suckling piglets) for which a request for an extension of use was made. The additive in both formulations (powder and liquid) is not irritant to skin or eyes but should be considered a dermal and respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation for weaned piglets. The Panel concluded that the additive is efficacious in suckling piglets at 2140 XU, 1230 BGU and 46 PGLU/kg complete feed.