Bioaccumulation of Polybrominated Diphenyl Ethers by Tubifex Tubifex.

The selective uptake of polybrominated diphenyl ethers (PBDEs) by oligochaetes makes it possible to assess the bioaccumulation of individual congeners in commercial mixtures. Twenty-one congeners from three BDE commercial mixtures (TBDE-71, TBDE-79 and TBDE-83R) and as individual congeners (BDE-77, BDE-126, BDE-198 and BDE-204) were tested on Tubifex tubifex in accordance with the OECD TG 315 "Bioaccumulation in Sediment-Dwelling Benthic Oligochaetes". All the congeners that were spiked in the sediment were detected at the end of the uptake phase and at the end of the experiment. The bioaccumulation factor (BAF), the kinetic bioaccumulation factor (BAFK) and the biotasediment accumulation factor (BSAF) were calculated, and indicate a high bioaccumulation potential for tri- to hexa-BDEs and a lower bioaccumulation potential for hepta- to deca-BDEs. The penta-homologues BDE-99 and BDE-100 showed the highest BSAFs of 4.84 and 5.85 (BAFs of 7.34 and 9.01), while the nona- and deca-BDEs exhibit bioaccumulation in up to one-order-lower concentrations. The change in the bioaccumulation potential between the group of trito hexa-BDEs and hepta- to deca-BDEs correlated with the generally accepted molecular-mass threshold for the molecular transition through biological membranes (700 g/mol).

Safety and efficacy of a feed additive consisting of Allura Red AC for small non-food-producing mammals and ornamental birds (Versele-Laga).

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 Allura Red AC for small non-food-producing mammals and ornamental birds when used as an additive that add or restore colour in feedingstuffs. The use of Allura Red AC up to the proposed conditions of use of 500 mg/kg complete feed is considered safe for guinea pig, chinchilla, degu, hamster, gerbil and chipmunk. The following maximum safe levels (mg/kg complete feed) apply to the following species: ferrets 99, rabbits 123, canaries, budgerigars, mynah and toucans 45, lovebirds 51, cockatiels 79, cockatoos 115, amazons 145, parrots 147, yellow breast macaw 150, blue-throated macaw 173 and hyacinth macaw 214. The maximum safe level of Allura Red AC for other small non-food-producing mammal is 99 mg/kg feed and for other ornamental birds is 45 mg/kg feed. Inhalation exposure of Allura Red is regarded as hazardous. In the absence of data, the Panel cannot conclude on the potential of Allura Red to be a skin/eye irritant or a skin sensitiser. The FEEDAP Panel cannot conclude on the efficacy of the additive.

Safety and efficacy of the feed additive consisting of Clostridium butyricum FERM BP-2789 (Miya-Gold® S) 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 minor porcine species (Miyarisan Pharmaceutical Co. Ltd.).

The feed additive under assessment (trade name: Miya-Gold® S) is based on viable spores of Clostridium butyricum FERM BP-2789. It is authorised for use in minor avian species (excluding laying birds), weaned piglets and minor weaned porcine species, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. This opinion concerns the request for renewal of the authorisation of Miya-Gold® S for the species/categories for which an authorisation exists, the use in chickens for fattening, for which the previous authorisation had expired, and the extension of use to suckling piglets and suckling minor porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that Miya-Gold® S remains safe for the animal species/categories, the consumer and the environment under the current and previously authorised conditions of use. This conclusion applies also to the new target species for which a request of use is made. Regarding the safety for the user, the Panel concluded that the additive is not irritant to skin and eyes and that sensitisation via respiratory route cannot be excluded. There is no need for assessing the efficacy of Miya-Gold® S in the context of the renewal of the authorisation in chickens reared for laying, turkeys for fattening and reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species. The additive has the potential to be efficacious in chickens for fattening, suckling piglets and suckling minor porcine species at the level of 2.5 × 108 CFU/kg complete feedingstuff. Miya-Gold® S is compatible with decoquinate, diclazuril, lasalocid, maduramicin ammonium, narasin, narasin/nicarbazin, monensin sodium, robenidine, salinomycin sodium and semduramicin.

Safety and efficacy of FSF10000 and FLF1000 (3-phytase) as a feed additive for turkeys for fattening or reared for breeding, pigs for fattening and minor porcine 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 3-phytase FLF1000 and FSF10000 as a feed additive for turkeys for fattening or reared for breeding, pigs for fattening and minor porcine species for growing. This additive contains 3-phytase produced by a genetically modified strain of Komagataella phaffii and it is authorised in the EU as a feed additive for feed for chickens for fattening, laying hens, chickens reared for laying and for minor poultry species for fattening or reared for laying/breeding. The applicant requested the extension of use of the additive (both forms) to turkeys for fattening or reared for breeding purposes, and the assessment of the solid formulation to be used in pigs for fattening and minor porcine species for growing. The FEEDAP Panel concluded based on previously evaluated data that the additive, in either form, is safe for turkeys for fattening or reared for breeding at the maximum recommended level of 1,000 FTU/kg feed. However, due to lack of data the Panel could not conclude on the safety for pigs for fattening or minor growing porcine species. The FEEDAP Panel concludes that the use of the additive under the proposed conditions of use is safe for the consumer and the environment. Both forms of the additive are not irritant to eyes and skin but should be considered a potential respiratory sensitiser. The liquid formulation is not a dermal sensitiser but the solid formulation is. The Panel also considered based on previously evaluated data that the additive has a potential to be efficacious as a zootechnical additive in turkeys for fattening and reared for breeding and in pigs for fattening and minor growing porcine species at 500 FTU/kg feed.

Efficacy of iron chelates of lysine and glutamic acid 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 efficacy of iron chelates of lysine and glutamic acid (Iron-LG) as nutritional feed additive for all animal species. The European Commission request followed an opinion of the FEEDAP Panel published in 2019; in that opinion the Panel could not conclude on the efficacy of the additive. The applicant submitted additional information to allow the FEEDAP Panel to complete its assessment; these additional data, related to the efficacy of the additive, are the subject of this opinion. Three studies were provided, one each with weaned piglets, pigs for fattening and laying hens. In the study in laying hens, improvements in iron content in egg yolk, iron in serum and in other iron-related blood endpoints were observed. Based on the results of this study, the FEEDAP Panel concluded that the additive is a source of bioavailable iron, comparable to the standard inorganic iron source, and therefore, the additive is efficacious in meeting the animals' requirements; the results of the study in pigs for fattening supported the bioavailability of Iron-LG. The conclusion drawn by the Panel could be extrapolated to all animal species and categories.

Safety and efficacy of APSA PHYTAFEED® 20,000 GR/L (6-phytase) as a feed additive for pigs for fattening.

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 APSA PHYTAFEED ® 20,000 GR/L (6-phytase) as a feed additive for pigs for fattening. The additive is a preparation of 6-phytase produced by a genetically modified strain of Komagataella phaffii and has been previously assessed by the FEEDAP Panel in the context of three applications for its use in different species. The Panel concluded in those opinions that the production strain is safe, and that the use of the additive as a feed additive would raise no safety concerns for the consumers and the environment. The additive was also considered not to be irritant to skin or eyes or a dermal sensitiser but it should be considered as a respiratory sensitiser. The Panel considered that the new use in pigs for fattening would not modify the previously drawn conclusions with respect to the consumers, users and the environment. A tolerance trial in weaned piglets and a subchronic oral toxicity study were made available to support the safety for the new target species. From the results obtained, the Panel concluded that the additive is safe for pigs for fattening at the level of 1,000 U/kg feed. The applicant submitted three efficacy trials to support the efficacy of the additive. In two trials the apparent faecal digestibility of phosphorus and bone ash/phosphorus content were measured and in the third the effects on the performance of the animals were studied. The results of the studies submitted showed an improvement on the faecal digestibility of phosphorus in two trials, with no improvements on the bone mineralisation. Significant improvements on zootechnical parameters were found in the performance of pigs for fattening that were fed 1,000 U/kg feed in the long-term trial. Since significant effects in relevant parameters were found only in one trial the FEEDAP Panel could not conclude on the efficacy of the product in pigs for fattening.

Safety and efficacy of microcrystalline cellulose 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 microcrystalline cellulose as a feed additive for all animal species. Microcrystalline cellulose is intended for use as a technological additive (functional groups: emulsifier, stabiliser, thickener, gelling agent and binder) in premixtures and feedingstuffs for all animal species with no minimum and maximum content. A proper identification and characterisation of microcrystalline cellulose as required for a feed additive is not available and the occurrence of potential toxic impurities cannot be assessed. The following conclusions apply only to microcrystalline cellulose meeting the food additive specifications. The FEEDAP Panel concluded that microcrystalline cellulose is considered safe for all animal species. The use of microcrystalline cellulose in animal nutrition is of no concern for consumer safety. In the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of microcrystalline cellulose for the user. The use of microcrystalline cellulose as a feed additive is considered safe for the environment. The additive is considered to be efficacious in feedingstuffs for all animal species.

Safety and efficacy of ethyl cellulose 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 ethyl cellulose as a feed additive for all animal species. Ethyl cellulose is intended for use as a technological additive (functional group: stabiliser) in premixtures and feedingstuffs for all animal species with no minimum and maximum content. A proper identification and characterisation of ethyl cellulose as required for a feed additive is not available and the occurrence of potential toxic impurities cannot be assessed. The following conclusions apply only to ethyl cellulose meeting the food additive specifications. The FEEDAP Panel concluded that ethyl cellulose is considered safe for all animal species. The use of ethyl cellulose in animal nutrition is of no concern for consumer safety. In the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of ethyl cellulose for the user. The use of ethyl cellulose as a feed additive is considered safe for the environment. The additive is considered to be efficacious in feedingstuffs for all animal species.

Safety and efficacy of sodium carboxymethyl cellulose 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 sodium carboxymethyl cellulose as a feed additive for all animal species. Sodium carboxymethyl cellulose is intended for use as a technological additive (functional groups: emulsifier, stabiliser, thickener, gelling agent and binder) in premixtures and feedingstuffs for all animal species with no minimum and maximum content. A proper identification and characterisation of sodium carboxymethyl cellulose as required for a feed additive is not available and the occurrence of potential toxic impurities cannot be assessed. The following conclusions apply only to sodium carboxymethyl cellulose meeting the food additive specifications. The FEEDAP Panel concluded that sodium carboxymethyl cellulose is considered safe for all animal species. The use of sodium carboxymethyl cellulose in animal nutrition is of no concern for consumer safety. In the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of sodium carboxymethyl cellulose for the user. The use of sodium carboxymethyl cellulose as a feed additive is considered safe for the environment. The additive is considered to be efficacious in feedingstuffs for all animal species.

Safety and efficacy of methyl cellulose 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 methyl cellulose as a feed additive for all animal species. Methyl cellulose is intended for use as a technological additive (functional groups: emulsifier, stabiliser, thickener, gelling agent and binder) in premixtures and feedingstuffs for all animal species with no minimum and maximum content. A proper identification and characterisation of methyl cellulose as required for a feed additive is not available and the occurrence of potential toxic impurities cannot be assessed. The following conclusions apply only to methyl cellulose meeting the food additive specifications. The FEEDAP Panel concluded that methyl cellulose is considered safe for all animal species. The use of methyl cellulose in animal nutrition is of no concern for consumer safety. In the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of methyl cellulose for the user. The use of methyl cellulose as a feed additive is considered safe for the environment. The additive is considered to be efficacious in feedingstuffs for all animal species.

Safety and efficacy of hydroxypropyl cellulose 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 hydroxypropyl cellulose as a feed additive for all animal species. Hydroxypropyl cellulose is intended for use as a technological additive (functional groups: emulsifier, stabiliser and thickener) in premixtures and feedingstuffs for all animal species with no minimum and maximum content. A proper identification and characterisation of hydroxypropyl cellulose as required for a feed additive is not available and the occurrence of potential toxic impurities cannot be assessed. The following conclusions apply only to hydroxypropyl cellulose meeting the food additive specifications. The FEEDAP Panel concluded that hydroxypropyl cellulose is considered safe for all animal species. The use of hydroxypropyl cellulose in animal nutrition is of no concern for consumer safety. In the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of hydroxypropyl cellulose for the user. The use of hydroxypropyl cellulose as a feed additive is considered safe for the environment. The additive is considered to be efficacious in feedingstuffs for all animal species.

Safety and efficacy of hydroxypropyl methyl cellulose 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 hydroxypropyl methyl cellulose as a feed additive for all animal species. Hydroxypropyl methyl cellulose is intended for use as a technological additive (functional group: stabiliser) in premixtures and feedingstuffs for all animal species with no minimum and maximum content. A proper identification and characterisation of hydroxypropyl methyl cellulose as required for a feed additive is not available and the occurrence of potential toxic impurities cannot be assessed. The following conclusions apply only to hydroxypropyl methyl cellulose meeting the food additive specifications. The FEEDAP Panel concluded that hydroxypropyl methyl cellulose is considered safe for all animal species. The use of hydroxypropyl methyl cellulose in animal nutrition is of no concern for consumer safety. In the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of hydroxypropyl methyl cellulose for the user. The use of hydroxypropyl methyl cellulose as a feed additive is considered safe for the environment. The additive is considered to be efficacious in feedingstuffs for all animal species.

Assessment of the application for renewal of authorisation of Biosprint® (Saccharomyces cerevisiae 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® (Saccharomyces cerevisiae MUCL 39885) as a feed additive for weaned piglets. Biosprint® is composed of only viable cells of Saccharomyces cerevisiae MUCL 39885. S. cerevisiae is considered by EFSA to have qualified presumption of safety status. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of the authorisation. The FEEDAP Panel confirms that the use of Biosprint® under the current authorised conditions of use is safe for weaned piglets, the consumers and the environment. The additive is considered as a potential skin and eye irritant and a skin and respiratory sensitiser. There is no need to assess the efficacy of Biosprint® in the context of the renewal of the authorisation.

Statement on the safety and efficacy of perlite for ruminants and poultry.

The additive perlite (sodium potassium aluminium silicate) is intended to be used as a technological additive (functional group: anticaking agents) for ruminants and poultry. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the data provided by the applicant in the technical dossier. During the course of the assessment, the need for additional information in order to be able to deliver an opinion on the safety and efficacy of this additive was identified and notified to the applicant. The information requested covered the characterisation and identification, the safety for the target species and user, and the efficacy of the additive. The applicant has failed to provide the additional information. Therefore, considering the data provided in the original dossier and the absence of response from the applicant to the requests from EFSA, the FEEDAP Panel is not in a position to deliver an opinion on the safety and efficacy of the additive perlite as a technological additive for ruminants and poultry.

Safety and efficacy of Sorbiflore®ADVANCE (Lactobacillus rhamnosus CNCM I-3698 and Lactobacillus farciminis CNCM I-3699) 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 safety and efficacy of Sorbiflore® ADVANCE when used as a zootechnical feed additive for weaned piglets. Sorbiflore® ADVANCE results from the fermentation of milk based-broth with Lactobacillus rhamnosus CNCM I-3698 and Lactobacillus farciminis CNCM I-3699. The additive is intended for use in feed for weaned piglets at the minimum concentration of 1.25 × 108 viable forming units (VFU)/kg and the maximum concentration of 5 × 108 VFU/kg complete feed. The data submitted did not allow a full characterisation of the additive, and therefore, uncertainty remains on the nature of the product in terms of viability, on the ratio between the active agents and on the stability of the additive. The active agents fulfil the requirements of the qualified presumption of safety (QPS) approach to the assessment of safety and no concerns are expected from other components of the additive. Consequently, Sorbiflore® ADVANCE is presumed to be safe for the target animals, consumers of products from animals receiving the additive and the environment. The additive should be considered a respiratory sensitiser. In the absence of data, no conclusions could be drawn on the irritancy of Sorbiflore® ADVANCE to skin and eyes and on its dermal sensitisation potential. Sorbiflore® ADVANCE at 1.25 × 108 VFU/kg feed has the potential to be efficacious in weaned piglets.

Safety and efficacy of Sorbiflore®ADVANCE (Lactobacillus rhamnosus CNCM I-3698 and Lactobacillus farciminis CNCM I-3699) as a feed additive for chickens for fattening.

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 Sorbiflore® ADVANCE when used as a zootechnical feed additive for chickens for fattening. Sorbiflore® ADVANCE is an additive resulting from the fermentation of milk-based broth with Lactobacillus rhamnosus CNCM I-3698 and Lactobacillus farciminis CNCM I-3699. Sorbiflore® ADVANCE is intended for use in feed for chickens for fattening at the minimum concentration of 5 × 107 Viable Forming Units (VFU)/kg and the maximum concentration of 2 × 108 VFU/kg complete feed. The data submitted did not allow a full characterisation of the additive, and therefore, uncertainty remains on the nature of the product in terms of viability, on the ratio between the active agents and on the stability and homogeneity of the additive. The active agents fulfil the requirements of the Qualified Presumption of Safety (QPS) approach to the assessment of safety and no concerns are expected from other components of the additive. Consequently, Sorbiflore® ADVANCE is presumed to be safe for the target animals, consumers of products from animals receiving the additive and the environment. The additive should be considered a respiratory sensitiser. In the absence of data, no conclusions can be drawn on the irritancy of Sorbiflore® ADVANCE to skin and eyes and on its dermal sensitisation potential. Sorbiflore® ADVANCE at 2 × 108 VFU/kg feed has the potential to be efficacious in chickens for fattening.

Safety and efficacy of ProEquo® (Lactobacillus plantarum DSM 11520) as a feed additive for horses.

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 ProEquo® as a feed additive for horses. This additive is a preparation single strain of Lactobacillus plantarum intended for use as a zootechnical additive in feed for horses. The identity of the bacterial strain was not established. Consequently, the qualified presumption of safety approach to safety assessment cannot be applied, and separate studies on target animals, consumer and environmental safety are required. The tolerance trial provided could not be considered due to non-compliance with the minimum requirements. No additional studies or data were provided for the other safety aspects. Therefore, in the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of ProEquo® for the target animals, consumers of products derived from animals fed the additive and the environment. ProEquo® should be considered a respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the irritancy potential of the additive to skin and eyes or on its dermal sensitisation potential. The FEEDAP Panel is not in the position to conclude on the efficacy of ProEquo® for horses.

Safety and efficacy of Biacton® (Lactobacillus farciminis CNCM I-3740) 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 safety and efficacy of Biacton® when used as a feed additive for weaned piglets. Biacton® is a preparation of viable cells of Lactobacillus farciminis CNCM I-3740 intended to be incorporated into feed for weaned piglets at a minimum recommended application level of 1 × 109 CFU/kg complete feed. L. farciminis is a species considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach to safety assessment which requires the identity of the strain to be conclusively established and evidence that it does not show acquired resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach to safety assessment and since concerns are not expected from other components of the additive, the additive is presumed safe for all target species, consumers and the environment. Biacton® is not irritant to skin, eyes or to the respiratory tract, but should be considered a prespiratory sensitiser. In the absence of data, no conclusions could be drawn on the potential skin sensitisation potential of the additive. No conclusion can be drawn on the efficacy of Biacton® for weaned piglets based on the data available.

Efficacy of calcium formate as a technological feed additive (preservative) for all animal species.

In 2014, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of calcium formate when used as a technological additive (preservative) for all animal species. Calcium formate was considered safe for all animal species at a maximum concentration of 10,000 mg formic acid equivalents/kg complete. Calcium formate was also considered safe for the consumer and the environment. The Panel also concluded that calcium formate is non-irritant to skin but causes severe adverse effects in eyes. It is likely that handling the additive could result in skin reactions and in the production of respirable dust that could present a risk to unprotected workers. The Panel also concluded that 'Data submitted do not provide convincing evidence of the efficacy of the additive when used as a preservative for compound feed or feed materials'. In the current opinion, additional data to demonstrate the efficacy of calcium formate as a preservative in feed for all animal species were assessed. The Panel concluded that calcium formate has the potential to be efficacious as a preservative in feedingstuffs for all animal species at the proposed use level.

Assessment of the application for renewal of authorisation of selenium-enriched yeast produced by Saccharomyces cerevisiae CNCM I-3399 for all animal species.

Selenium-enriched yeast produced by Saccharomyces cerevisiae CNCM I-3399 (selenised yeast inactivated) (SELSAF) is characterised as organic selenium mainly containing selenomethionine (Se-Met, ≥ 63%). The applicant requested for the renewal of the authorisation for selenium-enriched yeast produced by S. cerevisiae CNCM I-3399 when used as a feed additive for all animal species. The applicant has provided evidence that the additive in the market complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of selenium-enriched yeast produced by S. cerevisiae CNCM I-3399 under the current authorised conditions of use is safe for the target species, the consumers and the environment. The additive is non-irritant to skin and eyes but should be considered a respiratory sensitiser. No conclusion can be reached on its dermal sensitising properties. The additive is hazardous by inhalation. Exposure of users by inhalation is very likely. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.