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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. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of Lactobacillus parafarraginis DSM 32962 when used as a technological additive intended to improve the production of silage at a proposed application rate of 1 × 108 colony forming units (CFU)/kg fresh material. The bacterial species L. parafarraginis is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The additive is not an eye or dermal irritant but should be considered a potential respiratory sensitiser. No conclusions can be drawn on the skin sensitisation potential of the additive. Three studies with laboratory‐scale silos were made using samples of easy and moderately difficult to ensile forage. In each case, replicate silos containing untreated forage were compared with identical silos containing the same forage to which Lactobacillus parafarraginis DSM 32962 was added to reach an intended concentration of 1 × 108CFU/kg fresh matter. The results showed that the addition of the additive improves significantly the aerobic stability of the silage tested. [ABSTRACT FROM AUTHOR]

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 vermiculite as a feed additive for pigs, poultry, bovines, sheep, goats, rabbits and horses. Vermiculite, which is a magnesium aluminium iron silicate, is intended for use as a technological additive (functional groups: binders and anticaking agents) in premixtures and feedingstuffs for pigs, poultry, bovines, sheep, goats, rabbits and horses, with no proposed minimum or maximum concentration. The applicant reported a maximum inclusion level, derived from the use of the additive in premixtures of preservatives, of about 50,000 mg/kg complete feed, and suggested typical inclusion levels in complete feedingstuffs below 10,000 mg/kg. The FEEDAP Panel could not conclude on the safety of vermiculite for the target species and the users. The additive is considered safe for the consumer and the environment at the proposed conditions of use. In the absence of data, the Panel could not conclude on the efficacy of vermiculite as a pellet binder or as an anticaking agent. [ABSTRACT FROM AUTHOR]

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 Lactobacillus buchneri DSM 29026 when used as a technological additive to improve ensiling of forage. The additive is intended for use with all forages and for all animal species at a proposed minimum concentration of 1 × 108 colony‐forming units (CFU)/kg forage if used alone, or 5 × 107CFU/kg forage if used in combination with other authorised microorganisms. The bacterial species L. buchneri is considered by the EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and no acquired antimicrobial resistance determinants of concern were detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin/eye irritant or skin sensitiser. Given the proteinaceous nature of the active agent, the additive should be considered a respiratory sensitiser. The FEEDAP Panel concluded that Lactobacillus buchneri DSM 29026 at a minimum concentration of 5 × 107CFU/kg may improve the production of silage from easy and moderately difficult to ensile forage material. [ABSTRACT FROM AUTHOR]

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 Pediococcus pentosaceus DSM 16244 as a technological additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There was no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. The additive was not irritant to skin and eyes but considered a skin and respiratory sensitiser. The present application for renewal of the authorisation did not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of ammonium, calcium and sodium formate when used as a technological additive (preservative) for all animal species. Sodium formate was considered safe for all animal species at a maximum concentration of 10,000 mg formic acid equivalents/kg complete feed (with the exception of pigs, for which a maximum concentration of 12,000 mg formic acid equivalents/kg complete feed was considered safe). Sodium formate was also considered safe for the consumer and the environment. The Panel also concluded that sodium formate is non‐irritant to the skin, but mildly irritant to the eyes, and is a respiratory irritant with a potential for sensitisation. The Panel also concluded that 'Sodium formate or solid sodium formate had no discernible effects on microbial numbers in the feed materials examined. The preservative effect of the three formate salts in water for drinking was not demonstrated'. In the current opinion, additional data to demonstrate the efficacy of sodium formate as a preservative in feed for all animal species were assessed. The Panel concluded that sodium formate has the potential to be efficacious as a preservative in feedingstuffs for all animal species at the proposed use level. In the absence of data, the Panel cannot conclude on the efficacy of the use of the additive in water for drinking. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Following a request from European Commission, the Panel on Additives and Products or Substances used in animal Feed (FEEDAP) was asked to deliver a scientific opinion on the modification of the terms of authorisation of montmorillonite‐illite (FIMIX 1g557) for all animal species. The FEEDAP Panel adopted in 2014 an opinion on the safety and in 2015 on the efficacy of this additive. The additive montmorillonite‐illite (FIMIX 1g557) is currently authorised for use in feedingstuffs for all animal species as an anticaking agent with a minimum and a maximum content of 20,000 mg/kg. The applicant proposed to use the additive in premixtures and complementary feeds for all animal species and categories at a minimum concentration of 20,000 mg/kg premixture and 10,000 mg/kg complementary feeds. The FEEDAP Panel considers that the proposed modification (reduction of the inclusion level in feed) would not affect the conclusions reached in the previous assessment as related to the safety for the target species, consumers, users and the environment. Montmorillonite‐illite is efficacious as an anticaking agent in premixtures for all animal species at inclusions levels starting at 20,000 mg/kg premixture and in complementary feeds at inclusions levels starting at 10,000 mg/kg. When the premixtures or complementary feeds are incorporated into complete feed, the concentration of montmorillonite‐illite would range from 50 to 100 mg/kg complete feed for poultry and all other animal species, respectively. There is no evidence that the anticaking effect of the additive will persist at these concentrations in complete feed. In the absence of specific data, the FEEDAP Panel is not in the position to comment on the efficacy of the additive at these concentrations when used in complete feed. [ABSTRACT FROM AUTHOR]

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 ammonium formate for all animal species. In 2015, the FEEDAP Panel delivered an opinion on the safety and efficacy of ammonium formate, calcium formate and sodium formate. In that opinion, the Panel considered the unavoidable presence of formamide, as a contaminant of ammonium formate, of concern for developmental toxicity for reproduction animals and for carcinogenicity for non‐food‐producing animals. Regarding the safety for the consumer, the Panel concluded that: the use of the additive in dairy animals and laying poultry may raise concerns due to the potential exposure of consumers to formamide. In the current submission, the applicant proposed to reduce the maximum content of ammonium formate in feed to 2,000 mg formic acid equivalent/kg feed from the previously proposed 12,000 mg/kg for pigs and 10,000 mg/kg for all other animal species. Based on the calculation of the maximum safe concentration of formamide in feed, the FEEDAP Panel cannot conclude on the safety of ammonium formate in complete feed for laying hens and sows, since the calculate maximum concentration of formamide in feed (11.5 mg formamide/kg) exceed the maximum safe concentration in feed for these species (5.6 mg formamide/kg for laying hens and 9.9 mg formamide/kg for sows). Based on the results of a residue study in eggs, the use of ammonium formate in animal nutrition at a maximum content of 2,000 mg formic acid equivalent/kg complete feed would not result in concerns on the safety for the consumer. [ABSTRACT FROM AUTHOR]

The additive lignosulphonate of magnesium is intended to be used as a technological additive (functional group: binders) for all animal species. 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 absence and/or incompleteness of information needed 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 format requirements of the application and the structure of the dossier. 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 lignosulphonate of magnesium as a technological additive for all animal species. [ABSTRACT FROM AUTHOR]

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 propyl gallate as feed additive for all animal species. Propyl gallate is neither genotoxic nor carcinogenic. Propyl gallate a is safe for veal calves, cattle for fattening, dairy cows, sheep, goats, sows, horses and salmonids at the proposed maximum use level of 40 mg/kg and for ornamental fish at the proposed maximum use level of 100 mg/kg. The following concentrations (mg/kg complete feed) are considered safe for the other target species: 15 for chickens for fattening; 20 for turkeys for fattening, laying hens and rabbits; 27 for piglets and pigs for fattening and 71 for dogs. The Panel cannot conclude on a safe level for cats. The exposure of the consumer to propyl gallate and its metabolites cannot be estimated owing to the absence of reliable data on residues of propyl gallate and its metabolites in edible tissues and products. Therefore, the FEEDAP Panel is not in the position to conclude on the safety for the consumer of propyl gallate, when used as a feed additive for all food‐producing animal species. Propyl gallate is irritant to skin and eyes and a dermal sensitiser. Exposure via inhalation is possible and it is considered a hazard. The use of the additive in animal nutrition does not pose a risk for the environment. The FEEDAP Panel concludes that propyl gallate has the potential to act as an antioxidant in feedingstuffs. The Panel did not see a reason for the use of propyl gallate as an antioxidant in water for drinking. [ABSTRACT FROM AUTHOR]

The additive Shellac is intended to be used as a technological additive (functional group: stabiliser) for all animal species. 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 description of the additive/efficacy, and safety 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 request from EFSA, the FEEDAP Panel is not in a position to deliver an opinion on the safety and efficacy of the additive Shellac as a technological additive for all animal species. [ABSTRACT FROM AUTHOR]

The additive UD60 (phosphoric acid 60% on silica carrier) is intended to be used as a technological additive (functional group: preservative) for all animal species. 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, the safety for the target species 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 UD60 (phosphoric acid 60% on silica carrier) as a technological additive for all animal species. [ABSTRACT FROM AUTHOR]

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 hexamethylene tetramine (HMTA) for pigs, poultry, bovines, sheep, goats, rabbits and horses. In 2015, the FEEDAP Panel delivered an opinion on the safety and efficacy of HMTA. In that opinion, the Panel noted that the residues of HMTA in the silage amounted to about 5% of the inclusion level of 600 mg HMTA/kg fresh ensiling material. Since the HMTA residues in silage were analysed as formaldehyde, it was not possible to quantify the contribution of formaldehyde and HMTA to the residues. In the absence of a qualitative and quantitative characterisation of the residues, the Panel could not conclude on the safety of HMTA for the target species. Based on the results of a new study in which HMTA was measured in silage, the concentration of HMTA dropped below the limit of quantification of 6 mg HMTA/kg silage, which corresponds to ~ 1% of the HMTA inclusion level in the fresh ensiling material. However, the formaldehyde concentration was not analysed in the silage. In the absence of a qualitative and quantitative characterisation of the residues, the Panel cannot conclude on the safety of HMTA for the target species. [ABSTRACT FROM AUTHOR]

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 lignosulphonate, when used as a technological additive, functional group: binders. In a previous opinion, the FEEDAP Panel could not conclude on the safety of the additive for target species and for the environment. The applicant provided additional information that was assessed in the current opinion. As regards the safety for the target species, the maximum recommended content of lignosulphonate of 10,000 mg/kg complete feed is considered safe in weaned piglet. A safe concentration of lignosulphonate in feed for salmonids and dairy cows could not be identified. The FEEDAP Panel reiterates also its previous conclusions that '10,000 mg lignosulphonate/kg complete feed is safe for chickens for fattening, laying hens and cattle for fattening but a margin of safety cannot be identified. Therefore, this conclusion cannot be extended to all animal species/categories'. Considering the absence of adverse effects confirmed by all the ecotoxicity studies up to very high concentrations, no concerns for the environment are expected from the use of this additive in animal nutrition according the conditions of use. Lignosulphonate is efficacious as pellet binder. [ABSTRACT FROM AUTHOR]

Abstract Following a request from 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 environment of the proposed modification of the terms of the authorisation regarding the formulation of the additive Lactococcus lactis NCIMB 30160. The applicant has proposed to modify the manufacturing process by adding polyethylene glycol (PEG 4000) in the list of potential cryoprotectants that can be used in the freeze‐drying step, up to a maximum concentration of 0.025 mg PEG 4000/kg silage. The use of PEG 4000 as an excipient in formulations with Lactococcus lactis NCIMB 30160 would not change the previous conclusions regarding the safety for the target animals, consumers and users. No safety concerns are expected for the environment when PEG 4000 is used as a cryoprotectant in the additive Lactococcus lactis NCIMB 30160 up to a maximum concentration of 0.025 mg PEG 4000/kg silage.

Abstract The product under assessment is a preparation containing single strains of Saccharomyces cerevisiae, Lactobacillus plantarum and Lactobacillus casei to be used as a technological additive to improve the ensiling process. EFSA has been previously requested by the European Commission to evaluate this product. The safety of the additive for consumers, users, the environment and target animals was established at that time. There was, evidence for improved aerobic stability in forage materials with dry matter contents varying between 30% and 70%. Fluorescence in situ hybridisation methods were also introduced and a different culture medium to better characterise the additive but the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) remains unable to identify a minimum specification for the product or a minimum effective dose.

Abstract In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of formic acid, ammonium formate and sodium formate as feed hygiene agents for all animal species. In this opinion, two forms of the additive sodium formate, a solid form (specified to contain ≥ 98% sodium formate (w/w)) and a liquid form (specified to contain a minimum of 15% sodium formate, a maximum of 75% free formic acid and a maximum of 25% water), were assessed. Sodium formate was considered safe for all animal species at a maximum concentration of 10,000 mg formic acid equivalents/kg complete feed (with the exception of pigs, for which a maximum concentration of 12,000 mg formic acid equivalents/kg complete feed was considered safe). Sodium formate was also considered safe for the consumer and the environment. The Panel also concluded that sodium formate is corrosive. The Panel also concluded that ‘for sodium formate, limited data are available to demonstrate their effects in feed’. In the current opinion, additional data to demonstrate the efficacy of sodium formate liquid as a hygiene condition enhancer in feed for all animal species were assessed. The Panel concluded that sodium formate liquid has the potential to be efficacious as hygiene condition enhancer in feedingstuffs for all animal species at the proposed use level.

Abstract The additive under assessment is pure benzoic acid (> 99.8%), manufactured in the form of flakes. It is intended to be used as a technological feed additive (acidity regulator) in feedingstuffs for weaned piglets and pigs for fattening, with maximum contents of 5,000 and 10,000 mg/kg complete feed, respectively. Benzoic acid is safe for weaned piglets at 5,000 mg/kg complete feed, and at 10,000 mg/kg complete feed for pigs for fattening. The use of benzoic acid in feedingstuffs for piglets and pigs for fattening at the maximum application rate will not affect exposure of consumers to residues or metabolites of concern via food from treated animals. Therefore, the use of benzoic acid as technological additive in feeds for pigs to a maximum inclusion level of 10,000 mg/kg is considered safe for consumers. Benzoic acid is a skin and eye irritant but is not considered to be a skin sensitiser. Exposure via inhalation is unlikely. The use of benzoic acid in feedingstuffs for piglets and pigs for fattening will not pose a risk for the environment. Benzoic acid is efficacious as an acidity regulator in feedingstuffs for weaned piglets and pigs for fattening.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the additive based on fumonisin esterase (Free Yeast® F), produced with a genetically modified strain of Komagataella phaffii. The additive is categorised as a technological feed additive, for the reduction of the contamination of feed by mycotoxins and intended for use in all pigs species (piglets, pigs for fattening, sows and minor growing and reproductive porcine species). It was shown that the production strain and its recombinant genes are not present in the additive. The FEEDAP Panel concluded that the additive is safe for weaned and suckling piglets and pigs for fattening, and all minor growing porcine species up to 60 U/kg complete feed. No conclusions can be drawn on the safety of the additive in sows. The use of the additive in animal nutrition is of no concern for consumer safety. The additive is dust-free, and therefore, respiratory sensitisation/irritation is unlikely. The additive is non-irritant to the eyes and the skin. No conclusion could be made on skin sensitisation. The use of the additive as a feed additive is considered safe for the environment. The Panel concluded that the additive is efficacious as technological feed additive for the reduction of feed contamination by fumonisins, when used at the minimum recommended concentration of 60 U/kg. This conclusion can be extrapolated to all growing and reproductive pigs and other minor porcine species., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 microcrystalline cellulose and carboxymethyl cellulose as technological feed additives for all animal species. In its previous opinions on the safety and efficacy of the products, the FEEDAP Panel could not conclude on proper identification and characterisation as required for a feed additive. The occurrence of potential toxic impurities could also not be assessed. Based on the new data provided, the feed additives microcrystalline cellulose and carboxymethyl cellulose were properly identified and characterised and were shown to meet the specifications set for their use as food additives. Therefore, the conclusions of the safety reached in the previous opinions for microcrystalline cellulose and carboxymethyl cellulose meeting the food additive specifications apply to the microcrystalline cellulose and carboxymethyl cellulose under assessment as feed additives. The additives are considered safe for all animal species, the consumer and the environment. In the absence of data, the FEEDAP Panel is not in the position to conclude on the safety for the user., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 propyl gallate as a technological feed additive for all animal species. In its previous opinions on the safety and efficacy of the product, the FEEDAP Panel could not conclude on a safe level of propyl gallate for cats and on the safety for the consumer. Based on the new data provided, the FEEDAP Panel concluded that propyl gallate at a maximum concentration of 71 mg/kg complete feed is safe for cats. Propyl gallate is considered safe for the consumer when used in complete feed for all animal species at the concentrations considered safe for the target species., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 hydroxypropyl methyl cellulose and methyl cellulose as technological feed additives for all animal species. In its previous opinions on the safety and efficacy of the products, the FEEDAP Panel could not conclude on proper identification and characterisation as required for a feed additive. The occurrence of potential toxic impurities could also not be assessed. Based on the new data provided, the feed additives hydroxypropyl methyl cellulose and methyl cellulose were properly identified and characterised and were shown to meet the specifications set for the food additives. Therefore, the conclusions of the safety assessments reached in the previous opinions for hydroxypropyl methyl cellulose and methyl cellulose meeting the food additive specifications, apply to the hydroxypropyl methyl cellulose and methyl cellulose under assessment as feed additives. The additives are considered safe for all animal species, the consumer and the environment. In the absence of data, the FEEDAP Panel is not in the position to conclude on the safety for the user., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 ethyl cellulose as a technological feed additive for all animal species. In its previous opinions on the safety and efficacy of the product, the FEEDAP Panel could not conclude on proper identification and characterisation as required for a feed additive. The occurrence of potential toxic impurities could also not be assessed. Based on the new data provided, the feed additive ethyl cellulose was properly identified and characterised and was shown to meet the specifications set for the food additive. Therefore, the conclusions of the safety assessment reached in the previous opinions for ethyl cellulose meeting the food additive specifications, apply to the ethyl cellulose under assessment as a feed additive. The feed additive is considered safe for all animal species, the consumer and the environment. In the absence of data, the FEEDAP Panel is not in the position to conclude on the safety for the user., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 hydroxypropyl cellulose as a technological feed additive for all animal species. In its previous opinions on the safety and efficacy of the product, the FEEDAP Panel could not conclude on proper identification and characterisation as required for a feed additive. The occurrence of potential toxic impurities could also not be assessed. Based on the new data provided, the feed additive hydroxypropyl cellulose was properly identified and characterised and was shown to meet the specifications set for the food additive. Therefore, the conclusions of the safety assessment reached in the previous opinion for hydroxypropyl cellulose meeting the food additive specifications, apply to the hydroxypropyl cellulose under assessment as a feed additive. The feed additive is considered safe for all animal species, the consumer and the environment. In the absence of data, the FEEDAP Panel is not in the position to conclude on the safety for the user., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

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 23688, 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 additive was shown not to be irritant to skin or eyes. The Panel was not in the position to conclude on skin sensitisation potential of the additive, but it is considered to be a respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., Competing Interests: If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu., (© 2024 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii and of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 3.0 x 108 colony forming units (CFU)/kg fresh material. The two bacterial species are considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. In previous opinions the identity of the strains has been clearly established and no antibiotic resistance of concern was detected. Therefore, the use of the strains as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy or skin sensitisation of the additive. The additive should be considered a potential respiratory sensitiser. In a previous application, three studies involving both strains used in combination at the same concentration were made with samples of whole crop maize with varied dry matter content. The same studies have been submitted in this application. The Panel reiterates its previous conclusions that Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri NCIMB 40788/CNCM I‐4323 at 1.5 × 108 CFU of each active agent per kg of fresh forage, equivalent to 3 x 108 CFU total lactobacilli/kg of forage significantly improve the aerobic stability of the silage.

Abstract Fumonisin esterase produced from a genetically modified strain of Komagataella phaffi is intended to degrade fumonisin mycotoxins contaminants in feeds for pigs and poultry. The production strain and its recombinant genes are not present in the final product. The applicant selected 300 U/kg feed to represent a likely upper limit. This concentration showed to be safe for piglets, chickens and turkeys for fattening and laying hens; the additive is thus safe for those categories. This conclusion is extended to all pigs, chickens reared for laying and turkeys reared for breeding and extrapolated to all other poultry species for growing and laying and to minor porcine species. No evidence of mutagenicity or genotoxicity was detected and no evidence of toxicity from a repeated‐dose oral toxicity study; the residue assessment did not identify any concern. The use of the additive is, thus, considered safe for consumers. The additive is not toxic by inhalation and the respiratory exposure is likely to be low; however, a risk of sensitisation via the respiratory route cannot be excluded. The additive is non‐irritant to skin and eyes and is not considered a dermal sensitiser. No risks for the environment are expected following the use of the additive in feeds under the proposed condition of use. The additive has the capacity to degrade fumonisin contaminants in feed of marketable quality when used at the minimum recommended dose of 10 U/kg complete feed, as shown in studies with chickens for fattening, laying hens and weaned piglets. Since the mode of action of the additive can be reasonably assumed to be the same in animal species for which the application is made, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers the additive efficacious for all poultry and all pigs.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Pediococcus pentosaceus when used as a technological additive intended to improve ensiling at a proposed application rate of 5 × 107 CFU kg/fresh matter. The species P. pentosaceus is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment and not to require specific demonstration of safety other than the absence of resistance to antibiotics of human and veterinary significance. As the identity of the strain was clearly established and as no antibiotic resistance was detected, the use of the strain in the production of silage is presumed safe for livestock species, consumers of products from animals fed treated silage and the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy of the additive. The additive should be considered a potential respiratory sensitiser. Pediococcus pentosaceus DSM 32291 at a minimum dose of 5 × 107 CFU/kg has the potential to improve the production of silage from easy and moderately difficult to ensile materials by decreasing dry matter loss and protein degradation during ensiling.

Abstract Butylated hydroxyanisole (BHA) is a waxy solid consisting for > 98.5% of the active substance, a mixture of 3‐tert‐butyl‐4‐hydroxyanisole and 2‐tert‐butyl‐4‐hydroxyanisole. It is intended to be used as an antioxidant in feedingstuffs for all animal species and categories. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered BHA up to 150 mg/kg complete feed as safe for all animal species except for cats, for which a safe dose could not be established from the tolerance data. BHA is rapidly absorbed from the gastrointestinal tract; it is metabolised rapidly and excreted as such and as metabolites in the urine and faeces. The proportions of the different metabolites vary depending on species and dose. No accumulation of BHA or metabolites was observed in tissues. The Panel concluded that no concern for consumer safety would arise from the use of BHA as a feed additive at the maximum concentration of 150 mg/kg feed. The additive should be considered a skin, eye irritant and a potential skin sensitiser. Exposure of the user via inhalation was considered unlikely; therefore, a risk is not expected. The use of BHA at the maximum concentration proposed is unlikely to pose a risk to the environment. BHA is authorised as an antioxidant for food use at comparable use levels, therefore, no studies were required to demonstrate the efficacy of BHA as an antioxidant in feedingstuffs for all animal species.

Abstract Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the proposed modification of the terms of the authorisation regarding the formulation of the product Lactococcus lactis NCIMB 30160. The applicant has proposed to modify the manufacturing process by replacing one ingredient in the freeze‐drying step with polyethylene glycol (PEG 4000), a product authorised in the EU as a food additive. The use of PEG 4000 as an excipient in formulations with Lactococcus lactis NCIMB 30160 would not change the previous conclusions regarding the safety for the target animals, consumers and users. The FEEDAP Panel concludes that the additive is safe for target species and for consumers of products from animals fed the treated silage. The additive is not a skin irritant but is a potential skin/respiratory sensitiser. In the absence of data, the Panel is unable to conclude on the safety for the environment of the proposed use of PEG 4000 as excipient in formulations of the additive. The FEEDAP Panel sees no reason to reconsider the conclusions on efficacy previously drawn that the additive containing L. lactis NCIMB 30160 has the potential to improve the production of silage from all forages by increasing lactic acid content and the preservation of dry matter, by reducing the pH and moderately the loss of protein, as determined by ammonia‐N.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lactiplantibacillus plantarum LMG P-21295, a technological 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, consumers and the environment under the authorised conditions of use. The Panel is not in the position to conclude on the skin and eye irritation potential of the additive. No conclusions can be drawn on the potential of the additive to cause skin sensitisation, but it is considered to be a respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation., (© 2023 European Food Safety Authority. EFSA Journal published by Wiley‐VCH GmbH on behalf of European Food Safety Authority.)

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Pediococcus pentosaceus when used as a technological additive intended to improve ensiling at a proposed application rate of 5 × 107 CFU kg/fresh matter. The species P. pentosaceus is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment and not to require specific demonstration of safety other than the absence of resistance to antibiotics of human and veterinary significance. As the identity of the strain was clearly established and as no antibiotic resistance was detected, the use of the strain in the production of silage is presumed safe for livestock species, consumers of products from animals fed treated silage and the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy of the additive. The additive should be considered a potential respiratory sensitiser. Pediococcus pentosaceus DSM 32291 at a minimum dose of 5 × 107 CFU/kg has the potential to improve the production of silage from easy and moderately difficult to ensile materials by decreasing dry matter loss and protein degradation during ensiling. [ABSTRACT FROM AUTHOR]

Butylated hydroxyanisole (BHA) is a waxy solid consisting for > 98.5% of the active substance, a mixture of 3‐tert‐butyl‐4‐hydroxyanisole and 2‐tert‐butyl‐4‐hydroxyanisole. It is intended to be used as an antioxidant in feedingstuffs for all animal species and categories. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered BHA up to 150 mg/kg complete feed as safe for all animal species except for cats, for which a safe dose could not be established from the tolerance data. BHA is rapidly absorbed from the gastrointestinal tract; it is metabolised rapidly and excreted as such and as metabolites in the urine and faeces. The proportions of the different metabolites vary depending on species and dose. No accumulation of BHA or metabolites was observed in tissues. The Panel concluded that no concern for consumer safety would arise from the use of BHA as a feed additive at the maximum concentration of 150 mg/kg feed. The additive should be considered a skin, eye irritant and a potential skin sensitiser. Exposure of the user via inhalation was considered unlikely; therefore, a risk is not expected. The use of BHA at the maximum concentration proposed is unlikely to pose a risk to the environment. BHA is authorised as an antioxidant for food use at comparable use levels, therefore, no studies were required to demonstrate the efficacy of BHA as an antioxidant in feedingstuffs for all animal species. [ABSTRACT FROM AUTHOR]

Following a request from European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the proposed modification of the terms of the authorisation regarding the formulation of the product Lactococcus lactis NCIMB 30160. The applicant has proposed to modify the manufacturing process by replacing one ingredient in the freeze‐drying step with polyethylene glycol (PEG 4000), a product authorised in the EU as a food additive. The use of PEG 4000 as an excipient in formulations with Lactococcus lactis NCIMB 30160 would not change the previous conclusions regarding the safety for the target animals, consumers and users. The FEEDAP Panel concludes that the additive is safe for target species and for consumers of products from animals fed the treated silage. The additive is not a skin irritant but is a potential skin/respiratory sensitiser. In the absence of data, the Panel is unable to conclude on the safety for the environment of the proposed use of PEG 4000 as excipient in formulations of the additive. The FEEDAP Panel sees no reason to reconsider the conclusions on efficacy previously drawn that the additive containing L. lactis NCIMB 30160 has the potential to improve the production of silage from all forages by increasing lactic acid content and the preservation of dry matter, by reducing the pH and moderately the loss of protein, as determined by ammonia‐N. [ABSTRACT FROM AUTHOR]