Application For Renewal Of Authorisation Research Articles

Assessment of a feed additive consisting of all‐rac‐alpha‐tocopheryl acetate (vitamin E) for all animal species for the renewal of its authorisation (NHU Europe GmbH)

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of all‐rac‐alpha‐tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of all‐rac‐alpha‐tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance, however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of all‐rac‐alpha‐tocopheryl acetate in the context of the renewal of the authorisation.

Assessment of a feed additive consisting of all‐rac‐alpha tocopheryl acetate (vitamin E) for all animal species for the renewal of its authorisation (DSM)

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of all-rac-alpha tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of all-rac-alpha-tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of all-rac-alpha-tocopheryl acetate in the context of the renewal of the authorisation.

Assessment of a feed additive consisting of all-rac-alpha tocopheryl acetate (vitamin E) for all animal species for the renewal of its authorisation (EUROPE-ASIA Import Export GmbH).

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of all‐rac‐alpha tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of all‐rac‐alpha‐tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance; however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of all‐rac‐alpha‐tocopheryl acetate in the context of the renewal of the authorisation.

Assessment of a feed additive consisting of all-rac-alpha tocopheryl acetate (vitamin E) for all animal species for the renewal of its authorisation (BASF SE).

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of all‐rac‐alpha‐tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of all‐rac‐alpha‐tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of all‐rac‐alpha‐tocopheryl acetate in the context of the renewal of the authorisation.

Assessment of a feed additive consisting of RRR-alpha-tocopheryl acetate (vitamin E) for all animal species for the renewal of its authorisation (Specialty Ingredients (Europe) B.V. and Vitae Caps S.A.).

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of RRR‐alpha‐tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of RRR‐alpha‐tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance; however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of RRR‐alpha‐tocopheryl acetate in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of Enterococcus faeciumDSM 7134 (Bonvital®) for chickens for fattening for the renewal of its authorisation (Lactosan GmbH & Co. KG).

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 the additive consisting of Enterococcus faecium DSM 7134 (trade name: Bonvital®) as a zootechnical additive (gut flora stabiliser) for chickens for fattening. The additive is produced in powder and granulate (microencapsulated) forms. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of Bonvital® under the current authorised conditions of use is safe for the target species, the consumers and the environment. Bonvital® is not irritant to skin and eyes but should be considered a potential skin sensitiser and a respiratory sensitiser. There is no need to assess the efficacy of Bonvital® in the context of the renewal of the authorisation. The FEEDAP Panel reiterates its previous conclusions that E. faecium DSM 7134 is compatible with the coccidiostats robenidine hydrochloride, maduramicin ammonium, diclazuril, decoquinate, halofuginone hydrobromide, monensin sodium and lasalocid A sodium.

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

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of zinc chelate of hydroxy analogue of methionine (Mintrex®Zn) for all animal species. The FEEDAP Panel has delivered three opinions (during 2008 and 2009) on the safety and efficacy of the additive. The additive was authorised in 2010 as ‘Zinc chelate of hydroxy analogue of methionine’ containing 17.5−18 % zinc, 81 % (2‐hydroxy‐4‐methylthio)butanoic acid (dl‐methionine hydroxy analogue, HMTBa) and maximum 1% mineral oil. Following some modifications in the manufacturing process, the additive does not contain mineral oil and the applicant proposes the following specifications: ≥ 17 % zinc and ≥ 79 % HMTBa. The data provided indicate that the additive complies with the new specifications. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions on the safety for target species, consumers and environment. The applicant provided new studies on the effects of the additive on the respiratory tract and on skin and eyes. Data on the characterisation of the additive and the new studies on skin/eyes led the Panel to reconsider the safety for the user. Owing to the zinc and nickel content of Mintrex®Zn, the handling of the additive poses a risk to users by inhalation; the additive is not a skin or eye irritant but is considered a skin sensitiser. The present application 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.

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

Natugrain® TS/TS L is the trade name of the feed additive under assessment and contains endo‐1,4‐β‐xylanase and endo‐1,4‐β‐glucanase produced by genetically modified strains of Aspergillus niger. The product is currently authorised for use as a feed additive for poultry species, ornamental birds, weaned piglets and pigs for fattening. This scientific opinion concerns the renewal of the authorisation of this additive for poultry species, ornamental birds and weaned piglets. The applicant provided evidence that the additive in the market complies with the conditions of the authorisation. According to the information provided by the applicant, no new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions regarding the safety for the target species, consumer, user and environment under the authorised conditions of use. The additive is safe for the target species for which the renewal of the authorisation is requested, the consumers and the environment. The additive is a potential skin and a 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.

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

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of 6‐phytase produced by Trichoderma reesei CBS 122001 (brand name: Finase® EC). The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The Panel concludes that the additive remains safe for poultry for fattening, breeding and laying, and all pigs, the consumer and the environment under the authorised conditions of use. Regarding user safety, the Panel reiterates that the additive is not a skin or eye irritant or sensitiser but should be considered a potential respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. These conclusions also apply to the new proposed liquid formulation Finase® EC 5 L.

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

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of potassium diformate as a feed additive for sows (brand name Formi™ LHS). The additive was re‐evaluated by the Panel in 2009. In its assessment on the renewal of the additive adopted by the FEEDAP Panel in 2020, the Panel concluded that the information provided by the applicant did not fulfil the minimum requirements to support that Formi™ LHS remained safe under the approved conditions for target species, consumers and users. In the same opinion, the Panel concluded that the use of Formi™ LHS under the approved conditions remained safe for the environment. In the present assessment, the applicant conducted a literature search to fulfil the data requirements for the renewal application and no relevant information regarding adverse effects in target animals (pigs, piglets and sows), consumers and users were identified. Based on this, and the fact that the manufacturing and composition of the additive have not been modified, the FEEDAP Panel considers that there is no evidence to reconsider the conclusions reached in the previous re‐evaluation opinion adopted by the FEEDAP Panel in 2009. Therefore, the Panel concludes that the additive remains safe for sows and the consumer under the authorised conditions of use. Regarding user safety, the Panel reiterates that for the additive, ‘except for ocular irritation potential, no effects requiring specific user protection measures were found’.

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

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of Calsporin® (Bacillus velezensis DSM 15544) as a zootechnical additive for weaned piglets. The product under assessment is based on viable spores of a strain originally identified as Bacillus subtilis. During the course of the current assessment, the active agent has been reclassified as Bacillus velezensis DSM 15544. B. velezensis is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established and the compliance with the other qualifications confirmed. Therefore, B. velezensis DSM 15544 is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from the other components of the additive, Calsporin® is also considered safe for the target species, consumers of products derived from animals fed the additive and the environment. The additive is not a dermal/eye irritant or a skin sensitiser but should be considered a 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.

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

The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of manganese chelate of hydroxy analogue of methionine (Mintrex®Mn) for all animal species. The FEEDAP Panel has delivered three opinions (in 2008, 2009 and 2010) on the safety and efficacy of the additive. The additive was authorised in 2010 as ‘Manganese chelate of hydroxy analogue of methionine’ containing 15.5−17 % manganese, 77−78 % (2‐hydroxy‐4‐methylthio)butanoic acid (dl‐Methionine Hydroxy Analogue, HMTBa) and maximum 1% mineral oil. Following some modifications in the manufacturing process the additive does not contain mineral oil and the applicant proposes the following specifications: ≥ 14 % manganese and ≥ 76 % HMTBa. The data provided indicate that the additive complies with the new specifications. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions on the safety for target species, consumers and environment. The applicant provided new studies on the effects of the additive on the respiratory tract and on skin and eyes. Data on the characterisation of the additive and the new studies on skin/eyes led the Panel to reconsider the safety for the user. Owing to the manganese and nickel content of Mintrex®Mn, the handling of the additive poses a risk to users by inhalation; the additive is not a skin or eye irritant but is considered as a skin sensitiser. The present application 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.

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.

Assessment of the application for renewal of authorisation of pyridoxine hydrochloride (vitamin B6) as a feed additive for all animal species.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of pyridoxine hydrochloride (vitamin B6) produced by chemical synthesis as a feed additive for all animal species. The applicant has provided data demonstrating that the additive in the market complies with the conditions of the authorisation. The FEEDAP Panel confirms that the use of pyridoxine hydrochloride under the current authorised conditions of use is safe for the target species, the consumers and the environment. Pyridoxine hydrochloride is non‐irritant to skin and eyes and is not a skin sensitiser. It may cause photosensitisation. In the absence of inhalation toxicity studies, adverse effects in the respiratory tract cannot be fully excluded. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the application for renewal of the authorisation of Actisaf® Sc 47 (Saccharomyces cerevisiae CNCM I-4407) as a feed additive for calves for rearing.

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 Actisaf® Sc 47 (Saccharomyces cerevisiae CNCM I‐4407) as a zootechnical additive for calves for rearing. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for calves for rearing, consumers and the environment under the authorised conditions of use. The additive is not a skin or eye irritant. In the absence of data, no conclusions can be drawn on the dermal sensitisation potential of the additive. Inhalation exposure is unlikely. 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.

Assessment of the application for renewal of the authorisation of Pediococcus pentosaceus DSM 16244 as a feed additive for all animal species.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on 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.

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 Panelon 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.

Assessment of the application for renewal of authorisation of AveMix®XG 10 (endo-1,4-beta-xylanase and endo-1,3(4)-beta-glucanase) for chickens for fattening.

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 AveMix® XG 10 (endo‐1,4‐beta‐xylanase and endo‐1,3(4)‐beta‐glucanase) for chickens for fattening. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. There is no new evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for the target species, consumer and the environment under the authorised conditions of use. Regarding user safety, the additive is not considered to be a dermal or eye irritant but it is a dermal and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the application for renewal of authorisation of AviPlus® as a feed additive for all porcine species (weaned), chickens for fattening, chickens reared for laying, minor poultry species for fattening, minor poultry species reared for laying.

AviPlus® is an additive containing a mixture of sorbic acid, citric acid, thymol and vanillin. The applicant requested for the renewal of the authorisation for AviPlus® when used as a feed additive in all porcine species (weaned), chickens for fattening, chickens reared for laying, minor poultry species for fattening, minor poultry species reared for laying. 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 AviPlus® under the current authorized conditions of use is safe for the target species, the consumers, the users and the environment. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the application for renewal of authorisation of l-histidine monohydrochloride monohydrate produced with Escherichia coli NITE SD 00268 for salmonids and its extension of use to other fin fish.

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on l‐histidine monohydrochloride (HCl) monohydrate produced by fermentation using Escherichia coli NITE SD 00268 in the context of the renewal of the authorisation for salmonids when used as a nutritional additive. In addition, the applicant requested the extension of use of the additive for other fin fish. The applicant has provided evidence that the composition of the additive currently in the market complies with the conditions of authorisation. The production strain has been modified by conventional mutagenesis and it does not raise safety concerns. The use of l‐histidine HCl monohydrate produced by fermentation using E. coli NITE SD 00268 is safe for salmonids and other fin fish when used as a nutritional additive to supplement the diet in appropriate amounts to cover the nutritional requirements, depending on the species, the physiological state of the animal, the performance level, the environmental conditions, the background amino acid composition of the unsupplemented diet and the status of some essential trace elements such as copper and zinc. The FEEDAP Panel considers the maximum total concentration of 1.7% histidine in feed for salmonids proposed by the applicant as safe. For other fin fish species, the level of 1.7% appears to cause adverse effects. Therefore, it is not possible to define a maximum concentration of histidine in fish other than salmonids as it depends on histidine nutritional requirements in the different fish species. The use of the authorised additive in salmonids production does not pose a risk for consumers, and the proposed maximum total concentration of 1.7% histidine in feed is considered safe for the consumer. l‐Histidine HCl monohydrate produced using E. coli NITE SD 00268 supplemented at levels appropriate to cover the nutritional requirements of fish other than salmonids is considered safe for the consumer. The additive under assessment is not a skin irritant. In the absence of data, it is not possible to conclude on the potential of the additive to be toxic by inhalation, irritant to eyes or a skin sensitiser. The amino acid l‐histidine is a natural component of plants and animals. The use of the additive under assessment in animal nutrition does not represent a risk to the environment. The additive is considered an efficacious source of the amino acid l‐histidine for fish species.