Publications by authors named "Francesca Marcon"

342 Publications

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

EFSA J 2021 Apr 21;19(4):e06547. Epub 2021 Apr 21.

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 a tincture from the roots of L. (gentian tincture) when used as a sensory feed additive for all animal species. The product is a ■■■■■ solution, with a dry matter content of approximately 4.3%. The product contains on average 0.0836% polyphenols (of which 0.0463% are flavonoids and 0.0027% xanthones) and 0.0022% gentiopicroside. The FEEDAP Panel concludes that gentian tincture is safe at the maximum proposed use level of 50 mg/kg complete feed for short-living animals (animals for fattening). The FEEDAP Panel considers that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. Considering the genotoxic potential of gentiopicroside and xanthones (gentisin and isogentisin), no conclusions can be drawn for long-living animals (companion animals, horses and animals for reproduction). No safety concern would arise for the consumer from the use of gentian tincture up to the highest safe level in animal nutrition. In the absence of data, no conclusions can be drawn on the potential of the tincture to be a dermal/eye irritant or a skin sensitiser. The data available do not allow to conclude on risks of genotoxicity and carcinogenicity for dermal exposure. Use of the tincture derived from as a flavour in animal feed is not expected to pose a risk for the environment. Since and gentian root extract are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary for the tincture under application.
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http://dx.doi.org/10.2903/j.efsa.2021.6547DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8059737PMC
April 2021

Safety and efficacy of a feed additive consisting of ferrous lysinate sulfate for all animal species (Phytobiotics Futterzusatzstoffe GmbH).

EFSA J 2021 Apr 23;19(4):e06545. Epub 2021 Apr 23.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ferrous lysinate sulfate as nutritional feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel was assigned to this mandate. Based on the results of a tolerance study, the FEEDAP Panel concluded that ferrous lysinate sulfate is safe in chickens for fattening when used up to the current maximum authorised levels of total iron in feed; this conclusion was extrapolated to all animal species and categories, at the respective maximum authorised iron levels in complete feed. The use of ferrous lysinate sulfate in animal nutrition up to the maximum iron content in complete feed authorised in the EU poses no concern to the safety of consumers. The FEEDAP Panel concluded that ferrous lysinate sulfate poses a risk to users by inhalation; the additive is not a dermal irritant, but is irritant to eyes and a skin sensitiser. The FEEDAP Panel considered that the use of ferrous lysinate sulfate in animal nutrition would not pose a risk for the environment. Owing to the limitations in the study provided, the FEEDAP Panel could not conclude on the efficacy of the additive for chickens for fattening, and thus, on the efficacy of ferrous lysinate sulfate for all animal species and categories.
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http://dx.doi.org/10.2903/j.efsa.2021.6545DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8063210PMC
April 2021

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).

EFSA J 2021 Apr 19;19(4):e06533. Epub 2021 Apr 19.

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.
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http://dx.doi.org/10.2903/j.efsa.2021.6533DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8054563PMC
April 2021

Safety and efficacy of a feed additive consisting of a preparation of benzoic acid, calcium formate and fumaric acid (AviMatrix Z) for all avian species other than laying birds (Novus Europe S.A. / N.V).

EFSA J 2021 Apr 23;19(4):e06528. Epub 2021 Apr 23.

The additive AviMatrix Z is a preparation of benzoic acid, calcium formate and fumaric acid and is authorised as a feed additive in chickens for fattening and reared for laying. The applicant has requested to extend the use of the additive to all avian species other than laying birds at a concentration range from 500 to 1,000 mg/kg of complete feed. The safety of the additive was previously assessed by the FEEDAP Panel that concluded that there were no concerns for the consumers and no risks for the environment. Given the particle size distribution and low dusting potential of the additive, the exposure of workers by inhalation and the subsequent health risks were expected to be low. AviMatrix Z is not considered to be a skin/eye irritant or a skin sensitiser. The FEEDAP Panel is not aware of any new information that would lead to reconsider the conclusions drawn previously. The results of a new tolerance study showed that the additive is tolerated by turkeys for fattening at threefold the highest recommended dose (1,000 mg/kg feed). Therefore, the FEEDAP Panel concluded that the additive is safe for turkeys for fattening at the maximum recommended dose and this conclusion was extended to turkeys reared for breeding. Due to the absence of a margin of safety in a trial in chickens for fattening previously evaluated, the FEEDAP Panel could not extrapolate this conclusion to all other avian species up to the point of lay. The FEEDAP Panel concluded that the additive has the potential to be efficacious in all avian species other than laying and breeding birds.
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http://dx.doi.org/10.2903/j.efsa.2021.6528DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8063209PMC
April 2021

Safety and efficacy of a feed additive consisting of a dried extract from the roots of L. ( dry extract) for use in cats and dogs (C.I.A.M.).

EFSA J 2021 Apr 21;19(4):e06527. Epub 2021 Apr 21.

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 a dried extract prepared from the roots of L. ( dry extract) when used as a sensory additive (flavouring compound) in feed for cats and dogs. dry extract is specified to contain at least 2% inulin. Since uncertainty remains concerning the nature of up to 77% of the additive, the FEEDAP Panel was unable to conclude on the safety of the extract at the proposed use levels of up to 40 mg/kg complete feed for cats and dogs. In the absence of data, no conclusions can be drawn on the safety for the user. In the absence of convincing evidence that the extract acts as a flavour in animal feed or has an effect on palatability, the FEEDAP Panel was unable to conclude on the efficacy of the additive.
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http://dx.doi.org/10.2903/j.efsa.2021.6527DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8059735PMC
April 2021

Safety and efficacy of a feed additive consisting of a dried extract from the leaves of L. ( dry extract) for use in cats and dogs (C.I.A.M.).

EFSA J 2021 Apr 21;19(4):e06525. Epub 2021 Apr 21.

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 a dried extract prepared from the leaves of L. ( dry extract) when used as a sensory additive in feed for cats and dogs. dry extract is specified to contain at least 24% flavonol glycosides, at least 6% terpene lactones and less than 5 ppm ginkgolic acids. Since uncertainty remains concerning the nature of up to 75% of the extract, the additive is not sufficiently characterised to allow an assessment based on the individual components. In view of the indication of potential carcinogenicity from the results of studies by the National Toxicology Program of the USA, obtained with a extract comparable with the additive under assessment, the FEEDAP Panel concludes that the additive cannot be considered safe for cats and dogs. In the absence of data, no conclusions can be drawn on the safety for the user. In the absence of evidence that the extract acts as a flavour in animal feed or has an effect on palatability, the FEEDAP Panel was unable to conclude on the efficacy of the additive.
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http://dx.doi.org/10.2903/j.efsa.2021.6525DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8059750PMC
April 2021

Safety and efficacy of an additive consisting of  DSM 32325 for all animal species (Chr. Hansen A/S).

EFSA J 2021 Apr 19;19(4):e06524. Epub 2021 Apr 19.

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 additive consisting of  DSM 32325 when used as technological additive (hygiene condition enhancer) in feed for all animal species. The product is intended for use in dry feeds at a minimum inclusion level of 1 × 10 colony forming unit (CFU)/kg complete feedingstuff. The bacterial species  DSM 32325 is considered by EFSA to be eligible for the qualified presumption of safety approach. As the identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance, the use of the strain in animal nutrition is considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritancy or skin sensitisation potential of the product. Exposure of users by inhalation is likely and the product should be considered a respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of  DSM 32325 when used in animal nutrition as hygiene condition enhancer due to lack of data.  DSM 32325 is compatible with diclazuril, decoquinate and halofuginone. The data provided do not allow to conclude on the compatibility of the additive with monensin sodium, salinomycin sodium, narasin, robenidine hydrochloride and maduramicin ammonium.
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http://dx.doi.org/10.2903/j.efsa.2021.6524DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8054564PMC
April 2021

Safety and efficacy of an additive consisting of  DSM 32324 for all animal species (Chr. Hansen A/S).

EFSA J 2021 Apr 19;19(4):e06523. Epub 2021 Apr 19.

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 additive consisting of  DSM 32324 when used as a technological additive (hygiene condition enhancer) in feed for all animal species. The product is intended for use in dry feeds at a minimum inclusion level of 1 × 10 colony forming unit (CFU)/kg complete feedingstuff. The bacterial species  DSM 32324 is considered by EFSA to be eligible for the qualified presumption of safety approach. As the identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance, the use of the strain in animal nutrition is considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritancy or skin sensitisation potential of the product. Exposure of users by inhalation is likely and the product should be considered a respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of  DSM 32324 when used in animal nutrition as hygiene condition enhancer due to lack of data.  DSM 32324 is compatible with diclazuril, decoquinate and halofuginone. The data provided do not allow to conclude on the compatibility of the additive with monensin sodium, salinomycin sodium, narasin, robenidine hydrochloride and maduramicin ammonium.
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http://dx.doi.org/10.2903/j.efsa.2021.6523DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8054567PMC
April 2021

Safety and efficacy of an additive consisting of  DSM 25840 for all animal species (Chr. Hansen A/S).

EFSA J 2021 Apr 21;19(4):e06522. Epub 2021 Apr 21.

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 additive consisting of  DSM 25840 when used as technological additive (hygiene condition enhancer) in feed for all animal species. The product is intended for use in dry feeds at a minimum inclusion level of 1 × 10 colony forming unit (CFU)/kg complete feedingstuffs. The bacterial species  DSM 25840 is considered by EFSA to be eligible for the qualified presumption of safety approach. As the identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance, the use of the strain in animal nutrition is considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritancy or skin sensitisation potential of the product. Exposure of users by inhalation is likely and the product should be considered a respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of  DSM 25840 when used in animal nutrition as hygiene condition enhancer due to lack of data.  DSM 25840 is compatible with diclazuril, decoquinate and halofuginone. The data provided do not allow to conclude on the compatibility of the additive with monensin sodium, salinomycin sodium, narasin, robenidine hydrochloride and maduramicin ammonium.
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http://dx.doi.org/10.2903/j.efsa.2021.6522DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8059734PMC
April 2021

Safety and efficacy of a feed additive consisting of l-valine produced by  CGMCC 7.366 for all animal species (Ningxia Eppen Biotech Co., Ltd.).

EFSA J 2021 Apr 19;19(4):e06521. Epub 2021 Apr 19.

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 the feed additive consisting of l-valine produced by fermentation using a non-genetically modified strain of (CGMCC 7.366). The additive is intended to be used in feed and water for drinking for all animal species and categories. The production strain is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The FEEDAP Panel concludes that l-valine produced using  CGMCC 7.366 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. The FEEDAP Panel has concerns on the use of amino acids in water for drinking for hygienic reasons, and due to the risk of imbalances when administered simultaneously via feed. The use of l-valine produced using  CGMCC 7.366 in animal nutrition is considered safe for the consumer and for the environment. No conclusion could be drawn on the potential of l-valine produced using  CGMCC 7.366 to be toxic by inhalation, irritant to the skin or eyes, or a dermal sensitiser due to the lack of data. The additive l-valine produced by fermentation using  CGMCC 7.366 is regarded as an efficacious source of the essential amino acid l-valine for non-ruminant nutrition. For the supplemental l-valine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen.
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http://dx.doi.org/10.2903/j.efsa.2021.6521DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8054562PMC
April 2021

Safety of the feed additives consisting of l-lysine monohydrochloride and l-lysine sulfate produced by  CCTCC M 2015595 for all animal species (Kempex Holland B. V.).

EFSA J 2021 Apr 19;19(4):e06520. Epub 2021 Apr 19.

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 l-lysine monohydrochloride and l-lysine sulfate produced using  CCTCC M 2015595 for all animal species. In 2019, the FEEDAP Panel issued an opinion on the safety and efficacy of the products. In that assessment, the Panel could not conclude on the safety of the additives for the target species, the consumers and the environment due to the uncertainties regarding the possible genetic modification of the strain used to obtain the production strain  CCTCC M 2015595 and on the possible presence of viable cells and DNA of the production strain in the final products. Moreover, in the absence of data, the FEEDAP Panel could not conclude on the safety of the additives for the users. The applicant provided supplementary data to characterise the strain from which the production strain under assessment was obtained. However, uncertainties remain on its origin and history of modification, including whether it has been genetically modified. The production strain  CCTCC M 2015595 did not show the presence of acquired antimicrobial resistance genes nor of toxin and virulence factors genes. Moreover, as viable cells and DNA of the production strain were not detected in both final formulations, l-lysine HCl and l-lysine sulfate do not raise safety concerns as regards the production strain. The FEEDAP Panel concluded that l-lysine HCl and l-lysine sulfate produced by  CCTCC M 2015595 are safe for the target species, consumers and for the environment. No additional data have been provided on the safety of the additives for users. Therefore, the conclusions from the Panel remained that in the absence of data, no conclusions on the safety of the additives for the user can be drawn.
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http://dx.doi.org/10.2903/j.efsa.2021.6520DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8054565PMC
April 2021

Safety and efficacy of a feed additive consisting on ssp. ATCC PTA-6752 for all animal species (Chr. Hansen A/S).

EFSA J 2021 Mar 22;19(3):e06470. Epub 2021 Mar 22.

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 additive consisting of ssp. ATCC PTA-6752 when used as technological additive (acidity regulator) in dry feed at a minimum inclusion level of 2 × 10 colony-forming units (CFU)/kg and in complete or complementary liquid feed for all animal species at a minimum concentration of 1 × 10 CFU/L. No minimum concentration is proposed by the applicant when used in combination with other microbial technological additives. The bacterial species is considered by EFSA to be eligible for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance, the use of the strain in animal nutrition is considered safe for the target animals, consumers and the environment. No conclusions can be drawn on the skin/eye irritancy or skin sensitisation potential of the additive, but it should be considered a respiratory sensitiser. Exposure of users by inhalation is likely. No conclusions could be drawn on the efficacy of the additive when used alone as an acidity regulator in feed due to lack of data. The studies provided showed that ssp. ATCC PTA-6752 when used in combination with ATCC PTA-6750 has the potential to act as an acidity regulator. However, the Panel has reservations on the effects of this mixture in practical use conditions.
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http://dx.doi.org/10.2903/j.efsa.2021.6470DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7983728PMC
March 2021

Safety and efficacy of a feed additive consisting on  ATCC PTA-6750 (formerly ) for all animal species (Chr. Hansen A/S).

EFSA J 2021 Mar 23;19(3):e06469. Epub 2021 Mar 23.

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 additive consisting of (formerly known as ) ATCC PTA-6750 when used as a technological additive (acidity regulator, preservative and hygiene condition enhancer) in feed and water for drinking for all animal species. The product is intended for use as a single strain at a minimum inclusion level of 5 × 10 CFU/L or CFU/kg in water, liquid and dry feeds. No minimum inclusion level is proposed by the applicant when used in combination with other microbial technological additives. The bacterial species is considered by EFSA to be eligible for the qualified presumption of safety approach. As the identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance, the use of the strain in animal nutrition is considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritancy or skin sensitisation potential of the product, but it should be considered a respiratory sensitiser. Exposure of users by inhalation is likely. The Panel is not in the position to conclude on the efficacy of ATCC PTA-6750 when used in animal nutrition as an acidity regulator, preservative or hygiene condition enhancer due to lack of data. The studies provided showed that ATCC PTA-6750 when used in combination with ssp. ATCC PTA-6752 has the potential to act as an acidity regulator. However, the Panel has reservations on the effects of this mixture in practical use conditions.
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http://dx.doi.org/10.2903/j.efsa.2021.6469DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7986472PMC
March 2021

Safety and efficacy of a feed additive consisting of manganese chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.).

EFSA J 2021 Mar 22;19(3):e06468. Epub 2021 Mar 22.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of manganese chelate of ethylenediamine (Manganese-EDA-Cl) as feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) identified several issues related to the data provided concerning the chemical characteristics of the additive. Based on the information provided, the FEEDAP Panel considered unlikely that the additive consists only of manganese mono-chelate of EDA, but of several coexisting (manganese) species; therefore, the FEEDAP Panel was unable to confirm the identity of the additive. The FEEDAP Panel could not evaluate the safety for target species, consumer and environment and the efficacy of the additive owing to the uncertainties and limitations identified in the studies submitted. Concerning the safety of the additive for the users, the Panel considered that handling the additive poses a risk to users by inhalation. The additive should be considered as corrosive to eyes and a skin sensitiser.
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http://dx.doi.org/10.2903/j.efsa.2021.6468DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7983727PMC
March 2021

Safety and efficacy of a feed additive consisting of zinc chelate of ethylenediamine for all animal species (Zinpro Animal Nutrition (Europe), Inc.).

EFSA J 2021 Mar 22;19(3):e06467. Epub 2021 Mar 22.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of zinc chelate of ethylenediamine (Zinc-EDA-Cl) as feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) identified several issues related to the data provided concerning the chemical characteristics of the additive. Based on the information provided, the FEEDAP Panel considered unlikely that the additive consists only of zinc mono-chelate of EDA, but of several coexisting (zinc) species; therefore, the FEEDAP Panel was unable to confirm the identity of the additive. The FEEDAP Panel could not evaluate the safety for target species, consumer and environment and the efficacy of the additive owing to the uncertainties and limitations identified in the studies submitted. Concerning the safety of the additive for the users, the Panel considered that handling the additive poses a risk to users by inhalation. The additive should be considered as corrosive to eyes and a skin sensitiser.
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http://dx.doi.org/10.2903/j.efsa.2021.6467DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7983731PMC
March 2021

Safety and efficacy of a feed additive consisting of lasalocid A sodium and nicarbazin (Nilablend™ 200G) for chickens for fattening (Zoetis Belgium SA).

EFSA J 2021 Mar 22;19(3):e06466. Epub 2021 Mar 22.

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 coccidiostat Nilablend™ 200G containing lasalocid A sodium and nicarbazin. Nilablend™ 200G is not safe for chickens for fattening at the proposed maximum use level of 50 mg lasalocid A sodium + 50 mg nicarbazin/kg complete feed. Concurrent administration of Nilablend™ 200G (containing lasalocid A sodium) with tiamulin and certain other medicinal substances should be avoided. Lasalocid A sodium has antimicrobial activity against Gram-positive bacterial species while many Enterobacteriaceae are naturally resistant. Induction of resistance and/or cross-resistance was not observed in experimental conditions. No information on the interactions of nicarbazin with feed materials, other approved additives or medicinal products have been provided. No data were submitted on the microbiological safety of nicarbazin. The toxicological package for lasalocid A sodium and nicarbazin identified no observed adverse effect levels (NOAELs) that could be the basis for setting health-based guidance values (e.g. an acceptable daily intake (ADI)). The Panel concluded that a concern for the genotoxicity of nicarbazin in Nilablend™ 200G cannot be excluded and that clarification on the mechanism of action of the test items would be needed. Therefore, the FEEDAP Panel is not in the position to establish an ADI for DNC on which to base the assessment of consumer safety. Nilablend™ 200G is considered toxic by inhalation, corrosive and irritant to eyes, slightly irritant to the skin but not a skin sensitiser. Inhalation exposure is considered a risk to persons handling the additive. The FEEDAP Panel cannot conclude on the safety of Nilablend™ 200G for the environment due to a possible risk for aquatic compartment (freshwater) for DNC. The efficacy of Nilablend 200G was demonstrated.
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http://dx.doi.org/10.2903/j.efsa.2021.6466DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7984407PMC
March 2021

Safety and efficacy of the feed additive consisting of Vitamin B/Riboflavin produced by CCTCCM 2019833 for all animal species (Hubei Guangji Pharmaceutical Co., Ltd).

EFSA J 2021 Mar 22;19(3):e06462. Epub 2021 Mar 22.

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 feed additive Vitamin B/Riboflavin produced by CCTCCM 2019833 for all animal species and categories. The additive contains a minimum content of riboflavin of 5%. The production strain has been characterised and data showed that viable cells are not present in the final additive. The additive is not a skin or eye irritant nor a skin sensitiser, but it is considered to be a respiratory sensitiser. The lack of data on the toxicological profile of the additive, including its genotoxic potential, did not allow the Panel to conclude on the safety of the additive for the target species, consumers and users. The FEEDAP Panel concluded that the use of the product as a feed additive poses no concerns for the environment. The additive under assessment is effective in covering the animals' requirements for vitamin B when administered via feed.
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http://dx.doi.org/10.2903/j.efsa.2021.6462DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7983732PMC
March 2021

Efficacy of the feed additive consisting of amprolium hydrochloride (COXAM) for use in chickens for fattening and chickens reared for laying (Huvepharma N.V.).

EFSA J 2021 Mar 12;19(3):e06457. Epub 2021 Mar 12.

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 amprolium hydrochloride (COXAM ) for chickens for fattening and chickens reared for laying. COXAM is a coccidiostat intended to be used to control coccidiosis in chickens for fattening and chickens reared for laying up to 12 weeks of age at a dose of 125 mg amprolium hydrochloride (HCl)/kg complete feed. In its former opinion, the FEEDAP Panel was not in the position to conclude on the efficacy of COXAM for chickens for fattening and chickens reared for laying due to insufficient number of positive and significant effects on relevant parameters in one of the anticoccidial sensitivity tests (ASTs) evaluated. In the present submission, an additional AST has been provided by the applicant. In this study, challenge by an inoculum of low pathogenicity indicated the coccidiostatic potential of amprolium HCl based on the reduction of intestinal lesions. Considering the results of three floor pen trials and two ASTs described and assessed in a previous EFSA opinion and taking into account the newly submitted AST, the FEEDAP Panel concludes that COXAM is efficacious in controlling coccidiosis in chickens for fattening at a dose of 125 mg amprolium HCl/kg complete feed. This conclusion is extended to chickens reared for laying.
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http://dx.doi.org/10.2903/j.efsa.2021.6457DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7953173PMC
March 2021

Safety of the feed additive consisting of manganese chelates of lysine and glutamic acid for all animal species (Zinpro Animal Nutrition).

EFSA J 2021 Mar 8;19(3):e06454. Epub 2021 Mar 8.

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 for target animals of manganese chelates of lysine and glutamic acid (Manganese-LG) as a nutritional feed additive for all animal species. The European Commission request followed an opinion of the FEEDAP Panel published in 2020; in that opinion, the FEEDAP Panel could conclude on the safety of the additive for chickens for fattening, but not for the rest of the target animals. The applicant submitted additional information to allow the FEEDAP Panel to complete its assessment; these additional data, comprising two tolerance studies (one with chickens for fattening and one with laying hens), were the subject of this opinion. The tolerance study in laying hens was not considered for the assessment since the housing conditions of the animals were not appropriate according to the relevant EU provisions. The results of the tolerance study in chickens for fattening showed that Manganese-LG at the highest level tested - 800 mg Mn/kg feed - is safe for these target animals. The FEEDAP Panel also considered a previous tolerance study in chickens for fattening. Taking all the evidence together the Panel concluded that Manganese-LG is safe for chickens for fattening at 150 mg Mn/kg feed, with a margin of safety of 5.5. This conclusion can be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total manganese in feed are not exceeded.
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http://dx.doi.org/10.2903/j.efsa.2021.6454DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938354PMC
March 2021

Efficacy of the feed additive consisting of decoquinate (Deccox) for use in chickens for fattening (Zoetis Belgium SA).

EFSA J 2021 Mar 8;19(3):e06453. Epub 2021 Mar 8.

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 decoquinate (Deccox) for chickens for fattening. In a former opinion adopted by the FEEDAP Panel, the potential of decoquinate to prevent coccidiosis in chickens for fattening could not be established due to insufficient evidence. In the present assessment, the applicant submitted new efficacy studies in chickens for fattening to address the data gaps identified in the previous opinion. In addition, the applicant proposed to increase the minimum of the dose range from 20 mg decoquinate/kg complete feed to 30 mg/kg. The coccidiostatic efficacy of decoquinate from Deccox in chickens for fattening was shown in three floor pen studies at a level of 30 mg decoquinate/kg complete feed. Considering the results of three anticoccidial sensitivity tests (ASTs) with 30 mg decoquinate/kg complete feed for chickens for fattening already described and assessed in a previous FEEDAP opinion and taking into account the newly submitted floor pen data with 30 mg decoquinate/kg complete feed, the FEEDAP Panel concludes that decoquinate from Deccox is effective in controlling coccidiosis in chickens for fattening at a minimum dose of 30 mg/kg complete feed.
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http://dx.doi.org/10.2903/j.efsa.2021.6453DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938356PMC
March 2021

Safety and efficacy of the additive consisting of muramidase produced by DSM 32338 (Balancius™) for use in weaned piglets (DSM Nutritional products Ltd).

EFSA J 2021 Mar 8;19(3):e06452. Epub 2021 Mar 8.

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 muramidase produced by DSM 32338 (Balancius™) as a feed additive for weaned piglets. The additive has been previously assessed by the FEEDAP Panel in the context of other applications, and in the current assessment the applicant requests for an extension of use. Based on the data available in a sub-chronic oral toxicity study, the Panel concluded that the additive is safe for weaned piglets at the maximum recommended level of 65,000 LSU(F)/kg feed. The additive is safe for the consumers and the environment but should be considered a potential respiratory sensitiser. The Panel could not conclude on the potential of the additive for skin/eye irritancy and skin sensitisation. The additive has the potential to be efficacious as a zootechnical additive for weaned piglets at the dose of 50,000 LSU(F)/kg feed.
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http://dx.doi.org/10.2903/j.efsa.2021.6452DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938612PMC
March 2021

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

EFSA J 2021 Mar 8;19(3):e06451. Epub 2021 Mar 8.

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 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 DSM 7134 is compatible with the coccidiostats robenidine hydrochloride, maduramicin ammonium, diclazuril, decoquinate, halofuginone hydrobromide, monensin sodium and lasalocid A sodium.
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http://dx.doi.org/10.2903/j.efsa.2021.6451DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938351PMC
March 2021

Safety and efficacy of the feed additive consisting of 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.).

EFSA J 2021 Mar 8;19(3):e06450. Epub 2021 Mar 8.

The feed additive under assessment (trade name: Miya-Gold S) is based on viable spores of 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 × 10 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.
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http://dx.doi.org/10.2903/j.efsa.2021.6450DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938355PMC
March 2021

Safety and efficacy of the feed additive consisting of DSM 28710 (B-Act) for laying hens, minor poultry species for laying, poultry species for breeding purposes and ornamental birds (HuvePharma N.V.).

EFSA J 2021 Mar 8;19(3):e06449. Epub 2021 Mar 8.

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 the feed additive consisting of DSM 28710 (trade name: B-Act) when used in feed for laying hens, minor poultry species for laying and for breeding purposes and ornamental birds. is considered suitable for the qualified presumption of safety (QPS) approach to safety assessment. The identity of the active agent was established, and it does not harbour acquired antimicrobial resistance genes or has toxigenic potential. Following the QPS approach, DSM 28710 is presumed safe for the target species, consumers and the environment. Since no concerns are expected from the other components of the additive, B-Act is also considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritation or skin sensitisation potential of the additive, but B-Act is considered a respiratory sensitiser. B-Act when supplemented at 1.6 × 10 CFU/kg complete feed has the potential to be efficacious in laying hens. Considering also that the efficacy of the product was already shown in chickens and turkeys for fattening, the Panel concludes that the additive has the potential to be efficacious in minor poultry species for laying, poultry species for breeding purposes and for ornamental birds at the same inclusion level. The conclusions on the compatibility of B-Act with coccidiostats previously drawn apply to the current application provided that the maximum authorised concentrations of the coccidiostats for the target species are equal or lower than those for chickens.
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http://dx.doi.org/10.2903/j.efsa.2021.6449DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938357PMC
March 2021

Safety and efficacy of feed additives consisting of dried extracts from DC. or (L.) Moench for use in cats and dogs (C.I.A.M.).

EFSA J 2021 Mar 8;19(3):e06446. Epub 2021 Mar 8.

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 dried extracts prepared from the dried roots of DC. or the dried aerial parts of (L.) Moench, when used as sensory feed additives for cats and dogs. extract is specified to contain at least 4% echinacosides and extract at least 4% total phenols. Since about 75% of the composition of the extracts remained uncharacterised, the FEEDAP Panel was unable to conclude on the safety for the target species. In the absence of data, no conclusions can be drawn on the potential of the extracts to be dermal/eye irritants or skin sensitisers. In the absence of evidence that the extracts act as flavours in animal feed or have an effect on palatability, the FEEDAP Panel was unable to conclude on the efficacy of the additives.
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http://dx.doi.org/10.2903/j.efsa.2021.6446DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938353PMC
March 2021

Safety and efficacy of a feed additive consisting of the seed husk of Forssk. for use in cats and dogs (C.I.A.M.).

EFSA J 2021 Mar 8;19(3):e06445. Epub 2021 Mar 8.

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 the seed husk of Forssk. when used as a sensory additive in feed for cats and dogs. The additive is described as a mixture of mucopolysaccharides and specification is given as swelling index ≥ 40, which is considered as the marker parameter. Since the composition of the additive remained uncharacterised, and considering the limitations in the toxicological data set, the FEEDAP Panel was unable to conclude on the safety for the target species. In the absence of data, no conclusions can be drawn on the safety for the user. In the absence of evidence that the additive acts as a flavour in animal feed or has an effect on palatability, the FEEDAP Panel was unable to conclude on the efficacy of the additive.
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http://dx.doi.org/10.2903/j.efsa.2021.6445DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938352PMC
March 2021

Safety and efficacy of a feed additive consisting of a dried extract from (L.) Roxb. for use in cats and dogs (C.I.A.M.).

EFSA J 2021 Mar 8;19(3):e06444. Epub 2021 Mar 8.

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 dried extract from (L.) Roxb. (Garcinia extract) when used as a sensory additive in feed for cats and dogs. Garcinia extract is specified to contain at least 60% hydroxycitric acid. Since about 25% of the composition of the extract remained uncharacterised and in the absence of complete toxicological data, the FEEDAP Panel was unable to conclude on the safety for cats and dogs. In the absence of adequate data, no conclusions can be on the safety for the user. In the absence of evidence that the extract acts as a flavour in animal feed or has an effect on palatability, the FEEDAP Panel was unable to conclude on the efficacy of the additive.
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http://dx.doi.org/10.2903/j.efsa.2021.6444DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938401PMC
March 2021

Safety and efficacy of the feed additive consisting of l-tryptophan produced by KCCM 80210 for all animal species (Daesang Europe BV).

EFSA J 2021 Mar 8;19(3):e06425. Epub 2021 Mar 8.

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 the feed additive consisting of l-tryptophan produced by fermentation with KCCM 80210 when used as a nutritional additive in feed for all animal species and categories. The production strain KCCM 80210 is safe for the production of l-tryptophan and it was not detected in the final product. The Panel notes that two out of five batches of the additive do not comply with the minimum specification of 98% l-tryptophan on a dry matter basis proposed by the applicant. The use of l-tryptophan (≥ 98%) produced by KCCM 80210 in supplementing feed to compensate for l-tryptophan deficiency in feedingstuffs is safe for non-ruminant target species. There may be a risk for an increased production of toxic metabolites when unprotected l-tryptophan is used in ruminants. The use of l-tryptophan produced by KCCM 80210 in animal nutrition raises no safety concerns to consumers of animal products and to the environment. The additive under assessment is considered a mild eye irritant. The endotoxin activity of the additive and its dusting potential indicate a risk by inhalation for the users. The additive is not a skin irritant and is not a skin sensitiser. The additive l-tryptophan is regarded as an effective source of the amino acid l-tryptophan for all non-ruminant species. In order to be as efficacious in ruminants as in non-ruminants, it should be protected from ruminal degradation.
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http://dx.doi.org/10.2903/j.efsa.2021.6425DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938405PMC
March 2021

Safety and efficacy of a feed additive consisting of endo-1,4-β-xylanase produced by LMG S-15136 (Belfeed B MP/ML) for sows in order to have benefits in piglets and for all porcine species (Beldem, a division of Puratos NV).

EFSA J 2021 Mar 5;19(3):e06456. Epub 2021 Mar 5.

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 Belfeed B MP/ML as a feed additive for sows in order to have benefits in piglets. The additive is to be used in to sows in order to have benefits in piglets and to all porcine species at any developmental stage at 10 IU/kg feed. This additive consists of endo-1,4-β-xylanase produced by a genetically modified strain of (LMG S-15136). In a previous opinion, the FEEDAP Panel could not conclude on the safety of the additive for the users regarding the potential of the additive as dermal sensitiser and on the efficacy of the additive when added to feed for sows in order to have benefits in piglets. In the absence of new information, the FEEDAP Panel retained its previous conclusion that the additive is not irritant to skin or eyes but should be considered a respiratory sensitiser. No conclusions could be drawn on its potential to be a dermal sensitiser. The applicant provided new efficacy data and complementary information regarding a previous study. Based on the previously assessed data and the newly submitted ones, the Panel concludes that although the additive has a potential to be efficacious as a zootechnical additive in sows during the lactation period at the level of 10 IU/kg feed, the data are considered not sufficient to conclude on a beneficial effect on the performance of the litters.
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http://dx.doi.org/10.2903/j.efsa.2021.6456DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7934070PMC
March 2021

Safety for the user of the feed additive consisting of ferric citrate chelate (CI-FER™) for suckling and weaned piglets and minor porcine species (Akeso Biomedical, Inc.).

EFSA J 2021 Mar 5;19(3):e06455. Epub 2021 Mar 5.

Following a request from the European Commission (EC), the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety for the users of the feed additive consisting of ferric citrate chelate (CI-FER™) when used as a zootechnical additive for suckling and weaned piglets and minor porcine species. The EC request follows a previous opinion of the FEEDAP Panel. In that opinion, the Panel identified several risks for the users of the additive; it was listed that it posed a risk to users by inhalation, should be considered as an irritant to skin, eyes and mucous membranes, and also that, due to its nickel content, should be considered as a dermal and respiratory sensitiser. The applicant provided additional data including information on the manufacturing process of the additive and data supporting the safety of the additive for the users to address those concerns. Some changes have been applied to the original manufacturing process which led to a dust-free additive, with the following specifications: total iron ≤ 23%, iron (III) ≥ 16.5% and moisture ≤ 10.0%. The FEEDAP Panel concluded that CI-FER™ does not pose a risk by inhalation and is classified as non-irritant to the skin. The additive should be classified as a skin sensitiser. In the absence of new data, the FEEDAP Panel reiterates its previous conclusion that the additive should be considered irritant to eyes.
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http://dx.doi.org/10.2903/j.efsa.2021.6455DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7934069PMC
March 2021