Publications by authors named "Yolanda Sanz"

466 Publications

Guidance on the preparation and submission of the notification and application for authorisation of traditional foods from third countries in the context of Regulation (EU) 2015/2283 (Revision 1).

EFSA J 2021 Mar 26;19(3):e06557. Epub 2021 Mar 26.

[Table: see text] Following the adoption of Regulation (EU) 2015/2283 on Novel Foods, the European Commission requested EFSA to develop a scientific and technical guidance for the preparation and submission of notifications for traditional foods from third countries. This guidance presents a common format for the organisation of the information to be presented by applicant for the preparation of a well-structured dossier. The safety of a traditional food should be substantiated by reliable data on its composition, its experience of continued use and its proposed conditions of use. Its normal consumption should not be nutritionally disadvantageous. This guidance is also intended to support applicants in providing the type and quality of information EU Member States and EFSA need for the assessments of traditional foods from third countries. The applicant should integrate the information on the composition and the experience of continued use and provide a concise overall consideration on how this substantiates the history of safe use of the traditional food and how this relates to the proposed conditions of use for the EU. Where potential health hazards have been identified on the basis of the composition and/or data from the experience of continued use, they should be discussed. On the basis of the information provided, EFSA will assess the safety related to the consumption of the traditional food under the proposed conditions of use. This guidance was originally adopted by the NDA Panel in 2016. It has been revised in 2020 to inform applicants of the new provisions introduced by Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain.It is applicable to allnotifications and applications submitted as of 27 March 2021. The 2016 version remains applicable to notifications and applications submitted before 27 March 2021.
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http://dx.doi.org/10.2903/j.efsa.2021.6557DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996108PMC
March 2021

Scientific and technical guidance for the preparation and presentation of a dossier for evaluation of an infant and/or follow-on formula manufactured from protein hydrolysates (Revision 1).

EFSA J 2021 Mar 26;19(3):e06556. Epub 2021 Mar 26.

[Table: see text] Following a request from the European Commission, EFSA was asked to provide scientific and technical guidance for the preparation and presentation of a dossierfor evaluation of an infant and/or follow-on formula manufactured from protein hydrolysates. This guidance document addresses the information and data to be submitted to EFSA on infant and follow-on formulae manufactured from protein hydrolysates with respect to the nutritional safety and suitability of the specific formula and/or the formula's efficacy in reducing the risk of developing allergy to milk proteins. The guidance will be further reviewed and updated with the experience gained from the evaluation of specificdossiers, and in the light of applicable Unionguidelines and legislation. The guidance was adopted by the Panel on Dietetic Products, Nutrition and Allergies on 5 April 2017.Upon request from the European Commission in 2020, it has been revised to inform food business operators of the new provisions in the pre-submission phase and in the procedure set out in the General Food Law, as amended by the Transparency Regulation. This revised guidance applies to all dossiers submitted as of 27 March 2021 and shall be consulted for the preparation of dossiers intended to be submitted from that date onwards. For dossiers submitted prior to 27 March 2021, the previous guidance, published in May 2017 remains applicable.
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http://dx.doi.org/10.2903/j.efsa.2021.6556DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996106PMC
March 2021

Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 (Revision 1).

EFSA J 2021 Mar 26;19(3):e06555. Epub 2021 Mar 26.

[Table: see text] Following the adoption of Regulation (EU) 2015/2283 on novel foods, the European Commission requested EFSA develop scientific and technical guidance for the preparation and submission of applications for authorisation of novel foods. This guidance presents a common format for the organisation of the information to be presented by the applicant when preparing a well-structured application to demonstrate the safety of the novel food. It outlines the data needed for the safety assessments of novel foods. Requirements relate to the description of the novel food, production process, compositional data, specification, proposed uses and use levels, and anticipated intake of the novel food. Further sections on the history of use of the novel food and/or its source, absorption, distribution, metabolism, excretion, nutritional information, toxicological information and allergenicity should be considered by the applicant by default. If not covered in the application, this should be justified. The applicant should integrate the data presented in the different sections to provide their overall considerations on how the information supports the safety of the novel food under the proposed conditions of use. Where potential health hazards have been identified, they should be discussed in relation to the anticipated intakes of the novel food and the proposed target populations. On the basis of the information provided, EFSA will assess the safety of the novel food under the proposed conditions of use. This guidance was originally adopted in 2016.It has beenrevised to informapplicants of the new provisions introduced by Regulation (EC) No 178/2002, as amended by Regulation (EU) 2019/1381 on the transparency and sustainability of the EU risk assessment in the food chain.This revised guidance applies to all dossiers submitted as of 27 March 2021. The 2016 version of this guidance remains applicable to applications submitted before 27 March 2021.
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http://dx.doi.org/10.2903/j.efsa.2021.6555DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7996107PMC
March 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

Safety and efficacy of a feed additive consisting of serine protease produced by DSM 19670 (Ronozyme ProAct) for chickens for fattening (DSM Nutritional Products Ltd.).

EFSA J 2021 Mar 5;19(3):e06448. Epub 2021 Mar 5.

Ronozyme ProAct is the trade name of the feed additive under assessment and contains serine protease produced by a genetically modified strain of . 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 Ronozyme ProAct when used as a zootechnical additive for chickens for fattening. The additive is available in coated thermotolerant granulated and liquid forms (Ronozyme ProAct CT/L). The production strain and its recombinant DNA were not detected in an intermediate concentrated product used to produce the final formulations. The final products do not trigger a safety concern with regard to the genetic modification. Based on the results obtained in a tolerance study in chickens for fattening and the data from a subchronic oral toxicity study the FEEDAP Panel concluded that the additive is safe for chickens for fattening. The FEEDAP Panel concluded that the use of Ronozyme ProAct CT/L as a feed additive gives rise to no concern for consumers and for the environment. The additive, in either form, is not an eye irritant but should be considered a skin irritant. In the absence of data, no conclusions on the skin sensitisation potential can be reached. Owing to the proteinaceous nature of the active substance it should be considered a respiratory sensitiser. The FEEDAP Panel also concluded that the additive has the potential to be efficacious at 15,000 PROT/kg compound feed for chickens for fattening.
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http://dx.doi.org/10.2903/j.efsa.2021.6448DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7934068PMC
March 2021

Statement on the safety and efficacy of the feed additive consisting on tragacanth gum for all animal species (Association for International Promotion of Gums).

EFSA J 2021 Mar 2;19(3):e06447. Epub 2021 Mar 2.

The additive tragacanth gum is intended to be used as a technological additive (category: technological additive; functional groups: emulsifier, stabiliser, thickener, gelling agent) 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 and identification, 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 tragacanth gum as a technological additive for all animal species.
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http://dx.doi.org/10.2903/j.efsa.2021.6447DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7922159PMC
March 2021

Assessment of the feed additive consisting of endo-1,4-β-xylanase produced by CBS 114044 (ECONASEXT) for piglets (weaned), chickens reared for laying, chickens for fattening, turkeys for fattening and turkeys reared for breeding for the renewal of its authorisation (Roal Oy).

EFSA J 2021 Feb 23;19(2):e06458. Epub 2021 Feb 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 ECONASE XT, an enzyme based on endo-1,4-β-xylanase produced by a genetically modified strain of CBS 114044. The additive is currently authorised for use in chickens for fattening, chickens reared for laying, laying hens, turkeys for fattening, turkeys reared for breeding, minor poultry species, piglets (weaned) and pigs for fattening. ECONASE XT is currently authorised in two forms, a solid and a liquid form with activities of 4,000,000 and 400,000 BXU/g, respectively. In a previous opinion, the FEEDAP Panel could not exclude the potential presence of recombinant DNA derived from the production organism in recent batches of the additive. The applicant has submitted data to support the absence of recombinant DNA derived from the production organism in recent product batches. The FEEDAP Panel confirms that the data provided support the absence of recombinant DNA of CBS 114044 in the additive and thus, no safety concern was identified.
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http://dx.doi.org/10.2903/j.efsa.2021.6458DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7901290PMC
February 2021

Gut microbes and health.

Gastroenterol Hepatol 2021 Feb 27. Epub 2021 Feb 27.

Ecología Microbiana, Nutrición y Salud, Instituto de Agroquímica y Tecnología de Alimentos, Consejo Superior de Investigaciones Científicas (IATA-CSIC), Valencia, España.

The human body is populated by myriads of microorganisms throughout its surface and in the cavities connected to the outside. The microbial colonisers of the intestine (microbiota) are a functional and non-expendable part of the human organism: they provide genes (microbiome) and additional functions to the resources of our species and participate in multiple physiological processes (somatic development, nutrition, immunity, etc.). Some chronic non-communicable diseases of developed society (atopias, metabolic syndrome, inflammatory diseases, cancer and some behaviour disorders) are associated with dysbiosis: loss of species richness in the intestinal microbiota and deviation from the ancestral microbial environment. Changes in the vertical transmission of the microbiome, the use of antiseptics and antibiotics, and dietary habits in industrialised society appear to be at the origin of dysbiosis. Generating and maintaining diversity in the microbiota is a new clinical target for health promotion and disease prevention.
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http://dx.doi.org/10.1016/j.gastrohep.2021.01.009DOI Listing
February 2021

Sex, Food, and the Gut Microbiota: Disparate Response to Caloric Restriction Diet with Fiber Supplementation in Women and Men.

Mol Nutr Food Res 2021 Feb 24:e2000996. Epub 2021 Feb 24.

Microbial Ecology, Nutrition & Health Research Unit, Institute of Agrochemistry and Food Technology, Spanish National Research Council (IATA-CSIC), Valencia, 46980, Spain.

Scope: Dietary-based strategies are regularly explored in controlled clinical trials to provide cost-effective therapies to tackle obesity and its comorbidities. The article presents a complementary analysis based on a multivariate multi-omics approach of a caloric restriction intervention (CRD) with fiber supplementation to unveil synergic effects on body weight control, lipid metabolism, and gut microbiota.

Methods And Results: The study explores fecal bile acids (BAs) and short-chain fatty acids (SCFAs), plasma BAs, and fecal shotgun metagenomics on 80 overweight participants of a 12-week caloric restriction clinical trial (-500 kcal day ) randomly allocated into fiber (10 g day inulin + 10 g day resistant maltodextrin) or placebo (maltodextrin) supplementation groups. The multi-omic data integration analysis uncovered the benefits of the fiber supplementation and/or the CRD (e.g., increase of Parabacteroides distasonis and fecal propionate), showing sex-specific effects on either adiposity and fasting insulin; effects thought to be linked to changes of specific gut microbiota species, functional genes, and bacterially produced metabolites like SCFAs and secondary BAs.

Conclusions: This study identifies diet-microbe-host interactions helping to design personalised interventions. It also suggests that sex perspective should be considered routinely in future studies on dietary interventions efficacy. All in all, the study uncovers that the dietary intervention is more beneficial for women than men.
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http://dx.doi.org/10.1002/mnfr.202000996DOI Listing
February 2021

Complete Genome Sequence of Phascolarctobacterium faecium G 104, Isolated from the Stools of a Healthy Lean Donor.

Microbiol Resour Announc 2021 Jan 28;10(4). Epub 2021 Jan 28.

Rosell Institute for Microbiome and Probiotics, Montreal, Quebec, Canada

is a strict anaerobe belonging to the phylum that is found abundantly in the human gastrointestinal tract. Here, we report the complete genome sequence of G 104, a strain isolated from a fresh stool sample from a healthy lean donor.
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http://dx.doi.org/10.1128/MRA.01054-20DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7844068PMC
January 2021

combined with fiber amplifies metabolic and immune benefits in obese mice.

Gut Microbes 2021 Jan-Dec;13(1):1-20

Microbial Ecology, Nutrition & Health Research Unit. Institute of Agrochemistry and Food Technology, Spanish National Research Council (IATA-CSIC) , Valencia, Spain.

Gut microbiota represents a therapeutic target for obesity. We hypothesize that CECT 7771 combined with wheat bran extract (WBE), its preferred carbon source, may exert superior anti-obesity effects. We performed a 17-week intervention in diet-induced obese mice receiving either , WBE, or their combination to identify interactions and independent actions on metabolism and immunity. combined with WBE was the most effective intervention, curbing weight gain and adiposity, while exerting more modest effects separately. The combination restored insulin-dependent metabolic routes in fat and liver, although the bacterium was the primary driver for improving whole-body glucose disposal. Moreover, -combined with WBE caused the highest increases in butyrate and restored the proportion of induced intraepithelial lymphocytes and type-3 innate lymphoid cells in the intestinal epithelium. Thus, strengthening the first line of immune defense against unhealthy diets and associated dysbiosis in the intestine. This intervention also attenuated the altered IL22 signaling and liver inflammation. Our study shows opportunities for employing , combined with WBE, to aid in the treatment of obesity.
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http://dx.doi.org/10.1080/19490976.2020.1865706DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8018257PMC
January 2021

Identifying causative mechanisms linking early-life stress to psycho-cardio-metabolic multi-morbidity: The EarlyCause project.

PLoS One 2021 21;16(1):e0245475. Epub 2021 Jan 21.

Departament de Matemàtiques i Informàtica, Universitat de Barcelona, Barcelona, Spain.

Introduction: Depression, cardiovascular diseases and diabetes are among the major non-communicable diseases, leading to significant disability and mortality worldwide. These diseases may share environmental and genetic determinants associated with multimorbid patterns. Stressful early-life events are among the primary factors associated with the development of mental and physical diseases. However, possible causative mechanisms linking early life stress (ELS) with psycho-cardio-metabolic (PCM) multi-morbidity are not well understood. This prevents a full understanding of causal pathways towards the shared risk of these diseases and the development of coordinated preventive and therapeutic interventions.

Methods And Analysis: This paper describes the study protocol for EarlyCause, a large-scale and inter-disciplinary research project funded by the European Union's Horizon 2020 research and innovation programme. The project takes advantage of human longitudinal birth cohort data, animal studies and cellular models to test the hypothesis of shared mechanisms and molecular pathways by which ELS shapes an individual's physical and mental health in adulthood. The study will research in detail how ELS converts into biological signals embedded simultaneously or sequentially in the brain, the cardiovascular and metabolic systems. The research will mainly focus on four biological processes including possible alterations of the epigenome, neuroendocrine system, inflammatome, and the gut microbiome. Life-course models will integrate the role of modifying factors as sex, socioeconomics, and lifestyle with the goal to better identify groups at risk as well as inform promising strategies to reverse the possible mechanisms and/or reduce the impact of ELS on multi-morbidity development in high-risk individuals. These strategies will help better manage the impact of multi-morbidity on human health and the associated risk.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0245475PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7819604PMC
January 2021