The Experts below are selected from a list of 8271 Experts worldwide ranked by ideXlab platform
Androniki Naska - One of the best experts on this subject based on the ideXlab platform.
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Safety of viable embryonated eggs of the whipworm Trichuris suis as a Novel Food pursuant to Regulation (EU) 2015/2283
EFSA Journal, 2019Co-Authors: Novel Foods Efsa Panel On Nutrition, Dominique Turck, Stefaan De Henauw, Alexandre Maciuk, Inge Mangelsdorf, Karen Ildico Hirsch‐ernst, Harry J Mcardle, Jacqueline Castenmiller, John Kearney, Androniki NaskaAbstract:Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on viable embryonated eggs of the whipworm Trichuris suis as a Novel Food (NF) pursuant to Regulation (EU) 2015/2283. The applicant proposes to use the NF as a Food supplement in the format of a 15-mL bottle containing 250 viable embryonated eggs of T. suis. The target population for the NF is the general population. Considering the compositional data and proposed conditions of use, the consumption of the NF is considered of no nutritional relevance. Available data suggest that most larvae of T. suis after hatching in the intestinal tract of humans remain immature and live for several weeks in the gastrointestinal tract of the human host. Nevertheless, under certain circumstances, T. suis can be invasive in human, being able to mature into adult size and reproduce in humans. Human studies have also shown that administration of T. suis ova may increase the incidence of adverse gastrointestinal reactions. The Panel considers that there are no studies available that demonstrate the safety of this NF intended for the general population at a proposed intake of 250 viable embryonated eggs of T. suis ova per day. Based on the available information, the Panel cannot establish a safe dose at which no safety concerns would be expected. The Panel concludes that the safety of the NF has not been established.
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safety of viable embryonated eggs of the whipworm trichuris suis as a Novel Food pursuant to regulation eu 2015 2283
EFSA Journal, 2019Co-Authors: Novel Foods Efsa Panel On Nutrition, Dominique Turck, Stefaan De Henauw, Karen Ildico Hirschernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J Mcardle, Jacqueline Castenmiller, John Kearney, Androniki NaskaAbstract:Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on viable embryonated eggs of the whipworm Trichuris suis as a Novel Food (NF) pursuant to Regulation (EU) 2015/2283. The applicant proposes to use the NF as a Food supplement in the format of a 15-mL bottle containing 250 viable embryonated eggs of T. suis. The target population for the NF is the general population. Considering the compositional data and proposed conditions of use, the consumption of the NF is considered of no nutritional relevance. Available data suggest that most larvae of T. suis after hatching in the intestinal tract of humans remain immature and live for several weeks in the gastrointestinal tract of the human host. Nevertheless, under certain circumstances, T. suis can be invasive in human, being able to mature into adult size and reproduce in humans. Human studies have also shown that administration of T. suis ova may increase the incidence of adverse gastrointestinal reactions. The Panel considers that there are no studies available that demonstrate the safety of this NF intended for the general population at a proposed intake of 250 viable embryonated eggs of T. suis ova per day. Based on the available information, the Panel cannot establish a safe dose at which no safety concerns would be expected. The Panel concludes that the safety of the NF has not been established.
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guidance on the preparation and presentation of an application for authorisation of a Novel Food in the context of regulation eu 2015 2283
EFSA Journal, 2016Co-Authors: Dominique Turck, Jeanlouis Bresson, Susan J Fairweathertait, Barbara Burlingame, Tara Dean, Marina Heinonen, Karen Ildico Hirschernst, Inge Mangelsdorf, Harry J Mcardle, Androniki NaskaAbstract:Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Council on Novel Foods, the European Commission requested EFSA to update and develop scientific and technical guidance for the preparation and presentation of applications for authorisation of Novel Foods. This guidance presents a common format for the organisation of the information to be presented in order to assist the applicant in preparing a well-structured application to demonstrate the safety of the Novel Food. The application should be comprehensive and complete. This guidance outlined the data needed for the safety assessments of Novel Foods. Requirements which should be covered in all applications 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.
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Guidance on the preparation and presentation of an application for authorisation of a Novel Food in the context of Regulation (EU) 2015/2283
EFSA Journal, 2016Co-Authors: Dominique Turck, Jeanlouis Bresson, Barbara Burlingame, Tara Dean, Marina Heinonen, Inge Mangelsdorf, Karen Ildico Hirsch‐ernst, Harry J Mcardle, Susan J. Fairweather-tait, Androniki NaskaAbstract:Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Council on Novel Foods, the European Commission requested EFSA to update and develop scientific and technical guidance for the preparation and presentation of applications for authorisation of Novel Foods. This guidance presents a common format for the organisation of the information to be presented in order to assist the applicant in preparing a well-structured application to demonstrate the safety of the Novel Food. The application should be comprehensive and complete. This guidance outlined the data needed for the safety assessments of Novel Foods. Requirements which should be covered in all applications 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.
Harry J Mcardle - One of the best experts on this subject based on the ideXlab platform.
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Safety of viable embryonated eggs of the whipworm Trichuris suis as a Novel Food pursuant to Regulation (EU) 2015/2283
EFSA Journal, 2019Co-Authors: Novel Foods Efsa Panel On Nutrition, Dominique Turck, Stefaan De Henauw, Alexandre Maciuk, Inge Mangelsdorf, Karen Ildico Hirsch‐ernst, Harry J Mcardle, Jacqueline Castenmiller, John Kearney, Androniki NaskaAbstract:Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on viable embryonated eggs of the whipworm Trichuris suis as a Novel Food (NF) pursuant to Regulation (EU) 2015/2283. The applicant proposes to use the NF as a Food supplement in the format of a 15-mL bottle containing 250 viable embryonated eggs of T. suis. The target population for the NF is the general population. Considering the compositional data and proposed conditions of use, the consumption of the NF is considered of no nutritional relevance. Available data suggest that most larvae of T. suis after hatching in the intestinal tract of humans remain immature and live for several weeks in the gastrointestinal tract of the human host. Nevertheless, under certain circumstances, T. suis can be invasive in human, being able to mature into adult size and reproduce in humans. Human studies have also shown that administration of T. suis ova may increase the incidence of adverse gastrointestinal reactions. The Panel considers that there are no studies available that demonstrate the safety of this NF intended for the general population at a proposed intake of 250 viable embryonated eggs of T. suis ova per day. Based on the available information, the Panel cannot establish a safe dose at which no safety concerns would be expected. The Panel concludes that the safety of the NF has not been established.
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safety of viable embryonated eggs of the whipworm trichuris suis as a Novel Food pursuant to regulation eu 2015 2283
EFSA Journal, 2019Co-Authors: Novel Foods Efsa Panel On Nutrition, Dominique Turck, Stefaan De Henauw, Karen Ildico Hirschernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J Mcardle, Jacqueline Castenmiller, John Kearney, Androniki NaskaAbstract:Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on viable embryonated eggs of the whipworm Trichuris suis as a Novel Food (NF) pursuant to Regulation (EU) 2015/2283. The applicant proposes to use the NF as a Food supplement in the format of a 15-mL bottle containing 250 viable embryonated eggs of T. suis. The target population for the NF is the general population. Considering the compositional data and proposed conditions of use, the consumption of the NF is considered of no nutritional relevance. Available data suggest that most larvae of T. suis after hatching in the intestinal tract of humans remain immature and live for several weeks in the gastrointestinal tract of the human host. Nevertheless, under certain circumstances, T. suis can be invasive in human, being able to mature into adult size and reproduce in humans. Human studies have also shown that administration of T. suis ova may increase the incidence of adverse gastrointestinal reactions. The Panel considers that there are no studies available that demonstrate the safety of this NF intended for the general population at a proposed intake of 250 viable embryonated eggs of T. suis ova per day. Based on the available information, the Panel cannot establish a safe dose at which no safety concerns would be expected. The Panel concludes that the safety of the NF has not been established.
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Safety of Ecklonia cava phlorotannins as a Novel Food pursuant to Regulation (EC) No 258/97
EFSA Journal, 2017Co-Authors: Nutrition Efsa Panel On Dietetic Products, Jeanlouis Bresson, Barbara Burlingame, Tara Dean, Marina Heinonen, Dominique Turck, Inge Mangelsdorf, Karen Ildico Hirsch‐ernst, Susan J. Fairweather-tait, Harry J McardleAbstract:Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety of Ecklonia cava phlorotannins (marketed as SeaPolynol™) as a Novel Food submitted pursuant to Regulation (EC) No 258/97. The Novel Food is a phlorotannin-rich alcohol extract of Ecklonia cava, which is an edible marine brown alga species. The information provided on the composition, the specifications, the production process and the batch-to-batch variability of the Novel Food is sufficient and does not raise safety concerns. The intention is to market the Novel Food as a Food supplement for healthy individuals over the age of 12 years. A subchronic repeated dose oral toxicity study in rodents tested the Novel Food at daily doses of 0, 375, 750 and 1,500 mg/kg body weight (bw). The Panel considers the mid-dose as the no-observed-adverse-effect-level (NOAEL) of the study. Taking into account this NOAEL of 750 mg/kg bw per day and by applying an uncertainty factor of 200, the Panel considers an intake level of 3.75 mg/kg bw per day as safe. The Panel concludes that the Novel Food, Ecklonia cava phlorotannins, is safe for the use in Food supplements at a maximum daily intake level of 163 mg/day for adolescents from 12 to 14 years of age, 230 mg/day for adolescents above 14 years of age and 263 mg/day for adults.
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guidance on the preparation and presentation of an application for authorisation of a Novel Food in the context of regulation eu 2015 2283
EFSA Journal, 2016Co-Authors: Dominique Turck, Jeanlouis Bresson, Susan J Fairweathertait, Barbara Burlingame, Tara Dean, Marina Heinonen, Karen Ildico Hirschernst, Inge Mangelsdorf, Harry J Mcardle, Androniki NaskaAbstract:Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Council on Novel Foods, the European Commission requested EFSA to update and develop scientific and technical guidance for the preparation and presentation of applications for authorisation of Novel Foods. This guidance presents a common format for the organisation of the information to be presented in order to assist the applicant in preparing a well-structured application to demonstrate the safety of the Novel Food. The application should be comprehensive and complete. This guidance outlined the data needed for the safety assessments of Novel Foods. Requirements which should be covered in all applications 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.
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Guidance on the preparation and presentation of an application for authorisation of a Novel Food in the context of Regulation (EU) 2015/2283
EFSA Journal, 2016Co-Authors: Dominique Turck, Jeanlouis Bresson, Barbara Burlingame, Tara Dean, Marina Heinonen, Inge Mangelsdorf, Karen Ildico Hirsch‐ernst, Harry J Mcardle, Susan J. Fairweather-tait, Androniki NaskaAbstract:Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Council on Novel Foods, the European Commission requested EFSA to update and develop scientific and technical guidance for the preparation and presentation of applications for authorisation of Novel Foods. This guidance presents a common format for the organisation of the information to be presented in order to assist the applicant in preparing a well-structured application to demonstrate the safety of the Novel Food. The application should be comprehensive and complete. This guidance outlined the data needed for the safety assessments of Novel Foods. Requirements which should be covered in all applications 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.
Dominique Turck - One of the best experts on this subject based on the ideXlab platform.
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Safety of viable embryonated eggs of the whipworm Trichuris suis as a Novel Food pursuant to Regulation (EU) 2015/2283
EFSA Journal, 2019Co-Authors: Novel Foods Efsa Panel On Nutrition, Dominique Turck, Stefaan De Henauw, Alexandre Maciuk, Inge Mangelsdorf, Karen Ildico Hirsch‐ernst, Harry J Mcardle, Jacqueline Castenmiller, John Kearney, Androniki NaskaAbstract:Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on viable embryonated eggs of the whipworm Trichuris suis as a Novel Food (NF) pursuant to Regulation (EU) 2015/2283. The applicant proposes to use the NF as a Food supplement in the format of a 15-mL bottle containing 250 viable embryonated eggs of T. suis. The target population for the NF is the general population. Considering the compositional data and proposed conditions of use, the consumption of the NF is considered of no nutritional relevance. Available data suggest that most larvae of T. suis after hatching in the intestinal tract of humans remain immature and live for several weeks in the gastrointestinal tract of the human host. Nevertheless, under certain circumstances, T. suis can be invasive in human, being able to mature into adult size and reproduce in humans. Human studies have also shown that administration of T. suis ova may increase the incidence of adverse gastrointestinal reactions. The Panel considers that there are no studies available that demonstrate the safety of this NF intended for the general population at a proposed intake of 250 viable embryonated eggs of T. suis ova per day. Based on the available information, the Panel cannot establish a safe dose at which no safety concerns would be expected. The Panel concludes that the safety of the NF has not been established.
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safety of viable embryonated eggs of the whipworm trichuris suis as a Novel Food pursuant to regulation eu 2015 2283
EFSA Journal, 2019Co-Authors: Novel Foods Efsa Panel On Nutrition, Dominique Turck, Stefaan De Henauw, Karen Ildico Hirschernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J Mcardle, Jacqueline Castenmiller, John Kearney, Androniki NaskaAbstract:Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on viable embryonated eggs of the whipworm Trichuris suis as a Novel Food (NF) pursuant to Regulation (EU) 2015/2283. The applicant proposes to use the NF as a Food supplement in the format of a 15-mL bottle containing 250 viable embryonated eggs of T. suis. The target population for the NF is the general population. Considering the compositional data and proposed conditions of use, the consumption of the NF is considered of no nutritional relevance. Available data suggest that most larvae of T. suis after hatching in the intestinal tract of humans remain immature and live for several weeks in the gastrointestinal tract of the human host. Nevertheless, under certain circumstances, T. suis can be invasive in human, being able to mature into adult size and reproduce in humans. Human studies have also shown that administration of T. suis ova may increase the incidence of adverse gastrointestinal reactions. The Panel considers that there are no studies available that demonstrate the safety of this NF intended for the general population at a proposed intake of 250 viable embryonated eggs of T. suis ova per day. Based on the available information, the Panel cannot establish a safe dose at which no safety concerns would be expected. The Panel concludes that the safety of the NF has not been established.
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Safety of Ecklonia cava phlorotannins as a Novel Food pursuant to Regulation (EC) No 258/97
EFSA Journal, 2017Co-Authors: Nutrition Efsa Panel On Dietetic Products, Jeanlouis Bresson, Barbara Burlingame, Tara Dean, Marina Heinonen, Dominique Turck, Inge Mangelsdorf, Karen Ildico Hirsch‐ernst, Susan J. Fairweather-tait, Harry J McardleAbstract:Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety of Ecklonia cava phlorotannins (marketed as SeaPolynol™) as a Novel Food submitted pursuant to Regulation (EC) No 258/97. The Novel Food is a phlorotannin-rich alcohol extract of Ecklonia cava, which is an edible marine brown alga species. The information provided on the composition, the specifications, the production process and the batch-to-batch variability of the Novel Food is sufficient and does not raise safety concerns. The intention is to market the Novel Food as a Food supplement for healthy individuals over the age of 12 years. A subchronic repeated dose oral toxicity study in rodents tested the Novel Food at daily doses of 0, 375, 750 and 1,500 mg/kg body weight (bw). The Panel considers the mid-dose as the no-observed-adverse-effect-level (NOAEL) of the study. Taking into account this NOAEL of 750 mg/kg bw per day and by applying an uncertainty factor of 200, the Panel considers an intake level of 3.75 mg/kg bw per day as safe. The Panel concludes that the Novel Food, Ecklonia cava phlorotannins, is safe for the use in Food supplements at a maximum daily intake level of 163 mg/day for adolescents from 12 to 14 years of age, 230 mg/day for adolescents above 14 years of age and 263 mg/day for adults.
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guidance on the preparation and presentation of an application for authorisation of a Novel Food in the context of regulation eu 2015 2283
EFSA Journal, 2016Co-Authors: Dominique Turck, Jeanlouis Bresson, Susan J Fairweathertait, Barbara Burlingame, Tara Dean, Marina Heinonen, Karen Ildico Hirschernst, Inge Mangelsdorf, Harry J Mcardle, Androniki NaskaAbstract:Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Council on Novel Foods, the European Commission requested EFSA to update and develop scientific and technical guidance for the preparation and presentation of applications for authorisation of Novel Foods. This guidance presents a common format for the organisation of the information to be presented in order to assist the applicant in preparing a well-structured application to demonstrate the safety of the Novel Food. The application should be comprehensive and complete. This guidance outlined the data needed for the safety assessments of Novel Foods. Requirements which should be covered in all applications 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.
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Guidance on the preparation and presentation of an application for authorisation of a Novel Food in the context of Regulation (EU) 2015/2283
EFSA Journal, 2016Co-Authors: Dominique Turck, Jeanlouis Bresson, Barbara Burlingame, Tara Dean, Marina Heinonen, Inge Mangelsdorf, Karen Ildico Hirsch‐ernst, Harry J Mcardle, Susan J. Fairweather-tait, Androniki NaskaAbstract:Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Council on Novel Foods, the European Commission requested EFSA to update and develop scientific and technical guidance for the preparation and presentation of applications for authorisation of Novel Foods. This guidance presents a common format for the organisation of the information to be presented in order to assist the applicant in preparing a well-structured application to demonstrate the safety of the Novel Food. The application should be comprehensive and complete. This guidance outlined the data needed for the safety assessments of Novel Foods. Requirements which should be covered in all applications 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.
Inge Mangelsdorf - One of the best experts on this subject based on the ideXlab platform.
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Safety of viable embryonated eggs of the whipworm Trichuris suis as a Novel Food pursuant to Regulation (EU) 2015/2283
EFSA Journal, 2019Co-Authors: Novel Foods Efsa Panel On Nutrition, Dominique Turck, Stefaan De Henauw, Alexandre Maciuk, Inge Mangelsdorf, Karen Ildico Hirsch‐ernst, Harry J Mcardle, Jacqueline Castenmiller, John Kearney, Androniki NaskaAbstract:Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on viable embryonated eggs of the whipworm Trichuris suis as a Novel Food (NF) pursuant to Regulation (EU) 2015/2283. The applicant proposes to use the NF as a Food supplement in the format of a 15-mL bottle containing 250 viable embryonated eggs of T. suis. The target population for the NF is the general population. Considering the compositional data and proposed conditions of use, the consumption of the NF is considered of no nutritional relevance. Available data suggest that most larvae of T. suis after hatching in the intestinal tract of humans remain immature and live for several weeks in the gastrointestinal tract of the human host. Nevertheless, under certain circumstances, T. suis can be invasive in human, being able to mature into adult size and reproduce in humans. Human studies have also shown that administration of T. suis ova may increase the incidence of adverse gastrointestinal reactions. The Panel considers that there are no studies available that demonstrate the safety of this NF intended for the general population at a proposed intake of 250 viable embryonated eggs of T. suis ova per day. Based on the available information, the Panel cannot establish a safe dose at which no safety concerns would be expected. The Panel concludes that the safety of the NF has not been established.
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safety of viable embryonated eggs of the whipworm trichuris suis as a Novel Food pursuant to regulation eu 2015 2283
EFSA Journal, 2019Co-Authors: Novel Foods Efsa Panel On Nutrition, Dominique Turck, Stefaan De Henauw, Karen Ildico Hirschernst, Alexandre Maciuk, Inge Mangelsdorf, Harry J Mcardle, Jacqueline Castenmiller, John Kearney, Androniki NaskaAbstract:Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on viable embryonated eggs of the whipworm Trichuris suis as a Novel Food (NF) pursuant to Regulation (EU) 2015/2283. The applicant proposes to use the NF as a Food supplement in the format of a 15-mL bottle containing 250 viable embryonated eggs of T. suis. The target population for the NF is the general population. Considering the compositional data and proposed conditions of use, the consumption of the NF is considered of no nutritional relevance. Available data suggest that most larvae of T. suis after hatching in the intestinal tract of humans remain immature and live for several weeks in the gastrointestinal tract of the human host. Nevertheless, under certain circumstances, T. suis can be invasive in human, being able to mature into adult size and reproduce in humans. Human studies have also shown that administration of T. suis ova may increase the incidence of adverse gastrointestinal reactions. The Panel considers that there are no studies available that demonstrate the safety of this NF intended for the general population at a proposed intake of 250 viable embryonated eggs of T. suis ova per day. Based on the available information, the Panel cannot establish a safe dose at which no safety concerns would be expected. The Panel concludes that the safety of the NF has not been established.
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Safety of Ecklonia cava phlorotannins as a Novel Food pursuant to Regulation (EC) No 258/97
EFSA Journal, 2017Co-Authors: Nutrition Efsa Panel On Dietetic Products, Jeanlouis Bresson, Barbara Burlingame, Tara Dean, Marina Heinonen, Dominique Turck, Inge Mangelsdorf, Karen Ildico Hirsch‐ernst, Susan J. Fairweather-tait, Harry J McardleAbstract:Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on the safety of Ecklonia cava phlorotannins (marketed as SeaPolynol™) as a Novel Food submitted pursuant to Regulation (EC) No 258/97. The Novel Food is a phlorotannin-rich alcohol extract of Ecklonia cava, which is an edible marine brown alga species. The information provided on the composition, the specifications, the production process and the batch-to-batch variability of the Novel Food is sufficient and does not raise safety concerns. The intention is to market the Novel Food as a Food supplement for healthy individuals over the age of 12 years. A subchronic repeated dose oral toxicity study in rodents tested the Novel Food at daily doses of 0, 375, 750 and 1,500 mg/kg body weight (bw). The Panel considers the mid-dose as the no-observed-adverse-effect-level (NOAEL) of the study. Taking into account this NOAEL of 750 mg/kg bw per day and by applying an uncertainty factor of 200, the Panel considers an intake level of 3.75 mg/kg bw per day as safe. The Panel concludes that the Novel Food, Ecklonia cava phlorotannins, is safe for the use in Food supplements at a maximum daily intake level of 163 mg/day for adolescents from 12 to 14 years of age, 230 mg/day for adolescents above 14 years of age and 263 mg/day for adults.
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guidance on the preparation and presentation of an application for authorisation of a Novel Food in the context of regulation eu 2015 2283
EFSA Journal, 2016Co-Authors: Dominique Turck, Jeanlouis Bresson, Susan J Fairweathertait, Barbara Burlingame, Tara Dean, Marina Heinonen, Karen Ildico Hirschernst, Inge Mangelsdorf, Harry J Mcardle, Androniki NaskaAbstract:Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Council on Novel Foods, the European Commission requested EFSA to update and develop scientific and technical guidance for the preparation and presentation of applications for authorisation of Novel Foods. This guidance presents a common format for the organisation of the information to be presented in order to assist the applicant in preparing a well-structured application to demonstrate the safety of the Novel Food. The application should be comprehensive and complete. This guidance outlined the data needed for the safety assessments of Novel Foods. Requirements which should be covered in all applications 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.
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Guidance on the preparation and presentation of an application for authorisation of a Novel Food in the context of Regulation (EU) 2015/2283
EFSA Journal, 2016Co-Authors: Dominique Turck, Jeanlouis Bresson, Barbara Burlingame, Tara Dean, Marina Heinonen, Inge Mangelsdorf, Karen Ildico Hirsch‐ernst, Harry J Mcardle, Susan J. Fairweather-tait, Androniki NaskaAbstract:Following the adoption of Regulation (EU) 2015/2283 of the European Parliament and of the Council on Novel Foods, the European Commission requested EFSA to update and develop scientific and technical guidance for the preparation and presentation of applications for authorisation of Novel Foods. This guidance presents a common format for the organisation of the information to be presented in order to assist the applicant in preparing a well-structured application to demonstrate the safety of the Novel Food. The application should be comprehensive and complete. This guidance outlined the data needed for the safety assessments of Novel Foods. Requirements which should be covered in all applications 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.
Kyoungsik Moon - One of the best experts on this subject based on the ideXlab platform.
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safety assessment of freeze dried powdered tenebrio molitor larvae yellow mealworm as Novel Food source evaluation of 90 day toxicity in sprague dawley rats
Regulatory Toxicology and Pharmacology, 2016Co-Authors: Sori Han, Jae-sam Hwang, Eun-young Yun, Byoungseok Lee, Kyungjin Jung, Heejin Yu, Kyoungsik MoonAbstract:Worldwide demand for Novel Food source has grown and edible insects are a promising Food sources for humans. Tenebrio molitor, as known as yellow mealworm, has advantages of being rich in protein, and easy to raise as a Novel Food source. The objective of this study was to evaluate subchronic toxicity, including potential hypersensitivity, of freeze-dried powdered T. molitor larvae (fdTML) in male and female Sprague-Dawley rats. The fdTML was administered orally once daily at dose levels of 0, 300, 1000 and 3000 mg/kg/day for 90 days. A toxicological assessment was performed, which included mortality, clinical signs, body and organ weights, Food consumption, ophthalmology, urinalysis, hematology, serum chemistry, gross findings, histopathologic examination and allergic reaction. There were no fdTML- related findings in clinical signs, urinalysis, hematology and serum chemistry, gross examination, histopathologic examination or allergic reaction. In conclusion, the No Observed Adverse Effect Level (NOAEL) for fdTML was determined to be in excess of 3000 mg/kg/day in both sexes of rats under the experimental conditions of this study.
