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

Turck, Dominique; Bresson, Jean‐Louis; Burlingame, Barbara; Dean, Tara; Fairweather‐Tait, Susan J.; Heinonen, Marina; Hirsch‐Ernst, Karen Ildico; Mangelsdorf, Inge; McArdle, Harry J; Naska, Androniki; Neuhäuser‐Berthold, Monika; Nowicka, Grażyna; Pentieva, Kristina; Sanz, Yolanda; Siani, Alfonso; Sjödin, Anders; Stern, Martin; Tomé, Daniel; Vinceti, Marco; Willatts, Peter; Engel, Karl‐Heinz; Marchelli, Rosangela; Pöting, Annette; Poulsen, Morten; Salminen, Seppo; Schlatter, Josef Rudolf; Arcella, Davide; Gelbmann, Wolfgang; Sesmaisons‐Lecarré, Agnès de; Verhagen, Hans; Loveren, Hendrik van

doi:10.2903/j.efsa.2016.4594

Cited by 150 publications

(103 citation statements)

References 21 publications

(10 reference statements)

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“…Following a request from the European Commission, the European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver a scientific opinion on shrimp peptide concentrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The assessment of the safety of this NF, which follows the methodology set out in the EFSA Guidance on the preparation and presentation of an application for authorisation of a novel food Regulation (EU) 2015/2283 (EFSA NDA Panel, ) and in the Commission Implementing Regulation (EU) 2017/2469, is based on the data supplied in the original application, the initial assessment by the competent authority of Finland, the concerns and objections of a scientific nature raised by the other Member States and information submitted by the applicant following an EFSA request for supplementary information and additional data identified by the Panel.…”

Section: Discussionmentioning

confidence: 99%

“…A common and structured format on the presentation of NF applications is described in the EFSA guidance on the preparation and presentation of a NF application (EFSA NDA Panel, ). As indicated in this guidance, it is the duty of the applicant to provide all of the available (proprietary, confidential and published) scientific data, including both data in favour and not in favour to support the safety of the proposed NF.…”

Section: Data and Methodologiesmentioning

confidence: 99%

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Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283

Turck¹,

Bresson²,

Burlingame³

et al. 2018

EFS2

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Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on shrimp peptide concentrate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a peptide mixture obtained by an enzymatic proteolysis from northern shrimp (Pandalus borealis) shells and heads. The information provided on the composition, specifications, batch-to-batch variability, stability and production process of the NF is sufficient and does not raise safety concerns. The intention of the applicant is to use this NF as an ingredient in food supplements and to market it to adult consumers at a maximum proposed level of intake of 1,200 mg/day (corresponding to 17 mg/kg body weight (bw) per day for a 70 kg person). There are no concerns with regard to genotoxicity. The available human data do not raise safety concerns. Considering the no observed adverse effect level (NOAEL) of 2,000 mg/kg bw per day from a 90-day repeated-dose oral toxicity study, the maximum proposed level of intake and the nature of the NF, the Panel concludes that the margin of exposure (of 117) is sufficient. The Panel concludes that the NF, shrimp peptide concentrate, is safe to be used as a food supplement at the proposed maximum dose of 1,200 mg/day. The target population is adults. The Panel considered that the conclusion on the safety of the NF could not have been reached without the data from the unpublished study report on repeated-dose 90-day oral toxicity and from the unpublished study reports on two human studies.

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Section: Discussionmentioning

confidence: 99%

Section: Data and Methodologiesmentioning

confidence: 99%

Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283

Turck¹,

Bresson²,

Burlingame³

et al. 2018

EFS2

Self Cite

View full text Add to dashboard Cite

show abstract

“…4 As indicated in this guidance, it is the duty of the applicant to provide all of the available (proprietary, confidential and published) scientific data, including both data in favour and not in favour, to support the safety of the proposed NF. 4 As indicated in this guidance, it is the duty of the applicant to provide all of the available (proprietary, confidential and published) scientific data, including both data in favour and not in favour, to support the safety of the proposed NF.…”

Section: Datamentioning

confidence: 99%

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Turck¹,

Castenmiller²,

Henauw³

et al. 2019

EFS2

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Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver a scientific opinion on Yarrowia lipolytica yeast biomass as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is the dried and heat-killed biomass of Yarrowia lipolytica, a yeast species that is widespread in nature and which can be found in the environment as well as in foods. The production process is sufficiently described and does not raise safety concerns. The information provided on the composition of the NF is sufficient and does not raise safety concerns. The applicant proposed to use the NF as a food supplement in the form of capsules, tablets or powder. The target population for the NF is the general population above 3 years of age. The maximum proposed daily use levels are 3 g/day for children from 3 years to less than 10 years of age and 6 g/day thereafter. Taking into account the composition of the NF and the proposed use levels, the consumption of the NF is not nutritionally disadvantageous. No relevant toxicological information was provided. The Panel considers that given the qualified presumption of safety (QPS) status for production purposes of Yarrowia lipolytica and the fact that the production process of the NF does not raise safety concerns, no toxicological studies are needed for the safety assessment of the NF. The Panel concludes that the NF, Yarrowia lipolytica yeast biomass, is safe under the proposed conditions of use.

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“…Recently, the European Commission has requested the assessment of the safety of sources that would also fall under the definition of ‘novel food ingredients’ (NFI) according to the applicable Regulation (EU) No 2015/2283. Also in this case, the guidance has been updated to make reference to the latest available guidance issued by the EFSA Panel on Dietetic Products, Nutrition and Allergies (EFSA NDA Panel, ).…”

Section: Introductionmentioning

confidence: 99%

“…In the case of sources that fall under the definition of NFI, the information to be provided must be in accordance with the latest applicable guidance (EFSA NDA Panel, ).…”

Section: Introductionmentioning

confidence: 99%

Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources

Younes¹,

Aggett²,

Aguilar³

et al. 2018

EFS2

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Whenever new substances are proposed for use as sources of nutrients in food supplements, foods for the general population or foods for specific groups, EFSA is requested by the European Commission to perform an assessment of their safety and of the bioavailability of the nutrient from the proposed source. This guidance describes the scientific data required to allow an evaluation of the safety of the source within the established framework for risk assessment of food additives and novel food ingredients and the bioavailability of the nutrient from this source. This document is arranged in five main sections: one on technical data aimed at characterising the proposed source and at identifying potential hazards resulting from its manufacture and stability in food; one on existing authorisations and evaluation, providing an overview of previous assessments on the proposed source and their conclusions; one on proposed uses and exposure assessment section, allowing an estimate of the dietary exposure to the source and the nutrient based on the proposed uses and use levels; one on toxicological data, describing approaches which can be used to identify (in conjunction with data on manufacture and composition) and to characterise hazards of the source and any relevant breakdown products; the final section on bioavailability focuses on determining the extent to which the nutrient from the proposed source is available for use by the body in comparison with one or more forms of the same nutrient that are already permitted for use on the positive lists. This guidance document should replace the previous guidance issued by the Scientific Committee for Food and published in 2001.

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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

Cited by 150 publications

References 21 publications

Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283

Safety of shrimp peptide concentrate as a novel food pursuant to Regulation (EU) 2015/2283

Safety of Yarrowia lipolytica yeast biomass as a novel food pursuant to Regulation (EU) 2015/2283

Guidance on safety evaluation of sources of nutrients and bioavailability of nutrient from the sources

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