Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283

Nutrition, Efsa Panel on; Foods, Novel

doi:10.2903/j.efsa.2019.5658

Cited by 6 publications

(4 citation statements)

References 2 publications

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“…In a few cases, food additives (e.g., soy lecithin in beta-lactoglobulin) or bulking agents (e.g., maltodextrin in xylo-oligosaccharides (XOS)) are added into the final formulation of the NF for technological purposes. The end-products are commercialized in powder form (i.e., Galactooligosaccharides (GOS), as (concentrated) syrups/liquids (cocoa pulp), crystals (anhydrous or monohydrate betaine), or dried whole products (coffee husk (cascara) and coffee cherry pulp)) ( 23–27 , 29–32 , 36 ).…”

Section: Overview Of the Common Key Scientific Requirements For The S...mentioning

confidence: 99%

“…Nonetheless, particularly for certain NF derived from by-products, it can be challenging to collect a robust body of evidence, as a thorough characterization of the proteins contained in an NF is required. NF derived from rapeseed ( 33 ), coffee ( 25–27 ), and cacao ( 24 ), as well as betaine produced via yeast fermentation ( 29 ), are examples of NF for which the likelihood of allergic reactions was based on such body of evidence.…”

Section: Overview Of the Common Key Scientific Requirements For The S...mentioning

confidence: 99%

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Novel foods, food enzymes, and food additives derived from food by-products of plant or animal origin: principles and overview of the EFSA safety assessment

Precup,

Marini,

Zakidou

et al. 2024

Front. Nutr.

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The European Union (EU) is committed to transitioning toward a circular economy model, with food waste being one of the areas to be targeted. To close the loop of food waste generated during food processing and discarded at the retail or consumption phases, research and innovation parties proposed to valorize agro-food by-products to produce novel foods and food improvement agents (food additives, food enzymes, and food flavorings). In the EU, the authorization of such novel foods and food improvement agents is governed by different regulatory frameworks. A centralized safety assessment by the European Food Safety Authority (EFSA) is the prerequisite for their authorization through the so-called Union Lists. Up to December 2023, EFSA published 45 scientific opinions on the safety of novel foods, food enzymes, and food additives derived from by-products of plant and animal origin. The current study illustrates examples of these by-products for the production of novel foods or food improvement agents and the data requirements behind their respective safety assessments conducted by EFSA. In this review, applications on novel foods, food enzymes, and food additives received by EFSA were screened and analyzed to find the common scientific requirements and differences in terms of the safety evaluation of such products. Various by-products (i.e., corncobs, coffee husks, spent grains of barley and rice, grape pomace, pumpkin peels, bovine whey, eggshells, shrimp heads, and animal organs or tissues) were described in the applications as being processed (extraction, physical treatments, and chemical and enzymatic reactions) to obtain novel foods and food improvement agents. The heterogeneity and complexity of these products emphasize the challenge of their safety assessment, depending on the characteristics of each product. However, as this study shows, the scientific requirements underpinning their safety do not differ substantially in the different regulated product areas considered, with similar information needed to assess their safety in terms of identity, production process, compositional characterization, proposed/intended uses and exposure assessment, toxicological information, and allergenicity data. Additional nutritional information and data on the history of use are required in the case of novel foods.

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Section: Overview Of the Common Key Scientific Requirements For The S...mentioning

confidence: 99%

Section: Overview Of the Common Key Scientific Requirements For The S...mentioning

confidence: 99%

Novel foods, food enzymes, and food additives derived from food by-products of plant or animal origin: principles and overview of the EFSA safety assessment

Precup,

Marini,

Zakidou

et al. 2024

Front. Nutr.

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show abstract

“…The safety of betaine in human nutrition was evaluated by the Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA) in 2005, 2017 and 2019 (EFSA NDA Panel, 2005 , 2017 , 2019 ). Betaine was found to be not genotoxic on in vivo and in vitro tests.…”

Section: Assessmentmentioning

confidence: 99%

“…During both evaluations a NOAEL could not be derived from the study on chronic toxicity and carcinogenicity. Based on human intervention studies and information on highest reported mean intakes, which can sum up to 830 mg/day, an amount of 400 mg betaine per day (6 mg/kg body weight (bw) per day for adults) in addition to background exposure is considered safe by the NDA Panel (EFSA NDA Panel, 2017 , 2019 ).…”

Section: Assessmentmentioning

confidence: 99%

Safety and efficacy of a feed additive consisting of copper(II)‐betaine complex for all animal species (Biochem Zusatzstoffe Handels‐ und Produktionsges. mbH)

Bampidis¹,

Azimonti²,

Bastos³

et al. 2023

EFS2

Self Cite

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Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety and efficacy of a copper(II)‐betaine complex as nutritional feed additive for all animal species. Based on the results of a tolerance study carried out in chicken, the FEEDAP Panel concluded that the additive is safe for chickens for fattening when used up to the current maximum authorised levels of copper in feed; this conclusion was extrapolated to all animal species and categories at the respective maximum copper levels in complete feed authorised in the European Union. The FEEDAP Panel concluded that the use of the copper(II)‐betaine complex in animal nutrition at the maximum copper levels authorised for the animal species poses no concern to the safety of consumers. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals and land‐based aquaculture is considered safe under proposed conditions of use. The data available do not allow the conclusion to be made on the safety of the additive for marine sediment when it is used in sea cages. The additive is not a skin irritant, but it is an irritant to the eyes. Due to the traces of nickel, the additive is considered to be a respiratory and skin sensitiser. The Panel could not conclude on the efficacy of the product.

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Novel foods in the European Union: Scientific requirements and challenges of the risk assessment process by the European Food Safety Authority

Ververis

Ackerl

Azzollini

et al. 2020

Food Research International

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Safety of betaine as a novel food pursuant to Regulation (EU) 2015/2283

Cited by 6 publications

References 2 publications

Novel foods, food enzymes, and food additives derived from food by-products of plant or animal origin: principles and overview of the EFSA safety assessment

Novel foods, food enzymes, and food additives derived from food by-products of plant or animal origin: principles and overview of the EFSA safety assessment

Safety and efficacy of a feed additive consisting of copper(II)‐betaine complex for all animal species (Biochem Zusatzstoffe Handels‐ und Produktionsges. mbH)

Novel foods in the European Union: Scientific requirements and challenges of the risk assessment process by the European Food Safety Authority

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