Search

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 Acheta (A.) domesticus powder as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The main components of the NF are protein, fat and dietary fibre (chitin). The Panel notes that the concentration of contaminants in the NF depends on the occurrence levels of these substances in the insect feed. The Panel further notes that there are no safety concerns regarding the stability of the NF if the NF complies with the proposed specification limits during its entire shelf‐life. The NF has a high protein content, although the true protein content is overestimated when using the nitrogen‐to‐protein conversion factor of 6.25 due to the presence of non‐protein nitrogen from chitin. The applicant proposed to use the NF as food ingredient in a number of food products. The target population proposed by the applicant is the general population. Considering the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The panel notes that no safety concerns arise from the toxicological information of A. domesticus. The panel considers that the consumption of the NF might trigger primary sensitisation to A. domesticus proteins and may cause allergic reactions in subjects allergic to crustaceans, mites and molluscs. Additionally, allergens from the feed may end up in the NF. The panel concludes that the NF is safe under the proposed uses and use levels. [ABSTRACT FROM AUTHOR]

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 partially hydrolysed protein from spent barley (Hordeum vulgare) and rice (Oryza sativa) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is produced by enzymatically treating the pasteurised spent barley and rice residues of the mash step of beer production. Several mechanical treatment steps of the partial hydrolysate are employed to obtain the final product. The NF consists mainly of partially‐hydrolysed proteins from spent barley and rice and it is in powdered form. The Panel notes that there are no safety concerns regarding the stability of the NF if the NF complies with the proposed specification limits during its entire shelf life of 15 months. The NF is proposed to be used as an ingredient in various foods such as dairy products, bakery products, pasta, fruit and vegetable spreads, snacks, and single meal replacements for weight reduction. The target population is the general population. Considering protein quality aspects, the Panel concludes that the NF is not a suitable protein source for the nutrition of infants. The Panel notes that, considering the composition of the NF, the proposed conditions of use and that the NF will not be the sole source of dietary protein, the consumption of the NF is not nutritionally disadvantageous. Taking into account the production process, the extensive compositional characterisation of the NF and the history of use of the source the Panel considers that no toxicological studies are required on the NF. Moreover, the Panel considers that the NF has the potential capacity to sensitise individuals and to induce allergic reactions in individuals allergic to barley and rice. With the exception of possible allergenicity, the Panel concludes that the NF is safe under the proposed uses and use levels. [ABSTRACT FROM AUTHOR]

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 an ethanolic extract of the dried biomass of the microalga Phaeodactylum tricornutum as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is an ethanolic extract of the dried biomass of the microalga P. tricornutum diluted in a medium‐chain triglyceride oil carrier, with standardised fucoxanthin and tocopherol content. The main component of the NF is fat (78% on average), followed by crude protein (10% on average). The Panel is of the view that a consistent and safe production process has not been demonstrated. Additionally, the Panel considers that the information provided on the composition of the NF is not complete and may raise safety concerns. The applicant proposed to use the NF as a food supplement at the use level of 437 mg/day, with the target population being adults, excluding pregnant and breastfeeding women. There is no history of use of the NF or of its source, i.e. P. tricornutum. The Panel notes that the source of the NF, P. tricornutum, was not granted the qualified presumption of safety (QPS) status by the EFSA Panel on Biological Hazards (BIOHAZ), due to the lack of a safe history of use in the food chain and on its potential for production of bioactive compounds with toxic effects. There were no concerns regarding genotoxicity of the NF. In the 90‐day study provided, a number of adverse effects were observed, some of them seen already at the lowest dose tested (750 mg/kg body weight (bw) day), which was identified by the Panel as the lowest‐observed‐adverse‐effect‐level (LOAEL). The potential phototoxicity of pheophorbide A and pyropheophorbide A in the NF was not addressed in this study. Although noting the uncertainties identified by the Panel regarding the analytical determination of these substances in the NF and the limitations in the publicly available toxicity data, a low margin of exposure (MoE) was calculated for these substances at the proposed use levels. The Panel concludes that the safety of the NF under the proposed uses and use levels has not been established. [ABSTRACT FROM AUTHOR]

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 UV‐treated powder of whole yellow mealworm (Tenebrio molitor larva) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The term yellow mealworm refers to the larval form of the insect species T. molitor. The NF is the UV‐treated powder of the whole, thermally dried yellow mealworm. The NF consists mainly of crude protein, fat, digestible carbohydrates and fibre (chitin). The Panel notes that the levels of contaminants in the NF highly depend on the occurrence levels of these substances in the insect feed. The Panel notes furthermore that there are no safety concerns regarding the stability of the NF if the NF complies with the proposed specification limits during its entire shelf life. The NF has a high protein content, although the true protein content in the NF is overestimated when using the nitrogen‐to‐protein conversion factor of 6.25, due to the presence of non‐protein nitrogen. The applicant proposed to use the NF as an ingredient in various food products, such as bakery products, pasta, compotes of fruit/vegetables and cheese. The target population is the general population. The Panel notes that considering the composition of the NF, the proposed conditions of use and that the NF will not be the sole source of dietary protein, the consumption of the NF is not nutritionally disadvantageous. Despite the UV treatment, the Panel notes that the NF is not a significant dietary contributor of vitamin D3. The submitted toxicity studies from the literature did not raise safety concerns. The Panel considers that the consumption of the NF may induce primary sensitisation and allergic reactions to yellow mealworm proteins and may cause allergic reactions in subjects with allergies to crustaceans and dust mites. Additionally, allergens from the feed may end up in the NF. With the exception of possible allergenicity, the Panel concludes that the NF is safe under the proposed uses and use levels. [ABSTRACT FROM AUTHOR]

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 frozen and dried formulations from whole yellow mealworm (Tenebrio molitor larva) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The term yellow mealworm refers to the larval form of the insect species Tenebrio molitor. The NF comprises the frozen and freeze‐dried formulations of the yellow mealworm, whole or in the form of powder. The frozen formulation consists mainly of water, crude protein and fat whereas the freeze‐dried formulations of crude protein, fat, digestible carbohydrates and fibre (chitin). The Panel notes that the levels of contaminants in the NF depend on the occurrence levels of these substances in the insect feed. The Panel notes furthermore that there are no safety concerns regarding the stability of the NF if the NF complies with the proposed specification limits during its entire shelf‐life. The dried formulations of the NF have a high protein content, although the true protein levels in the NF are overestimated when using the nitrogen‐to‐protein conversion factor of 6.25, due to the presence of non‐protein nitrogen from chitin. The applicant proposed to use the NF as whole frozen or whole dried insect, or in the form of powder, added as an ingredient to various food products such as cereal bars, pasta, meat imitates and bakery products. The target population is the general population. The Panel notes that, considering that the NF will not be the sole source of dietary protein, and the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The submitted toxicity studies from the literature did not raise safety concerns. The Panel considers that the consumption of the NF may induce primary sensitisation and allergic reactions to yellow mealworm proteins and may cause allergic reactions in subjects with allergy to crustaceans and dust mites. Additionally, allergens from the feed may end up in the NF. The Panel concludes that the NF is safe under the proposed uses and use levels. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Food and Food Allergens (NDA) was asked to deliver an opinion on the safety of frozen and dried formulations from house crickets (Acheta domesticus) as a novel food pursuant to Regulation (EU) 2015/2283. The NF is proposed in three formulations: (i) frozen, (ii) dried, (iii) ground. The main components of the NF are protein, fat and fibre (chitin) in the dried form of the NF, and water, protein, fat and fibre (chitin) in the frozen form of the NF. The Panel notes that the concentrations of contaminants in the NF depend on the occurrence levels of these substances in the insect feed. The Panel further notes that there are no safety concerns regarding the stability of the NF if the NF complies with the proposed specification limits during its entire shelf‐life. The NF has a high‐protein content, although the true protein levels in the NF are overestimated when using the nitrogen‐to‐protein conversion factor of 6.25, due to the presence of non‐protein nitrogen from chitin. The applicant proposed to use the NF in the form of a snack, and as a food ingredient in a number of food products. The target population proposed by the applicant is the general population. The Panel notes that, considering the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The Panel notes that no genotoxicity and no subchronic toxicity studies with the NF were provided by the applicant. Considering that no safety concerns arise from the history of use of A. domesticus or from the compositional data of the NF, the Panel identified no other safety concerns than allergenicity. The Panel considers that the consumption of the NF might trigger primary sensitisation to A. domesticus proteins and may cause allergic reactions in subjects allergic to crustaceans, mites and molluscs. Additionally, allergens from the feed may end up in the NF. The Panel concludes that the NF is safe under the proposed uses and use levels. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Nutrition, Novel Food and Food Allergens (NDA) was asked to deliver an opinion on the safety of frozen and dried formulations from migratory locust (Locusta migratoria) as a novel food pursuant to Regulation (EU) 2015/2283. The term migratory locust refers to the adult of the insect species Locusta migratoria. The NF is proposed in three formulations i) frozen without legs and wings; ii) dried without legs and wings; iii) ground with legs and wings. The main components of the NF are protein, fat and fibre (chitin) in the dried form of the NF, and water, protein, fat and fibre (chitin) in the frozen form of the NF. The Panel notes that the concentration of contaminants in the NF depends on the occurrence levels of these substances in the insect feed. The Panel notes that there are no safety concerns regarding the stability of the NF if the NF complies with the proposed specification limits during its entire shelf-life. The NF has a high protein content, although the true protein levels in the NF are overestimated when using the nitrogen-to-protein conversion factor of 6.25, due to the presence of non-protein nitrogen from chitin. The applicant proposed to use the NF as frozen, dried and ground in the form of snack, and as a food ingredient in a number of food products. The target population proposed by the applicant is the general population. The Panel notes that considering the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The submitted history of use and toxicity studies from literature did not raise safety concerns. The Panel considers that the consumption of the NF might trigger primary sensitisation to L. migratoria proteins and may cause allergic reactions in subjects with allergy to crustaceans, mites and molluscs. Additionally, allergens from the feed may end up in the NF. The Panel concludes that the NF is safe under the proposed uses and use levels. [ABSTRACT FROM AUTHOR]

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 dried yellow mealworm (Tenebrio molitor larva) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The term yellow mealworm refers to the larval form of the insect species Tenebrio molitor . The NF is the thermally dried yellow mealworm, either as whole dried insect or in the form of powder. The main components of the NF are protein, fat and fibre (chitin). The Panel notes that the levels of contaminants in the NF depend on the occurrence levels of these substances in the insect feed. The Panel notes that there are no safety concerns regarding the stability of the NF if the NF complies with the proposed specification limits during its entire shelf life. The NF has a high protein content, although the true protein levels in the NF are overestimated when using the nitrogen-to-protein conversion factor of 6.25, due to the presence of non-protein nitrogen from chitin. The applicant proposed to use the NF as whole, dried insect in the form of snacks, and as a food ingredient in a number of food products. The target population proposed by the applicant is the general population. The Panel notes that considering the composition of the NF and the proposed conditions of use, the consumption of the NF is not nutritionally disadvantageous. The submitted toxicity studies from the literature did not raise safety concerns. The Panel considers that the consumption of the NF may induce primary sensitisation and allergic reactions to yellow mealworm proteins and may cause allergic reactions in subjects with allergy to crustaceans and dust mites. Additionally, allergens from the feed may end up in the NF. The Panel concludes that the NF is safe under the proposed uses and use levels. [ABSTRACT FROM AUTHOR]

In 2007, the EFSA NDA Panel concluded that Allanblackia seed oil obtained from the seeds of Allanblackia trees is safe for human consumption under the proposed conditions of use. Due to its high contents of stearic-oleic-stearic and stearic-oleic-oleic triglycerides, which made the oil suitable as a 'hardstock' component, the applicant applied for its use as a novel food (NF) ingredient in yellow fat and cream-based spreads at a level of 20% (w/w). In this application, the applicant seeks (1) to increase the authorised maximum use level (i.e. 20% w/w) in yellow fat spreads and cream-based spreads to 30% (w/w) and (2) the use of this NF in mixes of vegetable oils and milk up to a maximum use level of 30% (w/w). (3) The applicant proposes also some changes in the specifications of the NF, although he noted that the oil is collected, extracted and refined using the same processes that are currently used for other edible vegetable oils and which have been evaluated in the original application assed by EFSA in 2007. According to the information provided by the applicant, the production process and the composition of the NF do not change. The Panel notes that the revised specification limits on trans-fatty acid (TFA), unsaponifiable matter, peroxide value are similar to those for other edible oils and fats. The applicant also indicated that he had performed an updated comprehensive literature search using several different databases, but no preclinical studies or human studies on Allanblackia seed oil were identified which have not been provided for the previous EFSA assessment in 2007. The Panel notes that the proposed extended uses would increase the potential intake of the NF, which is considered not to be nutritionally disadvantageous. The Panel concludes that Allanblackia seed oil is safe at the extended uses and use level. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to revise the tolerable upper intake level (UL) for vitamin D for infants (≤ 1 year) set in 2012. From its literature review, the Panel concluded that the available evidence on daily vitamin D intake and the risk of adverse health outcomes (hypercalciuria, hypercalcaemia, nephrocalcinosis and abnormal growth patterns) cannot be used alone for deriving the UL for infants. The Panel conducted a meta-regression analysis of collected data, to derive a dose-response relationship between daily supplemental intake of vitamin D and mean achieved serum 25(OH)D concentrations. Considering that a serum 25(OH)D concentration of 200 nmol/L or below is unlikely to pose a risk of adverse health outcomes in infants, the Panel estimated the percentage of infants reaching a concentration above this value at different intakes of vitamin D. Based on the overall evidence, the Panel kept the UL of 25 μg/day for infants aged up to 6 months and set a UL of 35 lg/day for infants 6-12 months. The Panel was also asked to advise on the safety of the consumption of infant formulae with an increased maximum vitamin D content of 3 μg/100 kcal (Commission Delegated Regulation (EU) 2016/127 repealing Directive 2006/141/EC in 2020). For infants aged up to 4 months, the intake assessment showed that the use of infant formulae containing vitamin D at 3 μg/100 kcal may lead some infants to receive an intake above the UL of 25 lg/day from formulae alone without considering vitamin D supplemental intake. For infants aged 4-12 months, the 95th percentile of vitamin D intake (high consumers) estimated from formulae and foods fortified or not with vitamin D does not exceed the ULs, without considering vitamin D supplemental intake. [ABSTRACT FROM AUTHOR]

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 egg membrane hydrolysate as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is a water-soluble hydrolysate of egg membrane, produced by alkaline treatment of the thin layer lining the shells of chicken eggs. The main constituents of the NF are elastin, collagen and glycosaminoglycans. The information provided on the production process, batch-to-batch variability, composition and specifications of the NF is sufficient and does not raise safety concerns. The NF is proposed to be used as a food supplement for adults, at a maximum daily amount of 450 mg. The consumption of the NF is not nutritionally disadvantageous. One human study, which was not designed for safety but included a number of endpoints pertaining to safety, did not raise safety concerns. The Panel considers that taking into account the information provided and considering the nature, the source and the production process of the NF, there are no safety concerns for the NF at the proposed conditions of use. The Panel concludes that the NF, egg membrane hydrolysate, is safe as a food supplement at a dose of 450 mg/day. The target population for the NF is the general adult population. [ABSTRACT FROM AUTHOR]

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 a mixture of xylo-oligosaccharides (XOS) as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The NF is obtained from corncobs (Zea mays subsp. mays) via enzyme-catalysed hydrolysis and subsequent purification. The main components of the NF, the oligosaccharides, are resistant to human digestive enzymes and are fermented by colonic bacteria. The intention is to add the NF to a variety of foods such as bakery and dairy products, fruit jelly, chocolates and soy-drinks. The information provided on composition, specifications, production process and stability of the NF, does not raise safety concerns. There were effects observed in the animal studies with the NF or with other XOS which were considered by the Panel to be expected from the intake of non-digestible carbohydrates. The Panel notes that the acute and transient gastrointestinal observed in human intervention studies with the NF or with other XOS have also been associated with the consumption of other non-digestible carbohydrates. The Panel concludes that the NF, a mixture of XOS, is safe under the proposed uses and use levels. The target population is the general population. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to update its scientific opinion on the safety of EstroG-100™ as a novel food (NF) in the light of additional information submitted by the applicant. In its previous scientific opinion of 2016, the Panel concluded that EstroG-100™, which is a hot-water extract of a mixture of three herbal roots, is safe for the use in food supplements at the maximum intake level of 175 mg/day in post-menopausal women, which is lower than the maximum intake level proposed by the applicant (514 mg/day). The Panel reached its conclusions based on the effects of EstroG-100™ on liver and haematology as observed in several oral toxicity studies, the lack of information on liver and haematological parameters in human studies and the absence of chronic toxicity data. In view of the Panel's conclusion on the safety of EstroG-100™, the applicant has now provided additional information on haematological and liver parameters for the human intervention study with EstroG-100™ and historical control data related to the subchronic 90-day oral toxicity study with EstroG-100™. After assessing the additional information provided by the applicant, the Panel considers that the conclusion of the scientific opinion on the safety of EstroG-100™ does not need to be revised, and thus, the Panel reconfirms that the NF is safe for the use in food supplements at the maximum intake level of 175 mg/day in post-menopausal women. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on 'cranberry extract powder' as a novel food (NF) submitted pursuant to Regulation (EC) No 258/97 of the European Parliament and of the Council. The NF contains about 55-60% proanthocyanidins (PACs). The Panel considers that the information provided on the composition, the specifications, batch-to-batch variability and stability of the NF is sufficient and does not raise safety concerns. Cranberry extract powder is produced from cranberry juice concentrate through an ethanolic extraction using an adsorptive resin column to retain the phenolic components. The Panel considers that the production process is sufficiently described and does not raise concerns about the safety of the novel food. The NF is intended to be added to beverages and yogurts to provide 80 mg PACs per serving. The target population is the adult general population. The mean and 95th percentile estimates for the all-user intakes from all proposed fooduses are 68 and 192 mg/day, respectively, for female adults, and 74 mg/day and 219 mg/day, respectively, for male adults. Taking into account the composition of the novel food and the intended use levels, the Panel considers that the consumption of the NF is not nutritionally disadvantageous. While no animal toxicological studies have been conducted on the NF, a number of human clinical studies have been conducted with cranberry products. Considering the composition, manufacturing process, intake, history of consumption of the source and human data, the Panel considers that the data provided do not give reasons for safety concerns. The Panel concludes that the cranberry extract powder is safe as a food ingredient at the proposed uses and use levels. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to provide scientific and technical guidance for the preparation and presentation of applications for authorisation of 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 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 specific applications for authorisation, and in the light of future Community guidelines and legislation. The NDA Panel endorsed a draft of this scientific opinion on 14 December 2016 for public consultation. The draft document has been revised and updated according to the comments received, where appropriate. [ABSTRACT FROM AUTHOR]

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 develop a scientific and technical guidance for the preparation and presentation of notifications for traditional foods from third countries. This guidance presents a common format for the organisation of the information to be presented in order to assist the applicant in 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. Besides, its normal consumption should not be nutritionally disadvantageous. To that end, information is requested on the description, production process, composition, stability data, specifications, data from experience of continued use in a third country and on the proposed conditions of use of the traditional food for the EU market. The structure of the notification dossier should follow the sections presented in this guidance. 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 application should be comprehensive and complete. 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 synthetic l-ergothioneine, marketed as Ergoneine®, as a novel food submitted pursuant to Regulation ( EC) No 258/97 of the European Parliament and of the Council. The novel food, synthetic l-ergothioneine, is produced by a one-pot patented manufacturing process. Chemically, l-ergothioneine is a derivative of thiolhistidine, and it is naturally present in a number of foodstuffs such as mushrooms, some varieties of black and red beans, offal and cereals. The production process for the novel food is sufficiently described and does not raise concerns about the safety of the novel food. The information on the composition, specifications, batch-to-batch variability and stability of the novel food is sufficient and does not raise safety concerns. The applicant intends to use the novel food in quantities of up to 5 mg per serving in alcohol-free beverages, cereal bars, milk, fresh dairy products and chocolate. The applicant also proposes to provide the novel food as a food supplement, with a daily dose of up to 30 mg/day for adults and 20 mg/day for children. The target population is children above 3 years of age and the general adult population, except pregnant and breastfeeding women. Considering the NOAEL of 800 mg/kg bw per day, which was based on two subchronic toxicity studies in rats, and the maximum estimated intake levels for l-ergothioneine from all sources, the Panel concludes that the margins of safety of 470 for adults (except pregnant and breastfeeding women) and of 216 for children above 3 years of age are sufficient. The Panel concludes that the novel food, synthetic l-ergothioneine (marketed as Ergoneine®), is safe under the intended conditions of use as specified by the applicant. [ABSTRACT FROM AUTHOR]

Piperine is a natural ingredient of Piper nigrum (black pepper) and some other Piper species. Compared to the use of pepper for food seasoning, piperine is used in food supplements in an isolated, concentrated form and ingested as a bolus. The present review focuses on the assessment of the possible critical health effects regarding the use of isolated piperine as a single ingredient in food supplements. In human and animal studies with single or short-term bolus application of isolated piperine, interactions with several drugs, in most cases resulting in increased drug bioavailability, were observed. Depending on the drug and extent of the interaction, such interactions may carry the risk of unintended deleteriously increased or adverse drug effects. Animal studies with higher daily piperine bolus doses than in human interaction studies provide indications of disturbance of spermatogenesis and of maternal reproductive and embryotoxic effects. Although the available human studies rarely reported effects that were regarded as being adverse, their suitability for detailed risk assessment is limited due to an insufficient focus on safety parameters apart from drug interactions, as well as due to the lack of investigation of the potentially adverse effects observed in animal studies and/or combined administration of piperine with other substances. Taken together, it appears advisable to consider the potential health risks related to intake of isolated piperine in bolus form, e.g., when using certain food supplements. [ABSTRACT FROM AUTHOR]

Following an application from Essential Sterolin Products (Pty) Ltd., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of the Netherlands, the European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods and Food Allergens (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to a combination of beta‐sitosterol and beta‐sitosterol glucoside and normal function of the immune system. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is a combination of beta‐sitosterol and beta‐sitosterol glucoside in a ratio 100:1. The Panel considers that a combination of beta‐sitosterol and beta‐sitosterol glucoside in a ratio 100:1 is sufficiently characterised. The claimed effect proposed by the applicant is 'normal function of the immune system by restoring balance between TH1‐TH2 mediated immunity'. The Panel notes that the claimed effect 'normal function of the immune system by restoring balance between TH1‐ and TH2‐mediated immunity' does not refer to a specific function of the body which can be assessed in vivo in humans by generally accepted methods, but rather to a mechanism of action by which the food/constituent could exert the claimed effect. The Panel considers that the claimed effect does not refer to any specific health claim as required by Regulation (EC) No 1924/2006. The Panel concludes that a cause and effect relationship cannot be established between the consumption of a combination of beta‐sitosterol and beta‐sitosterol glucoside in a ratio 100:1 and a beneficial physiological effect. [ABSTRACT FROM AUTHOR]

The EFSA Scientific Committee addressed in this document the peculiarities related to the genotoxicity assessment of chemical mixtures. The EFSA Scientific Committee suggests that first a mixture should be chemically characterised as far as possible. Although the characterisation of mixtures is relevant also for other toxicity aspects, it is particularly significant for the assessment of genotoxicity. If a mixture contains one or more chemical substances that are individually assessed to be genotoxic in vivo via a relevant route of administration, the mixture raises concern for genotoxicity. If a fully chemically defined mixture does not contain genotoxic chemical substances, the mixture is of no concern with respect to genotoxicity. If a mixture contains a fraction of chemical substances that have not been chemically identified, experimental testing of the unidentified fraction should be considered as the first option or, if this is not feasible, testing of the whole mixture should be undertaken. If testing of these fraction(s) or of the whole mixture in an adequately performed set of in vitro assays provides clearly negative results, the mixture does not raise concern for genotoxicity. If in vitro testing provides one or more positive results, an in vivo follow‐up study should be considered. For negative results in the in vivo follow‐up test(s), the possible limitations of in vivo testing should be weighed in an uncertainty analysis before reaching a conclusion of no concern with respect to genotoxicity. For positive results in the in vivo follow‐up test(s), it can be concluded that the mixture does raise a concern about genotoxicity. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2019.EN-1539/full [ABSTRACT FROM AUTHOR]