Guidance on the preparation and submission of an application for authorisation of a novel food in the context of Regulation (EU) 2015/2283 (Revision 1)2.

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

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

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

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

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

Assessing Diet Quality of Indigenous Food Systems in Three Geographically Distinct Solomon Islands Sites (Melanesia, Pacific Islands).

Indigenous Solomon Islanders, like many living in Pacific Small Island Developing States (PSIDS), are currently experiencing the global syndemic-the combined threat of obesity, undernutrition, and climate change. This mixed-method study aimed to assess nutrition transitions and diet quality by comparing three geographically unique rural and urban indigenous Solomon Islands populations. Participants in rural areas sourced more energy from wild and cultivated foods; consumed a wider diversity of foods; were more likely to meet WHO recommendations of >400g of non-starchy fruits and vegetables daily; were more physically active; and had significantly lower body fat, waist circumference, and body mass index (BMI) when compared to urban populations. Urban populations were found to have a reduced ability to self-cultivate agri-food products or collect wild foods, and therefore consumed more ultra-processed foods (classified as NOVA 4) and takeout foods, and overall had less diverse diets compared to rural populations. Clear opportunities to leverage traditional knowledge and improve the cultivation and consumption of underutilized species can assist in building more sustainable and resilient food systems while ensuring that indigenous knowledge and cultural preferences are respected.

Are Households in Kiribati Nutrition Secure? A Case Study of South Tarawa and Butaritari.

BACKGROUND AND OBJECTIVES: This study assessed the nutritional status among householders in urban South Tarawa and rural Butaritari in Kiribati. METHODS AND STUDY DESIGN: In this cross-sectional study, we assessed energy and nutrient intakes, food variety scores, and dietary diversity scores of men and women from 468 households randomly selected in South Tarawa (n = 161) and Butaritari (n = 307) using a 24-hour dietary recall. Nutrient adequacy ratios and mean adequacy ratios of selected nutrients were also determined from 3-day weighed food records collected among participants living in a further 28 households from South Tarawa (n = 29) and Butaritari (n = 44). RESULTS: Based on the 24-hour dietary recall, the average energy intake for men and women was 2536 kcals and 2068 kcals, respectively. Carbohydrate (CHO), fat, and protein intakes for men and women were 332.5 g, 76.5 g, and 130.4 g and 291.7 g, 55.1 g, and 103.5 g, respectively. The mean and standard deviation of household Food Variety Score and Dietary Diversity Score was 3.90 ± 1.25 and 5.44 ± 1.92, respectively. Intakes of vitamin A, calcium, and iron, and zinc were notably deficient in both locations, with the urban participants having lower intakes of vitamin B-1, vitamin B-2, magnesium, and potassium than their rural counterparts. Mean sodium intakes exceeded recommendations for all age groups in South Tarawa except children aged 4 to 6 years. CONCLUSIONS: Food consumption patterns of the households in South Tarawa and Butaritari reflected high consumption of nontraditional diets and refined foods, which manifested in inadequate micronutrient intake estimates and low dietary diversity: strong risk factors for noncommunicable diseases such as obesity and diabetes.

Goals in Nutrition Science 2020-2025.

Five years ago, with the editorial board of Frontiers in Nutrition, we took a leap of faith to outline the Goals for Nutrition Science - the way we see it (1). Now, in 2020, we can put ourselves to the test and take a look back. Without a doubt we got it right with several of the key directions. To name a few, Sustainable Development Goals (SDGs) for Food and Nutrition are part of the global public agenda, and the SDGs contribute to the structuring of international science and research. Nutritional Science has become a critical element in strengthening work on the SDGs, and the development of appropriate methodologies is built on the groundwork of acquiring and analyzing big datasets. Investigation of the Human Microbiome is providing novel insight on the interrelationship between nutrition, the immune system and disease. Finally, with an advanced definition of the gut-brain-axis we are getting a glimpse into the potential for Nutrition and Brain Health. Various milestones have been achieved, and any look into the future will have to consider the lessons learned from Covid-19 and the sobering awareness about the frailty of our food systems in ensuring global food security. With a view into the coming 5 years from 2020 to 2025, the editorial board has taken a slightly different approach as compared to the previous Goals article. A mind map has been created to outline the key topics in nutrition science. Not surprisingly, when looking ahead, the majority of scientific investigation required will be in the areas of health and sustainability. Johannes le Coutre, Field Chief Editor, Frontiers in Nutrition.

New Zealand's Food System Is Unsustainable: A Survey of the Divergent Attitudes of Agriculture, Environment, and Health Sector Professionals Towards Eating Guidelines.

Background: The Food and Agriculture Organisation has called for sustainable diets, which align with SDG 2, Zero Hunger, and SDG 12, Sustainable Consumption and Production. The inclusion of sustainability characteristics in New Zealand's (NZ) eating and activity guidelines (EAGs) may lead to achieving sustainable diets. This study aimed to evaluate the agreement among sectoral professionals of including sustainability characteristics within the guidelines. Methods: Agriculture, environment, and health sector professionals were invited to complete an online survey to establish agreement with sustainability characteristics and sustainability statements. Opinion and attitude questions were completed using a 5-item Likert scale. One-way ANOVA analyses were conducted to compare the level of agreement and differences in means of the sector levels of agreement whilst controlling for covariates. Post-hoc tests were used to determine sectoral differences. Results: Overall, 298 (65% female) respondents completed the survey from the agriculture (37%), environment (22%), and health (41%) sectors. Two-thirds (66%) of respondents were over 35 years and 90% had a tertiary education. Two-thirds (63%) of respondents disagreed that NZ's current food system is sustainable; health (77%) and environment (78%) sector respondents had greater disagreement than those from agriculture (35%; P = 0.00). Overall, 77% of respondents agreed that sustainability characteristics should be included in guidelines; health (90%) and environment (84%) sector respondents had greater agreement than from agriculture (58%; P = 0.00). Five sustainability characteristics received high levels of agreement (>90%) for inclusion: dietary diversity, sustainable seafood, limit processed foods, reduced food waste, and sustainable lifestyle behaviours. Agreement for eight sustainability characteristics was highest among the health and environment sectors vs. the agricultural sector (P < 0.05). A relatively low level of agreement was received from all three sectors, particularly the environmental sector (68.7%), towards the characteristic "to consume recommended serves of dairy products." Only 38.5% of all respondents agreed with the inclusion of "organic food produce." Negative associations were observed between respondents' opinions regarding the sustainability of NZ's current food system and familiarity with the EAGs. Conclusion: Professionals from the agriculture, environment, and health sectors largely support the inclusion of sustainability characteristics in NZ's EAGs. A multi-sectoral approach will be required to address areas of divergence.

Review of Methodologies for Assessing Sustainable Diets and Potential for Development of Harmonised Indicators.

The underlying values and priorities that drive policy responses depend largely on the constructs that researchers and decision makers select to measure and the metrics used. Despite much recent attention being given to sustainable diets and food systems and to the importance of clearly measuring sustainability to meet targets, to achieve goals, and to appraise dietary and environmental policies, it is not commonly agreed how the different indicators of sustainable diets are assessed. The evidence base for assessment of these indicators are frequently weak, fragmented, and arbitrary. The aim of this paper was to compare a range of published methods and indicators for assessing sustainable diets and food systems in order to harmonise them. Keyword and reference searches were performed in PubMed, Scopus, CAB Abstracts, and Web of Knowledge. Fifty-two studies (21 proposed methods and 31 used methods) that combined environment, nutrition and health, and socioeconomic aspects of sustainable diets were reviewed. The majority (over 90%) of the studies focused on high-income countries. Twenty-eight studies assessed the environmental effects of different dietary practices, eight of the studies examined the nutrition and health indicators used for assessing sustainable food systems, and seven studies assessed the social and economic costs of diets. A classification of the elements was developed, and common elements are proposed for standardizing. These elements were categorized into nutrition and health indicators, environment indicators, and socioeconomic indicators. Standardized or harmonized indicators can be used for consistency and applicability purposes and to support, implement, and monitor relevant policies.

Quantitative estimates of dietary intake in households of South Tarawa, Kiribati.

BACKGROUND AND OBJECTIVES: Malnutrition is a public health problem especially among the Pacific Small Island developing nations. This study assessed malnutrition with dietary intakes in households of South Tarawa, Kiribati, a West Pacific Island Nation State. METHODS AND STUDY DESIGN: A cross-sectional community-based study design was used. One hundred and sixty-one households were selected from Betio, Bikenibeu and Teaorereke towns using a systematic random sampling method. About 35% each of the households was selected from Bikenebue and Besio while 30.4% was selected from Teaoraeke. Family (including children) dietary surveys including 24- hour dietary recall were administered to assess adequacy of nutrient intakes and dietary diversity using Household Diet Diversity Scores. A 3-day weighed food record was collected on a sub-sample. Data were analysed using FoodWorks Pro 8 for nutrient intake and Statistical Product for Service Solution (SPSS) version 21 for descriptive statistics. RESULTS: Sixty-one percent of the subjects had the lowest dietary diversity, 36.3% had a medium dietary diversity and only 2.7% had the highest dietary diversity. Based on the weighed food record results (n=29), male subjects of all age groups had adequate intakes of riboflavin, niacin, vitamin C, magnesium, iron and zinc, but had high intakes of protein and sodium; and low intakes of potassium and calcium. Female subjects had adequate intakes of vitamin C, iron, magnesium and zinc, but had high intakes of protein and sodium; and low intakes of potassium and calcium. CONCLUSIONS: Across all groups, 61% of the adult Kiribati population studied showed low dietary diversity, and a high prevalence of multiple micronutrient deficiencies.

Guidance for the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health: (Revision 1).

EFSA asked the Panel on Dietetic Products, Nutrition and Allergies (NDA) to update the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health published in 2011. The update takes into accounts experiences gained with evaluation of additional health claim applications related to antioxidants, oxidative damage and cardiovascular health, and the information collected from a Grant launched in 2014. This guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to the antioxidants, oxidative damage and cardiovascular health. The document was subject to public consultation (from 12 July to 3 September 2017). This document supersedes the guidance on the scientific requirements for health claims related to antioxidants, oxidative damage and cardiovascular health published in 2011. It is intended that the guidance will be further updated as appropriate in the light of experience gained from the evaluation of health claims.

L-carnitine and contribution to normal lipid metabolism: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006.

Following an application from Lonza Ltd., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to L-carnitine and normal lipid metabolism. The food that is proposed as the subject of the health claim is L-carnitine. The Panel considers that L-carnitine is sufficiently characterised. The claimed effect proposed by the applicant is 'normal lipid metabolism'. The target population proposed by the applicant is the general population. The Panel considers that contribution to normal lipid metabolism is a beneficial physiological effect. The applicant proposes that the claim submitted with this application is based on the essentiality of a nutrient. The Panel considers that the evidence provided does not establish that dietary L-carnitine is required to maintain normal lipid metabolism in the target population, for which the claim is intended. The Panel concludes that a cause and effect relationship has not been established between the consumption of L-carnitine and contribution to normal lipid metabolism in the target population.

Black tea and maintenance of normal endothelium-dependent vasodilation: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006.

Following an application from Unilever NV, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to black tea and maintenance of normal endothelium-dependent vasodilation. 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 black tea beverages, either freshly prepared or reconstituted from water extract powders of black tea, characterised by the content of flavanols (expressed as catechins plus theaflavins) of at least 30 mg per 200 mL serving. The Panel considers that black tea characterised by the content of flavanols (expressed as catechins plus theaflavins) is sufficiently characterised. The claimed effect proposed by the applicant is 'improvement of endothelium-dependent vasodilation'. The Panel considers that maintenance of normal endothelium-dependent vasodilation is a beneficial physiological effect. Of the five human intervention studies provided on the chronic effect of black tea consumption on endothelium-dependent vasodilation, two investigated the effect after regular consumption of black tea for a sufficiently long time period (i.e. at least 4 weeks). These two studies did not allow an effect of black tea on endothelium-dependent vasodilation to be established. The Panel concludes that a cause and effect relationship has not been established between the consumption of black tea and maintenance of normal endothelium-dependent vasodilation.

NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk and reduction of the loss of vision: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006.

Following an application from Newtricious R&D B.V., 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 EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to NWT-02 and a reduction of the loss of vision. The food proposed by the applicant as the subject of the health claim is NWT-02. NWT-02 is standardised by its content in lutein (≥ 1.10 mg), zeaxanthin (≥ 0.20 mg) and docosahexaenoic acid (DHA) (≥ 170 mg). The Panel considers that the food/constituent that is the subject of the health claim, NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, is sufficiently characterised. The claimed effect proposed by the applicant is 'reduces loss of vision'. The target population proposed by the applicant is 'healthy adults over 50 years of age'. The Panel considers that a reduction of the loss of vision is a beneficial physiological effect. The applicant provided two human intervention studies for the scientific substantiation of the claim. The Panel considers that the only study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of NWT-02 on vision. The Panel concludes that a cause and effect relationship has not been established between the consumption of NWT-02, a fixed combination of lutein, zeaxanthin and docosahexaenoic acid in egg yolk, and a reduction of the loss of vision.

Guidance on the scientific requirements for health claims related to muscle function and physical performance: (Revision 1).

EFSA has asked the Panel on Nutrition, Novel Foods and Food Allergens (NDA) to update the guidance on the scientific requirements for health claims related to physical performance published in 2012. The update takes into account the experience gained by the NDA Panel with the evaluation of additional health claim applications, changes introduced to the general scientific guidance for stakeholders for health claims applications and information collected from a grant launched in 2014 which aimed at gathering information in relation to claimed effects, outcome variables and methods of measurement in the context of the scientific substantiation of health claims. The guidance is intended to assist applicants in preparing applications for the authorisation of health claims related to muscle function and physical performance. The draft guidance was subject to public consultation from 16 July to 2 September 2018. This document supersedes the guidance on the scientific requirements for health claims related to physical performance published in 2012. It is intended that the guidance will be further updated as appropriate in the light of experience gained from the evaluation of health claims.

Carbohydrate solutions and contribute to the improvement of physical performance during a high-intensity and long-lasting physical exercise: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006.

Following an application from Specialised Nutrition Europe (SNE), submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to carbohydrate solutions and contribute to the improvement of physical performance during a high-intensity and long-lasting physical exercise. 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 carbohydrate solutions containing glucose, mixtures of glucose and fructose, sucrose and/or maltodextrins. The Panel considers that carbohydrate solutions are sufficiently characterised in relation to the claimed effect. The claimed effect proposed by the applicant is 'contribute to the improvement of physical performance during a high-intensity and long-lasting physical exercise', which is considered by the Panel as a beneficial physiological effect. The Panel concludes that a cause and effect relationship has been established between the consumption of carbohydrate solutions and the improvement of physical performance during high-intensity and long-lasting physical exercise. The target population is healthy trained adults performing high-intensity (at least at 65% of the VO 2max) and long-lasting (at least 60 min) physical exercise.

Xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006.

Following an application from TA-XAN AG, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to xanthohumol in XERME ®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage. 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 xanthohumol in XERME ®, a xanthohumol-enriched roasted malt extract. The Panel considers that xanthohumol in XERME ®, a xanthohumol-enriched roasted malt extract, is sufficiently characterised. The claimed effect proposed by the applicant is 'helps to maintain the integrity of DNA and protects against oxidative damage in the cells of the body'. The Panel considers that protection of DNA from oxidative damage is a beneficial physiological effect. The only human study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of xanthohumol in XERME ® on the protection of DNA from oxidative damage. In the absence of evidence for an effect of xanthohumol in XERME ® on the protection of DNA from oxidative damage, the studies provided by the applicant on the proposed mechanisms by which the food/constituent could exert the claimed effect were not considered by the Panel for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of xanthohumol in XERME ®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage.

Safety of d-ribose as a novel food pursuant to Regulation (EU) 2015/2283.

Following a request from the European Commission, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on D-ribose as a novel food (NF) pursuant to Regulation (EU) 2015/2283. The applicant intends to market the NF as ingredient in a variety of foods, food supplements and in certain foods for specific groups. The NF is produced by fermentation using a transketolase-deficient strain of Bacillus subtilis and marketed as Bioenergy Ribose™. The information provided on the batch-to-batch variability, specifications, stability, production process and history of the organism used as a source of the NF is sufficient and does not raise safety concerns. The Panel considers that the effects observed in a subchronic toxicity study in rats could be the consequence of nutritional imbalances, but toxicological effects could not be ruled out; from this study, the Panel derived a No observed adverse effect level (NOAEL) of 3.6 g/kg body weight (bw) per day. From the human studies indicating a potential decrease in glucose levels and/or the occurrence of transient symptomatic hypoglycaemia at intakes of 10 g of d-ribose, the Panel defined 70 mg/kg bw per day as the NOAEL with respect to hypoglycaemia that can be considered applicable for adults. For children, the Panel acknowledges the lack of human data directly relevant for this population group. Based on the NOAEL derived from the subchronic toxicity study in rats, an acceptable level of intake of 36 mg/kg bw per day was defined that would also take into account the potentially increased sensitivity of certain population groups to hypoglycaemia. The Panel concludes that the NF is safe for the general population at intake levels up to 36 mg/kg bw per day and considers that the safety of the NF at the intended uses and use levels as proposed by the applicant has not been established.

Black tea and improvement of attention: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006.

Following an application from Unilever NV, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Ireland, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to black tea and improvement of attention. 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 black tea. The Panel considers that black tea characterised by its content of tea solids, caffeine and l-theanine, which is the subject of the health claim, is sufficiently characterised in relation to the claimed effect. The claimed effect proposed by the applicant is 'improves attention'. The Panel considers that improvement of attention is a beneficial physiological effect. Three human intervention studies provided by the applicant show an effect of black tea on attention under the conditions of used proposed by the applicant. The applicant proposed that the claimed effect depends on the concerted action of two substances, caffeine and l-theanine, both of which are present in black tea. The Panel considers that the effect of black tea on attention observed in the three human intervention studies provided by the applicant can be explained by its caffeine content. The Panel concludes that a cause and effect relationship has been established between the consumption of black tea and improvement of attention. The Panel considers that the effect of black tea on attention can be explained by its caffeine content. The following wording reflects the scientific evidence: 'Owing to its caffeine content, black tea improves attention'. In order to obtain the claimed effect, 2-3 servings of black tea providing at least 75 mg of caffeine in total should be consumed within 90 min.

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

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.