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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 an opinion on selenite triglycerides as a novel food (NF) pursuant to Regulation (EU) 2015/2283, their safety when added for nutritional purposes to food supplements as a source of selenium and the bioavailability of selenium from this source, in the context of Directive 2002/46/EC. The proposed NF is the first lipophilic organic form of selenium so far described in the literature. It is composed by a mixture of individual Se-containing lipids which do not occur in nature. The Panel considers that the information provided on the composition of the NF does not allow a complete characterisation of the product. From the data provided to characterise the absorption, distribution, metabolism and excretion of the NF, it cannot be established in which chemical form Se is systemically available and if it can enter the functional Se body pool to fulfil Se physiological functions. The Panel considers that, since it is not demonstrated that the NF is converted to a known form of Se following ingestion and absorption, the NF is to be treated as a xenobiotic with unknown properties in the body. From a subchronic toxicity study in rats, the Panel derives a lowest observed adverse effect level (LOAEL) for general toxicity of 2 mg Se/kg body weight (bw) per day based on findings indicating liver as a target organ, as it has been shown for other studies on dietary Se. The Panel concludes that the NF is absorbed and provides Se, but in an unknown form of which the bioavailability has not been determined. The Panel also concludes that the safety of the NF under the intended conditions of use cannot be established. (C) 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

The European Food Safety Authority (EFSA) has been involved in the risk assessment of novel foods since 2003. The implementation of the current novel food regulation in 2018 rendered EFSA the sole entity of the European Union responsible for such safety evaluations. The risk assessment is based on the data submitted by applicants in line with the scientific requirements described in the respective EFSA guidance document. The present work aims to elaborate on the rationale behind the scientific questions raised during the risk assessment of novel foods, with a focus on complex mixtures and whole foods. Novel foods received by EFSA in 2003-2019 were screened and clustered by nature and complexity. The requests for additional or supplementary information raised by EFSA during all risk assessments were analyzed for identifying reoccurring issues. In brief, it is shown that applications concern mainly novel foods derived from plants, microorganisms, fungi, algae, and animals. A plethora of requests relates to the production process, the compositional characterization of the novel food, and the evaluation of the product's toxicological profile. Recurring issues related to specific novel food categories were noted. The heterogeneous nature and the variable complexity of novel foods emphasize the challenge to tailor aspects of the evaluation approach to the characteristics of each individual product. Importantly, the scientific requirements for novel food applications set by EFSA are interrelated, and only a rigorous and cross-cutting approach adopted by the applicants when preparing the respective application dossiers can lead to scientifically sound dossiers. This is the first time that an in-depth analysis of the experience gained by EFSA in the risk assessment of novel foods and of the reasoning behind the most frequent scientific requests by EFSA to applicants is made.

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 the extension of use of calcium L-methylfolate to be used as a source of folate added for nutritional purposes to infant and follow-on formula, baby food and processed cereal-based food pursuant to Regulation (EU) 609/2013. In 2004, EFSA assessed the use of calcium L-methylfolate as a source of folate in foods for particular nutritional uses, food supplements and foods intended for the general population. The new alternative synthetic step proposed to produce the nutrient source, using platinum as a catalyst, did not raise any safety concern and the production process was found to consistently yield a product in line with the proposed specifications. Based on the studies assessed in the previous evaluation, it was concluded that calcium L-methylfolate is non-genotoxic and that subchronic and embryotoxicity/teratogenicity studies in rats did not reveal any adverse effects up to the highest doses tested. The Panel considered that no additional toxicological studies are required on the nutrient source. The intervention study in healthy infants provided by the applicant did not indicate differences in growth and tolerance parameters in infants who consumed either an infant formula supplemented with calcium L-methylfolate or with folic acid, and did not raise concerns regarding safety or tolerability of the infant formula with the proposed nutrient source. The study also provided further supporting evidence for the bioavailability of calcium L-methylfolate. The Panel considers that calcium L-methylfolate is a source from which folate is bioavailable and concludes that calcium L-methylfolate is safe under the proposed uses and use levels for infants and young children. (C) 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

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 (TM). 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. (C) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

In 2018, the EFSA NDA Paneladopted the Scientific Opinion on the safety of D-ribose as a novel food pursuant to Regulation (EU) 2015/2283 when used in a variety of food, concluding that D-ribose is safe for the general population at intake levels up to 36mg/kg body weight (bw) per day, but that its safety at the intended uses and use levels as proposed by the applicant could not be established. Following a request from the European Commission, the EFSA NDA Panelwas asked to carry out a supplementary safety assessment for D-ribose by considering the new proposed uses and use levels submitted by the applicant. In order to address the present mandate, an intake assessment was carried out based on individual data from the EFSA Comprehensive European Food Consumption Database. Intakes were estimated for all age groups of the general population. The resulting ranges for the mean and high-level estimated intakes of D-ribose for all the population groups, including the target population groups, did not exceed the acceptable level of intake for the general population previously defined, i.e. 36mg/kg bw per day, except for one survey on adolescents where the mean and 95th percentile of the intake estimates were 8.6 and 39.4mg/kg bw per day, respectively. The Panelconcludes that the novel food, D-ribose, is safe under the new proposed conditions of use. (c) 2018 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.

Event report. The issue of epigenetic changes and their impact on human health and life span was prominently discussed at EFSA’s second scientific conference ‘Shaping the future of food safety, together’ in Milan. Epigenetic changes are molecular changes mainly in chromatin, such as DNA methylation, histone modifications, that modulate gene expression directly or indirectly through the expression of noncoding RNAs. There is increasing evidence to suggest that individual lifestyles, nutrition and environmental stressors can affect epigenetic processes and as a result, alter phenotypes, longevity, health and disease both within generations (from embryogenesis to adulthood) and in a transgenerational manner. In response to the interest in this issue, EFSA has selected epigenetics as the subject of its 22nd scientific colloquium, which was held on 14 and 15 June 2016 in Valencia, Spain. About 100 scientists, risk managers and policymakers discussed where we stand regarding our knowledge of epigenetic mechanisms. The overall objective of the discussions was to identify the potential role of epigenetics in food safety risk assessment. The colloquium was organised around four discussion groups looking at the following themes: incorporating epigenetics data in mode of action analysis; epigenetics and chemical risk assessment in humans; epigenetics in risk assessment of farmed animals for food production; epigenetics and environmental risk assessment. The main takehome message from the colloquium was to ask and seek answers to those questions that will increase our understanding of epigenetics. What do epigenetic modifications mean for safety assessment? How do we study them? What is the size of such modifications that we need worry about? Cooperation and collaboration between the various scientific disciplines and with the clinical side of epidemiology was identified as a necessary strategic element to improve scientific risk assessment.

The EFSA 2nd Scientific Conference ‘Shaping the Future of Food Safety, Together’ gathered an international audience composed of scientists, risk assessors, risk managers, as well as non-governmental organisations and industry representatives. This article summarises the final plenary session where a panel was asked to draw out overall impressions and conclusions for the EFSA to take away for its strategic planning into the future. The main conclusions of the conference are presented under five major themes. With new methodologies, technologies, big data and the increased societal demand for enhanced engagement in the risk assessment process, there is a clear need to maintain levels of expertise from traditional areas and to consider the inclusion of new areas and sources of expertise to perform scientific assessments. Academia, industry, research and regulatory science should work together to achieve this goal. As science progresses at pace, the continued development of assessment methodologies to deal with increasingly complex assessment questions is necessary, as is the need for applied research to underpin the support to policy development that EFSA provides. Greater collaboration is needed to reach agreement on best methods and practices for scientific assessment not just internationally, but also, equally importantly, across legislative areas and scientific disciplines, and in consultation with society at large. The communication of complex science, including important concepts such as uncertainty and risk perception, is not a trivial task, and must be integrated into the scientific process. As such, the relationship between risk assessment and risk management must continue to mature, remaining close, yet independent.

Methodologies for integrating (weighing) evidence and assessing uncertainties are of utmost importance to ensure that scientific assessments are transparent, robust and fit for purpose to support decision-makers. One of the key challenges remains the development of harmonised methodologies for both weighing scientific evidence and assessing uncertainties in the food safety area mainly because of the multidisciplinary and complex nature of the topics involved. The breakout session ‘Weighing evidence and assessing uncertainties’ was held at the EFSA 2nd Scientific Conference ‘Shaping the Future of Food Safety, Together’. This paper aims at summarising the contributions of this breakout session and formulates recommendations to further support the development of harmonised methodologies and practical applications for weighing evidence and analysing uncertainty in key areas of food safety, including chemical risk assessment, microbiological risk assessment and environmental risk assessment.

Tomatoes and tomato products, obtained from a market, from companies or prepared in research laboratories, were tested in order to investigate how different processes could modulate the IgE reactivity of these products. The protein fraction of the samples was extracted by using a low-temperature method in order to avoid degradation, and then separated on SDS PAGE to evaluate the protein profile. All the separated samples were blotted onto nitrocellulose membranes and then individually tested with pooled human sera that had been obtained from patients allergic to tomato, in order to evaluate the potential IgE binding of the protein bands. Heat treatments conventionally employed for the production of tomato-based products were found to strongly degrade proteins thus dramatically reducing their IgE reactivity; characteristic protein profiles were found for specific processes such as hot and cold break. Ultra-high-pressure treatments were found to generally preserve the integrity of tomato proteins and this was reflected by the unaltered IgE reactivity observed. Copyright © 2007 Society of Chemical Industry

A duplex PCR method was developed to simultaneously detect the presence of hazelnut and peanut in raw materials and commercial products. It was found to be able to specifically detect traces of the investigated products down to 50 pg of their target DNA.

Background According to EU legislation, genetically modified plants (GM plants) should follow a scientific assessment of any risk that they may pose to human and animal health, including an allergenicity assessment. According to the EFSA guidance, the allergenicity assessment of GM plants is structured into the assessment of i) the newly expressed proteins and ii) the whole GM plant. For the latter and as a part of the assessment, if the GM plant receiving the introduced gene(s) is known to be allergenic, its endogenous allergenicity is compared with that of its non-GM comparator(s).

Allergenicity assessment of genetically modified (GM) plants is one of the key pillars in the safety assessment process of these products. As part of this evaluation, one of the concerns is to assess that unintended effects (e.g. over-expression of endogenous allergens) relevant for the food safety have not occurred due to the genetic modification. Novel technologies are now available and could be used as complementary and/or alternative methods to those based on human sera for the assessment of endogenous allergenicity. In view of these developments and as a step forward in the allergenicity assessment of GM plants, it is recommended that known endogenous allergens are included in the compositional analysis as additional parameters to be measured.

This chapter discusses the safety and nutritional assessment of transgenic plants and their derived products in the European Union. The nutritional and safety assessment of transgenic plants in other parts of the world is also summarized briefly.

The detection of genetically modified organisms (GMOs) in food and feed is an important issue for all the subjects involved in raw material control, food industry, and distribution. Because the number of GMOs authorized in the EU increased during the past few years, there is a need for methods that allow a rapid screening of products. In this paper, we propose a method for the simultaneous detection of four transgenic maize (MON810, Bt11, Bt 176, and GA21) and one transgenic soybean (Roundup Ready), which allows routine control analyses to be sped up. DNA was extracted either from maize and soybean seeds and leaves or reference materials, and the recombinant DNA target sequences were detected with 7 primer pairs, accurately designed to be highly specific for each investigated transgene. Cross and negative controls were performed to ensure the specificity of each primer pair. The method was validated on an interlaboratory ring test and good analytical parameters were obtained (LOD = 0.25%, Repeatability, (r) = 1; Reproducibility, (R) = 0.9). The method was then applied to a model biscuit made of transgenic materials baked for the purpose and to real samples such as feed and foodstuffs. On account of the high recognition specificity and the good detection limits, this multiplex PCR represents a fast and reliable screening method directly applicable in all the laboratories involved in raw material and food control.