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Following a request from the European Commission, EFSA developed a new scientific guidance to assist applicants in the preparation of applications for the authorisation of flavourings to be used in or on foods. This guidance applies to applications for a new authorisation as well as for a modification of an existing authorisation of a food flavouring, submitted under Regulation (EC) No 1331/2008. It defines the scientific data required for the evaluation of those food flavourings for which an evaluation and approval is required according to Article 9 of Regulation (EC) No 1334/2008. This applies to flavouring substances, flavouring preparations, thermal process flavourings, flavour precursors, other flavourings and source materials, as defined in Article 3 of Regulation (EC) No 1334/2008. Information to be provided in all applications relates to: (a) the characterisation of the food flavouring, including the description of its identity, manufacturing process, chemical composition, specifications, stability and reaction and fate in foods; (b) the proposed uses and use levels and the assessment of the dietary exposure and (c) the safety data, including information on the genotoxic potential of the food flavouring, toxicological data other than genotoxicity and information on the safety for the environment. For the toxicological studies, a tiered approach is applied, for which the testing requirements, key issues and triggers are described. Applicants should generate the data requested in each section to support the safety assessment of the food flavouring. Based on the submitted data, EFSA will assess the safety of the food flavouring and conclude whether or not it presents risks to human health and to the environment, if applicable, under the proposed conditions of use. This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2022.EN-7669/full

The electronic cigarette ( e-cigarette ), for many considered as a safe alternative to conventional cigarettes, has revolutionised the tobacco industry in the last decades. In e-cigarettes , tobacco combustion is replaced by e-liquid heating, leading some manufacturers to propose that e-cigarettes have less harmful respiratory effects than tobacco consumption. Other innovative features such as the adjustment of nicotine content and the choice of pleasant flavours have won over many users. Nevertheless, the safety of e-cigarette consumption and its potential as a smoking cessation method remain controversial due to limited evidence. Moreover, it has been reported that the heating process itself can lead to the formation of new decomposition compounds of questionable toxicity. Numerous in vivo and in vitro studies have been performed to better understand the impact of these new inhalable compounds on human health. Results of toxicological analyses suggest that e-cigarettes can be safer than conventional cigarettes, although harmful effects from short-term e-cigarette use have been described. Worryingly, the potential long-term effects of e-cigarette consumption have been scarcely investigated. In this review, we take stock of the main findings in this field and their consequences for human health including coronavirus disease 2019 (COVID-19).

RationaleThere is limited understanding regarding how various e-cigarette flavorings may influence the behavior of non-regular e-cigarette users who are regular cigarette smokers.ObjectivesTo assess differences in nicotine delivery, puffing topography, subjective effects, and user satisfaction from different flavored e-liquids.MethodsEighteen daily smokers (average age, 44.1 ± 7.0; 9 males; average CPD, 13.0 ± 5.8) smoked their tobacco cigarettes during an initial visit and returned five times to try an e-cigarette (eGo type) refilled with a nicotine solution (24 mg/ml) of five different flavors: cherry, tobacco, espresso, menthol, and vanilla (randomized order). Assessments at each visit included puffing topography, blood samples for nicotine analysis, and subjective reports of nicotine effects and flavor satisfaction.ResultsVaping different flavors resulted in different levels of plasma nicotine. The flavor producing the highest plasma nicotine concentration (Cmax) was cherry (median 21.2 ng/ml), which was not significantly different than nicotine delivery from a combustible cigarette (29.2 ng/ml, p > .05). Vanilla e-liquid produced the lowest Cmax (9.7 ng/ml), and participants tended to puff less frequently on vanilla compared to tobacco flavor (p = .013). Flavors did not differ significantly in the speed of nicotine delivery (Tmax). During controlled use, puff duration for all flavors was significantly longer than a combustible cigarette (p < 0.05). After controlling for nicotine delivery, significant differences in flavor enjoyment were detected. Menthol flavored e-liquid was rated as more enjoyable than vanilla and tobacco flavored e-liquids (p < 0.05).ConclusionsFlavors tested in this study yielded different patterns of nicotine delivery and led to differences in reduction in smoking urges.Trial registrationClinicalTrials.gov Identifier: #NCT02575885

Liquid smoke products are widely used as a food additive to create a desired smoke flavour. These products may contain hazardous chemicals generated during the wood-burning process. However, the toxic effects of these types of hazardous chemicals constituting in the commercially available products are largely unknown. Therefore, a test battery of cell-based in vitro methods, covering different modes of actions of high relevance to human health, was applied to study liquid smoke products. Ten liquid smoke flavourings were tested as non-extracted and extracted. To assess the potential drivers of toxicity, we used two different solvents. The battery of in vitro methods covered estrogenicity, androgenicity, oxidative stress, aryl hydrocarbon receptor activity and genotoxicity. The non-extracted samples were tested at concentrations 0.002 to 1 μL liquid smoke flavouring/mL culture medium, while extracted samples were tested from 0.003 to 200 μL/mL. Genotoxicity was observed for nearly all non-extracted and all hexane-extracted samples, in which the former had higher potency. No genotoxicity was observed for ethyl acetate-extracted samples. Oxidative stress was activated by almost all extracted and non-extracted samples, while approximately half of the samples had aryl hydrocarbon receptor and estrogen receptor activities. This study used effect-based methods to evaluate the complex mixtures of liquid smoke flavourings. The increased bioactivities seen upon extractions indicate that non-polar chemicals are driving the genotoxicity, while polar substances are increasing oxidative stress and cytotoxic responses. The differences in responses indicate that non-extracted products contain chemicals that are able to antagonize toxic effects, and upon extraction, the protective substances are lost.

Vanilla planifolia is native to the Mexican tropics. Despite its worldwide economic importance as a source of vanilla for flavoring and other uses, almost all vanilla is produced by expensive hand-pollination, and minimal documentation exists for its natural pollination and floral visitors. There is a claim that vanilla is pollinated by Melipona stingless bees, but vanilla is more likely pollinated by orchid bees. Natural pollination has not been tested in the Yucatán region of Mexico, where both vanilla and potential native bee pollinators are endemic. We document for the first time the flowering process, nectar production and natural pollination of V. planiflora, using bagged flower experiments in a commercial planting. We also assessed the frequency and visitation rates of stingless bees and orchid bees on flowers. Our results showed low natural pollination rates of V. planifolia (~ 5%). Only small stingless bees (Trigona fulviventris and Nannotrigona perilampoides) were seen on flowers, but no legitimate visits were witnessed. We verified that there were abundant Euglossa and fewer Eulaema male orchid bees around the vanilla plants, but neither visited the flowers. The introduction of a colony of the stingless bee Melipona beecheii and the application of chemical lures to attract orchid bees failed to induce floral visitations. Melipona beecheii, and male orchid bees of Euglossa viridissima and E. dilemma may not be natural pollinators of vanilla, due to lack of attraction to flowers. It seems that the lack of nectar in V. planifolia flowers reduces the spectrum of potential pollinators. In addition, there may be a mismatch between the attractiveness of vanilla floral fragrances to the species of orchid bees registered in the studied area. Chemical studies with controlled experiments in different regions would be important to further elucidate the potential pollinators of vanilla in southern Mexico.

Following a request from EFSA, the Scientific Committee was asked to deliver a statement on the applicability of the margin of exposure approach for the safety assessment of impurities which are both genotoxic and carcinogenic in substances added to food or feed. The Scientific Committee acknowledges that analytical methodology is continually improving, and an increasing number of impurities, including some substances which are both genotoxic and carcinogenic, can be detected at low levels in, for example, food/feed additives or food contact materials. As a result it can be foreseen that these impurities may end up in food, including products from animal origin. The Scientific Committee is of the opinion that the MOE approach can be applied to impurities which are both genotoxic and carcinogenic, irrespective of their origin. The Scientific Committee reiterates its view expressed in 2005 that in general a margin of exposure of 10,000 or higher, if it is based on the BMDL10 from an animal study, and taking into account overall uncertainties in the interpretation, would be of low concern from a public health point of view; the magnitude of an MOE however only indicates a level of concern and does not quantify risk. When using the MOE approach for assessing impurities, the derivation of the MOE, its magnitude, and the uncertainties regarding its derivation should be described. A conclusion on whether the MOE is of high concern, low concern, or unlikely to be of safety concern should also be provided. The Scientific Committee reiterates its recommendation that follow‐up discussion should be organised with EFSA partners on the weighing of the potential health significance of the magnitude of particular MOEs and how to band MOEs with respect to conclusions that use expressions such as high concern, low concern, or unlikely to be of safety concern.

This document should be used for the reporting to EFSA of the no presence of food additives and food flavourings in samples. It provides guidance on how to use the data model and gives information on the different data elements and business rules.

This document should be used for the reporting to EFSA of the use levels of food additives and food flavourings in product categories/foods. It provides guidance on how to use the data model and gives information on the different data elements and business rules.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of 41 compounds to provide a Herbal flavour and belonging to different chemical groups, when used as sensory additives in feed for all animal species. Fourteen out of the 41 compounds were tested in tolerance studies in chickens for fattening, piglets, cattle for fattening and Atlantic salmon. No adverse effects were observed in the tolerance studies at 10‐fold the intended level. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the 14 tested compounds were safe for these species at the proposed use level and conclusions were extrapolated to all animal species. For the remaining 27 compounds, read‐across from structurally similar compounds tested in tolerance trials and belonging to the same chemical group was applied. The FEEDAP Panel concluded that these 27 compounds were safe for all animal species at the proposed use level. No safety concern would arise for the consumer and the environment from the use of the 41 compounds up to the maximum proposed use level in feed.