Scientific Opinion on the evaluation of the safety in use of Yohimbe (Pausinystalia yohimbe (K. Schum.) Pierre ex Beille)

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion evaluating the safety in use of yohimbe bark and its preparations originating from Yohimbe (Pausinystalia yohimbe (K. Schum.) Pierre ex Beille when used in food, e.g. in food supplements. The bark of the plant contains a number of indole alkaloids of biological relevance and preparations of yohimbe bark have been traditionally used as general tonic, performance enhancer and as an aphrodisiac. Food supplements containing yohimbe bark preparations are available nowadays, especially via internet retail. Yohimbine, the major alkaloid of yohimbe bark and raubasine, another alkaloid occurring in lower concentrations in the bark, are used as active ingredients in a number of medicinal products for which adverse effects are described. The Panel reviewed the available scientific data on a possible association between the intake of yohimbe bark and its preparations and potential harmful effects on health. When those data were not available, priority was given to yohimbine, as the only alkaloid for which occurrence had been shown and quantified in food supplements containing yohimbe bark. The Panel concluded that the chemical and toxicological characterisation of yohimbe bark and its preparations for use in food are not adequate to conclude on their safety as ingredients of food, e.g. in food supplements. Thus the Panel could not provide advice on a daily intake of yohimbe bark and its preparations that do not give rise to concerns about harmful effects to health. An estimation of exposure to yohimbine from food supplements was performed showing that theoretical maximum daily intake may exceed the maximum approved daily dose of yohimbine from use as a medicinal product

Guidance on aneugenicity assessment

The EFSA Scientific Committee was asked to provide guidance on the most appropriate in vivo tests to follow up on positive in vitro results for aneugenicity, and on the approach to risk assessment for substances that are aneugenic but not clastogenic nor causing gene mutations. The Scientific Committee confirmed that the preferred approach is to perform an in vivo mammalian erythrocyte micronucleus test with a relevant route of administration. If this is positive, it demonstrates that the substance is aneugenic in vivo. A negative result with evidence that the bone marrow is exposed to the test substance supports a conclusion that aneugenic activity is not expressed in vivo. If there is no evidence of exposure to the bone marrow, a negative result is viewed as inconclusive and further studies are required. The liver micronucleus assay, even though not yet fully validated, can provide supporting information for substances that are aneugenic following metabolic activation. The gastrointestinal micronucleus test, conversely, to be further developed, may help to assess aneugenic potential at the initial site of contact for substances that are aneugenic in vitro without metabolic activation. Based on the evidence in relation to mechanisms of aneugenicity, the Scientific Committee concluded that, in principle, health-based guidance values can be established for substances that are aneugenic but not clastogenic nor causing gene mutations, provided that a comprehensive toxicological database is available. For situations in which the toxicological database is not sufficient to establish health-based guidance values, some approaches to risk assessment are proposed. The Scientific Committee recommends further development of the gastrointestinal micronucleus test, and research to improve the understanding of aneugenicity to support risk assessment

Scientific Opinion on Priority topics for the development of risk assessment guidance by EFSA?s Scientific Committee

The European Food Safety Authority (EFSA) asked its Scientific Committee to review its own cross cutting risk assessment Guidance Documents to identify gaps requiring either the development of new guidance or the revision of existing guidance. The Scientific Committee identified topics for further strategic discussion without ranking their priority. Four topics were identified as gaps requiring the development of new guidance: the interpretation of epidemiological studies; the use of weight of evidence approach in risk assessment; the identification of biological relevance in toxicology; import risk assessment. Two topics were identified where existing guidance documents require updating or follow up: harmonisation of the assessment of human exposure; terminology in risk assessment. Work for the development of guidance documents is already ongoing on environmental risk assessment, and uncertainty in risk assessment. The assessment of food allergenicity was identified as a further topic where the development of guidance document would be beneficial to applicants and for risk assessment by EFSA. There are some developing scientific issues (e.g. omics, synthetic biology) which the Scientific Committee considers to be too premature for the development of meaningful guidance but which EFSA should keep under review and, when appropriate, should evaluate their importance for food safety risk assessment. The topics identified in this opinion will be discussed further within EFSA to develop its multiannual workplan, the strategic work programme of the Scientific Committee and future priorities

Statement on the benefits of fish/seafood consumption compared to the risks of methylmercury in fish/seafood

Following a request from the European Commission to carry out a risk benefit analysis as regards the risks and benefits to human health of fish/seafood consumption related to methylmercury, the EFSA Scientific Committee used previous work performed by the EFSA Panel on Contaminants in the Food Chain and the EFSA Panel on Dietetic Products, Nutrition and Allergies to create scenarios based on typical fish consumption patterns of population groups at risk of exceeding the tolerable weekly intake (TWI) for methylmercury. The Scientific Committee then estimated how many servings of fish/seafood per week these population groups would need to reach the TWI for methylmercury and the dietary reference value (DRV) for n-3 (Long-Chain) Polyunsaturated Fatty Acid (LCPUFA). When consuming species with a high methylmercury content, only a few numbers of servings (<1–2) can be eaten before reaching the TWI, which may be attained before the DRV. To protect against inter alia neurodevelopmental toxicity of methylmercury and achieve the benefits of fish consumption (effect of fish/seafood consumption during pregnancy on functional outcomes of children’s neurodevelopment and on cardiovascular diseases in adults), which are associated with 1–4 fish servings per week, fish/seafood species with a high content of mercury in the daily diet should be limited. Because a variety of fish species are consumed across Europe, it is not possible to make general recommendations on fish consumption. The Scientific Committee therefore recommends that each country needs to consider its own pattern of fish consumption, especially the species of fish consumed, and carefully assess the risk of exceeding the TWI of methylmercury while obtaining the health benefits from consumption of fish/seafood

Obituary, In Memoriam: Dr. Iona Pratt

No abstract availabl