Updating of Upper Levels for Micronutrients: Vitamin A, Lot 1

Reference number: OC/EFSA/NUTRI/2021/01

Description: Updating of Upper Levels for Micronutrients: Vitamin A, Lot 1

The objectives of the contract resulting from this procurement procedure for each of the micro-nutrients are as follows:
• objective 1 for each micro-nutrient Where needed, to further specify the parts of the protocol that will be implemented, in consultation with EFSA. This may include, for instance, further specification of the literature search strategy(ies), specification of data extraction processes, specification of the analytical plan for the statistical synthesis of the evidence, tailoring of risk of bias tools.
• objective 2 for each micro-nutrient To collect and appraise scientific evidence that could be used to derive an UL for each micronutrient. The data
collection and appraisal process should follow the requirements of the “high- level” protocol agreed with EFSA. It will include systematic review(s) of the literature (SR) on the relationship between the dietary intake of the awarded micronutrient and health outcomes identified in the protocol. This entails literature screening, data extraction, evidence appraisal (i.e. risk of bias assessment) and evidence (statistical) synthesis (e.g. meta-analysis, dose- response modelling, where appropriate) (EFSA, 2010) 11 . Narrative reviews may be required to gather contextual evidence relevant to the interpretation of the main body of evidence (e.g. absorption, distribution, metabolism, elimination, of the micronutrient; mechanistic data and modes of action).
• Objective 3 for each micro-nutrient Preparatory work for Hazard identification & for Hazard characterisation using the scientific evidence retrieved from (ii) and in accordance with EFSA’s updated Guidance for establishing UL for vitamins and minerals. In particular: i. To critically summarise the evidence concerning the capacity of the micronutrient to cause one or more types of adverse effects in humans. This includes an analysis of the uncertainties in the body of evidence according to the framework that will be provided by EFSA. Critical outcomes, for various life-stage groups within the population, that could be used to derive UL for the micronutrient should be identified as the result of this step. ii. To characterise the dose–response relationship between micronutrient intake (dose) and identified adverse effects, where applicable.
• Objective 4 for each micro-nutrient To characterise sub-groups of the general populations having distinct and exceptional sensitivities to the adverse effects of the micronutrient, where relevant.
• Objective 5 for each micro-nutrient To identify data gaps

Duration in months: 12
This contract is subject to renewal: no