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. 2020 Jun 30;18(6):e06153. doi: 10.2903/j.efsa.2020.6153
Kind of data Data requested in the call for data Responses from interested business operators Comment
A. Information regarding the follow‐up of the conclusions and the recommendations for ascorbyl palmitate (E 304(i)) for all uses (EFSA ANS Panel, 2015a , b )
1. Technical data Analytical data on current levels of arsenic, lead and mercury commercial samples of the food additive Received Assessed, no further follow‐up
The lowest technologically achievable level for lead, mercury and arsenic in order to adequately define their maximum limits in the specifications Received Assessed, no further follow‐up
The lowest technologically achievable level for residual solvents which can be used when manufacturing ascorbyl palmitate (E 304(i)) Received Assessed, no further follow‐up
2. Literature searches Literature searches from 31/9/2015 up to the date of the data submission Received Assessed, no further follow‐up
B. Information required for the risk assessment of ascorbyl palmitate (E 304(i)) for uses in foods for infants below 16 weeks of age
1. Technical data Information on the levels of use of ascorbyl palmitate (E 304(i)) as well as analytical data on the concentration of ascorbyl palmitate in these foods Received Assessed, no further follow‐up
Information on the fate and the reaction products of ascorbyl palmitate (E 304(i)) No specific data Assessed, no further follow‐up
Proposals for particular specification requirements for identity and purity of ascorbyl palmitate (E 304(i)) used in these food categories (e.g. toxic elements, solvents) No specific data Assessed, no further follow‐up
2. Toxicological data Post‐marketing surveillance reports on undesired and adverse reactions, indicating the ages and other relevant data of the exposed infants and young children and the use levels in the marketed products Received Assessed, no further follow‐up
Published and unpublished case reports (e.g. available nutrivigilance data) on undesired and adverse effects, associated with the oral administration of ascorbyl palmitate in any form to infants and young children No data besides the postmarketing surveillance data Assessed, no further follow‐up
No other studies are required provided that the total amount of vitamin C (nutrient and food additive use) resulting from the use of ascorbyl palmitate (E 304(i) in food for infants (FC 13.1.1 and FC 13.1.5.1) does not exceed the levels of vitamin C as currently authorised in the Council Directive 2006/141/ EC Received Assessed, no further follow‐up
3. Literature searches Literature searches should be conducted relevant for the safety evaluation of ascorbyl palmitate (E 304(i) when used in foods for infants below 16 weeks of age Received Assessed, no further follow‐up