|
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| Published and unpublished case reports (e.g. available nutrivigilance data) on undesired and adverse effects, associated with the oral administration of ascorbyl palmitate in any form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 |