BRIEFING

 European Elder Berry Liquid Extract. A new monograph for this dietary ingredient is being proposed. On the basis of comments received, the proposal published in PF 50(3) has been canceled and is being replaced with this new proposal with the following revisions:

1. Revise the description of the Acceptance criteria for 365 nm in Identification B.

2. Revise the preparations of Standard solution B and the Sample solution in the test for Content of Anthocyanosides.

3. Revise the limit of citric acid in the test for Organic Acids.

4. Revise the limit of dextrose and fructose in the test for Content of Dextrose and Fructose.

5. Add a new caution statement in the Labeling section about allergenicity.

 (BDSHM: M. Monagas)

 Case ID—SUB-2318