BRIEFING

 European Elder Berry Dry Juice. A new monograph for this dietary ingredient is being proposed. On the basis of comments received, the proposal published in PF 49(6) has been canceled and is being replaced with this new proposal with the following revisions:

1. Add a footnote in the Definition to describe the meaning of the term "anthocyanosides".

2. Revise the Definition to include a new limit for total anthocyanosides on the dried basis.

3. Revise the Definition to eliminite the limit amount of suitable carriers and anti-caking agents, as well as the content ratios of malic acid to citric acid and malic acid to shikimic acid.

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

5. Revise the preparations of Standard solution C and Sample solution in the test for Content of Anthocyanosides and Cyanidin.

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

 (BDSHM: M. Monagas)

 Case ID—SUB-1629