The Cosmetic Ingredient Review Expert Panel devoted a substantial portion of its June 4-5 meeting in Washington, D.C. to discussing recent changes to the cosmetic ingredient review process.

The discussion was led by CIR Director Alan Andersen, PhD, who walked the panel through a flowchart describing the revised process.

The diagram, which tracks a report from its scientific literature review through its final safety assessment, reflects three major changes to the CIR procedure, Andersen told "The Rose Sheet" June 6.

One of those changes affects the preliminary phase of a review - the gathering of information for the scientific literature review. Whereas historically only published scientific studies have been accepted, now unpublished data are considered as well, Andersen noted.

After the scientific literature review is drafted, it is posted for a 60-day comment period - a change adopted by the CIR Steering Committee meeting Feb. 23 (¹ Also see "CIR Reopens Shampoo Ingredient, Asks Industry About Impurity Levels" - HBW Insight, 23 April, 2007., p. 3).

The review then moves to a draft report, which is subjected to expert panel review. If the panel rules that additional data is needed, an insufficient data announcement is made and the report is posted for another 60-day comment period.

If the data is found adequate and the ingredient safe, the panel will issue a tentative safety assessment, which is posted for another 60-day comment period.

Assuming no obstacles arise, the tentative safety assessment then moves to a final safety assessment. The panel follows up with a monograph, which ultimately undergoes peer review via publication in the International Journal of Toxicology, Andersen said.

He acknowledged, however, that CIR currently has a backlog of ingredients in the queue for publication.

The final safety assessment is brought up for re-review after 15 years or when new safety concerns or industry data surface, Andersen said.

At the 15-year mark, the panel can opt not to reopen the report if there is no new safety data, the new safety data is "not actionable" or there are no new ingredients.

Conversely, if the panel decides to reopen the report, it does so either because there is new safety or use data, there is new industry data to address insufficiency or there are new ingredients to assess.

The option to reopen a report to add ingredients is another recent change to the review process that was adopted during the Feb. 23 CIR Steering Committee meeting, Andersen noted.

Once a report is reopened, the review process is repeated from the beginning, starting with a new scientific literature review.

The procedural changes are being instituted now, Andersen said, pointing to 2,4-Diaminophenoxyethanol HCI - which underwent review during the June 4-5 meeting - as one example of a substance for which a report will be reopened to consider the addition of a new ingredient.

To encourage the submission of data and to "alert all interested parties what is coming down the pipe," the expert panel released a list of the ingredients slated for review in 2008, compiled from CIR's "high-priority lists" (see chart: " ² Cosmetic Ingredient Review - 2008 New Ingredient Reviews ").

"By announcing the list of ingredients to be considered in 2008, it presents an opportunity for interested parties to submit published and/or unpublished data they find relevant to that ingredient," he said. "If you know what's coming in 2008, you have the opportunity to look at them and determine what needs to be done."

The proactive posting of ingredients up for review will occur every June going forward, according to Andersen.

The director noted that the panel made several requests during its discussion of the flowchart, including that a protocol exist so that the re-opening of reports is done in a clear and consistent manner.

"The panel is of the mind that once reopened, these reports should follow a single path and not different paths according to the level of data," Andersen explained.

The matter will go to the CIR Steering Committee for consideration, he said.

- Melina Vissat (m.vissat@elsevier.com)

CIR Panel Discusses Revised Ingredient Review Process

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