New Streamlined Voluntary Electronic Registration System for
Cosmetic Industry Announced

The Food and Drug Administration (FDA) is announcing a new electronic system for the Voluntary Cosmetic Registration Program (VCRP). Beginning December 1, 2005, cosmetic firms will be able to register their establishments and file their cosmetic formulations with FDA electronically for cosmetics on the market in the U.S. From information maintained in the VCRP database, FDA can estimate the extent and use of a cosmetic ingredient in the event the agency has to develop safety messages to alert manufacturers and the public.

The new electronic system for the VCRP is designed to streamline the process, which should encourage greater participation by the cosmetics industry. To learn more and to register, go to FDA's website: Voluntary Cosmetic Registration Program (VCRP).

Cosmetic firms that already have participated in the VCRP using paper forms do not need to resubmit this information. However, firms participating through the online system can submit a written request on company letterhead if they would like to have cosmetic formulations previously filed on paper forms transferred to their online account.

As FDA's primary method of compiling information on cosmetic establishments and cosmetic product formulations on the market in the U.S., the VCRP not only helps FDA in its mission to protect consumers, but it also helps cosmetic manufacturers and distributors make informed decisions. Benefits of the VCRP include:

• FDA can notify participating firms about important safety information related to cosmetic ingredients; and
• Information from the VCRP database assists the Cosmetic Ingredient Review (CIR) Expert Panel to establish priorities for ingredient safety review. The CIR is an independent, industry-funded panel of scientific experts who regularly assess the safety of cosmetic ingredients and publish its findings.

FDA Publishes A Proposed Rule
To Expand the Nutrient Content Claim, "Lean"

FDA published in the Federal Register a proposed rule to amend food labeling regulations that will expand the use of the nutrient content claim, "lean." The proposed regulation would extend the claim to foods categorized as "mixed dishes not measurable with a cup" (for example, burritos, egg rolls, enchiladas, pizza, quiches, and sandwiches) that meet certain criteria for total fat, saturated fat, and cholesterol.

The criteria for lean categorized as "mixed dishes not measurable with a cup" is:

• less than 8 grams total fat;
• 3.5 grams or less of saturated fat; and
• less than 80 milligrams of cholesterol per serving.

This proposed rule has different criteria than in the final rule issued on January 6, 1993, where FDA defined "lean" for:

• seafood and game meat using the criteria of less than 10 grams total fat, 4.5 grams or less of saturated fat, and less than 95 milligrams cholesterol per reference amount customarily consumed and per 100 grams; and
• meal and main dish products using the criteria of less than 10 grams total fat, 4.5 grams or less of saturated fat, and less than 95 milligrams cholesterol per 100 g and per labeled serving.

Comments may be submitted to Docket No. 2004P-0183, as indicated in the Federal Register notice, which is online: 70 FR 71041.

Office of Food Safety, Defense, and Outreach

Office Number: (301) 436-2277 · FAX (301) 436-2605 CFSAN Web site: http://www.cfsan.fda.gov/