REGULATORY UPDATES

aminophenol and p-Phenylenediamine. The conclusion for DM Hydantoin was insufficient data. Dilauryl Thiodipropionate, the Jojoba Oil group, Tall Oil Acid, Hydroxyethylcellulose, Shellac, Coconut Oil and Butyl Myristate were all reopened under CIR’s normal re-review process. With the exception of corn silk which lacked sufficient safety data, all items in the Zea Mays (Corn) group were tentatively determined as safe. …………
Senator John Kerry (D-Mass.) has criticized FDA for not allowing the public to take part in the International Cooperation on Cosmetics Regulations. According to Kerry, "In order to ensure a more complete system of public health protection, it is critical to include the view of the consumer and public health community" The ICCR’s first meeting in Brussels, September 27, included regulatory agencies from the U.S., Canada, the E.U. and Japan. CTFA, which was allowed to attend the meeting, has urged FDA’s CFSAN office to make global harmonization an A-list priority for fiscal 2008. …………
FDA’s Office of Cosmetics and Colors has recently had its budget increased by two million dollars. CTFA president and CEO Pamela Bailey commented that "This increase will enhance consumer protections and provide the cosmetics office with much needed inspectors and compliance officers. … This funding increase will allow critical FDA participation in international discussions" …………
The National Advertising Division has agreed that submitted data shows the Neutrogena’s "best," "strongest" and "longest-lasting" claims are substantiated for its Helioplex-containing sun-care products introduced in January. Helioplex is a patented technology that combines avobenzone with diethyl 2,6-oxybenzone to prevent degradation on exposure to sunlight. Neutrogena’s product claims an SPF70 and the ‘highest UVA protection.’ Neutrogena uses the persistent pigment darkening method to substantiate its UVA claim. …………
The European Commission has determined that more data is necessary to substantiate the safety of propyl, buytl, isopropyl and isobutyl paraben. …………
In a general policy statement about its role in regulating nanotechnology products, FDA has stated that "FDA has only limited authority over some potentially high-risk products, e.g. cosmetics." "Many products are regulated only if they cause adverse health-related events in use. To date there have been comparatively few resources available to assess the risk of these products." The FDA’s Nanotechnology Task Force had previously stated that "current science does not support a finding that classes of products with nanoscale materials present greater safety concerns than classes of products without nanoscale materials." Meanwhile Friends of the Earth recently released the results of their survey looking for nanoscale ingredients in 120 sunscreen products. They found nine products were nanoparticle free, twenty-four products contained nanoparticles and ninety-five products were "unclear or chose not to respond." Friends of the Earth cautioned "Sun worshippers beware. While slathering up with sunscreens to block dangerous rays, you may be exposing yourself to a new danger. Sunscreen manufacturers are adding nanoparticles to sunscreens without labeling and reliable safety information." ………..
The European Commission’s Scientific Committee on Consumer Products has stated that phthalates in cosmetic products at current levels pose no significant risk to consumers.