ICCR Accepts Four Regulatory Guidance Reports; NGOs Seek Bigger Role

Regulators from the U.S., Canada, the EU and Japan accepted reports offering guidelines for regulatory harmonization within the areas of nanotechnology, alternative test methods, trace materials and safety assessments at the fifth meeting of the International Cooperation on Cosmetic Regulation.

The meeting, held June 28-July 1 in Paris, also marked the first time a portion of the annual event was open to NGOs and interested stakeholders.

“We really support the goals of the ICCR, but we think the process is fundamentally flawed, and it’s just not right that government agencies would work with industry trade associations and not provide that equal access to stakeholder consumer advocates.” – Lisa Archer, director of the Campaign for Safe Cosmetics

“It was probably the most substantively rich meeting we’ve had in the ICCR so far,” remarked Francine Lamoriello, executive vice president for global strategies at the Personal Care Products Council.

“A number of important documents were accepted, [which] will provide very good guidance, not only to industry and regulators in those countries who participate in the ICCR, but also to other countries who might be considering regulatory approaches,” she said in a July 21 interview with “The Rose Sheet.”

FDA posted a notice on its website July 8 listing “outcomes” of the ICCR meeting, but the agency has not released details of the reports accepted by regulators.

The reports include “Applicability of Animal Testing Alternatives in Regulatory Frameworks within ICCR Regions” and “Principles of Cosmetic Product Safety Assessment,” as well as reports on handling trace materials and the characterization of nanomaterials.

The document on nanomaterials “is extremely important,” according to Lamoriello. “I think we all see that nanotechnology is a very, very important and emerging issue in all four countries, and we want to make sure that there’s as much alignment internationally as possible.”

The report will help industry identify ingredients that fall into the “nano” category, which is especially significant now that the EU requires cosmetic products containing nanomaterials to be labeled as such.

Without the guidance, “if you don’t know how to measure or how you can assess whether your material meets that definition, you don’t know if you have to label it or not,” Lamoriello said.

Last year, the ICCR group endorsed its technical working group’s characterization of nanotechnology in cosmetics (Also see "International Regulators Endorse Definition For Nanotech In Cosmetics" - HBW Insight, 9 Aug, 2010.).

According to FDA’s list of meeting outcomes, ICCR decided it will form a new working group in the nanotechnology area “to examine methods to characterize insolubility, biopersistance and measurement of size in the realm of 1 to 100 nanometers in final formulations.”

Additionally, the group received a progress update from a working group regarding safety assessments of nanomaterials, as well as results from an industry survey on nanomaterial use in cosmetics.

As for animal testing, the report that was accepted “captures the current situation and the regulatory framework in all the different countries, and now going forward we want to look for ways to promote more regulatory acceptance” of alternative test methods, Lamoriello said.

For trace contaminants, ICCR continued discussions toward a recommended ceiling on lead concentration levels and initiated work on a document pertaining to 1,4 dioxane, according to FDA.

NGOs Push For Seat At The Table

This year, for the first time, the annual ICCR meeting included a session for NGOs and regulators of non-member countries to join the dialogue (Also see "ICCR To Open Portion Of Annual Meeting To “Interested Parties,” NGOs" - HBW Insight, 2 May, 2011.).

“It was a fairly diverse group, and frankly quite an interesting discussion,” Lamoriello said. “Industry continues to be interested in including and incorporating other countries into the ICCR work, and we’re hopeful that’s something that’s going to be approached in the coming year.”

The Campaign for Safe Cosmetics said while it was pleased to have the opportunity to participate in the forum, it would like to have a greater role in the ICCR process.

The group did not attend the meeting, but had Dr. Nita Chaudhuri from European NGO Europe for a Common Future read its comments during the open meeting session.

“We feel strongly that a 10-minute presentation at a side meeting is not a substitute for full participation in a three- to four-day meeting,” Lisa Archer, the Campaign’s director, said in a July 26 interview with “The Rose Sheet.”

“We really support the goals of the ICCR, but we think the process is fundamentally flawed, and it’s just not right that government agencies would work with industry trade associations and not provide that equal access to stakeholder consumer advocates.”

CSC’s submitted comments focused on harmonizing global cosmetics regulations “upward” to the highest standards.

The group feels that other ICCR members have stronger cosmetics standards than the U.S., and is opposed to regulators “harmonizing downward” in order to achieve consensus, Archer said.

“We really urge [ICCR] to look to the highest and most health-protective standard that we see in other countries that are leading the way in this regard,” she said, pointing to the EU and Canada as examples.

The exec suggested that the U.S. should overhaul its regulations to the standards set forth in the Safe Cosmetics Act of 2011, which would help the country set a “gold standard for safe cosmetics” and become a leader “instead of a laggard” among ICCR countries. The bill was introduced by Rep. Jan Schakowsky, D-Ill., in June (Also see "Safe Cosmetics Act Would Remedy “Broken Regulatory System,” Says CFSC" - HBW Insight, 4 Jul, 2011.).

Nanomaterial safety assessment and alternatives to animal testing are two of the “most critical” areas for international alignment, according to Archer.

If regulators harmonize testing “and ensure that data is made widely available when it happens, that would be really useful across the whole industry and really help increase consumer confidence in the safety of cosmetics,” she said.

CSC also requests that the ICCR process become more transparent.

“It’s been very difficult for us to find the full proceedings for the meeting, and what exactly happens behind those closed doors,” Archer said.

CSC will continue its advocacy efforts for international “health-protective” standards and for representation equal to industry in the ICCR process, according to group’s director.

The sixth annual ICCR meeting will be held in the U.S. in 2012, with plans to include a similar session for interested stakeholders, according to FDA. A specific location has not yet been selected, Lamoriello said.

By Lauren Nardella