At the sixth annual meeting of the International Cooperation on Cosmetics Regulation, regulators from the U.S., the EU, Canada and Japan reached agreements on reports offering guidelines for regulatory harmonization regarding nanomaterials, trace impurities and animal testing alternatives.

“We hope that ICCR can be a facilitator of greater global harmonization because countries who are not yet participating in ICCR or are participating as observers can have access to these reports, and frankly, these reports can serve as guidances for industry worldwide,” Lamoriello suggested.

The member-country regulators are working to finalize those reports, which are slated for release this fall, according to Francine Lamoriello, executive vice president of global strategies for the Personal Care Products Council.

“Guidances or recommendations that come out of ICCR hopefully are going to be adopted by the four ICCR countries at least in practice if not in regulation, depending on their individual systems and how they work,” she explained in a July 25 interview with “The Rose Sheet.”

FDA posted a notice on its website July 24 listing “outcomes” of the ICCR meeting but has not released details of the reports. The meeting was held July 10-13 in Rockville, Md.

In the nanotech realm, the reports include “Characterization of Nanomaterials II: Insoluability, Biopersistence and Size Measurement in Complex Media” and “Safety Approaches to Nanomaterials in Cosmetics.”

According to Lamoriello, the nanomaterial characterization report builds on a report accepted during ICCR-5, which suggested that nanomaterials should be measured in final personal-care product formulations, not at earlier stages in the development process Also see "Nanomaterials Should Be Measured In Final Product Formulations – ICCR Report" - HBW Insight, 7 November, 2011..

The report on nanomaterial safety approaches is important as well, she noted. “The document was worked on last year, but it wasn’t ready for publication last year, and more work was done throughout this year in order to finalize it,” she said.

As for trace impurities, the reports make recommendations for limits for lead and 1,4-dioxane in cosmetic products, Lamoriello said.

Over the past few months, ICCR regulators have been reviewing a draft report on lead levels. FDA officials were optimistic that the regulators would adopt a 10-ppm lead limit at their sixth meeting Also see "ICCR Aims To Adopt Tolerable Lead Level For Cosmetics At July Meeting" - HBW Insight, 16 April, 2012..

ICCR members also reached an agreement on the revised report “Applicability of Animal Testing Alternatives in Regulatory Framework within ICCR Regions,” according to the FDA posting.

Additionally, ICCR regulators received an updated report on activities of the International Cooperation on Alternative Test Methods and “acknowledges the usefulness” of a separate ICATM status report on alternative test methods, validation and regulatory acceptance as a reference for industry, FDA says.

Expansion On Horizon?

While ICCR membership currently comprises four regulatory bodies, the group may be looking to expand in the future.

Regulators and industry associations from Australia, Brazil, China, South Korea and Saudi Arabia attended the event this year and participated in select ICCR sessions as observers.

Lamoriello said industry was pleased with the introduction of new countries as observers, calling it “one of the most exciting developments this year.”

Industry hopes that the countries can be included in ongoing ICCR work as ICCR regulators consider growing the organization’s membership, she said.

“We hope that ICCR can be a facilitator of greater global harmonization because countries who are not yet participating in ICCR or are participating as observers can have access to these reports, and frankly, these reports can serve as guidances for industry worldwide,” Lamoriello suggested. “From our perspective, these can be really useful ways to promote harmonization.”

Last year for the first time, ICCR featured a session in which NGOs and regulators of non-member countries were invited to join the dialogue Also see "ICCR Accepts Four Regulatory Guidance Reports; NGOs Seek Bigger Role" - HBW Insight, 1 August, 2011..

That opportunity was repeated this year, with consumer groups and industry associations presenting to regulators at a stakeholder meeting July 12.

Developments Ahead

Work has already begun for ICCR-7, to be held July 2013 in Tokyo.

ICCR members will “continue to consider additional issues pertinent to the characterization and safety of nanomaterials,” according to the FDA website.

As for trace impurities, industry has proposed that the group now focus on other heavy metals and mercury, according to Lamoriello. ICCR has formed a Traces Working Group to address those concerns.

Regulation of endocrine disruptors is another area that will be explored in the future, the exec said.

“There’s an interest in at least considering how this can be worked on by ICCR,” she remarked. “Industry is going to try to put together a proposal for work in this area.”

ICCR will also develop a working group to explore in silico (computer simulation) methods and their use in assessing cosmetic ingredient safety. During the meeting in Rockville, ICCR members learned about Quantitative Structure-Activity Relationship (QSAR) prediction models and their role in safety evaluations.

ICCR Finalizing Nanotech, Trace Impurities Reports Following 6th Meeting

More from Europe

More from Geography

ICCR Finalizing Nanotech, Trace Impurities Reports Following 6^th Meeting