The International Cooperation on Cosmetics Regulation signaled a readiness to address the issue of product preservation – and to communicate its position on the matter to consumers and other regulators around the globe – with the acceptance of a preservatives paper at its ninth meeting.

ICCR brings together cosmetics regulators and industry representatives from the US, EU, Canada, Japan and, this year, Brazil to "enable the highest level of global consumer protection by working towards and promoting regulatory convergence, while minimizing barriers to international trade," according to its website.

In a Nov. 23 interview, Francine Lamoriello, executive VP of global affairs at the Personal Care Products Council, suggested that the preservative document's acceptance was the highlight of the league's 2015 annual meeting, held Nov. 4-6 in Brussels.

International regulatory consensus around preservative use would be beneficial to the cosmetics industry, which currently faces varying prohibitions and restrictions on preservative agents from one country or region to the next.

However, the larger issue faced by cosmetic manufacturers is a lack of consumer understanding when it comes to the importance of product preservation and the limited options at companies' disposal for ensuring against spoilage.

Increasing consumer and NGO pressure on firms to discontinue use of proven preservative systems, such as parabens, due to perceived hazards – despite the proportionately greater health benefits they may provide – is depleting industry's preservative palette, raising concerns about potential contamination risks.

"The industry and the regulatory community recognize that this is a very important issue. We have to protect our products, we have to assure product safety, and preservatives are absolutely an important way to do that," Lamoriello asserted.

To raise awareness of the issue, ICCR participants have developed a Frequently Asked Questions document, which will soon go live on the ICCR website, the exec said.

According to Lamoriello, the resource includes information on preservatives' critical role in cosmetic products and the safety testing they undergo prior to market use. She said the document is composed in "top-level" consumer-friendly language to be accessible to the public and then offers links to more detailed information and scientific papers for those interested in exploring the issue in greater depth.

The FAQ also seeks to impress on readers the importance of maintaining a wide selection of preservatives for industry use.

The document currently is in its final editing stages, Lamoriello said. According to the exec, ICCR regulators were receptive to the idea of using their public-affairs resources and communications platforms to promote the FAQ once it publishes.

At a September meeting held in preparation for ICCR, Linda Katz, director of FDA's Office of Cosmetics and Colors, noted that preservatives were on the group's agenda for the first time Also see "ICCR Adds Cosmetic Product Preservation To Agenda For Ninth Meeting" - HBW Insight, 18 September, 2015..

ISO Standards On ICCR Radar

Also at the meeting, industry presented a report on the International Standards Organization's work in the area of cosmetics, and ICCR members agreed to develop a new working group "tasked with prioritizing the list of relevant ISO standards to be considered for new work items."

ISO, an international non-governmental organization, develops standards for products, services and systems across "almost every industry," drawing on the cooperative efforts of more than 160 national standard bodies, including the American National Standards Institute.

Lamoriello said industry has been working to coordinate ICCR's work with ISO activities, recommending in its report that ICCR consider ISO documents in development before taking on new projects.

Currently, ISO's cosmetic standards catalogue includes a slew of documents in varying stages of development, addressing such topics as microbiology (Evaluation of the antimicrobial protection of a cosmetic product), which has published already, and natural/organic cosmetics (Guidelines on technical definitions and criteria for natural and organic cosmetic ingredients and products), Part 1 of which is nearing publication, according to ISO's website.

Other published (but not yet reviewed or confirmed) ISO standards include one detailing an "analytical approach for screening and quantification methods for heavy metals in cosmetics," as well as two related to sunscreen UVA testing. While sunscreens are regulated as OTC drugs in the US, the EU and other jurisdictions consider such products cosmetics.

According to Lamoriello, the next step for ICCR will be to look at existing ISO documents "and try to prioritize those so that we can make some decisions on which of them ought to be looked at more in-depth for ICCR recommendations – the ones that have the greatest impact."

Context Sought For Emerging Animal-Test Alternatives

Much of the work tackled at the November ICCR meeting represented a continuation of earlier initiatives regarding animal testing alternatives, allergens, microbial contaminants and trace contaminants.

Reports on trace contaminants mercury and 1,4-dioxane continue to undergo review, according to Lamoriello.

ICCR participants received an update on the activities of the European Union Reference Library for Alternatives to Animal Testing, hosted by the European Commission's Joint Research Center, and the broader International Cooperation on Alternative Test Methods, which involves alternative-testing authorities from other ICCR countries.

Industry members proposed a new working group to focus on "integrated methods and approaches for safety assessments of ingredients used in cosmetic products."

From industry's point of view, available lists of alternative methods "are not as useful as a document or work that would consider how industry can use a variety of integrated methods and approaches to assure the ingredient safety," according to Lamoriello.

A new working group could look at alternative testing strategies in context and assess their viability for use by the cosmetics industry, she suggested.

"We really want to demonstrate how industry can proceed with a more integrated approach regarding alternatives," the exec said. "It potentially has a lot of value not only for industry and regulators in the ICCR network, but around the world where regulators are considering what to do about alternatives."

The meeting marked the first time that Brazilian regulators have participated in ICCR on a full membership basis. Brazil's National Health Surveillance Agency (ANVISA) was accepted as a full member at ICCR-8 in Ottawa.

Regulators representing China, Thailand, South Africa and Saudi Arabia were in attendance as observers at the latest ICCR meeting.

The interest shown by those parties points to "the real value of ICCR," according to Lamoriello, who noted that they "expressed a great deal of interest in participating in ICCR going forward."

ICCR-10 will be held in July 2016 in Washington, with US regulators taking the lead on proceedings.

Cosmetic Preservation Issue Taken Up By ICCR Regulators

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