Policy work from the International Cooperation on Cosmetics Regulation will gain momentum as member authorities continue to jell, with increasing influence on outside jurisdictions and stakeholders, trade groups close to the process predict.

Francine Lamoriello, executive vice president for global strategies at the Personal Care Products Council, and Darren Praznik, president and CEO at the Canadian Cosmetic, Toiletry and Fragrance Association, recently spoke with “The Rose Sheet” about ICCR’s bearing on regulatory issues in the cosmetics sector.

Both trade-association reps have noted a growing acceptance and respect among ICCR member regulators over the coalition’s eight meetings since its inception in 2007.

“The ICCR process, we believe, has led to more understanding and more willingness [among regulators] to cooperate on matters related to cosmetics regulation,” Lamoriello said.

Praznik offered a similar observation. “They’re starting to understand how each other operates, they’re starting to understand where they’re able to cooperate,” he said. “There’s a trust that’s built up between them as regulators.”

In light of these maturing relationships, “I think you’re going to be able to see an accelerated amount of work done at ICCR moving forward,” the exec added.

ICCR – made up of regulators from the U.S., Canada, the EU and Japan, who receive ongoing support and input from PCPC, CCTFA and other trade groups within their jurisdictions – held its eighth annual meeting July 8-9 in Ottawa. While agreements on topics of interest take time to filter down to the level of regulation in individual member regimes, there have been developments to date that reflect ICCR’s influence.

FDA, for example, has issued guidances on cosmetics good manufacturing practices and nanomaterials in cosmetics based on ICCR work, Lamoriello pointed out Also see "Existing Safety Principles Suffice For Nano-Cosmetics Evaluation – FDA" - HBW Insight, 7 July, 2014..

Such guidances have been “not entirely consistent with ICCR documents, but clearly the ICCR documents that [FDA] endorsed are reflected in their viewpoints,” she said.

According to Praznik, Health Canada has eagerly adopted elements of ICCR agreements.

“We have been able to access some world-class expertise in a variety of subject matters that would not necessarily been available,” he noted. “And they [Health Canada] have been very quick where there’s information out of the ICCR process to incorporate it in their regulatory work.”

The agency’s guidance on heavy metal impurities in cosmetics states that trace lead concentrations exceeding 10 ppm in cosmetic products are “technically avoidable” and could warrant regulatory scrutiny, a position largely consistent with ICCR consensus, Praznik noted.

ICCR Website To Promote Global Convergence

Both trade-organization reps are confident that ICCR’s reach will expand as the group’s work progresses, informing oversight policy in jurisdictions outside its core membership.

“I personally believe that the ICCR documents reflecting the expert opinions of regulators and industry and in some cases outside experts can really be a value beyond the ICCR jurisdictions to countries that are looking to model or looking to revise or update their own regulatory systems and approaches,” Lamoriello said.

Praznik agreed, noting that ICCR’s new central website, launched in July, will play a key role in apprising non-members of the coalition’s decisions and supporting their own efforts at alignment ([A#02140721002]).

Whereas previously ICCR information was published on member-authorities’ respective websites, the newly created online portal will serve as a “one-stop-shop” for insight into ICCR developments, providing links to the group’s position papers and other key documents, Praznik said.

Lamoriello was similarly enthusiastic. “We feel that it’s not only important to make progress within ICCR, but we really hope to promote the findings within ICCR with industry and other countries around the world. Having a dedicated website is really going to be helpful with that.”

Outside stakeholders may begin to approach ICCR position papers with the same reverence increasingly shown by industry within the group’s core jurisdictions.

Lamoriello explained: “In my own point of view, I believe that those kinds of documents will be every bit as important as guidance documents for industry.”

Industry is free to implement best practices defined by ICCR even if they have not been distilled into formal guidances or regulations, as long as they do not conflict with existing regulations, she noted.

“I think implementation of [ICCR] results is in many ways going to be reflected in industry’s practices,” Lamoriello said. “With that endorsement of the regulators you have more confidence to do that.”

Lead Report Accepted

Member regulators have not yet published the outcomes of the latest ICCR meeting, which was closed to the public in accordance with ICCR policy, but the group was scheduled to discuss and hear reports from working groups regarding allergens, alternative test methods, nanomaterials, in silico prediction models and trace metals Also see "ICCR To Consider Regulatory Harmonization On Allergen Issues" - HBW Insight, 16 June, 2014..

ICCR’s core regulators accepted a report on trace lead in cosmetics, which supports a 10-ppm limit for the contaminant, according to Praznik.

The report on lead has been an ongoing project and was nearly finalized at ICCR-7, but was delayed due to differences related to testing methods, among other considerations Also see "ICCR Addresses Lead Limit, Endocrine Disruptors At 7th Meeting" - HBW Insight, 29 July, 2013..

“Getting agreement on that was important because it sets up a common standard for the world on this,” Praznik said. “If you’re going to align, you have to agree at least on your methodology.”

Also during the meeting, industry expressed support for Brazil’s Health Surveillance Agency (ANVISA) to become a full member of the ICCR, according to Lamoriello.

The agency has participated in a number of ICCR meetings as an observer and is now on the path to membership. China’s Food and Drug Administration and General Administration of Quality Supervision, Inspection and Quarantine also have attended ICCR meetings as observers, and while PCPC backs their membership as well, “they are still considering whether to apply for membership at this time,” Lamoriello said.

PCPC is already preparing for the next ICCR meeting and plans to propose new topics for consideration at that session.

ICCR-9 will be held in Rome in 2015.

“International Consumer” Drives Reform

According to Praznik, the ICCR process helps to facilitate changes demanded by an increasingly international consumer.

“That’s the person who can shop online, who sees products from around the world, is well-traveled and purchases products that are being sold around the world,” he explained. “Their expectation is that those products are going to meet the highest standards and be safe wherever they make their purchase.”

Further, as a result of manufacturing and competitive necessities in the global marketplace, materials are being sourced from all over the world and products shipped everywhere.

“In order to have economies of scale when they manufacture, manufacturers need to export to be able to compete,” Praznik said. “Products that are manufactured in any one jurisdiction likely include a host of ingredients or components that are supported by [contributions from] many other jurisdictions.”

He noted that in Canada, approximately 80% to 90% of cosmetic products manufactured in the country are exported, and the country imports a significant amount of cosmetics as well, all of which lends to global integration of manufacturing and supply chains.

“The question then becomes – in this world of integrated economic activity, and with the growing role of the international consumer – have regulations kept up with these realities?” Praznik asked. “It comes down to often some of the basic fundamentals of regulation, which ICCR is well-positioned to address.”

Moving forward, ICCR members should “find effective ways that maintain the highest standards for that international consumer while at the same time avoiding misalignments that really just create unnecessary burdens and impediments for consumers,” he asserted.

ICCR Will Have Growing Role In Setting Global Policy – Industry Groups

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