California DTSC’s Draft Work Plan Includes Personal Care, But Few Surprises

“Beauty, personal care and hygiene” as one of seven product categories could be priorities in the next round of product selections in California’s Safer Consumer Products program. PCPC welcomes the direction DTSC appears to be taking toward more active industry engagement over the next three years.

The California Department of Toxic Substances Control identified “beauty, personal care and hygiene products” as one of seven product categories from which priority product/chemical combinations will be selected for regulation over the next three years under the state’s Safer Consumer Products program.

In its Draft Three-Year Priority Product Work Plan released Sept. 12, DTSC says a combination of factors informed its decision to choose beauty and personal care as a targeted category, including the products’ widespread daily use, chemical exposure profiles, labeling concerns and recent regulatory movement at the state and federal level addressing cosmetics-related safety and other issues.

“Industry, the general public and regulators have become increasingly concerned about potential exposure to hazardous chemicals from beauty, personal care and hygiene products, and some have taken actions to limit the use of certain chemicals or increase awareness of the chemical ingredients,” DTSC explains.

“Our work for the next three years will be to move from these broad categories to specific product/chemical combinations that warrant consideration as potential priority products,” the department adds, noting that it expects to identify no more than 10 priority products per year.

DTSC says it will work with industry, NGOs and other stakeholders as it narrows its focus and selects priority products, which ultimately will require affected manufacturers to conduct alternatives analyses and potentially reformulate products if safer replacement chemicals are identified in the course of those evaluations.

For personal care and beauty – which for DTSC’s purposes encompasses skin care, hair care, nail care, body wash and soaps, deodorants, lip balms/gloss and fragrance, among other subcategories – candidate chemicals include:

• aldehydes, formaldehyde
• alkyl phenols & ethoxylates
• azo dyes, coal tars, lead and lead acetate
• phthalates
• triclosan
• toluene.

In an interview. Tom Myers, associate general counsel at the Personal Care Products Council, commended California DTSC for extending industry a “heads-up” via the work plan and said personal-care’s nomination came as little surprise.

“DTSC has said all along that personal care products were going to be under consideration, so I wouldn’t say it’s at all a surprise,” he said. “Personal care products are applied directly to the skin so there’s a direct exposure to the human body, so they’re going to focus on our industry as a result of that.”

As for the specific ingredients flagged for potential listing, Myers noted that broadly speaking, neither formaldehyde nor lead are substances intentionally added to personal care products, though lead can be a trace contaminant in products such as lipstick due to the color additives used in their formulation, and some preservatives used in cosmetic products release trace amounts of formaldehyde.

Under the Safer Consumer Products program, part of California’s 2008 Green Chemistry Law, DTSC sets de minimis chemical thresholds to exclude products containing prioritized chemicals at levels that do not pose a health risk, which likely would exonerate most personal care firms from having to conduct alternative analyses for products containing trace amounts of lead or formaldehyde (Also see "Pending Calif. Consumer Products Reg Inconsistent, Unfair – Trade Groups" - Pink Sheet, 27 May, 2013.).

However, Myers said he expects DTSC will need education on the issue of formaldehyde-releasing preservatives and the “vanishingly small” amounts of formaldehyde they release over time to prevent product contamination and ensure safe consumer use.

He pointed out the industry largely has moved away from use of phthalates as solubulizers and denaturants in personal care products due to safety concerns in some cases and public pressure in others. Procter & Gamble Co. is among firms that have reduced or discontinued phthalate use, announcing in 2013 that it would eliminate the final remaining phthalate from its personal care products to set consumers at ease (Also see "In Brief: Clearblue estimates weeks, Barry Meltzer dies, P&G eliminating phthalates and triclosan, NPLEx adds Delaware" - Pink Sheet, 2 Sep, 2013.).

Similarly, controversy around triclosan and its widely cited endocrine-disrupting potential has moved [Avon Products Inc.] and others to eliminate the antimicrobial ingredient from their products (Also see "Lawsuit Seeking FDA Triclosan Action Stays Alive On Appeal" - Pink Sheet, 25 Mar, 2013.).

Toluene is another chemical that personal care firms have abandoned of their own accord. While traditionally used as a solvent in the formulation of nail polishes, many manufacturers have eliminated the ingredient, along with formaldehyde and dibutyl phthalate, to join the “3-Free” marketing movement.

Stakeholder Engagement Promised

DTSC announced the first priority product/chemical combinations under the Safer Consumer Products regulation in March, zeroing in on children’s foam-padded sleeping products containing flame retardant chlorinated tris; spray polyurethane foam systems containing unreacted diisocyanates; and paint stripper containing methylene chloride (Also see "California Safer Products Review’s First Swing Misses OTC, Personal Care" - Pink Sheet, 4 Apr, 2014.).

While no personal care products made the list, PCPC and other industry groups submitted comments seeking greater visibility into the department’s selection process and more active consultation with stakeholders in subsequent rounds (Also see "Industry Seeks Perspective, Greater Role In California Safer Products Process" - Pink Sheet, 16 May, 2014.).

The newly released three-year draft plan, required of DTSC under the regulation, is a positive step toward improved transparency, serving as a “signal” to manufacturers that their products could be on the department’s radar. “Identification of these categories provides a preliminary level of regulatory certainty for manufacturers,” DTSC says, adding it expects manufacturers “will consider the product categories in this work plan, in conjunction with the candidate chemical list, to evaluate their product portfolios.”

Myers lauded the move. “They’ve given the industry not only a heads-up, but they’re also saying, ‘We’re going to be coming to you and making specific requests for information, and we want to kind of partner with you in trying to identify products.’” Compared with the first round of selections, which was based largely on a review of publicly available literature, this approach “is better for us in the sense that we’ll have the opportunity to demonstrate the safety of our products before any listing actually occurs,” Myers noted.

DTSC says it may solicit data from manufacturers and their supply chain partners, as well as trade associations and others with relevant expertise. “We expect to engage in discussions with industry experts about product formulations, supply chain considerations and industrial toxicology studies among other topics that can expand and refine our knowledge for the purposes of priority product selection,” it says.

The department will hold a workshop with stakeholders on Sept. 25 and 28, with the goal of publishing a finalized work plan soon. The six other product categories named in DTSC’s work plan are cleaning products, clothing, household/office furniture/furnishings, office machinery consumable products, building products and fishing and angling equipment.

Myers was optimistic about the “more engaged process” DTSC appears to be implementing and the ability of personal care manufacturers to respond accordingly.

“Over the next three years before the next listing takes place, it gives our companies an opportunity to look these things over and make sure they have all their ducks in a row. I’m sure they have reams and reams of safety data and information, all of which they can share with DTSC, probably ad nauseum, and give them the comfort they need not to list a particular product or chemical,” he concluded.