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Spray Jan 15

Farah K. Ahmed & Tom Myers, Associate General Counsel, The Personal Care Products Council (PCPC) Sunscreens are an important over-the-counter (OTC) drug used to protect individuals from the damaging effects of the sun. Sunscreen sprays are a popular means of administering sunscreens on children, especially because we know that one bad sunburn in childhood doubles the risk of developing skin cancer later in life. The U.S. Food & Drug Administration (FDA) is in the process of developing regulations addressing the use of spray sunscreens. In 2011, FDA published an advance notice of proposed rulemaking (ANPR) acknowledging sprays as an appropriate sunscreen dosage form and requested additional data to support their effectiveness and safety, as well as comments on potential changes in labeling of sunscreen sprays (e.g., hold container four to six inches from the skin to apply; do not spray directly into face; spray on hands then apply to face; do not apply in windy conditions; use in a well-ventilated area). PCPC provided data and information supporting the efficacy and safety of sunscreen sprays, and supported FDA’s proposed labeling changes. In addition, PCPC has worked to scale back the scope of a consumer product survey being conducted by the California Air Resources Board (CARB), which requires companies to report formulations and sales data over a three-year period in an effort to develop a baseline for volatile organic compound (VOC) emissions in the California marketplace. Sunscreens, and other OTC drugs, are included within the scope of the survey. Although the survey continues to be challenging for reporting companies, it is far less onerous than originally proposed thanks to an engaged business community. Likewise, PCPC continues to focus on challenges presented by California’s Proposition 65, which lists chemicals that have been identified by an authoritative body as carcinogenic or reproductive toxicants. In 2012, titanium dioxide (TiO2), an important sunscreen ingredient, was listed as a carcinogen. After many rounds of intense negotiations with CARB, we were successfully able to ensure that certain “qualifiers” were included in the Prop 65 listing, limiting TiO2 to only that which is airborne, respirable and unbound. In 2015, PCPC will work with the FDA to make progress on advancing the ANPR towards finalization of regulations on sunscreen spray dosage forms; help companies as they seek to comply with the onerous CARB survey; and take steps to ensure that ingredients important to sunscreen formulations—and other personal care product formulations—are not listed to Prop 65, or if they are, to ensure an appropriate “safe harbor” level is established. Heidi McAuliffe, Senior Counsel, Government Affairs, American Coatings Association (ACA) In California, the amendments to the aerosol coatings reactivity regulation have become final and aerosol coatings manufacturers The regulatory arena… their background paper that they intend to focus on paper and plastic products and its preference to implement mandatory Extended Producer Responsibility (EPR) programs (a strategy designed to promote the integration of environmental costs associated with goods throughout their life cycles into the market price of the products) to meet the aggressive requirement of 75%. CalRecycle did say they currently do not have the authority to implement mandatory programs, which should lead to legislation in 2015 designated to give them that power. OEHHA is pursuing changes to the Prop 65 regulations that require businesses to list warnings on their products if they contain chemicals known to cause cancer or birth defects or other reproductive harm. The department has shared draft regulations for stakeholders to review and share feedback. These draft regulations included a requirement to identify up to 12 specific chemicals in a warning, foreign language requirements for warnings and changes to the safe harbor provisions. The formal regulation process is expected to begin in early 2015. Doug Raymond, Raymond Regulatory Resources (3R), LLC I have been accused of being a bearer of bad news; so as to not to disappoint anyone, here is my outlook for 2015. Two areas of regulation I see ramping up are volatile organic compounds (VOC) and Green Chemistry. The U.S. Environmental Protection Agency (EPA) is likely to pass a new, stricter ozone standard early in 2015. This means that numerous states will be trying to find more emission reductions. Therefore, more states are likely to follow the Ozone Transport Commission’s (OTC) and California Air Resources Board’s (CARB) lead on Consumer Product regulations. Likewise, CARB and OTC will then need to find more emission reductions. CARB will likely start new Consumer Product rule developments in late 2015 and early 2016. Regarding Green Chemistry regulations, California has taken the lead on these types of regulations, calling them the Safer Consumer Products regulations. I believe most states will hold off on these types of regulations until they see how California handles its current regulation. This current draft regulation will likely take a year to finalize, which means very late in 2015. Green Chemistry-type regulations are new for the industry and affect how products are formulated. Currently, California has a three-year plan that includes a majority of our aerosol products. Therefore, for the foreseeable future, Green Chemistry will be another regulation that the industry will need to deal with on an ongoing basis. This adds another dimension to the formulation of Consumer Products. Another extremely important issue involves trying to comply with the Global Harmonization System (GHS) by the 2015 deadlines. Likewise, the Significant New Alternatives Policy (SNAP) amendments will be finalized in 2015 and we will have to deal with that regulation, as well. Myers Raymond 14 Spray January 2015


Spray Jan 15
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