It’s Time: New Prop 65 Warnings are Required August 30, 2018

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In November 2017, we advised readers of Conkle, Kremer & Engel’s blog that products sold in California would become subject to new Proposition 65 warning requirements beginning August 30, 2018.  The new “Clear and Reasonable Warning Regulations” from California Office of Health Hazard Assessment (OEHHA) significantly changed warning requirements for affected products that are manufactured on or after August 30, 2018.  Among other changes, the new regulations affect the safe-harbor warning requirements that govern the language, text, and format of such warnings, and also impose downstream warning mandates through retail, online and catalog sales channels. Generally, some of the major changes that companies selling consumer products should be aware of include:

  • The “warning symbol” :  A graphic “warning symbol” is now required on consumer products, other than food products. The “warning symbol” must be printed in a size no smaller than the height of the bolded word “WARNING,” and should be in black and yellow, but can be in black and white if the sign, label, or shelf tag for the product is not printed using the color yellow. The entire warning must be in a type size no smaller than the largest type size used for other “consumer information” on the product, and in no case should be smaller than 6-point type.
  • Listing of a specific chemical:  Warnings must now specifically identify at least one listed ingredient chemical for each toxicological endpoint (cancer and reproductive toxicology) and include a link to OEHHA’s new website P65Warnings.ca.gov. Certain special categories of products, such as food and alcoholic beverages, have a specialized URL that must be used instead.
  • New warning language:  Warning language must now warn of an exposure to a chemical or chemicals from the product, rather than just warn that the product contains the chemical or chemical. For example, “ WARNING: This product can expose you to diethanolamine, which is known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.”
  • Internet and catalog requirements:  For internet sales, warnings must be provided with a clearly marked hyperlink on the product display page, or otherwise prominently displayed to the purchaser before completion of the transaction. It will not be sufficient if the product sold on the internet bears the required label, but the internet point of purchase listing does not. For catalog sales, a warning must be provided in a manner that clearly associates it with the item being purchased.
  • Short-form warnings:  The regulations allow the use of certain abbreviated “short-form” warnings, which may omit the identity of any specific chemical, only if the warning is printed on the immediate container, box or wrapper of the consumer product or is affixed to the product.  For example, “ WARNING: Cancer – www.P65Warnings.ca.gov.”  If a short-form warning is used on the product, the same short-form warning may be used for internet and catalog sales.

The regulations seek to minimize the burden on retail sellers of consumer products, but there are some obligations affecting resellers. Manufacturers, producers, distributors, and other upstream businesses comply with warning requirements if they affix a clear and reasonable warning to the product, or provide written notice and warning materials to an authorized agent of a retailer, among other requirements.  Retailers who receive products with a Proposition 65 warning on the label, or who receive proper notice that a warning is required, are responsible for placement and maintenance of internet warnings for those products before selling to consumers in California.  Retailers should only be liable for Proposition 65 violations under limited circumstances, such as if they cover, obscure, or alter a product’s warning label, or if they receive notice and warning materials but fail to display a warning, including catalog and internet warnings preceding consumer sales into California.

The particular requirements for each specific product can vary, so manufacturers and resellers are well-advised to seek qualified counsel to review their circumstances before committing to potentially costly label and website changes that may not comply with the new requirements.  Conkle, Kremer & Engel attorneys stay up to date on important regulatory developments affecting their clients in the manufacturing and resale industries, and are ready to help clients navigate the changing regulatory landscape in California and elsewhere.

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October 2018 Update

H. Kim Sim of CK&E was interviewed and quoted extensively in ChemicalWatch about the difficulties manufacturers face in implementing the “very confusing and very complex” requirements of the new warning label requirements of Prop 65.  For example, as Kim said, “The requirement that manufacturers name at least one substance for which they are providing warning has proven particularly challenging. Determining which one to include ‘can be tricky for companies to decide’, she said. ‘Is one more scary to the public than another?'”

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The Conkle Firm Presentation at 2018 PCPC Legal & Regulatory Conference

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On May 9, 2018 Conkle, Kremer & Engel attorney John A. Conkle presented on “The State of the States” panel at the 2018 Personal Care Products Council’s Legal & Regulatory Conference.  The panel focused on the increasingly strong role of state legislatures and state regulatory bodies in addressing issues of importance to the personal care products and cosmetics industries.  The panel featured lively discussion of issues arising from the evolving patchwork of laws and regulations among numerous states, including California’s infamous Proposition 65, slack fill laws, and labeling and ingredient disclosure regulations, ingredient phase-out requirements and outright bans, volatile organic compound limitations to protect air quality, and animal testing regulations.  The discussion included the importance of preservation and presentation of evidence to support manufacturers’ positions, including testimony in depositions and at trial.

The panel’s presentation is available here for review.  Contact John Conkle to discuss the latest issues affecting the state of the personal care products and cosmetics industries.

 

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The Conkle Firm to Present at 2018 PCPC Legal & Regulatory Conference

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Conkle, Kremer & Engel attorney John A. Conkle will be on the panel opening the 2018 Personal Care Products Council’s Legal & Regulatory Conference.  The panel will present “The State of the States,” which will focus on the increasingly strong interest of state legislatures and state regulatory bodies in addressing issues of importance to the personal care products and cosmetics industries.

States have come to recognize that, with the U.S. Congress largely gridlocked and federal regulatory agencies in a deregulation mood, the path is open for the states to regulate consumer industries in manners that they deem fit.  The result is a continuously evolving patchwork of laws and regulations that can be difficult for industry participants to navigate.

Issues to be discussed at the May 9, 2018 panel presentation include California’s infamous Proposition 65, slack fill laws, and labeling and ingredient disclosure regulations that include even public databases disclosing products’ ingredients found by state governments to be detrimental.  Further, state regulations can include ingredient phase-out requirements and outright bans, volatile organic compound limitations to protect air quality, and even animal testing regulations that can affect industry participants’ ability to compete in international trade.

A lively discussion is inevitable given the rich and topical subject matter and the vital industry interests affected.  The rest of the Legal and Regulatory Conference program should be just as engaging, covering topics such as employment law, cannabis (THC, CBD, marijuana extracts and hemp) in cosmetics and personal care products.  The many other topics to be covered in the three-day conference in Savannah, Georgia can be found in the conference program.

 

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CK&E Attorneys Lobby California Legislature with PCPC

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On March 20, 2018 Conkle, Kremer & Engel attorneys Eric S. Engel and Aleen Tomassian helped the Personal Care Products Council fulfill part of its mission by organizing and executing an effective lobbying day to advance the legislative interests of the industry.  Led by PCPC Senior Vice President Government Affairs Mike Thompson and PCPC Director of Government Affairs Karin Ross, a group of personal care product industry members, lobbyists and advisors heard presentations by pivotal regulatory agencies and then met with key legislators and their staffs to address issues of importance to the industry.

PCPC Chief Scientist Alex Kowcz seminar to Calif Legislative Staff

The PCPC held a luncheon at which it presented its first Legislator of the Year Awards to congresspersons who have been the most effective in advancing the important interests of both business and consumers in relation to personal care products.  Legislative staff also received an educational presentation from PCPC’s new Chief Scientist, Alex Kowcz, to help bring to Legislators the most current scientific information about issues affecting personal care products.  After a long day of meetings, participants unwound and connected at an informal reception for legislators, the governor’s office and administration officials at Ella, a popular restaurant near the State Capitol.

 

Eric S. Engel and Aleen Tomassian at PCPC Calif Lobby Day Reception

Some of the highlights of the 2018 PCPC California Lobby Day included a presentation by Meredith Williams, Deputy Director of Department of Toxic Substances Control (DTSC), and Rick Brausch, Chief of DTSC’s Policy and Program Support Division, Hazardous Waste Management.  The mission of the DTSC is the Safer Consumer Products (SCP) program, directed toward advancing the design, development and use of products that are chemically safer for people and the environment.  The aim is to reduce toxic chemicals in consumer products and create new business opportunities in green chemistry.

Dr. Williams advised the PCPC group that DTSC’s SCP program intends to focus over the next three years on nail salon products, particularly to assure a safe working environment for salon employees as well as customers, such as by assuring adequate ventilation and safety equipment.  Dr. Williams also noted that Volatile Organic Compounds (VOCs) are not only within the ambit of California’s Air Resources Board (ARB) as to their effect on the environment, but they are also within the scope of DTSC’s authority when regulation of VOCs can meaningfully enhance protection of human health.

On February 8, 2018, DTSC released a draft 2018-2020 Priority Product Work Plan for public review, in which “Beauty, Personal Care and Hygiene Products” are identified as targets for possible regulation.  Of some concern to PCPC, the Priority Product Work Plan includes DTSC’s interest in broad classifications of chemicals without defining exactly which chemicals in what formulations are of concern.  For example, DTSC’s Priority Product Work Plan identifies oxybenzone, BPA, DEA, formaldehyde, phthalates, parabens, triclosan, titanium dioxide, tolulene and VOCs as classes chemicals being considered for possible regulation, but there are a great many specific chemicals, formulations and uses within such classes, and not all of them are likely to be of concern to DTSC.  PCPC expressed its concern that broad classifications can cause confusion among manufacturers and consumers, and unnecessarily inhibit product development and sales.  For example, oxybenzone (aka Benophenone-3) is one of just 16 chemicals approved by the US Food and Drug Administration (FDA) as safe and effective for use as an ultraviolet (UV) filter to achieve broad-spectrum sun protection.  The health benefits of effective UV sunscreens are well documented, but the broad suggestion of “endocrine toxicity” or “dermatoxicity” in DTSC’s identification of oxybenzone is on shaky scientific footing.  Dr. Williams noted that the 2018-2020 Priority Product Work Plan is only in draft form, and that DTSC recognizes the broad nature of the chemical groups identified and is working on identifying specific chemicals of concern rather than entire classes of chemicals.

DTSC’s Richard Brausch spoke of the hazardous waste logistics issues facing the personal care product industry, affecting the entire supply chain from manufacturers to retailers.  The issue often occurs when products are returned from retailers, and questions arise as to whether they may be regarded as hazardous waste if they are no longer considered fit for regular sale, such as when new product labeling is introduced.  Issues can arise as to who has responsibility for proper transportation and disposal of the products, whether by sale in secondary markets, repair or refurbishment, donation to charities or recycling.  It is notable here that improper transportation and disposal has led some local authorities to sue retailers and wholesalers for failing to use hazardous waste transporters.  That in turn has caused retailers to impose anticipatory disposal charges on manufacturers and wholesalers for a wide range of products.  PCPC therefore supports Assembly Member Bill Quirk’s introduction of new legislation, AB 2660, which places the onus on the disposal company to determine the correct method of transportation, as that is not within the expertise expected of retailers.

The overriding hazardous waste concern is that California uses an “aquatic toxicity” (aka “fish kill”) test that is grossly out of alignment with federal law, and which results in most cosmetic products being characterized as hazardous under California law.  The “fish kill” test is exactly like it sounds – it tests only whether quantities of the subject product added to a water tank will kill fathead minnows.  The test is not regarded as especially accurate, notably because high viscosity products that are otherwise harmless can kill the fish by clogging their gills.  Further, the test presents a significant problem for the personal care products industry, which has taken a strong stand against animal testing, so manufacturers generally do not conduct this “fish kill” test on finished products.  PCPC therefore advocates a more modern approach to accomplish the same goal, by use of a more recently developed fish embryo test (FET), in which live fish are not killed.

An interesting side note is that SB 1249 was introduced by Senator Cathleen Galgiani to prohibit importation or retail sale of any cosmetic that was developed or manufactured using animal testing after January 1, 2020.  While PCPC takes a strong stand against animal testing, it could not support the bill as written because it included no exception for products marketed in countries (notably China) which require that products be subject to animal testing.  Rather, the PCPC has been working to obtain an amendment of the proposed legislation to make it conform to that of the European Union, which has strong anti-animal testing regulations but allows for accommodations to make products acceptable for sale in China.

Dr. Michael Benjamin, Air Resources Board Chief of Air Quality Planning and Science spoke about the substantial product data that ARB had collected from product manufacturers selling in California, through extensive annual surveys conducted over the past three years.  From that data, ARB is working to identify trends in emissions of VOCs.  Of particular interest is a February 15, 2018 publication in the academic journal Science of a study of VOC emissions from consumer products.  The Science publication (Volatile Chemical Products Emerging as Largest Petrochemical Source of Urban Organic Emissions, by Brian C. McDonald, Joost A. de Gouw, Jessica B. Gilman and others), Science Vol. 35, Issue 6377, pp. 760-764 (Feb. 16, 2018)) caught popular attention and some popular press because it found that vehicle emissions had become so much cleaner over the past decades that they were now responsible for less than half of VOC emissions.  Overall, the total volume of VOCs had diminished greatly.  Further, while the Science article authors made many assumptions on which they based their assessment of VOC contributions of consumer products, Mr. Benjamin pointed out that ARB has the actual data from its industry surveys to determine whether the author’s assumptions and conclusions are well founded.  ARB therefore intends to do its own assessment of the points made in the Science article to determine what further action is appropriate.

PCPC’s first Legislator of the Year Awards were presented to Senator Ed Hernandez, Assembly Member Bill Quirk and Senator Galgiani.  In his comments to PCPC members, Senator Hernandez emphasized, “We want business to stay here in California, we want businesses to be successful.  There’s a lot of people here that purchase your products.”   Assemblyman Quirk addressed the need for common sense limitations on legislation such as Proposition 65, remarking that “[Someone] sent me a package of Coors beer with a Prop 65 warning on it.  We now have cases in court where people want Prop 65 warnings on coffee. * * * One study after another shows it’s not a health risk. * * * We’ve got to do something about this.  I’m definitely going to be working as time goes on in the legislature so that we don’t end up with things that are harmless being labeled.”  Finally, Senator Galgiani observed that good legislative policy is not a zero sum game:  “It’s not about having a proposal that’s just good for the environment or just good for business but we can meet in the middle and have regulations and policies that work for both sides and help everybody involved.  It’s just harder to get there – it takes more work, it takes more time and it takes patience, and all of you [at PCPC] have done a great job.”

 

 

 

 

 

 

 

 

 

 

See the Beauty Industry Report article on the PCPC California Lobby Day here.

 

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CK&E Sponsors 2016 PCPC Emerging Issues Conference

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Conkle, Kremer & Engel is proud to once again sponsor the Personal Care Products Council Emerging Issues Conference on November 10, 2016 at the Ritz Carlton Hotel in Marina Del Rey, California.

John Conkle will attend the conference on behalf of CK&E to address current legal trends and developments in the cosmetic and personal care products industry.  This annual event by the PCPC – the leading national trade association for the cosmetic and personal care products industry – is a must-attend for beauty companies across the country, with its unique focus on the many challenges that are on the horizon for the beauty industry.  The presentation this year will include a particularly timely focus on international trade issues affecting the cosmetics industry, including appearances by industry representatives from Canada and Mexico.

This year’s conference is particularly topical panel discussion entitled “2016 Elections: What happened and what it means for you!”   The panel included Dan Schnur, a leading political strategist and Director of Jesse Unruh Institute of Politics at University of Southern California, which runs the USC-Los Angeles Times Daybreak Poll that was one of the few polls to correctly predict Donald Trump’s election.  In comments during their PCPC presentation, the panel noted that if President Trump follows through with pledges such as environmental regulation rollbacks, it is likely that California will respond by enacting its own additional rules and regulations.

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Michael Thompson, Senior VP, PCPC Government Affairs; Dan Schnur Director, Jesse Unruh Institute of Politics, USC; Darius Anderson, CEO, Platinum Advisors

CK&E is pleased to once again participate in this annual event and to offer its experience and insight into legal issues affecting the industry to the PCPC and its members.

2016-emerging-issues-conference-cke-sponsor

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CK&E to Present on Emerging Legal Issues at PCPC Emerging Issues Conference

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Conkle, Kremer & Engel attorneys John Conkle and Kim Sim will once address current legal trends and developments in the cosmetic and personal care products industry at the Personal Care Products Council (PCPC)’s Emerging Issues Conference on November 18, 2015 at the Ritz Carlton Hotel in Marina Del Rey, California.

John and Kim will present on “Emerging Legal Issues in the Cosmetic and Personal Care Products Industry.”  The topics to be discussed include recent developments involving enforcement of prohibitions on container slack fill, trends in lawsuits and agency action concerning advertising, an update on the California Air Resources Board’s ongoing Consumer and Commercial Products Survey, as well as a discussion about protecting companies from counterfeiting and cybersquatting in the digital age.

CK&E’s presentation from last year’s Emerging Issues Conference can be found here.

The annual event by the PCPC – the leading national trade association for the cosmetic and personal care products industry – is a must-attend for beauty companies across the country, with its unique focus on the many challenges that are on the horizon for the beauty industry.

This year’s agenda will also include updates from the PCPC on key issues for the industry and from the California Department of Toxic Substances Control on the California Safer Consumer Products and Workplaces regulations, as well as presentations on emerging issues in the Americas, safety standards for cosmetics, current and future challenges for Proposition 65.  In addition, Deputy Attorney General Robert Sumner is slated to speak at the conference.

CK&E is pleased to once again participate in this annual event and to offer its experience and insight into legal issues affecting the industry to the PCPC and its members.

 

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The Conkle Firm to Advance Legislative Awareness of Personal Care Product Issues

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On April 22, 2015, Conkle, Kremer & Engel attorney John Conkle will again participate in the Personal Care Products Council California Lobby Day, an annual event organized by the PCPC and held at the California State Capitol in Sacramento.

The ambitious, single-day event puts the spotlight on the personal care industry as a key industry for the California economy.  According to the PCPC, the beauty and personal care products industry positively affects California in at least the following ways:

  • The industry contributes $22 billion to the state’s Gross Domestic Product (GDP)
  • The industry contributes $6 billion to the state in taxes
  • The industry employs over 500,000 workers associated with the manufacture, distribution and sale of cosmetics and personal care products
  • There are over 550,000 licensed beauty professionals in the salon and spa industry

The PCPC’s annual Lobby Day includes a full day of meetings with legislators and state officials, starting with a meeting at the Governor’s Office with top administrative officials.  The meetings are followed by educational briefings for legislative staff.  While the briefings for staff are taken place, PCPC staff and members will visit legislative offices to speak with lawmakers about bills of interest.  The day concludes with a legislative reception for California legislators, the Governor’s Office staff and Administration officials.

Among the legislation that is likely to be addressed with lawmakers at Lobby Day are

  • Assembly Bill (AB) 888 (Bloom), which would prohibit the sale of personal care products containing plastic microbeads after January 1, 2020, and
  • AB 708 (Jones-Sawyer), which would prohibit the manufacture, sale or distribution of certain consumer products unless the manufacturer discloses each ingredient contained in the product by posting that information on the product label and on the manufacturer’s website, and provides the website and web page address on the product label, along with a prescribed statement.

Other bills of interest to PCPC include the Proposition 65 bill AB 543 (Quirk), which would provide that a person in the course of doing business does not knowingly and intentionally expose an individual to a chemical known to the State of California to cause cancer or reproductive toxicity if there exists an exposure assessment that meets specified requirements.  In addition, the PCPC will present its positions on hazardous waste bill AB 1075 (Alejo) and pharmaceutical waste bills AB 901 (Gordon) and AB 45 (Mullin) with legislative officials.  Other key regulatory issues of importance to the personal care industry such as Green Chemistry, Proposition 65, Hazardous Waste, California Organic Products Act and Air Quality are also expected to be addressed at Lobby Day.

CK&E regularly participates in personal care product industry events.  As an active member of the PCPC, CK&E is pleased to support the industry’s efforts to advance the legal and regulatory interests of the PCPC and its member companies and is proud to have been invited to again participate in California Lobby Day.

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The Conkle Firm to Present on Emerging Legal Trends in Personal Care Products Industry

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On November 19, 2014, Conkle, Kremer & Engel attorneys John Conkle and Kim Sim will speak on emerging legal trends in the cosmetic and personal care products industry at the Emerging Issues Conference in Santa Monica, California.  Their topics will include recent developments concerning hazardous waste regulation, trends in advertising and class action litigation affecting the personal care products industry, and an update on California’s regulation of volatile organic compounds in consumer products.

The Emerging Issues Conference is an annual presentation by the Personal Care Products Council.  The PCPC is the leading national trade association for the cosmetic and personal care products industry and represents the most innovative names in beauty today.  For more than 600 member companies, the PCPC is the voice on scientific, legal, regulatory, legislative and international issues for the personal care product industry. The PCPC is a leading and trusted source of information for and about the industry and a vocal advocate for consumer safety and continued access to new, innovative products.

Please join CK&E at the conference to hear important information on the latest legal trends affecting the industry.

 

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The Conkle Firm is Featured in April 2014 Beauty Industry Report

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Conkle, Kremer & Engel is proud to again be the subject of a feature interview in the industry-leading publication, Beauty Industry Report (BIR).  BIR is a monthly 24-page executive newsletter for professionals that focuses on the emerging trends affecting the beauty industry.  CK&E’s feature interview assessed the latest legal trends, based on CK&E’s decades of experience in the industry.  Topics covered included trademark and brand protection, both international and domestic, regulatory compliance issues such as California’s Proposition 65 and the Safe Cosmetics Act, issues in manufacturer-distributor relationships, and more.

The attached article includes links to topical blog posts and websites referenced in the interview.  CK&E wishes to thank BIR’s Mike Nave for taking the initiative to disseminate information about these important industry issues.  BIR proved again that working in the beauty industry without reading BIR is like working in finance without reading The Wall Street Journal.

BIR Feature Interview of CK&E

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DTSC Announces Proposed Priority Products Subject to California Green Chemistry Initiative

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The California Department of Toxic Substances Control (DTSC) has identified the first three groups of products that may become “Priority Products” subject to reporting and alternatives assessments requirements under California’s strict new Safer Consumer Products (SCP) Regulations.

The three groups of products on this initial list of proposed “Priority Products” are:

  • Children’s foam padded sleeping products containing the flame retardant Tris(1,3-dichloro-2-propyl) phosphate (TDCPP or Tris)
  • Spray polyurethane foam (SPF) systems containing unreacted diisocyanates
  • Paint and varnish strippers and surface cleaners containing methylene chloride

Rulemaking on the proposed “Priority Products” list is expected to begin in late June 2014, with the final “Priority Products” list to be finalized by the following year by adoption of regulations.

If the product-chemical combinations announced by DTSC end up on the list of final “Priority Products,” manufacturers and other responsible entities (including importers, assemblers and even retailers) of these products will be required to notify DTSC and either remove the product from sale, reformulate to remove or replace the chemical of concern in the product, or perform a complex “Alternatives Analysis” to retain the chemical in the product.

As widely expected, the initial “Priority Products” list targets children’s foam padded sleeping products containing the flame retardant Tris(1,3-dichloro-2-propyl) phosphate (TDCPP or Tris), such as nap mats and pads in soft-sided portable cribs, infant travel beds, portable infant sleepers, playards, play pens, bassinets and nap cots.

In addition, the initial “Priority Products” list targets all paint and varnish removers, paint and varnish strippers and surface cleaners that contain methylene chloride.  Spray polyurethane foam systems containing diisocyanates, both professional and consumer grade, are also proposed to be subject to regulation.  Such products are used for insulation, roofing, sealing and filling of voids and gaps.

TDCPP, methylene chloride, and toluene diisocynate are known carcinogens and exposures to the chemical to Californians above the no significant risk level require a warning under Proposition 65.  TDCPP was recently listed in October 2011 as a chemical regulated by Proposition 65.

The announcement of these three product groups as proposed “Priority Products” does not trigger any duty on product manufacturers until the DTSC finalizes the list of priority products by adopting regulations.  However, manufacturers of children’s foam padded sleeping products containing TDCPP, spray polyurethane foam systems containing diisocyanates, and paint and varnish strippers and surface cleaners containing methylene chloride are well advised to be proactive and take steps to determine whether the chemical can be removed from their products or replaced with a safer alternative chemical.

Conkle, Kremer & Engel regularly assists businesses to develop plans to ensure compliance with California’s ever-changing regulations, including the Safer Consumer Products Regulations and Green Chemistry Initiative.

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