Will 2019 be the Year of Federal Cosmetics Regulation?

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2019 is starting to look like the year Congress may make good on its efforts to pass federal cosmetics reform legislation, with legislation in the works in both the U.S. Senate and the U.S. House of Representatives that would increase federal regulatory oversight for cosmetics. In addition, Senate and House committees have been active in demanding more information and action from the Food and Drug Administration (FDA) to ensure cosmetics safety.

Feinstein/Collins Personal Care Products Safety Act Bill

As they have in previous sessions of Congress, Sens. Dianne Feinstein (D-California) and Susan Collins (R-Maine) re-introduced the “Personal Care Products Safety Act” (S. 726) in March, a bill that would strengthen the FDA’s efforts to regulate ingredients in personal care products.

The Personal Care Products Safety Act bill would amend the Federal Food, Drug & Cosmetic Act (FDCA) by:

  • • Requiring annual registration of cosmetic facilities with the FDA and impose tiered registration fees;
  • • Requiring cosmetic ingredient statements for all cosmetics, including fragrances, flavors and colors, as well as a range of possible amounts of each ingredient;
  • • Providing the FDA the authority to suspend registration of a facility (and any import, export or distribution of cosmetics from the facility) or a cosmetic ingredient statement (and all cosmetics that are the subject of the statement) if there is a reasonable probability of serious adverse health consequences or death to humans;
  • • Directing the FDA to review ingredients and non-functional constituents, including coal tar chemicals) for safety at a rate of at least five ingredients per year;
  • • Directing the FDA to issue regulations to establish Good Manufacturing Practices for cosmetics;
  • • Requiring timely reporting of serious adverse events and annual reporting of adverse events;
  • • Allowing the FDA wide authority to inspect records;
  • • Providing mandatory recall authority to the FDA;
  • • Requiring labeling of cosmetics that are not appropriate for use in the entire population, including warnings that vulnerable populations, such as children or pregnant women, should limit or avoid using the product;
  • • Requiring ingredients, warnings and statements on professional products;
  • • Requiring complete label information to be placed online for online sales of cosmetics; and
  • • Requiring a telephone number or electronic contact information on the label.

In the first year, the FDA would evaluate the safety and appropriate use of the following five chemicals, which could be banned from cosmetics or limited in their allowed use:

• Diazolidinyl urea, which is used as a preservative in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotion.
• Diethyl phthalate, which is used as a binding agent in some fragrances and cosmetics.
• Methylene glycol/formaldehyde, which is used in hair treatments.
Propyl paraben, which is used as a preservative in a wide range of products including shampoo, conditioner and lotion.
• Quaternium-15, which is used as a preservative in a wide range of products including shampoo, shaving cream, skin creams and cleansers.

Pallone/Shimkus Discussion Draft

Meanwhile, House Energy & Commerce (E&C) Committee Chairman Frank Pallone Jr. (D-NJ) and Rep. John Shimkus (R-Ill.) in March released a bipartisan discussion draft of legislation that is very similar to the Personal Care Products Safety Act, which is expected to be introduced in the House soon.

Action by Congressional Committees

Congressional committees have also been flexing their investigative and oversight muscles by demanding additional information from and calling for more action by the FDA, separately from the status of any reform legislation.

After the FDA announced in March that its testing (almost two years after the fact) confirmed the presence of asbestos in cosmetics, including eye shadows, compact powders and contour palettes, sold in 2017 at children and teen stores Claire’s and Justice stores, Sen. Patty Murray (D-Wash.), ranking member of the Senate Health, Education, Labor and Pensions (HELP) Committee, called for further investigation by the FDA into whether cosmetic products that contain talc “may be contaminated with asbestos.”  Sen. Murray is also urging the FDA to conduct additional testing to ensure the safety of cosmetic products containing talc, and in particular cosmetics that are marketed to children and teenagers.  Separately, Sen. Murray demanded that Claire’s provide more information about the possible sources of asbestos contamination and the process and procedures Claire’s takes to assess the safety of its products before they reach customers.

There have been further regulatory and legislative developments on these subjects in June 2019. Additional cosmetics, including a JoJo Siwa makeup set sold by Claire’s, were found to be contaminated with asbestos and were recalled in June 2019. Rep. Pallone then sent a letter to the FDA requesting updated information about the agency’s inspections of imported cosmetic products. Specifically, Rep. Pallone sought FDA foreign inspections data from Fiscal Year (FY) 2017-2019, including the number and kinds of personal care products imported each year, the number of imported products subjected to inspections each year, and the number of contaminated products intercepted each year. According to Rep. Pallone, the FDA has not conducted any foreign cosmetic inspections in FY 2019 and intends to conduct no foreign cosmetic inspections in FY 2020.

This was not the first such request to the FDA, as Rep. Pallone previously sent a letter to the FDA requesting similar information in 2016. In response, the FDA stated that in FY 2016, less than one percent of cosmetic products that arrived in U.S. ports were physically examined by FDA inspectors; of those inspected, inspectors reported adverse findings such as illegal color additives and microbial contamination in 15 percent of the imports.

The push toward federal cosmetics reform has been many years in the making, and now gathers industry support from such heavyweights as The Estee Lauder Companies, Johnson & Johnson, L’Oreal and Procter & Gamble.  While the industry by and large appears to agree that updates are needed to the current regulatory system and would increase consumer confidence, there are concerns about the extent of the reform and the scope and breadth of the power to be vested in the FDA.  Key stakeholders are involved in the process and engaging with the House, Senate and FDA. 

While it remains to be seen whether 2019 will be the year of significant cosmetic legislation reform, one thing is certain – increased regulation for the personal care products industry is inevitable, and the question is just one of how much regulation and the extent to which the FDA will preempt state and local regulations.

Cosmetics manufacturers should take heed as they plan their product formulations, manufacturing and labeling of existing and planned product lines, whether made in the U.S. or abroad. Conkle, Kremer & Engel attorneys stand ready to help clients plan their responses to current and developing regulatory changes affecting the beauty industry.

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California’s SB 574 and AB 495 Would Expand Regulation of Cosmetics Labeling and Ingredients

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California has always led the way when it comes to regulating cosmetic products, and bills recently introduced by Senator Connie Leyva (Senate Bill No. 574 or SB 574) and Assemblymembers Al Muratsuchi and Buffy Wicks (Assembly Bill No. 495 or AB 495) is in keeping with California’s reputation as a trailblazer in the cosmetics regulatory space.

SB 574, the “Toxic Fragrance Chemicals Right to Know Act of 2019”

SB 574, the “Toxic Fragrance Chemicals Right to Know Act of 2019,” was introduced last month. It would require cosmetic manufacturers, starting July 1, 2020, to disclose whether any of their cosmetic products contains a toxic fragrance or flavor ingredient.

Fragrance or flavor ingredients that appear on any one of 27 “designated lists” would be subject to public disclosure. The designated lists include chemicals listed as known to cause cancer or reproductive toxicity pursuant to California’s Proposition 65; chemicals classified by the European Union as carcinogens, mutagens or reproductive toxins; chemicals included in the European Union Candidate List of Substances of Very High Concern; and Group 1, 2A or 2B carcinogens identified by the International Agency for Research on Cancer (IARC) among many others.

Existing law – the California Safe Cosmetics Act of 2005 (“Safe Cosmetics Act”) – requires cosmetic manufacturers to disclose to the California Department of Public Health (CDPH) Safe Cosmetics Program whether any of their cosmetic products contain chemicals known or suspected to cause cancer or reproductive toxicity. The Safe Cosmetics Act’s list of reportable ingredients is compiled from a more far limited set of five designated lists. This self-reported information, in turn, is publicly available through the CDPH’s Safe Cosmetics Database.

While the Safe Cosmetics Act does not exempt fragrances and flavorings from being reported, the reportable chemicals in those cases are often identified simply as “trade secrets.” The proposed legislation would require the disclosure of the identities of the reportable chemicals or ingredients, but for trade secret purposes, would not require the weight or amount of a fragrance or flavor ingredient to be disclosed or any disclosure of how the fragrance or flavor is formulated. In addition, a manufacturer would not have to disclose any fragrance or flavor ingredients that are not found on any of the 27 designated lists. It is important to note that SB 574 as proposed would not ban or otherwise regulate the use of any fragrance or flavor ingredients.

AB 495, the “Toxic Free Cosmetics Act”

AB 495, also introduced in February 2019, would amend both California’s Sherman Food, Drug and Cosmetic Law and the Safe Cosmetics Act.

California’s Sherman Food, Drug and Cosmetic Law prohibits the manufacture, sale, delivery, holding or offer for sale of adulterated cosmetics. AB 495 would greatly expand the definition of an “adulterated cosmetic” to include cosmetics that contain specific ingredients. Any cosmetic that contains lead or asbestos or any of the following 13 intentionally added ingredients – without regard to the amount or exposure levels – would be banned from sale in California:

  • Butylparaben
  • Carbon black
  • Dibutyl phthalate
  • Diethylhexyl phthalate
  • Formaldehyde
  • Formaldehyde releasers
  • Isobutylparaben
  • Isopropylparaben
  • Mercury and related compounds
  • Per- and Polyfluoroalkyl substances (PFAS)
  • Propylparaben
  • Toluene
  • Triclosan

The bill would also amend the Safe Cosmetics Act by requiring referrals to be made to the Department of Justice for any sale of adulterated cosmetics, as well as any violation of the Safe Cosmetics Act.

If passed, the legislation would have the effect of requiring companies doing business anywhere in the United States to reformulate their cosmetics to remove these ingredients, effectively creating a nationwide ingredient ban. The bill comes as the FDA confirmed that cosmetic products sold in 2017 by Claire’s and Justice tested positive for asbestos.

It has become clear that California’s leadership position on cosmetic regulation has effectively driven changes in cosmetic products and labeling throughout the United States. Conkle, Kremer & Engel will continue to follow and update these important developments affecting the cosmetics industry.

Update on AB 495 as of April 9, 2019

Efforts to pass AB 495 have temporarily stalled.  On April 9, 2019, the Assembly’s Environmental Safety and Toxic Materials Committee postponed a scheduled vote to move the bill to the Assembly Health Committee due to lack of support.  The bill is not expected to be brought back again until next year. It is anticipated that the bill will be in a revised form when reintroduced.  Conkle, Kremer & Engel will continue to monitor the developments of AB 495.

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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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California Green Chemistry Initiative: Are You Manufacturing or Selling a “Priority Product”?

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The new Safer Consumer Products (SCP) regulations require the California Department of Toxic Substances Control (DTSC) to initially identify up to five proposed “Priority Products” or categories of products containing what DTSC regards as “Chemicals of Concern.”  By April 1, 2014, DTSC will publish a list of Priority Products selected because of their use of one or more of 164 “Priority Chemicals” listed on the “Initial Candidate Chemicals” list.  Scroll to the bottom of this post for the full list of the 164 Priority Chemicals.

There will be a public review and comment period following publication of the Priority Products list.  It has been widely speculated that nail polish, formaldehyde-based hair straighteners, carpet adhesives and furniture seating foam are among the possible Priority Products that may be identified first by DTSC.

Once a product is identified as a Priority Product, manufacturers or other responsible entities (including importers, assemblers and even retailers) will be required to notify DTSC that their product is a priority product.  The manufacturer or other responsible entity then has some unpleasant options:  It can 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.  The Alternatives Analysis report must be submitted to DTCS for evaluation to determine if there are adverse environmental or public health impacts associated with the product that can be remedied by regulatory responses.  The regulatory responses could require product warnings to consumers, restrictions on the use of the chemical during manufacture, place of sale restrictions, administrative controls, further research regarding alternative ingredients, end-of-life disposal requirements, or even a ban on sales of the product in California.

Manufacturers, retailers, importers and assemblers of consumer products for sale or distribution in California should diligently keep informed about developments in the DTSC’s “Candidate Chemicals” list (currently 1,060 chemicals),  as well as the development of the Priority Products list.  Manufacturers should also consider whether reformulation of their products to exclude the priority chemicals from the “Initial Candidate Chemicals” list is possible.  In addition, it is important that businesses establish clear agreements among manufacturers, importers, distributors, retailers and others in the supply chain specifying who will be responsible for complying with California’s tough new regulatory program, including responding to DTSC if a product is identified as a priority product.  Conkle, Kremer & Engel’s lawyers stay current on the latest developments, and guide the firm’s clients through the thicket of expanding regulatory issues affecting their businesses.

The 164 chemicals found on the “Initial Candidate Chemicals” list, from which the Priority Products will be identified by DTSC, are:

1,1,1,2-Tetrachloroethane 1,1,1-Trichloroethane; Methyl chloroform
1,1,2,2-Tetrachloroethane 1,1,2-Trichloroethane
1,1-Dichloroethane 1,2,3-Trichloropropane
1,2-Diphenylhydrazine; Hydrazobenzene 1,2-Epoxybutane
1,3-Butadiene 1,3-Propane sultone; 1,2-Oxathiolane 2,2-dioxide
1,4-Dioxane 2,2-Bis(bromomethyl)propane-1,3-diol
2,4,6-Trinitro-1,3-dimethyl-5-tert-butylbenzene; musk xylene 2,4,6-Tri-tert-butylphenol
2,4.6-Trinitrotoluene (TNT) 2?Acetylaminofluorene
2-Methylaziridine (Propyleneimine) 2-Methylphenol, o-Cresol
2-Nitropropane 3-Methylphenol; m-Cresol
4,4′-Methylenedianiline; 4,4’-Diaminodiphenylmethane (MDA) 4-Bromophenyl phenyl ether, Bromophenyl Phenyl Ether
4-Nitrobiphenyl 4-Tert-Octylphenol; 1,1,3,3-Tetramethyl-4-butylphenol
Acetaldehyde Acetamide
Acrylamide Acrylonitrile
Allyl chloride Aluminum
Aniline Aromatic amines
Aromatic Azo Compounds Arsenic and inorganic arsenic compounds
Asbestos (all forms, including actinolite, amosite, anthophyllite, chrysotile, crocidolite, tremolite) Benzene
Benzene, Halogenated derivatives Benzotrichloride
Benzyl chloride Beryllium and Beryllium compounds
Biphenyl-3,3′,4,4′-tetrayltetraamine; Diaminobenzidine Bisphenol A
Bisphenol A diglycidyl ether polymer; [2,2′-bis(2-(2,3-epoxypropoxy)phenyl)-propane] Bisphenol B;  (2,2-Bis(4-hydroxyphenyl)-n-butan)
Bromate Butylbenzyl phthalate and metabolite
Cadmium and cadmium compounds Captan
Carbon monoxide Carbon tetrachloride; CCl4
Catechol Chlorendic acid
Chlorinated Paraffins Chlorine dioxide
Chlorite Chloroalkyl ethers
Chloroethane; ethyl chloride Chloroprene; 2-chlorobuta-1,3-diene
Chromium hexavalent compounds (Cr (VI) Chromium trioxide
Cobalt metal without tungsten carbide (including dust and cobalt compounds) Cresols, Cresol mixtures
Cumene, [ isopropylbenzene] Cyanide and Cyanide compounds
Cyclotetrasiloxane; Octamethylcyclotetrasiloxane (D4) Diazomethane
Dibromoacetic acid Dibutyl phthalate and metabolites
Dichloroacetic acid Dichloroethylenes
Dichloromethane; methylene chloride Dicyclohexyl phthalate and metabolite
Diesel engine exhaust Diethanolamine
Diethyl hexyl phthalate and metabolites Diethyl phthalate and metabolite
Diisobutyl phthalate and metabolite Di-isodecyl phthalate and metabolite
Di-isononyl phthalate and metabolites Dimethyl sulfate
Dimethylcarbamoyl chloride Dinitrotoluenes
Di-n-Octyl Phthalate and metabolites Dodecamethylcyclohexasiloxane (D6)
Emissions, Cokeoven Epichlorohydrin; 1-Chloro-2,3-epoxypropane
Ethyl acrylate Ethylbenzene
Ethylene dichloride; 1,2-Dichloroethane Ethylene Glycol
Ethylene oxide; oxirane Ethylene Thiourea
Ethyleneimine, Aziridine Ethyl-tert-butyl ether
Formaldehyde Fuel oils, high-sulfur; Heavy Fuel oil; (and other residual oils)
Gasoline (automotive, refined, processed, recovered, and other unspecified fractions) Glutaraldehyde
Glycol ethers Glycol ethers acetate
Hexabromocyclododecane (HBCD), and mixed isomers Hexachlorobuta1,3-diene
Hexachloroethane Hexamethylene-1,6-diisocyanate
Hexamethylphosphoramide HMX
Hydrazine, Hydrazine compounds and salts Hydrogen sulfide
Jet Fuels, JP-4, JP-5, JP-7 and JP-8 Lead and Lead Compounds
Maleic anhydride Manganese and manganese compounds
Mercury and mercury compounds Methanol
Methyl chloride Methyl isobutyl ketone, Isopropyl acetone; (MIBK)
Methyl isocyanate Methylene diphenyl diisocyanates
Methylhydrazine and its salts Methylnaphthalene; 2-Methylnaphthalene
Mineral Oils: Untreated and Mildly Treated N,N-dimethylformamide; dimethyl formamide
N,N-Dimethylhydrazine Naphthalene
n-Hexane Nickel and Nickel Compounds; Nickel refinery dust from the pyrometallurgical process
Nickel oxides Nickel, metallic and alloys
Nitrate+Nitrite Nitrobenzene
Nitrosamines Nonylphenol, nonylphenol ethoxylates (NP/NPEs) (and related substances)
Parabens Pentabromophenol
Perfluorochemicals Petroleum; Crude oil
Phthalic anhydride Polybrominated diphenyl ethers (PBDEs) congeners
Polychlorinated biphenyl (PCB) congeners Polychlorinated dibenzo-p-dioxins (PCDDs)
Polychlorinated dibenzo-p-furans (PCDFs) and Furan Compounds Polycyclic Aromatic Hydrocarbons (PAHs)
Propylene oxide Quinoline and its strong acid salts
Silica, Crystalline (Respirable Size) Stoddard solvent; Low boiling point naphtha – unspecified;
Strong Inorganic Acid Mists Containing Sulfuric Acid Styrene and derrivatives
Sulfur dioxide Tetrabromobisphenol A (TBBPA)
Tetrachloroethylene; Perchloroethylene; (PERC) Thallium
Toluene Toluene Diisocyanates
Trichloroethene (TCE) Trihalomethanes
Tris(1,3-dichloro-2-propyl) phosphate (TDCPP) Tris(2,3-dibromopropyl) phosphate
Tris(2-chloroethyl)phosphate (TCEP) Vanadium pentoxide
Vinyl acetate Vinyl Bromide, Bromoethylene
Vinyl chloride; chloroethylene Xylenes; [o-xylene (95-47-6), m-xylene(108-38-3)and p-xylene (106-42-3)]

 

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California Green Chemistry Initiative: Does Your Product Contain a "Candidate Chemical” that Could Become a “Chemical of Concern” to the California Department of Toxic Substances Control?

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Effective October 1, 2013, companies doing business in California will have to navigate and comply with yet another system of complex regulations:  The Safer Consumer Products (SCP) regulations adopted by the California Department of Toxic Substances Control (DTSC) will require manufacturers, importers, assemblers and retailers to seek safer alternatives to certain harmful chemical ingredients in widely used products.

The SCP regulations are the first step in implementing California’s Green Chemistry Initiative. The goal of the SCP regulations is to accelerate the manufacture and use of safer versions of products in California by:  (1) establishing a process to identify and prioritize chemical ingredients in consumer products that may be considered “chemicals of concern,” and (2) establishing a process for evaluating chemicals of concern and their potential alternatives, to determine how best to limit exposure to or to reduce the level of hazard posed by chemicals of concern.

The SCP regulations apply to all consumer products that contain a “Candidate Chemical” and are sold, offered for sale, distributed, supplied, or manufactured in California.  The regulations do not apply to food, pesticides, dangerous prescription drugs and devices, dental restorative materials or medical devices.  There are currently 1,060 “Candidate Chemicals” that DTSC believes have hazard traits or environmental or toxicological effects.

The DTSC has already released its list of  “Initial Candidate Chemicals” that will receive DTSC’s priority attention.  Toluene, formaldehyde and bisphenol A are among the 164 “Initial Candidate Chemicals” that DTSC will consider to identify the “priority products” that DTSC will address first.

Conkle, Kremer & Engel’s lawyers stay current on the latest developments, and guide the firm’s clients through the thicket of expanding regulatory issues affecting their businesses.  Watch for our next post on Green Chemistry, identifying the chemicals that can make your product a candidate to be a “priority product” for the DTSC.

 

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