Parabens Dropped as a Priority Chemical Under New Green Chemistry Regulations – DTSC Updates List of Initial Candidate Chemicals

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On October 18, 2013, the California Department of Toxic Substances Control (DTSC) released an updated “Initial Candidate Chemicals List” – a list of chemicals that will be the first to receive the DTSC’s attention when it identifies “Priority Products” for regulation in 2014 under the new Safer Consumer Products Regulations.

The DTSC first released the list of “Initial Candidate Chemicals” on September 26, 2013, four days before the Safer Consumer Products Regulations implementing California’s Green Chemistry Initiative went into effect.  The Regulations require the list to be updated periodically.  With the update, the number of “Initial Candidate Chemicals” drops from 164 to 155.

The following chemicals were removed from the updated “Initial Candidate Chemicals List,” although each still appears on the “Candidate Chemical List”:

  • 4-Tert-Octylphenol; 1,1,3,3-Tetramethyl-4-butylphenol
  • Bisphenol A diglycidyl ether polymer; [2,2′-bis(2-(2,3-epoxypropoxy)phenyl)-propane]
  • Bisphenol B; (2,2-Bis(4-hydroxyphenyl)-n-butan)
  • Bromate
  • Dibromoacetic acid
  • Dichloroacetic acid
  • Dicyclohexyl phthalate and metabolite
  • Diethyl phthalate and metabolite
  • Nonylphenol, nonylphenol ethoxylates (NP/NPEs) (and related substances)
  • Parabens

In addition, Bis(2-chloro-1-methylethyl)ether,technical grade was added to the Initial Candidate List.

Scroll to the bottom of this post for the full list of the 155 priority chemicals, updated as of October 18, 2013.

Chemicals are placed on the “Initial Candidate Chemicals List” if they have both a hazard trait and environmental or toxicological effects.  Chemicals that have only a hazard trait or only environmental or toxicological effects are placed on the more extensive “Candidate Chemicals List,” of which the “Initial Candidate Chemicals List” is a subset.

The updated list of “Initial Candidate Chemicals” is significant in that it removes parabens as a priority chemical.  Parabens are commonly used in cosmetics as a preservative.  The family of parabens on the “Candidate Chemicals List” includes Butylparaben (includes n-butylparaben and isobutylparaben); Ethyl paraben, Ethyl 4-hydroxybenzoate; Methylparaben; Methyl p-Hydroxybenzoate; and n-Propylparaben.

What this means is that parabens will not be targeted by DTSC as a potential “chemical of concern” when the DTSC identifies priority products containing chemicals that will need to be subject to an alternatives analysis and regulatory response.  The DTSC must propose its list of up to five priority products, or categories of priority products, for regulation by April 1, 2014.  However, parabens continue to appear on the DTSC’s exhaustive list of more than 1,016 “Candidate Chemicals” so they may yet draw attention from the DTSC.

Conkle, Kremer & Engel attorneys stay up to date on the latest regulatory developments to provide expert guidance to clients seeking to avoid regulatory compliance issues and the potential liability that may follow.

DTSC list of 155 Priority Chemicals, updated as of October 18, 2013:

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

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

Bis(2-chloro-1-methylethyl)ether,technical grade

Bisphenol A

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

Dibutyl phthalate and metabolites

Dichloroethylenes

Dichloromethane; methylene chloride

Diesel engine exhaust

Diethanolamine

Diethyl hexyl phthalate and metabolites

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

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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Navigating Civil Regulatory Issues: CK&E Presentation Highlights Key Regulations for Beauty Companies Doing Business in California

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Conkle, Kremer & Engel attorneys were featured speakers at the Beauty Industry West presentation “Navigating in Challenging Regulatory Waters:  Updates on California and Federal Compliance.”  About 150 entrepreneurs, consultants, executives and beauty industry professionals attended the event at the Crowne Plaza Hotel LAX in Los Angeles on October 15, 2013, which included a valuable networking session and a post-presentation Q&A.

CK&E’s presentation about legal regulatory issues for personal care product companies doing business in California included an overview of the California Organic Products Act (COPA), Proposition 65 (California’s Safe Drinking Water and Toxic Enforcement Act) and California’s Green Chemistry Initiative including the new Safer Consumer Products Regulations.  Conkle, Kremer & Engel’s materials from the BIW event, including the “Navigating Civil Regulatory Issues” presentation and its “Resource Guide for Regulatory Compliance,” are available for download on CK&E’s Regulatory Compliance web page.

Co-presenter Donald Frey, an industry veteran, regulatory expert and product development and innovation consultant, presented on key regulatory issues from the business perspective, including how to effectively deal with regulators. Mr. Frey has generously agreed to share his presentation, available for download here.

Among the questions and answers covered after the presentation were the addition of titanium dioxide (airborne, unbound particles of respirable size) to the Proposition 65 list of chemicals, responsible entities for purposes of compliance with the Safer Consumer Products Regulations, and the determination of organic ingredients under the National Organic Program standards.

Conkle, Kremer & Engel attorneys are frequent speakers at events of interest to the beauty industry due to their expertise in representing manufacturers, distributors, suppliers, retailers and salons in all aspects of their business, including the challenges of regulatory compliance.

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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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