Impending Regulations: CARB & The Personal Care...

Angela Diesch Jay Hensel

Senior Counsel

Kronick Moskovitz Tiedemann & Girard

Director of Quality Assurance and Regulatory Affairs

John Paul Mitchell Systems

Impending Regulations: CARB & The Personal Care Products Safety Act Where We Are & How Should Brands Be Prepared

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May 26, 2015 Cal. Society of Cosmetic Chemists | May Meeting

2013 Survey Purpose and Rational


Provide scientific foundation for best decision making in the 2016 State Implementation Plan Evaluate the feasibility of further reducing

VOC emissions from consumer products

Update emissions inventory by gathering current information on VOC and LVP-VOC emissions

Evaluate the use of LVP-VOCs

Innovation

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2013 Consumer & Commercial Products Survey 3

Survey start date………..............September 2, 2014

Completed surveys due to ARB…....March 2, 2015

Additional Extensions…………….........April 1, 2015

Small Business surveys due ………….…July 1, 2015


Data Requirements

Reporting sales and formulation data for three consecutive years 2013 sales and detailed formulation of all products 2014 and 2015 sales only

Reporting all products per their UPC number

Product grouping is allowed for selected organic and inorganic compounds - designed to minimize ingredient and label reporting

Products containing low or no VOCs must be reported


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Confidentiality

Confidentiality concerns

ARB’s Response:

Worked with legal staff and Data Security Officer to ensure confidentiality

Grouping of products by multiple types of ingredients

Formulator tool to ensure manufacturers do not inadvertently view confidential ingredient information from formulators

Public Records Act Exemptions: “trade secrets,” “information that may be kept

confidential pursuant to state and federal law.”


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What’s Next

2014 Data Reporting

July 1, 2015: Beginning of 2014 data reporting

Webinars: 10a -1p PST

July 1: https://attendee.gotowebinar.com/register/119958403

September 16: https://attendee.gotowebinar.com/register/119958542

November 1, 2015: End of 2014 data reporting period


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ARB VOC Regulations


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Covers 25,000+ products in 165 categories VOC levels different by category, so correct categorization is

critical ARB investigators purchase products for testing

Online, mail order, in-stores

Written notice / response ARB either negotiates settlement or refers case for civil

litigation or criminal prosecution Potential for large penalties: $1,000 per violation per day to $1 million per

violation per day for corporate violators & $250,o00 per violation per day for individuals, in cases of willful and intentional emissions that result in great bodily harm or death Settlements generally seek $17,000 per ton of excess emissions

Criminal & injunctive relief is also available

Personal Care Products

Antiperspirants & Deodorants 17 C.C.R. Sections 94500-94506.5

Last amended in 2005 VOC limits apply to aerosol antiperspirants

Consumer Products 17 C.C.R. Sections 94507-94517

Last amended in 2009 (effective 2010)

Hairspray Credit Program 17 C.C.R. Sections 94560-94575

Approved 1997, effective 1998

Cal. Society of Cosmetic Chemists | May Meeting

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May 26, 2015

Definitions

LVOC Contains at least 1 carbon atom and meets one of the following

< 0.1 mm Hg when measured at 20◦ C chemical compound with <12 carbon atoms, or chemical mixture

comprised solely or compounds with <12 carbon atoms is a chemical compound with boiling point <216◦ C is the weight percent of a chemical mixture that boils at 216◦ C

Medium VOC > 2 mm Hg and < 80 mm Hg when measured at 20◦ C

HVOC > 80 mm Hg when measured at 20◦ C


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May 26, 2015

Reporting Requirements

Upon 90 days written notice: Brand name of each subject product; Owner of the TM or brand name; Product forms (aerosol, pump, liquid, solid, etc.); California annual sales in pounds per year & method used to calculate Total VOC content in percent by weight which

Has a VP of < 2.0 mm Hg at 20◦ C, or Consists of > 10 carbon atoms, if VP unknown

Total HVOC and MVOC content and type in percent by weight Percent by weight of VOC, water, solids, propellant, and any

compounds…the formula Any additional info. necessary to determine total VOC emissions


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May 26, 2015

Settlements


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L’Oreal: 9/14, Redken products, $146,500 “no claims to ‘finish, maintain, or hold previously styled hair” 11.5 tons of excess VOC emissions Hairspray vs. Hair Styling Products

Pro’s Choice Beauty Care, Inc.: $1.25 Million Distribution network lacked regulatory controls

Personal Care Products, Inc. : $22,500 Score Body Spray > 0% VOC limit for aerosol deodorants 3.38 tons of excess emissions ($6,657 per ton)

CVS Pharmacy: 2/15, $9,750, 0.62 tons in excess emissions Claire’s Stores: 11/14, nail polish remover, $5,100, 0.26 tons excess

emissions Advanced Beauty Systems: hair styling product (aerosol & pump), 0.94

tons, $14,500

Hairspray Hair Styling Products


55% VOC limit Claims: hold, retain, finish the

hair for a period of time Simply adding “finish” or

“finishing spray” does not qualify the product as a hairspray.

Directions for use of the product to “finish, maintain, and hold previously styled hair”

Section 94508(a)

6% VOC limit Claims: sculpt, mold, scrunch,

add volume, define, shape, enhance, rejuvenate, or fix

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Hairspray vs. Hair Styling Products

Personal Care VOC % by Weight Limits


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EPA CA IL IN MI OH OTC NH'17

UT

Antiperspirants Aerosol

HVOC MVOC

Non-Aerosol HVOC MVOC

40 10 0 0

40 10 0 0

40 10 0 0

40 10 0 0

40 10 0 0

40 10 0 0

40 10 0 0

Astringent/Toner 35 Deodorants

Aerosol HVOC MVOC

Non-Aerosol HVOC MVOC

0 10 0 0

0 10 0 0

0 10 0 0

0 10 0 0

0 10 0 0

0 10 0 0

0 10 0 0

0 10 0 0

Hair Mousse 16 6 6 6 6 6 6 6 Hair Shine 55 55 55 55 55 55 55 Hairspray 80 55 55 55 55 55 55 55 Hair Styling Gel 6 6 6 6 6 6 6 6 Hair Styling Products

Aerosol/Pump Non-Aerosol

6 2

6 2

6 2

6 2

6 2

6 2

6 2

Nail Polish Remover 85 1 75 75 75 75 75 1 1 Personal Fragrance

<20% fragrance >20% fragrance

75 65

Shaving Creams 5 5 5 5 5 5 5 5 Shaving Gels 4 7 7 7 7 7 4 Temporary Hair Color (Aerosol)

55 55 55

OTC=Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont, Virginia, and Washington D.C. NH’17=New Hampshire recently amended its VOC limits for a number of product categories which become effective January 1, 2017. *http://www.issa.com/data/moxiestorage/regulatory_education/regulatory-reference-library/voc/voc_limits_summary_1-30-15.pdf

Personal Care Products Safety Act

Introduced 04/20/2015, Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

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Feinstein/Collins Intro.

Sec. 101 Facility Registration & Ingredient Statements


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Registration of existing cosmetics facilities (factory, warehouse, or establishment (including a factory, warehouse, or establishment of an importer) that manufactures, processes, packs, or holds cosmetic products or cosmetic formulations, or any other entity whose name and address appear on the label of a cosmetic product.

Among other things, excludes domestic manufacturers with less than $100,000 in gross annual sales of cosmetic products.

Requires the "responsible person" to submit the cosmetic ingredient statement for each cosmetic product. 12/1/15 existing products submission due Within 60 days of first marketing for new products.

In filing the ingredient statement, the responsible person must attest that the safety of the product and each ingredient has been substantiated.

After notice and opportunity to respond, if FDA determines that a cosmetic formulation or product has a "reasonable probability of causing serious " harm, it may suspend the ingredient statement and the facility registration if there is reason to believe the problem affects multiple products in that facility.

Sec. 102 FDA Ingredient Review / Approval


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FDA must evaluate a minimum of five ingredients per year to determine safety and appropriate use. (see below) A public comment period of 60 days must be provided in the process. Beginning fiscal year 2017, the FDA shall annually select and complete a safety review of "at least 5" cosmetic ingredients or non-functional constituents that were not reviewed in the prior 3 years from a list determine in consultation with industry and consumer groups.

Provides for the establishment of a Cosmetics Safety Advisory Committee which shall advise the FDA of ingredients to be considered for review.

FDA's final order on an ingredient shall include conditions of use, permitted tolerances, limits on the amount or concentrations, and warnings, including warnings related to use by children, pregnant women, or other vulnerable populations.

The responsible party must before first distributing the product for sale, make a written determination that the product is safe under the conditions of use recommended in the labeling of the product.

Requires responsible party to maintain records documenting the safety determination.

Sec. 103 GMPs for Cosmetics


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Within 18 months of enactment of the bill, FDA shall develop and implement through regulation standards for cosmetic good manufacturing practices.

Large businesses, GMP requirements take effect beginning 180 days of the final regulations.

Small businesses, the GMP requirement shall take effect beginning 2 years after promulgation.

Sec. 108 Animal Testing Alternatives


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FDA shall encourage alternative testing methods to animal testing and within 3 years the FDA shall issue a guidance on the acceptability of scientifically reliable and relevant alternatives to animal testing.

Questions

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Angela Diesch [email protected] D (916) 321-4545 O (916) 321-4200 C (530) 400-4369 www.CosmeticsAndTheLaw.com

Jay Hensel [email protected] D (323) 683-1442

Impending Regulations: CARB & The Personal Care...

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