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    Cal Prop 65 Introduction

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    hoangmyduyen1001
    California Proposition 65 requires businesses to provide warnings to Californians about significant exposures to chemicals known to cause cancer, birth defects or other reproductive harm. It covers approximately 950 chemicals and applies to businesses with 10 or more employees. Compliance typically involves assessing chemicals in products against safe harbor levels, conducting toxicological assessments if no level exists, and providing clear and reasonable warnings to consumers about exposures over established limits. The law is enforced through government lawsuits and private legal action, with penalties up to $2,500 per day. Recent settlements often involve chemicals like lead in various consumer products and total tens of millions of dollars annually.

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    Cal Prop 65 Introduction

    Uploaded by

    hoangmyduyen1001
    38 views21 pages
    California Proposition 65 requires businesses to provide warnings to Californians about significant exposures to chemicals known to cause cancer, birth defects or other reproductive harm. It covers approximately 950 chemicals and applies to businesses with 10 or more employees. Compliance typically involves assessing chemicals in products against safe harbor levels, conducting toxicological assessments if no level exists, and providing clear and reasonable warnings to consumers about exposures over established limits. The law is enforced through government lawsuits and private legal action, with penalties up to $2,500 per day. Recent settlements often involve chemicals like lead in various consumer products and total tens of millions of dollars annually.

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    California Proposition 65 requires businesses to provide warnings to Californians about significant exposures to chemicals known to cause cancer, birth defects or other reproductive harm. It covers approximately 950 chemicals and applies to businesses with 10 or more employees. Compliance typically involves assessing chemicals in products against safe harbor levels, conducting toxicological assessments if no level exists, and providing clear and reasonable warnings to consumers about exposures over established limits. The law is enforced through government lawsuits and private legal action, with penalties up to $2,500 per day. Recent settlements often involve chemicals like lead in various consumer products and total tens of millions of dollars annually.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    38 views21 pages

    Cal Prop 65 Introduction

    Uploaded by

    hoangmyduyen1001
    California Proposition 65 requires businesses to provide warnings to Californians about significant exposures to chemicals known to cause cancer, birth defects or other reproductive harm. It covers approximately 950 chemicals and applies to businesses with 10 or more employees. Compliance typically involves assessing chemicals in products against safe harbor levels, conducting toxicological assessments if no level exists, and providing clear and reasonable warnings to consumers about exposures over established limits. The law is enforced through government lawsuits and private legal action, with penalties up to $2,500 per day. Recent settlements often involve chemicals like lead in various consumer products and total tens of millions of dollars annually.

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    © All Rights Reserved
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    of 21

    California Proposition 65

    An Introduction

    TUV Rheinland
    California Proposition 65

    Table of Contents

     What is California Proposition 65?


     Which chemicals are included?
     How are the restrictions defined?
     How to check if labelling is required?
     How is Cal Prop 65 enforced?
     What are the recent settlements about?
     What is the impact of the law?
     What is the outlook of the law?
     How TUV Rheinland can help me comply with Cal Prop 65?

    2 01/01/2016 TUV Rheinland


    California Proposition 65

    What is California Proposition 65?

     What is Cal Prop 65?

    - Safe Drinking Water and Toxic Enforcement Act of 1986

    - Originally intended to protect drinking water sources from chemicals known to


    cause cancer, birth defects or other reproductive harm, and to inform citizens
    about exposures to such chemicals

    - Businesses need to notify Californians about significant amounts of chemicals in


    products, their homes, workplaces or that are released into the environment

    - Only businesses with 10 or more employees need to comply

    3 01/01/2016 TUV Rheinland


    California Proposition 65

    Which chemicals are included?

     Approx. 950 chemicals that are known to

    - cause cancer or birth defects or


    - other reproductive harm

     List of substances can be downloaded

    - Includes links to basis for listing or risk assessment of Safe Harbour Levels for
    some of the substances
    - http://oehha.ca.gov/prop65/prop65_list/Newlist.html

    4 01/01/2016 TUV Rheinland


    California Proposition 65

    Which chemicals are included?

     Office of Environmental Health Hazard Assessment (OEHHA)


    - Part of California Environmental protection Agency (EPA)
    - OEHHA’s advisory board
    - Carcinogen Identification Committee (CIC)
    - Developmental and Reproductive Toxicant (DART) Identification Committee

     How chemicals are included


    - Identification by CIC or DART or
    - Identification by an designated “authoritive body“ (e.g. EPA, FDA, NIOSH, National
    Institute for Research on Cancer) or
    - State or federal agency is requiring labeling (e.g. FDA requires drugs to contain
    warnings relating to cancer or birth defects) or
    - Identified in the California Labor Code as causing cancer or reproductive harm

    5 01/01/2016 TUV Rheinland


    California Proposition 65

    How are the restrictions defined?

     Exposure
    - Restrictions are given as daily exposure levels
    - ‘Expose’: to ingest, inhale, contact via body surfaces or otherwise come into
    contact with a listed chemical.
    - Presence of listed chemical not automatically harmful

     Safe Harbour Level


     Until now 300 out of the 950 chemicals have an established Safe Harbour Level

     Chemicals with no Safe Harbour Level

    6 01/01/2016 TUV Rheinland


    California Proposition 65

    How are the restrictions defined?

    Safe Harbour Level

    Carcinogenic Reproductive
    Chemicals harmful Chemicals

    NSRL MADL
    No significant risk level Maximum allowable dose
    levels
    Level of exposure result in not more
    than one case of cancer in 100,000 Toxicological “ No observable effect
    individuals level (NOEL) “ devided by margin of
    safety 1000

    7 01/01/2016 TUV Rheinland


    California Proposition 65

    How are the restrictions defined?

     Safe Harbour Level vs material‘s content of a chemical


    Safe Harbour Level Material‘s content of a chemical
    Definition Daily intake of the chemical per Amount (percentage) of the chemical
    individual within the material
    Expressed as Amount of chemical/day Weight of chemical/weight of materials

    Example DEHP Safe Harbour Level: DEHP Restriction within a material:


    410 µg/day (oral intake) 0.1 % or 1000 ppm

     How to convert?
    - Apply toxicological assessment taking into account
    - Product’s formulation
    - Routes of exposure – oral, inhalation, transdermal or hand-to-mouth
    - Level of exposure ...in a worst case scenario
    ...in a worst case scenario

    8 01/01/2016 TUV Rheinland


    California Proposition 65

    When Labelling is required?

    9 01/01/2016 TUV Rheinland


    California Proposition 65

    How to check if labelling is required?

     Chemicals with established Safe Harbour Level


    - A chemicals‘ concentration exceeding the Safe Harbour Level needs to be labelled

     Chemicals with no established Safe Harbour Level


    - Toxicological assessment to check if the anticipated exposure level will pose a
    significant risk of cancer or reproductive harm
    - Guidance within Article 7 and Article 8 of Title 27, California Code of
    Regulations

    10 01/01/2016 TUV Rheinland


    California Proposition 65

    How to check if labelling is required?

     Toxicological Assessment
    Review composition of
    product’s all different
    materials against Prop 65
    chemical list

    Contains Chemical of No further action


    NO
    Concern required

    YES

    Define Exposure Check amount in material Compare against limits


    of related products in
    respective lawsuits (if
    available)
    Established Safe No established Safe
    Harbor Level Harbour Level

    Define Safe Harbour


    Below: Above: Levels by use of
    No Label Label toxicological date
    (NSRL, MADL)

    11 01/01/2016 TUV Rheinland


    California Proposition 65

    How to check if labelling is required?

     Risk orientated approach


    - Test chemicals in high-risk materials for products which are commonly target of
    lawsuits
    - Compare to limits in related law-suits

     Preventative labelling of the product without investigation about chemical’s presence


    - Might violate FTCs premise of true claims
    - Information concerning the actual hazard need to be provided to the public on
    request
    - Might prevent customers from buying the product

     Ignore and hope to not get targeted

     No sale in California

    12 01/01/2016 TUV Rheinland


    California Proposition 65

    How is Cal Prop 65 enforced?

     Public Enforcement
    - Filing of a lawsuit by California Attorney General's Office, district or city attorneys

     Private Enforcement
    - Filing of a lawsuit by any individual acting in the public interest
    - Requires 60-days notice

    13 01/01/2016 TUV Rheinland


    California Proposition 65

    How is Cal Prop 65 enforced?

     60-day notice
    - Enables law enforcement officials to investigate a notice and to decide if they
    should persue the action in lieu of private enforcement
    - Provides violator an opportunity to cure of violation and cut off continuing penalties
    - Government prosecutors such as the Attorney General and District Attorney may
    file Proposition 65 enforcement lawsuits without serving a 60-day notice

     Penalties
    - Can be as high as $2,500 per violation per day

    14 01/01/2016 TUV Rheinland


    California Proposition 65

    What are the recent settlements about?

     Amount of settlements and their payments

    700 $35,000,000 2014:


    600 $30,000,000
    71 % Attorney’s Fees
    500 $25,000,000

    400 $20,000,000 17 % Civy Penalty


    300 $15,000,000
    12 % Other
    200 $10,000,000

    100 $5,000,000

    0 $0
    2014 2013 2012 2011 2010

    Amount of Settlements Total Settlements Payments

    15 01/01/2016 TUV Rheinland


    California Proposition 65

    What are the recent settlements about?

     Typcical Chemicals and Product Categories


    - Lead
    - Plastic (e.g. footware, stationary, etc.)
    - Paint and surface coatings (e.g. Toys, Furniture)
    - Textile materials (e.g. Apparel, bags)
    - Metal materials (e.g. Jewellery)
    - Food Contact Materials (Ceramic Ware, Aluminium Cookware, Espresso
    Machines)
    - Cosmetics and Dietary Supplements

    - Phthalates
    - Soft plastic materials (e.g. Toys, childrens products, footware, cable cords)
    - Coatings and laminations (e.g. Apparel, books with PVC cover)

    16 01/01/2016 TUV Rheinland


    California Proposition 65

    What are the recent settlements about?

    - Flame Retardants
    - Upholstered furniture, cushions

    - Cadmium
    - Paint and surface coatings (e.g. Bicylcles)
    - Food Contact Materials (e.g.Glass and Ceramicware)
    - Dietary supplements

    - Toluene
    - Chemical preparations (e.g. Sprays, Sealers, Oil removers)

    - Formaldehyde
    - Apparel

    17 01/01/2016 TUV Rheinland


    California Proposition 65

    What is the impact of the law?

     “Bounty-hunters“
    - Citizens or organizations are awarded one-quarter of the civil penalty paid by a
    business found in violation
    - Majority of businesses opt to settle lawsuits out of court rather than going through
    the expensive and time consuming process of a trial

     Over-use of warning labels


    - To avoid lawsuites and associated costs businesses tend to label products even
    when listed substances are not present or below Safe Harbour Level
    - Decreasing sensitivity of consumers

     No impact on public health


    - Research has shown no decrease in incidences of cancer in California

    18 01/01/2016 TUV Rheinland


    California Proposition 65

    What is the outlook of the law?

     OEHHA publishes a list of chemicals under consideration to be added to the list and
    allows public to comment on

    - Styrene
    - Considered as a carcinogenic
    - PS-Foam for industrial use, food contact
    - Molded PS for casings

    - Pentachlorphenol
    - Considered as a carcinogenic
    - Wood preservative

    - http://oehha.ca.gov/prop65/CRNR_notices/admin_listing/abtracking.html, e.g.

    19 01/01/2016 TUV Rheinland


    California Proposition 65

    How TUV Rheinland can help me comply with Cal Prop 65?

     Toxicological Assessment
    - Submission of materials composition data to a certified toxicologist
    - Identification of Cal Prop 65 listed hazardous chemicals
    - Test of chemical content within the respective materials in our labs
    - Evaluation of actual exposure level by a certified toxicologist OR
    - Comparison to limits set up be recent related lawsuits (if available)

     Risk orientated approach


    - Identification of risk materials
    - Review of established lawsuits
    - Testing acc. to indicated Cal Prop 65 test methods
    - Assessment of warning label need based on the test result

    20 01/01/2016 TUV Rheinland


    California Proposition 65

    Questions?

    21 01/01/2016 TUV Rheinland

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