3. INJUNCTIVE RELIEF, REFORMULATION, TESTING AND WARNINGS
3.1 Beginning twelve months from the Effective Date (“Compliance Date”), CO.EXIST shall be permanently enjoined from manufacturing for sale in the State of California, “Distributing into the State of California”, or directly selling in the State of California, any Covered Products which exposes a person to a “Daily Lead Exposure Level” of more than 0.5 micrograms of lead per day and/or “Daily Cadmium Exposure Level” of more than 4.10 micrograms of cadmium per day unless it meets the warning requirements under Section 3.2.
3.1.1 As used in this Consent Judgment, the term “Distributing into the State of California” shall mean to directly ship a Covered Product into California for sale in California or to sell a Covered Product to a distributor that CO.EXIST knows or has reason to know will sell the Covered Product in California.
3.1.2 For purposes of this Consent Judgment“Daily Cadmium Exposure Level” shall be measured in micrograms, and shall be calculated using the following formula: micrograms of cadmium per gram of product, multiplied by grams of product per serving of the product (using the largest serving size appearing on the product label), multiplied by servings of the product per day (using the largest number of servings in a recommended dosage appearing on the product label), which equals micrograms of cadmium exposure per day.
For purposes of this Consent Judgment, the “Daily Lead Exposure Level” shall be measured in micrograms, and shall be calculated using the following formula: micrograms of lead per gram of product, multiplied by grams of product per serving of the product (using the largest serving size appearing on the product label), multiplied by servings of the product per day (using the largest number of servings in a recommended dosage appearing on the product label), which equals micrograms of lead exposure per day, excluding amounts of allowances of lead in the ingredients listed in the table below:
INGREDIENT ALLOWANCES OF AMOUNT OF LEAD
Calcium (Elemental) 0.8 micrograms/gram
Ferrous Fumarate 0.4 micrograms/gram
Zinc Oxide 8.0 micrograms/gram
Magnesium Oxide 0.4 micrograms/gram
Magnesium Carbonate 0.332 micrograms/gram
Magnesium Hydroxide 0.4 micrograms/gram
Zinc Gluconate 0.8 micrograms/gram
Potassium Chloride 1.1 micrograms/gram
Cocoa-powder 1.0 micrograms/gram
If, at any time after the Compliance Date, ERC tests a Covered Product that does not contain a warning described in Section 3.2, and the test results indicate that the Daily Lead Exposure Level is greater than 0.5 micrograms per day, CO.EXIST agrees to confidentially supply to ERC, within 30 days of ERC’s written request, a list of ingredients, including the percentage of each ingredient (“Ingredient List”), of that particular covered product so that ERC may be able to calculate the daily exposure based on the allowances in the table above.
3.2 Clear and Reasonable Warnings
If CO.EXIST is required to provide a warning under Section 3.1, the following warning must be utilized (“Warning”):
WARNING: This product contains chemicals known to the State of California to cause [cancer and] birth defects or other reproductive harm.
or
WARNING: This product can expose you to chemicals including [lead] [and] [cadmium] which is [are] known to the State of California to cause [cancer and] birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov/food.
CO.EXIST shall use the phrase “cancer and” in the Warning only if the “Daily Lead Exposure Level” is greater than 15 micrograms of lead as determined pursuant to the quality control methodology set forth in Section 3.4. As identified in the brackets, the warning shall appropriately reflect whether there is lead, cadmium, or both chemicals present in each of the Covered Products.
The Warning shall be securely affixed to or printed upon the container or label of each Covered Product. In addition, for any Covered Product sold over the internet, the Warning shall appear on the checkout page when a California delivery address is indicated for any purchase of any Covered Product. An asterisk or other identifying method must be utilized to identify which products on the checkout page are subject to the Warning.
The Warning shall be at least the same size as the largest of any other health or safety warnings also appearing on its website or on the label or container of CO.EXIST’s product packaging and the word “WARNING” shall be in all capital letters and in bold print. No statements contradicting or conflicting with the Warning shall accompany the Warning.
CO.EXIST must display the above Warning with such conspicuousness, as compared with other words, statements, design of the label, container, or on its website, as applicable, to render the Warning likely to be read and understood by an ordinary individual under customary conditions of purchase or use of the product.
3.3 Reformulated Covered Products
A Reformulated Covered Product is one for which the “Daily Lead Exposure Level” is no greater than 0.5 micrograms of lead per day and/or “Daily Cadmium Exposure Level” is no more than 4.10 micrograms of cadmium per day as determined by the quality control methodology described in Section
3.4 Testing and Quality Control Methodology
3.4.1 Beginning within one year of the Effective Date, CO.EXIST shall arrange for lead and/or cadmium testing of the Covered Products at least once a year for a minimum of three consecutive years by arranging for testing of three randomly selected samples of each of the Covered Products, in the form intended for sale to the end-user, which CO.EXIST intends to sell or is manufacturing for sale in California, directly selling to a consumer in California or “Distributing into the State of California.” If tests conducted pursuant to this Section demonstrate that no Warning is required for a Covered Product during each of three consecutive years, then the testing requirements of this Section will no longer be required as to that Covered Product. However, if during or after the three-year testing period, CO.EXIST changes ingredient suppliers for any of the Covered Products and/or reformulates any of the Covered Products, CO.EXIST shall test that Covered Product annually for at least four (4) consecutive years after such change is made.
3.4.2 For purposes of measuring the “Daily Lead Exposure Level” and/or “Daily Cadmium Exposure Level,” the arithmetic mean of the lead and/or cadmium detection results for the three (3) randomly selected samples of the Covered Products will be controlling.
3.4.3 All testing pursuant to this Consent Judgment shall be performed using a laboratory method that complies with the performance and quality control factors appropriate for the method used, including limit of detection, qualification, accuracy, and precision that meets the following criteria: Inductively Coupled Plasma-Mass Spectrometry (“ICP-MS”) achieving a limit of quantification of less than or equal to 0.010 mg/kg or any other testing method subsequently agreed to in writing by the Parties and approved by the Court through entry of a modified consent judgment.
3.4.4 All testing pursuant to this Consent Judgment shall be performed by an independent third party laboratory certified by the California Environmental Laboratory Accreditation Program or an independent third-party laboratory that is registered with the United States Food & Drug Administration.
3.4.5 Nothing in this Consent Judgment shall limit CO.EXIST’s ability to conduct, or require that others conduct, additional testing of the Covered Products, including the raw materials used in their manufacture.
3.4.6 Within thirty (30) days of ERC’s written request, CO.EXIST shall deliver lab reports obtained pursuant to Section 3.4 to ERC. CO.EXIST shall retain all test results and documentation for a period of five years from the date of each test.
3.4.7 Notwithstanding any of the foregoing, Section 3.4 shall not apply with respect to any Covered Product for which CO.EXIST is providing a warning pursuant to Section 3.2 of this Consent Judgment.
