60 Day Notice 2025-04534

3.1. Effective on and after the Compliance Date Bioworld shall not sell the Covered Product for distribution to consumers in California unless the product is a “Reformulated Covered Product” as defined in Paragraph 3.2 or unless Bioworld provides a Compliant Warning as defined in Paragraph 3.3 for any non-reformulated Covered Product that it sells to consumers in California. Compliance with this Settlement Agreement by Bioworld shall constitute compliance under Proposition 65 with regard to Covered products sold, offered for sale, imported, manufactured or otherwise distributed after the Compliance Date. The requirements of Section 3 shall not apply to Covered Products in the stream of commerce or in Bioworld’s inventory prior to and through the Compliance Date, and such Covered Products are expressly subject to the releases in this Settlement Agreement. 3.2. For purposes of this Settlement Agreement, “Reformulated Covered Products” are Covered Products containing no more than 1,000 parts per million (0.1%) DEHP in any accessible component when analyzed pursuant to U.S. Environmental Protection Agency testing methodologies 3580A and 8270C, or any other methodologies utilized by federal or state agencies for the purpose of determining the DEHP content in a solid matrix (“accessible component” is defined as any component that could be touched by a person during reasonably foreseeable use). In order to determine compliance with this reformulation standard, Bioworld may rely on third party testing from an accredited laboratory.