Vol. 1234 | 29 Mar 2021

On March 1, 2021, the Oregon Health Authority (OHA) has published the final rule implementing Phase 3 requirements of Oregon’s 2015 Toxic Free Kids Act (TKFA).

The Toxic-Free Kids Act requires manufactures of children’s products sold in Oregon to report and ultimately, for certain product categories, to remove the High Priority Chemicals of Concern for Children’s Health (HPCCCHs). A list of Oregon's 68 HPCCCH is referenced here: https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=276960

The Phase 3 final rule establishes detailed requirements, to remove HPCCCH or substitute HPCCCH with an alternative to make the product less hazardous or have a waiver approved by OHA for the HPCCCH by January 1, 2022 (the third deadline for the biennial reporting rule), for manufacturers of three product categories listed below:

  • Mouthable products
  • Children’s cosmetics
  • Products made for or marketed to children under three years of age

If seeking waiver, manufacturers must apply to OHA for a waiver by their third biennial reporting deadline, January 1, 2022. For waiver the company must either:

  • perform an exposure assessment and demonstrate that the chemical of concern does not migrate into children’s bodies under condition of normal use of the product; or
  • conduct an alternatives assessment to validate that eliminating or substituting the HPCCCH is not financially or technically feasible.

If the manufacturer substitutes an HPCCCH with an alternative chemical, it must submit a hazard assessment to the OHA demonstrating that the new chemical is less hazardous than the substituted HPCCCH.

The manufacturer or trade association may request for exemption when HPCCCHs are present only as a contaminant at or above the de minimis level, and a manufacturing control process (MCP) is in place.

Manufacturers with annual global gross annual sales below $5 million are exempt from all requirements of this rule.

Details of Phase 3 final rule can be reviewed at https://www.oregon.gov/oha/PH/HEALTHYENVIRONMENTS/HEALTHYNEIGHBORHOODS/TOXICSUBSTANCES/Pages/Toxic-Free-Rules.aspx#phase3

For questions, please contact Dr. Stella Li (xingyu.li@intertek.com, +1- 503-351-9612), Dr. Pratik Ichhaporia (pratik.ichhaporia@intertek.com, +1-847-212-8273).


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