SAFEGUARDS | Consumer ProductsNO. 040/21
In 2015, the U.S. state of Oregon signed into law the ‘Toxic-Free Kids Act’ (the Act). The Act authorizes the Oregon Health Authority (OHA) to establish and maintain a list of High Priority Chemicals of Concern for Children’s Health (HPCCCH) that are used in the manufacture of products for children under the age of 12, and to establish rules governing what manufacturers must do to comply with the Act (SafeGuardS 141/15). These rules and implementation processes were to be established over Phases 1 to 3.
According to the Act, children’s product has the following meaning:
- Any of the following products that are made for, or marketed for use by children under 12 years of age:
- A product designed or intended to facilitate sucking, teething, sleep, relaxation, feeding or drinking
- Children’s clothing and footwear
- Car seats
- Children’s cosmetics
- Children’s jewelry
- Any component part of a product specified above
Per the Act, reporting is required if an HPCCCH meets the following:
- Intentionally added and is equal to or greater than the practical quantification limit (PQL) or
- A contaminant that is equal to or greater than 100 ppm
An HPCCCH, however, will need to be removed, substituted with a less hazardous alternative or have a waiver approved by the OHA, by January 1, 2022 (the third biennial notice) if the children’s product fall under the following three categories:
- Intended for children under the age of three, or
- ‘Mouthable’ as defined under ORS 431A.253(8)
In February 2021, the OHA approved Permanent Administrative Order (PAO) PH 9-2021 for Phase 3 Rulemaking of the Toxic-Free Kids Act. In addition to revising the language in the Act, including consistent chemical nomenclature for HPCCCH with chemicals of high concern for children (CHCC) under Washington State’s Children’s Safe Products Act (CSPA), this POA contains several new provisions for substitution, removal or waiver procedures for the aforementioned three categories of children’s products. These provisions include, inter alia, the following:
- ‘Removal of Substitution of High Priority Chemicals’:
- Procedures required by manufacturers who remove an HPCCH from, or cease to manufacture, the above three categories of children’s products
- Procedures for manufacturers with no more than 25 employees who wish to apply for a two-year extension of the date in ORS 431A.260 to meet the requirements
- ‘Exemptions from Removal or Substitution Requirements’ – manufacturers may request an exemption to the removal or substitution of an HPCCCH under ORS 431A.260 if they meet at least one of four conditions, including an HPCCCH meeting the limits under the Consumer Product safety Improvement Act of 2008 (CPSIA)
- ‘Requirements for Chemical Substitution and Hazard Assessment (HA) for Substitute Chemicals’ – requirements for HA for manufacturers who wish to substitute an HPCCCH with a less-hazardous chemical and procedures for considering the HA
- ‘Application process and timelines for waivers from removal or substitution requirements’ – this includes a quantitative exposure assessment (QEA) demonstrating an HPCCCH is not reasonably anticipated to result in exposure to a child based on an analysis of the leaching and bioavailability of the HPCCCH
- Alternative Assessment (AA) – manufacturers must perform an AA to evaluate the possibility of replacing chemicals in products with a safer alternative. The AA must be carried out by starting with the HA and the following assessments in any order – QEA, technical feasibility assessment and financial feasibility assessment
- Details of the the requirements for manufacturers (also means importers (owners) or domestic distributors)
It is interesting to note that entry 28 to the HPCCCH list applies to 4-nonylphenol (CAS 104-40-5) under PAO PH 9-2021, as opposed to 4-nonylphenol (CAS 104-40-5), 4-NP and its isomer mixtures including CAS 84852-15-3 and CAS 25154-52-3 under the same entry in PAO PH 252-2018.
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