Toxic-Free Kids Program

The Toxic-Free Kids Act was passed during the 2015 legislative session. This law requires manufacturers of children's products sold in Oregon to report products containing one or more High Priority Chemicals of Concern for Children's Health (HPCCCH) if found at or above specific levels in those products. Ultimately, manufacturers are to remove these chemicals from certain products or seek a waiver. Products that fall under this law are those that are marketed to or intended for children.

The Oregon Health Authority's Toxic-Free Kids program is responsible for implementing this law. Our goal is to reduce children’s exposure to chemicals of concern and improve our understanding of how children are exposed to these chemicals.

Requirements for Manufacturers

Is your company required to report children's products?

Per Oregon Revised Statute (ORS) 431A.258, manufacturers must provide Biennial Notices (reports) to OHA of children's products sold or offered for sale in Oregon that are covered by the Oregon Toxic-Free Kids Act (TFK Act) and contain High Priority Chemical(s) of Concern for Children’s Health (HPCCCH) in the final product that are at or above de minimis.

Per ORS 431A.253(5)(a) and (b), de minimis levels for all HPCCCH found as contaminants is at or above a concentration of 100 parts per million. [Reporting under the TFK Act is not required for products
containing HPCCCH below 100 ppm).] ORS 431A.253(4) defines 'contaminant' for the TFK Act. The de minimis for intentionally-added HPCCCH is the practical quantification limits (PQL). The PQLs for intentionally-added HPCCCH vary and may be found in OAR 333-016-2035 Exhibit A.

A fee of US $250.00 per unique HPCCCH in a manufacturer’s biennial notice must be paid as well. The first biennial notice (for products sold or offered for sale in Oregon in 2017) was due January 1, 2018. The second due date for such products sold or offered for sale in 2018 through 2019 was January 1, 2020. And the third, products sold or offered for sale in 2020 through 2021, was January 1, 2022

***Sold or offered for sale products with HPCCCH in 2017 through 2021, but haven't yet reported?

You should report now to avoid enforcement action by OHA.***

How to Report

See Frequently Asked Questions on Complying with the Biennial Notice Requirement/Reporting for the Toxic Free Kids Act and Due Dates and Important Points for the 2024 Reporting Period.

Have you removed HPCCCH(s) from children's products previously reported to OHA?

If your company has provided OHA notice of children's products containing HPCCCH(s), but the HPCCCH(s) has been removed, this change must be reported to OHA per OAR 333-0160-2060(14). This must be done within 180 days of the change. See the Form and instructions for making this report.

This reporting helps OHA avoid unnecessary enforcement actions.

Requesting Exemption from Notice Requirement (MCP)

For the 2024 Biennial Notice Period (i.e. children's products with HPCCCH(s) sold or offered for sale in Oregon in 2022 through 2023), manufacturers of children’s products and trade associations may submit a request to be exempt from reporting (Notice Requirement) per OAR 333-016-2060. This exemption is only available for children's products with HPCCCH as 'contaminants' (per ORS 431A.253(4)) at concentrations at or above 100 parts per million (ppm).

Exemption requests must be accompanied by a Manufacturing Control Program (MCP) as defined in OAR 333-16-2010.

Exemption requests are not available for an 'intentionally added chemical' per ORS 431A.253.

Exemption requests-MCPs must be submitted for products sold or offered for sale in Oregon in 2022 through 2023 on or before the next Biennial Notice due date: January 31, 2024.

MCPs should be developed in accordance with OAR 333-016-2070 Exemption from Notice Requirement. Please see Guidance for Manufacturing Control Program per OAR 333-016-2070.

Manufacturers interested in requesting an Exemption from Notice Requirement for the 2024 Biennial Notice Period (i.e., sold or offered for sale in Oregon in 2022 through 2023) should contact OHA at toxicfreekids.program@odhsoha.oregon.gov

Exemption requests previously approved by OHA do not need to be submitted again unless one or more of changes per OAR 333-016-2070(14) occur.

Upload Use the same portal below for Chemical Substitution submissions as well. See Frequently Asked Questions on Exemption from Notice Requirement/MCP.

Requests for Exemption from Notice Requirement per OAR 333-016-2070 is no longer available for products that must be reported for the 2022 Biennial Notice Period (i.e. those sold or offered for sale in Oregon in 2020 through 2021).

Manufacturers may have to remove or substitute high priority chemicals in certain products after 3 Biennial Notices

OAR 333-016-3010 requires manufacturers that have made three Biennial Notices to remove or substitute HPCCCH(s) present at de minimis in children's products that are:

“Mouthable per ORS 431A.253;
A children's cosmetic; or
Made for, marketed for use by or marketed to children under three years of age.

Product models/styles specified in OAR 333-016-3010 containing a HPCCCH(s) at or above de minimis may no longer be sold or offered for sale in Oregon after their product category/HPCCCH combination has been reported in three Biennial Notices unless requests for one or more of the following has been made of OHA by January 31, 2024:

A Chemical Substitution (OAR 333-016-3020 and OAR 333-016-3030);
A Waiver (OAR 333-016-3040)
An Exemption from Removal or Substitution Requirements (OAR 333-016-3015)

See Alternatives to Removal of HPCCCH and How to Send Requests to OHA below for details, including a secure portal to upload requests and pay fees. Frequently Asked Questions on HPCCCH Removal/Substitution Requirement and Waiver and Exemptions from Removal/Substitution

Alternatives to Removal of HPCCCH and How to Send Requests to OHA

Manufacturers may request one or more of the following for products in the OAR 333-016-3010 subset:

A Waiver from Removal or Substitution Requirement per OAR 333-016-3040.

Applications must be accompanied by either an Quantitative Exposure Assessment (QEA) per OAR 333-016-3050 or an Alternatives Assessment (AA) per OAR333-016-3060.

Guidance for a Quantitative Exposure Assessment (QEA) per OAR 333-016-3050 is available to assist in development of a QEA per OAR 333-016-3050. [A QEA is a required component of an AA, so the QEA Guidance applies to both.]

Request Exemptions from Removal or Substitution Requirements per OAR 333-016-3015. Please see Guidance for Requesting Exemptions from Removal or Substitution Requirements per OAR 333-016-3015.

Request Exemption from Notice Requirement (MCP). See text column to left. [This exemption is not available for product models affected by OAR 333-016-3010 after their 3rd Biennial Notice Period.]

Amendment to a PREVIOUSLY Approved Exemption from Notice Requirement Request per OAR 333-016-3015.

Request Chemical Substitution per OAR 333-016-3020 and OAR 333-016-3030.

All requests may be uploaded and application fee paid at TFK's secure Fee Payment & Application Upload Portal.

Models/styles affected by OAR 333-016-3010 must be reported to OHA.

Manufacturers that have made two notices to OHA for products affected by OAR 333-016-3010(1), but not applied or been approved for one or more of the alternatives above, must report to OHA the specific product models belonging to the GS1 'brick.'

Criteria for reporting includes those products that:

Will not be offered for sale in Oregon on January 1, 2022 and after because of OAR 333-016-3010(3); or
Have had HPCCCHs removed and do not have a substitute chemical; or
Are no longer being manufactured; or
Contain substitute chemicals that are no longer being used.

OAR 3 33-016-3010(4) through(6) should be reviewed as well. See the notification form and instructions for both. OHA will accept these notices on or before January 31, 2024.

Other Key Points:

If you are unable to access OAR links, TFK rules, current as of 1.1.2022, are also found here . Current PQLs (OAR 333-016-2035) are here.

A manufacturer with 25 or fewer employees may apply for a two-year extension to meet the "removal or substitution requirements. This application must address requirements of OAR 333-016-3010(2) and sent to toxicfreekids.program@oha.oregon.gov

Children's products that don't fit criteria in OAR 333-016-3010(1) are not affected by its removal or substitution requirements.

However, those products (right above), if sold or offered for sale in Oregon, must continue to be reported per OAR 333-016-2060 as long as they contain HPCCCHs at or above de minimis unless OHA has approved an Exemption from Notice Requirement (MCP) for them per OAR 333-016-2070.

Would you like updates on rule changes and reminders on compliance due dates? Please send your name and company name (if applicable) to: toxicfreekids.program@odhsoha.oregon.gov

Why focus on kids?

Of the thousands of chemicals present in our environment, some have toxic effects that are harmful to human health, in particular to children. Children are more vulnerable than adults to permanent injury from toxic chemicals because:

They are going through critical stages of growth and development;

Their bodies are smaller than adults, so by comparison their exposure level to toxins is higher; and

They do things that can put them at risk, such as babies putting things in their mouth and playing on the floor.

Harm or injury from toxic chemicals can permanently alter a child’s lifelong development and health.

The presence of these chemicals in a product does not necessarily mean the product will harm a child's health, or that there is any violation of existing safety standards or laws. In order for a child’s health to be harmed by a toxic chemical, that chemical must somehow get out of the product and into their body.

There is a lot we don't know about how people may be exposed to chemicals based on how they use a product, or how the product degrades over time. Information gathered from manufacturers as part of this program will improve our understanding, and help OHA answer questions about children’s exposure to these chemicals.

Other agencies that regulate chemicals in children's products

The Toxic-Free Kids program is the only Public Health Division program that regulates chemicals in consumer products.

Other state and federal agencies that play a role in chemical regulation and consumer products include:

The federal Consumer Product Safety Commission (CPSC)
The federal Food and Drug Administration (FDA)
The federal Environmental Protection Agency (EPA)
The Oregon Department of Environmental Quality (DEQ)
The Oregon Department of Agriculture (ODA)

Each of these agencies regulate chemicals in different types of consumer products ranging from toys to food to pesticides. The scope of Oregon’s Toxic-Free Kids program is limited to children’s products, excluding products like food, food packaging and pharmaceuticals that are already regulated by other state and federal agencies.