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. 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 Biennial Notice due date (for such products sold or offered for sale in 2018 through 2019) was January 1, 2020.

***Sold or offered for sale products with HPCCCH in 2017 through 2019, but haven't yet reported?

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

How to Report

Requesting Exemption from Reporting

Manufacturers of children’s products and trade associations may submit a request to be exempt from reporting (Notice Requirement) per OAR 333-016-2060 for children's products with HPCCCH as contaminants 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 2020 through 2021 before the next Biennial Notice due date: January 1, 2022.
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 ver2.1
Exemption requests previously approved by OHA do not need to be submitted again unless the approved processes and procedures change. Before re-submitting, entities with approved Exemption Requests should contact OHA at toxicfreekids.program@state.or.us

Download the TFK Exemption Request MCP Form for directions on paying the Exemption Request fee, and sending the Exemption Request MCP to the Toxic Free Kids Program at OHA.

Pay $1500 exemption request fee with a credit card online

Do HPCCCHs need to be removed from certain children's products?

By January 1, 2022, Oregon Administrative Rule (OAR) 333-016-3010 requires manufacturers that have made three Biennial Notices to remove or substitute HPCCCH(s) present at or above 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.

Manufacturers intending to substitute a HPCCCH must comply with OAR 333-016-3020. Manufacturers that have made at least one Biennial Notice and removes the HPCCCH from the product, or is no longer selling the product in Oregon must follow OAR 333-016-3010(3) through (6).

Products containing a HPCCCH at or above de minimis may no longer be sold or offered for sale in Oregon after being reported in three Biennial Notices unless OHA's approves a waiver or exemption request for such products.

Alternatively, manufacturers of children's products listed above may do one or both of the following:

Submit to OHA a request for a Waiver from Removal or Substitution Requirement per OAR 333-016-3040. To be considered, waiver applications must be submitted by December 31, 2021. Applications must be accompanied by either an Quantitative Exposure Assessment (QEA) per OAR 333-016-3050 or an Alternatives Assessment (AA) per OAR 333-016-3060. 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. [Because a QEA is a required component of an AA, the QEA Guidance applies to both.]

Submit to OHA a request to be exempt from the removal or substitution requirements. Manufacturers who've determined their products meet one or more of the categories in OAR
333-016-3015(2) must request exemption on or before January 1, 2022.

Other Key Points:

OHA will accept waiver applications and exemption requests per OAR 333-016-3015 starting October 1, 2021.

A manufacturer with 25 or fewer employees may apply for a two-year extension to meet the "removal or substitution" requirements. This application, per 333-016-3010(2), must be received by OHA before January 1, 2022.

Children's products that don't fit criteria in OAR 333-016-3010(1) are not affected by its "removal or substitution requirements," but must continue to be reported per OAR 333-016-2060 as long as they contain HPCCCHs at or above de minimis or unless OHA has approved an Exemption from Reporting for them per OAR 333-016-2070.

OHA will release additional guidance documents as well as instructions for the submission of requests in the coming months.

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@state.or.us.

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.