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

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 before the next Biennial Notice due date: January 1, 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. Entities with approved Exemption Requests that wish to make one or more changes in OAR 333-016-2070(14) should contact OHA at toxicfreekids.program@odhsoha.oregon.gov

Requests for Exemption from Notice Requirement (reporting) 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 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) that are 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 sell in Oregon a product in OAR 333-016-3010 containing a substitute chemical after its third Biennial Notice Period, must have complied with OAR 333-016-3020 by the last day of that period.

See Still need to report products sold/offered in Oregon in 2017-2021+ to determine Biennial Notice Periods and their due dates. [All TFK OARs may accessed on TFK's Rules and Implementation page under the Phase 3 section.]

Products specified in OAR 333-016-3010 that contain a HPCCCH at or above de minimis may no longer be sold or offered for sale in Oregon after their product categories (GS1'bricks') have been reported in three Biennial Notices unless requests for chemical substitution (OAR 333-016-3020); a waiver (discussed below); or exemption from removal/substitution (discussed below)are made on or before the end of the third Biennial Notice Period for the product's HPCCCH/product category combination.

Alternatives to Removal or Substitution

Manufacturers may make one or more of the following requests for products in the OAR 333-016-3010 subset. OHA must receive completed requests before the end of the third Biennial Notice Period for a HPCCCH/product category combination:

Request a Waiver from Removal or Substitution Requirement per OAR333-016-3040.

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.

Finally, manufacturers may apply for exemption from reporting (biennial notice) an HPCCCH found as a contaminant in ALL children's products before the end of ANY Biennial Notice Period in which a children's product containing a HPCCCCH was sold or offered in Oregon.

If approved, HPCCCH/product categories listed in the request would not need to be reported again. In addition, HPCCCH in products in the OAR 333-016-3010 subset would not be subject to removal or substitution requirements after the third Biennial Notice Period. See details in Requesting Exemption from Notice Requirement (MCP).

None of these requests are available for the 2022 Biennial Notice Period. If you wish to learn more about these options for 2024, please contact OHA toxicfreekids.program@odhsoha.oregon.gov

Do you have models/styles affected by OAR 333-016-3010(1)?

They must be reported to OHA.

Manufacturers that have made two notices to OHA for products affected by OAR 333-016-3010(1), must report to OHA the specific product models belonging to the GS1 'brick' by the end of the third biennial notice period per OAR 333-016-3010(3).

The criteria 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.

See the notification form and instructions. OARs 3 33-016-3010(4) through(6) should be reviewed as well.

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.