| Which children's products need to be reported and who is responsible for doing so? |
What must be reported?
If a manufacturer can answer "Yes" to each of the following questions about one or more of its products:
Then a biennial notice/report for the product(s) must to be made. See Oregon Administrative Rule
(OAR) 333-016-2060 for the data that must be reported. Note: For the Toxic Free Kids Act, HPCCCH are also referenced as high priority chemicals (HPC), chemicals of concern or
Chemicals of High Concern to Children (CHCC). All terms refer to the same chemicals as specified in OAR 333-016-2020.
Who’s responsible? The Toxic Free Kids (TFK) Act broadly defines “manufacturer” to include the producer, importer, and domestic distributor of the product. See
ORS 431A.253 for complete definition. OAR 333-016-2060(12) states who, in order, is primarily responsible for a complete, accurate, and timely biennial notice/report for the children's product. That order is:
(a) Any person or entity that manufactured the children's product, unless it has no presence in the United States.
(b) Any person or entity that distributed or made available for distribution the children's product, unless it has no presence in the United States.
(c) The importer or owner of the children's product in the United States. OHA recognizes the complexities of the vendor and/or supply chains for many children’s products. Many products have multiple companies or "links" in their producer/importer/domestic distributor "chains" that enable those products to be sold or offered for sale in Oregon. Companies along a product's chain should work together to ensure biennial notices/reports are filed accurately and submitted on time. IMPORTANT: Only one person or entity that falls within the definition of manufacturer is required to report a particular children’s product, per
OAR 333-016-2060. Companies meeting the definition of manufacturer should work together to avoid overreporting.
OAR 333-016-2060(13) states that OHA will enforce reporting requirements in the same priority order. How can manufacturers prepare for the requirement that HPCCCH in certain children’s products be removed or substituted?
Manufacturers should determine if their company’s products are included in one or more of three subsets of children’s products (OAR 333-016-3010(1)). Those subsets are:
- “Mouthable” products (per
ORS 431.253(8));
- Children’s cosmetics; or
- Products for children <3 years-old?
For products in one or more of these subsets, manufacturers are required to take additional actions on or before the end of the third biennial notice period for the HPCCCH found in specific models/styles in a product category. This is called the product category/HPCCCH combination in these FAQs.
Beginning January 1st of the fourth biennial notice period for a product category/HPCCCH combination, product models in one or more of the subsets in
OAR 333-016-3010 may NOT be sold or offered for sale in Oregon unless action is taken.
The Act provides for several years of research and development so manufacturers and suppliers may identify less hazardous alternatives before either chemical removal or substitution of an HPCCCH from products in these three subsets is required. Chemical(s) that are substituted for HPCCCH in product models belonging to one or more of the subsets in OAR 333-016-3010 must be approved by OHA. See HPCCCCH Substitution in FAQ #37 for details.
Instead of removing or substituting an HPCCCH per OAR 333-016-3010, manufacturers may apply for either of the following: a Waiver from Removal or Substitution Requirement (OAR 333-016-3040) or an Exemption from Removal or Substitution Requirements (OAR 333-016-3015). See
Alternatives to Removal or Substitution of an HPCCCH per
OAR 333-016-3010 in these FAQs. For
any product category/GS1 ‘brick’ combination where an HPCCCH is a contaminant, manufacturers may apply for an Exemption from Notice Requirement (OAR 333-016-2070). See
FAQ# 28.
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| Who is exempt from the biennial notices/reporting requirement under the TFK Act? |
A retailer may be exempt. A retailer of a children's products is not considered manufacturer and therefore, responsible under the TFK Act for making biennial notices/reports unless that retailer is
also the producer, or manufacturer, or importer, or domestic distributor of the product. Manufacturers of children’s products with annual worldwide gross sales of less than $5 million, as reported on the most recent tax return filed by the manufacturer, are exempt this requirement and all other provisions of the TFK Act per
ORS 431A.268. |
| When are biennial notices/reports due? |
Biennial notice/reports are due January 31st of even numbered years for the previous two-year biennial notice period. The next biennial reporting deadline is Jan. 31, 2024. This 2024 Biennial Notice Period due date is for products sold or offered for sale in Oregon from Jan. 1, 2022, to Dec. 31, 2023.
However, manufacturers should not report until the December before the reporting deadline because they are unlikely to have all the information needed. See FAQ #17 to learn more.
To avoid enforcement action by OHA, manufacturers should report children's products with HPCCCH's at or above de minimis that were sold or offered for sale in recent years if they haven't done so. Below is a chart of Oregon's biennial notice periods and due dates.
Products sold/offered
for sale in Oregon in: | Are reported for this
Biennial Notice Period:
| 1/1/2017 - 12/31/2017
| 2018 | 1/1/2018 - 12/31/2019 | 2020 | 1/1/2020 - 12/31/2021 | 2022 | 1/1/2022 - 12/31/2023 | 2024 (Available Dec. 2023) | 1/1/2024 - 12/31/2025 | 2026 (Available Dec. 2025) |
IMPORTANT: Reporting for Washington State's Children's Safe Products Act (CSPA) is annual . When reporting children's products sold or offered for sale in 2023 in that state, manufacturers should select 2022 (1/31/2023) as the Reporting Period when creating a report in the High Priority Chemicals Data System (HPCDS). The HPCDS is the online reporting system used by both states.
In constrast, reporting for Oregon is biennial, the even-numbered year that immediately follows the two-year period during which the products were sold or offered for sale, should be selected as the Reporting Period in the HPCDS.
EXAMPLE: If reporting children's products sold or offered for sale in calendar years 2022 and/or 2023, manufacturers should select 2024 (1/31/2024) as the Reporting Period.
Instructions for reporting for both states' laws are found in the High Priority Chemicals Data System Reporting Guide
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| What do you need to report? |
Manufacturers must report products that contain
one or more HPCCCHs. The data that manufacturers must include in a biennial notice/report is found in OAR 333-016-2060). For each HPCCCH, include the “function set,” which is the unique combination of the following information:
Product Category The term Product category or GS1 ‘brick’ is used to describe similar products by the Global Product Classification (GPC) system. GPC is a system commonly used in the import/export of trade goods. An explanation of how 'brick' fits into other parts of the GPC system is here. The TFK Act requires reporting of a children's product by its product category/GS1 'brick.' - Submit one report for all products that fit into a product category/GS1 ‘brick’.
- A drop-down list of children’s product categories is available in the reporting platform.
Product Component
A product component is the uniquely identifiable material or coating of the product. Choices for product components were developed in consultation with product testing laboratories and are available for you to select when you file your report:
- Indicate which product component part contains HPCCCHs. See Chemical (below) to learn how concentration(s) of a HPCCCH in a unit/component part is to be calculated for the TFK Act.
- IMPORTANT: The location of the HPCCCH in the product does not matter under the TFK Act. Oregon’s law does not distinguish whether or not the component part, which may contain a HPCCCH, is ‘accessible’ or ‘internal.’
Under Oregon’s law, if an HPCCCH is in any components in the product (at/above de minimis), it is subject to reporting.
Chemical
Report the concentration of each HPCCCH found at or above de minimis in a component part/unit in each product category. See Oregon Revised Statute (ORS) 431A.253 for the two definitions of "de minimis" for the Toxic Free Kids Act. See FAQ #13 to learn how concentrations should be calculated.
- If the HPCCCH is present as a ‘contaminant’ as defined in ORS 431A.253, report any amount at or above 100 parts per million (ppm).
- In ORS 431A.253 'contaminant' means trace amounts of chemicals that are incidental to manufacturing and that serve no intended function in the product component, including but not limited to:
(a) Unintended by-products of chemical reactions during the manufacture of the product component; (b) Trace impurities in feedstock; (c) Incompletely reacted chemical mixtures; and (d) Degradation products.
- If the HPCCCH is ‘intentionally added’ as defined in
ORS 431A.253, report any amount at or above the practical quantitation limit (PQL).
OAR 333-016-2035 has a table (Exhibit A) with PQLs for all HPCCCHs.
- In ORS 431A.253 'intentionally added chemical' means means a chemical in a product that serves an intended function in the product component.
Concentration Category
You can report the concentration of a HPCCCH in a range rather than its exact amount, based either on test results or manufacturing knowledge.
Chemical Function A list of chemical functions is available to select when you file your report in HPCDS.
Target Age Category Select the target age category for whom the children’s product is intended, either
Under 3, Ages 3-12 or
Birth-12 years old. For those product categories/GS1 ‘bricks’ containing product models/styles intended for children in both the Under 3 and Ages 3-12 groups, select
Birth-12.
Bricks Sold in Oregon Report the number of items in the product category/GS1 ‘brick’ that were sold in Oregon during the biennial reporting period. Reporters should provide the quantity or volume of items sold in Oregon per product category/GS1 ‘brick’ reported in the HPCS during the Biennial Notice Period. This means the cumulative total of the items, whether specified by SKU, UPC, model or style, sold during the 24-month period, which make up the particular brick being reported.
See FAQ#17 to learn how this may be determined.
As an alternative to reporting the number of items in product category/GS1 ‘brick’ sold in Oregon, a manufacturer may report….
Bricks Offered for Sale in Oregon Report the number of items in the product category/GS1 ‘brick’ that were offered for sale in Oregon during the Biennial Reporting Period. FAQ#17 to learn how this may be determined.
Report on
either items that were sold or items that were offered for sale. It is the manufacturer’s choice. Both numbers are not required. |
| How do you submit a biennial notice/report? |
- This system allows you to file children's product reports for multiple states.
- Manufacturers with large data sets can access a function set template to upload inventory to their HPCDS account?
- Technical questions about using the HPCDS should be addressed to:
hpcds@theic2.org.
- Questions about the content, timing and payment for biennial notices/reports made under the TFK Act should be addressed to
toxicfreekids.program@odhsoha.oregon.gov.
IMPORTANT: When paying Oregon's fee by credit card, the address entered must be the same as the billing address used by the credit card company. If it is not, the payment will be rejected and your submission will not be accepted by OHA.
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| Does a manufacturer need to test their products? |
No, under the TFK Act and its rules, manufacturers do not need to have their products tested for the purposes of reporting. Product testing results do not need to be reported. [There is no mechanism in the HPCDS to receive these reports.]
However, manufacturers are responsible for knowing about
all concentrations of HPCCCH in their products, regardless of location. Manufacturers should ask suppliers of component parts for product models/styles to ensure they have information needed to make an accurate biennial notice/report.
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| Does Oregon require the reporting of children’s products below the GS1 brick level? | Currently, Oregon and Washington do not require manufacturers to report by brand name or product model (i.e., with more specificity beyond the product category/GS1 ‘brick’ level). |
| What is the rationale for having to report the HPCCCH in a product regardless of location? |
The Toxic Free Kids Act does not make a distinction between "accessible" and so-called "inaccessible" or “internal” components. The Oregon Legislature, when developing the Toxic-Free Kids Act, was looking at all the potential ways a child could be exposed to a HPCCCH from a children’s product. They felt that children can be both destructive and curious when it comes to children’s products, and that many component parts that seem to be hard to access may in actuality become accessible, especially to older children who can either break them open or take them apart and therefore potentially be exposed to the chemicals in these components.
Under Oregon’s law,
if a HPCCCH is anywhere in a children's product (at/above de minimis), it is subject to reporting. |
| For the purposes of reporting, how should concentration(s) of a HPCCCH in a unit/component part be calculated? |
For purposes of reporting, “unit” has the same meaning as “component part” per OAR 333-016-2010. The concentration of HPCCCH used in each unit/component part within each product category/GS1 ‘brick’ is to be reported. If there are multiple concentrations for a given unit in a particular product category/GS1 ‘brick’, the manufacturer must use the highest concentration for reporting
The calculation of a HPCCCH's concentration in a given unit/component part within each product category/GS1 'brick' is the HPCCCH's proportion of the mass of a sample of that unit/component part, expressed as parts per million (ppm). The concentration of the chemical used in each unit of the children’s product is to be reported as a range rather than an exact amount.
The method for calculating ppm in component parts/units for TFK is the same as is used for reporting under Washington State's
Children's Safe Products Act. |
| For the purposes of reporting, what is definition of “component part"? |
Per
OAR 333-016-2010, "component part" means a uniquely identifiable material or coating (including ink or dye) that is intended to be included as a part of a finished children's product, including, but not limited to:
(a) Bio-based materials (animal or plant based);
(b) Synthetic polymers (such as but not limited to synthetic rubber, plastics, and foams); (c) Metals (including alloys); (d) Glass, ceramic and siliceous material; (e) Surface coatings (such as but not limited to paints, plating, and waterproofing); (f) Homogenous mixtures (gels, creams, powders, liquids, adhesives, synthetic fragrances); (g) Inks/dyes/pigments; and (h) Textiles (synthetic fibers and blends).
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| For the $250.00 reporting fee, what is meant by "...per unique HPCCCH in a manufacturer’s biennial notice(s)"? |
This means that a fee of $250 is required for each chemical (HPCCCH) that is reported by a manufacturer, or a supplier reporting on the manufacturer's behalf, for a Biennial Notice Period. [See definition of 'manufacturer' in ORS 431A.253(7).]
The fee amount stays the same regardless of the number of children's product categories (GS1 'bricks') containing that HPCCCH that are reported for that biennial notice period. If additional children's product categories (GS1 ' contains an additional chemical(s), the fee would increase.
EXAMPLE: Tommy Tinkleberry Toys reports seven items in a Product Bricks each containing 1,1,2,2-Tetrachloroethane for the January 1, 2020 due date, the fee would be $250. If one of those reported bricks also contained 2-Ethylhexanoic acid, the fee would be $500. HPCDS will automatically calculate the fees owed.
Once the $250 fee for a HPCCCH in a product category/GS1 ‘brick’ is paid for a biennial notice period, the HPCCCH ‘remembers’ that payment has been made for that HPCCCH. If the manufacturer reports additional product categories/GS1 ‘bricks’ containing that HPCCCH for that particular biennial notice period, the manufacturer will not be charged. |
| For reporting to Oregon, what exactly is meant by "number" of bricks? |
The "number of bricks" (in the HPCDS) or "number of children's products" ( OAR 333-016-2060(5)) refers to quantity of items for each of the GS1 'bricks' specified in the HPCDS that were sold or offered for sale during the Biennial Notice Period.
Reporters have a choice of providing a number for either
Number Sold OR Number of Bricks Offered for Sale. Manufacturers are not required to report both. Reporting should be on the number of items of the product brick as it is typically made available for sale in a single package to consumers.
For example, if your company reported the brick, “Viewing Toys (Powered)-10005171,” the TFK Act requires your company to report how many individual models/units/packages of this brick were sold (or offered for sale) in Oregon during the biennial notice period.
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| When reporting for Oregon, reporters are asked either for the number of products sold or offered for sale in Oregon during the biennial notice period. I represent a manufacturer, and don’t know the answer. What should I do? |
As discussed above, reports must include the number of items/units sold
or offered for sale. If your company is required by contract to report on behalf of retailers or distributors, OHA recommends you ask them to track the number of items/units sold/offered in their Oregon locations during the biennial notice period.
Retailers, distributors, or whichever entity brought your company’s products into Oregon should send that information to you in the December before the January 31st Biennial Notice due date. Because most manufacturers will not know the total number of units/items sold in the biennial notice period until its end, reporting should not be done until period's second December. |
| How long am I required to submit biennial notice/reports for the children’s products I manufacture? |
Manufacturers are required to submit biennial notice/reports at the end of
every biennial notice period in which they sold or offered for sale in Oregon a children’s product containing a HPCCCH at de minimis unless items in the product categories/HPCCCH combinations are:
1) Subject to OAR 333-016-3010(1), which prohibits the sale of such items in Oregon after three biennial notice periods;
OR
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| How do I know if a report/biennial and payment of my Biennial Notice fee have been made successfully? |
As discussed in the HPCDS Reporting Guide, one a reporter has completed Step 2. Review Report for Oregon, they should continue to Step 3. Payment. There are two options: Pay Using a Credit Card or Submit Payment by Check: A. 'Pay Using a Credit Card' takes the reporter to a secure third-party payment website required of all online transactions made to Oregon agencies by the State of Oregon. [There is no additional service fee to the reporter for use of this payment website.] Once Submit Payment is clicked a Payment Receipt Confirmation message will appear. It will also be emailed to the address entered by the reporter. Reporters should keep this Payment Receipt Confirmation as proof of payment.
B. 'Submit Payment by Check' allows the reporter to pay the fee with a check drawn on a U.S. bank. After following the directions and clicking the ‘Submit’ button, an HPCDS Submission Confirmation message will appear. It will also be emailed to the address entered by the reporter. It should be kept as proof of submission.
Reporters should be sure to mail that check or have it expressed delivered (courier) to one of the two addresses on the screen at their earliest convenience. OHA staff will be matching received checks to the submissions made. Checks mailed from outside the United States should be expressed delivered
Reporters who have already reported (and paid for) a HPCCCH in a product category/GS1’brick’ will not be asked to pay again when reporting the same HPCCCH in another product category/GS1’brick in the same biennial notice period.
Instead, they will receive a Submission Revied email with a unique Disclosure ID number. This should be kept as proof of their submission, and provided to OHA, upon request. |
| Reporting requirements under the TKFA seem similar to the state of Washington’s Children’s Safe Products Act. What are some important differences? |
(a) Oregon’s Toxic-Free Kids Act differs from Washington’s Children’s Safe Products Act in how the laws treat component parts that are not accessible to a child through normal and reasonably foreseeable use and abuse.
While Washington’s law does not require reporting of these components, under Oregon’s law, they are subject to reporting.
Oregon’s law does not exempt a component based on its location in the product. If an HPCCCH is in any component or location of the final product at the applicable de minimis level, it is subject to reporting using the HPCDS.
(b) Oregon charges a fee per chemical for biennial notice reporting. Oregon also has enforcement provisions and civil penalties established in rule that can be imposed in the event that a manufacturer does not comply with the requirements. You can find the language for fees in
OAR 333-016-2080 and language pertaining to enforcement and penalties in
OAR 333-016-3080.
(c) A manufacturer of children’s products with annual worldwide gross sales of less than $5 million, as reported on the most recent tax return filed by the manufacturer before the notification required under OAR 333-016-2060, is exempt from all the requirements of these rules. |
| What strategies could businesses use to comply with these requirements to ensure their products do not contain any of the listed chemicals, and in turn, avoiding the need to report? |
One strategy for ensuring products do not contain HPCCCH, and for complying with
ORS 431A.258 is for manufacturers to test the final children’s product or require suppliers to test their products (and the raw materials that go into them) to determine if
HPCCCH are present.
Though product test results do not need to be reported to TFK for reporting, testing should help manufacturers determine the levels (PPM-parts per million) of HPCCCH found in components in final products made available for sale in Oregon to assess whether they are at or above de minimis levels. Products containing HPCCCH above de minimis levels are subject to reporting. |
| How can I stay informed of important announcements and changes to the TFK Act and its rules? | |
| Are foods, beverages and the packaging of children's products, all exempt from requirements of the TFK Act? | There are two important points about packaging and the TFK Act:
- Food, beverages and their packaging, which are regulated by U.S. Food & Drug Administration (FDA), are exempt from all requirements of the TFK Act. See
ORS 431A.253.
- The packaging of a children's product, which is intended to be opened and discarded when the product is first used, is also exempt from all requirements of the TFK Act.
However, a container that is intended to be present for the life of a children's product is considered to be a component of that children's product, so is subject to the requirements of the TFK Act. EXAMPLE: The tube housing lipstick that meets the definition of a children's cosmetics per
ORS 431A.253 is a component of that lipstick. |
| Are items, which are generally used outdoors, exempt from all requirements of the TFK Act? | It depends.
Some items like children’s bicycles, balls, tents model rockets, and snow sports equipment are EXEMPT from the TFK Act. Other outdoor equipment, like children’s play structures or water toys, ARE subject to the requirements of the TFK Act. See
ORS 431A.253.
If you have questions about whether or not an item is subject to the requirements of the TFK Act please do not hesitate to contact the TFK Program. See FAQ# 27. |
| Is furniture marketed for children covered by the TFK Act? |
Furniture products intended to facilitate sleep or relaxation are part of the this definition of “children’s product” and ARE subject to the requirements of the TFK Act. This means children’s beds, head boards for children’s beds and cribs, children’s stuffed chairs, bean bags or other furniture for relaxing as well as other sleep-related products (sheets, pillows, blankets, etc.), should be reported if they contain ( HPCCCH) at de minimis levels.
Furniture products that do not facilitate sleep or relaxation are EXEMPT from the TFK Act and its rules. Exempted furniture products intended for children include: children’s dressers, desks, nightstands, hard chairs, tables, toy-storage containers and any other furniture that does not facilitate sleep or relaxation.
If you have questions about whether or not a product is subject to the requirements of the TFK Act please do not hesitate to contact the TFK Program. See FAQ# 27. |
| Do children’s products containing lead (Pb) need to be reported under the TFK Act? |
No, lead is not a HPCCCH so is not covered by the TFK Act.
However, lead is toxic to people, particularly children where lead exposure may result in slow growth and development, behavior and learning problems, or health effects such as kidney or liver damage. And lead is not permitted in children’s products sold or offered for sale in Oregon. Learn how to
Protect Your Family From Lead.
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| Are you unsure if your product is in-scope for the Toxic Free Kids Act? Do you have questions about the TFK Act and its rules? |
Avoid the potential for enforcement action for your company and ask the TFK Program. TFK staff are happy to advise on a particular product or reporting situation. Send questions and/or pictures of an item and its packaging to: toxicfreekids.program@odhsoha.oregon.gov. |