TSCA vs REACH: How US and EU Chemical Rules Differ in Practice
TSCA requires each substance to be on the EPA Inventory or cleared as new; REACH requires EU registration at 1 tonne or more yearly. For one product sold in both markets, TSCA screens every component against the Inventory at any volume, while REACH counts tonnes per EU manufacturer or importer and sizes the data dossier to that tonnage.
A new chemical substance needs a premanufacture notice to EPA at least 90 calendar days before manufacture, which includes import, begins (40 CFR 720.40, 2026).
REACH registration applies to each manufacturer or importer of a substance at one tonne or more per year (Regulation 1907/2006, Article 6).
The July 2026 TSCA Inventory update lists 42,698 chemicals as active in US commerce and 44,043 as inactive (US EPA, 2026).
A US importer of a chemical substance in bulk or in a mixture files a positive or negative TSCA certification with US Customs and Border Protection before release (19 CFR 12.121, 2026).
This comparison covers federal TSCA and the EU REACH text consolidated on 22 June 2026, checked on 13 October 2026. It does not cover UK REACH, K-REACH, US state laws, hazard communication under OSHA or CLP, or restrictions on existing substances under TSCA section 6 and REACH Annex XVII.
How do TSCA and REACH differ?
TSCA and REACH differ in what triggers the duty: TSCA asks whether a substance is new to the EPA Inventory, while REACH asks how many tonnes each EU manufacturer or importer handles. Under the US Toxic Substances Control Act (TSCA), a new chemical substance is any chemical substance not on the list EPA compiles under section 8(b) (15 U.S.C. 2602, as amended 2016). Under the EU Registration, Evaluation, Authorisation and Restriction of Chemicals regulation (REACH), substances on their own, in mixtures or in articles may not be manufactured in the EU or placed on the market unless they have been registered where registration is required (Regulation 1907/2006, Article 5).
The table below shows what a supplier files before selling one substance in each market.
Duty | US TSCA | EU REACH |
|---|---|---|
Pre-market step | Inventory check; premanufacture notice (PMN) for a new substance at least 90 calendar days before manufacture or import (40 CFR 720.40, 2026) | Registration dossier to the European Chemicals Agency (ECHA) (Regulation 1907/2006, Article 6) |
Volume trigger | None for a PMN: any person who intends to manufacture a new substance for commercial purposes submits a notice unless it is excluded (40 CFR 720.22, 2026); a low volume exemption covers up to 10,000 kg a year, not for a PFAS or certain PBT substances, with an exemption notice at least 30 days before manufacture (40 CFR 723.50, 2026) | One tonne or more per year per manufacturer or importer (Regulation 1907/2006, Article 6) |
Who files | Manufacturer or principal importer; only manufacturers incorporated, licensed or doing business in the US may submit (40 CFR 720.22, 2026) | EU manufacturer or importer, or an only representative appointed by a non-EU manufacturer (Regulation 1907/2006, Article 8) |
Data and its owner | All test data in the submitter's possession or control, filed by that submitter (40 CFR 720.50, 2026) | Annex VII minimum at 1 tonne a year (physicochemical part only for some phase-in substances), more at 10, 100 and 1,000 tonnes (Regulation 1907/2006, Article 12); hazard data submitted jointly through a lead registrant (Article 11) |
When sale can start | After EPA review and determination; EPA can extend the review for good cause by up to 90 days in total (15 U.S.C. 2604, as amended 2016); the 90-day period runs from a complete notice and can be suspended at the submitter's request if EPA agrees (40 CFR 720.75, 2026) | If ECHA gives no contrary indication within three weeks after submission (Regulation 1907/2006, Article 21) |
Import paperwork | Positive or negative TSCA certification filed with CBP before release (19 CFR 12.121, 2026) | No REACH filing at customs; the registration number appears on the safety data sheet when an SDS is required: section 1.1 for a substance, and section 3, where available, for a registered substance in a mixture (Regulation 1907/2006, Article 31 and Annex II) |
The row that most changes a launch plan is timing: TSCA needs the notice at least 90 calendar days before the first US manufacture or import of a new substance, and the review runs from a complete notice and lasts longer if EPA extends it or the submitter suspends it, while REACH lets a registrant start if ECHA raises nothing within three weeks after submission (40 CFR 720.40, 2026; 40 CFR 720.75, 2026; Regulation 1907/2006, Article 21).
Does TSCA require registration like REACH?
TSCA does not require registration like REACH: a substance already on the EPA Inventory needs no pre-market filing, and a premanufacture notice is needed for a new substance. EPA treats a substance on the Inventory as an existing chemical substance in US commerce and any chemical not on it as a new chemical substance (US EPA, 2026). The Inventory lists more than 86,000 chemicals (US EPA, 2026).
Inventory status has two flags. In the July 2026 update, 42,698 chemicals were designated active in US commerce and 44,043 inactive (US EPA, 2026). Starting 5 August 2019, manufacturers and processors must notify EPA before reintroducing an inactive substance into US commerce (US EPA, 2026).
For a new substance, the PMN must contain all test data in the submitter's possession or control on health or environmental effects (40 CFR 720.50, 2026). The rule asks for data the submitter holds; it does not set a test package by tonnage band the way REACH Article 12 does. After the review, the submitter files a notice of commencement no later than 30 calendar days after the first day of manufacture (40 CFR 720.102, 2026). Once EPA receives a complete notice of commencement, the substance is on the Inventory and becomes an existing chemical (US EPA, 2026).
REACH works the other way. Its "no data, no market" rule covers established substances as well as new ones whenever the one tonne per year trigger is met (Regulation 1907/2006, Articles 5 and 6).
When is TSCA the harder market to enter?
TSCA is the harder market when the product contains a substance that is not on the EPA Inventory, even in small amounts, because that substance needs EPA review before any commercial manufacture or import. A person may not manufacture a new chemical substance unless a notice reaches EPA at least 90 days before, and EPA has reviewed it and made a determination within the review period (15 U.S.C. 2604, as amended 2016).
A small volume does not remove the step. The low volume exemption covers up to 10,000 kg a year, but the manufacturer still files an exemption notice at least 30 days before manufacture, and EPA reviews it for 30 days (40 CFR 723.50, 2026). EPA does not allow the exemption for a substance it determines is a PFAS, is a PBT substance with anticipated environmental releases and potentially unreasonable exposures, or may cause serious acute, serious chronic or significant environmental effects (40 CFR 723.50(d), 2026). A substance made under that exemption is not added to the Inventory (US EPA, 2026), so it stays a new substance for any other US manufacturer or importer.
Under TSCA, manufacture includes import (15 U.S.C. 2602, as amended 2016), and only manufacturers incorporated, licensed or doing business in the United States may submit a notice (40 CFR 720.22, 2026). A non-US producer therefore works through a US importer. If the foreign supplier keeps the chemical identity confidential, it must give that identity to EPA directly, in a joint submission or a letter of support, before the review period starts (40 CFR 720.45, 2026). A mixture is excluded from notification as a whole, but each new substance inside it is not (40 CFR 720.30, 2026).
When is REACH the harder market to enter?
REACH is the harder market when any substance in the product reaches one tonne per year for an EU manufacturer or importer, because registration then applies whether the substance is new or decades old (Regulation 1907/2006, Article 6). The dossier must include, as a minimum, the Annex VII information at one tonne or more per year, or only the Annex VII physicochemical information for a phase-in substance that meets neither Annex III criterion (Regulation 1907/2006, Article 12). Annex VIII is added at 10 tonnes, testing proposals for Annex IX at 100 tonnes, and testing proposals for Annex X at 1,000 tonnes or more per year per manufacturer or importer (Regulation 1907/2006, Article 12).
Where several companies make or import the same substance, a lead registrant submits the hazard information on behalf of the others, and each registrant then submits its own part (Regulation 1907/2006, Article 11).
REACH defines an importer as a person established within the EU who is responsible for import (Regulation 1907/2006, Article 3). A non-EU manufacturer may appoint an only representative established in the EU, and the importers in that supply chain are then regarded as downstream users (Regulation 1907/2006, Article 8).
REACH also requires registration of a substance in articles above one tonne per producer or importer per year when it is intended to be released under normal or reasonably foreseeable use (Regulation 1907/2006, Article 7). The TSCA notice rule excludes a substance imported as part of an article (40 CFR 720.22, 2026).
How do you prepare one product for both markets?
To prepare one chemical product for both TSCA and REACH, build one substance list, then check Inventory status for the United States and tonnage per legal entity for the EU. Both laws work at substance level. The TSCA mixture exclusion applies to the mixture as a whole, not to the substances in it (40 CFR 720.30, 2026), and REACH Article 6 covers substances on their own or in mixtures (Regulation 1907/2006, Article 6).
List every component and its CAS number from supplier safety data sheets (SDS).
For the US, check each component on the TSCA Inventory, including its active or inactive flag; for a confidential identity, a bona fide notice gets EPA's written answer (40 CFR 720.25, 2026).
For the EU, estimate tonnes per year of each substance for each importer or manufacturer, and decide whether the EU importer or an only representative registers.
Plan the calendar: a PMN at least 90 calendar days before the first US import, longer if EPA extends or the submitter suspends the review (40 CFR 720.40, 2026; 40 CFR 720.75, 2026), and a complete REACH registration at least three weeks before the first EU import above the trigger (Regulation 1907/2006, Article 21).
At the border, the US importer files the TSCA certification for each shipment before release (19 CFR 12.121, 2026). The EU has no REACH filing at customs; the registration number goes on the safety data sheet when an SDS is required (Regulation 1907/2006, Article 31 and Annex II).
Matching supplier SDSs, certificates and formulation records against both lists for each component is the kind of case Lubinpla structures into one cited document for your review.
FAQ
Is a REACH registration accepted in the United States?
No. TSCA defines a new chemical substance as any substance not on the EPA Inventory (15 U.S.C. 2602, as amended 2016), and the exclusions in 40 CFR 720.30 do not include a REACH registration. A REACH-registered substance that is not on the Inventory still needs a premanufacture notice or an exemption before US manufacture or import.
Who carries the duty under TSCA and under REACH?
Under TSCA, the US manufacturer or the principal importer submits the notice, and EPA holds the principal importer liable for completing it and for the truth of what it submits (40 CFR 720.57, 2026). Under REACH, the EU manufacturer or importer registers, or an only representative takes on the importer's obligations for a non-EU manufacturer (Regulation 1907/2006, Article 8).
Does a product imported as an article need a TSCA certification?
Not by default. An importer of a chemical substance or mixture as part of an article must file the TSCA certification only if a rule or order under TSCA requires it (19 CFR 12.121, 2026).
Working a case like this? Lubinpla works it from your own documents and site history, step by step with your approval. Free to start, no card.
Lubinpla does not sell chemical products and names no brands in recommendations. Our reviewer also leads a specialty chemicals distribution company.
Sources checked 2026-10-13.
Sources
US Congress. Toxic Substances Control Act, 15 U.S.C. 2602, Definitions (as amended 2016). Cornell Legal Information Institute. https://www.law.cornell.edu/uscode/text/15/2602
US Congress. Toxic Substances Control Act, 15 U.S.C. 2604, Manufacturing and processing notices (as amended 2016). Cornell Legal Information Institute. https://www.law.cornell.edu/uscode/text/15/2604
US EPA. 40 CFR Part 720, Premanufacture Notification. eCFR, current as of October 2026. https://www.ecfr.gov/current/title-40/chapter-I/subchapter-R/part-720
US EPA. 40 CFR 723.50, Chemical substances manufactured in quantities of 10,000 kilograms or less per year. eCFR, current as of October 2026. https://www.ecfr.gov/current/title-40/chapter-I/subchapter-R/part-723/subpart-B/section-723.50
US Customs and Border Protection. 19 CFR 12.121, Reporting requirements. eCFR, current as of October 2026. https://www.ecfr.gov/current/title-19/chapter-I/part-12/subpart-A/subject-group-ECFRe2b9d3b0add9a83/section-12.121
US EPA. About the TSCA Chemical Substance Inventory. Accessed 2026-10-13. https://www.epa.gov/tsca-inventory/about-tsca-chemical-substance-inventory
US EPA. TSCA Inventory Notification (Active-Inactive) Rule. Last updated 5 March 2026. https://www.epa.gov/tsca-inventory/tsca-inventory-notification-active-inactive-rule
US EPA. How to Access the TSCA Inventory. July 2026 update. https://www.epa.gov/tsca-inventory/how-access-tsca-inventory
European Parliament and Council. Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), consolidated text. 22 June 2026. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02006R1907-20260622
Written by the Lubinpla team from the sources listed and checked against them before publication.