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USA - United States of America
ESS USA REACH
Chemical; material compliance; substance; substance of very high concern; SVHC; REACh

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Anwendungsbereich des Regulatory Essentials

This ESSENTIAL describes the legal obligations for manufacturers and the regulatory requirements for substances in articles as specified in the Toxic Substances Control Act (TSCA).

Stakeholder:

User

Geltende Rechtsvorschriften:

The "The Frank R. Lautenberg Chemical Safety for the 21st Century Act" amended 2016 the "Toxic Substances Control Act of 1976 (TSCA)". On June 22, 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act which amends the Toxic Substances Control Act (TSCA), the Nation’s primary chemicals management law was signed into law. The Toxic Substances Control Act of 1976 provides EPA with authority to require reporting, record-keeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. Certain substances are generally excluded from TSCA, including, among others, food, drugs, cosmetics and pesticides. The implementation of the specific requirements (for certain chemicals) are laid down in 40 CFR Subchapter R. CFR = Code of Federal Regulations Title 40 - Protection of Environment Subchapter R - Toxic Substances Control Act

Nationale Anwendungsebene:

articles, substances

Länder:

 

USA - United States of America

Kommentar bezüglich der Vergleichbarkeit mit der EU-Gesetzgebung:

Comparability EU REACH and TSCA (simplified)...

Status:

Published 2020-05-12 by Inken Green and Linda Kritzler
Last change 2026-01-08 by Linda Kritzler: Scope of legislation, Chemical requirements (general) (REACh)

ID:

#d86w


Inhalt des Regulatory Essentials

Legislation in force for this PCT
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Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

Scope of legislation
The US chemicals legislation Toxic Substances Control Act (TSCA) regulates most industrial chemicals that are manufactured, imported or processed in the United States. It applies to all substances that pose an "unreasonable risk to health or the environment" and also applies to imports.

An "article" is defined in 40 CFR 704.3 as
“a manufactured item
(1) which is formed to a specific shape or design during manufacture,
(2) which has end-use function(s) dependent in whole or in part upon its shape or design during end use, and
(3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design.”'

Scope of legislation
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Responsible actors
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Which actor(s) are responsible for compliance with the legal provisions: e. g. - economic operators (manufacturer, importer, distributor, fulfilment service provider), - user (commercial/industrial/professional), - user (private, consumer)?

Regulatory market access conditions for the actor(s)
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What are the main regulatory requirements (e. g. conformity assessment fulfilment of essential requirements of Annex I 2006/42/EC) prior placing on the market, importation and putting into service (brief description)

Penalty by this legislation
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What are the possible penalties (e. g. sales ban, fines) in the case of non-compliance?

Exemption clauses
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Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties
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E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

Sub-federal legislation of states/counties
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E. g. by 2019 an Inter-Governmental Agreement (IGA) on governance of the Electrical Equipment Safety System (EESS) has been signed by Queensland, Victoria, Western Australia and Tasmania.

FTA/MRA status with EU
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Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority
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Name of the authority for approval, registration, market surveillance and/or enforcement

Market surveillance authority
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Name of the authority for market surveillance and/or enforcement

Link/Reference to other reference document(s)
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Link/Reference to other reference document(s)
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(Zugang nur mit erweiterter ATERIOS Lizenz)

Comment on the comparability to EU legislation
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Hints
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Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?
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Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
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[Yes/No]

Hints
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Specific recommendations, information or most common mistakes

Obligations of producers, suppliers and users of articles

Producers, suppliers and users of articles can have information and notification obligations as well as the obligation to register substances in certain circumstances.

Registration obligations for substances
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Registration requirements for substances in articles

Registration obligations for articles
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Hints
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Obligations for substances of very high concern (SVHC)

Obligations (notification, information) in relation to substances of very high concern (SVHC) or other special substances

Substances of very high concern (SVHC)
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what are the criteria for these substances? (e.g. Art. 57 REACH)

Substances of very high concern (SVHC)
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what are the criteria for these substances? (e.g. Art. 57 REACH)

Hints
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Specific recommendations, information or most common mistakes

Notification obligations
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e.g. Art. 7 (2) REACH Notification to ECHA if SVHC is present in those articles above a concentration of 0,1 % weight by weight (w/w).

Notification obligations
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e.g. Art. 7 (2) REACH Notification to ECHA if SVHC is present in those articles above a concentration of 0,1 % weight by weight (w/w).

Required information for notification
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Which information shall be submitted?

Deadline for the notification
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Hints
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Duty to communicate information on substances in articles
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Required information to communicate
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Deadline for the information
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Hints
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Allgemeine Informationen

   
USA - United States of America

Code, Kontinent, Wirtschaftsraum

USA, North America

Wirtschaftsraum

Offizielle Amtssprache

The United States of America doesn’t have an official language on the federal level. They do use English as the primary language for official documents and publications, legislation, orders, regulations and rulings. The states with English as the only official language are: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Louisiana, Massachusetts, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Carolina, North Dakota, South Carolina, South Dakota, Tennessee, Utah, Virginia and Wyoming. Puerto Rico has declared Spanish the principal language, but both English and Spanish are official languages. In the US Virgin Islands, only English is official, while American Samoa has English and Samoan. Guam has English and Chamorro has official languages and in the Northern Mariana Islands, English, Chamorro and Carolinian are official.

Normen Institut

American National Standards Institute - ANSI | https://ansi.org/

HS Codemitglied

Yes, since 1970

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