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Regulatory ESSENTIAL
USA - REACH

Modular information package with all the essential information for compliant products in your target market.
Conveniently read online at Product-Compliance-Portal ROGER WILLCO.

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Stakeholders:      User     
Application: articles, substances
Countries: Image for US USA - United States of America,  
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Status: Published 2020-05-12 by Inken Green and Michael Loerzer
Last change 2024-01-18 by Inken Green: Regulatory market access conditions for the actor(s), Chemical requirements (general) (REACH)
   
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Subject Areas of this Essential:


Chemicals (REACH)

Scope of this ESSENTIAL
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).'

Analysis of regulatory requirements

Legislation in force for this PCT
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

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 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.”'

Responsible actors
here you will get textual information

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)
here you will get textual information

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)

Exemption clauses
here you will get textual information

Exempted devices/products or industry sectors.

Sub-federal legislation of states/counties
here you will get textual information

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
here you will get related hyperlink(s)

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
here you will get textual information

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

Authority
here you will get related hyperlink(s)

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

Link/Reference to other reference document(s)
here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO licence)

Link/Reference to other reference document(s)
here you will get related hyperlink(s)

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

Route to compliance

Formal and administrative requirements

Registration at related authority required?
here you will get textual information

Product registration? Manufacturer registration? Importer / Representative registration? if required.

Local representative legally required?
here you will get textual information

[Yes/No]

Hints
here you will get textual information

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
here you will get textual information

Registration requirements for substances in articles

Registration obligations for articles
here you will get textual information


Hints
here you will get textual information

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)
here you will get textual information

what are the criteria for these substances? (e.g. Art. 57 REACH)

Substances of very high concern (SVHC)
here you will get related hyperlink(s)

what are the criteria for these substances? (e.g. Art. 57 REACH)

Hints
here you will get textual information

Specific recommendations, information or most common mistakes

Notification obligations
here you will get textual information

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
here you will get a image or chart

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
here you will get textual information

Which information shall be submitted?

Deadline for the notification
here you will get textual information

Duty to communicate information on substances in articles
here you will get textual information


Required information to communicate
here you will get textual information

Deadline for the information
here you will get textual information

Hints
here you will get textual information

General Information:

   USA - United States of America

Code, ContinentUSA, North America
Economic Area
Official LanguageThe 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.
Standard InstituteAmerican National Standards Institute - ANSI | https://ansi.org/
HS CodememberYes, since 1970

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