Regulatory ESSENTIAL
USA - 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

Code, Continent	USA, North America
Economic Area
Official Language	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.
Standard Institute	American National Standards Institute - ANSI | https://ansi.org/
HS Codemember	Yes, since 1970