Regulatory ESSENTIAL
USA - Hygienic Design

Scope of this ESSENTIAL

This ESSENTIAL decribes hygienic design requirements on the basis of the following US Laws: - Code of Federal Regulations - Title 21 - Part 117 - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food - FDA Food Safety Modernization Act - Food Code 2017 - plus the voluntary NSF (National Sanitation Foundation) certification rules for food contact and processing materials. For other aspects of food contact (e.g.: materials, migration limits, see: ESSENTIAL USA Food Contact Materials.'

Analysis of regulatory requirements

Legislation in force for this PCT

here you will get related hyperlink(s) Are legal provisions regulates the product compliance topic? If yes, what is the reference (title, number)?

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)?

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)?

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 a linked document in ROGER WILLCO (only reachable with additional ROGER WILLCO licence) Has the country signed a Free Trade Agreement (FTA) or a Mutual recognition agreement (MRA) with EU?

Authority

here you will get textual information 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)

Route to compliance

Hints

here you will get textual information Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

Approval process (conformity assessment procedure)

here you will get related hyperlink(s) Means each legally required approval process prior placing on the market, importation or putting into service

Approval process (conformity assessment procedure)

here you will get textual information Means each legally required approval process prior placing on the market, importation or putting into service

Hints

here you will get a image or chart Specific recommendations, information or most common mistakes

Testing & Standards

Specific requirements for testing

here you will get textual information e. g. is an accredited test lab. mandatory, limits, test samples, product description

General information to the application of standards

here you will get related hyperlink(s) e. g. China: GB standards are mandatory, EU: harmonized standards shall be published in the OJEU with respect to "presumption of conformity"

Regulatory labelling, markings and user information

Regulatory label (mandatory)

here you will get textual information e. g. product label

Hints

here you will get a image or chart Specific recommendations, information or most common mistakes

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