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Regulatory ESSENTIAL
USA - Hygienic Design

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:      Manufacturer, Importer     
Application: USA, FDA Requirements, Voluntary NSF Mark
Countries: Image for US USA - United States of America,  
#866t  
Status: Published 2023-02-17 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2023-09-25 by Anette Dunkel-Reinboth: Application procedure for database admission, Food contact materials
   
Price 365 day licence for 695.00 € net         Buy this REGULATORY ESSENTIAL >>

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Subject Areas of this Essential:


Food contact materials

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

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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