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USA - United States of America
ESS USA Food Contact Materials
Food contact materials; food contact substances; food processing machinery; hygienic design of food processing machinery; hygienic design; hygienic sanitary design; product contact surfaces; cleaning; disinfection; dead spaces; bakery machines; grocery machines; meat; diary

89.00 € NET

30-Tages-Lizenz

Anwendungsbereich des Regulatory Essentials

This ESSENTIAL describes conformity procedures for food contact materials (FCM), based on the US Federal Food, Drug, and Cosmetic Act (21 CFR) and official FDA information/documents.

Stakeholder:

Manufacturer, Importer

Geltende Rechtsvorschriften:

PART 170 - Food Additives Subpart B - Food Additive Safety § 170.39 Threshold of regulation for substances used in food-contact articles. ... Subpart D - Premarket Nortifications PART 174 - INDIRECT FOOD ADDITIVES: GENERAL § 174.5 General provisions applicable to indirect food additives. § 174.6 Threshold of regulation for substances used in food-contact articles (link to §170.39) PART 175 - INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS Subchapter B) Food for Human Consumption Subpart B) Substances for Use Only as Components of Adhesives § 175.105 Adhesives: contains a list of substances permitted for use. § 175.125 Pressure-sensitive adhesives: Pressure-sensitive adhesives may be safely used as the food-contact surface of labels and/or tapes applied to food, in accordance with the following prescribed conditions. Subpart C) Substances for Use as Components of Coatings § 175.210 Acrylate ester copolymer coating § 175.230 Hot-melt strippable food coatings § 175.250 Paraffin (synthetic) § 175.260 Partial phosphoric acid esters of polyester resins § 175.270 Poly(vinyl fluoride) resins § 175.300 Resinous and polymeric coatings Table 1 - Types of Food Table 2 - Test Procedures for Determining Amount of Extractives From Resinous or Polymeric Coatings, Using Solvents Simulating Types of Foods and Beverages § 175.320 Resinous and polymeric coatings for polyolefin films. § 175.350 Vinyl acetate/crotonic acid copolymer § 175.360 Vinylidene chloride copolymer coatings for nylon film § 175.365 Vinylidene chloride copolymer coatings for polycarbonate film § 175.380 Xylene-formaldehyde resins condensed with 4,4'-isopropylidenediphenol-epichlorohydrin epoxy resins § 175.390 Zinc-silicon dioxide matrix coatings PART 176 - INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS B) Substances for Use Only as Components of Paper and Paperboard ... § 176.170 Components of paper and paperboard in contact with aqueous and fatty foods - contains a positive list (substances which may be safely used) Table 1 - Types of Raw and Processed Foods Table 2 - Test Procedures with Time Temperature Conditions for Determining Amount of Extractives From the Food-Contact Surface of Uncoated or Coated Paper and Paperboard, Using Solvents Simulating Types of Foods and Beverages § 176.180 Components of paper and paperboard in contact with dry food - contains a positive list § 176.200 Defoaming agents used in coatings - contains a positive list § 176.210 Defoaming agents used in the manufacture of paper and paperboard - contains a positive list ... § 176.300 Slimicides - contains a positive list ...

Nationale Anwendungsebene:

USA, Food Contact Substances, FDA

Länder:

 

USA - United States of America

Status:

Published 2021-11-10 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2025-04-22 by Anette Dunkel-Reinboth: Which documents are required by an approval body?, Food contact materials

ID:

#mg6u


Inhalt des Regulatory Essentials

Regulatory market access conditions for the actor(s)
Hier erhalten Sie textbasierte Informationen

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
Hier erhalten Sie zugehörige weiterführende Links

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

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)
Hier erhalten Sie zugehörige weiterführende Links

Link/Reference to other reference document(s)
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)

Abbreviations
Hier erhalten sie eine Tabelle

Important abbreviations which are special for this legislation or theme.

Route to compliance

Formal and administrative requirements

Registration at related authority required?
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)

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

Hints
Hier finden Sie ein thematisch passendes Dokument in ATERIOS
(Zugang nur mit erweiterter ATERIOS Lizenz)

Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

Approval process (conformity assessment procedure)
Hier erhalten Sie textbasierte Informationen

Means each legally required approval process prior placing on the market, importation or putting into service

Which documents are required by an approval body?
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e .g. formal application

Is a factory inspection legally required
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Hints
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Specific recommendations, information or most common mistakes

Testing & Standards

Specific requirements for testing
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e. g. is an accredited test lab. mandatory, limits, test samples, product description

National Standardisation Organisation
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Link to organisation

Are national standards based on IEC/ISO standards?
Hier erhalten sie eine Tabelle

Undetailed information

Regulatory labelling, markings and user information

Regulatory label (mandatory)
Hier erhalten Sie textbasierte Informationen

e. g. product label

Regulatory e-labelling allowed?
Hier erhalten Sie textbasierte Informationen

e. g. put the regulatory information and labels in a software menu

Required information on the product and/or packaging
Hier erhalten Sie textbasierte Informationen

e. g. address of the manufacturer/importer, serial number

Warnings, symbols
Hier erhalten Sie ein Foto oder Diagram

e. g. ANSI Z 535.4


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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