Regulatory ESSENTIAL



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

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
Scope: This ESSENTIAL describes conformity regulations for food contact materials, based on the Japanese Food Sanitation Act and the MHLW notifications on positive lists for UCP (Utensils, Containers, Packaging (for food contact)).

Stakeholders: Manufacturer, Importer
Legislation in force: The Food Sanitation Act defines 2 categories for food contact articles: a) Apparatus/Utensils = means tableware, kitchen utensils, and other machines, equipment, and other articles which are used for collecting, producing, processing, cooking, storing, transporting, displaying, delivering, or consuming food or additives and which come into direct contact with food or additives; b) Containers and Packaging = articles which contain or wrap food or additives and are presented "as is" when delivering food or additives. Food Contact Articles are regulated in Chapter III (Articles 15 - 18) Definition of "Business" = collecting, producing, importing, processing, cooking, storing, transporting, or selling food or additives, or the act of producing, importing, or selling apparatus, or containers and packaging, in the course of trade; provided, however, that the term does not include the business of harvesting food in agriculture and fisheries. Definition of Article 18-3 materials (Food Sanitation Act) Article 1: The material specified by Cabinet Order referred to in Article 18, paragraph (3) of the Food Sanitation Act (hereinafter referred to as the "Act") is synthetic resin. Food Labelling Act - Content: Chapter I General Provisions Chapter II Food Labeling Standards Chapter III Measures against Improper Labeling Chapter IV Demand for Injunction and Report Chapter V Miscellaneous Provisions Chapter VI Penal Provisions MHLW notifications on positive lists for UCP (Utensils, Containers, Packaging (for food contact))

Application national: Japan, Food Contact Materials, Food Sanitation Act, Positive Lists

Countries: Image for JP Japan,  
Comment on the comparability to EU legislation: The EU legislation (several regulations and directives) is not comparable with the Japanese specific "Positive List"....
Status: Published 2021-12-21 by Anette Dunkel-Reinboth and Michael Loerzer
Last change 2024-03-08 by Anette Dunkel-Reinboth: Which documents are required by an approval body?, Food contact materials
ROGER WILLCO ID: #526u
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Scope of this ESSENTIAL
This ESSENTIAL describes conformity regulations for food contact materials, based on the Japanese Food Sanitation Act and the MHLW notifications on positive lists for UCP (Utensils, Containers, Packaging (for food contact)).'

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 license)

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 related hyperlink(s)

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)?

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)

Penalty by this legislation
Here you will get textual information

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

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.

FTA/MRA status with EU
Here you will get a linked document in ROGER WILLCO
(only reachable with additional ROGER WILLCO license)

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

Market surveillance authority
Here you will get textual information

Name of the authority for 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 license)

Comment on the comparability to EU legislation
Here you will get textual information

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]

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 a image or chart

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

Which documents are required by an approval body?
Here you will get related hyperlink(s)

e .g. formal application

Is a factory inspection legally required
Here you will get textual information

Hint to voluntary certification scheme
Here you will get textual information

If a important voluntary certification schemes exists, one link will be given. Important voluntary schemes are for example: UL, CSA, VCCI (Japan)

Testing & Standards

Specific requirements for testing
Here you will get related hyperlink(s)

e. g. is an accredited test lab. mandatory, limits, test samples, product description

Migration Limits
Here you will get textual information

Application procedure for database admission
Here you will get related hyperlink(s)

National Standardisation Organisation
Here you will get related hyperlink(s)

Link to organisation

Are national standards based on IEC/ISO standards?
Here you will get textual information

Undetailed information

Regulatory labelling, markings and user information

Regulatory label (mandatory)
Here you will get related hyperlink(s)

e. g. product label

Regulatory e-labelling allowed?
Here you will get textual information

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

User instructions language(s)
Here you will get textual information

Regulated by the legal provisions

Digital user documentation allowed?
Here you will get textual information

User instructions allowed by QR-Code/internet or digital medium or integrated in device with display? Safety instruction allowed by QR-Code or digital medium?


Code, ContinentJPN, Asia
Economic AreaAPEC
Official LanguageThe official language is Japanese.
Standard InstituteJSA - Japanese Standards Association | https://www.jsa.or.jp/en/
HS CodememberYes - since 1964






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