ESS ESS JPN Hygienic Design

Regulatory ESSENTIAL

Japan - Hygienic Design

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 decribes hygienic design requirements on the basis of -The Food Sanitation Act and its enforcement regulation and guidelines. For other aspects of food contact (e.g.: materials, migration limits, see: ESSENTIAL JPN Food Contact Materials.
Stakeholders:	Manufacturer, Importer, Operator
Legislation in force:	Chapter I General Provisions Article 3(1) A food business operator (meaning a person or corporation who is engaged in collecting, producing, importing, processing, cooking, storing, transporting, or selling food or additives, or producing, importing, or selling apparatus, or containers and packaging, or a person or corporation who continuously provides food to many and unspecified persons at schools, hospitals or other facilities; the same applies hereinafter), on their own responsibility, must endeavor to ensure the safety of the food, additives, apparatus, or containers and packaging which they collect, produce, import, process, cook, store, transport, sell, provide to many and unspecified persons, or use in business (hereinafter referred to as "food for sale, etc."), and for that purpose, they must endeavor to obtain the knowledge and skills necessary to ensure the safety of food for sale, etc., ensure the safety of raw materials of food for sale, etc., conduct voluntary inspections of food for sale, etc., and take other necessary measures. Art.4 (4) The term "apparatus" as used in this Act 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; provided, however, that this term does not include machines, equipment, and other articles used for harvesting food in agriculture and fisheries. Chapter III Apparatus, and Containers and Packaging Article 15 Apparatus, and containers and packaging used in conducting business must be clean and sanitary Article 18 (1) From the viewpoint of public health, the Minister of Health, Labour and Welfare may establish standards for apparatus, or containers and packaging, or the raw materials thereof to be served for the purpose of sale or to be used in business, or may establish the criteria for the production methods thereof, by hearing the opinions of the Pharmaceutical Affairs and Food Sanitation Council. (2) When the standards or criteria have been established pursuant to the provisions of the preceding paragraph, the apparatus, or containers and packaging that does not conform to the standards must not be sold, produced or imported for the purpose of sale, or used in business; raw materials that do not conform to the standards must not be used; and the apparatus, or containers and packaging must not be produced by methods that do not conform to the criteria. Chapter V Import Notification Article 32 Importers have to submit a written import notification, containing (excerpt): (i) the name and address (for a corporation, its name and the location of its principal office); (ii) whether the cargoes are food, additives, apparatus, containers and packaging, or toys, the names of the articles, loaded quantity, loaded weight, type of packaging, and intended use, and when the cargoes have any marks and numbers affixed, the marks and numbers ... Apparatus are listed in Appended Table 12 - 1 - Machines used for producing foods - Apparatus or containers and packaging made of aluminum - Apparatus or containers and packaging made of stainless steel - Apparatus or containers and packaging made of colorless glass
Application national:	Japan, Hygienic Design, Food Sanitation Act
Countries:	Japan,
Status:	Published 2023-05-25 by Anette Dunkel-Reinboth and (Marius Galka) Last change 2023-09-25 by Anette Dunkel-Reinboth: Application procedure for database admission, Food contact materials
ROGER WILLCO ID:	#sp6h
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Content of this Essential

Scope of this ESSENTIAL

This ESSENTIAL decribes hygienic design requirements on the basis of
-The Food Sanitation Act and its enforcement regulation and guidelines.

For other aspects of food contact (e.g.: materials, migration limits, see: ESSENTIAL JPN Food Contact Materials.'

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)?

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)

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.

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 license)

Link/Reference to other reference document(s)

Here you will get related hyperlink(s)

Hints

Here you will get related hyperlink(s)

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.

Hints

Here you will get textual information

Specific recommendations, information or most common mistakes

Equipment authorization (approval process)

Hints

Here you will get textual information

Specific recommendations, information or most common mistakes

Testing & Standards

General information to the application of standards

Here you will get textual information

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

User instruction requirements and specific compliance notes

Here you will get textual information

Form, sentence inside, simple text. E. g. FCC/ISED compliance information, SAR information, battery, environmental information like waste

General Information:

Code, Continent	JPN, Asia
Economic Area	APEC
Official Language	The official language is Japanese.
Standard Institute	JSA - Japanese Standards Association \| https://www.jsa.or.jp/en/
HS Codemember	Yes - since 1964