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Japan - Regulation

In Japan, there are four laws to regulate the industrial chemicals which are :

  • Chemical Substance Control Law (CSCL)
  • Industrial Safety and Health Law (ISHL)
  • Law for PRTR and Promotion of Chemical Management (PRTR Law)
  • Poisonous and Deleterious Substances Control Law (PDSCL)

Recent trend on chemical regulations in Japan is Chemical Substance Control Law (CSCL) aiming to prevent environmental pollution from PCBs and other hazardous chemicals.

The Act on the Chemical Substance Control Law came into force in 1973 to prevent environmental pollution by chemical substances that pose a risk to human health or the environment. But it was later updated and amended on May 20th 2009. Full implementation of amended CSCL started from 1 April 2011.

The three government bodies responsible for the implementation of CSCL are the Ministry of Economy, Trade and Industry (METI), Labor and Welfare (MHLW), and the Ministry of the Environment (MOE).

Japan CSCL entirely covers general industrial chemical products; which include both new and existing chemicals (as listed in the Existing and New Chemical Substances Inventory (ENCS).

For New Substances, A Strict Pre-Manufacture Evaluation System Is Implemented.
  • For existing substances, manufacturers or importers are required to report their quantity and uses annually if the volume of manufacture (M) or importation (I) exceeds certain
  • Food or feed additives, pharmaceuticals, cosmetics, agricultural chemicals and fertilizers are subject to different laws and
  • The regulation excluded specific chemicals covered by other regulations, e.g. agrochemicals, pharmaceuticals, food,

New chemical substances are substances not listed in the inventory of existing and new chemical substances (Japan ENCS). Manufacturers, importers and foreign company of new chemical substances are required to notify those substances at least three months prior to manufacture/import. For adding a substance in substance inventory will take 5 years of time span. The three ministries are the Ministry of Economy, Trade and Industry (METI), the Ministry of Labour and Welfare (MHLW), and the Ministry of the Environment (MOE).

There are two types of notification:

Standard Notification:

A standard notification has no volume limit, while a low volume notification is only applicable if the total volume of the substance manufactured and imported in Japan is = 10 t/y. A standard notification requires data on bio degradation, bio accumulation, and toxicity and Eco toxicity endpoints.

Low volume Notification:

A low volume notification requires data only on bio degradation and bio accumulation, but this type of notification must be renewed once a year.

Substances imported or manufactured in quantities = 1 t/y in Japan, polymers of low concern, intermediates and export only substances are eligible for an exemption from standard notification. Prior confirmation of this exemption status must be obtained on an annual basis. Naturally occurring substances, impurities < 1% w/w, Substance for R&D purposes and substances regulated by other laws (e.g. pesticides, pharmaceuticals, cosmetics) are completely exempt from CSCL notification requirements.

All substances other than Priority Assessment Chemicals (PACs), Class I/II Specified Substances, Monitoring Substances and Exempt Substances;

Existing chemical substances (Approx. 20,600 substances):

Chemical substances that were already manufactured/imported at the time of the promulgation of the Chemical Substance Control Law Mandatory reporting of amounts manufactured and/or imported (I 1 ton/year, usage, etc.

Substances prioritized for assessment due to their potential risks of long-term toxicity to human health or the environment; Annual report if the volume of M/I is >=1t/y; Manufacturers and importers may be requested to provide more hazard data.

Substances which are suspected long-term toxicity for humans or flora and fauna in the human living environment. Suspected risk Mandatory reporting of actual amounts manufactured and/or imported, detailed usage, etc. Companies handling these substances are obliged to make utmost efforts to disclose information.

For existing substances, manufacturers or importers

are required to report their quantity and uses annually if the volume

of manufacture (M) or importation (I) exceeds certain amount.

Class-I Specified Chemical Substances:

The Regulation excluded specific chemicals covered by other regulations, e.g.

agrochemicals, pharmaceuticals, food, fertilizers.

Persistent, bio accumulative, and hazardous (long-term human toxicity or Eco toxicity to higher predators.

Regulation on Chemicals:

Prior permission required for manufacture and/or import (Note: Permission is prohibited (virtually) Prohibition of use unless authorized in advance. Prohibition of import of products containing them recovery of the products.

Class-II Specified Chemical Substances:

Persistent, hazardous (long-term human toxicity or Eco toxicity to living organisms), with concern for long-term existence in the environment.

Mandatory reporting of planned manufactured and/or imported amounts subject to governmental orders that require the change of planned amounts labeling. Compliance with technical guideline provided by Government of Japan (GOJ) and/or governmental recommendation on a legal basis Compliance with guidance provided by GOJ.

Type-I Monitoring Chemical Substances:

Persistent and bio accumulative, but hazardous properties unknown.

Type-II Monitoring Chemical Substances

Persistent and suspected as hazardous to human health.

Persistent and suspected as hazardous to Living Organism

Regulation on Chemicals:

Mandatory reporting of manufactured and/or imported amount annually (Note: These amounts are announced publicly.) Compliance with guidance provided by Government of Japan (GOJ). The GOJ can instruct manufacturer/importer investigate their long- term toxicity.

Japanese ENCS: List of Existing and New Chemical Substances:

The inventory of existing and new chemical substances (Japan ENCS) consists of two parts:

  • Existing chemical substances placed on Japanese market before 16 Oct 1973 (approximately 20,600 substances);
  • New chemical substances that must be notified under the CSCL, published on government Gazette (approximately 8,000 substances)

ENCS is available for search or download from Chemical Risk Information PlaVorm (CHRIP) or J-check.

General : Industrial Safety and Health Law (ISHL) was firstly introduced in 1972 and this law ensures the safety and health of workers in workplaces. The substances which are prohibited to manufacture or import,

substances requiring permission and chemical substances requiring safety data sheets and labels are included in ISHL. This law controls new substances and requires manufacturers and importers to notify them to the Ministry of Labour and Welfare (MHLW) prior to production and importation.

  • For new substance approval required prior to import or
  • Harmful substances to be prohibited from import or
  • Prior permission is necessary for manufacturing or importation of harmful
  • Labels must be used to indicate that the substances are in harmful Also GHS Compliance SDS is also required for harmful substances.
  • For notification of new substances which are not on ISHL list must be notify prior to manufacture or importation. Whereas ISHL consist of two parts:
    • Existing chemical substances under CSCL (in commerce in Japan before 1973) - approximately 20,600 substances;
    • New substances notified under ISHL and published on government Gazette;

In 1950, to protect the public health from a hygiene point of view from poisonous and deleterious substances, Poisonous and Deleterious Substances Control Law was implemented. This law imposes a license requirement on manufacturers, importers and sellers of poisonous or deleterious substances. It also requires that persons engaged in relevant businesses meet prescribed standards for manufacturing or storing equipment of poisonous or deleterious substances and comply with specific requirements on storing, labeling or Transferring.

The environment of specific chemical substances and promoting improvement in their management ("Law for PRTR and Promotion of Chemical Management" or "PRTR Law") was came into force in 1999. The purpose of this law is to promote businesses' voluntary improvements in the management of specified chemical substances and to prevent any environmental protection impediments.

Under PRTR law,

  • Class I Designated Chemical Substances are subject to both the PRTR system and the SDS system while
  • Class II Designated Chemical Substances are subject to SDS system only

Only businesses in the published types of industries are obliged to confirm and notify the release amounts of chemical substances in the environment.

PRTR notification requires two parts of information: amount of release and amount of transfer:

Amount of release: Release into atmosphere, release into public bodies of water, release into soil within the place, and reclamation within the place of business concerned.

Amount of transfer: Transfer to sewage and transfer to outside of place of business concerned as a waste;

GHS Implementation In Japan:

GHS SDSs and labels are mandatory for certain specified substances and mixtures regulated by the following regulatory framework:

  • Industrial Safety and Health Law (ISHL);
  • PRTR law;
  • Poisonous and Deleterious Substances Control Law (PSSCL);

For other hazardous chemicals meeting GHS Classification criteria, industry shall comply with the following two industrial standards on chemical Classification and hazard communication in Japan as JIS 7252 (Latest Version JIS7252-2014) based on GHS rev. 4 and JIS 7253 (Latest Version JIS7253-2012) based on GHS Labeling and Safety Data Sheet.

Exemption: Products with low contents of specified chemical substances (<0.1% for Specific Class I designated substances and <1% for other substances), solid substances, products for general consumer purposes and sealed products are exempt from PRTR due to their low emission levels.

To promote businesses voluntary improvements in the management of specified chemical substances and to prevent any environmental protection impediments.

This law controls new substances and requires manufacturers and importers to notify them to the Ministry of Labour and Welfare (MHLW) prior to production and importation.

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The Reorganization and Rationalization Plan for Special Public Corporations that was approved in a Cabinet meeting in 2001, was followed by the establishment of the Pharmaceuticals and Medical Devices Agency (PMDA) and came into service on April 1, 2004, under the Law for the Pharmaceuticals and Medical Devices Agency, as a consolidation of the services of the Pharmaceuticals and Medical Devices Evaluation Center of the National Institute of Health Sciences (PMDEC), the Organization for Pharmaceutical Safety and Research (OPSR/KIKO), and part of the Japan Association for the Advancement of Medical Equipment (JAAME). The Pharmaceuticals and Medical Devices Agency (PMDA) is Japan's regulatory authority. It is subordinate to the Ministry of Health, Labour and Welfare (MHLW). The mission of the MHLW is to protect the population of Japan against health hazards caused by pharmaceutical products and medical devices that are not sufficiently safe or effective or not of sufficiently high quality 

With regard to the regulation of medical devices, the MHLW's tasks include: 

  • Registering manufacturers 

  • Licensing certain actors (MAH, dealers and repair service providers) 

  • Enacting ministerial ordinances, guidelines and industry standards 

  • The final release of medical device authorizations 

  • Monitoring the PMDA 

The PMDA, which was created in 2004, is responsible for the actual tasks within the authorization procedures for medicinal products, medical devices and regenerative medicine products for the Japanese market. The PMDA’s most important tasks include: 

  • Conducting the authorization procedures, including the regulatory review 

  • Providing advice on clinical studies and authorizations being targeted 

  • Inspections of manufacturers for compliance with Good Manufacturing Practices (GMP) 

  • Market surveillance. 

Step 1: Establish a QM system 

As a foreign manufacturer, you do not have to demonstrate “home country approval” to have a medical device authorized in Japan. However, an ISO-13485 certificate will help you a lot when it comes to demonstrating that the Japanese quality management (J-QMS) requirements have been met.

Step 2: Establish the necessary roles 

Marketing Authorization Holder (MAH) 

As the next step, as the manufacturer, you have to appoint a local authorized representative, known as the Marketing Authorization Holder (MAH). The MAH assumes liability for your devices in Japan and is the owner of the authorization. Not every citizen is allowed to be an MAH. The MAH must first apply for a license (business license known as KYOKA) from the MHLW.

Step 3: Register as a manufacturer 

Before having your medical device authorized in Japan, you must, with the help of the marketing authorization holder (MAH), register as a foreign manufacturer with the Ministry of Health, Labour and Welfare (MHLW). All manufacturing sites responsible for development and final assembly or production must be registered. Component manufacturers do not have to register. 

  • Information on the person responsible for regulatory compliance 

  • Information on the production site

Step 4: Classify the medical device 

The PMD Act differentiates between three types of medical device: general, controlled and specially-controlled medical devices. These are divided into four classes: I (low risk), II, III, IV (high risk).

Medical device companies interested in offering their products in Japan must comply with Japan's Pharmaceuticals and Medical Devices Act (PMD Act). Complying with the PMD Act can be challenging for foreign manufacturers, as very few regulatory documents are published in English. As part of the approval process, medical device manufacturers must: 

  • Comply with MHLW Ordinance No. 169 related to quality management systems 

  • Appoint an in-country representative (MAH/D-MAH) 

  • Register design and manufacturing facilities, among other requirements 

Device Category 

Process Undergone 

Timeline Validity 

Cost (Fee structure) 

Low Risk Medical Devices 

These are subjected to Pre-Market submission (PMS), also known as ‘Todokede’. Applications submitted to the PMDA & considered accepted upon submission. 

It takes one week to get the PMS number. 

There is no PMDA fees to process the application 

Most medium Risk Class II & Few High Risk Class III 

 

 

Qualify for Pre-Market Certification (‘Ninsho’). 

Reviewing & Quality system conformity assessments are outsourced by PMDA to Registered Certification Bodies (RCB) 

Average time taken for PMC processing is 3 months 

US $30,000 

New Class II, Class III & Class IV devices 

Subjected to Pre-Market Approval (‘Shonin’).  

Time for processing application varies from 6 months to 36 months. 

US $20,000 (6 months) & US $120,000 (36 months). 

  • Identification of compliance requirements under various guidelines including all data requirements.​ 

  • Data gap analysis and pre-assessment support​ 

  • Technical documentation support​ 

  • Pre and post submission support and technical liaison with authorities.

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The Cosmetic Act is issued by the Pharmaceutical and Medical Devices Agency (PMDA) of Japan, and it is supported by a series of subsidiary rules, standards and guidance documents issued by the competent authority, Ministry of Health, Labour and Welfare (MHLW). The main regulations concerning cosmetics in Japan are  “Pharmaceutical and Medical Device Law”(issued 14/09/2019)  and “Standards for Cosmetics”(issued 01/04/2001)

There are more than 10 Existing Key Cosmetic Regulations in force, for example, “Act for Ensuring Quality, Effectiveness, and Safety of Pharmaceutical and Medical Devices”, which came into force on September 14th, 2019.

According to Article 2.3 of the Pharmaceutical Affairs Law, “cosmetics” is defined as articles with mild action on the human body which are intended to be applied to the human body through rubbing, sprinkling or other similar methods, aiming to clean, beautify and increase the attractiveness, alter the appearance or to keep the skin or hair in good condition.

Cosmetic products include two main categories in Japan.

  1. Cosmetics: products that aim to maintain beauty, which can enter the market without notification nor registration.
  2. Quasi-drugs: products that contain an active ingredient with a weak but real pharmacological activity on the human body (while not falling into the category of drugs) and aim at prevention and modification, which need approvement by authorities to enter the market.

The common quasi-drugs product types in Japan include the following:

  1.  
  • Anti-dandruff
  • Whitening
  • Anti-acne
  • Anti-bacterial
  • Anti-chapping
  • Against drought
  • Medicated soaps
  • Haircare
  • Deodorant
  • Antiperspirant
  • Product for hair regrowth
  • Hair dyes
  • Perm products
  • Toothpaste
  • Bath salts
  • Products for breath
  • Oral care

Ingredients:

  1. Actives: the registration is easier for recognized actives that are already listed, but it is also possible to use new active(s)
  2. Excipients: limited to the positive ingredient list (around 8000 substances), but also possible to use new excipient(s)

A thorough documentation of the active ingredient should be provided to the Pharmacy agency: Pre-Marketing Registration and Approval (PMDA). The agency will fully verify the product and claimed effects and then a specific labelling with the term "quasi drug" will be provided. A monograph is possible to follow for certain products.

 

The ingredients

"The ingredients of cosmetic products, including the impurities they contain, must not contain anything that could cause infection or make the use of cosmetic products hazardous to health” --Standard for Cosmetics

To help the manufacturers with their formulation, the Cosmetic Act has establish the following documents :

  • Prohibited substances list, it is annexed to the Standard for Cosmetics. It gathers 30 prohibited substances, the Class I and II lists of the Chemical Substances Control Law (CSCL) and the substances from the Poisonous and Deleterious Substances Control Act.
  • A restricted substances list
  • An authorized preservatives list
  • A positive list of the UV filters

The Label and claims

The labelling should be in Japanese and present the following :

  • Name and Address of Marketing License Holder
  • Product name
  • Batch number
  • Net weight
  • List of ingredients (Japanese INCI)
  • The expiry date for cosmetics specified by the MHLW announcement
  • Precautions for use, instructions for use
  • Country of origin

"Codes on Fair Competition regarding the representations of cosmetics" are Volontary standards on labelling and claims which are widely observed in Japan.

A list of 56 accepted efficacy claims for cosmetics is establish to prevent companies from giving unreasonable premiums and misleading representations claims. The Cosmetic Act :

  • Ban wrong, misleading or exaggerated statements
  • Prohibit assigning unprovable properties to the product
  • Inhibit claims related to quasi-drugs or drugs for cosmetics

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Nanotechnology in Japan has been controlled under existing regulatory frameworks for the safe management of tiny particles, such as the Roudou Anzen Eisei Ho (the Industrial Safety and Health Act) and the Haikibutsu Shori Ho (the Chemical Substances Control Act). While there is no nanotechnology-specific law, the Ministries of Economy, Trade, and Industry (2009) and Health, Labor, and Welfare (2008a) have been actively interested in researching nanomaterial safety measures. Engineered nanomaterials represent exceptional safety hazards due to their potential toxicity to people, particularly when breathed, and their ability to stay in the environment and accumulate in biological tissues.

The Ministry of Health, Labor, and Welfare (2008b) published a tsuuchi (notice) on occupational safety measures to avoid nanomaterials exposure during production and treatment. A year later, a group of Japanese experts from industry and academia, the Independent Study Group on Environmental Impacts of Nanomaterials (2009), produced a "Guideline for the Prevention of Environmental Impact with Regard to Industrial Nanomaterials." It's worth noting that Japan's regulatory emphasis has been on avoiding and limiting nanomaterial exposure—for example, through rules on wearing masks, providing ventilation, and monitoring aerosolized nanoparticles.

In order to establish effective safety measures, the Ministry of Economy, Technology, and Industry (Meti) has focused on hazard testing and risk assessment. It produced a study in March 2009 that suggested broad safety procedures for preventing occupational exposure to nanoparticles and recommended industry to perform voluntary safety audits and communicate information across the supply chain. The next year, the Ministry of Environment launched the Nanomaterial Information Collection and Communication Program to encourage producers to exchange danger information and develop voluntary safety measures. Meti's assessment on the programme identified six key nanomaterials: carbon nanotubes, carbon black, titanium dioxide, fullerenes, zinc oxide, and silicon dioxide. These are based on reports from 31 firms on their produced nanomaterials. The report examined the properties of each chemical, as well as its production volume and principal application in Japan, as well as exposure and emission avoidance methods.

Meti and the New Energy and Industrial Technology Development Organization collaborated on a five-year initiative to investigate and develop nanoparticle characterisation methods in order to expand scientific understanding about the hazards presented by nanomaterials. It was completed in February 2011 and focused on producing risk assessments for nanomaterials as well as establishing a risk management policy. The study resulted in thorough risk evaluations of three nanoparticles (titanium dioxide, fullerenes, and carbon nanotubes), a report on toxicity testing of manufactured nanomaterials, and recommendations for hazard assessment testing of industrial nanomaterials in animals by respiratory exposure.

It focuses on nanomaterial exposure in goods and to develop suitable management processes from the standpoint of usage and life cycles. Following its first meeting in December 2011, a report describing three major topics of debate was issued in January 2012: hazard, exposure, and risk assessment; risk management; and definition and technical measurement. Its key conclusions were:

 • evaluation of hazard, exposure, and risk;

• risk management; and

• definition and technical measurement.

Regulatory science in Japan attempts to attain the greatest possible outcome for human health and society, as determined by suitable healthcare policy, with the goal of promptly translating research findings into practical applications. The Japanese Ministry of Health, Labour, and Welfare (MHLW), the Pharmaceutical and Medical Devices Agency (PMDA), the National Institute of Health Sciences (NIHS), and the Agency for Medical Research and Development are in charge of regulation and regulatory science in this domain (AMED). A Regulatory Science Centre was formed inside the PMDA in 2018 to promote, among other things, creative approaches to advanced medicines and technologies, including nanotechnologies, with a significant emphasis on horizon scanning to allow regulators to keep up with new advances.

  • Identification of compliance requirements under various guidelines including all data requirements.

  • Data gap analysis and pre-assessment support

  • Technical documentation support

  • Pre and post submission support and technical liaison with authorities.

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