Nanomaterials have been used in Japan for some time in products such as home appliances, food, food containers, cosmetics, automobile parts, pharmaceuticals, paints and inks, and textiles.
Overview of the regulations
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.
Met: Risk assessment
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.
Nanomaterials Safety Management Committee- Japan
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.
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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.