FUJIFILM Wako Pure Chemical receives Japan's the first flexible scope of accreditation as a reference material producer

Capable of swift and stable production and supply of new reference materials

OSAKA, March 2, 2023 - FUJIFILM Wako Pure Chemical Corporation (President&CEO: Koichi Yoshida) is pleased to announce that it will gain flexible scope of accreditation*1 as a reference material producer*2. This is the first accreditation of this kind granted in Japan.

The flexible scope of accreditation is issued by the National Institute of Technology and Evaluation (NITE) to reference material producers that demonstrate the ability to quickly and reliably produce and supply new reference materials that do not require accreditation for specific reference materials. The latest accreditation covers the our Tokyo plant, and the accredited reference materials Tokyo plant produced is metal elements used for measuring trace metal elements.

Reference materials hold the key to achieving reliability in various studies and tests including water/soil testing and quality inspections for semiconductors, pharmaceuticals and foods. Chemical analysis and elemental measurement must be carried out urgently following a food contamination incident and/or an environmental release of toxic substances on water quality, demanding quick supply of reference materials.

In Japan, producers are generally accredited for individual reference materials at a specific concentration. However, this makes it necessary for producers to gain accreditation each time they produce a new reference material, extending the lead-time to supplying the material to the market. In the EU and USA, the flexible scope of accreditation approach has been gaining momentum, accrediting producers based on their ability to develop a measurement method or capacity to manage production, rather than issuing accreditation to individual reference materials. In the midst of this trend, NITE has developed a flexible scope of accreditation structure in 2020 as a way of encouraging prompt supply of reference materials to the market.

In the latest move, FUJIFILM Wako Pure Chemical has gained flexible scope of accreditation based on its track record and experience of attaining numerous accreditations as the producer of various reference materials, such as becoming Japan's first accredited producer for amino acids mixtures as reference materials. The latest accreditation will allow the company to initiate the planning, management and production of new reference materials required for measuring metal elements at the Tokyo Plant, and supply them to the market, thereby substantially reducing the supply lead-time of reference materials and catering to chemical analysis and measurement needs swiftly.

Under the corporate mission of "With commitment to the future of science, our company is dedicated to create the source of happiness for all people," FUJIFILM Wako Pure Chemical will continue to develop and provide high-quality cutting-edge products that meet the needs of society, and contribute to the development of a wide range of academic research projects, industrial process improvements and medical science breakthroughs.

*1: Accreditation extended to producers who use, as a pattern of producing new reference materials, one or a combination of the following:
① Using multiple reference materials, for which the producer already has production capacity as single-component reference solutions, and mixing them at a desired density ratios to prepare multi-ingredient reference material solution
② Using measurement technology that has its implementation capacity confirmed and certified to prepare reference material solutions containing a new component

*2: Reference materials are used as reference for chemical analysis and measurement. Reference material producers are those who produce reference materials that contribute to developing the supply structure for various reference materials (manufacturing, bottling, density determination, etc.). NITE International Accreditation Japan examines compliance with ISO 17034 (general requirements for the competence of reference material producers) and extends accreditation to reference material producers under the Accreditation System of National Institute of Technology and Evaluation (ASNITE).

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