JP Control of Aromatic Amine Impurities in Pigment Yellow 74 (Household Products Regulation and Industry Self-Regulation)
ENFORCEMENT TIMELINE
Effective April 1, 2016 (household products regulation; industry self-regulation on specified aromatic amines continues)
Overview
This is a safety management requirement covering trace impurities, byproduct aromatic amines such as ortho-anisidine, found in azo pigments including the organic pigment Pigment Yellow 74 (PY74). Under the Ministry of Health, Labour and Welfare's Act on Control of Household Products Containing Harmful Substances, limits are set on the leaching of specified aromatic amines known to be carcinogenic, and industry bodies such as the Japan Chemical Industry Association have established voluntary standards for safe use in printing inks, paints, stationery, and textiles.
Enforcement Timeline
April 1, 2016: Restrictions on the use of azo compounds that generate specified aromatic amines take effect under the Act on Control of Household Products Containing Harmful Substances, setting a limit of 30 ppm or below.
2019: Voluntary analysis guidelines for byproduct aromatic amines generated during azo pigment manufacturing are revised.
Ongoing: Management of impurity content certification, such as non-content warranties and analytical data, is maintained throughout the supply chain.
Business Impact
Pigment manufacturers, ink and paint manufacturers, and manufacturers of finished products that use them, such as apparel, packaging materials, stationery, and toys, are required to verify and warrant that specified aromatic amines, including ortho-anisidine, are not detected above 30 ppm in the azo pigments they use. Selecting high-purity pigments, managing impurities during the manufacturing process, and obtaining analytical certificates from upstream suppliers are essential practical requirements.