Japan Plans to Designate NPE as Class II Specified Chemical Substances

Recently, Japan's Ministry of the Environment hosted a public symposium focused on the topic of designating polyoxyethylene nonylphenyl ether (NPE) as Class II Specified Chemical Substances under the Chemical Substances Control Law (CSCL). This symposium marks a significant improvement in the management of substances that pose potential risks to the environment and health.

The CSCL designates substances as Class I, Class II Specified Chemical Substances, etc. based on their degradability, accumulability, toxicity, and environmental residues. This classification aims to strictly regulate the manufacturing, importation, and use of chemicals that could be damage to human health or habitats of flora and fauna, thus preventing environmental pollution.

NPE is suspected of being an endocrine disrupting chemical (EDCs). EDCs are exogenous substances or mixtures that can alter the function of the endocrine system and thus have detrimental health effects on living organisms and their offspring. NPE is produced by reacting Nonylphenol (NP) with Ethylene Oxide (EO) under alkaline conditions and is an ideal component in surfactants. It is widely used in industrial cleaning agents, plastic and rubber emulsifiers, pesticide additives, paint emulsifiers, and leather processing agents. However, the widespread use of NPE and its environmental permeation have raised serious concerns among environmental agencies. Its degradation products in the environment, especially NP, pose significant threats to aquatic ecosystems.

The NPE assessment indicates that its degradation products remain prevalent in various regions when used in open environments, such as in cleaning agents, leading to many areas exceeding ecological safety standards for NP concentrations. Therefore, the MOE proposes designating NPE as Class II Specified Chemical Substances to strengthen control over its production, import, and use.

Name of Priority Assessment Chemicals	[Priority Assessment Chemical Substance General Number 86] α-(nonylphenyl)-ω-hydroxypoly(oxyethylene) (also known as polyoxyethylene nonylphenyl ether)
Name of the Class II Specified Chemical Substance after designation (proposed)	Poly (oxyethylene) alkylphenyl ether (limited to substances with the alkyl carbon atom number of 9) (also known as NPE)
CAS Number	26571-11-9、27177-08-8、20427-84-3、104-35-8 etc.
CSCL Official Gazette Consolidation Number	3-589、7-172

When NPE is designated as Class II Specified Chemical Substance, it will be subject to stricter regulations:

1. Manufacturers and importers of Class II Specified Chemical Substances shall report planned production or import quantities in advance, implement leak prevention measures during storage, properly label products, follow technical guidelines to prevent environmental pollution and report actual quantities.
2. If production or import may pose risks to the environment or public health, the relevant producers, manufacturers, users, or processors may be required to adjust their plans to mitigate these risks.

The MOE plans to request public comments in the spring of 2024, revise and announce the relevant notice in the summer, and formally implement the regulations in the spring of 2025.

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Further Information

www.env.go.jp