### 5. Measures and Policies on the Assessment and Control of the Environmental Risk of Chemical Substances

To prevent adverse environmental effects from the production, distribution, use, or disposal of the several tens of thousands of chemical substances that are traded in Japan, it is necessary to evaluate and properly address the risk that chemical substances could harm human health and the environment (environmental risks).

During FY2006, the 5th assessment report was issued, wherein five specific substances were designated as “candidates for detailed assessment,” with two for health risk and three for ecological risk.

In accordance with the Chemical Substances Control Law, the government controls new chemical substances that are manufactured or imported based on an evaluation of their manufactured or imported based on an evaluation of their biodegradability, bioaccumulation, and toxicity to human, plants and animals.

During FY2006, a total of 503 notifications on the manufacture or import of a new chemical substance were made (of which 219 were of low manufacture or import quantities), and pre-market evaluations were conducted for those notifications.

Japan has also implemented the PRTR (Pollutant Release and Transfer Register) system for chemical substances possibly harmful to human health or ecosystems. Under the PRTR system, businesses identify and report to the government the amount of chemical substances that are released to the environment or transferred as waste materials. The government then aggregates the data from businesses and publishes them together with the estimation of releases that are not reported to the government (e.g. household, transport, small businesses, etc). The fifth aggregate result was published in February 2007.

Figure 5-5-2: Changes over Time of Total Dioxin Emissions

Source: Ministry of the Environment

Base year	H10	H11	H12	H13	H14	H15	H16	H17
49.0~51.9	60.6~62.6	68.8~68.9	75.2~75.3	87.7~88.1	95.1~95.2	95.5~95.6	95.7~95.8

Figure 5-5-1: Outline of the Law concerning the Evaluation of Chemical Substances and Regulation of Their Manufacture, etc.

The aim of the Law is to prevent toxic chemical substances from the environmental pollutions.

☐ The prevention scheme is structured from two angles: evaluation and regulation.

### 1. Evaluation

A pre-market evaluation is supposed to be conducted on the production or import of any new chemical substances, for the purpose of evaluating the following:

(1) Biodegradability,

(2) Bio-accumulation, and

(3) Toxicity to humans, animals and plants.

The evaluation is to be conducted rationally, taking into consideration the volume of production or import and the probability of the release to the environment.

### 2. Regulation

Regulations on the production, import or use are to be implemented according to characteristics of the chemical substance concerned, taking into consideration the results of the pre-market evaluation for new chemicals and the assessment for existing chemicals

Category	Regulatory measures
Class 1 Specified Chemical Substances (15 substances including PCB)	· Virtually ban on production, import or use in real terms
Class 2 Specified Chemical Substances (23 substances including trichloroethylene)	· Mandatory notification on planned and actual amounts of production or import· Restriction on the quantity to be produced or imported, as necessary· Required observation of technical guidelines as to treatment
Monitoring chemical substances	· Mandatory notification on actual amounts of production or import· Move to the category “specified chemical substance” according to the results of hazard assessment, risk evaluation, etc.
Class 1: 28 substances Class 2: 859 substances Class 3: 51 substances