The Third Joint Working Group to review the CSCL (hereinafter referred to as the CSCL WG) was held on May 29th, 2008. The CSCL WG comprises 18 members such as scientists, chemical and downstream industry organization representatives, consumers, and NPOs. The theme of the third CSCL WG was the hazard assessment strategy for new chemical substances under the CSCL. All distributed documents are available on the following website (Japanese only) :
http://www.meti.go.jp/committee/gizi_1/17.html

A summary of the handout document showing discussion points in the third CSCL WG is as follows:

- In order to establish more risk-based chemical management system under the CSCL, would it be important to incorporate certain risk assessments into the existing hazard assessment at the time of the pre-marketing phase evaluation?
- In this regard, would it be necessary to consider an International risk assessment/management system and international development of taking actions on existing chemical substances which are already placed on the market?

- Based on the possibility of environmental pollution regarding exposure, a confirmation system was introduced and steadily implemented.
- Regarding confirmation of small quantity of new chemical substances, is it appropriate to review the reference for confirmation from the total volume in Japan to volume per company (applicant)?
- In cases where several applicants are asking for confirmation for the same substance, is it appropriate not to provide confirmation for those with higher potential risks?

- How can CSCL deal with PLCs that are subject to exemption of application in many countries?

- There are some countries which disclose hazard assessment results and adopt a generic chemical name. Considering the importance of communication, disclosure, ensuring the competitive position of the applicant corporation and international conformity, how should we deal with hazard assessment results and generic chemical names under CSCL?

- Effective and efficient risk assessment for a large number of chemical substances, how to utilize hazard assessment method such as QSAR and a category approach.
- Are there any points to notice for the use of QSAR and a category approach, especially at the evaluation of a new chemical substance?

- Persistent chemical substances are subject to control under CSCL. What system is more rational to deal with the possibility for those substances as residual substances remaining in the environment?

- How to deal with nanomaterials under current status?

- It is appropriate for chemical substance management to combine pre-marketing phase evaluation and after the fact control.
- Pre-marketing phase evaluation/control system is important. The current system functions effectively as there has been no Class II specified chemical substance.
- We should make it clear that how to conduct after the fact control, making sure we understand volume and usage, etc. for all marketed chemical substances, before determining the pre-marketing phase evaluation system.

- From the viewpoint of innovation of technology, a confirmation system for small quantity of new chemicals is effective. Reflecting the systems used by other countries, the basis of calculation would be reasonable at 1 ton per company.
- 1 ton per company as average volume notified per company is 300-500kg.
- There is concern that certain substances notified by multiple companies and totaling over 1 ton turn out to be persistent and bioaccumulative. Utilization of QSAR is one solution.
- Several liquid crystals with similar structures and several chemical substances with the same cationic part (with only difference of the anionic part) are notified. Government should not provide confirmation for those notifications, which are considered to mark a deviance from the spirit of the law.
- There should be a maximum allowable total volume across the country. Low production volume notification should be required if total volume notified is over maximum volume.
- A threshold of 10 tons per year (across the country) for low production volume notification has been set according to environmental monitoring results. We should re-evaluate this threshold based on risk assessment of low production volume chemicals.

- Excepting a few special cases, it is common knowledge that polymers are extremely stable. It is not necessary to submit a test report but, at the very least, physicochemical data is necessary to show that the said chemical substance falls under the category of PLC.
- We should carefully evaluate oligomers (dimers and trimers, etc.) with stronger toxicity.
- PLC criteria are trying to define PLC by such information as the molecular weight and structure etc. The definition of PLC should be carefully evaluated as it is not always compatible with criteria of CSCL, such as persistent and bioaccumulation.

- If the point is to protect companies’ competitive position, we should examine which how to effectively make public the announcement of the chemical name; e.g. Protect the name of substance for a 5-year period and then announce the proper chemical name or; announce the generic chemical name immediately.
- A public announcement of the generic chemical name is accepted in the United States, but not in Japan. The generic name is preferable to protect information in both countries. The U.S. has an inquiry system to check the identity of the chemical substance to be notified and that is already listed in the inventory. This inquiry system also needs to be examined.
- In order to improve QSAR, the proper chemical name is needed to identify the chemical structure. It could be a separate discussion from that of the announcement of the chemical name.
- The name of substance and hazard data should be announced publicly as much as possible, so that NGOs, etc. can check chemical safety data by themselves.
- Global harmonization should be ensured. In this regard, a five-year-period is too long.

- QSAR has been improved, but it is not yet a main method for hazard assessment. We should utilize QSAR under CSCL process.
- It is still difficult to apply QSAR for new chemical substances because of the lack of information.
- QSAR can be applied for the proposal of small quantity of new chemicals. Information on new chemical substances would help quality improvement of QSAR.
- Several QSARs can be used in combination for the assessment.
- QSAR should be utilized more. For the sake of improvement of QSAR, industry side should offer as much information as possible.
- QSAR should be developed to make predictions ranging on the safe side.

- Readily biodegradable chemical substances are not in the scope of regulation under CSCL. In order to control substances such as CMR, we should examine which regulation is appropriate (emission control or CSCL). - Aquatic orgasms are readily exposed to chemical substances before decomposition. Various assessment methods should be studied such as the atmospheric pathway and substances which decompose by hydrolysis and photolysis.
- It should be noted that the CSCL cannot cover all pathways and cases.
- Information gathering (Japan challenge) on readily biodegradable chemical substances can be examined, if their production/import volumes are high.
- We should not say that readily biodegradable chemical substances are safe. If production volume is high, certain amount will stay in environment. To proceed with risk assessment, the discharge amount as well as the degradation property is essential.
- It seems that readily biodegradable substances are not needed to be regulated in the pre-marketing phase. On the other hand, it is important for those readily biodegradable substances to be subject to detailed risk assessment after the marketing phase, if necessary.

- Nanomaterials have a high future growth potential for such areas as next generation LSIs and fuel cell technologies. This potential should not be undermined.
- MHLW has published guidelines for workplace safety. For a time, measures for workplace safety should be proceeded with.
- Firstly, we should find out what aspects are real problems for nanomaterials, and then, examine whether the current CSCL can cover those problems or not. Thereafter, we should discuss what can be done under CSCL system.
- There are high expectations for nanomaterials. The challenge is that we cannot even establish test methods as the action mechanisms are unclear. The current situation tells us that we are not at the phase at which we can regulate nanomaterials under CSCL.
- Study and examination of nanomaterials should be conducted continuously to establish safety measures.

- The Bureau announced symposium on CSCL on June 29, and the J-check database renewal.