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The Fourth Joint Working Group to Review CSCL

Summary

The fourth Joint Working Group to review the CSCL (hereinafter referred to as the CSCL WG) was held on July 10, 2008. The CSCL WG comprises of 18 members such as scientists, chemical and downstream industry organization representatives, consumers, and NPOs. The theme of the fourth CSCL WG was future chemical substance management policy. 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:

1. Basic idea for chemical substance management system based on the WSSD 2020 objectives.

- In light of WSSD 2020 objectives, risk assessment of chemical substances manufactured/imported in Japan should be conducted and risk-based management of chemical substances should be completed by 2020.

2. Establishment of phased risk assessment scheme

- Under the CSCL, "monitoring chemical substances" identified by hazard assessment are subject to risk assessment/management, monitoring annual volume of manufacturing/importing. Though the current system has been playing a certain role, there are many existing chemical substances in the market that lack sufficient hazard assessment.
- Considering hazard information gathering through testing requires substantial costs and time, it is not reasonable to conduct uniform detailed risk assessment for all chemical substances in the interest of efficiency and swiftness.
- Under the revised CSCL, the volume of manufacturing/importing and use information for all chemical substances above a certain threshold are collected from manufacturers/importers and risk assessments are conducted by governments based on the information gathered (estimated environmental exposure) and known hazard information. Taking that result into account, some chemical substances are classified as "priority assessment chemical substances (tentative name)" if those risks are NOT sufficiently low and need further assessment. How about gathering information on the "priority assessment chemical substances" and conducting further risk assessment? Can efficient and appropriate risk-specific chemical management be realized through this scheme?
- Regarding new chemical substances, the pre-marketing evaluation should be continued. In addition to hazard information, how about taking estimated exposure information into account at the pre-marketing evaluation to evaluate risks?
- Considering the improvement of risk assessment/management after the marketing phase, how about reviewing the evaluation method for persistency etc. as necessary?

3. Information gathering in phased risk assessment scheme

- For "priority assessment chemical substances", how about collecting hazard and use etc. information with certain legal engagements? Is it appropriate to collect information gradually, from SIDS required items, using information? If there is a need to collect more detailed data (long-term test data etc.), how about requiring those data to companies as with the existing CSCL scheme?
- If there are chemical substances subject to PRTR law, the utilization of PRTR data will enable more precise risk assessment. Regarding the fact that PRTR subject substances are selected by the toxicity of chemicals via the environment for humans, animals and plants, how about proceeding with harmonization between PRTR substances and "priority assessment chemical substances"?

4. Risk reduction measures for chemical substances evaluated as high-risk chemicals

- As a result of phased risk assessment, high risk chemical substances should be subject to risk reduction measures under the CSCL, such as import regulations, proper handling, and transmitting safety information.
- For high-hazard chemical substances which are very persistent, very bioaccumulative and very toxic (have long-term toxicity), strict control measures are appropriate, considering the "Stockholm Convention on Persistent Organic Pollutants."

5. Information disclosure on risks and continuous risk assessment/management.

- Information on risks of chemical substances is very important not only for manufacturers/importers but also for users/consumers. Governments should disclose information on chemical substances, such as hazard information and hazard/risk assessment results conducted by the government, in a manner that users can utilize easily.
- Especially for user companies of chemical substances, information for chemical management is needed. To this end, how about conveying hazard information by MSDS etc. for chemical substances above a certain hazard level?
- In order to keep chemical substances' risk at appropriate levels, should governments continue to conduct risk assessments, disclose their results, promote proper management by companies, and implement necessary regulation?

Comments of Members in the meeting

1. The basic idea for chemical substance management system is based on the WSSD 2020 objectives.

- In the third basic environmental plan, the target year is written as "around 2025". It should clearly state "by 2020" according to the international consensus (WSSD 2020 target).
- The WSSD 2020 target should be achieved by comprehensive management of chemical substances including pesticides, etc.

2. Establishment of phased risk assessment schemes

- In light of pre-marketing evaluation and after-the fact control, the proposed scheme is fine. This scheme will not drop chemical substances of low risk from assessment as they will be subject to further risk assessment if the volumes of manufacturing/importing increase.
- The risk assessment scheme by gathering volume of manufacturing/importing annually is an effective preventive scheme. On the other hand, it seems to be burdensome for both government and industry. An effective risk assessment scheme should be established.
- When will the list of "priority assessment chemical substance" be fixed?
- The proposed scheme is good, but the workload seems to be high. How about receiving the volume of manufacturing/importing information, for instance, every five years? We should prevent too much workload from occurring by setting proper thresholds for manufacturing/import volume notification, etc.
- The relationship between existing "monitoring chemical substances" and "priority assessment chemical substances" should be defined.
- The new scheme is different from the ongoing one while "monitoring chemical substances" are determined by hazard assessment and "priority assessment chemical substances" are determined by risk assessment.
- If the new scheme is based on risk assessment, non-persistent chemicals should also be under the new scheme.
- Further discussion is needed to set a certain threshold for manufacturing/import volume notification.
- It is preferable to make public the method of risk assessment in an easily understood manner.

3. Information gathering in phased risk assessment schemes

- It seems that detailed use information is difficult to collect. Clear guidelines for information collection are need. An information conveying scheme for SVHC substances under REACH should be referred to.
- It is difficult to use SIDS required items for predictions of long-term toxicity. There is a shortage of human resources to make assessments of such toxicity.
- Information gathering should be made not by regulation but by the voluntary action of industries. If needed information is not offered by industry, conducting risk assessment with built in margins on the safe side will be one option.
- "Instruction of study of hazardous properties" is proposed to be put after risk assessment (II). It is preferable that legally binding actions such as instructions can be made earlier than the proposed timing in case there are uncooperative companies.
- Regarding the detailed use information, in cases when detailed use information is unobtainable, or when there is an incorrect point in the detailed use, information should be clearly set.
- Regarding hazard information collection, merely the cooperation of industries alone is insufficient. "Instructions" should be made at the final phase.
- For existing "reporting requirements (CSCL Art.31-2)," there are no provisions for information known before the revision of the law. There is a need to improve this provision to cover existing hazard information.
- Regarding the relationship between the CSCL and PRTR law, though the assessment can be made by using notified data under both laws, harmonization between "priority assessment chemical substances" and object substances under PRTR is practically difficult as these laws have different definition for chemical substance etc.
- Lack of information will be a big challenge for the new scheme. It is necessary to make a scheme that automatically gathers the needed hazard and use information for "priority assessment chemical substances."

4. Risk reduction measures for chemical substances evaluated as high-risk chemicals

- Strict regulation for high hazard chemical substances is good.
- It should be clearly stated what the "essential use" in this discussion stands for. It seems to be in line with the discussion under the POPs convention.
- It is important whether the risk can be managed or not. There is a case that the risk management is not able to be performed because there is not any method for measurement. The effectiveness of risk management measures should be examined when each essential use is discussed.

5. Information disclosure on risks and continuous risk assessment/management.

- Chemical substances are sometimes distributed in the form of mixtures. MSDS information from upstream companies is important and thus needs further improvement.
- It is not clear what chemical substances are subject to MSDS. There should be clear guidance.
- It is necessary to establish an information infrastructure to show the material information for consumer products. A simplified "MSDS" for consumers is necessary. The GHS classification is also important.
- MSDS is basically shows hazard etc. information for products (mixtures). MSDS in Japan also shows information on regulated substances under CSCL etc. It is possible to describe "priority assessment chemical substance" information for MSDS.
- Information distribution for articles under CSCL is not clear.
- Disclosure of chemical substances for consumer products is important so that consumers can select what to buy (not necessarily under CSCL).
- There are some challenges; for some companies, the current MSDS is difficult to understand; GHS information distribution is conducted only among companies etc.

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