The Second Meeting of the Joint Committee to review the CSCL (hereinafter referred to as the CSCL Committee) was held on August 28th, 2008. All distributed documents are available on the following website (Japanese language only)
http://www.meti.go.jp/committee/gizi_1/17.html
A summary of the handout document showing the discussion points in the second CSCL Committee is as follows:

Draft outline of the CSCL committee report

I. Background and current enforcement status of the CSCL
i) Establishment and revision of the CSCL
ii) Development of risk-based chemical substance management
iii) The role of risk assessment at the chemical substance management system
iv) International trends of the pre-marketing evaluation system
v) Action toward 2020

II. New CSCL system for 2020
1. Chemical management based on the WSSD target
- The basic idea of the CSCL is to manage chemical substances (regulation of manufacturing/use etc., risk management measure, information distribution) based on scientific risk assessment, keeping WSSD 2020 objectives and a precautionary approach in mind.

2. Establishment of a risk assessment system based on the status in the post-marketing phase
- The current system selects substances to be further assessed through hazard assessment. The new system will take all the chemical substances for risk assessment. First, government collects the manufacturing/import volume and uses information by manufacturers/importers and calculates exposure to the environment. At the same time, existing hazard information will be used for risk assessment to select substances to be further assessed. For selected substances, government will conduct a detailed risk assessment with additional hazard and use information collected as necessary. By establishing this phased risk assessment system, effective risk management and the WSSD target will be realized.

i) Establishment of a system to gather exposure information on chemical substances in the market.
- Government will establish a system to require periodical manufacturing/import volume of companies which manufacture/import chemical substances above a certain threshold.
- Government will also require use information (internationally harmonized and objective) from the companies in order to calculate exposure to the environment.
- CMR information (GHS classification) will be also submitted by companies (on a voluntary basis), if any, as there is a need to assess CMR substance in a cautious way.

ii) Priority consideration at risk assessment (I)
- Government will determine and publish "Priority Assessment Chemical Substances" whose risk is not determined to be sufficiently low by risk assessment (screening level). Risk assessment (I) will be conducted based on the submitted information (chemical substances with exposure (discharge to environment)) and existing hazard information.
- If certain hazard information is already known, that information should be taken into account to determine "Priority Assessment Chemical Substances." To make existing hazard information useful, government should disclose hazard information obtained through hazard/risk assessment. Government will also disclose hazard information voluntary gathered by companies through the "Japan Challenge Program," etc.
- As establishing "priority assessment chemical substances", existing "type 2 and 3 monitoring chemical substances (except for type I monitoring chemical substances)" will be abolished.

iii) Risk assessment (II) and cooperation by companies for information collection
- Government will conduct risk assessment (II) for "Priority Assessment Chemical Substances" and collect hazard and use, etc. information with certain legal engagements.
- Regarding hazard information, SIDS-required items will be asked to manufacturers/importers. If manufacturers/importers already have that hazard information and/or long-term toxicity data, those data will be submitted to the government (expansion of Article 31-2 (Reporting, etc., of Hazardous Properties) of the CSCL). Regarding exposure information, usage information will be asked also to users.
- For chemical substances whose risk concern is high and further detailed risk assessment (risk assessment (III)) is needed, long-term toxicity data, etc. will be requested from manufacturers/importers (as existing Instruction of study of hazardous properties).

iv) Risk assessment after-marketing phase (consideration for persistency)
- Regardless of persistency, chemical substances may remain in environment if their speed of exposure is higher than that of degradation. Thus, the possibility of causing environmental pollution and adverse effects on the health of humans/animals by non-persistent chemical substances cannot be denied. It should be reviewed whether the CSCL is an appropriate law to prevent above-mentioned adverse effects or not, considering the relationship between other laws and actual manufacturing/import/use condition of non-persistent chemical substances.

v) Information gathering/distribution and development of assessment method for after-marketing phase
- In order to conduct more precise risk assessment, PRTR data and environmental monitoring data will be utilized.
- In that regard, harmonization between "Priority Assessment Chemical Substances" (CSCL) and "Designated Chemical Substances" (PRTR Law) will be developed.
- Under the current CSCL, effects mainly in the water environment are assessed. Assessment methods should be studied not only in water environment but also other environments which reflect actual exposure conditions in the after-marketing phase.

3. Development of a pre-marketing evaluation scheme based on risk assessment
- Risk assessment methods and the classification of notification and new assessment methods (technologies) will be reviewed.

i) Risk assessment for pre-marketing evaluation scheme
- Current pre-marketing evaluation for new chemical substances is important. Under this scheme, companies must obtain necessary hazard data for hazard assessment conducted by the government and promote proper management of chemical substances in the after-marketing phase. This scheme also has prevented chemical substances with high hazard (as Class I Specified Chemical Substances) from entering the market.
- Under the new CSCL, government will conduct risk assessment based not only on hazard data but also on projected volume and usage to determine whether the chemical substance falls under the category of "Priority Assessment Chemical Substances" or not.

ii) Disclosure of hazard assessment results (including the name of the substance)
- In order to avoid duplicated notification and evaluation, chemical substance name needs to be disclosed by IUPAC etc. On the other hand, there is a need to examine disclosure of the generic name in order to prevent late-entry companies from producing the same chemical substances without any costs and to secure the antecessors' benefit.
- In order to utilize hazard information of chemical substances for safety management and QSAR etc., it should be noted that hazard information needs to have the corresponding exact name (structure). Data regarding similar substances needs to be also utilizable.
- The benefit to the developer has been already ensured by intellectual property rights and the current CSCL system (ensuring a certain period before the disclosure of the name). Further discussion is needed to identify the negative effects of publishing the detailed (IUPAC) chemical name.

iii) Utilization of QSAR/category approach
- As the precision of the QSAR/category approach depends on the accumulation of information on similar substances, it is more reasonable that the QSAR/category approach is applied basically to hazard assessment of existing chemical substances. On the other hand, QSAR etc. is currently utilized at the new chemical substances development phase and it is possible that QSAR etc. can complement actual test data by combining it with other methods (OECD toolbox, etc.).

iv) Pre-marketing evaluation of new chemical substances with low risk (new chemical substances of small quantities)
- Under other countries' systems, new chemical substances of small quantities are not subject to risk assessment/management by governments etc. and are left to the management of companies. This is because new chemical substances of small quantity are regarded as low risk and that it is inconceivable that many companies deal with the same chemical substances at once at the same time.
- The confirmation scheme for new chemical substances of small quantity under the CSCL has been implemented properly. The scheme does not prevent several companies from submitting proposal for the same substance, and in that case, confirmation is done for those companies proposed so that the total confirmed volume is adjusted to 1 ton/year by government.
- In order to develop a risk-specific chemical management scheme, individual chemical management by companies for new chemical substances of small quantity is needed. Therefore, confirmation of 1 ton per company will be the principle of the new scheme, while ensuring compatibility with the low production volume (-10t) scheme. However, if several companies propose government about the same new chemical substances of small quantity confirmation, government will assess the risk using QSAR and the total volume proposed, etc. and in cases in which the risk seems to be high, government will not confirm such notifications as new chemicals of small quantity.

v) Establishment of a confirmation scheme for Polymers of Low Concern (PLCs)
- Regarding PLCs (polymers of low concern), in view of harmonization, pre-market evaluation based on hazard test data is exempted for PLCs when the notification is confirmed by government.

4. Risk reduction measures for chemical substances evaluated as high-risk chemicals
i) International harmonization for Class I Specified Chemical Substances
- Strict regulation measures for Class I Specified Chemical Substances will be continued as they are
- When new chemical substances are added to the POPs convention ("Stockholm Convention on Persistent Organic Pollutants"), the CSCL also needs to regulate those chemical substances in order to comply with the Convention. At the same time, for substances whose alternative substances do not exist, internationally allowed uses (POPs, etc.) will be allowed also under the CSCL with a certain conditions.
- As for allowing "essential use," Class I Specified Chemical Substances will be distributed. In order to ensure strict management by companies that deal with Class I Specified Chemical Substances, am information distribution obligation will be introduced.

ii) Promotion of information distribution for Type I Monitoring Chemical Substances
- An information distribution system will be introduced for Type I Monitoring Chemical Substances. When Type I Monitoring Chemical Substances are transferred, information on Type I Monitoring Chemical Substances and handling methods should also be transferred between related companies.
- Information transfer will be introduced also for products which include Type I Monitoring Chemical Substances and for substances that may be released into the environment.

iii) Risk reduction measures for chemical substances evaluated as high-risk chemicals
- As a result of phased risk assessment, high risk chemical substances will be designated as Class II Specified Chemical Substances and be subject to risk reduction measures under the CSCL, such as manufacture/import regulations, proper handling, and transmitting safety information.
- Risk reduction measures will be also required to products including Class II Specified Chemical Substances if Class II Specified Chemicals seem to be released to the environment.

III. Schedule toward 2020, role sharing among the public and private sectors
i) New Chemical Substances Management System
- Revision of the CSCL mentioned above will ensure the safety of people and the environment through improving chemical management standards in Japan. In order to achieve the WSSD 2020 target and realize proper chemical management, implementation of new CSCL scheme will be launched promptly in the manner stated below, for example.
- After one year after the new CSCL scheme implementation has started, the manufacture/import volume, etc. of all chemical substances in market will be notified. Government will conduct risk assessment (screening level) and identify chemical substances which need further risk assessment with priority ("Priority Assessment Chemical Substances"). To facilitate notification of manufacture/import volume etc., government will develop an effective notification management system and publish them in concordance between the METI number and the CAS number.
- For risk assessment (screening level), various existing knowledge, such as outcome of i) the Japan Challenge Program, ii) individual assessment results by companies, iii) international actions such as the OECD HPV (High volume production) program, iv) test data on existing chemicals conducted by government etc., will be used. For those chemical substances with no hazard data, cooperation on gathering data especially for HPV chemical substances will be asked for from the corresponding companies, while government will also gather data on MPV (medium production volume) chemical substances while considering the situation of producer companies.
- Government will publish the risk assessment (screening level) method and encourage companies to manage chemical substances and to collect/submit hazard data by themselves.
- The detailed name of "Priority Assessment Chemical Substances" will be published as soon as possible after risk assessment (screening level). Government will review the "Priority Assessment Chemical Substances" periodically based on notified manufacture/import volume etc. and publish the results.
- Further risk assessment will be conducted for "Priority Assessment Chemical Substances." All needed actions (including strict risk reduction measures) will be conducted by 2020.
- Regarding nanomaterials, further scientific knowledge and international trends (definitions, test methods, assessment methods, etc.) will be taken into consideration.
- Risks, costs and benefits will be analyzed for the above-mentioned phased risk assessment system and other assumed options.

ii) Information disclosure regarding chemical management
- It is necessary to disclose safety (hazard) information gathered under the new CSCL scheme, taking due consideration of corporate confidentiality. Government will take special notice of companies' rights om primary information (such as testing reports).

iii) Improvement of information infrastructure on chemical safety
- In order to publish safety (hazard) information of chemical substances, the development of an information infrastructure is necessary. For databases (J-CHECK, CHRIP), enhancement of information and development of user-friendly interface are needed.
- Interconnection between international databases should also be considered.
-Consolidation of GHS classification information through a database is expected.

Others

- procedural flow (image) (PDF 80KB)

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

- Industries will ask for a certain level of consideration at the time of the implementation phase. For industry, maintaining international competitiveness is important as there are a wide range of industries with various capabilities.
- It is good scheme to collect manufacture/import volume data and use information on all chemical substances above a certain threshold periodically.
- This can be called "screening assessment" rather than "risk assessment" as this scheme will use only existing knowledge and manufacture/import volume data, etc.
- Hazard information will be collected in a stepwise manner. How about exposure information collection? Why are persistency and level of bioaccumulation also assessed at first under the new scheme?
- An effective risk assessment scheme (data collection, risk assessment, disclosure of the assessment result, asking industry to cooperate on data gathering, etc.) should be established by government.
- A specific schedule for 2020 is needed. It is important to conduct an assessment of "priority assessment chemical substances" and to regulate high risk substances of concern as soon as possible before 2020.
- The WSSD 2020 target cannot achieve only by the CSCL and PRTR laws. Possible points under the CSCL should be clearly stated in the report. An opinion that a grand design for chemical management is needed is also included in the report.
- Use information collected should also be utilized in consumer safety policy. Government should make it clear how to deal with the chemical substances that have risk concerns that cannot be precisely assessed.
- Regarding information collection, a new scheme in which voluntary efforts made by companies are rewarded is ideal. In case there is no hazard information submitted, it is possible that government assesses with margins on the safe side so that information submission will be an incentive for companies.

2. Development of a pre-marketing evaluation scheme based on risk assessment

- Regarding polymers of low concern (PLCs), data (molecular weight distribution, etc.) which represents the nature of the substances should be submitted.
- It is preferable to use QSAR at the risk assessment (screening level) phase.
- The PLC confirmation scheme as well as the current polymer flow scheme is important.
- Regarding the confirmation scheme for new chemical substances of small quantity, some sort of handling should be needed for substances with uncertain safety information (such as nanomaterials). In case there are several notifiers for the confirmation of small quantity (for example, 10 companies ask for confirmation for the same substances), some sort of guidance is needed.

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

- Strict management in order not to expose such substances to the environment is necessary if we allow the essential use of Class I specified chemical substances.
- The international harmonization aspect is important when essential use is examined. Essential use should be allowed on condition that the companies will introduce alternatives in the near future.
- If Class I Specified Chemical Substances, which are permitted for use as essential use, are included in consumer products, certain considerations to draw the attention of consumers are necessary.
- Information disclosure which shows companies' efforts to produce alternative substances is desirable for consumers.

4. Schedule toward 2020, role sharing among public and private sectors

- Regarding the gathering of data for HPV chemical substances with no hazard data, companies' voluntary cooperation is necessary. If there are needs for substances with no cooperation, it is preferable that government can conduct instruction of studies of hazardous properties.
- Regarding nanomaterials, an examination whether new regulations are needed or not should be conducted at the time of scientific outcomes, while asking companies to disclose information, etc. on their products including nanomaterials.
- Regarding information disclosure by government, companies' intellectual property rights as well as interests protected by law are important.
- Information infrastructure development with the cooperation of industry is important. The proper transaction of information should be ensured by an international database led by the government.
- Ensuring necessary human resources by the government is important.
- Role sharing between the public and private sectors should be clearly stated for information gathering of HPV, MPV and LPV chemical substances.
- Databases are not always friendly for consumers. One idea is to attach the GHS label to certain products.
- For better chemical management infrastructure, a database should be developed with those under other related laws.
- Disclosure of safety information should also be examined in light of utilization in other countries. For consumers, information which can be useful at the time of merchandise choice is needed.
- An ideal scheme is one in which companies' efforts to gather safety information is rewarded.
- Consumers are also interested in safety information disclosure on other chemical substances which is not under the CSCL, such as pesticides.
- We should rely not only on companies' voluntary actions but also on legal regulation in light of the schedule toward 2020.

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

- It should be clearly defined what "private" means in this discussion. MOE's environment monitoring can be utilized in the new CSCL scheme.
- Revision of existing chemical substances inventory is necessary. For example, chemical substances with uncertain structures can be re-classified as new chemical substances.