The Chemical Manufacturers Committee highly appreciates the efforts of government agencies to engage in two-way communication with industrial stakeholders, conduct effective inter-agency cooperation, and pursue efforts to improve Taiwan’s chemical management in line with global standards and practices.
Regarding the application and review criteria for the withholding of confidential business information (CBI) on Safety Data Sheets (SDS) and product labels, the Committee is concerned that the Ministry of Labor (MOL) is setting the most stringent standard globally. The Committee hopes that MOL will refine the review criteria and provide an exemption for products used for scientific research and development to better protect workers and downstream users without compromising further industrial development.
Although the Existing Chemical Substance Standard Registration requirement went into effect in January this year, the technical guidance as well as the corresponding measures have yet to be specified. The Committee urges the Environmental Protection Administration (EPA) to promulgate the technical guidance and corresponding measures as early as possible to enable industrial stakeholders to start the registration planning with greater certainty.
Suggestion 1: Refine the application and review criteria for withholding CBI under the “Regulations for the Labeling and Hazard Communication of Hazardous Chemicals.”
1.1 Simply the application process. The EU and Taiwan are the only markets that have set criteria for the withholding of confidential business information (CBI) on labels and SDS. In other countries such as the U.S., Japan, and China, if the hazardous substances are promulgated by the authorities, chemicals containing those hazardous substances have to be disclosed with their exact chemical names; for hazardous substances not listed, use of the generic names in the SDS is sufficient. In some jurisdictions, use of the generic name on the SDS is permitted without any application or government approval.
Even though Taiwan OSHA/MOL accepts test reports and scientific reference, as well as alternative methods such as Quantitative Structure-Activity Relationship (QSAR) prediction, it is still very challenging and resource-consuming for industrial stakeholders to either collect all the data end-points needed for GHS Hazard Classification, or to use alternative methods such as QSAR prediction, read-across, or weight of evidence to prove that a substance does NOT fall into any of the nine health hazard classifications. The dossier preparation is almost as much work as the EPA chemical-substance standard registration.
1.2 Add flexibility by accounting for substances that cannot be classified. Taiwan has primarily adopted the CBI withholding requirements from the EU’s classification, labeling, and packaging regulations (CLP, 1272/2008/EC). However, the European Chemicals Agency (ECHA) offers some flexibility by accepting applications of chemical substances that lack supporting data, regarding them as Can Not be Classified (CNC). Another option for such substances is to provide a well-explained exposure scenario and control measures demonstrating the safe use of the substance.
In the absence of similar flexibility in Taiwan, however, industry is not able to apply for CBI withholding for substances that lack toxicological data and reports, especially for substances under development and polymers where QSAR normally does not apply. There have been cases where ECHA approval was granted but the substance then failed to pass the application for Taiwan SDS CBI withholding, although the above-mentioned conditions were applied. The Committee urges OSHA/MOL to consider the actual situation in Taiwan and adopt the ECHA approach of accepting CNC as a possible classification and a statement of chemical safe use as proof that exposure can be confined and controlled.
1.3 Provide for CBI exemption for R&D samples. Taiwan and Korea are the leading countries in the semiconductor industry. Following Korea’s recent amendment to its Industrial Safety and Health Act (ISHA), Korea’s Ministry of Employment and Labor (MOEL) is considering the possibilities of exempting R&D samples from chemical substance disclosure on SDS and labels. In Taiwan, OSHA/MOL has engaged in partial harmonization with the EPA to enable the generic name approved in the new-chemical substance registration to be shown on the SDS as a substitute for the exact chemical name and CAS Registry Number. However, OSHA/MOL has not considered that numerous existing chemical substances are also used in R&D samples and new product development. In addition, OSHA/MOL has failed to leverage EPA’s R&D exemption mechanism, which for several years has been encouraging R&D activities in Taiwan oriented toward scientific purposes as well as product and process functions.
The Committee urges MOL to set a pioneering example of balancing labor health and safety without compromising industrial development by designing a simplified or exempted CBI withholding mechanism for R&D samples, even if there is no existing international practice to follow.
1.4 Regularly publish application data. The Committee urges MOL to periodically publish the number of CBI withholding cases that have been applied for, rejected, withdrawn, or approved in recent years to let stakeholders understand the application status and difficulties being encountered. We also suggest that MOL use the successful applications to help educate applicants about the process in order to increase the approval rate and reform what is the world’s most stringent CBI application criteria.
Suggestion 2: Promulgate the technical guidance and the corresponding measures for Priority Existing Chemical registration as early as possible.
2.1 Accelerate release of the technical guidance. The Priority Existing Chemical (PEC) registration process, which is a matter of major concern for industrial stakeholders, was launched on January 1 this year, but the relevant technical guidance remains in draft form as released in September 2019. Because the data requirements and specifications, as well as the corresponding measures, have yet to be finalized, industrial stakeholders have been unable to begin negotiations with data owners of REACH (Restriction, Evaluation, Authorisation and Restriction of Chemicals) dossiers and to purchase letters of access. The Committee urges the EPA to publish the technical guidance as soon as possible to enable registrants to complete the standard registration by the deadline without further delay and uncertainty. We also expect that following the current registration, rolling updates to the technical guidance will be published.
2.2 Build up industry competence in hazard and exposure assessment. Hazard and Exposure Assessment Reports are required for PEC registration levels 2 and above, but the pertinent technical guidance and reference have been in draft form only, with no further progress or update since 2016. As most industrial stakeholders were not even aware of the draft, they had no choice but to turn to consulting companies for support, which involved considerable burden and expense. The Committee urges the EPA to publish the technical guidance as soon as possible – and also to take into consideration the lack of expertise among many industrial stakeholders in conducting reliable hazard and exposure assessments. To help build up this competence, we urge EPA to offer workshops and training or counseling programs so that the goal of implementing world-class chemical source management in Taiwan can be achieved.
2.3 Remind stakeholders about copyright issues. The draft technical guidance for PEC registration recommends reference to open databases, but many industry stakeholders may be unaware of the potential copyright implications. We suggest that the EPA provide companies with reminders regarding the copyright issue in dealing with open databases and guidance on how to avoid any risk of copyright infringement.
Suggestion 3: Ease the chemical registration and annual reporting process for industry stakeholders.
3.1 Update the technical guidance periodically. New-chemical-substance registration has been implemented for several years; however, the technical guidance for the “Regulations of New and Existing Chemical Substances Registration” has not been updated since 2015. Considering the resulting practical difficulties that industrial stakeholders have encountered, the Committee urges the EPA to update the technical guidance periodically by leveraging ECHA’s experience and/or provide Q&A support as ECHA does to compensate for the insufficiency of the technical guidance.
3.2 Facilitate the annual reporting process. The requirement for annual reporting of registered chemical substances went into effect on April 1 this year. In consideration of the enormous volume of substances to be reported, as well as the complex third-party representation situation between upstream and downstream stakeholders in Taiwan, the Committee urges the EPA to provide a user-friendly platform as early as possible with batch-upload function and offline version of the reporting tool.
1.3 科學研發樣品豁免或申請簡化: 台灣和韓國同為全球半導體產業發展領先國家，韓國就業和勞動部（MOEL）近期在研擬勞動安全衛生法（Industrial Safety and Health Act）保留揭示申請規則時，也將科學研發樣品特性納入考量。我國職安署雖於申請指引中訂有環保署核准保密的類名及登錄碼得取代安全資料表應揭露訊息，然而此調和僅限於新化學物質，未能考量到國內許多研發樣品及新產品的開發同樣會以既有化學物質作為選擇。另職安署仍尚未善用環保署針對研發樣品另訂立的簡易報請備查機制：其立意多年來即為鼓勵在台產業做科學、產品製造等研發。