Fostering a regulatory environment for chemicals that supports industrial development while safeguarding public safety and health.
The Chemical Manufacturers Committee highly appreciates the efforts of the Environmental Protection Administration (EPA) and Ministry of Labor (MOL) 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.
Following the promulgation of the Toxic and Chemical Substances of Concern Control Act in January this year, the scope of “chemical substances of concern” and details regarding chemical substance handling fees have yet to be specified. The Committee urges the EPA to further communicate with industrial stakeholders on these points as early as possible to enable them to engage in business planning with greater certainty.
Regarding the MOL’s amendment to the Regulations for the Labeling and Hazard Communication of Hazardous Chemicals, the Committee is concerned that the application and review criteria for the withholding of confidential business information (CBI) has become more stringent. The Committee hopes that MOL will provide an exemption for products used for scientific research and development (R&D), and also refine the review criteria to better protect workers and downstream users without compromising industrial R&D capability.
Suggestion 1: Clarify requirements under the Toxic and Chemical Substances of Concern Control Act.
1.1 Industry stakeholders are awaiting the issuance of implementation regulations for the new Toxic and Chemical Substances of Concern Control Act. At this point, key conditions under the Act are still unclear, including the definition of “chemical substances of concern,” the threshold in terms of degree of chemical concentration and handling volume, and the measures that companies dealing with these substances will be required to put in place. The Committee urges the EPA to communicate with the various stakeholders as early and fully as feasible to give them sufficient time to prepare for the new requirements.
1.2 Article 47 of the Act calls for the establishment of a chemical substance management fund to be financed through user fees. The fund would presumably be used for such purposes as chemical substance handling expenses and bolstering emergency response capability. Still undefined are the mechanism for calculating the fees and precisely how the fund will be utilized. The Committee notes that while the major chemical manufacturers in Taiwan already have a well-established mutual-aid alliance for emergency chemical response, the alliance members are also supportive of the government’s efforts to expand the network of national chemical emergency response teams and technical centers, which presumably would be financed through the user fund. However, the industry stakeholders urge the EPA to clearly define the respective responsibilities of the private and public sectors for emergency response personnel training and competency-building to avoid any duplication of effort.
Furthermore, since related funds already exist under the existing air and water pollution and soil-contamination prevention laws, the Committee urges the EPA to thoroughly evaluate the requirements for any new fees to prevent any overlap with the charges currently being imposed. The operation of the chemical substance management fund should be totally transparent and the money used for the appropriate defined purposes only.
1.3 Article 71 of the Act stipulates that those who use toxic and chemical substances of concern shall submit a site-storage layout. However, both the National Fire Agency and the Ministry of Economic Affairs similarly require the public declaration of hazardous materials and the layout of the hazardous materials storage site at the factory’s emergency response center. The Committee recommends that the various authorities agree on an integrated procedure regarding the chemical storage site layout. That arrangement would relieve companies of the burden of repeated demands for compliance, while still fulfilling the purpose of ensuring prompt emergency response.
Suggestion 2: Regulations for the Labeling and Hazard Communication of Hazardous Chemicals.
The amendment to the Regulations for the Labeling and Hazard Communication of Hazardous Chemicals that went into effect last November requires disclosure of the substance’s Chemical Abstract Service (CAS) number unless an application to withhold the number has been approved. In addition, applications for Confidential Business Information (CBI) treatment are no longer permitted for hazardous substances listed in the Standards of Permissible Exposure Limits at Job Site. The Committee is concerned that the overall application and review criteria for CBI protection are becoming more and more stringent.
The Committee suggests that special treatment should be given to R&D samples, considering their generally low volume and very short life cycle. On the condition that product hazards are correctly classified and noted on the Safety Data Sheet (SDS) with appropriate volume control and validity, we propose that declared R&D samples be accorded the flexibility of using the generic name. This solution would be in line with European Chemical Agency (ECHA) provisions. Such flexibility for R&D samples, which would reflect Taiwan’s R&D competence and unique position in the global semiconductor business, would in no way impair the protection of chemical industry workers and downstream users from exposure to hazards.
To prove that a substance does not fall into any of the nine hazardous-to-health classifications defined in Article 18-1, MOL requires applicants to provide toxicological data regarding health hazards for all nine categories, along with a summary. However, toxicological data and reports do not exist for all chemical substances, posing a huge burden for industrial stakeholders when trying to defend and protect their CBI. The Committee urges MOL to refer to ECHA’s practices regarding human health and environmental endpoints. Under certain well-defined principles, ECHA will accept the lack of data for a given classification, instead of constantly asking applicants to generate new data or testing.