By James Lin
SEOUL--The Law on the Registration and Evaluation of Chemicals was formally promulgated May 22, completing the enactment of South Korea's landmark chemical law that will start rolling out a European Union-style system of registration, evaluation, authorization, and restriction of chemical substances, the Ministry of Environment said.
President Park Geun-hye signed into law the REACH bill (No. 1904754), which was passed by the National Assembly April 30 after repeated delays over industry opposition (37 CRR 526, 5/6/13).
The law sets Jan. 1, 2015, as the starting date for annual registration.
“The purpose of the REACH law is to protect public health and the environment from risks of chemical substances and adapt to international trends toward mandating registration and evaluation of chemical substances,” the ministry said in a statement.
The law provides two important annual tonnage thresholds that respectively trigger registration and evaluation requirements for chemicals manufactured here or imported from abroad: 1 metric ton for registration and 10 metric tons for evaluation. The toxicity risk assessment threshold for the evaluation group will be phased in over a five-year period, beginning with 100 metric tons in 2015 and going down every year to reach 10 metric tons in 2020.
The REACH law agenda comes down to the idea of establishing data on every large-volume industrial chemical substance. “The law's stated objective is to realize preventive controls by establishing the 'no data, no market’ principle,” Cho Eun-hee, chemical substances department director at the ministry's Division of Environmental Health Policy, told BNA.
That means a big change from what has been the case since South Korea began regulating chemical substances in 1991 under the Toxic Chemicals Control Act. According to the ministry's estimate, 85 percent of some 44,000 chemical substances known to have existed or still existing in South Korea do not have authentic hazard profiles.
The REACH law will eliminate this vast gray area and increased data coverage will combine with tighter regulatory action that involves restriction and authorization for proven toxic substances under the Toxic Chemicals Control Act.
The law's implications on businesses also extend to products containing chemicals. Manufacturers and importers now are required to report to the ministry prior to product introduction if any chemical in their product exceeds 1 metric ton in terms of annual aggregate content.
The ministry may require risk assessments for products with suspected chemical toxicity. Common household items such as synthetic detergents, fabric whiteners, cleansers, air fresheners, and adhesives are cited by the ministry as among product examples requiring risk communication. Also included are biocidal products such as insect killing sprays.
The consequences of product chemical risk assessments may include product recalls and outright sales prohibitions by the ministry.
These and other provisions in the REACH law will be further specified in subordinate enforcement rules and regulations, which the ministry will develop in coming months with input from industry organizations, private-sector experts, and environmental groups.
The ministry said compliance will be made easier by electronic handling of all paperwork for the reporting, registration, notification, and evaluation involved in the REACH process. Furthermore, joint submissions will be allowed whenever possible to reduce filing costs for multiple manufacturers and importers reporting the same chemical substance.
Nevertheless, industry experts say the cost of compliance should be significant for businesses, especially small organizations lacking access to proprietary data on chemical substances.
At a chemical regulation webinar presentation organized by REACH24H Consulting Group May 22, Park Sang-hee, a researcher at Seoul-based chemical regulatory service provider Chemtopia, said that the cost of obtaining data from foreign data holders in the United States, China, Japan, and the European Union--South Korea's main chemicals trading partners--could add up. “The biggest burden for small companies will come from data acquisition fees they need to pay to foreign data holders.”
Foreign companies selling chemicals and chemical-based products to South Korea also face compliance challenges, including the requirement for maintaining a local representative as a channel of REACH-related communication, she said. “Based on the European Union's experience with REACH,” she said, “supply chain management will be key to staying in compliance for all relevant chemical ingredients going through the supply chain.”