Allison Tracy is a Chemicals Policy Fellow. Richard Denison, Ph.D., is a Senior Scientist.
The November 31st deadline for the first batch of registrations under REACH (the European Union’s Regulation for Registration, Evaluation, Authorization and Restriction of Chemicals) may have passed, but life is far from dull on the international scene of chemicals policy. As discussed in a previous post, chemicals policy enhancements are ramping up across the globe, many of them mirroring the innovations introduced under REACH.
In this post, we’ll discuss significant advances in Japan, Turkey and South Korea that drive home the message that the ripples from REACH are ever-widening.
Japan’s enhanced system for collecting hazard and use data, which came into full effect on April 1st of this year, improves the government’s ability to determine the potential risks posed by both existing and new chemicals. The new system was mandated by the country’s Chemical Substances Control Law (CSCL), amended in 2009, which required companies to report hazard and use information for chemicals manufactured in or imported into Japan. The reporting threshold of one tonne (i.e., one metric ton or 2,200 lbs) per year per company is the same as the threshold under REACH, and is far lower than the 25,000 lbs per year per site threshold of the Inventory Update Reporting (IUR) rule in the United States.
Japanese authorities will use the new information to prioritize certain chemicals for risk assessment and request further exposure and hazard information from the companies that manufacture or import those substances. Chemicals found to be of highest concern will be virtually prohibited, with prior permission required to continue any specific uses – quite similar to REACH’s authorization process.
Guidance from Japan’s Ministry of Economy, Trade and Industry states that companies “are obliged to make utmost efforts to disclose information,” but the law only requires companies to report information that is available to them, including unpublished data as well as new data as they become available. (Additional detail and links to guidance documents are available in this article in Chemical Watch (subscription required).)
Japan will require annual reporting, which, if production and import in Japan are anything like they are in the U.S., will be essential to capture the substantial year-to-year fluctuation in chemical manufacture. In this regard, REACH takes a different tact by requiring registrants to update their registrations whenever there is a significant change in a chemical’s status or when the next highest production volume tier in its four-tier system is reached. In contrast, the current IUR requires reporting only once every five years, and then only for a single year’s production.
Fortunately, the U.S. EPA is in the process of amending the IUR to require more frequent reporting and to lower the reporting threshold for at least certain chemicals; the final rule is pending approval by the White House Office of Management and Budget (OMB), and will hopefully be released very soon for use in this year’s reporting cycle.
Turkey’s “ Regulation on the Inventory and Control of Chemicals,” adopted in 2008, requires companies to submit information on existing chemicals manufactured or imported in quantities over one tone, the same as the threshold under REACH. It also requires notifications for new chemicals within nine months of their first manufacture or import.
Companies have just submitted notifications for new and existing chemicals in response to a March 31st deadline. Preliminary counts reported in a Chemical Watch article (subscription required) show that roughly 2,000 companies submitted approximately 40,000 notifications.
Chemical Watch has published a comprehensive guide to the Turkish regulation that can be found here (subscription required). In brief, data are required to accompany notifications and vary depending on the tonnage band of the substance, as is the case under REACH, but with only two tonnage bands: 1-1,000 tonnes/year and over 1,000 tonnes/year. Each notification must include the uses, production volume, and classification and labeling of the substance.
Notifications for substances in the higher tonnage band must also include intrinsic physical and chemical properties, environmental impact, and toxicity data. However, for these additional categories, companies need only submit data that already exist and are available through “reasonable efforts.” The Ministry of Environment and Forestry can request additional information after reviewing the submission. Another Chemical Watch article (subscription required) indicates that additional regulations are in the pipeline that would add “obligations to provide missing test data and information on use, exposure and risk management measures.”
According to a 2010 publication by Keller and Heckman LLP, the regulation also requires updates to notifications in the case of certain changes in status, including new uses or safety-related information. Turkey has also mirrored REACH by establishing a priority list to expedite assessment and management for certain substances.
Turkey’s regulation requires companies to substantiate all confidential business information (CBI) claims by proving that disclosure “might industrially or commercially harm” the company. The ministry is required to review all claims and approve only those that meet the standard. The new regulation mandates publication of a list of the substances that exceed the 1,000 tonnes per year threshold. Notably, companies are not permitted to claim results of animal tests as CBI, in an effort to reduce animal testing.
Most interestingly, Turkey indicated it launched its chemicals management program to avoid becoming a dumping ground for unsafe chemicals. According to Chemical Watch (subscription required): “The Turkish government is aware that the introduction of new restrictions on the use of certain substances in the EU could result in companies adopting new marketing strategies and start exporting to Turkey instead. This would transfer the same hazards there unless similar restrictions are imposed.”
In February of 2011, the South Korean Ministry of the Environment released a draft of the “Act on the Registration and Evaluation of Chemicals” that would revise the South Korean Toxic Chemicals Control Act. The proposed legislation would regulate both existing and new chemicals. Chemical Watch’s summary of the draft Act can be found here (subscription required), and a summary by Keller and Heckman LLP is here.
The initial step of the registration process requires companies to submit production volume information to the government, which then uses the information to prioritize certain chemicals. During registration, manufacturers and importers must identify their chemical as belonging to one of seven categories in order to continue using the chemical. Submissions for chemicals produced above 100 tonnes/year, the higher of two tonnage bands, must include risk assessment information.
South Korea further incorporates the approach of REACH by including an “evaluation” process. Evaluation includes hazard evaluation by the government and approved laboratories and may lead to a risk assessment. Companies may be asked to submit more data for both steps. Evaluation may ultimately lead to prioritization for authorization, restriction or prohibition.
In regards to these latter steps, South Korea departs slightly from REACH by allowing the Ministry to unilaterally designate a chemical as a candidate for authorization. Such chemicals include Carcinogenic, Mutagenic or Reproductive toxicants (CMRs), very persistent or very bioaccumulative chemicals (vPs or vBs), or chemicals that may cause “equivalent concern” (PBTs appear not to be separately delineated). These criteria are virtually the same used to identify chemicals for REACH’s Candidate list, and Korea’s resulting list is required to be published as well. Restriction or prohibition proceeds from a determination that a substance poses a serious risk to human health or the environment, according to either South Korea or an international body.
What does this all boil down to?
It’s looking like more and more of the globe is falling under coverage of REACH-like policies, with the notable exception, of course, of the U.S. And two major drivers appear to be at play: First, the desire of other governments to enhance the protections afforded their people in a manner that reflects and is harmonized with the “best practices” emerging from the EU. And second, a fear that, if they don’t do so, they may well become the recipient of chemicals and chemical products that can’t be sold elsewhere because they don’t meet increasingly global chemical safety standards.
Meanwhile, here at home, Nero continues to fiddle.