Reach-like regulations enacted globally
THE EU’s Reach chemical legislation may attract the most attention, but other regions have also been busily establishing or strengthening their own programs for the regulation of chemicals, including Canada, the US, Japan, Taiwan, China, Turkey and Switzerland. How do they compare?
The Chemical Substances Control Law (CSCL) of 1973 was amended in May 2009 to minimize adverse effects of chemicals and ensure consistency the Global Harmonized System of Classification and Labeling of Chemicals (GHS) established by the 2002 World Summit for Sustainable Development (WSSD ) and the 2006 Strategic Approach to International Chemicals Management (SAICM ).
The new system covers all industrial chemicals. It includes a move from hazard- to risk-based management and risk assessment, partnership between government and manufacturers and importers, and development of a priority list for precise risk assessment. Annual amounts must be reported with use and exposure each year.
For existing chemicals, a three-stage approach is planned: risk characterization; primary risk assessment; and precise risk assessment. The Japanese government will do both risk characterization assessment. Manufacturers and importers will be encouraged to work with the government, which will gather hazard and use/exposure information from them under a mandatory system. Government will also request information from downstream users.
Comparison with Reach: The amendment aims for some similarities to Reach. However, the mechanism of the risk evaluation is different, in that the government gradually evaluates the risk and requests appropriate management by manufacturers and importers according to the risk in CSCL.
Switzerland has decided to move toward Reach implementation. The partial revision of the Swiss Chemicals Ordinance (ChemO, RS 813.11) came into force on February 1, 2009. It adopts Reach-like registration requirements, but only new substances placed on the Swiss market in quantities over 1m tonnes/year.
Comparison with Reach: ChemO is closely aligned to the Reach regulation, but there are differences. For example, it is still essentially a pre-marketing program. However, as revisions continue, further elements of Reach are likely to be adopted.
When Reach came into effect on June 1, 2007, it replaced roughly 40 different regulatory programs with a single set of rules for the management of chemicals in the EU.
Reach changed the nature of chemical regulation by asking industry to demonstrate the safety of chemical manufacturing and use. Compliance requires manufacturers and importers to go through a registration (notification) process with deadlines determined by volume and hazard. The process is tiered between “old” (phase-in) and “new” (non phase-in) chemicals. Registration is made following a process of sharing and generating information among all the parties notifying for a same substance.
The new Chemicals Management Regulation in Turkey might be a bridge to the adoption of Reach, planned for 2013. The initial aim is an inventory improving market visibility.
Often referred to as the by-law, the regulation updates the 1983 Environmental Law and the 2003 Law on Establishment and Duties of Ministry of Environment and Forestry. It was enforced in December 2008. The by-law was amended in November 2009.
The Inventory targets certain substances imported or manufactured in Turkey. There is a list of exempt substances. For in-scope substances first manufactured or imported after December 26, 2008, reporting is required within the two months after the start date.
The inventory phase is in line with a data reporting project, which covers substances in two volume bands (1-1,000 tonnes/year and more than 1,000 tonnes/year).
Comparison with Reach: Coverage of all substances at 1 tonne is similar to Reach, but the focus is on submission of data in the nominator’s possession. Industry is responsible for providing and filling in the data, similar to Reach, but the authority keeps control. There is no data sharing, but group submission is allowed. The entire process is purely substance-driven.
Canada aims to review existing chemicals, to prioritize them for action, and to develop controls and risk-management plans for high-priority chemicals.
The system is based on an inventory update (initiated October 3, 2009) and categorization of chemicals resulting in a Chemicals Management Plan (CMP) that restricts and/or phases out substances. After rapidly screening about 23,000 substances, the vast majority were set aside as not requiring further effort. Based on human and environmental effects, 4,300 were deemed to require additional review and subdivided into high, medium, and low priority.
Initial data-gathering is almost complete. Industry must now review the screening assessment reports and provide input into proposed risk-management scope documents. The outcome of the risk assessment could determine the course of actions such as Risk Management Measures. In cases of indeterminate toxicity, the substance will be added to the Priority Substances List for further evaluation. Current plans are to have the survey efforts and screening assessments completed for all 2,600 medium-priority substances by 2020.
Comparison with Reach: The inventory leads to categorization and prioritized assessment of existing substances that need further evaluation. Industry should supply information for high-priority “batches” of chemicals. However, the new-chemical notification program remains unchanged.
In April 2009, Taiwan announced the draft Guidelines for Existing Chemical Substance Nomination (ECN) and New Chemical Notification (NCN).
The regulation is intended to compile an inventory of existing substances that have been manufactured or imported; establish a new chemical notification program; implement and strengthen GHS introduction and ensure consistency and compliance.
If a hazard and risk assessment report has not been submitted or the registration is not approved, the import, manufacture, disposal, use or selling of substances not listed in the Existing Chemical Substances inventory will be prohibited. Exemptions would apply for substances similar to those exempted in ECN as mentioned earlier. Substances restricted in other regulations and those manufactured or imported under 10kgs/year would also be exempt.
Comparison with Reach: This is an authority-driven process aimed at GHS compliance.
Chemical management in China has moved toward a more rational and coherent system in compliance with and supporting GHS.
In May 2009, China’s Ministry of Environmental Protection (MEP) proposed amending the “Measures for the Environmental Administration of New Chemical Substances” of 2003. The details for notification will come with the Implementation Guidelines of the revision, which are still under development.
The New Chemical Substance Management distinguishes between General Chemical Substances that are not hazardous, Dangerous Chemical Substances that are, and Concerned Chemical Substances using GHS criteria. Notification testing is volume based, but risk assessment has been introduced.
Comparison with Reach: The updated law is still an authority-driven process with the emphasis almost exclusively on new chemicals and their notification program.
The major piece of chemical control legislation in the US is the Toxic Substance Control Act (TSCA), which is more than 30 years old.
On September 29, 2009, the US Environmental Protection Agency (EPA) announced the release of a set of “Essential Principles for Reform of Chemicals Management Legislation.” The principles express support for measures to prioritize chemicals in commerce and a risk-based, science-justified safety assessment for priority chemicals.
On April 15, S.3209, the “Safe Chemicals Act of 2010,” was proposed in the US Senate and a discussion draft was circulated in the House of Representatives. It appears unlikely that the proposals will be approved in this session of Congress.
Comparison with Reach: There are similarities, including expanded data and information requirements and enhanced transparency elements. Differences include a process for safety decisions on all chemical substances and mixtures, and a standard for safety determinations, which relies on aggregate and cumulative exposure assessments.
The EPA has also initiated its Enhanced Chemical Management Program, which relies on its existing authority.
Sunanda Banerjee is responsible for communications product stewardship and a manager for Global Emerging Regulations at Cefic.
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