Worldwide Regulation
Chemical Regulation Around the World
Our current approach to the management of chemicals has led to unacceptable impacts to human health and the planet’s environment. International, national, regional and local governments are making efforts to shift to a more comprehensive approach to managing industrial chemicals. Some industries and companies are also taking the lead.
Chemical Regulation in Other Countries
Countries around the world have chemical regulations that require public disclosure on the safety of chemicals and require substitution with a safer alternative if one is available.
The European Union’s REACH Regulation
In 2007, the European Union’s regulation on chemicals and their safe use, the Registration, Evaluation, Authorisation and Restriction of Chemical substances (REACH) entered into force. REACH shifted the burden of proof of safety of chemicals from government to chemical manufacturers. Under REACH, manufacturers and importers of chemicals are required to gather information on the chemical properties of their substances and submit the information to the European Chemicals Agency (ECHA). This chemical information will be publically available and accessible to consumers and other downstream chemical users. Significantly, REACH calls for the substitution of the most dangerous chemicals when suitable alternatives have been identified.
China REACH
In June of 2010, the Ministry of Environmental Protection in China adopted the Provisions on Environmental Regulations of New Chemical Substances, replacing a previous regulation from 2003. The 2010 regulations are similar to the EU’s REACH and are known as “China REACH”.
Canada’s Domestic Substances List
The Canadian Environmental Protection Act (CEPA) that came into force in 1999 required the government to categorize all existing chemicals in Canada and catalog them into an inventory, the Domestic Substances List. Chemicals on the list would then be assessed for their potential to be toxic to either human health or the environment. Canada completed the inventory of approximately 23,000 chemicals in 2006. Canada subsequently developed a Chemicals Management Plan for approximately 200 chemicals, a little more than half (129 chemicals) of which were selected for potential environmental impacts. The 200 high priority chemicals are being assessed in batches of 15 to 30 chemicals, with industry required to provide information on their import, use and manufacture.
US: Frank R. Lautenberg Chemical Safety for the 21st Century Act which amends the Reformed Toxic Substances Control Act
The Toxic Substances Control Act (TSCA) is the primary vehicle for enabling the government to review most chemicals, other than foods, drugs, cosmetics and pesticides, before they are introduced into commerce. TSCA was updated in June, 2016 when the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) was signed into law.
The Lautenberg Act is written for lawyers and regulatory affairs specialists who need to understand the details of the law and know what regulations and guidances have been issued and proposed. It includes new regulations issued by the EPA to meet statutory deadlines, such as on risk prioritization and risk assessment, the core elements of the reformed TSCA. There is also in-depth coverage of state chemical regulation laws, and helpful guidance including model procedures for incorporating TSCA requirements into daily operations, a model training program for TSCA as reformed by the Lautenberg Act, and practice pointers.
The new law, which received bipartisan support in both the U.S. House of Representatives and the Senate, includes much needed improvements such as:
Mandatory requirement for EPA to evaluate existing chemicals with clear and enforceable deadlines
Risk-based chemical assessments
Increased public transparency for chemical information
Consistent source of funding for EPA to carry out the responsibilities under the new law.
State Efforts: Maine, Washington, California
In the continuing absence of meaningful reform of the federal Toxic Substances Control Act, many states are considering legislation focused on toxic chemicals (see map below.) Maine, Washington and California have passed comprehensive chemicals policy bills; Maine and Washington’s bills cover chemicals of concern specifically in children’s products. California’s draft Safer Consumer Product regulations cover all consumer products, and will require companies to assess safer alternatives if their product is identified as containing a chemical of concern. California’s regulations identify workers as a potential population of concern for exposure when considering alternatives.
Chemical Conventions
A series of conventions, or international agreements, address specific chemical issues, including the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and their Disposal (1989), the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides (1998) and the Stockholm Convention on Persistent Organic Pollutants (2001). The Basel, Rotterdam and Stockholm Conventions and SAICM are all hosted by the United Nations Environment Program (UNEP).
Other Global Chemical Efforts
The World Health Organization has convened the Intergovernmental Forum on Chemical Safety (IFCS) as a mechanism to implement chemical safety, which they define as “the prevention of the adverse effects, both short- and long-term, to humans and the environment from the production, storage, transportation, use and disposal of chemicals.” The IFCS contributes to the implementation of other non-binding international agreements, such as the Strategic Approach to International Chemicals Management (SAICM), hosted by the United Nations Environmental Program (UNEP) which was created to create a policy framework to meet the WSSD Generational Goal described above.
What is the Comprehensive Chemicals Policy?
The Lowell Institute for Sustainable Production at the University of Massachusetts at Lowell describes comprehensive chemicals policy as “a holistic approach that is integrated and prevention-oriented, ensuring protection of workers, communities, and consumer health while stimulating the development and use of non-hazardous and sustainable chemicals in production systems, materials, and products.”
The 2002 World Summit on Sustainable Development (WSSD) created a Generational Goal that says that nations should "Renew the commitment, aiming to achieve, by 2020, that chemicals are used and produced in ways that lead to the minimization of significant adverse effects on human health and the environment, which says that threats posed by toxic chemicals should be eliminated within one generation."