Chemical Regulation

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The framework represents China’s first comprehensive regulation of environmental risks from chemical substances.

By Paul A. Davies and R. Andrew Westgate

The Chinese Ministry of Ecology and Environment’s (MEE’s) draft Regulation on Environmental Risk Assessment and Control of Chemical Substances (Regulation) is likely to have broad implications for companies that manufacture, process, import, or export more than 100kg of any chemical substance in China. The framework represents China’s first comprehensive regulation of environmental risks from chemical substances.

Companies should be aware of MEE’s action plan for enforcing the Regulation, as well as those provisions that will impact their business activities.

China’s MEE is seeking comment on new chemical regulation framework, which includes a comprehensive environmental risk assessment.

Paul A. Davies, Ethan Prall, and R. Andrew Westgate

In January 2019, China’s Ministry of Ecology and Environment (MEE) issued a draft Regulation on Environmental Risk Assessment, and Control of Chemical Substances (the Chemical Substances Regulation or CSR) in conjunction with 20 other ministries and agencies, including the Supreme People’s Court, the National Development and Reform Commission, and the Ministry of Commerce. MEE is seeking comment on the draft regulation through February 20, 2019, which is available in Chinese only.

This draft regulation is significant because it represents China’s first comprehensive regulation of environmental risks from chemical substances, similar to the Toxic Substances Control Act in the United States or the Registration, Evaluation, Authorization, and Restriction of Chemicals Regulation (REACH) in the European Union. In the past, China’s chemical regulations, such as Order 7 issued by the former Ministry of Environmental Protection (also known as China REACH), have been more narrowly focused on requiring the registration of “new chemical substances” and on the import and export of toxic chemicals. As discussed below, the draft CSR incorporates not only most of the existing chemical registration requirements under Order 7, but would also introduce additional requirements creating a broader new chemical regulation framework.

Waste producers must comply with new criteria and procedures for objects and products to benefit from end of waste status.

By Paul Davies

The French government has developed many measures to foster circular economy approaches. Most recently, a Ministerial Order of 11 December 2018 (Order) sets out criteria and procedures to end the waste status of certain objects and chemical products, to encourage their preparation for re-use.

The French Code of the Environment[i] defines “preparing for re-use” as “checking, cleaning or repairing recovery operations, by which products or components of products that have become waste are prepared so that they can be re-used without any other pre-processing.”

The Order requires that the objects and products meet specific criteria in order to benefit from the end of waste status. The criteria relate to:

  • The nature of the object or product
  • Techniques and treatment processes
  • Qualities and properties of objects and products resulting from such treatments
  • Contractual conditions subject to which such objects and products will be sold
  • Operator’s obligations in relation thereto (traceability)

The new department will assume broad oversight responsibilities as part of a broader government restructuring.

By Paul A. Davies and R. Andrew Westgate

China’s Ministry of Emergency Management (MEM) has announced the establishment of a new department responsible for the safety, supervision, and management of hazardous chemicals. The MEM replaced the former State Administration of Work Safety (SAWS), and took over responsibility for product safety relating to fireworks, pharmaceuticals, and the chemical industry.

The creation of the new department reflects increasing focus on chemical safety after the 2015 explosion at the Port of Tianjin, which killed 173 people and injured 797. More recently, an explosion at a chemical factory in the city of Yibin, Sichuan province in July killed 19 people. These incidents highlight that hazardous material storage remains a challenge in China.

Zhang Xingkai, the president of the China Academy of Safety Science and Technology noted that in the four years between 2011 and 2015, approximately US$89.4 billion was lost due to workplace accidents. The MEM was established in March 2018 in order to respond more effectively to crises like the Tianjin and Yibin explosions. With overall responsibility for safe chemical production and work environments, the MEM will provide a unified system focused on disaster prevention.

Significant English Supreme Court decision overturns High Court and Appeal Court ruling on personal injury compensation.

By Paul A. Davies and Michael D. Green

Three former employees of a chemical company appealed against the decisions of the High Court and the Court of Appeal that held they could not claim against their employer for damages for personal injury.

Johnson Matthey, the respondent employer, allegedly failed to properly clean the areas in which three of its employees worked and, as a result, they developed a sensitivity to platinum salts whilst working on the production of catalytic converters. Two of the men were dismissed on medical grounds and the other was given a lesser paid position as a result. The sensitivity was discovered after a routine skin prick test was carried out.

By Richard P. Bress, Philip J. Perry, Andrew D. Prins, Ryan Baasch and Alexandra Shechtel

On February 26, for the first time ever, a federal district court has enjoined a California Proposition 65 warning requirement on First Amendment grounds. Under California’s Safe Drinking Water and Toxic Enforcement Act of 1986 — colloquially known as “Proposition 65” — the State listed the herbicide glyphosate, the most widely used herbicide in the world, as a chemical “known” to the…

By Michael Green and Paul Davies

A coalition of medical and environmental groups has called upon the European Commission (EC) to propose specific legislation that will address pollution, in particular, by active pharmaceutical ingredients (APIs). This political development highlights the complex debate currently taking place over how to identify and address the effects of APIs.

An API is the biologically active component of a pharmaceutical drug. Other ingredients, known as “excipients”, are the inert substances present in a pharmaceutical drug. For example, if a product is in syrup form, the excipient is the liquid being used.

The coalition has raised the concern that APIs make their way into groundwater, rivers, lakes, oceans, and even drinking water after being disposed, with potentially harmful effects on the environment and human health. APIs are specifically designed to trigger a biological process (unlike most other chemical pollutants). As such, if APIs are present at significant-enough levels, biological processes in humans and/or animals may be unintentionally activated with potentially harmful effects. For example, some evidence suggests that the environmental presence of antibiotics contributes to developing antibiotic-resistant strains of bacteria, and that synthetic hormones found in contraceptive pills cause infertility in fish. Moreover, the effects on humans of inadvertent long-term exposure to low levels of APIs in drinking water, particularly given the potential for the presence and interaction of multiple APIs, are relatively unknown.

By Paul Davies and Michael Green

A new European Parliament briefing highlights the benefits of, and difficulties associated with, transitioning the chemicals industry to a circular economy.

The traditional economy typically involves purchasing and using a product, and then disposing that product when it no longer has utility (i.e. the “take-make-dispose” approach to resources). Conversely, a circular economy seeks to extend the life cycle of products by aiming to both extract and retain the maximum value of their component materials.

A greater emphasis on product re-use and mechanical recycling in the chemicals industry requires developing new solutions and manufacturing products intentionally designed for re-use. This presents a growth opportunity and a new source of competitiveness for European operators compared with raw material-rich regions, whilst providing the more obvious benefits of preserving increasingly scarce resources and injecting renewed value into waste products.

By Paul Davies and Michael Green

On 16 June 2017, the Member State Committee (MSC) of the ECHA unanimously agreed to identify BPA as a substance of very high concern (SVHC) under the REACH regime. BPA is common in a variety of household products, typically used in the manufacture of plastics and resins found in insulation, reusable containers and bottles, kettles, and DVDs. This identification follows the 2011 EU ban on BPA as an ingredient in babies’ bottles.

At the end of 2015, the European Commission (EC) proposed a roadmap — Proposal for a new measure on bisphenol A (BPA) in food contact materials — to harmonise BPA classification. Further, the British Plastics Federation (BPF) contributed to the Joint Value Chain Input to DG Health & Food Safety in support of option 3 of the roadmap, which proposed a decrease in the migration limit from 0.6mg/kg to 0.05mg/kg. This new Specific Migration Limit (SML) came into force in March 2016, and is applicable to plastics, coatings, and varnishes for metals and other food contact sources of BPA. In addition, in October 2016, the European Food Standards Agency (EFSA) published a review of two 2014 studies, concluding that “New data confirm EFSA’s previous conclusion that BPA might affect the immune system in animals but the evidence is too limited to draw any conclusions for human health.” As a result, EFSA stands by its original position of January 2015 that there is “no consumer health risk from BPA exposure at current exposure levels.” Some argue that, as BPA is one of the most researched chemicals in the industry, and as there are safety measures such as the new SML in place, both the public and the environment are adequately protected. The risk of BPA has also been extensively assessed within the areas of consumer, worker, and environmental safety to ensure that there is no health risk at current exposure levels.