REACH Revisited, Part 2: Lessons from Canada and Japan

This is the second in a short series of articles on REACH’s registration and data-gathering requirement.

In Part 1, we explored REACH and the costly, cumbersome nature of its chemical registration process, which WTO members argued was overly restrictive to international trade. Here we look at the chemical regulatory frameworks of Canada and Japan as feasible alternatives to the EU’s REACH. The final article in the series asks whether a less restrictive option deserves serious consideration.

Canada: CEPA 1999 and the Chemicals Management Plan

The Canadian Environmental Protection Act, 1999 (“CEPA 1999”) was put in place primarily “to contribute to sustainable development through pollution prevention. It provides the legislative basis for a range of federal environmental and health protection programs.” CEPA 1999 informs the prioritization processes of Canada’s Chemicals Management Plan (“CMP”). The Government of Canada summarizes CEPA’s chemical assessment process (as carried out through the CMP) as follows:

Under the purview of the Minister of Health and the Minister of the Environment, scientists assess existing substances that are in commerce in Canada … and new substances not yet on the Canadian market … to determine whether these substances present or may present a risk to the environment or to human health. Decisions are based on a scientific evaluation of the risk posed by a substance, which considers both the hazardous properties of the substance (such as toxicity to aquatic organisms or cancer-causing properties) and the nature and extent of the exposure of Canadians or the environment to the substance. This allows the Government of Canada to determine whether a risk management measure is needed, and if so, what type of control is best suited for reducing or preventing the potential harm.

Hazard Versus Risk

Herein lies a key difference between REACH and the CMP: REACH functions on hazard analysis, while the CMP functions on risk analysis. As we discussed in Part 1, this focus on hazard over risk is a significant obstacle in REACH’s registration and data-gathering requirement.

REACH places the burden of data gathering on industry, and its hazard-focused process expands the scope of pre-registration research to the point of redundancy. The CMP, on the other hand, focuses on scientific risk assessment and has developed a Rapid Screening Approach in which resources are invested only in investigating and managing substances that are actually likely to cause harm. This addresses the costly and cumbersome elements of REACH that WTO members were struggling with.

Consider an example. In 2007, of the more than 1,000 substances evaluated through Canada’s Rapid Screening Approach, only about 30% were considered risky enough to require any kind of additional assessment, let alone management requirements or outright prohibition. Under REACH, the remaining 70%, representing chemicals considered relatively benign, would have required the same attention and resources. “Redundant” would be the friendly way of putting it; “useless” is more appropriate.

Sharing Information

The CMP has another edge over REACH in its mechanisms for sharing up-to-date information on chemicals and their management. For both industry and the public, relevant information is readily available through the Canadian government’s Chemical Substances, CEPA Environmental Registry, and Chemicals Management Plan websites. With searchable and downloadable lists, relevant content is more easily accessed, shared, and understood. A system like this not only facilitates research; it would also ease the workload of EU institutions that are overwhelmed with questions from confused stakeholders.

Japan: Kashinho

Japan’s chemical management strategy is another that, at least on paper, is much more efficient than REACH. Enacted in 1973, the Act on the Evaluation of Chemical Substances and Regulation of Their Manufacture, or the Chemical Substance Control Law, is more commonly known as “Kashinho.” In its early years, Kashinho operated much like REACH, relying on hazard-based assessment of chemical substances. As we have seen, that approach can be costly and cumbersome, and a 2009 amendment began Japan’s two-year transition to a risk-based chemical assessment policy. As with the CMP, this policy establishes a prioritization filter for the assessment of chemical substances that avoids potentially redundant research and registration work. As Kogan explains:

[T]he Amended Kashinho imposes a significantly lower informational and testing burden on manufacturers and importers than does the EUREACH … . This lower burden is attributable in part to the relatively lower responsibility imposed on Japanese industry to generate information with respect to chemical substances. REACH obliges European industry to provide better information, including risk assessments, as a precondition to entering the market, per the “no data, no market” rule of REACH Article 5. The Amended Kashinho, by contrast, sets forth a prioritization approach pursuant to which government remains responsible for demanding additional data from industry concerning prioritized substances.

So Why Not Switch?

It seems clear at this point that the CMP and Kashinho both offer examples of a much more efficient data-gathering and registration process than the one REACH stipulates. The answer to the WTO members’ original complaints of “too cumbersome” and “too costly” appears to be a risk-based assessment strategy, which fosters a more stratified approach to resource allocation, combined with a straightforward system for making up-to-date information readily available.

So why not simply adopt such an alternative? That is the subject of the final article in this series, in which we consider the potential risks of a less restrictive approach and explore possibilities for the future of REACH. Back to Part 1: Registration Burden, or continue to Part 3.