Paradigm Shift - Europe's chemical industry is working hard to implement Reach, and the first phase of registration will draw to a close at the end of November. Despite this deadline, globally active companies cannot afford to lose sight of the fact that numerous other jurisdictions are currently making changes to pertinent legislation, too.

While established industrial nations such as Switzerland, Japan, Canada and the U.S. have already decided on their own strategies, regulations are now also appearing in a number of emerging markets that are of great importance to the European chemical industry, including Turkey, China and Malaysia.

Establishing Strategies

Regardless of their current implementation status, all these reforms involve considerable increases in cost and complexity. As a result, the industrial and trade companies affected consider themselves to be increasingly restricted in their areas of activity, particularly as these regulations generally go hand-in-hand with a paradigm shift in the evaluation of existing chemicals. Although this change has far-reaching consequences for the marketability of product portfolios, obliging providers to make major adjustments to their business processes, many of those in positions of responsibility have still not made adequate provision for the new time frames involved. Depending on the organization of the specific company, it will be either logistics or technical marketing teams that will have to deal with the changes initially.

In many cases, it is important to recognize that registrations and notifications can no longer rest solely on the hazard-based evaluation of chemicals. Instead, companies are required to introduce risk-based assessments that can be used to describe and evaluate the uses and exposure scenarios of their products. As manufacturers and importers will have to document exactly where and how a specific chemical may be used from now on, they are defining a set of risk exposure scenarios that naturally restricts the marketability of such chemicals.

To safeguard their access to the market, companies must therefore establish strategies that make it possible to incorporate new uses promptly. In particular, this relies on integrating sales teams into the task of researching potential uses by customers. What's more, operational conditions must, from the very outset, be described in such a way that new regulations can be integrated into product safety with as little additional outlay as possible. This requires a company-wide management solution that supports a standardized process framework and central data storage.

Driving Development

The wave of regulatory changes sweeping the globe has by no means come unannounced. To a large extent, these were initiated by the Strategic Approach to International Chemical Management (SAICM), itself rooted in rulings made at the World Summit on Sustainable Development in Johannesburg in 2002. As a policy framework to foster the sound management of chemicals, SAICM calls on countries to implement regulations by 2020 to minimize the negative impact chemicals have on the environment and human health. With the EU leading the way in terms of implementation, an increasing number of non-EU governments are now also launching efforts to introduce corresponding legislation.

This trend is being driven by one voluntary industry initiative in particular - the Global Product Strategy (GPS) of the International Council of Chemical Associations (ICCA). In essence, this is a guideline that can be used to communicate the risks associated with the production, use and disposal of chemicals. The Global Product Strategy is seen to contribute to SAICM, making it possible to achieve standardized evaluation of chemicals along the entire value added chain. GPS is helping to define safe use conditions for chemicals and providing guidance to companies to help them meet these conditions. By doing so, the initiative improves product stewardship cooperation with downstream customers.

Common Features of the Regulations

In practice, international companies find themselves facing a network of regulations that have common features and differences in equal measure. All jurisdictions take a similar line when it comes to the core work of registration, and each company importing to or manufacturing in these countries has to notify the import prior to the first import or within a certain time frame. All regulations require companies to track annual quantities of substance volumes, and the applicable thresholds vary. Data requests are generally similar to Reach. The task of filling any gaps identified in the data will be coordinated by the government or a competent authority. The evaluation of risk profiles and provision of the required legal response will be handled by public authorities, too.
No specific type of organization is required at enterprise level.

However, it is likely that a consortia-style structure will be considered, at least for funding the costs associated with testing. As it stands, there are no plans for data sharing or establishing a Substance Information Exchange Forum (SIEF)-type organization. However, supply chain communication is becoming increasingly important. More than ever before, international companies must develop a type of "radar" that, when new regulations emerge, will tell them exactly which areas of their portfolio are affected and what information is required from the supply chain in order to ensure the new requirements are implemented successfully. 

Switzerland
Switzerland is of strategic importance to numerous EU companies as a chemicals location. Reciprocal relationships generate intensive trade links. A comparatively complex regulation was brought into force in February 2009 in the form of the Swiss Chemical Ordinance (ChemO). There are different intervention levels for different substances. In addition, ChemO is based on a complex quantity regulation that requires the companies affected to adapt their substance volume tracking accordingly. As the notification process draws on the approach taken by the EU, the regulation permits partial usage of Reach data. Companies can use the OECD template for the purposes of harmonized data capture.

Turkey
Over the last ten years, Turkey has developed into a key European chemicals location. Numerous EU companies have established bases there, particularly for mass production. The Turkish government is currently working to align its chemical regulation with EU law in order to reduce the barriers leading to the country's entry into the Union, and to avoid the need for a new legislation. The original schedule has been postponed. Although registration was due to begin at the start of July, work to build up a chemicals inventory detailing existing and imported substances is still continuing. The entire registration process will be conducted exclusively in the Turkish language. Turkey plans to make a web-supported tool (HEDSET) available for notification purposes.

U.S.
A reform of the Toxic Substance Control Act (TSCA) is pending in the U.S. Overall, TSCA is starting to focus more intensively on creating substance groups based on specific criteria and working with industry representatives to develop corresponding risk management plans. Alongside TSCA, the California Green Chemistry Initiative is also attracting increasing attention. While TCSA regulates the substance sector, the California Green Chemistry Initiative operates at product level. Other U.S. states are working to develop similar regulations. In order to avoid a complex patchwork of different product regulations, it is in the interests of the industries affected that the Californian initiative is adopted on a nation-wide basis.