Revolutionary Chemical Regulations Celebrate Milestone


Speakers from the chemical industry, governments and organizations shared minds and viewpoints at the Helsinki Chemicals Forum.

Celebrating the 10th anniversary of the REACH regulations, keynote speakers and panelists at the recent Helsinki Chemicals Forum (HCF) examined what the chemicals legislation has accomplished so far.

The REACH regulations have two main goals. The overriding aim is to protect human health and the environment by identifying chemical substances and regulating them through a four-part process of registration, evaluation, authorization and restriction. The second goal is to spur innovation and competitiveness in the European Union’s chemicals industry.

So far, over 11,500 companies have complied with the legislation with over 60,000 registrations.

When it was enacted, “the REACH regulation was revolutionary in worldwide chemicals policy,” said Geert Dancet, ECHA’s Executive Director, in a keynote address at HCF. “Before REACH, the responsibility was with the regulators to prove that a substance was dangerous – a situation that resulted in approximately 140 existing substances being regulated over 14 years.

“After REACH, the burden of proof is now with the companies who make chemicals,” he added. “They have to register their chemicals, documenting their hazards, the likely levels of exposure and the purposes for which they are used. And companies also need to demonstrate how they can be used safely.

“The evidence shows that it has not been easy, but it is being achieved.”

Challenges are still ahead. Bjorn Hansen, unit head with the European Commission, noted that many dossiers are still not compliant, and testing has proved to be very difficult due to animal protection provisions in REACH. Alternative test methods are being developed, but have taken much longer than originally anticipated. And because of the incomplete dossiers, few substances of very high concern have as yet been identified.

Jan Wijmenga, with The Netherlands government’s ministry of infrastructure and environment, said that although more focus is needed on new substances such as nanomaterials, REACH has been successful so far in making more data available on substances. Looking down the road, he said REACH needs to be connected with other legislation, such as that related to occupational health and safety, waste and water, in order to support the development of the circular economy.

Andrea Paetz, Director of Regulatory Policy with Bayer AG, says that REACH has addressed many of the weaknesses of previous legislation, although its switch in burden of proof was very new to the chemical industry. So far, from the industry perspective, under REACH, data collection is more systematic and the fact that the regulations apply uniformly throughout the EU is very positive. Challenges for industry, particularly SMEs, include the amount of work in collecting data, making updates, and improving dossiers.

Environment Canada’s Jake Sanderson, provided an interesting perspective on the impact of REACH on government policy outside the EU. He said that in 2006, Canada’s existing hazardous chemicals program had reviewed a total of 69 substances over 10 years – a very slow process. Staff looked at REACH as it was being introduced, and watched how it was received by industry in Europe. In addition, they also considered the legislation across the border in the United States. Readiness and political will came together, and Canada’s new Chemicals Management Plan was launched in December 2006. Sanderson said that key priority areas included having a government-wide approach, targeting chemicals of higher concern, having transparent, predictable timetables, integrating research and monitoring programs to align with the priorities, looking at international collaborations, and enhanced engagement with various groups through the supply chain. As a result, 2,800 assessments were completed in 10 years, 370 substances were found to be harmful and 80 risk management plans were created. Next steps, beyond 2020, include more cross-cutting issues, such as pharmaceuticals in the environment.

Looking down the road beyond REACH’s first 10 years, the panel members agreed that it would be ideal to be able to share information internationally by using existing facilities and tools that have already been developed.

Posted by Leslie Burt

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