Interview with Teresa Bernheim, Expert on chemical policy, COM GF. 

“REACH is becoming increasingly stringent”

Twenty years ago, the EU’s REACH chemicals regulation was introduced with the goals of enhancing safety for people and the environment, establishing uniform rules in the single market, and fostering a strong European chemical industry. Today, the question is: Which expectations has it met—and in what areas does it fall short of its own standards?

What are the origins of REACH?
Teresa Bernheim: The introduction of this EU chemicals regulation was marked by considerable uncertainty. For the first time, companies were required to register their chemical substances, collect extensive data, and coordinate with competitors—in accordance with the “one substance, one registration” principle. While this has reduced duplicate animal testing, it has also led to conflicts, such as over the allocation of costs for expensive studies. At the same time, the regulation was also uncharted territory for the authorities. This led to a pragmatic “learning by doing” phase characterized by close collaboration between industry and government.

And how do things stand today?
Today, REACH is significantly more stringent and more complex. The requirements relating to data and evaluations have increased, and many provisions have been more precisely defined or tightened over time. At the same time, the focus of regulation has shifted—instead of considering individual substances in isolation, the focus is increasingly on entire groups of substances. A current example is PFAS, a large group of extremely persistent chemicals that accumulate in the environment and in living organisms. This shows how dynamically REACH has evolved—from a new set of regulations to a central, constantly evolving instrument used to steer chemicals policy.
 
Which LANXESS products were affected, and how did we respond?
REACH generally applies to all substances that LANXESS places on the market in the EU in relevant quantities—in accordance with the “no data, no market” principle. Without sufficient data and registration, we aren’t permitted to distribute the products. Regulation has a correspondingly significant impact on our product portfolio. This is particularly evident in the case of substances classified as hazardous. For example, LANXESS has completely removed the flame retardant HBCD from its product portfolio because it is considered harmful to the environment and human health. At the same time, we developed Emerald Innovation® 3000, an alternative that performs the same function but has an improved sustainability profile.

Another example is phthalate plasticizers such as DBP and DIBP. After these were classified as substances of very high concern, LANXESS systematically discontinued their production. This wasn’t a matter of finding substitutes within its own product portfolio, but rather a clear phase-out.

Does LANXESS develop alternatives?
Absolutely. We place a strong emphasis on targeted substitution. The tire additive 6PPD is currently under scrutiny, in part because of its potential environmental impact. Vulkanox® 4060 was developed early on as an alternative that offers a safer profile.
These examples illustrate our basic approach: LANXESS systematically evaluates hazardous substances and then decides whether to replace them, make them safer, or phase them out of its portfolio—taking future regulatory developments into account as well.

What does the future hold? 
The EU currently has no plans for a fundamental overhaul of REACH. Instead, the Union is continuing to refine the existing regulatory framework in a targeted manner, primarily through amendments to the so-called technical annexes. These annexes specify in detail what data companies must provide and how substances must be tested and evaluated. If these requirements are changed, it will have a direct impact on real-world business activities—companies will, for example, have to conduct additional studies or provide new data on environmental and health impacts, even if the actual text of the law remains unchanged.

Have the requirements changed?
In terms of regulatory content, it is foreseeable that the pressure will tend to increase. Regulatory agencies are constantly working on new restrictions, and the trend toward regulating entire groups of substances further reinforces this development. For companies, this means continuously reviewing their substances, keeping registrations up to date, and working on alternatives early on.
One particularly critical issue here is competition—European companies invest a great deal of time and money to comply with the strict REACH requirements. At the same time, imported products that do not meet these requirements—and in some cases even contain banned chemicals—continue to enter the EU market. Since these products are often cheaper, this creates a clear competitive disadvantage for manufacturers who comply with the rules, while also posing a risk to consumers and the environment. Consequently, pressure is mounting to significantly tighten import controls.