ALTANA

It is not only important to our customers that our additives exactly fit their applications. They also want to be sure that our specialty chemicals comply with the various regulatory requirements of the different markets in relevant countries. Megan McCutcheon has the necessary solid expertise. She is part of the BYK International Regulatory Service Team. This team is well prepared to continually adapt to meet new challenges.

ONE ADDITIVE CAN BE USED IN ACCORDANCE WITH DIFFERENT REGULATORY REQUIREMENTS AND SAFETY GUIDELINES AROUND THE WOLRD: BYK OFFERS ITS CUSTOMERS THIS COMPETITIVE EDGE.

National and International Regulations
Does the additive contain volatile organic compounds (VOCs) or other critical substances? Does it meet the requirements of the international Globally Harmonized System (GHS)? Can it be used in toys or in contact with foodstuffs? Hundreds of such questions reach BYK USA every month.

Questions are asked by purchasing agents, specialists from our customers’ research departments, or by experts who oversee customers’ regulatory product documentation, says Megan McCutcheon. As Manager Regulatory Affairs, she coordinates a four-member team based at BYK’s U.S. site in Wallingford that informs customers in the NAFTA region about the additive’s status under relevant safety, health, and environmental protection regulations. Many of the questions the team in Wallingford receives concern laws and regional regulations that are valid in the U.S., Canada, and Mexico.

BRIEF Document for Each Additive

“Some of these questions can be answered quickly,” says the manager. “For example, we send these customers the appropriate BRIEF document.” BRIEF is an abbreviation for BYK Regulatory Information Extended Form, a document that is compiled for each additive. It contains relevant regulatory data. For example, it provides information about whether an additive contains VOCs and in which National Chemical Inventories it is listed.

Other questions are more complex. “Then we may need to compile a small dossier containing specialist literature or studies in which the background is explained in more depth, or even contact external experts,” explains McCutcheon.

Global customers need details on European or Asian legislation. If need be, McCutcheon clarifies these issues with the help of her colleagues in Germany, China, Japan, or Korea who are experts on such regional regulatory matters. “All in all, our service gives us a significant competitive edge,” McCutcheon says confidently. “Our customers know they can use one additive at different sites in different regions without regulatory risks, and in turn can offer customers around the globe the same product.”

Sustainable Product Planning
The global Regulatory Service Team’s work is facilitated by the sustainable approach BYK takes to develop and manage its portfolio. At the beginning of product development, the researcher ensures that no critical substances are used. Once the formulation has been established, BYK registers the new product in all relevant countries worldwide in accordance with the respective national or industry regulations, including the Toxic Substances Control Act (TSCA) in the U.S. or the Canadian Domestic Substance List (DSL).

Moreover, the experts on the Regulatory Service Team maintain contact with associations, networks, and authorities in their regions. As a result, they can adapt to new legal developments at an early stage. Megan McCutcheon has observed that such legislative procedures have been spawned increasingly by supranational developments. “The trend toward internationally harmonized guidelines is growing,” she says. “And we are well positioned here too.”

Megan McCutcheon is a biologist and also holds a master’s degree in environmental law. She has worked for BYK USA for almost 30 years. While at first her primary area of responsibility was environmental protection, over the years she has taken on additional tasks revolving around health and occupational safety, and today, among other things, she is an expert on regulatory requirements.

She is convinced that changes are part of life. It is critical to be open to change, she believes, in order to shape it.