California’s Proposition 65 is usually one of the first topics when the subject of chemical regulations in the US comes up. Prop 65, or the Safe Drinking Water and Toxic Enforcement Act of 1986, its formal title, was approved by California voters in November 1986. Its stated goal, according to The Office of Environmental Health Hazard Assessment (OEHHA) website, is as follows:
 
“The proposition protects the state's drinking water sources from being contaminated with chemicals known to cause cancer, birth defects or other reproductive harm, and requires businesses to inform Californians about exposures to such chemicals. Proposition 65 requires the state to maintain and update a list of chemicals known to the state to cause cancer or reproductive toxicity."
 
OEHHA’s stated mission is to protect the health of Californians. This, of course, is a reasonable goal, and ink manufacturers have eliminated many ingredients from ink formulations over the years.

“The original intent of Proposition 65 was for chemical manufacturers to replace carcinogens and reproductive toxic materials with safer ingredients,” said Duane Ness, director of EHS and regulatory compliance for INX International Ink Co. “That is still a valid goal for chemical manufacturers.”
 
“The ink industry is continuously developing new technologies designed to be safer and to provide better performance,” Michael Gould of Rahn, RadTech North America’s EHS chair, noted.
 
However, Prop 65 has become increasingly controversial over the years, as more chemicals have been added to the list. Understandably, chemical-like asbestos and lead are labeled. So are more common items, like alcohol and aspirin. These chemicals require warning labels, and lawyers actively look for cases involving chemicals to bring to the courts.
 
“Proposition 65 is a legal and regulatory compliance nightmare, and a wealth generator for trial lawyers and bounty hunter organizations,” said David Wawer, executive director, Color Pigments Manufacturers Association, Inc. (CPMA). “In other words, lawsuit heaven.”
 
The addition of new chemicals is a source of concern for the ink industry and suppliers.
 
“CALEPA and OEHHA continue to use less common sense and little scientific rationale in their regulatory processes,” said Wawer. “Not sure how Proposition 65 can get worse than it already is. Companies, for the most part, have adapted to the irrational regulatory activities that these agencies tend to generate.”
 
To avoid litigation, more and more companies are adopting Proposition 65 as an exclusion list for ingredients. How should the ink industry prepare for further Proposition 65 issues?
 
“Prop 65, since the outset, has been a very difficult compliance issue for ink manufacturers,” said George Fuchs, director, regulatory affairs and technology for the National Association of Printing Ink Manufacturers (NAPIM). “The absence of a de minimis level and difficult and expensive tests to demonstrate no significant risk levels continue to this day to be very problematic.”
 
“The listing of a chemical on Proposition 65 would essentially have the same impact to a multinational company as an SVHC listing,” Gould said. ‘Any type of “negative’ list ultimately yields exclusion. Unfortunately, there are substantial barriers to innovation when considering the regulatory costs (time and money) for a new chemical registration. These greater costs must be factored into a company’s budget as well as their strategic planning.”
 
“In recent years, the number of CPGs have specified in their certificates of compliance (CoC) the non-use of any Prop 65 substances,” Fuchs added. “This has renewed the focus on Prop 65. Ink manufacturers should be screening their input raw materials for Prop 65 substances and be prepared to substitute alternate raw materials where possible.”