Proposed changes to Proposition 65 labeling requirements can teach manufacturers an important lesson about preparing their programs to handle change. Assent’s Neil Smith explores what proactive compliance means and charts what the changes could mean to various industries.
For manufacturers operating within or distributing to California, compliance with the Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65, as it’s better known) is not just another box to check — it’s the price of admission. Failing to comply can result in significant legal fees and fines.
Proposed changes to short-form labels have reared their ugly head again following a rule-making lapse in 2022. This change would require that short-form warning labels identify at least one Proposition 65-listed chemical for each endpoint (i.e., cancer or reproductive harm), just like the long-form label format, regardless of package size.
Manufacturers in scope of Proposition 65 are once more wondering if and how they’ll be affected. When California’s Office of Environmental Health Hazard Assessment (OEHHA) enacts the proposed changes, it will directly impact labels, packaging and the compliance strategy of all in-scope businesses.
But the critical lesson for manufacturers here is not in the specifics of the proposal — after all, the changes could fall through again — but in how to create resilient compliance processes so that the threat of regulatory change doesn’t disrupt their operations and put them at risk.
Reducing risks through proactive compliance
Companies often fall into the “wait and see” trap whenever regulatory changes are on the horizon. They wait until the last minute to take action, hoping for a delay or exemption, and then scramble to meet whatever new deadline regulators have set. For too many companies, it’s not a priority if it isn’t an emergency.
Manufacturers that are proactive about compliance with regulatory changes, like those currently under evaluation for Proposition 65, have a few key things in common:
- They actively monitor regulatory proposals and seek to understand new requirements.
- Their chemical/part data is not siloed, and it can be used for more than one purpose.
- They provide education and support for suppliers around new requirements.
There’s nothing inherently surprising about this list, but it can be challenging for companies to meet these requirements. More often than not, companies need more time to really dig into proposed changes and get their processes up to date with still-hypothetical regulations.
However, planning to meet requirements in advance pays off. Many U.S.-based manufacturers discovered this when per- and polyfluoroalkyl substances (PFAS) reporting came into effect. The Environmental Protection Agency (EPA) had been indicating that PFAS reporting was on their radar, and in late 2023, the Toxic Substances Control Act (TSCA) was updated to include new reporting rules. Proactive manufacturers that were paying attention and dedicating resources to regulatory monitoring could start collecting PFAS data as soon as the new reporting guidelines were published. Reactive companies are just now beginning to Google PFAS to figure out how to get a program started. Too many companies are feeling the crunch as the deadline — no longer a “what if?” — looms.
The impact of labeling changes on key industries
The proposed updates to Proposition 65’s labeling requirements are set to affect all industries, but some will feel the changes more acutely than others. Here’s a closer look at a few of the situations where companies can expect outsized impacts:
Companies supplying spare and replacement parts
New labeling requirements may present a significant challenge for companies that supply parts. This is because while a product might come with one label, a replacement part that is shipped to California might require a different label due to a different Proposition 65 substance being present than is identified on the product label. This added layer of complexity will require companies to adopt a proactive strategy that ensures continued compliance.
Online retailers
Online retailers have leaned heavily on short-form warnings, and the need to update labels with specific Proposition 65 chemicals means countless product listings and/or labels will need to be changed within the two-year grace period from the date Proposition 65 is updated.
Large distributors
Large distributors also find themselves in a tricky position, as they will also only have a two-year grace period. The need for detailed chemical information means they will likely receive an onslaught of updated customer requests and will have to rely heavily on manufacturers for accurate product data and updated labeling to satisfy them. Without clear communication between manufacturers and distributors, companies are at serious risk of noncompliance.
Neil Smith is a regulatory and sustainability expert in product sustainability at Assent. He helps companies manage their product compliance and sustainability programs with a focus on environmental, health and safety (EHS). 
