Reviewing California Proposition 65

Investigating one of the most stringent requirements for chemicals – currently in force in California.

'Proposition 65' is also known as the 'Safe Drinking Water and Toxic Enforcement Act'. Published in 1986, it is intended to improve consumer health protection by requiring suppliers to label their products containing chemicals identified as being carcinogenic or having an adverse effect on development or reproductive health.

A requirement of the legislation is that at least once a year the list of chemicals known to cause cancer or have reproductive toxicity is updated by the office of the governor of California. At the time of writing the current list, published in April 2016, encompasses in excess of 700 substances. Small businesses (those with less than ten employees), governmental agencies and public water systems are exempt from the requirements of Proposition 65.

Proposition 65 warnings

The statute requires that 'no person in the course of doing business shall knowingly and intentionally expose any individual to a chemical known, to the state (California), to cause cancer or reproductive toxicity without first giving a clear and reasonable warning…'. This means that if products supplied to the public are known to contain any of the chemicals included in the Proposition 65 list at a level that could be judged to pose a risk to the user, the product should be labelled with a clear warning at the point of sale.

In order to determine if the level of the Proposition 65 chemical is sufficiently high to pose a risk to the user, the Californian Office of Environmental Health Hazard Assessment (OEHHA) publishes the ‘safe harbor’ levels for some (but not all) of the chemicals listed. These are exposure levels quantified in microgrammes per day (µg/day). These are expressed as 'no significant risk levels' (NSRLs) for carcinogenic chemicals and 'maximum allowable dose levels' (MADLs) for substances that cause reproductive toxicity.

Where safe harbor numbers do not exist for a chemical on the Proposition 65 list, the supplier of any product containing any of these substances should take a decision based on a risk assessment, taking into account the concentration of the chemical and the potential exposure routes for the user.

The list of the Proposition 65 chemicals should not be seen as a ban on the specific chemical. It should, rather, be viewed as a requirement to ensure that users are informed about the potential risks involved and are able to make decisions based on that information.

In 2013, the government of California introduced the 'Safer Consumer Products Regulation' which describes how chemicals of concern should be evaluated and, where possible, replaced in consumer goods.

Testing for Proposition 65 chemicals

There is no mandatory requirement to carry out testing as part of the risk assessment within Proposition 65, but testing may become necessary where detailed information on the chemicals used in the formulation of the product may not be available. Testing should be based on known product composition and processing techniques; it is clearly not practical to analyse the full range of materials that may be present in a single consumer product item for all of the proposition 65 chemicals.

Communication is, therefore, an important element within the California Proposition 65 legislation. Suppliers need to provide concise information about the formulation and also the use of any chemicals in the manufacturing process. This will apply to all products – whether they are manufactured in the USA or elsewhere.

Specific concerns have been expressed about the use of phthalate plasticisers in flexible PVC materials and the use of lead and cadmium pigments. However, the new requirements for lead in the Consumer Product Safety Improvement Act (CPSIA), which is federal legislation (that is, law across the USA), will take precedence over Californian State law. Therefore, where the requirements are more stringent, the federal law will apply.

To determine whether footwear could contain any of the Proposition 65 chemicals, each material will have to be considered – including leathers, textiles, polymers, rubbers and accessories. The materials will all have different issues, dependent on the processing and source of the material. Care should also be taken with the use of solvent-based adhesives and cleaners, as some solvents are also contained within the list and these should not be residual within the footwear.

Enforcement of the legislation is often linked to campaigns by members of the public and pressure groups. They search out products which contain Proposition 65 chemicals but are not labelled, and bring cases against the supplier and/or retailer, as they are entitled to part of any compensation payment from the courts. This means that, as there is no requirement to demonstrate actual injury to bring a prosecution, some companies may feel exposed if they do not possess a robust chemical management policy around which to base their defence.

California Proposition 65 requires businesses to ensure that there is information available at point of sale to warn consumers of carcinogens and chemicals that are toxic to reproduction, so that informed decisions can be taken. Organisations should ensure that their supply chain is familiar with the current list and to highlight if any of these chemicals are used. As mentioned earlier, the legislation is not a ban on the chemicals listed; it is a mechanism to reduce exposure and, thereby, reduce risk of ill health.

Publishing Data

This article was originally published on page 46 of the February 2017 issue of SATRA Bulletin.

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