Proposition 65

In 1986, California voters approved Proposition 65, officially known as the Safe Drinking Water and Toxic Enforcement Act, to address their growing concerns about exposure to toxic chemicals. The law requires California to publish a list of chemicals known to cause cancer or reproductive toxicity, and for businesses with 10 or more employees to provide warnings when they knowingly and intentionally cause significant exposures to listed chemicals.The list currently includes more than 900 chemicals. Proposition 65 does not ban the use of chemicals on the list. The warnings are intended to help Californians make informed decisions about their exposures to these chemicals from the products they use.

New product labelling requirements take from August 2018

In August 2016 the Office of Environmental Health Hazard Assessment (OEHHA) introduced new regulations which change the “safe harbour” warnings which are deemed to comply with the law. The new product labelling requirements take effect from 30 August 2018. For example, the new “safe harbour” warnings for consumer products include a triangular yellow warning symbol and the word “WARNING:” in bold capital letters followed by:

  1. For exposures to listed carcinogens, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer. For more information go to www.P65Warnings.ca.gov.”
  2. For exposures to listed reproductive toxicants, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
  3. For exposures to both listed carcinogens and reproductive toxicants, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer, and [name of one or more chemicals], which is [are] known to the State of California to cause birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”
  4. For exposures to a chemical that is listed as both a carcinogen and a reproductive toxicant, the words, “This product can expose you to chemicals including [name of one or more chemicals], which is [are] known to the State of California to cause cancer and birth defects or other reproductive harm. For more information go to www.P65Warnings.ca.gov.”

Businesses must include the full chemical name as it appears on the Proposition 65 list and do not need to list more than one chemical for each endpoint. For example, if there are five possible chemical exposures from a given product, and all five chemicals are listed only as carcinogens, then the business would only be required to name one of those five chemicals in the warning. If there are exposures to both carcinogens and reproductive toxicants, a business would be required to name one of the chemicals that is a carcinogen and one of the chemicals that is a reproductive toxicant. If the warning covers exposure to a chemical that is listed as both a carcinogen and a reproductive toxicant, the warning would only need to name that one chemical, however both endpoints would need to be included in the warning.

Businesses may use truncated “short-form” warning content on a product label. The “short-form” warning content includes the same triangular yellow warning symbol and the word “WARNING::” in bold capital letters followed by:

  1. For exposures to listed carcinogens, the words, “Cancer - www.P65Warnings.ca.gov.”
  2. For exposures to listed reproductive toxicants, the words, “Reproductive Harm - www.P65Warnings.ca.gov.”
  3. For exposures to listed carcinogens and reproductive toxicants, the words, “Cancer and Reproductive Harm - www.P65Warnings.ca.gov.”

The short-form warning on the product label is not required to include the name(s) of listed chemical(s). However, the name(s) of listed chemical(s) must be disclosed on request.

Businesses need to evaluate the options and choose the “safe harbour” warnings options which best meet their needs.

Using BOMcheck to assess if your product requires “safe harbour” warnings

Dr Paul Goodman at RINA Consulting carried out a screening of the 900 plus substances on the Proposition 65 list and identified 105 substances that may be relevant to component parts of mechanical or electrical products (in other words, any component of a manufactured product which is not defined as a substance or preparation (mixture) under the REACH regulation). Dr Goodman’s screening shows that 39 of these substances do not require “safe harbour” warnings. This leaves 66 substances which may be found in component parts of mechanical or electrical products and may require “safe harbour” warnings.

BOMcheck has assessed Dr Goodman’s screening and identified that 29 of these 66 substances are already regulated under RoHS, REACH substance restrictions, POPs regulation or REACH Candidate List in BOMcheck. In other words, if supplier parts are already compliant to the RoHS, REACH substance restrictions, POPs regulation and REACH Candidate List lists in BOMcheck then there are only 37 new substances that suppliers need to assess for Proposition 65. The detailed screening assessment is published inside BOMcheck and reduces the time and cost for Proposition 65 compliance by 97%.

If the finished product includes a supplier part which contains Proposition 65 substance(s) then you need to assess whether the user could be exposed to the part during normal use of the product. If yes, then you need to provide an a ppropriate “safe harbour” warning and communicate the name of one Proposition 65 substance for each endpoint (for example, one carcinogen of the Proposition 65 substance(s) are listed for cancer).