15 Sept 2017
Update on Recent Changes to California’s Proposition 65 List of Chemicals
Hong Kong and mainland Chinese exporters should be aware that a number of watchdog groups and private citizens continue to target hazardous chemicals in consumer products under California’s Safe Drinking Water and Toxic Enforcement Act (commonly known as Proposition 65), a trend that is expected to continue. Among other things, Proposition 65 requires the state of California to publish a list of chemicals known to cause cancer or reproductive harm such as birth defects and update this list every year. The list was originally published in 1987 and has grown to include more than 900 naturally occurring and synthetic chemicals ranging from acrylamide and formaldehyde gas to arsenic, lead, cadmium, mercury and certain phthalates.
The list is frequently modified, with 13 chemicals added and no chemicals removed in 2016 and four chemicals added and no chemicals removed during January-August 2017. Chemicals added so far this year include pertuzumab and vismodegib (added 27 January), glyphosate (added 7 July) and pentabromodiphenyl ether mixture [DE-71 (technical grade)] (added 7 July). It should be noted that one or more of these chemicals or a closely related substance may have already been on the list for a hazard other than that specified in the official notice adding the chemical to the Proposition 65 list. California has also announced its intention to list N, N-dimethylformamide, 2-mercaptobenzothiazole and tetrabromobisphenol A and is also currently scrutinising various chemicals for potential toxicity, including coumarin, chlorpyrifos and n-hexane.
Prop 65 does not ban or restrict the use of listed chemicals. Instead, beginning one year after a chemical is added to the Prop 65 list businesses are required to provide a “clear and reasonable” warning before knowingly and intentionally exposing anyone to that chemical unless they can show that the anticipated exposure level will not pose a significant risk of cancer or is significantly below levels observed to cause birth defects or other reproductive harm. This warning can be given in several ways; e.g., labelling a consumer product. No such warning is required if exposure to a chemical occurs at or below any established safe harbour level.
According to new regulations adopted by California in August 2016 that will be mandatory from 30 August 2018, a warning meets the applicable requirements if the name of one or more of the listed chemicals in the consumer product or affected area for which the warning is being provided is included in the text of the warning. Where a warning is being provided for more than one endpoint (cancer and reproductive toxicity), it must include the name of one or more chemicals for each endpoint unless the named chemical is listed as known to cause both cancer and reproductive toxicity and has been so identified in the warning.
The new regulations require consumer product exposure warnings to be prominently displayed on a label, labelling or sign. Specifically, they must be displayed with such conspicuousness as compared with other words, statements, designs or devices on the label, labelling or sign as to render the warning likely to be read and understood by an ordinary individual under customary conditions of purchase or use. The warning content may contain information that is supplemental to the required content only to the extent that it identifies the source of the exposure or provides information on how to avoid or reduce exposure to the identified chemical or chemicals.
According to the new regulations, a warning meets the relevant requirements if it contains certain elements and is provided using (i) a product-specific warning provided on a posted sign, shelf tag or shelf sign for the consumer product at each point of display of the product; (ii) a product-specific warning provided via any electronic device or process that automatically provides the warning to the purchaser prior to or during the purchase of the consumer product, without requiring the purchaser to seek out the warning; (iii) a label that complies with certain content requirements; or (iv) an on-product warning that complies with certain content requirements (the entire warning must be at least 6-point type and no smaller than the largest type size used for other consumer information on the product). Where a consumer product sign, label or shelf tag used to provide a warning includes consumer information in a language other than English, the warning must also be provided in that language in addition to English.
It is also worth mentioning that California’s Office of Environmental Health Hazard Assessment sought input through 7 September on a proposal to modify the regulations outlined above to further clarify and correct certain language and include tailored warnings for several specific types of exposure situations, specifically exposures to listed chemicals that can occur at hotels and other transient lodging establishments.
The Prop 65 labelling requirements are enforced through litigation initiated by the California attorney general or through a private lawsuit. A plaintiff is required to provide a 60-day prior notice of an alleged violation to the defendant before it can proceed with a legal action under Prop 65. A record high 2,048 notices of violation (60-day notices) were filed under Prop 65 from 1 January through 31 August 2017, involving such diverse products as footwear, gloves, armbands, vinyl aprons, vinyl/PVC tubing, purses, bags, make-up, earphones, furniture, cookware, glassware, drinkware, popcorn machines, charcoal grills, shower curtains, steel cables, car chargers, sink mats, litter mats, liquid soaps, snack foods, dietary supplements, olives and cocoa powder. By comparison, 985 notices were filed under Proposition 65 from 1 January through 31 August 2016 and a 14-year high of 1,576 notices (including supplemental notices) were filed in 2016, which followed 1,336 notices in 2015, 1404 notices in 2014 and 1,097 notices in 2013.
Six-hundred and eighty three notices or 33.3 percent of the 2,048 notices filed during 1 January through 31 August 2017 involved myclobutanil, a triazole chemical used as a fungicide. Four-hundred and forty three or 21.6 percent of all notices involved di(2-ethylhexyl)phthalate (DEHP), 448 involved lead and lead compounds, 447 involved carbaryl, 175 involved DINP, 124 involved acrylamide, 39 involved cadmium and cadmium compounds, 30 involved di-n-butyl phthalate (DBP), 23 involved bisphenol A and 21 involved di-isodecyl phthalate (DIDP). While DEHP is banned in children’s toys and childcare articles nationwide under the CPSIA, most of the California notices targeting this chemical appear to involve a range of products that are destined for adult consumption or do not otherwise fall within the scope of the CPSIA phthalate ban.