California has added bisphenol A (BPA) to its “Proposition 65” list of chemicals known to cause reproductive toxicity. The US state’s decision to add the chemical used to make polycarbonate resin and epoxy resins for can liners follows an analysis by the Developmental and Reproductive Toxicant Identification Committee (DART-IC), an advisory panel to the state Office of Environmental Health Hazard Assessment. DART said that through scientifically valid testing BPA had been “clearly shown to cause reproductive toxicity based on the female reproductive endpoint.”

Businesses using chemicals listed in Proposition 65, formally the Safe Drinking Water and Toxic Enforcement Act passed by California voters in 1986, are required to provide a “clear and reasonable warning” before “knowingly and intentionally” selling a product that could potentially expose them to carcinogens or reproductive toxins – unless the business can prove that the product poses “no significant risk.” For consumer products, the warning can be a printed label. A warning can also take the form of notices in a workplace or rental housing complex or in a newspaper.

The rules for dealing with the listed chemicals are currently being challenged in US courts. Last month, in a case involving lead, a California court of appeals ruled in favour of processed food manufacturer Beech-Nut in a challenge by the US Environmental Law Foundation (ELF). The Foundation maintained that the company should have provided a warning. The court said Beech-Nut had no duty to warn as it had satisfactorily demonstrated that the average consumer’s reasonably expected rate of exposure fell below relevant regulatory levels. ELF has petitioned the California Supreme Court to review the ruling.

A challenge to the BPA listing could be more difficult, as there are no binding US regulations for the chemical’s use in specific applications, only recommendations for daily intake levels. As could be expected, environmental and health advocates have hailed its inclusion in Proposition 65, while associations representing manufacturers of cans, epoxy resins and polycarbonate have slammed the listing. John Rost, chairman of the North American Metal Packaging Alliance, commented that the decision is “contradictory to the findings of leading regulatory bodies throughout the world that have determined BPA to be safe at the levels used in food contact applications.”

The American Chemistry Council (ACC, Washington DC / USA; www.americanchemistry.com) says the evidence used to back the California decision is not supported by the extensive scientific record presented to the committee and is “completely contrary to explicit input provided by the US Food and Drug Administration (FDA).” In a statement, Steven Hentges of ACC's Polycarbonate/BPA Global Group, noted that the FDA’s acting chief scientist submitted a letter to the DART-IC in April, pointing out that the FDA’s own comprehensive research “does not support BPA as a reproductive toxicant.”

Like its European counterpart European Food Safety Agency (EFSA; www.efsa.europa.eu), the FDA has not reached a definitive conclusion on all possible health risks associated with exposure to BPA, although in a report published in January of this year, EFSA largely absolved the chemical of blame as an endocrine disruptor – see Plasteurope.com of 23.01.2015. Both the European and US food watchdogs are holding off with any final verdicts pending the conclusions of a long-term study by the US National Toxicology Program which will be available for evaluation in two- to three-years’ time.

In contrast, the Risk Assessment Committee of ECHA, the body that administers REACH, last year unanimously supported France in proposing that BPA's mandatory classification should be “strengthened” from a category 2 to a 1B ("presumed human reproductive toxicant that may damage fertility") – see Plasteurope.com of 24.03.2014.

The European plastics producers’ association PlasticsEurope (Brussels / Belgium; www.plasticseurope.org), however said data from the guideline studies it believed were used by ECHA did not support this classification.