Product Stewardship

The state of California enacted the Safe Drinking Water and Toxic Enforcement Act, also known as Proposition 65, in 1986. Proposition 65 is administered by the California Office of Environmental Health Hazard Assessment (OEHHA) and enforced by the California Attorney General’s Office. This act is aimed at protecting California’s drinking water from contamination by chemicals known to cause cancer, birth defects, or other reproductive harm.

The list of chemicals on the Proposition 65 list is updated at least once a year and contains more than 900 chemicals. Chemicals can be added to the list in one of four ways.

1. Chemicals identified by the World Health Organization’s International Agency for Research on Cancer (IARC) as causing cancer in humans or laboratory animals are required to be included in the Proposition 65 list.
2. The State’s Qualified Experts (SQE) can determine that a chemical causes cancer, birth defects, or other reproductive harm. SQE’s can be members of the Carcinogen Identification Committee (CIC) or the Developmental and Reproductive Toxicant Identification Committee (DARTIC).
3. Chemicals identified by Authoritative Bodies such as the US Environmental Protection Agency, US Food and Drug Administration, National Institute for Occupational Safety and    Health, the National Toxicology Program of the US Department of Health and Human Services, and IARC.
4. Chemicals required by an agency of the state or federal government to be labeled as causing cancer, birth defects, or other reproductive harm.

Businesses are required to inform consumers about exposure to chemicals on the Proposition 65 list. Penalties for violating Proposition 65 can be up to $2,500 per day.

Visit the OEHHA website for more details.

The Toxic Control Substance Act (TSCA) was introduced in Congress in 1971 following a series of pesticide and worker-related chemical scares in the late ’60s and early ’70s. TSCA become law in 1976 and between 1976 and 2020, the EPA restricted 9 substances or substance families under TSCA.

• Polychlorinated biphenyls (PCBs)Lead (in paint)
• Asbestos
• Dioxins (e.g., Agent Orange)
• Chlorofluorocarbons (Ozone Depleting Substances)
• Metallic mercury (in consumer products)
• Formaldehyde (in composite wood)
• Nitrites (in certain cutting fluids)
• Hexavalent chromium compounds (in water treatment)

In 2016, the TSCA regulation was revised by the Frank R. Lautenberg Chemical Safety for the 21^st Century Act. Under the TSCA revision, the EPA is required to develop risk-based chemical assessments. The amendment also provides the EPA with funding for surveillance and enforcement.

TSCA Section 6(h) provides the EPA with the “authority to prohibit or limit the manufacture, processing, distribution in commerce, use, or disposal of a chemical if EPA evaluates the risk and concludes that the chemical presents an unreasonable risk to human health or the environment.” On January 6, 2021, the EPA published five final rules restricting these substances deemed to be persistent, bioaccumulative, and toxic (PBT):

• Phenol, Isopropylated phosphate (3:1) (PIP 3:1)
• Decabromodiphenyl ether (DecaBDE)
• 2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP)
• Hexachlorobutadiene (HCBD)
• Pentachlorothiophenol (PCTP)

Visit the EPA website for more details.

In January 2003, the Restriction of Hazardous Substances Directive (RoHS) entered into force in the European Union. This directive was enacted to address the growing amount of waste electrical and electronic equipment (WEEE). By restricting the use of hazardous substances in electrical and electronic equipment (EEE), RoHS promotes the recyclability of EEE. Unless exempted, all products containing an electrical or electronic component manufactured, imported, or sold in the EU must comply with the RoHS restrictions.

The RoHS Directive was amended in 2011 and 2017, bringing the restricted substance total to ten: lead, cadmium, mercury, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP).

Visit the RoHS directive website for more details.

The European Union adopted REACH (registration, evaluation, authorization, and restriction of chemicals) to reduce the human health and environmental risks associated with exposure to chemicals. The Substances of Very High Concern (SVHC) falls under the authorization section of the REACH regulation. The European Chemical Agency (ECHA) publishes the SVHC Candidate List which is typically updated twice a year. The aim of the SVHC list is to drive innovation and replacement of SVHCs with less dangerous substances or technologies.

Any EU member state can submit a proposal for a substance to be added to the SVHC Candidate List. The substance must meet the on of the below criteria.

• Classified as carcinogenic, mutagenic, or toxic for reproduction (CMR) category 1A or 1B per the CLP regulation.
• Classified as persistent, bioaccumulative, and toxic (PBT) or very persistent and very bioaccumulative (vPvB) per REACH Annex XIII.
• Case-by-case scenario for substances deemed to cause an equivalent level of concern as substances identified as CMRs, PBTs, or vPvBs.

Once a substance is added to the SVHC list, Article 33(1) requires manufacturers and importers of articles containing an SVHC above the 0.1% by weight threshold to notify their customers of the presence of the SVHC substance(s). Notification to ECHA is also required if the SVHC substance totals over one ton per year.

Visit the candidate list table for more details.

To address the concern of adverse impacts of waste, the EU implemented the Waste Framework Directive. The Waste Framework Directive became effective in July 2018 as part of the EU’s action plan for the circular economy. Manufacturers, importers, and sellers of articles containing SVHC substances in the EU have to submit information to the SCIP (Substances of Concern in Articles) database. The SCIP database is aimed at decreasing the generation of waste containing SVHCs, improving information availability regarding waste treatment options, and allowing authorities to monitor SVHCs over the lifecycle of parts and goods (e.g., an “article” per REACH definitions).

Visit the Waste Framework Directive site for more details.