Regulations Regarding Bisphenol A in Children's Products and Food Contact Materials
Legislative Bans of Bisphenol A (BPA)
- 2009: Minnesota bans the sale of baby bottles and children’s cups containing BPA (effective January 2010)
- 2013: Minnesota prohibits BPA in children’s food containers. The ban includes food containers intended for use by infants and children under three years of age. (effective August 2014 for manufacturers/wholesalers and August 2015 for retailers)
- 2013: Minnesota prohibits the use of BPA-replacement chemicals that are known or suspected to cause reproductive/developmental toxicity, cancer, or other systemic toxicity. (effective August 2014)
The text of the Minnesota statutes regarding BPA is available from the Minnesota Office of the Revisor of Statutes and appears as Minn. Stat. 325F.172 to 175 as of 2013.
- 2012: The U.S. Food and Drug Administration (FDA) bans the use of BPA in baby bottles and children’s spill-proof cups.
- 2013: The FDA bans the use of BPA in infant formula packaging materials.
FDA emphasized that their decisions to ban these uses of BPA were not due to public safety concerns. The decision was based on market abandonment (i.e., most of the U.S. companies had stopped using BPA for these uses in response to public pressure).
Minnesota Toxic Free Kids Act
In 2009 Minnesota passed the Toxic Free Kids Act, which requires the Minnesota Department of Health (MDH) to create two chemical lists: one list called Chemicals of High Concern and one called Priority Chemicals. BPA has been identified as a Priority Chemical. Priority Chemicals are a subset of the Chemicals of High Concern list and are of greater concern because they are high-production volume chemicals and have been found in humans and/or the environment. For more information about the Toxic Free Kids Act or either of these chemical lists visit the Toxic Free Kids website.
FDA Regulatory Framework for BPA
BPA has been regulated by FDA as an indirect food additive since the early 1960s through the food additive petition (FAP) process. In light of recent public concern about BPA, FDA is exploring options to regulate BPA as a Food Contact Substance (FCS) under a newer framework designed specifically for substances that can enter food when it comes in contact with packaging material. This framework, called the Food Contact Notification (FCN) process, has been widely used since it was implemented in 1997 and allows for expedited review of indirect additives and greater flexibility for FDA action. Through the FCN program FDA can better assess and control how widespread the uses become over time and can track cumulative human exposures (FDA's CEDI Database).
The FCN process does not replace the traditional FAP process, which remains in effect for direct food additives and for FCSs with very high estimated human exposures or FCSs that have a cancer bioassay with unclear results that FDA has not yet reviewed. The FCN process is not currently required for additives already approved through the FAP process, such as BPA; however, FDA believes the more modern FCN framework may be better suited for regulating BPA. In the meantime, FDA is encouraging manufacturers or suppliers of BPA materials to provide FCN submissions voluntarily.