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On 27 October 2017, the U.S. Consumer Product Safety Commission (CPSC) finalized a rule to prohibit a content greater than 0.1% of diisononyl phthalate (DINP), diisobutyl phthalate (DIBP), di-n-pentyl phthalate (DPENP), di-n-hexyl phthalate (DHEXP), and dicyclohexyl phthalate (DCHP) in children’s toys and child care articles. The rule will enter into force on 25 April 2018 under the authority of section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA).
The prohibitions are based on the findings of the Chronic Hazard Advisory Panel (CHAP) report. CHAP studied the potential health effects of, human exposures to, and the assessment of risks of an array of phthalates. The report summarized that:
- DINP could increase the risk of male reproductive development due to its antiandrogenic effects;
- DNOP and DIDP both have the potential of a developmental toxicant and systemic toxicant, yet depicts no antiandrogenic effects; and
- DIBP, DPENP, DHEXP and DCHP are associated with adverse effects on male reproductive development.
As a result of these findings, the CPSC issued interim prohibitions on DINP, DNOP and DIDP. Yet, of these three, the finalized rule only maintains the prohibition on DINP and also expands the scope of its restriction. The rule also includes language to restrict to 0.1% of DIBP, DPENP, DHEXP and DCHP in children’s toys and child care articles as a result of the CHAP report.
The prohibiting measure applies to consumer products that fall within the meaning of the following:
- Children’s toy: consumer product designed or intended by the manufacturer for a child 12 years of age or younger for use by the child when the child plays; and
- Child care article: consumer product designed or intended by the manufacturer to facilitate sleep or the feeding of children age 3 and younger, or to help such children with sucking or teething.
Furthermore, the rule clarifies that the prohibited content applies to plasticized component parts of children’s toys and child care articles, or other component parts that are made of materials that may contain phthalates.
Commercial activities subject to the prohibition include manufacture for sale, offer for sale, distribution in commerce and importation into the U.S.
Upon the new regulatory controls, businesses may need to perform testing prior to manufacturing children’s toys and child care articles containing DINP, DIBP, DPENP, DHEXP or DCHP. Placement of these consumer goods on the U.S. market will be deemed unlawful if the specified phthalates are present in concentrations higher than 0.1%. The prohibitions on DNOP and DIDP are lifted as a result of this regulatory action.