US CPSC votes to ban phthalates in children's products, by Jairo Andrade Junior, C&J Consulting, Chemical Engineer, 2017-11-02

The United States Consumer Product Safety Commission (CPSC) issues this final rule prohibiting children's toys and child care articles that contain some phthalates (see below which phthalates were ban). Section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) established permanent and interim prohibitions on the sale of certain consumer products containing specific phthalates. That provision also directed the CPSC to convene a Chronic Hazard Advisory Panel (CHAP) to study the effects on children's health of all phthalates and phthalate alternatives as used in children's toys and child care articles and to provide recommendations to the Commission regarding whether any phthalates or phthalate alternatives, other than those already permanently prohibited, should be prohibited. The CPSIA requires the Commission to promulgate a final rule after receiving the final CHAP report. This rule fulfills that requirement.

On October 18, 2017, the US Consumer Products Safety Commission (CPSC) voted 3-2 in to end the regulation banning five phthalates in children's products, despite the Republican Commissioners' arguments that the decision was not supported by research. A Republican Commissioner announced that he was leaving the CPSC in the middle of his term, which may leave Democrats in control longer than expected. The Commission issued a proposed rule in late 2014 to ban five phthalates in toys, and various other children's products, at levels greater than 0.1%.

The banned phthalates were:

? diisobutyl phthalate (DIBP);

? di-n-pentyl phthalate (DnPP or DPENP);

? di-n-hexyl phthalate (DnHP or DHEXP);

? dicyclohexyl phthalate (DCHP); and

? diisononyl phthalate (DINP).

The rule expands an interim on DINP, which had applied only to toys that can be placed in the mouth to all toys. It lifts interim bans on two phthalates, DNOP and DIDP, which the committee staff concluded have not been shown to have the antiandrogenic effects that the rule addresses. DEHP, BBP and DBP were already banned above de minimis levels in children's products.

The CPSC agreed to vote on a final rule by October 18, 2017 to settle lawsuit brought by NGOs.

DINP ban questioned

The Discussion was focused on diisononyl phthalate (DINP), aiming at its provisional prohibition.  The proposal was based on data concerning a few individual women, and ignores trends in the most recent research. The rationale for expanding the DINP was no more than the observation that a child's exposure to phthalates could also result from handling or licking toys rather than placing in the mouth.

It added that the reasoning behind it is superior to that underpinning the commission's decision in September to move towards organohalogen flame retardants in certain consumer products. There are similarities between phthalates but the researchers examining the substances did not treat them all the same.

A Democrat Commissioner said the approaches are similar in that they take aim at a class of substances to guard against substitution. While DINP may be less toxic than some other phthalates, it had become a popular alternative to its more toxic similar. Merely because there is a reduced risk does not mean there is no risk, said another Democrat Commissioner.

Another Phthalates Restrictions  in USA

US Consumer Products Safety Improvement Act (CPSIA) has also banned 6 phthalates in children's toys and child care articles.

The restriction limits are listed as follows:

It should be noted that DEHP, BBP, DBP, DIDP are also on California Proposition 65 list. The State of California require manufacturers of articles and consumer products (including non-toys and non-childcare products) containing listed chemicals to place "reasonable warnings" on product packaging to alert purchasers. 

Main Effects of Phthalates

Phthalates are a group of chemical substances used to soften plastics. They are also called plasticizers and can be found in many articles and consumer products. Some phthalates have shown adverse effects on reproductive system and endocrine system. In this article, we are summarizing known phthalate restrictions in articles and consumer products in some countries (US, EU and Japan). 

Phthalates Restrictions in Other Countries

- Phthalates and EU REACH Annex XVII

Phthalates are included in REACH Annex XVII restricted substances list (entry 51 and 52). Currently phthalates are restricted in plasticised material in toys and childcare articles. The restriction conditions are listed as follows:

- Phthalates and EU RoHS 2

On 4 June 2015, the EU commission has published a new Directive (EU) 2015/863 to amend Annex II to EU RoHS 2 (Directive 2011/65/EU) to add the following 4 phthalates onto the list of restricted substances under EU RoHS 2.

·        Bis(2-Ethylhexyl) phthalate (DEHP): <= 0.1%;

·        Benzyl butyl phthalate (BBP): <= 0.1%;

·        Dibutyl phthalate (DBP): <= 0.1%;

·        Diisobutyl phthalate (DIBP): <= 0.1%.

DEHP, BBP, DBP and DIBP will be restricted from 22 July 2019 for all electrical and electronic equipment apart from Category 8 (medical devices) and Category 9 (monitoring and control equipment) that will have an additional two years to comply by 22 July 2021.

- Phthalates Restrictions in Japan

References

·        https://www.regulations.gov/document?D=CPSC_FRDOC_0001-0916

·        ANNEX XVII to REACH – Entry 51 for Phthalates (DEHP, DBP, BBP)

·        ANNEX XVII to REACH – Entry 52 for Phthalates (DINP, DIDP, DNOP)

·        Phthalates and CPSIA

·        Revision of Japan Toy Safety Standard ST-2002 by BV