ECHA Drops Proposal to Restrict Four Phthalates

The European Chemicals Agency (ECHA) has dropped its plan to restrict the use of four phthalate chemicals. The proposal had been put forth last year on the chemicals commonly called DIBP, DBP, BBP, DEHP.  However, after review an expert committee determined that the proposed restrictions could not be justified, ECHA last week retracted the proposal.


Denmark had asserted in 2011 that the four phthalates could affect sexual development.  The expert committee disagreed - they noted that the "available data does not indicate that there is currently a risk from combined exposure to the four phthalates." The committee also concluded that regulatory actions already being put into place would result in significant reduction of exposures, thus making the proposed restrictions somewhat redundant, yet overly punitive.


The decision is the first time the expert committee has refuted a proposed restriction from ECHA.  


A summary of the Danish report can be read here.

The full proposal can be downloaded here.

EPA Kicks Off Initiative to Find Alternatives to Phthalates

The kickoff meeting of a partnership between the USEPA and interested parties was held August 24, 2011 in the Washington DC area.  The goal is for EPA and industry to work within the Design for the Environment (DfE) framework to "evaluate phthalates and potential alternatives based on a range of human health and environmental endpoints, and provide this information to stakeholders for informed decision making."

Participants in the kickoff meeting included a variety of stakeholders ranging from manufacturers, state and local regulatory agencies, trade associations, international regulatory bodies, and NGOs. Individual manufactures and users of phthalates present included ExxonMobil, BASF, IBM, Dow Chemical, and others.  It is expected that future activities will include development of a list of existing potential alternatives and an evaluation of the potential environmental and human health effects of those alternatives that seem most viable.  The next meeting of the partnership initiative is will be in October 2001, with early spring 2013 planned for a final report on the project.

An action plan on which this DfE initiative is based was released in December of 2009.  The phthalates identified in the action plan for assessment are:

• Dibutyl phthalate (DBP)
• Diisobutyl phthalate (DIBP)
• Butyl benzyl phthalate (BBP) 
• Di-n-pentyl phthalate (DnPP) 
• Di(2-ethylhexyl) phthalate (DEHP) 
• Di-n-octyl phthalate (DnOP) 
• Di-isononyl phthalate (DINP) and associated chemical*
• Di-isodecyl phthalate (DIDP) and associated chemical*

 *each are a mixture of two phthalates

The partnership participants will decide on which substances offer the potential as alternatives.  Collaboration with ongoing reviews by the US Consumer Product Safety Commission (due to use of phthalates in children's toys and baby bottles) and the Green Chemistry in Commerce Council will also be part of the review process.

More information the Design for the Environment Program can be found here.

EPA's Design for the Environment (DfE) Issues Final Alternatives Assessment Criteria

The USEPA Office of Pollution Prevention and Toxics has released its final alternatives assessment criteria for evaluating human and environmental effects in accordance with its Design for the Environment (DfE) program.  DfE helps companies, states and other organizations to "identify safer alternatives to chemicals that may pose a concern to human health and the environment."  More information on the DfE program can be found on EPAs web site.

DfE Alternatives Assessments are "multi-stakeholder partnerships convened to evaluate priority chemicals and functional alternatives."  The goal is to "inform substitution to safer alternatives and reduce the likelihood of unintended consequences that might result if poorly understood alternatives are chosen."  In other words, they don't want to replace one bad chemical with another bad chemical just because they don't know enough about it.  According to DfE, its "expertise and focus is on chemical hazard," and encourages stakeholders to "assist with the selection of the scope of the alternatives assessment, help EPA consider economic realities, and identify likely functional alternatives for evaluation."

So whereas REACH in the EU specifies substances of very high concern and requires authorization for continued use (along with a substitution plan), the DfE program works directly with companies and other stakeholders to fix the problem together.

EPA is currently preparing DfE alternatives assessments for Bisphenol A (BPA), Decabromodiphenyl ether (decaBDE), and Nonylphenol ethoxylate (NPE) surfactants.  The draft reports for public comment are expected to be released by EPA later this year.  In addition, EPA has underway an alternatives assessment for Hexabromocyclodecane (HBCD) in polystyrene insulating foam.  And EPA also plans to conduct an alternatives assessment for phthalates with a kickoff meeting scheduled for August 24, 2011.

Version 2.0 of the Alternatives Assessment Criteria document can be downloaded as a PDF here.

More information and links to the phthalates kickoff meeting signup materials can be found in the right sidebar of the DfE page.

US Chemical Makers to Seek Authorization for Continued European Use of Phthalates Under REACH Regulation

As noted previously the European Commission has announced that "six substances of very high concern will be banned within the next three to five years unless an authorisation has been granted to individual companies for their use." Three of these substances (DBP, BBP, and DEHP) fall into a general category called phthalates and now a major US trade association has indicated that phthalate manufacturers they represent will file applications for authorization to continued use in "important medical applications."  According to Steve Risotto, Phthalate Esters Panel, quoted in the American Chemical Council (ACC) statement:

"There is a large body of scientific information and a number of government safety assessments in the U.S. and abroad that give the manufacturers of these three phthalates confidence that their products are being used safely. In fact, phthalates are one of the most extensively studied groups of chemical compounds in the world." 

US manufacturers "will work with European regulatory authorities" (primarily the European Chemicals Agency, ECHA, in Finland) to "submit all the necessary data and seek approval for the continued use of these substances."  Without authorization, use of all six of the substances of very high concern (SVHC) will cease at their sunset dates in either 2014 or 2015. According to ECHA, these SVHCs are "are carcinogenic, toxic for reproduction or persist in the environment and accumulate in living organisms."

More information on phthalates can be found on the Phthalates Wikipedia page or ACC's Phthalate Esters Panel web page.  For contrasting information from an NGO activist organization, the Environmental Working Group also has a Phthalate web page.

Priority Chemicals Listed by the Minnesota Department of Health - Toxic Free Kids Act

Under the Toxic Free Kids Act, the state of Minnesota Department of Health, in consultation with the Minnesota Pollution Control Agency, has listed a total of nine chemicals as "priority chemicals."  The statute, which passed in 2009 "required MDH to develop two lists of chemicals: Chemicals of High Concern and Priority Chemicals." The Chemicals of High Concern list was published on July 1, 2010 and be found on the Chemicals of High Concern page. 

The Priority Chemicals list can be found here.  The nine chemicals listed (click on the name for links to PDFs of summary information for each chemical) are:

Bisphenol A

Cadmium

Decabromodiphenyl Ether (DecaBDE)

Formaldehyde

Hexabromocyclododecane

Lead

And three phthalates:

Butyl benzyl phthalate (BBP)
Dibutyl phthalate (DBP)
Di(2-ethylhexyl) phthalate (DEHP)

The Minnesota Department of Health has also provided a handy priority chemicals summary table here.

Additional information on the methodology employed to select priority chemicals, as well as a FAQ sheet, can be found on the MDH web site.

Consumer Product Safety Commission Names Phthalate Advisory Panel Members

Phthalates are big. Well, at least from a public health policy perspective. These chemicals are the most commonly used plasticizers worldwide, being used to soften PVC and other products. One of the biggest concerns by regulators and activists is the use of phthalates in toys. A few days ago the Consumer Product Safety Commission (CPSC) in the United States appointed seven independent scientists to serve on a Chronic Hazard Advisory Panel (CHAP) to assess the potential health risks from exposure to phthalates and phthalate substitutes.

The CHAP is required under the provisions of the Consumer Product Safety Improvement Act, signed into law by then-President George W. Bush in 2008. The specific charge of the CHAP is to examine the potential effects on children's health of phthalates and any alternatives to phthalates as used in children's toys and child care articles.

The seven scientists appointed from a list nominated by the President of the National Academy of Sciences are:

Chris Gennings, Ph.D.
Medical College of Virginia

Russell Hauser, M.D., Sc.D., M.P.H.
Harvard School of Public Health

Holger M. Koch, Ph.D.
Ruhum University of Bochum, Germany

Andreas Kortenkamp, Ph.D.
University of London

Paul J. Lioy, Ph.D.
Robert Wood Johnson Medical School

Philip E. Mirkes, Ph.D.
Washington State University, Vancouver

Bernard A. Schwetz, D.V.M., Ph.D.
U.S. Department of Health and Human Services (retired)