June 20, 2001

RISK ASSESSMENT REVIEWS OF TRIS(NONYLPHENYL) PHOSPHITE (TNPP)

European Union and United States

There are several ongoing reviews of tris(nonylphenyl) phosphite (TNPP) within the European Union and the United States.

European Union Review of Nonylphenol

The European Union (EU) is in the latter stages of completing its risk assessment/risk reduction strategy on nonylphenol (NP). The EU report reviewed environmental release and exposure concerns regarding NP and from the production and use of derivatives like TNPP. While that assessment is expected to result in the imposition of risk reduction measures on NP and NP ethoxylates, TNPP is not expected to be affected.

According to the EU Report, only releases from the manufacture of TNPP were considered in its environmental assessment due to lack of information on releases of NP during use of TNPP. However, the report states that releases to the environment of NP during use of TNPP are thought to be "negligible."

The assessment also reviewed information on the use of TNPP as an antioxidant to stabilize polymer coatings used as food contact materials. The report presented worst-case dietary exposure estimates to NP from the use of TNPP. Systemic dose from food contact materials was calculated to be 0.2 µg/kg/day based on the estimate that the total exposure is 2 µg/kg/day and 10% of the NP is bioavailable by the oral route. The EU assessment concludes that "there is no cause for concern for consumers from these materials" since the systemic dose is "several orders of magnitude below the NOAEL and LOAELs from repeat dose and reproductive toxicity studies."

The bottom line conclusion from the EU NP Risk Assessment Report is that there is no need for any additional information, testing or risk reduction measures regarding TNPP.

European Union Review of TNPP

Unrelated to the EU assessment of NP, TNPP itself was recently added to the EU's Priority List of existing chemicals for review (4th Priority List). France is serving as the rapatteur and the Alkylphenols & Ethoxylates Research Council (APERC) is the lead industry organization addressing the assessment. APERC has met with the French authorities and last month submitted a package of available health and environmental studies.

Over the next several months, there will be an increased need to present more detailed information on human exposure and environmental release, particularly from the processing and use of TNPP within the EU. APERC is encouraging any company or association with an interest in TNPP to work cooperatively on this issue. Interested companies should contact APERC.

APERC does not expect any significant issues to be raised as a result of the EU's review of TNPP.

HPV Testing Activities

The European and North American producers of TNPP volunteered to provide a base set of health and environmental effects information on TNPP as part of the High Production Volume (HPV) Challenge Program. Testing has already begun and should be completed by mid-2002. The information will be submitted to the US Environmental Protection Agency as part of their HPV Challenge Program and to the French authorities for consideration as part of the EU assessment.

The information to be generated is expected to further reinforce the widely accepted view that TNPP is a cost-effective and safe product from both a human health and environmental perspective.

 

Site Map   ·   Feedback/Contact Us   ·   Members Only