BPA – The Data Game

Over in Europe, the Member State Committee (MSC) has agreed that the European Chemicals Agency (ECHA) should request further information on six substances. This is the first batch of substance evaluations agreed on by the MSC.

Of particular note is the now infamous BPA. BPA is a carbon-based synthetic compound. It belongs to the group of diphenylmethane derivatives and bisphenols. BPA is used to make certain plastics and epoxy resins. The MSC has determined that more information is needed in order to properly assess the world’s most notorious plastic ingredient. In the US, the FDA has reached similar conclusions.

So why did the MSC agree that ECHA should request more information on six substances? This is essentially because the currently available information is insufficient to enable adequate health and environmental risk assessments. These particular six substances listed in the Community Rolling Action Plan (CoRAP) were evaluated by Germany, France, Denmark, the United Kingdom, Belgium and Spain.

Further information on Bisphenol-A (BPA) will be requested to clarify a number of concerns. First, the MSC agreed to request a new in vitro skin absorption study to assess the risk to consumers from, for example, toys and PVC articles. Second, information on the emissions and environmental exposure of BPA will be requested in order to assess the impact on the environment. The information will help to finalize the risk assessment. It will also help to determine whether further risk management measures are needed. There are on-going studies on BPA in the US which the German authority will also take into account in the next step of the assessment on endocrine disrupting properties for humans. See also BPA and California thresholds.

Other chemicals on the list

The MSC also agreed to request further information on the reproductive toxicity of carbon tetrachloride in an extended one generation reproductive toxicity study (EOGRTS, OECD 443). (More information on worker exposure to carbon tetrachloride will also be necessary).

The MSC agreed to request further information on oligomerisation and alkylation reaction products of 2-phenylpropane and phenol (previously registered as Phenol, methylstyrenated). The information requested is a bioaccumulation study in fish to clarify the concern for potential persistent, bioaccumulative and toxic properties. A combined repeated dose toxicity (90 day) and reproductive toxicity study is also requested (EOGRTS, OECD 443) to investigate endocrine disrupting effects.

The MSC agreed to ask for further information on worker exposure to imidazole and on its reproductive toxicity effects. Information will also be requested on short-term toxicity in the environment and on mutagenicity through an in vitro study.

The MSC agreed to request further information on N,N’-bis(1,4-dimethylpentyl)-p-phenylenediamine to clarify the concerns relating to persistent, bioaccumulative and toxic properties of the substance. A soil simulation test will be requested to look at aerobic and anaerobic transformation in soil.

Finally, information will be requested on a mixture of cis- and trans- tetrahydro-2-isobutyl-4-methylpyran-4-ol to clarify concerns relating to the environment. The requested study will be a short-term growth inhibition study, followed if necessary, by a long-term toxicity study in the aquatic environment.

About Kal

Kal Kawar, CIH, PE, has a bachelor's in chemical engineering and a master's in industrial hygiene. His professional experience includes serving as staff industrial hygienist for IBM's New York semiconductor manufacturing facility, and as industrial hygienist for IBM’s US headquarters. Now executive vice president of Actio, Kal taps more than 20 years' worth of chemical engineering, industrial hygiene, and environmental engineering experience. His far-reaching expertise with global regulatory challenges created by EPA, TSCA, REACH, RoHS, WEEE – and hundreds of others – aid in developing Actio software solutions for MSDS management, raw material disclosure compliance, and product stewardship in a supply chain.
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