New ‘Extended’ Safety Data Sheet in REACH

Many companies use safety data sheet software for updating, searching and viewing SDSs. What surprises people is that under the REACH regulation in Europe, companies must produce something called an extended-Safety-Data-Sheet, or e-SDS.

REACH regulation is the Registration, Evaluation, Authorization of Chemicals — Europe’s famous regulatory behemoth for managing hazardous substances in the marketplace. If you use hazardous substances registered under REACH, your suppliers now have to provide you with a new, extended safety data sheet that includes exposure scenarios.

What’s an exposure scenario?

Exposure scenarios are the new, key element in safety documentation. They include safe use conditions, the operational conditions and necessary risk management measures.

In other words, exposure scenarios say, “We tested this spray paint for spraying paint, and we assume your use will be similar.” But if you want to use the spray can to blow up a balloon, that’s a different story, and for that you will need to get a new exposure scenario from the supplier. Get more detail about exposure scenarios.

What’s in the extended-SDS?

Ideally, the extended safety data sheet should cover all uses in the life cycle of the substance, from manufacture through to waste, including:

  1. Uses within your own company
  2. Uses by your customers in their processes or products, i.e. mixtures or articles
  3. Uses by companies supplied with chemicals by your customers
  4. Thus, the extended safety data sheet provided by your supplier should include:
  5. The main technical function of the substance (e.g. flame retardant, pigment, stabilizer) and the uses covered in the exposure scenarios
  6. Threshold values of the exposure levels for human health and the environment that should not be exceeded, according to the assessment made by your supplier
  7. Physicochemical data needed to carry out exposure assessments (e.g. water solubility, vapor pressure, biodegradability)
  8. One or more exposure scenarios containing practical advice on the conditions of safe use, including risk management measures and waste management measures

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.

Kal Kawar Joins Blogging Team

I’d like to welcome our newest blogger, Kal Kawar of Actio.

A chemical regulations expert, Kal 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.

Welcome, Kal!