REACH Update: Exposure Assessment Elements
By: Annelie Struessmann, PhD, CONUSBAT
Posted: August 19, 2009
Article 14 of the REACH regulation requires a Chemical Safety Report (CSR) for all substances subject to registration in quantities of 10 tonnes or more per year and per registrant. The provisions of how to assess a substance and prepare a CSR are outlined in Annex I. The CSR must contain a chemical safety assessment (CSA) with a minimum of four steps:
1. A human health hazard assessment;
2. A physicochemical hazard assessment;
3. An environmental hazard assessment; and
4. A persistent, bioaccumulative and toxic (PBT), and very persistent and very bioaccumulative (vPvB) assessment.
Regarding substances used as ingredients in cosmetic products, which are regulated within the scope of the Cosmetics Directive 76/768/EEC, the CSR does not require information on risks to human health.
If results of the four initial assessment steps conclude that the substance meets the criteria for a classification as "dangerous" according to Regulation (EC) No 1272/2008 CLP, or the substance is assessed to be a PBT or vPvB, additional steps for exposure assessment must be performed and added to the CSR.
The main element of this additional exposure assessment is an Exposure Scenario (ES), which considers the life cycle of a substance including the production by the manufacturer and all of its identified uses. In addition, the manufacturer or importer has to describe how to control the exposure to humans and the environment to the substance. As such, the ES should communicate operational conditions such as quantities handled, duration and frequency of use, the process temperature, pH, etc., and the risk management measures such as emission or exposure determinants (waste water treatment, local exhaust ventilation, etc.)