REACH Update: Exposure Assessment Elements

$$item.publishDate) | Contact Author | By: Annelie Struessmann, PhD, CONUSBAT
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Title: REACH Update: Exposure Assessment Elements
  • Article

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.)

Further elements of the exposure assessment are exposure estimations and risk characterizations, which must be conducted for each ES. They also must demonstrate the risks that are controlled. Estimates on the expected exposure to humans and the environment must be compared to the no effect levels determined in the initial steps of the CSA. WIth that, the registrant demonstrates that the risks are controlled.

The detail level for an ES depends upon the use of a substance, its hazardous properties and the amount of information available. The ES should describe all relevant factors determining the exposure using a standardized structure. An ES may summarize the information for several individual processes or uses of a substance. The REACH term for an ES covering a wide range of processes or uses is Use and Exposure Category (UEC), according to definition in Article 3(38).

When a substance is used in a preparation, an ES may need to be developed for this use, and manufacturers or downstream users may initiate this process. Also, the incorporation of the substance into an article may be an identified use, which should be included in the CSR.

An ES must be annexed to a safety data sheet (SDS). Also, summaries of the results from the exposure assessment have to be added to the various chapters of the SDS. For questions on the SDS, please refer to the REACH Update Exposure Scenario Annexes and Other Changes to the SDS.

If an agreement among the members of a SIEF is reached, the Chemical Safety Report (CSR) of the substance can be jointly submitted.

Key Summary:
• A chemical safety report (CSR) is required for the registration of substances manufactured or imported in quantities of 10 tonnes or more.
• The CSR must contain a chemical safety assessment (CSA) consisting of a minimum of four steps.
• When substances are identified during the initial CSA as meeting the criteria for classification as "dangerous," additional steps for exposure assessment are requested for the CSR.
• The main element of the exposure assessment is an exposure scenario (ES).
• With the ES, the registrant must demonstrate the control of risks during manufacture for a substance and for all its identified uses.
• The ES must communicate operational conditions and risk management measures.
• When a substance is used in a preparation or in an article, it should be determined whether this is an identified use that must be included in the ES.
• The ES must be annexed to the SDS developed in accordance with Article 14 of the REACH Regulation—i.e., for substances manufactured or imported in quantities of 10 tonnes or more.

Readers are reminded that this free service provides basic answers to questions about REACH, but in-depth, consultative services are provided by CONUSBAT for a fee. CONUSBAT reserves the right to determine what information can be provided at no cost, and to refer readers to its services when detailed information is requested.