A.I.S.E. REACH implementation and communication support

A.I.S.E. use information to support preparation of registration dossiers and communication in the supply chain

A.I.S.E. REACT: Reach Exposure Assessment Consumer Tool

The A.I.S.E. REACT Consumer Tool allows quantitative estimation of systemic consumer exposures to substances that are present in preparations used by consumers. The tool calculates substance exposure via inhalation, dermal, and oral routes separately and also provides a summation of all the relevant exposure routes. The tool can also calculate Risk Characterization Ratios (RCR) for the different exposure routes separately and for the overall exposure. RCRs are only calculated provided that substance specific hazard data values (e.g., DNELs) are entered in the User Input worksheet by the user. The tool does not provide hazard data values and these need to be defined by the user.
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This User Manual provides guidance for working with the A.I.S.E. REACT Consumer Tool.
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Tiered approach for exposure assessment, including table of “Habits and Practices” for consumers

Table 4: Product categories for which quantification of exposure is addressed by HERA methodology, to be considered as guidance for exposure scenarios.

Note: Accidental exposure is indicated only for product stewardship reasons, not for Exposure Scenarios development.

Table 5: Habits and practices for a range of detergents and cleaning products used in the consumer sector (human health part)

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As the ECHA guidances on information requirement and chemical safety assessment indicates a “tiered” or staged approach to exposure assessment is recommended.

A.I.S.E. believes that both simplicity and flexibility are essential for exposure assessment. Applying a tiered approach is the only way to keep the workload manageable.
In general, such a tiered approach would entail:

1. Using the ECETOC Targeted Risk Assessment tool and scenarios as a first step, where applicable. Other tools may also be considered. 
2. Refine the exposure assessment by using higher-tier tools when necessary.

The diagram below graphically represents exposure assessment tools that apply at each “Tier”/level:

• Tier 1: 'Easy' cases are dealt with by Tier-1 assessments. A.I.S.E. supports the substance suppliers in their exposure assessments by providing them with information on uses as outlined in the following link: Use description and mapping for cleaning and maintenance products. This basic use information (use descriptors) serves to direct the assessment using the ECETOC TRA exposure estimation tool.
• Tier 1.5: For refining the Tier-1 exposure estimations, A.I.S.E. has collected additional information. It includes refined exposure parameters such as duration and frequency of exposure (workers, consumers, and environment), refined emission fractions (environment), and possible risk management measures (workers, consumers, and environment). The information has been collected among other as part of the HERA project (http://www.heraproject.com). This additional information can be processed in the ECETOC TRA exposure assessment tool. A.I.S.E. refers to the resulting assessments as Tier 1.5 assessments.
• Higher-Tier: the additional information also serves as input for Tier 2 exposure estimations. The above diagram shows an arbitrary selection of higher Tier exposure assessment tools which may be found appropriate and are frequently applied in our sector.
  Measurements: finally, the assessor may come to the conclusion, that exposure estimation is insufficient to demonstrate that the use is safe. In that case, exposure measurements represent an additional option.

  For more information on uses and exposure see section:
  Use description and mapping for cleaning and maintenance products

• Higher-tier assessments: More detailed information on “operational conditions” for a range of detergent products used by consumers is made available in the Table of Habits and Practice below. This information was originally developed under the voluntary risk assessment HERA project http://www.heraproject.com). Such detailed information would primarily be used when “higher-tier” tools need to be considered.

Table 4 below illustrates the exposure routes, by product category (for consumer uses only), that may require in-depth assessment for human health.
Table 5 shows the detailed operational conditions (habits and practices) for the range of A.I.S.E. consumer products.