Analysis of exposure to chemicals is a key area of regulatory compliance. In Europe most legislation (REACH, IED) places important responsibilities on chemical suppliers and downstream industrial users or formulators.
Exposure assessment of a chemical substance involves identifying all the different ways that humans and the environment may be exposed to it throughout its life cycle, from manufacture to disposal, demanding detailed knowledge of the various ways that the chemical is used. Site-specific knowledge may be important.
Suppliers and downstream users are presented with a complex set of challenges, including:
- realistic modelling of exposure
- managing identified risks
- modifying on-site operational protocols.
Companies may need to exchange information when co-operating in the supply chain or collaborating within a sector, consortium or joint submission.
It is important that risk assessments reflect realistic uses and conditions of use, based as much as possible on the current practices in industry.
In the context of the REACH Regulation, regulators and industry sector groups have been active in making available generic tools and reference materials, such as:
- Use Maps generated by downstream user sector organisations, who have collected information on the uses and the conditions of use of chemicals in their sector;
- SPERC (Specific Environmental Release Category) Factsheets, summarising emission estimations that have broad applicability within a specified use;
- ENES (Exchange Network on Exposure Scenarios) forum for information-sharing, support, and input of all stakeholders.
In REACH dossier and substance evaluations, the authorities are now focusing on exposure scenarios, and registrants are already receiving demands for additional information on exposure and risk reduction measures from ECHA and Evaluating Member State Competent Authorities. This is likely to increase in future! Both human and environmental exposure are under scrutiny.
Any parameters used in the exposure assessment that are not the conservative, generic ‘defaults’, may need further justifications to demonstrate that they are appropriate and applicable – registrants should be preparing for this.
PFA can offer you a strong and experienced exposure assessment team. We have:
- Extensive skills in the exposure assessment of substances, including UVCBs
- Wide expertise in using exposure assessment models – standard models and project specific
- Carried out many REACH exposure assessments for various clients, including collection and interpretation of measured data
- Team members that were involved in the development of numerous emission scenario documents (ESDs) adopted by OECD.
PFA offers services relating to exposure for registrants and downstream users and user groups.
PFA provides services to REACH registrants in:
- Maintaining the registration dossier post-registration, ensuring integration of new exposure information on a voluntary basis.
- Addressing queries arising within the joint submission and supply chain.
- Acting on feedback received from regulators, e.g. decision letters.
- Planning more widespread activities, such as monitoring at industrial locations, to support and validate environmental modelling.
The PFA team has extensive expertise with developing Exposure Scenarios. We are regular users of the recognised exposure modelling tools including:
- CHESAR (Chemical Safety Assessment and Reporting);
- EUSES (European Union System for the Evaluation of Substances);
- ECETOC TRA (Targeted Risk Assessment);
We can also help with refinement, validation and site-specific assessment.