Cefic-lri Programme | European Chemical Industry Council

Establish a Database of Parameters Sufficient to Reliably Predict European Consumer Exposures

Background

There is a need for consensus amongst industry, academia and regulators concerning the extent to which existing consumer exposure data are sufficient to reach conclusions within those areas of EU legislation where risk assessment is undertaken; and which areas require further exploration and research. There is a need to update our current understanding of consumer product use scenarios with a programme to allow ongoing refinement as new technologies and new product uses are introduced. Although much work has been carried out to describe and at least semi-quantify the nature of these exposures for specific applications e.g. household cleaning products, cosmetics, food contact materials, personal care products, many gaps in the broader understanding still remain. For example, much of the data is regionally derived and therefore may not be truly representative throughout the European Union. There is therefore a need for a general database of human parameters, including physiological parameters for European populations and information on human lifestyles and task/activity patterns reflecting in detail the different regional habits and practices.

Objectives

Proposals
Proposals submitted for consideration should follow the format of the application from'Application for a CEFIC-LRI Grant' and should address the following areas under individual subheadings:
The title of the research proposal.
The name and affiliation of the principal investigator and the laboratory or laboratories in which the research will be conducted.
Evidence of the principal investigator's knowledge of, and contribution to, current understandings. of the role consumer exposure assessment in general, and in EU risk assessment in particular.
A clear definition of the research objectives, including a description of the mechanistic basis for the proposed research.
A clear plan of investigation, including a clearly defined milestone plan that identifies all critical decision points in the research programme.
A detailed breakdown of costs.
Monitoring
The successful applicant(s) will be required to submit a progress report every 6 months during the course of the programme. At the end of the project a detailed review of the project and the achievements made will be provided by the principal investigator, in order to ensure a working consensus exists concerning the database parameters, and that there is ownership for these within the key industry sectors. The successful applicant(s) will also be required to prepare for publication a manuscript describing the work undertaken and the results achieved.

Scope

Establish the framework/operating system for compiling and managing a database of parameters sufficient to be useful to reliably predicting consumer exposures across Europe.
Definition of the scope of in/outputs in the context of the uses to which the database can be expected to be put e.g. Product Stewardship, regulatory compliance, ESR risk assessments, predictive estimates for new substance assessments etc.
An assessment of the merits of existing and planned regulatory and in-house databases e.g. EPA, BGVV, UK MAFF, various consumer product companies.
Identifying potential contractors/software vendors.
Establishing collaborative partnerships with other interested stakeholders.
Define supporting data needs and incorporate sufficient flexibility to account for future developments such as introduction of new technologies for consumer products and of novel uses for existing product types.
Encourage the use of tools that allow the representative nature of the captured data to be critically evaluated and the data to be quantified such that statistical procedures can be performed as needed.
Procedures (and supporting systems) will also need to be developed to address issues such as the practicalities of data acquisition and supply, data identification/ anonymity sensitivities, and confidentiality. For example, development of electronic data transfer would be a preferred mechanism for data supply and entry e.g. in an IUCLID compatible format.

Cost: Estimated costs of $250,000 for the first year (12 months for initial system architecture and support processes), to commence H2/2000. Thereafter $75,000 ongoing annual maintenance.

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