A framework for risk assessment of plastic additives - Part 1: fundamental elements.

There is a growing worldwide focus on evaluating the risk potential of substances associated with the manufacture and use of plastic, including the intentionally added constituents (additives) that impart specific technical functions as well as their transformation products. To enhance the consistent and effective evaluation of plastic additive uses, the European Centre for Ecotoxicology and Toxicology of Chemicals (ECETOC) is proposing a framework for risk assessment of plastic additives in complex scenarios. Here, the fundamental elements of the framework are presented, including an overview of available databases, tools and methodologies that enable the safety assessment of individual additives in plastic. The framework is comprised of five modules to identify and efficiently gather pertinent information. Data needs are tailored to the specific plastic additive and/or its major known transformation product(s) and to the scope of the risk assessment. As a risk-based approach, the five modules are pursued in an iterative, 'circular' manner. The risk assessment is terminated as soon as it is possible to either exclude risk potential or to characterise and manage any identified risks. While the framework for plastic additive risk assessment, as presented here, is applicable to individual plastic additives and/or their major known transformation products, it can be supplemented by further considerations for the assessment of aggregate or cumulative exposures and complex material cycles. Building thereupon, the second article by ECETOC shall present such further elements to consider when applying the framework for risk assessment of plastic additives at diverse recycling stages.