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Towards improved safety assessment of combined exposure to chemicals

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Nov 24, 2014
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The report "Assessment of Mixtures – Review of Regulatory requirements and Guidance" provides an overview of EU regulations and risk assessment regimes and requirements regarding potential mixtures effects

In the context of the initiative launched by the Commission to ensure that risks associated with cumulative and combined exposure to chemical mixtures are properly understood and assessed (The combination effects of chemicals Chemical mixtures - COM/2012/0252 final), the JRC has published a comprehensive overview of methodological approaches and regulatory requirements for assessing the toxic effects of chemical mixtures. Humans and the environment are continuously exposed to a multitude of substances whose combined effects need to be evaluated in addition to the effects of the individual substances. The extensive state-of-the-art review supports the EU policy on combined exposure of chemicals and chemical mixtures and promotes a basis for the safe use of chemicals and mixtures covered under EU legislation.

The report "Assessment of Mixtures – Review of Regulatory requirements and Guidance" (downloadable below) provides an up to date overview of EU regulations and risk assessment regimes and requirements regarding potential mixtures effects. It introduces the theory and current methodologies underlying the risk assessment of chemical mixtures, and summarizes the regulatory requirements linked both to intentional mixtures (such as plant protection products, cosmetics, biocides), and to generated or coincidental mixtures (for example chemical residues present in drinking water), taking into consideration more than 20 pieces of the European legislation. It also focuses on existing guidance on mixture toxicity assessment in Europe, the USA and Canada, as well as on existing guidance from major international bodies. It provides a valuable resource for any actor interested in the risk assessment of chemical mixtures such as regulatory bodies, industry and other non-governmental organisations.

In general, the assessment of the risks to humans and the environment resulting from long term exposure to low doses of chemical mixtures is mainly based on in vivo toxicity data generated from exposure to a single substance (or specific mixture) through a single exposure route and medium. However, to safeguard public health and environment, it is essential to take into account the combined exposure, including potential interactions that can influence the overall effect. Moreover, as it is legally established within the EU to reduce the use of laboratory animals and promote alternative methods, in vivo testing of the whole mixture is in many cases not allowed or should be avoided. Therefore, since current risk assessments of chemicals are conducted for defined uses within specific pieces of EU legislation, there is a need to develop a consistent, cross-sector approach to deal with the combined exposure to multiple chemicals.

See also full reference of the Report in the JRC Publication Repository