Niemelä, Jay Russell2; Wedebye, Eva Bay2; Nikolov, Nikolai Georgiev2; Jensen, Gunde Egeskov2; Ringsted, Tine3; Ingerslev, Flemming4; Tyle, Henrik4; Ihlemann, Christina4
1 Division of Toxicology and Risk Assessment, National Food Institute, Technical University of Denmark2 National Food Institute, Technical University of Denmark3 National Institute of Aquatic Resources, Technical University of Denmark4 Environmental Protection Agency
DK EPA Environmental project No. 1303 2009
All chemical substances marketed in the EU must be classified and labelled according to the regulation on classification and labelling of dangerous substances (7). Substances with harmonised classifications adopted in the EU are to be found on the List of harmonised classification and labelling of hazardous substances (Annex VI of 1272/2008/EU). This list covers around 7000 substances which have been classified for their hazardous properties. However, this also means that about 93,000 of the 100,204 existing substances in the EU (EINECS list), are not formally classified. With these substances, it is the manufacturer's or importer's responsibility to carry out an appropriate classification of the dangerous intrinsic properties (“self-classification”). In most cases, no test data (from animal testing, etc.) is available on their hazardous properties in relation to human health or the environment. To address this issue, the Danish Environmental Protection Agency published the Advisory Self-classification List /5/. This report describes the updating of this list. The Advisory Self-Classification list is created by the use of (Q)SARs ((Quantitative) Structure-Activity Relationships) to predict the effects of chemicals. The updated Advisory Self-Classification list contains the results of a systematic assessment of 49,292 discrete organic EINECS substances in relation to the following endpoints for which new and/or improved (Q)SAR model predictions were available: o Mutagenicity o Carcinogenicity o Reproductive toxicity (possible harm to the unborn child) o Danger to the aquatic environment The advisory classifications for mutagenicity, carcinogenicity and danger to the aquatic environment are updates of the advisory classifications on the previous self-classification list. Reproductive toxicity is a new endpoint on the self-classification list. Advisory classifications from the previous advisory list for two endpoints have not been updated in the current project. For these endpoints the advisory classifications from the previous list still apply (and are not discussed further in this report): o Acute oral toxicity o Skin sensitisation The updated advisory list is available as an Excel file for download from DK-EPA's website and as an online searchable database. This includes the 23,922 chemicals with new advisory classifications resulting from this project, making in all, a total of 30,179 chemicals with advisory classifications, either from this project, or with advisory classifications for acute oral toxicity or skin sensitisation from the previous advisory list. The advisory classifications are made by using combinations of (Q)SAR models relevant for each classification endpoint . This report describes the methodology and the models applied. Further updates of the advisory list are also under consideration. One relevant update would be to modify it to meet the criteria set out in the new CLP-regulation for the classification and labelling of chemicals. The list could also be updated based on new or updated (Q)SAR model predictions for other endpoints.