Summary

The Advisory list for self-classification of dangerous substances

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 included in 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 classified in a harmonised way. For 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 however, there are currently no test data (from animal testing, etc.) available on their properties in relation to human health or the environment hazards.

To address this issue, the Danish Environmental Protection Agency published the Advisory self-classification list in 2001 /5/.

The Advisory self-classification list is created by the use of (Q)SARs ((Quantitative) Structure-Activity Relationships) to predict the intrinsic properties and harmful effects of chemicals.

The updated Advisory self-classification list contains the results of a systematic assessment of 49,292 discrete^[1] organic EINECS substances in relation to the following endpoints for which new and/or improved (Q)SAR model predictions were available:

Mutagenicity
Carcinogenicity
Reproductive toxicity (possible harm to the unborn child)
Acute oral toxicity
Skin irritation
Danger to the aquatic environment

The advisory classifications for mutagenicity, carcinogenicity, and danger to the aquatic environment are 2009 updates of the advisory classifications on the 2001 self-classification list, and reproductive toxicity is a new classification endpoint from 2009 /62/.

Acute oral toxicity is a new 2010 update of the advisory classifications from 2001, and skin irritation is a new 2010 endpoint.

The Advisory self-classification list also contains the 2001 results of a systematic assessment of approximately 47,000 EINECS substances for the following endpoint /5/:

Skin sensitisation

For the classification endpoint skin sensitisation the advisory classifications of the Advisory self-classification list (2001) has been maintained. The reason is that technical issues related to new modelling tools prevented the update of these advisory classifications.

The updated advisory list is available as an Excel file for download and as an online searchable database from DK-EPA's website (http://www.mst.dk).

The consolidated Advisory self-classification list including the current 2001, 2009 and 2010 advisory classifications contains 34,292 chemicals with advisory classifications for one or more of the selected endpoints.

The advisory classifications are made by using combinations of (Q)SAR models relevant for each classification endpoint . This report describes the basic methodology used and how specific model predictions have been applied.

This report is an update of the report published in October 2009 /62/. One further update of the advisory list is planned; to modify the advisory classifications to meet the classification criteria set out in the new CLP-regulation for the classification and labelling of chemicals /7/.

[1] Discrete organic substance means organic substances with an unambiguous 2D structural formula.