DK-EPA - Danish Advisory List
Danish Advisory List for Self-Classification of Hazardous Substances
Lack of data on hazardous properties of chemicals makes it difficult for companies to meet their obligations to self classify the chemicals they import or produce. To address this issue, The Danish Environmental Protection Agency publishes an advisory list for self classification of chemical substances – with advisory classifications of more than 54,000 substances.
The list has two main purposes:
- To help companies fulfilling their obligations according to the regulation for classification and labelling (the CLP-regulation) with self classification of the chemicals they place on the market within EU. All self classifications need to be notified (reported) to the European Chemicals Agency (ECHA).
- To help companies to decide, whether they can make a restricted registration for low tonnage substances under REACH or if a full data set is required for the given substance. REACH Annex III contains specific rules governing low tonnage substances (1-10 ton per year), which need to be registered no later than 2018. Low tonnage substances only initiate the information requirements in REACH Annex VII, if (Q)SAR models or other knowledge indicate that the substances may fulfill classification criteria as a) CMR or b) other hazard classifications combined with widespread use.
How to use the list
The advisory classifications are based on predictions of hazardous properties of chemicals from computer models - so-called (Q)SARs - which has a built-in uncertainty. Statistical methods estimate that the predictions are correct in approximately 80% of the cases. Therefore, in relation to self-classification of chemicals, the Danish Environmental Protection Agency (EPA) recommends that:
- If a substance has an EU-harmonised classification, then this harmonised classification must be followed and the advisory classification should be neglected.
- All reliable information (test data and other types of information) must be considered together with the advisory classification using a weight of evidence based approach. This means that if the substance does not have an EU-harmonised classification it should be classified according to the criteria in the CLP Regulation using all available test and non-test data.
- In cases where no other reliable information exist for a substance for the endpoints covered by this advisory list, the Danish EPA recommends the use of the advisory classifications given in the Advisory self-classification list.
Additional information on self-classification and the advisory list
The list is based on (Q)SAR predictions conducted by the Research Group for Molecular and Reproductive Toxicology from DTU National Food Institute, who has been an essential part in the international work on development and extending the use of (Q)SARs. (Q)SAR predictions are combined in algorithms, which to the extent possible reflect the rules of classification. These algorithms are developed in cooperation with the Danish EPA.
The advisory list for self classification was first published in 2001 and was updated in 2010 to include classifications according to the CLP regulation. Since then, the list has gone through an extensive update. More information is available in the brief documentation.
The list includes advisory classifications on:
- Mutagenicity
- Carcinogenicity
- Reproductive toxicity
- Acute toxicity, oral
- Skin irritation
- Skin sensitization
- Hazards to the aquatic environment