More information on the Environmental Protection Agency's advisory list for self classification of chemicals

Regulation

Chemical substances being marketed in the EU must be classified, packaged and labelled according to the CLP-regulation before 1st of December 2010 and chemical mixtures not later than 1st of June 2015.

The classification of mixtures is based on the classifications of each substance in the mixture, and therefore the old rules for classification and labelling of chemicals are still relevant until 1st of june 2015.
The list of dangerous substances has been transferred from the previous directive for classification and labelling (Council Directive 67/548/EEC) to the CLP-regulation (1272/2008/EU, Annex VI, Table 3.2). This list covers around 7,000 substances and substance groups, which have been classified for their dangerous properties by the EU competent authorities. This means that about 93,000 of the 100,204 existing substances in the EU (EINECS) are not formally classified with a harmonized EU classification. For these substances, it is the manufacturer or importer's responsibility to assign the proper classification of the substance's intrinsic hazardous properties ("self-classifications"). However, only a scarce number of test results (from animal studies, etc.) exist in relation to the high number of chemicals and in relation to the number of hazardous properties for which classification criteria have been established.

Substances on the advisory list

As a contribution to remedying this problem, the Danish Environmental Protection Agency published the so-called advisory list for self-classification where (Q)SAR models ((quantitative) structure-activity relationships) have been used to predict hazardous effects of chemicals. The models predict the hazardous properties of a substance using information on the structural and physical-chemical properties of the substances and compare this information with the information of similar substances with known hazardous properties. The accuracy of the models used ranges from approximately 70 to 85%. This means that there will be some substances - approx. 20% - for which QSAR models overestimate or underestimate the hazard (false positive / false negative predictions).

The models are used in a systematic assessment of the effects of 49,292 single organic substances from EINECS inventory covering the following endpoints:

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

How to use the list

Available, reliable test data or predictions using other non-test methods on specific substances should always be considered in parallel to computer predictions and expert judgements in a weight of evidence (WoE) approach to decide on the appropriate classification for a given endpoint.

It is recommended that the list is used in the following way in relation to self-classification of chemicals:

  1. Examine the existence of a harmonised classification for the substance. That means if the substance is on Annex VI, table 2 of the EU Regulation for classification, labelling and packaging of dangerous substances. If so it should be classified accordingly. For non-classified endpoints no classification can be recommended, unless new information becomes available.
  2. All reliable information must be considered together with the advisory classifications using a weight of evidence based approach. This means if the substance is not in Annex VI, table 2, it should be classified according to the criteria in the Regulation for classification, packaging and labelling of dangerous substances using all available test and non-test data.
  3. In cases where other reliable information does not exist for a substance for the endpoints covered by this list, the Danish EPA recommends the use of the advisory classifications given in the Advisory self-classification list.

International experts are behind the list

The list is based on assessments made by researchers at the Department of Toxicology and Risk Assessment from DTU National Food Institute, who for many years have contributed to international work on development, validation and dissemination of (Q)SAR models.

Read more about the advisory self classification list

Thorough documentation of the current advisory list is available as environmental projects.
Environmental project 1350, 2010 (CLP-version)
Environmental project 1322, 2010

DK-EPA published in 2001 an earlier version of the advisory list. This report was updated in the revision of the list in 2009. Both the earlier versions of the list can be downloaded here:
Environmental project 1303, 2009
Environmental project 635, 2001