Classification & Labelling

The pre-existing EU chemicals legislation already requires industry to classify and label dangerous substances and preparations according to standard criteria.

REACH builds on this existing legislation but does not contain the criteria nor the obligations relating to classification and labelling. These are currently laid down in the classification and labelling section of Directive 67/548/EEC and the dangerous preparations Directive 1999/45/EC. REACH refers to this classification and labelling system, until it in future is replaced by a new Regulation on Classification, Labelling and Packaging of substances and mixtures.

REACH also specifies the obligations for substances and preparation classified as dangerous, such as making a Safety Data Sheet available or conducting an exposure and risk assessment during the course of a chemical safety assessment.

To ensure that hazard classifications (and consequent labelling) of all substances manufactured in or imported into the EU are transparent, industry will be required to submit a notification of the hazard classification to the Agency at the latest by 1 December 2010 unless already submitted as part of a registration. The Agency will then include this information in a classification and labelling inventory in the form of a database accessible via internet.

This transparency will highlight divergences between classifications of the same substance and thereby create pressure to remove them over time through co-operation between notifiers and registrants or by an EU harmonised classification.

The harmonisation of EU classifications will especially be conducted for substances that are carcinogenic, mutagenic, toxic to the reproduction or respiratory sensitisers. It is nevertheless also possible to harmonise the classification and labelling of other substances if justified at EU level. Member States can make such proposals to harmonise the classification of a substance by submitting an Annex XV dossier.

In view of the extensive global trade in chemicals and the aim to ensure safe use, transport and disposal, an internationally harmonised approach to classification and labelling has been developed by the United Nations (Globally Harmonised System for classification and labelling of chemicals, GHS). The new Regulation on Classification, Labelling and Packaging will introduce the criteria of the GHS in the EU legislation. In order to facilitate its implementation, the timing of the obligations will as far as possible be aligned with the relevant deadlines in the REACH Regulation.