The CLP Regulation

In accordance with the criteria set out in the CLP Regulation, all chemical substances and mixtures placed on the market in the EU must be classified into hazard classes and hazard categories according to their hazardous properties (physical hazards, health hazards, environmental hazards). A hazard class is further subdivided into hazard categories, thus permitting differentiation within a hazard class between different degrees of severity of a hazard (e.g. the "acutely toxic" hazard class with hazard categories 1 to 4, where category 1 indicates the highest hazard level).

Labelling includes the globally standardised hazard statements (H statements), precautionary statements (P statements) and GHS hazard pictograms; supplementary EUH statements apply in addition throughout the EU. These label elements are intended to provide users of a substance or mixture with information on the associated risks and to ensure safe handling of the chemicals. Labels and safety data sheets are used for labelling and communication of the hazards.

For substances and mixtures posing hazards such as respiratory sensitisation, germ cell mutagenicity, carcinogenicity, reproductive toxicity and endocrine disruption or that are persistent, bioaccumulative or toxic, the EU reserves the right to specify classification, labelling and harmonisation (CLH), also termed legal classification. This classification is performed in a defined process (the CLH process) in response to proposals by Member States, manufacturers, importers or downstream users. The Committee for Risk Assessment (RAC) of the European Chemicals Agency (ECHA) reviews the proposal with reference to scientific findings and prepares a classification dossier (CLH dossier) for public consultation. Based upon these results, the European Commission adopts a delegated act establishing the harmonised classification.

Substances with a harmonised classification are listed in Table 3 of Annex VI to the CLP Regulation. This information is continually supplemented with new harmonised classifications by way of ATPs (Adaptations to Technical and Scientific Progress).

Where a substance is listed in Table 3, Annex VI, a manufacturing or importing company must adopt the listed harmonised hazard classes and hazard categories (CLP, Article 15 (4)). No changes may be made to the hazard classes and hazard categories listed in Table 3.

Exceptions are the “minimum classifications”, which are defined in Annex VI, No 1.2 of the CLP Regulation. These are a result of conversion of classifications from Directive 67/548/EEC, now repealed, to the hazard classes and hazard categories of the CLP Regulation. Minimum classifications are marked */**/*** or **** in Table 3.

Where a minimum classification is stated, the manufacturer or importer is obliged to check it and, should he have new information, adapt the classification. Should a change be made to the minimum classification, it may only be made more severe.

Minimum classifications may relate to:

• the hazard category (*) (e.g. for the "acute toxicity" hazard class),
• the route of exposure (**) (e.g. for the "specific target organ toxicity" (STOT) hazard class), or
• the specific effect of concern (***) in the case of hazard statements H360/H361.
• If a physical hazard is specified as the minimum classification (****), the manufacturer/importer must review it and, if appropriate, assign a more severe hazard category or even, if necessary (for physical hazards only), reclassify it in a more severe hazard class.

Responsibility for the classification and labelling of hazardous substances and mixtures – with the exception of harmonised classifications – lies with the manufacturers, importers and downstream users (e.g. when formulating mixtures). They are required to make the identified hazards available to all parties in the supply chain, including consumers, in a suitable form.

Manufacturers, importers and downstream users are required under Article 15 (1) CLP to make themselves aware of new scientific and technical information that may affect the classification of the substances or mixtures they place on the market, and to adapt the classification accordingly.

In the case of a harmonised classification, manufacturers, importers and downstream users must adopt the hazard classes and hazard categories listed in Annex VI, Table 3. In the process, they must supplement the harmonised classification with further hazard classes should they have information that requires classification in a further hazard class. If, in their view, the harmonised classification must be made more severe, a CLH process must be followed.