CLP Regulation

On 20 January 2009, the European GHS Regulation (EC) no. 1272/2008, referred to as the CLP (Classification, Labelling and Packaging) Regulation, came into force. The coming into force of this Regulation marked the trans-European introduction of a new system for the classification, labelling and packaging of substances and mixtures. EC Directives 67/548/EEC (Dangerous Substances Directive) and 1999/45/EC (Dangerous Preparations Directive), which form the current legal basis for the existing classification and labelling system, will be repealed with effect from 1 June 2015. Long transition periods have been provided for the changeover to the new regulation. Thus the EU GHS must be applied to substances from 1 December 2010, and to mixtures from 1 June 2015.

In contrast to Directives 67/548/EEC and 1999/45/EC, which had to be transposed into national law, Regulation 1272/2008 and the REACH regulations (1907/2006) are directly applicable in the EU Member States. Until the end of the transitional periods, therefore, it is possible to place a chemical on the market using either the ”old” EU or the new GHS labelling system. "Dual labelling" with both labelling elements is however not permissible at any time.

The list of the harmonised classification and labelling of certain dangerous substances contained in Annex I of the Dangerous Substances Directive (67/548/EEC) was included in Annex VI, Table 3.2 of the new CLP Regulation; Table 3.1 contains its "translations" according to GHS. Further information can be found on the website of the European Chemicals Agency in Helsinki.

Harmonised classification (legal classification) results from the inclusion into the list of substances in Annex VI of the CLP Regulation (formerly Annex I Directive 67/548/EEC). The principle established by the Dangerous Substances Directive is thereby retained, according to which the supplier of a substance categorised according to harmonised criteria is obliged to adhere to the legal classification requirements.

In future new legal classifications for industrial chemicals will normally be restricted to CMR substances and respiratory sensitisers. Legal classifications for other substances will only be undertaken in individual cases – if regulation at EU level is necessary. It is thought that this is the case for active substances in biocidal and plant protection products and that legal classification will continue to be necessary for these substances in future. The harmonised list is therefore expandable.

The transposition of the harmonised classifications in Annex I of the Dangerous Substances Directive into corresponding classifications pursuant to the CLP Regulation was not unambiguously possible for all properties. The CLP Regulation here calls upon the principle of minimum classification. According to this, it is in the first instance the less stringent classification which applies in those cases – in other words, those classes – for which no simple transposition into the GHS system was possible. Dies ist z. B. bei der akuten Humantoxizität der Fall.If, however, the person responsible for the classification has access to data which necessitate the application of more stringent classification, he is then obliged to adapt the classification accordingly. This applies, for example, to cases of acute human toxicity.

The GHS itself is to be understood as a "living document", i.e. it is still undergoing development. In the environment field in particular there is still much to do. The Federal Environment Agency is actively participating in the development of the system of classification and labelling of environmentally hazardous chemicals and is involved in the work of OECD expert groups . Focal points in the further development of the GHS are the creation of classification systems for aquatic and terrestrial toxicity, as well as for substances hazardous to the ozone layer.

Classification and labelling of environmentally hazardous substances

An important part of the CLP Regulation is the hazard class of environmentally hazardous substances and mixtures - more precisely, that of substances and mixtures hazardous to the aquatic environment. There is already a parallel additional EU hazard class for substances hazardous to the ozone layer. The GHS will soon also contain the criteria for the classification and labelling of environmentally hazardous substances with terrestrial toxicity. The hazard class ”hazardous to the aquatic environment” is subdivided into the following categories:

In the context of the REACH Implementation Project 3.6 (RIP 3.6) guidelines are currently being developed for the application of the provisions of the new regulation on the classification, labelling and packaging of substances and mixtures. For questions on the classification and labelling of environmentally hazardous substances and mixtures we are the correct point of contact.