Chemicals: classification, labelling and packaging of substances and mixtures. Downstream legislation - Regulation

PURPOSE: to amend an existing Regulation to the provisions of the proposal for a Regulation on classification, labelling and packaging of substances and mixtures which will repeal and replace Directives 67/548/EEC and 1999/45/EC.

PROPOSED ACT: Regulation of the European Parliament and of the Council.

CONTENT: this proposal accompanies the Commission proposal for a Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (see COD/2007/0121). The latter proposal builds on existing chemicals legislation and establishes a new system on classification, labelling and packaging of hazardous substances and mixtures by implementing in the EU the international criteria agreed by the United Nations Economic and Social Council (UN ECOSOC) for the classification and labelling of hazardous substances and mixtures, called the Globally Harmonised System of Classification and Labelling of Chemicals (GHS).

Classification of substances and preparations under the currently applicable Directives 67/548/EEC and 1999/45/EC triggers other obligations in EU legislation, referred to as “downstream legislation”.

The Commission services have assessed the potential effects of the implementation of the GHS criteria on downstream legislation. Their analysis concludes that effects are either minimal or can be minimised by appropriate changes to particular downstream acts. This proposed Regulation aims to make such changes to such a downstream act, through amendments which take account of the effects of the proposal on classification, labelling and packaging of substances and mixtures. It is presented together with a proposed Decision aiming to make changes in order to address the effects of the proposal on classification, labelling and packaging for six existing Directives (see COD/2007/0212).

The criteria for the classification of substances and mixtures as hazardous and the rules on the labelling and packaging of hazardous substances and mixtures are contained in the proposal for a Regulation on classification, labelling and packaging of substances and mixtures. To ensure legal certainty and clarity of the obligations of the operators concerned, the provisions of Regulation (EC) 648/2004 should be amended to reflect the new situation. This proposed Regulation amends an existing Regulation to the provisions of the proposal for a Regulation on classification, labelling and packaging of substances and mixtures which will repeal and replace Directives 67/548/EEC and 1999/45/EC. The objective is to reflect the introduction of a new Regulation on classification, labelling and packaging of substances and mixtures and of new terminology for a Regulation which refers to classification of substances or mixtures. The term “mixture” is introduced to replace the term “preparation”, in line with the proposal on classification and labelling of substances and mixtures.

The Commission launched a public stakeholder consultation on the proposal for a Regulation on classification, labelling and packaging of substances and mixtures on the internet: 97% of the responses support the implementation of the GHS in the EU. Overall the draft proposals of the Commission services were well appreciated by Member State authorities and industry. A majority of respondents (59%) supported neither extending nor lowering the level of protection in comparison with the current EU system, except where necessary to ensure consistency with transport legislation or with the GHS.