EU Regulatory Update: Deadlines loom for EU Classification, Labelling and Packaging Regulation
The provisions of the new EU Classification, Labelling and Packaging Regulation 1272/2008 (the "CLP Regulation"), based on the United Nations Globally Harmonized System, will replace the Dangerous Substances Directive 67/548/EEC (the "DSD Directive") and the Dangerous Preparations Directive 1999/45/EC (the "DPD Directive") in a stepwise approach. Industry needs to establish what the hazards of substances and mixtures are before they are placed on the market, classify them in line with the identified hazards, and label and package hazardous substances and mixtures so that workers and consumers know about their effects before they handle them. The CLP Regulation requires that the EU Member States introduce penalties for non-compliance with its provisions. For example, in the UK, national enforcement provisions provide maximum penalties of an unlimited fine and/or up to two years' imprisonment following conviction on indictment for relevant infringements.
1. Obligation to notify the European Chemicals Agency
Under the CLP Regulation, manufacturers and importers in the EU (including US-based companies which import substances into the EU) will need to notify certain substances to the Classification and Labelling ("C&L") Inventory maintained by the European Chemicals Agency by January 3, 2011 unless they have already submitted a registration under the EU REACH chemical substances legislation for the substance.
Under the CLP Regulation, this notification requirement applies to:
- Substances subject to registration under REACH and placed on the market;
- Substances classified as hazardous under the CLP Regulation and placed on the market, irrespective of the tonnage band; and
- Substances classified as hazardous under the CLP Regulation and present in a mixture above certain concentration limits which results in the classification of the mixture as hazardous, and where the mixture is placed on the market.
2. Obligation to classify, label, and package substances
Manufacturers, importers and downstream users in the EU will need to classify, package and label substances or mixtures in accordance with the CLP Regulation before placing them on the market. This obligation is independent of the tonnage to be placed on the market. Furthermore, manufacturers and importers in the EU will need to classify substances which are not placed on the market if they are subject to registration or notification in accordance with REACH. The following timelines shall apply:
- From December 1, 2010, substances must be classified using the provisions of the CLP Regulation. Until June 1, 2015, a classification under the DSD Directive must also be provided alongside any CLP Regulation classification.
- From December 1, 2010, substances must be labelled and packaged in accordance with the CLP Regulation only. Prior to December 1, 2010, substances must continue to be classified, labelled and packaged in accordance with the DSD Directive. However, substances may also be classified, labelled and packaged in accordance with the CLP Regulation before that date, in which case the provisions regarding labelling and packaging in the DSD Directive shall not apply.
- From June 1, 2015, mixtures must be classified, labelled and packaged using the provisions of the CLP Regulation only. Prior to June 1, 2015, mixtures must continue to be classified, labelled and packaged in accordance with the DPD Directive. However, mixtures may also be classified, labelled and packaged in line with the CLP Regulation before that date in which case the provisions regarding labelling and packaging within the DPD Directive will not apply.
It is advisable for suppliers of substances or mixtures in the EU to:
- Develop a company inventory of their substances and mixtures, including those substances contained in mixtures; (this information may have already been collected in relation to REACH);
- Assess the need for training of the appropriate technical and regulatory staff in their company;
- Begin to notify, classify, label and package the substances and mixtures in line with the CLP Regulation as soon as possible rather than waiting for the deadlines;
- Update Safety Data Sheets if the classification of a substance or a mixture changes as a result of implementing the CLP Regulation.
In order to obtain assistance for compliance with the CLP Regulation or any other EU regulatory issues, please contact the professional listed to the left, or your regular Crowell & Moring contact.
For more information, please contact the professional(s) listed below, or your regular Crowell & Moring contact.