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EU Regulatory Update: CLP Deadlines and Consequences
By: Annelie Struessman, PhD, CONUSBAT
Posted: March 3, 2010
The European Union’s adaptation of the Globally Harmonized System (GHS) is Regulation (EC) No. 1272/2008 on the classification, labeling and packaging (CLP) of substances and mixtures, which entered into force on Jan. 20, 2009. On Dec. 1, 2010, CLP will apply to substances and replace the Dangerous Substances Directive (DSD) (DSD/67/548/EEC), whereas the Dangerous Preparations Directives (DPD/1999/45/EC) will be affected only as of June 1, 2015, at which point both frameworks will be repealed.
The Dec. 1, 2010, deadline requires manufacturers and importers to classify, label and package substances according to CLP before placing them on the market. Also affected are: the REACH-defined substance classes (REACH Articles 6, 9, 17 and 18) that are not directly marketed; monomers; on-site isolated intermediates; transported intermediates; and substances used for product and process-orientated research and development (PPORD). The classification is part of all registration or notification information required under REACH. Registrations submitted before Dec. 1, 2010, should contain the classification and labeling according to the DSD. However, it is recommended to include CLP classification and labeling.
In preparation for a publicly accessible Classification and Labeling Inventory, CLP has its own notification provisions (CLP Article 40), which also will be effective on Dec. 1, 2010. When the CLP classification is provided in the REACH registration dossier, an additional CLP notification is not necessary. All other manufacturers or importers of substances must provide a notification to the European Chemicals Agency (ECHA) according to CLP Article 39 for the following substances:
1) Substances classified as hazardous under CLP imported or manufactured and placed on the EU market, either individually or included in a mixture above the legally defined concentration limits and irrespective of the tonnage. In other words, the requirement for notification goes beyond substances manufactured or imported in quantities of 1 tonne or more per year. Also included are polymers that fulfill the criteria for classification as hazardous and that are placed on the market; and
2) Substances subject to registration under REACH (≥ 1 tonne/year) that are not yet registered but have been placed on the market.