The European Chemicals Agency has started to check the compliance ofdossiers for substances notified before the REACH Regulation entered into force. The focus is on those substances produced in quantities above 100 tonnes per year for which key safety information is likely to be missing.
One of the predecessors to the REACH Regulation, Directive 67/548/EEC, introduced a notification requirement for so-called new substances, not appearing on the European Inventory of Existing Commercial Chemical Substances but placed on the European market or imported into the European Community. Such notifications are regarded as registrations under the REACH Regulation.
Under the previous legislation, the Member State competent authorities had the obligation to assess notified substances if the quantity of the substance reached 100 and 1000 t, respectively, and to request additional testing as specified in the Annexes of the directive. In some cases, Member State competent authorities could not finalise their assessment because the directive was revoked when REACH entered into force.
As a consequence, there is a high likelihood that relevant safety information is missing for such substances. ECHA is therefore subjecting these substances to a compliance check. Before initiating a compliance check, the relevant companies have been informed and invited to voluntarily propose the testing required in order to be in compliance with REACH. The deadline for the provision of testing proposals was November 30 2009.
European Chemicals Agency