The first deadline to register so-called phase-in substances (already existing chemicals) with the European Chemicals Agency (ECHA) under Regulation EC/1907/2006 on the Registration, Authorisation, Evaluation and Restriction of Chemicals (REACH) ended at midnight, 30 November 2010.
The 30 November 2010 deadline was crucial for phase-in substances manufactured in the Community or imported in quantities above 1000 tonnes per year, substances very toxic to the aquatic environment (R50/53) over 100 tonnes per year and CMR substances, categories 1 and 2 pursuant to the Dangerous Substances Directive 67/548/EEC (corresponding to categories 1A and 1B pursuant to Regulation EC/1272/2008 on the Classification, Labelling and Packaging of substances and mixtures – CLP Regulation), in quantities above 1 tonne per year. Substances meeting these criteria, but not registered by 30 November 2010 cannot be placed on the European market after 1 December 2010.
Registration is considered as one of the key tools of the REACH Regulation for chemical risk management. The REACH Regulation states as a principle that substances manufactured in the Community or imported in a quantity of 1 tonne or above per year and manufacture cannot be placed on the EU market, unless they have been registered with ECHA (no data, no market). The registration requirement for substances has applied since 1 December 2008, but phase-in substances pre-registered between 1 June 2008 and 30 November 2008 benefit from extended registration deadlines (2010, 2013 and 2018). These pre-registered substances could continue to be marketed after 1 December 2008, before a full registration dossier is submitted in accordance with the relevant phase-in periods.
ECHA received a total of 24,675 chemical registration dossiers by companies covering around 4,300 substances, including about 3,400 phase-in substances to which the first registration deadline applied. The number of registration dossiers received for substances having a harmonised classification at EU level as CMR was indicated with 400 and more than 150 for substances classified as very toxic to the aquatic environment. These figures were published by ECHA on 1 December 2010, the day following the deadline. The final number of successful registrations and substances, however, will be made available by ECHA in the coming weeks after all submitted dossiers have been processed. ECHA will carry out an accuracy inspection for 5% of the submitted dossiers for each tonnage band. All non-confidential information provided by registrants in the dossiers will be made available to the public on the ECHA website over the coming months. ECHA will also investigate why the number of registered substances by 30 November 2010 is lower than expected based on information received by industry. A list of substances identified for registration in 2010 published by ECHA contained about 4,900 substances, of which 2,921 had already been registered by 30 November 2010. This list indicated 224 substances which will not be registered in 2010.
Germany was the Member State from which the highest number of registrations were received (23%), followed by the United Kingdom (12%) and the Netherlands and France sharing the third position (9%). ECHA highlighted that registrations were received from companies from all Member States. Large companies accounted for around 86% of the total registrations, while 14% of the registration dossiers were submitted by medium, small and micro-sized enterprises. 82% of the registrations accepted for processing by ECHA were submitted jointly by member registrants, while joint registrations by lead registrants accounted for 12% and individual registration dossiers for 6% of the total submissions.
ECHA identified only 17 cases where companies have asked to be granted an exemption from 30 November 2010 registration deadline based on the guidance published by ECHA earlier in 2010, identifying 28 different scenarios under which exceptions were defined to be possible.
Even though this first challenge under REACH was successfully mastered by registering companies, the next important deadline will not take a long time in coming: by 3 January 2011 companies have to notify substances to the classification and labelling inventory (C&L Inventory), newly established under Regulation EC/1272/2008 on the Classification, Labelling and Packaging of substances and mixtures (CLP Regulation). This notification applies only if the registration dossiers submitted by 30 November 2010 did not contain the classification and labelling information for a substance in accordance with the CLP Regulation, but according to the Dangerous Substances Directive 67/548/EEC. The aim of the C&L Inventory is to build up a database with basic information from manufacturers and importers of substances on their classification and labeling.
Furthermore, ECHA stated in this context that the information needed for future registrations was modified with effect from 1 December 2010, resulting from the entry into force of provisions of the CLP Regulation applicable to substances. All registration dossiers submitted from 1 December 2010 will have to contain the classification and labeling criteria in accordance with the requirements of the CLP Regulation.
The two remaining REACH registration deadlines for phase-in substances are:
31 May 2013 for phase-in substances manufactured or imported in quantities over 100 tonnes or more per year and manufacturer in the Community or per importer at least once after 1 June 2007:
31 May 2018 for phase-in substances manufactured or imported in quantities over 1 tonne or more per year and manufacturer in the Community or per importer at least once after 1 June 2007.
– Judit Beress, EHS Consultant