The REACH panel at the 2010 UEIL Congress
UEIL Congress delegates will have the opportunity to ask questions and explore with an eminent panel of industry and regulatory experts pertinent aspects of the REACh legislation.
Many of the critical strands of European chemical regulations are coming together by the end of this year. 2010 is the second, critical, milestone in the evolution of REACH, the Restriction, Evaluation, Authorisation (and Restriction) of Chemicals. The most complex of all chemical legislation anywhere in the world is now about to enter a defining phase. Earlier, during the latter half of 2008 all chemicals manufactured or imported into the EU at greater than one tonne per annum underwent a pre-registration process to allow their continued commerce. By 1st December 2010, those pre-registered chemicals manufactured or imported at greater than 1000 tpa, or are Substances of Very High Concern (SVHC), will have to have a full registration dossier prepared and submitted to the European Chemicals Agency (ECHA) in Helsinki. This dossier, prepared by the use of software known as IUCLID 5.2, will need to contain detailed information on the identification, uses, and hazards of the substance, together with a Chemical Safety Report and the preparation of an extended safety data sheet if the substance is determined to be hazardous.
Since this is the first tranche of registrations in bulk, industry and its advisors are using novel techniques and software where there has been little prior experience. Significant amounts of data are being generated and processed ready to be submitted to ECHA. ECHA is providing assistance by the publication of strategic and technical guidance with the intention to facilitate a smooth registration process. A key area that is occupying much time and effort is in the preparation of the Chemical Safety Assessments and the Chemical Safety
Reports. This requires the use of various software tools to integrate industry, professional and consumer exposure data, together with toxicology and ecotoxicology hazard data. Many of these high volume substance producers are working in consortia to pull together the various strands of the Registration process, to facilitate the provision of exposure data, and to share as much information as legally possible without contravention of the strict EU competition rules. Nevertheless, Consortia are not legally required within REACH, where it is the Substance Information Exchange Forums (SIEFs) that prepare and submit joint dossiers via a Lead Registrant.
In parallel to the REACH process, and somewhat eclipsed by it, is the requirement to notify the hazard classifi- cation of all substances on the EU market to ECHA. This has to take place by 3rd January 2011 if substances are on the market on 1st December 2010. It is unclear whether all companies affected by this Classification, Labelling and Packaging (CLP) Regulation are fully aware of their obligations and the work involved in preparing and submitting the Notifications should not be underes- timated. This is particularly relevant since if no adequate and reliable physico- chemical data is available for a number of endpoints, then it has to be generated before Notification.
The REACH panel at the UEIL Congress will explore these and other REACH- related issues by means of an interactive discussion, with representatives from industry and regulators present to provide an insight into the issues, problems and potential solutions. The
theme for the panel will be ‘Preparing for REACH’, and will include the current status and its implications, Chemical Safety Reports, the Safety Data Sheet, and preparing for Authorisation.
Paul Whitehead Principal Consultant, wca environment limited
LINK
www.wca-environment.com
PAUL WHITEHEAD
Paul Whitehead BSc DABT FRSC FBTS is a Principal Consultant at wca environment and an American Board Certified Toxicologist with many years experience in the Chemical, Pharmaceutical and Toiletry industries. He has been responsible for the hazard/risk assessments and risk management of a wide range of chemical substances on a global basis. This has included notification of new chemicals in the major regulatory regions, and face to face discussions with regulators. Paul has been involved for several years in the implementation of the EU REACH Regulation, including the preparation of briefing documents and advocacy within Cefic working groups. He has chaired a number of UK and EU industry health and safety associations, developing harmonised policies for the safe handling and use of chemicals. For a number of years Paul was employed in the industrial lubricants industry, taking responsibility for the raw material and product risk management policy development and implementation. Paul is a Fellow of the UK Royal Society of Chemistry and is Chairman of its Environment, Health and Safety Committee. He is also a Fellow of the British Toxicology Society.
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LUBE MAGAZINE No.99 OCTOBER 2010
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