There is no time to lose to begin work in earnest on preparing for joint submission of dossiers for high volume chemicals that need to be registered under the REACH Regulation by 30 November 2010, industry leaders have been warning at international conferences since the beginning of the year.
Now, the European Chemical Industry Council (CEFIC) has published a timeline spelling out the many tasks that need to be achieved in order to force companies to focus on key priorities.
A key warning to companies is that in practice, they should aim to submit lead registration dossiers by June 2010 - six months before the deadline - to be on the safe side. This is so that it can undergo a technical completeness check and secure registration - after the registration fee has been paid - in time so that all other members of the substance information exchange forum (SIEF) that are sharing data in that dossier can refer to it. They too are likely to want the security of having approved registrations by the deadline, rather than taking the risk of waiting to see if their dossiers are approved afterwards.
Mike Rasenberg, regulatory affairs consultant at chemicals multinational Du Pont, urged companies at the Chem Con Asia conference in Kuala Lumpur not to get unecessarily distracted by the current communication challenges and politics of working with others in SIEFs.
He listed the key priorities for firms right now as being:
- securing a lead registrant for dossiers quickly
- establishing whether anyone has 28-day and reprotox screening study data for the substance to be registered. (These studies are necessary for high volume chemicals and if SIEFs do not have them, they will need to start work on them within weeks)
- tracking ECHA's REACH-IT system to understand by when dossiers need to be submitted
Earlier this year, at the Fourth International Conference on REACH in Houston, organised by Smithers Rapra, a number of industry experts stated that lead dossiers for substances that have to be registered by 30 November 2010, will need to be submitted to ECHA in June 2010. Mike Penman, of Penman Consulting, said this was necessary in order to allow the complex task of registration to be completed in time.
CEFIC said its SIEF timeline chart shows what needs to be achieved to ensure industry can fulfil its obligations by the first registration deadline of 30 November 2010. The chart indicates that lead registration dossiers should be submitted and the registration fee paid for between May and June next year.
Our message is that the clock is ticking and industry can not afford to waste time, said the association’s REACH/chemicals policy director Erwin Annys. He added that the proposed deadlines are very tight, but are based on industry experience. SIEFs and consortia are free to adapt the tasks and deadlines as appropriate.
The timeline also indicates that already: SIEF formation facilitators should have been identified; codes reflecting the role companies will play within SIEFs should have been communicated; and agreement on the sameness of a substance represented by the SIEF should have been achieved. For many SIEFs this will not have happened--it is understood that only 10% of pre-SIEFs had a potential formation facilitator lined up via the pre-registration process.
SIEFs should have also begun to discuss an agreement on how they will operate, including cost-sharing and the appointment of a lead registrant.
Other important tasks coming up include the identification of data gaps, including the availability of 28-day sub-acute toxicity and reprotoxicity screening tests, which CEFIC advised should be confirmed before 1 May 2009. Tests laid out in Annexes VII and VIII of REACH need to be initiated—some tests may take up to a year to complete the association said.
SIEFs jointly preparing chemical safety reports should make a start this summer, and have completed them, including any new data from test results, by spring 2010. CEFIC is also advocating that individual SIEF members start submitting their registration dossiers as soon as the lead dossier has been accepted by ECHA.
The Agency has not published a date when lead registration dossiers have to be submitted. Under the regulation, the agency has to undertake a completeness check within three weeks of submission, or within three months if the dossier is submitted within two months of the deadline. According to sources, industry’s calculation of a submission date around June 2010 is reasonable, if cautious.