20 April 2010 17:41 [Source: ICIS news]
By Nigel Davis
LONDON (ICIS news)--Downstream users of chemicals were given the opportunity last week to check to see whether the substances they need are going to be registered in time under Reach, the EU’s chemicals registration and authorisation regulation.
But they were also given a stark warning by the European Chemicals Agency (ECHA): “If a substance should be registered in 2010 and it is not, it will be illegal to manufacture or sell it within the EU after 30 November 2010.”
Downstream users, chemicals makers and importers need to check the list to make sure it is up to date with their own planned registrations, the agency added.
The trouble with the Reach process is that, with the onus on producers and sellers of chemicals to register substances and provide health and safety information on them, the agency charged with running the basics of the regulation is at times kept in the dark.
The ECHA now only knows for certain that just over 4,400 substances will be registered by 30 November. There have been suggestion that some 9,000 substances will be registered in this phase of Reach: it requires the registration of chemicals manufactured or imported into the EU in quantities over 1,000 tonnes a year and those that are, according to the regulation, the most hazardous to the environment (100 tonnes) and to humans (above 1 tonne).
“Based on our own information and also information provided to us by the industry, the ECHA expects over 4,600 substances to be registered by the end of November 2010. This might mean between 28,000-35,000 registration dossiers,” an ECHA spokesman said on Tuesday.
The agency has been concerned for months that producers and importers were not really up to speed with their registrations. It has, however, pulled out quite a few stops in recent weeks to try to help speed up the registration process.
The number of substance information exchange forums (SIEFs) that have been established to help streamline the registration process for particular chemicals has only crept up slowly so far, as the ECHA knows. It notes the existence of 2,448 SIEFs on its website.
It is urging lead registrants - the companies or organisations within the SIEFs that will make the first, lead registration of the substance concerned - including all the relevant health and safety and substance information garnered from the SIEF members - to make their registration submission on time.
It is easy to think that 30 November is a long way off, but the agency has said before that it can only guarantee to process registrations in time to meet the registration deadline if they are submitted by the end of June. Any later and it looks as though the deadline date will be missed and the companies concerned will be barred from selling the product in the EU.
Reach applies to all legal entities involved in chemicals trade within the EU. Once the lead registrant has successfully registered a substance, other members of the SIEF can follow with their own, cut-down registration dossiers.
To help focus and streamline SIEF operation the agency and the main industries affected by Reach in January this year established a Director’s Contact Group (DCG) to help pick up areas of concern and see what is important to the main participants in the registration process. At the time, the ECHA and the industries affected were, in the ECHA’s words, concerned to “secure the supply of high volume substances to downstream users”.
This is worrying and shows that bottlenecks could lead to very real problems for chemical industry customers. It is not simply a question of suppliers adhering to the law but of their customers being able to source product to keep their own businesses going.
The DCG is recommending that lead registrants set a cut-off date for their own SIEF members of two months before they intend to make the lead registration of the SIEF substance. By that time safety data should have been made available and shared within the group and any joint chemical safety report - that forms part of the Reach lead registration - should have been completed.
The recommendation is yet further evidence of the fact that time is running out for those intending to participate in the Reach high-volume chemicals registration process.
The agency stressed in late 2009 that it could not guarantee to respond to registrations if substance dossiers were not submitted before the end of June 2010. After that date it reckoned it could be hard pressed to respond quickly to verify and accept registrations.
That means that SIEFs and lead registrants have to be working hard now to finalise registration data and details. Unfortunately there is little tangible evidence that that is the case.
This is a particularly testing time for Reach. The clock is ticking on registrations. Companies of all sizes are burdened with a huge amount of registration work but it is far from clear whether they really are mindful of what might happen if deadlines are missed. The advisory document from ECHA on reach registration alone runs to 3,000 pages
The ECHA meets its 'stakeholders' at a conference in
To discuss Reach issues visit the ICIS Reach forum on ICIS connect
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