Echa Under-performance Puts Reach Deadline At Risk

March 15, 2010 - PRLog -- The under-performance of the European Chemicals Agency (ECHA) and its failure to resolve a number of key issues are placing the first REACH deadline - 1 December 2010 - at risk according to the Chemical Business Association (CBA).  

Melvyn Whyte, Chairman of CBA's REACH Task Force said, "We are increasingly concerned that ECHA's under-performance may jeopardise REACH implementation. We are now just nine months away from the first REACH deadline and major issues such as the acceptability of alternatives to animal testing, late and changing ECHA guidance, rights to use of publicly available data, the classification of intermediates, and the lack of clarity relating to exposure scenarios - are all conspiring to create costly uncertainty for industry.  ECHA is failing to deliver on behalf of industry and consumers."

Animal Testing

The consensus on the need to minimise animal testing created by the REACH legislation is now being undermined by ECHA's failure to date to accept the validity of 'non-animal testing' such as Quantitative Structural Activity Relationships (QSARs).  
"ECHA must be far more positive about the acceptability of QSARs and in the promotion of data-waiving principles and ensure this is communicated effectively," said Melvyn Whyte.  "The UK Health & Safety Executive (HSE) has produced excellent guidance on minimising animal testing which has been broadly accepted by industry and animal welfare groups. To avoid further delay and uncertainty, ECHA should adopt this guidance from the UK's Competent Authority as a matter of urgency," he added.

ECHA Guidance

Both ECHA and the European Commission have produced guidance to assist registrants with REACH.  Industry is concerned by the frequency with which these guidance documents are being changed - a process often involving significant amendments.  For example, the interpretation of what constitutes an 'Only Representative' was changed no fewer than three times during 2008, with two of these changes taking place during the pre-registration period.  

ECHA currently has at least one dozen guidance documents still under development.  The scope of chemical safety assessments required for the December 2010 deadline have still not been finalised and discussions on interpretation are still on-going. This situation is placing registrants in real difficulty.  "It may seem obvious that industry requires a stable and authoritative guidance system, but this   fact appears not to be recognised by ECHA.  CBA believes that there should be a moratorium on any changes to such guidance for a period of one year prior to any major regulatory deadline," said Melvyn Whyte.


Substance Information Exchange Forum (SIEF)

Many issues concerning data-sharing within SIEFs remain unresolved with the position of smaller companies (SMEs) being particularly vulnerable.  There is evidence that lead registrants are using SIEFs to serve their own financial interests by attempting to recover already amortised testing costs from other SIEF members.  Further issues on the transparency of communication and equitable cost-sharing are fuelling the fears of SMEs.
"CBA believes that the simplest way to tackle this situation is for all parties to a SIEF to accept that the original costs of any test data more than five years old should not be recoverable from other SIEF members.  New data or data less than five years old would be cost-recoverable in a fair and proportionate manner.  We believe this should be a key outcome of the tri-partite discussions currently being undertaken on SIEF issues," said Melvyn Whyte.  "In addition, CBA believes that ECHA and the European Commission should complete a review of the acceptability of test data already in the public domain.  This will allow data to be shared at minimal cost and without formal proof of ownership being necessary - and would be another step towards minimising animal testing," he added.

Intermediates

With only nine months to the first REACH deadline, discussions have been re-opened on the definition of an intermediate. Since the CARACAL meeting in February 2010, ECHA has reversed its previous guidance and is now applying a fundamentally different definition to that which industry has been using for the last two years.  

"Intermediates are a central part of the chemical supply chain as they can be reacted to produce chemicals which can be other intermediates or substances in their own right.  Distributors often supply bulk and packaged intermediates to small manufacturers which in turn produce the key chemical components used by other companies.  Changing the status of intermediates - particularly at this late stage - could have a major impact on the industry from manufacturing and distribution through to downstream users," said Melvyn Whyte.

Exposure Scenarios

Exposure scenarios are a major part of REACH registration as they allow risk reduction and management measures to be communicated to chemical users.  A combination of late guidance, access to data, and a lack of clarity is causing confusion and may result in REACH registrants failing to produce appropriate scenarios.  
"ECHA must complete its work in developing an exposure scenario tool and publish it without delay to allow an orderly submission of REACH dossiers and CLP-compliant data sheets.  CBA believes that exposure scenarios should be simple and generic.  This will bring clarity to the process of helping downstream users comply with their obligations and ensure these requirements are within the technical resources of most SMEs," said Melvyn Whyte.

Conclusion

"The chemical industry is devoting major resources to REACH compliance against a background of the worst recession in living memory.  It has every right to expect a higher standard of performance and more effective communication from ECHA.   If REACH implementation is to be completed satisfactorily and on schedule, ECHA must urgently resolve these outstanding issues," said Melvyn Whyte.

NOTE - CBA raised the issues outlined in this News Release by letter to ECHA's Executive Director, Geert Dancet, on 9 March 2010.

Further Information from: Peter Newport, CBA Director, 01270 258200