01 June 2010 16:40 [Source: ICIS news]
By Anna Jagger
The agency is becoming increasingly concerned that many substance information exchange forums (SIEFs), which bring together companies that have to register the same substances, are still not operating smoothly and could struggle to submit their joint registrations in time.
As a result, ECHA is introducing some additional flexibility into the Reach rules under which companies have to register high tonnage substances by 30 November 2010. Geert Dancet, ECHA’s executive director, insisted the deadlines are fixed, but said ECHA planned to give companies extra time to add information to incomplete dossiers. From 1 October 2010, the length of time companies have to add missing information and resubmit their dossiers will increase from four to six months.
But this is not a reason to delay submission, he stressed, because on 1 October the period ECHA has to accept or reject a dossier increases from three weeks to three months.
“We advise the resubmission takes place before the end of September, because from 1 October the technical completeness check (TCC) deadline for us moves from three weeks to three months,” he told ICIS on the sidelines of ECHA’s fourth stakeholder day [on 19 May] in Helsinki.
Alison Cohen, a Fulbright scholar funded by the
One reason for the problem, she suggested, was that industry competitors who are not accustomed to collaborating, have found it difficult to work together to create and share information. She also blamed the chaotic transition many companies undergo when they move from pre-registration to registration.
Small- and medium-sized enterprises (SMEs) are particularly disadvantaged by language barriers and the high cost of accessing data, Cohen told delegates. In addition, not all SIEFs have lead registrants, “in part because lead registrant responsibilities and incentives are unclear”.
According to a survey conducted by industry-backed consultancy ReachReady, one third of the SIEFS working towards the November 2010 deadline have still not appointed a lead registrant. Under Reach rules, the lead registrant for each SIEF must attain the first registration of a particular substance. Significantly, some 30% of respondents have little confidence they will meet all their Reach deadlines in time, even where a lead has been appointed.
Cohen said that, in her research involving interviews with over 60 ‘key informants’, the candidate list for substances of very high concern (SVHC) was the topic that elicited the greatest divergence in opinion. The debate centres on the size and pace of expansion of the candidate list, she said.
“Civil society and some government respondents say that there are too few chemicals on the candidate list and that the pace of expansion is too slow, whereas industry and other government respondents found the pace and size of the candidate list to be satisfactory, especially given government capacity,” she said.
The full potential of the candidate list remains to be seen. “All sectors agree that the authorisation landscape will change when information from the registration dossiers begins to be used to inform the development of dossiers of SVHCs,” added Cohen
ECHA used the stakeholder day to provide feedback from registration and dossier evaluation and to showcase some of the IT tools it has developed.
Wim de Coen, from the ECHA’s evaluation unit, urged companies to make the most of any feedback from the dossier evaluation in cases where additional information was requested.
“Use the opportunities given during decision-making to bring dossiers into compliance,” he told delegates. “We have seen companies discussing a decision rather than providing the new information as requested... It’s an opportunity to provide information, not to battle with ECHA.”
Animal testing should be used as a last resort, he stressed. “To avoid animal testing, build scientifically sound evaluations.”
Helene Magaud, from ECHA’s scientific IT tools unit, demonstrated the first version of ECHA’s chemical safety assessment and reporting (Chesar) IT tool. The tool is designed to help companies automate their chemical safety assessments (CSAs) and, in later versions, will be able to support the preparation of their chemical safety reports (CSRs). CSAs and CSRs are required for the registration dossiers of certain substances under Reach.
Chesar can also be used to generate information on uses and conditions of use for registrants, she said.
Throughout the stakeholder day, companies were urged to speed up the preparation of their registration dossiers. ECHA says it is preparing to receive registration dossiers for some 5,000 high-tonnage substances by the first deadline of 31 November 2010.
“The key message is: don’t wait until the last minute,” said Christel Musset, ECHA’s director of registration.
Listen to an interview with Alison Cohen here
Debate Reach issues on ICIS connect
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