Scrutiny criteria for ECHA Reach dossiers inadequate: academic

18 June 2013 17:45  [Source: ICIS news]

HELSINKI (ICIS)--The European Chemicals Agency's (ECHA) current approach to screening the thousands of registration dossiers submitted for the Registration, Evaluation and Authorisation of Chemicals (Reach) is insufficient to adequately assess the quality of the information submitted, an academic specialising in toxicology said on Tuesday.

According to Christina Ruden, a professor of regulatory toxicology and ecotoxicology at Stockholm University, the ECHA’s pledge to analyse 5% of submissions, aided by computer tools that will screen all dossiers and flag problematic data for further investigation, is not comprehensive enough.

Speaking at a press conference at the Helsinki Chemicals Forum, Finland, Ruden said: “What [the screening] enables the ECHA to do is to screen all the dossiers, but only for a very simple question. It’s good but it’s definitely not sufficient. The devil is in the detail in these cases.

“We made a scrutiny of the dossier of bisphenol A [BPA]. In the chemical safety report, they dismissed around 150 scientific reports on low-dose effects of endocrine disruption in one sentence. To find [instances like that] and to understand what [they] mean [requires] the dossiers to be checked in much [more] detail than just an automated computer screening," she added

Ruden added that the true significance of shifting testing and safety evaluation responsibilities to the industry may not yet be widely appreciated.

She said: “It is a total paradigm shift to put the whole responsibility for testing and safety of chemicals on the entity that actually has the economic advantage of selling [the chemicals]. I’m not sure that everyone is aware of the revolution this implies.

“We have just done random checks and found that the industry has been submitting studies that are over 100 years old,” she added.

Erwin Annys, director of Reach and chemicals safety policy at trade body the European Chemical Industry Council (Cefic), disagreed that the level of in-depth analysis of Reach dossiers was insufficient, stating that he advised Cefic member companies against skimping on data quality, as a result of the strength of ECHA’s IT screening tools.

Due to the logistical issues involved in the comprehensive evaluation of thousands of dossiers, each containing hundreds of pages of data, the ECHA introduced IT tools as a means of filtering submissions.  

Annys said: “I tell [Cefic] members that I would not count on the fact that only 5% is really scrutinised in depth. I start from the principle that if I look at the IT tools that they are using to find potential problem dossiers, that they are indeed screening 100% of the database, and that they are filtering out the ones that are the most suspect.  

“I think they have a rather intelligent way of finding... those 5% [of dossier submissions] that are probably the most problematic, and then they are going into much greater detail,” he added.


By: Tom Brown
+44 208 652 3214



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