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Sustainability // REACH

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Echa urges 'transparency' on lead registrant role

Chemical Watch reports that Echa has announced plans to publish a list of substances for which there is an appointed lead registrant (LR).

The agency is responding to calls for clarity on the issue, and hopes that as many names as possible will appear on the list.

"Echa is encouraging all lead registrants to accept the publication of their name on the list, which will be available in September on our website," Javier Sánchez, from the agency's dossier submission unit, said at Cefic's REACH information and experience exchange forum (RIEF V) on 1 July.

"We want to be more transparent and show what is happening for these substances, which helps everyone to monitor the registration process."

"In the past we had a 'lead registrant notification scheme' which worked in a different way: potential lead registrants communicated to us their nomination and we included them in a list. However, we did not receive many notifications," Mr Sánchez told Chemical Watch.

"We have changed the approach now: we will take the information on the lead registrant directly from REACH-IT and publish it on the website if the company agrees to it. We believe this is more effective and efficient for everybody."

Low registration numbers

At the conference, Jan Tuinstra, senior regulatory consultant at Knoell Netherlands, said "only 100 additional lead registrants are known on top of the ones that have already submitted lead registration dossiers."

According to Echa figures on registration dossiers for the 2018 deadline compiled at the end of May, there have been 5,773 registrations for 3,075 unique substances. Some 1,522 companies have submitted registrations – a figure "far from the 20,000 expected", said Mr Tuinstra.

"It is a very tiresome process to find out who is the lead registrant for a substance and getting feedback from other members during pre-Sief."

Call for communication

Earlier this year, Echa urged companies intending to register substances under the 2018 deadline to contact their fellow registrants and organise their Siefs as soon as possible.

Mercedes Viñas, from Echa's computational assessment and dissemination unit, said the agency shares the concern that there are many substances for which there is no movement on registration yet.

"Echa has taken all actions it can to raise awareness and we hope you, as an industry, echo those actions," she told the audience. "If we get closer to the deadline and still it is the case, then maybe we were over-optimistic

EU-ToxRisk project underway

Chemical Watch reports that the EU-ToxRisk, a €30m project to develop an animal-free, mechanism-based approach to risk assessment, has started work on a number of case studies, following a kick-off meeting on 13-15 January in Egmond aan Zee, the Netherlands.

The project's ultimate goal is to develop a new way to do risk assessment, Marcel Leist from the University of Konstanz in Germany, a member of EU-ToxRisk's executive office, told Chemical Watch.

Speaking at the meeting, Bennard van Ravenzwaay from German chemical company BASF, one of 39 EU-ToxRisk partners, explained that the aim is to meet regulatory risk assessment needs, rather than focus on pure method development.

The six-year project will focus on repeat-dose systemic toxicity testing in the liver, kidneys, lungs and nervous system, as well as developmental and reproductive toxicity.

Read-across is a central feature. “We really want to focus our resources so that, after three years, we have a new way of doing read-across in Europe, especially for evaluating REACH compounds,” professor Leist told Chemical Watch.

The aim is to build a more “quantitatively structured” system, including a web application, he added. This read-across work will use existing data as well as providing new information, including from high-throughput transcriptomics.

EU-ToxRisk will also build in biological read-across, adding biological descriptors such as gene expression profiles to toxicological and chemical descriptors. “This means that compounds that do not share structural similarity may be used for read-across using biological data,” explained professor Leist.

He described how adverse outcome pathways (AOPs) form the project's backbone.

“We will look at how we can use AOPs practically in risk assessment,” he said. For example, teams will test AOPs using data-rich compounds and optimise or alter them accordingly. Case studies could also look at how they aid risk assessment.

Professor Leist also spoke of developing quantitative AOPs (qAOPs) to predict hazard thresholds from in vitro test system data.

EU-ToxRisk already has about 17 case studies lined up and its partners will soon begin work to test the predictivity of a battery of assays, using data-rich pharmaceutical compounds. Over the course of the project, case studies will progress to less characterised chemicals, including industrial compounds.

A systems evaluation task force, within EU-ToxRisk, will scrutinise any proposed model systems, using a set of criteria. Such criteria are already used widely in industry but less so in academic labs, said professor Leist. “Only models that fit the criteria will be used.” 

The project also has links to the US National Toxicology Programme and EPA. 

“There appear to be multiple points of intersection between the EU-ToxRisk project and the research being undertaken by the US EPA in the National Center for Computational Toxicology,” said Rusty Thomas, director of the EPA's National Center for Computational Toxicology. “I look forward to working with and advising the EU-ToxRisk project. It is poised to have a significant impact on the way we evaluate chemicals for human safety.”

“EU-ToxRisk has really hit the ground running. This was very clear from how focused and productive the kick-off meeting was," said Maurice Whelan, head of the European Union Reference Laboratory for alternatives to animal testing (EURL-Ecvam). 

“I am particularly excited that EU-ToxRisk has fully embraced Adverse Outcome Pathways as a means to manage mechanistic toxicological knowledge and to provide the theoretical basis to design Integrated Approaches to Testing and Assessment (IATA), including a strong emphasis on new ways of incorporating mechanistic toxicity data into grouping and read-across,” he added.

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