Data gaps found in majority of chemical registrations

27th February 2017

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Cheryl Robb

Important information was missing from more than 90% of applications to register the most harmful chemicals under the EU's REACH regulation, according to the regulator.

The European Chemicals Agency (ECHA), which monitors compliance with the regulation, scrutinised the information dossiers accompanying 184 registration applications, focusing on substances with the greatest potential to negatively affect people and the environment, and produced in volumes of more than 100 tonnes a year.

It found that important information was missing in 168 cases. The agency has asked registrants to provide more data on their substances, mostly on the issues of pre-natal developmental toxicity, alteration of DNA, and reproduction and long-term aquatic toxicity.

The Helsinki-based organisation is pushing registrants to update the information to avoid enforcement action.

ECHA’s executive director Geert Dancet said: ‘Our evaluation report shows that crucial data is still missing for most substances subject to compliance check. I encourage companies to take stock of our recommendations and update their dossiers especially when their substance is shortlisted for regulatory action. Authorities need the data to conclude whether further risk management is required on these substances.’

ECHA’s report contained several recommendations to registrants, including:

  • regularly review registration dossiers and update them with any new and/or relevant information;
  • ensure that assessments of exposure and risk cover all hazards; and
  • if your firm is eligible under the next round of REACH registration in 2018, allow sufficient time to understand the requirements and determine if data needs to be generated.

ECHA’s report highlighted that a ‘large majority’ of registrants provide missing information when asked to do so. Out of 355 cases regarding poor information it had followed up on in 2016, 33 were outstanding, it said. ECHA has reported such cases to regulatory authorities in member states so that they can consider national enforcement action.

The latest report from the agency backs up findings from previous studies. Its second annual progress report published last summer found that a significant proportion of registration dossiers were lacking key information.

Michael Warhurst, executive direct of campaign group CHEM Trust, said that ECHA had started monitoring more information in response to criticism of poor data. However, its enforcement was weak as it gave companies the opportunity to improve data before taking any action, he said.

‘ECHA has removed the incentive for companies to provide quality information. They need to be a bit tougher,’ he said.

ECHA should not allow chemicals that do not have sufficient information onto the market, he said.


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