A new study, commissioned by CIEL, ECOS, and the Oeko-Institute shows that most of the information made available by the Sponsorship Testing Programme of the Organisation for Economic Co-operation and Development (OECD) is of little to no value for the regulatory risk assessment of nanomaterials.
The study was published was published by the Institute of Occupational Medicine (IOM) based in Singapore. IOM screened the 11,500 pages of raw data of the OECD dossiers on 11 nanomaterials, and analysed all characterisation and toxicity data on three specific nanomaterials – fullerenes, single-walled carbon nanotubes, and zinc oxide.
“EU policy makers and industry are using the existence of the data to dispel concerns about the potential health and environmental risks of manufactured nanomaterials,” said David Azoulay, Senior Attorney for CIEL. “When you analyse the data, it is impossible to assess what material was actually tested in most cases. The fact that data exists about a nanomaterial does not mean that the information is reliable to assess the hazards or risks of the material.”
The dossiers were published in 2015 by the OECD’s Working Party on Manufactured Nanomaterials (WPMN), which has yet to draw conclusions on the data quality. Despite this missing analysis, some stakeholders participating in EU policy-making – notably the European Chemicals Agency (ECHA) and the European Commission’s Joint Research Centre – have presented the dossiers as containing information on nano-specific human health and environmental impacts. Industry federations and individual companies have taken this a step further emphasizing that there is enough information available to discard most concerns about potential health or environmental risks of manufactured nanomaterials.
“Our study shows these claims that there is sufficient data available on nanomaterials are not only false, but dangerously so,” said Doreen Fedrigo, Senior Policy Officer of ECOS. ”The lack of nano-specific information in the dossiers means that the results of the tests cannot be used as evidence of no ‘nano-effect’ of the tested material. This information is crucial for regulators and producers who need to know the hazard profile of these materials. Analysing the dossiers has shown that legislation detailing nano-specific information requirements is crucial for the regulatory risk assessment of nanomaterials.”
The report provides important recommendations on future steps in the governance of nanomaterials. “Based on our analysis, serious gaps in current dossiers must be filled in with characterisation information, preparation protocols, and exposure data,” said Andreas Hermann of the Oeko-Institute. “Using these dossiers as they are and ignoring these recommendations would mean making decisions on the safety of nanomaterials based on faulty and incomplete data. Our health and environment requires more from producers and regulators.”