07 Jun 2013

Improving transparency in data evaluation for product safety regulatory dossiers

We have been participating in a project aiming at establishing a new methodology to evaluate ecotoxicological studies that are more precise and reliable than the existing one.

We have been participating in a project aiming at establishing a new methodology to evaluate ecotoxicological studies that are more precise and reliable than the existing one. In so doing, we help to provide you with sound ecotoxicological data and assessments, making your product portfolio more secure, sustainable, valuable and in tune with changing environments.

The objective of ecotoxicological risk assessments is to determine the potential risk of chemicals for the environment. Dependable and relevant ecotoxicological data are necessary to derive standard values for critical concentrations in the environment. These values comprise the Environmental Quality Standards (EQS) or Predicted No-Effect Concentration (PNEC).

So far, regulations were requiring the use of a scoring system from 1 to 4 for the reliability and relevancy of studies (Klimisch et al., 1997). This was also known as the Klimisch score, or simply ‘Klimisch’. With our experience in regulatory affairs and our knowledge in ecotoxicology, we realised that this scoring method was not enough for proper and sound risk assessment of chemicals. A comparison of regulatory frameworks even showed that for the same dataset, the level of protection of aquatic ecosystems could be very different.

We got involved in a research project led by the ecotox centre of the Swiss Competent Authorities – EAWAG. This project focused on the assessment of eight studies evaluated for reliability and relevancy by 81 ecotoxicologists of various experience and professional backgrounds. At the end of the project, a new scheme was issued. This would help to evaluate studies with more transparency, good reproducibility and less heterogeneity among ‘expert judgement’.

Data evaluation is critical for proper risk assessment and is mandatory in more and more regulatory frameworks of environmental or chemical regulations. Sound knowledge of ecotoxicology and environmental fate and behaviour are required to:

  • produce sound data assessment
  • make good use of the data in a regulatory dossier
  • remove unreliable data
  • share the most valuable data

Data evaluation can also be part of due diligence and provides scientific criteria for the use of those data in regulatory dossiers.